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Providing expert insight on orthopaedic technology, development, and manufacturing

O
r
t
h
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e
c
.
c
o
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COMPRESSED
FOR TIME
Molding Joint
Replacement
Parts
page 20
USE PROTECTION
Patent Reform
Strategies for
Your IP Portfolio
page 24
SEPTEMBER/OCTOBER 2011
VOL. 2 NO. 4
SURFACE MANUFACTURING
Implant Tech
Trends
page 8
A SUPPLEMENT TO
and
ORT1109 001 1 9/27/11 3:39:44 PM
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ORT1109 002 2 9/27/11 3:39:57 PM
Contents
ORTHOTEC | SEPTEMBER/OCTOBER 2011 3 orthotec.com
September/October 2011 • Volume 2 • Issue 4
Features Columns
Departments
20 16
On the Cover
Surface
Manufacturing
Plasma spray coatings and additive manufacturing technology
offer orthopaedic device manufacturers big benefts.
BY LEO GLASS AND PIERFRANCESCO ROBOTTI
16 Materials Characterization
3-D Optical Microscopy Solves Material
Selection Challenges
This method of precision surface metrology provides improved
characterization of implant materials.
BY ROGER POSUSTA AND MATT NOVAK, PHD
20 Compression Molding
Joint Replacements Fit The Mold
Compression molding offers cost benefts over other methods of
molding joint replacement parts.
BY ROBERT BOLAND
24 Intellectual Property
How to Weather the Patent Reform Storm
Orthopaedic device companies are entering a brave new world of IP
and patent reform.
BY DAVID J. DYKEMAN AND DANIELLE T. ABRAMSON, PHD
30 Testing
Testing Protocols Keep Customers Happy
Find out how to create effcient test protocols throughout the product
life cycle.
BY DANIEL SANTOS
The backside of a femoral condylus has been
coated with hydroxyapatite. Image courtesy of
Eurocoating s.p.a. (Ciré-Pergine, Italy).
42 Ortho Scope
Wright Medical restructures
following the departure of several
executives.
6 From the Editor
14 Blog Teasers
34 Products & Services
39 Supplier Beat
41 Contributors
41 Advertisers Index
IMPLANT MANUFACTURING
Cover Story
14
8
ORT1109 003 3 9/27/11 3:42:15 PM
www.orthotec.com
Online Contents
4 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
ACCOUNT MANAGERS
Matthias Gasser
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EXECUTIVE OFFICERS
CHIEF EXECUTIVE OFFICER
Paul Miller
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Fred Gysi
CHIEF INFORMATION OFFICER
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VICE PRESIDENT AND EXECUTIVE DIRECTOR
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CULTURE
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ORT/OrthoTec (ISSN 2153-9782, print; ISSN 2153-9790, online) is published quarterly by UBM Canon, 11444
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reserved. Reproduction in whole or part without written permission is prohibited.
Monkeys Walk with Spinal
Implant; Humans Next
The once-paralyzed CEO of InVivo
Therapeutics designed his own
physical therapy program and
regained the ability to walk. Not all
patients with spinal cord injuries
(SCIs) are so lucky. Frank Reynolds
wants to save as many of them as
possible from life in a wheelchair
with an implant that protects the spinal cord from
infammation, further bleeding, and cell death
following SCI.
Check out the top OrthoTec’s news story of the summer at
orthotec.com/article/invivo-implant
Get the
OrthoTec
Weekly
Subscribe to OrthoTec’s
weekly e-newsletter for the
latest news and technology
trends in orthopaedics.
Also featured are business
developments and
Q&A’s with experts who
provide industry insider
perspectives.
New Implants,
Components,
and More
Recently given FDA
510(k) clearance, DePuy’s
Trumatch Personalized
Solutions system (right)
uses technology that customizes the ft of a knee
replacement. CT scans and software create femoral and
tibial cutting blocks that match the bone surfaces of a
specifc patient. These scans are quicker, cheaper, and
provide better imaging than MRIs. Get more product
and company updates at
orthotec.com/news
Follow Us on Twitter
For instant updates from OrthoTec,
follow @orthoteconline on Twitter.
EDITORIAL STAFF
DIRECTOR OF CONTENT,
MEDICAL DEVICE BRANDS
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EDITOR-IN-CHIEF
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EDITOR, ORT
Maria Fontanazza
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INTERNATIONAL
INTERNATIONAL SALES DIRECTOR
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ORT1109 004 4 9/30/11 1:51:57 PM
7
U
X
H
Copyright © 2011 Tegra Medical. All rights reserved.
At Tegra Medical precision is our passion, which is why leading orthopaedic companies turn to us for help
with medical devices that enable successful outcomes. Looking for quick response times? With 200,000 sq. ft.
of manufacturing space, we have the capacity to respond quickly. Need flawless manufacturing? We offer
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dedicated resources accelerate product development and improve design for manufacturing and assembly.
Engineered solutions. Precise products. True passion about the work we do. That’s Tegra Medical.
BOSTON MEMPHI S COSTA RI CA
Your customers require a passion for precision
www.tegramedical.com I 508.541.4200
ORT1109 005 5 9/27/11 3:44:05 PM
From the Editor
6 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
T
he business of manufacturing anything
isn’t easy. Within the orthopaedics
segment, I often wonder how a company
can not just survive but also thrive in this
hostile economic environment. Is it luck
or smart business practices and strategic
thinking? In most circumstances I’d say
that it’s a little bit of both. But times
are diffcult now; people who have lost
their jobs aren’t going to pay for elective
hip or knee surgeries. Implant manufac-
turers are being hit especially hard. In
2011 alone, Stryker, Biomet, Zimmer, and
Wright Medical have cut or announced
plans to cut jobs.
Manufacturers and suppliers must
think and operate strategically at all
times. We’re seeing a lot more partner-
ships and acquisitions that are generating
new business. First, let’s look at a young
company. OrthoSensor Inc. (Sunrise, FL)
was founded four years ago, and CEO
Jay Pierce is directing the company right
where he sees orthopaedics headed—into
an era of smart technology that integrates
electronics and sensors into implants. He
thinks his company’s technology will be
a disruptive force in orthopaedics, and
so far, this strategy is leading to success.
Following a partnership announced with
Stryker in August, Pierce told the South
Florida Business Journal that OrthoSen-
sor is planning to hire up to 40 people
during the next year. Most of these jobs
will be in sales because the company out-
sources its manufacturing, which leads
me to another part of the equation—the
supplier.
Seasoned supplier Oberg Industries
(Freeport, PA) has been around for more
than 60 years. Its U.S. medical device
business has recently exploded. During
the past three years, the company has
experienced a compound annual growth
rate of more than 20%, according to Da-
vid Bonvenuto, executive vice president
and general manager at Oberg. “Contrary
to the unemployment rates and the focus
on jobs [in] a stalling economy over the
last several years, we’ve seen the oppo-
site,” he says. Oberg wants to add more
than 50 positions to its U.S. workforce,
and the company recently held its frst job
fair to fnd candidates.
Oberg, too, is looking at where the in-
dustry is headed but is doing so from the
standpoint of what OEMs want. “[OEMs]
are looking to consolidate their supply
chains,” says Bonvenuto. “OEMs have
maintained supplier bases that are un-
manageable because they’re so large and
diverse. As we talk to OEMs about what
type of suppliers they want, they seek
to improve quality, delivery, and pricing
[while working] with fewer top tier–type
suppliers.” Operating in harmony with
what OEMs need has been the key to
Oberg’s recent growth. Looking ahead to
2012 and 2013, the company is planning
to continue its upward trajectory.
Sometimes it’s easier to get caught up in
the negative news, but right now, I think
we need to talk about the positive things
happening in our industry. That being
said, how are you turning challenges into
success stories? Let me know what’s going
on at your company.
—MARIA FONTANAZZA
maria.fontanazza@ubm.com
Focusing on the future and listening to what customers want will help manufacturers
keep a strategic eye on the prize.
What’s Your Success Story?
ORT1109 006 6 9/27/11 3:45:40 PM
CORPORATE PROFILE
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Pro-Dex, Inc
Pro-Dex, Inc. designs, develops, and manufactures custom electric, air
and battery-powered surgical devices for leading Medical Device OEMs.
Headquartered in California, with facilities in Oregon and Nevada, Pro-Dex is
focused on getting customers to market faster, at a lower total cost, with a safe
and reliable product.
Pro-Dex’ headquarters, based in Southern California, is an ISO 13485-certified
manufacturer of cutting-edge powered surgical devices to leading OEM’s. Prior to
its move in 2008, Pro-Dex took two years to design and architect a 30,000 sq. foot,
state-of-the-art, manufacturing facility with a focus on concurrent engineering,
prototyping, in-process inspection and lean manufacturing cells in order to deliver
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market. Pro-Dex also operates an ISO 2001 facility in Nevada that manufactures
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that produces multi-axis motion control products for leading research labs,
semiconductor, and medical diagnostics applications.
At the start of every project, Pro-Dex implements a process that incorporates
a proven, proprietary six-phase product development cycle consisting of the
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Process Development , Design Verification and Validation, Product Transfer and
Release, Post-Production Evaluation. This thorough approach guarantees that the
end product will be safe, reliable and delivered on time, every time.
Pro-Dex understands how important it is to keep up with the ever-changing
regulatory guidelines. Safe and effective products are paramount to our clients’
success. This is why Pro-Dex, Inc. has introduced its new 13485-certified contract
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Phone: (800) 562-6204
e-mail: info@pro-dex.com
Website: www.pro-dex.com
Marketing contact: Tricia Rodewald O
Sales Contact: Jim McKenney O
ORT1109 007 7 9/27/11 3:45:45 PM
8 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Plasma spray coatings and additive
manufacturing technologies offer signifcant
value to orthopaedic device manufacturers.
LEO GLASS AND PIERFRANCESCO ROBOTTI
T
he practical application of a
technology that differentiates a
product from its competition isn’t
always the most novel approach. In
today’s world, OEMs must consider us-
ing technologies to make products that
prove their relevance based on both in-
creased regulatory scrutiny and a cost-
beneft ratio. Plasma spray and additive
manufacturing technologies, which
are used to manufacture macroporous
surfaces for orthopaedic implants, can
accomplish this mission.
Part 1: Plasma Spray Coatings
The use of plasma spray coatings in
the manufacture of medical devices
began in the early 1980s with Bi-
omet’s introduction of the titanium
porous plasma spray coating. Another
breakthrough came later that decade
with the introduction of hydroxy-
apatite (HA) coatings for dental im-
plants. HA is a naturally occurring
mineral form of calcium apatite with
the formula Ca
10
(PO4)
6
(OH)
2
. The
material is synthetically derived into
a powder form and applied using an
air plasma system (see Figure 1). Un-
like many technologies in use during
the 1980s, plasma spray was a special
process technology that was not easily
verifable without destructive testing.
However, within the past fve years,
the technology has proven itself reli-
able, safe, and effective, with new
engineered process controls and auto-
mated equipment that is all validated
as a complete system.
When applied to a substrate, the
plasma spray process depends on
thermal conditions (the temperature
must be at the melting point) and
kinetic energy. The material melted
in the plasma is simultaneously ac-
celerated by high-velocity plasma-gas
stream. The molten or semimolten
droplets attach to the roughened
substrate and splats of particles. In-
ert gases (argon-nitrogen) fow over
a cylindrical copper anode and a
tungsten cathode. A dc arc is
maintained, which creates
gas plasma with a core tem-
perature that can reach up
to 30,000°C. Powder met-
al or ceramics are injected
into the plasma stream in-
ternally or externally and
are then melted
and accelerated
at the substrate.
The entire pro-
cess is carefully
automated and controlled to prevent
the application or transfer of exces-
sive energy—specifcally heat—to the
substrate.
The air plasma spray is used to
process an HA coating but is not typ-
ically used for processing titanium
metal powder. Controlled atmospher-
ic plasma spray (CAPS) or vacuum
plasma spray (VPS) is used to pro-
cess metallic powders that exhibit
oxygen-sensitive properties. In the
orthopaedics market, plasma-sprayed
titanium coatings are commonly
used to make titanium alloy hip im-
Macromanagement:
Surface Manufacturing
for Implants
Implant Technology
An acetabular
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ORT1109 008 8 9/27/11 3:58:19 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 9 orthotec.com
plants. Titanium coatings are being
applied to knee, shoulder, elbow,
and ankle implants, along with oth-
er products made from titanium and
cobalt-chromium-molybdenum alloys.
Titanium is extremely sensitive to
oxygen pick-up in high-temperature
environments. CAPS and VPS meth-
ods process titanium powder using
plasma spray technology but perform
the same process in a different manner
with different equipment. The CAPS
unit processes the coating and the
implant in a positive-pressure inert at-
mosphere, while the VPS unit processes
at a controlled low-vacuum pressure.
Both processes can successfully pro-
duce porous coatings that are benefcial
for bone up-growth and in-growth.
A porous coating is defned as one
that exhibits bone in-growth into the
coating. Bone will not grow into pores
that are less than 100 μm.
1,2
Today,
plasma-sprayed titanium coatings
exhibit the minimum pore size char-
acteristics needed to be defned as a
porous coating. The porosity profle
is not an ordered structure like po-
rous beads but instead is a completely
random structure that is rough and
porous. The thickness of the coating
determines the predictable amount of
pore size, volume, and overall poros-
ity that can be achieved.
Tight Process Control
What are the distinct advantages to
plasma-sprayed titanium porous coat-
ings, and how do we understand how
to best use the technology? The an-
swer is multifaceted and depends on
the device market.
Advances in process control have
enabled the application of thick coat-
ings (up to 1000 μm), which allows for
high porosity and interconnecting po-
rosity that is suitable for joint replace-
ment components. Ti-Growth is a VPS
coating that eliminates the pore-size
advantage of sintered beads. However,
the VPS coating process introduces
considerable heat. This process nor-
mally requires the use of metallic hard
masking to protect parts and can raise
the overall cost of production.
The CAPS coating process main-
tains a low-temperature coating
substrate interface that avoids metal-
lurgical bonding or elemental migra-
tion. It offers mechanical performance
benefits and allows for parts to be
moved in and out of the chamber. The
ease of manufacturing allows for great-
er overall output, which in turn gives
a service manufacturer more fexibility
on delivery times and overall cost.
Figure 2 shows the results that can
be obtained with tight process con-
trol over the application of a porous
titanium coating onto PEEK implants.
PEEK is used in fusion devices that are
designed to be inert, high strength, and
radiolucent. The spinal device market
will continue to use PEEK in a range
of applications, though the material
does have one limitation. Although
noted for its bioinert properties, PEEK
has little direct bone attachment. This
means that bone treats the polymer as
inert but does not want to attach to it
mechanically or chemically. The search
for a process that improves the uses of
this material has led OEMs to work with
a variety of surface-modifcation tech-
nologies. The basic concept is simple.
Apply a bioactive coating to a bioinert
material to enhance bone up-growth
or osseointegration. This application
fts into many of the uses for PEEK,
especially when applied to fusion-type
devices.
Process Capability of CP-Ti on Peek Tensile (PSI)
LSL
3500 4000 4500 5000 5500 6000 6500
LSL 3190
Target *
USL *
Sample Mean 5290.68
Sample N 34
StdDev(Within) 370.218
StdDev(Overall) 388.65
Process Data
PPM < LSL 0.03
PPM > USL *
PPM Total 0.03
Exp. Overall Capability
PPM < LSL 0.01
PPM > USL *
PPM Total 0.01
Exp. Within Performance
PPM < LSL 0.00
PPM > USL *
PPM Total 0.00
Observed Performance
Cp *
CPL 1.89
CPU *
Cpk 1.89
Potential
(Within) Capability
Pp *
PPL 1.80
PPU *
Ppk 1.80
Cpm *
Overall Capability
Within
Overall
Figure 2. This chart shows the resulting data from the tight process control of a porous
titanium coating onto PEEK implants.
- + +
Plasma Spray Process
Powder
Arc
Substrate
Anode
Cathode
Molten Particle Splat
Powder Spray Film
Water Ar, H
2
Water
Plasma Jet
Figure 1. The plasma spray process must be controlled to avoid excessive heat transfer to a
surface.
ORT1109 009 9 9/27/11 3:58:35 PM
10 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Implant Technology
However, manuf act ures f ace
challenges when applying thermal-
ly sprayed materials to PEEK. The
physical and thermal properties of
polymeric materials are very differ-
ent from those of metallic or ceramic
materials. The chemical structure of
PEEK exhibits outstanding chemical
and radiation resistance. It can also
withstand structural degradation at
high temperatures. Nevertheless, the
material must be kept at a temperature
that does not exceed the glass transi-
tion temperature of 143°C. To address
the challenges related to these char-
acteristics, the titanium coating can
be applied using specially developed
air or vacuum plasma spray processes
that provide low-temperature stabil-
ity during processing. CAPS has also
shown superior capability in enabling a
porous titanium coating on PEEK with-
out chemical or mechanical deteriora-
tion during the plasma-spray process.
The plasma spray process has
evolved from a misunderstood tech-
nology method to a mainstream
technology for manufacturing po-
rous coatings. These coatings can be
applied to almost any material and
geometry. Thus, the plasma spray pro-
cess is used extensively in the device
market. In addition, rapid or addi-
tive manufacturing (AM) technolo-
gies, although not new to the world,
are showing they can compete with
traditional coating technologies in
manufacturing porous titanium sur-
faces and offer the added beneft of
a complete near-net part construct.
Improved software and process con-
trols enable these technologies to pro-
duce devices with porous structures
that compete directly with those pro-
duced by alternative machining and
porous coating methods of manufac-
turing. By eliminating several manu-
facturing steps and inventory costs,
AM has created a loyal following
among suppliers.
Part 2: Additive Manufacturing
For at least two decades, there has
been technology that can build up solid
parts from 3-D computer-aided design
models. Starting materials are in liquid
or powder form and are subjected to
consolidation upon local energy sup-
ply, stimulating a specifc chemical or
Human mesenchemal stem cells proliferate onto a titanium additive-manufactured
macroporous surface.
ELEMENT WEIGHT (%) ISO 5832-3
Ti Balance Balance
Al 5.97 5.5–6.75
V 4.01 3.5–4.5
O 0.16 Max 0.2
N 0.01 Max 0.05
C 0.013 Max 0.08
H 0.0025 Max 0.015
Fe 0.056 Max 0.3
This image and table are an example of
atomized Ti-6Al-4V powder and its chemical
composition.
By eliminating
several
manufacturing
steps and inventory
costs, AM has
created a loyal
following among
suppliers.
ORT1109 010 10 9/27/11 3:59:09 PM
CORPORATE PROFILE
ADVERTISEMENT
Orchid Orthopedic
Solutions
Corporate Description
Orchid Orthopedic Solutions is a worldwide leader in contract design and
manufacturing solutions for the orthopedic, dental and cardiovascular markets.
Orchid’s key mission is to be the leader in contract medical design and
manufacturing by compressing time to market, providing new technology and
being the best total supply-chain value. The company meets the ISO 13485:2003
international standard for medical devices and related services that consistently
meet customer requirements and regulatory requirements. Orchid’s purpose is
to provide an opportunity for people to live a better life. The company offers an
array of implants and instruments within five core capabilities: design, forging,
machining, plastics and coatings.
Products/Services
Orchid Orthopedic Solutions specializes in implants, instruments and innovative
technologies for the following markets: reconstruction, trauma, spine, sports
medicine, orthobiologics, extremities, dental and medical devices. Orchid
Orthopedic Solutions’ contract design and manufacturing divisions offer the
following products and services: contract design and development (e.g., implant
and instrument systems, design troubleshooting; customs and specials; and
gage design and fabrication); near-net forging (e.g., joint and bone replacement
components, plates and extremity parts); advanced machining (e.g., implants,
surgical instruments, screws, nails, plates and joint replacement parts); medical-
grade precision-machined and molded plastic products (e.g., medical devices,
implants, components and delivery systems); and HP, TPS and RBM, porous
and bead coatings and surface treatments (e.g., implants). New technologies,
products,and design innovations are constantly being developed for Orchid
customers.
Facilities & Capabilities
Headquartered in Holt, Michigan, Orchid Orthopedic Solutions has more than 900
skilled employees at locations throughout the United States. The company provides
unparalleled customer service through innovative design and development, implant
manufacture, advanced machining, plastic technology, quality and regulatory,
instrument manufacture, implant coatings and surface treatments and packaging
for the medical device industry.
Major Markets Served
Orchid Orthopedic Solutions specializes in implants, instruments and innovative
technologies for the following markets: reconstruction, trauma, spine, sports
medicine, orthobiologics, extremities, dental and medical devices.
Orchid Orthopedic
Solutions
1489 Cedar Street
Holt, MI 48842
Phone: (517) 694-2300
Fax: (517) 694-2340
Sales@orchid-orthopedics.com
www.orchid-orthopedics.com
02_55565598 OT1004 re
CORPORATE PROFILE
ADVERTISEMENT
ORT1109 011 11 9/30/11 1:53:10 PM
12 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Implant Technology
physical reaction. Technologies that
produce components according to this
strategy are categorized under AM.
3,4

The second part of this article fo-
cuses on two specifc AM technologies
—electron beam melting (EBM) and
direct metal laser sintering (DMLS).
These technologies can produce parts
made of implantable metals such as
titanium alloy (Ti6Al4V).
The common feature of these AM
technologies is that they melt and
rapidly solidify portions of a metal
powder layer according to the specifc
drawing being replicated. Under spe-
cifc process conditions, solidifcation
results in a fully dense solid body.
In an EBM machine, an electron
beam gun preheats the powder layer
using a relatively low beam current
and a relatively high scan speed. This
process has two effects: frst, the par-
tial sintering of the powder, which
holds it in place during the subsequent
melting; and second, the high tem-
perature (about 600°C) maintained
during the process reduces the ther-
mal gradient between the just-melted
layer and the already built-up body of
the part. This approach substantially
reduces residual stresses. A typical
layer thickness is 70–100 μm.
5
A DMLS machine for titanium al-
loys uses a laser beam with a higher fo-
cus capacity than EBM. Each layer can
be as thin as 30 μm. The process leads
to improved resolution and accuracy
in the pieces manufactured compared
with those made via EBM. However,
tolerances against nominal design are
about 0.1 mm and are a long way
from typical values obtained by ma-
chining. Productivity for the DMLS
process as defned (melted material per
hour) is lower when compared with
the high-energy EBM process.
6
Designing and Manufacturing
Macroporous Surfaces
When a contract manufacturer uses
both EBM and DMLS technologies in
serial production, it can establish a pro-
cess surveillance strategy. One critical
concern is that titanium is chemically
prone to oxidation. If the oxide con-
tent in the manufactured parts exceeds
standard requirements (i.e., < 0.2%,
per ISO 5832-3), it may decrease mate-
rial ductility. The production cycle of
Ti-6Al-4V alloy-based parts presents
challenges. Part of the powder loaded
into the equipment that is not melted to
form the solid parts will eventually be
reused in the next manufacturing
cycle. The powder feeder tanks
are also routinely reflled with
new powder so that a blend
between reused and new pow-
der is permanently in place. Nu-
merous analyses were performed
to obtain a statistical picture of
the oxygen and carbon rate variation
against powder reuse, both for the
powder in the tanks and for the fnal
parts. Results revealed a high capabil-
ity to maintain the material within
specifcation when the processes are
performed correctly.
7
If porous structures are manufac-
tured on the pieces, a critical post-
process step such as titanium debris
cleaning may be required. The porous
structures, as manufactured, contain
a number of loosely adhered surface
beads, and it is necessary to remove
these particles. The most practiced
particle-removal methods are thermal
treatments, sandblasting, and chemi-
cal etching, or a combination of these
methods.
8
Once components with their po-
rous coating surface are additive
manufactured, they may be subjected
to further critical postprocess steps,
such as thermal treatments, hipping,
or machining, when high dimensional
accuracy is required for coupling com-
ponents. When additional mechanical
work is applied, it is crucial to avoid
or remove contaminants such as emul-
sions and lubricant residuals from
porous structures.
Both technologies release the Ti-
6Al-4V alloy with a specifc acicular
microstructure that cannot be modi-
fed by heat treatment and can be con-
sidered a building process fngerprint.
It does not fnd a correspondence in
the international standard dealing
with titanium alloy microstructures
for biomedical applications (ISO
20160). Nevertheless, a number of
studies have demonstrated how the
mechanical properties of the titanium
alloy obtained by AM may fully sat-
isfy the applicable standards and fa-
tigue resistance requirements.
5,6

When using AM technologies,
a number of different topographic
structures can be achieved with ex-
cellent performances. The ultimate
goal of porous titanium structures is
to host living bone tissue in a man-
ner that guarantees device fxation by
osseointegration. Such data has been
proven successful through in vitro and
animal testing. Properly engineered
and EBM-manufactured surface struc-
tures allow human mesenchemal stem
cells to attach to the structures and
spread.
9
Studies also showed that Ti
alloy macroporous structures that
were EBM-manufactured and surgi-
HA and titanium coatings were applied to
this PEEK Motis implant.
An HA coating is applied via the plasma
spray process onto a femoral hip stem.
ORT1109 012 12 9/27/11 3:59:17 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 13 orthotec.com
cally placed in immediate stable con-
ditions promoted a bone in-growth
of about 1.5 mm after six weeks of
implantation time in goats.
10
These
results show favorable conditions to
enable device fxation.
Applying Additive
Manufacturing
AM has a host of possibilities. The
main advantage is design freedom. The
method enables complex surface com-
ponents to be manufactured in a cost-
effective and timely manner. It enables
the delivery of intricate geometrical
components completed with designed
lattice surface topography in one
manufacturing step. Using the process
with titanium produces orthopaedic
components with a surface trabecular
(porous) structure that promotes bone
colonization and in growth, which
improves device fxation strength. The
method can also be used in the rapid
manufacture of complex-shaped cus-
tom implants and thousands of acetab-
ular components for hip arthroplasty.
Implant makers are examining ways
to meet inventory volume needs while
adhering to regulatory requirements.
AM technologies are proving to be the
way of the future.
References
1. CA Engh et al., “Porous-Coated Hip Replace-
ment, The Factors Governing Bone In-Growth,
Stress Shielding, and Clinical Results,” Brit-
ish Bone and Joint Surgery 69-B, no.1 (January
1987).
2. JD Bobyn et al., “The Optimum Pore Size for
the Fixation of Porous-Surfaced Metal Implants
by the Ingrowth of Bone,” Clinical Orthopaedics
150, (1980):263–70.
3. T Wirtz et al., “New Possibilities for the Design
and Manufacturing of Bone Implants with Ex-
ternal and Internal Functional Architecture,”
Proceedings of the Second International WLT-
Conference on Lasers in Manufacturing (Munich,
June, 2003).
4. C Over et al., “Rapid Manufacturing of Metal Parts
and Tools Using Laser Melting,” Proceedings of the
Second International WLT-Conference on Lasers in
Manufacturing (Munich, June, 2003).
5. L. Facchini et al., “Microstructure and Mechani-
cal Properties of Ti64 Produced by EBM of Pre-
Alloyed Powders,” Rapid Prototyping Journal 15,
no. 3 (2009): 171–178.
6. Facchini et al., “Effect of the Microstructure on
the Ductility of a Ti-6Al-4V Alloy Produced by
SLM of Prealloyed Powders,” Rapid Prototyping
Journal 16, no. (2010): 450–459.
7. E Magalini et al., “Industrialization and Valida-
tion of RM Process,” Proceedings RAPID 2010
and 3D Imaging Conferences (Anaheim, CA, May
18–20, 2010).
8. E Magalini et al., “Porous Titanium Foams with
Additive Manufacturing Technologies,” Proceed-
ings RAPID 2010 and 3D Imaging Conferences
(Minneapolis, May 24–26, 2011).
9. JE Biemond et al., “The Effect of E-Beam Engi-
neered Surface Structures on Proliferation and
Differentiation of hMSCs,” Proceedings at ORS
2010: Orthopaedic Research Society (Louisiana
March 6–9, 2010).
10. JE Biemond et al., “Frictional and Bone In-
growth Properties of Engineered Surface To-
pographies Produced by E-Beam Technology,”
Archives Orthopaedic and Trauma Surgery131,
no. 5 (2011):711–718.
Leo Glass is president of Surface
Dynamics (Cincinnati). Pierfrancesco
Robotti is responsible for scientifc
marketing in Eurocoating s.p.a (Ciré-
Pergine, Italy).
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personal and need very specifc
fnishes. So who do you trust to
provide the exact fnishes your OEM
requires? Rosler has specialized in
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ORT1109 013 13 9/27/11 3:59:37 PM
14 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Blog Teasers
OrthoTec’s blog covers the latest development in the orthopaedics industry. Visit orthotec.com
Advanced electronics technology is
boosting the power of a lower-limb
prosthetic, enabling simultaneous knee
and ankle joint use. Developed at Van-
derbilt University’s Center for Intelli-
gent Mechatronics (Nashville), the de-
vice is an improvement over traditional
prosthetics, which tend to drag or have
a lag in motion. It is designed to sim-
plify the daily movement (walking,
sitting, standing, etc.) that many take
for granted. According to studies, us-
ers who were equipped with the device
walked 25% faster on level surfaces
then they did when they used passive
lower-limb prosthetics.
Sensors monitor the prosthetic’s mo-
tion. Microprocessors take the data to
predict the user’s desired movement
and act accordingly. The development
of the device came after seven years of
research and was funded by the Na-
tional Science Foundation and the Na-
tional Institutes of Health. Vanderbilt
University patented parts of the design
and has given prosthetic manufacturer
Freedom Innovations (Irvine, CA) ex-
clusive rights to make the device.
“With our latest model, we have
validated our hypothesis that the right
technology was available to make a
lower-limb prosthetic with powered
knee and ankle joints,” said Michael
Goldfarb, H. Fort Flowers professor of
mechanical engineering at Vanderbilt,
who directed the research. “Our device
illustrates the progress we are making
at integrating man and machine.”.
So what’s next? The Center for In-
telligent Mechatronics is working on
an anthropomorphic prosthetic arm
project and an exoskeleton for use in
physical therapy.
—Maria Fontanazza
Bionic Leg Integrates Man and Machine
Professor Michael Goldfarb (right) stands with
amputee Craig Hutto, who is wearing the new
bionic leg developed at Vanderbilt University.
P
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/
V
A
N
D
E
R
B
I
L
T

U
N
I
V
E
R
S
I
T
Y
Since April, the following executives have left Wright Medical:

Gary Henley, CEO.

Frank Bono, senior vice president and chief technology offcer.

Raymond Kolls, senior vice president, general counsel, and secretary.

Cary Hagen, senior vice president, EMEA commercial operations.

Alicia Napoli, vice president, clinical and regulatory affairs.

Lisa Michaels, vice president and chief compliance offcer.
Fast facts about
Vanderbilt’s bionic leg:

Weight: 9 lb.

Operation time on a single
charge: Three days of normal
activity/13–14 km of continuous
walking.

Antistumble routine: If the leg
senses that the user is about
to stumble, it lifts the leg to get
away from the obstruction and
plants the foot on the ground.

Better hardware design: The
hardware has endured seven
designs, and the electronics
board has been revised 15 times.
Will Wright
Medical Straighten
Out Compliance
Issues?
The compliance scandal at Wright
Medical continued during the sum-
mer with the resignation of Lisa
Michaels, vice president and chief
compliance offcer. The company’s
board of directors plans to hire a
recruiting frm to fnd Michaels’ re-
placement. John Knighton, compli-
ance director at the company, will
fll in for now. However, Wright Medi-
cal is trying to get back on track. It
has named Robert J. Palmisano CEO
and announced a signfcant restructur-
ing plan, which includes layoffs. The
company also voluntarily extended its
deferred prosecution agreement until
September 29, 2012. Read more about
this news on p. 42.
—MF
ORT1109 014 14 9/27/11 3:47:04 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 15 orthotec.com
Smart Idea:
Stryker Embeds
Microelectronics
from OrthoSensor
At the start of 2011, OrthoSensor Inc.
(Sunrise, FL) was positioning itself to
be a disruptive force in orthopaedics
through its strategy of integrating elec-
tronics and sensors into implants. The
company is beginning to put this plan
into action, forming a partnership with
Stryker Orthopaedics. As part of this
agreement, the company is providing its
OrthoSensor KneeTrial system for use
with Stryker’s Triathlon Knee System.
“The single-radius design philoso-
phy of Stryker knees is a perfect com-
plement to OrthoSensor’s innovative
technology,” said Doug Leach, vice
president of global R&D, knee recon-
struction, at Stryker Orthopaedics, in
a statement.
The OrthoSensor Knee Trial has
embedded sensors and microelectron-
ics that give surgeons real-time feed-
back about ligament balance and joint
kinematics during knee arthroplasty
procedures. The data is wirelessly
transmissed onto a graphic display.
Surgeons use this information to alter
the position of an implant, change leg
alignment, and optimize soft tissue
balance.
—MF
Glory Days of
Orthopaedics Are
Over
Although analysts are positive about
the gradual improvement of business
in orthopaedics, they say the industry
will never be the same.
“The days of lavish spending on
surgeons and consulting agreements
are a thing of the past, while strug-
gling procedure volume growth com-
bined with steady price degradation
is the sign of the times,” analysts with
investment research frm Canaccord
Genuity wrote in its assessment of
the market. They noted that business
should get better with the economy—
but the question is when. “We expect
medtech investors to play the waiting
game for many of these stocks until
consistent growth and subsequent
leverage opportunity returns.”
The latest confusion surrounds joint
reconstruction volumes. Biomet saw
its sales fall in Q4 2011, right on the
heels of the previous quarter’s fat U.S.
sales. And the fallout from the metal-
on-metal hip controversy has yet to be
fully realized.
However, it’s not all bad news. Ro-
botics manufacturer Mako Surgical and
China-based KangHui Medical could
experience better-than-expected results
this year, according to the analysts.
KangHui’s growth will be driven by
the eight trauma and spine products
that it released in 2009 and 2010. The
company, which enjoyed a strong
second quarter, launched a kypho-
plasty system earlier this year and
could be entering the joint implant
segment next year. Kanghui also has
an advantage in competing against
multinational companies in China,
because the medical insurance com-
panies prefer to reimburse domestic
implants, which tend to cost less than
imported implants.
Mako Surgical reported second
quarter revenues of $18.6 million, an
81% increase over Q2 2010. The com-
pany sold 12 of its RIO systems during
the quarter, which accounted for $9.5
million in revenue. Last year, the com-
pany began an orthopaedic surgeon
preference evaluation following the
clearance of its Makoplasty system for
the hips, which it says is progressing
according to plan.
—MF
Zimmer Fights Back
Against Plaintiffs’
Attorneys by Suing
Them
As is true of most product liability
litigation, the legal wrangling over Zim-
mer’s NexGen knee implants has been
contentious, to say the least. An article
in Bloomberg provides a snapshot of
just how contentious this fght has been,
detailing how Zimmer has begun suing
plaintiffs’ attorneys.
Zimmer is accusing the attorneys of
being dishonest about the safety records
of the knee implants in their zeal to
recruit potential plaintiffs. According to
the article, several frms have launched
campaigns to attract clients, campaigns
the company says have unfairly ma-
ligned its reputation.
There is generally a rough-and-
tumble favor to most product liability
litigation. Neither the aggressive cam-
paigns from plaintiffs’ attorneys nor
the aggressive response from Zimmer
are particularly surprising. However,
the article makes it clear that Zimmer’s
move is innovative. Roger Williams
University law professor David Logan
stated that it “opens up a new front in
the product-liability wars.”
Do you think he’s right? Is this tac-
tic something other orthopaedic and
medical device companies can use in
future product liability defense efforts?
Or is it going to backfre? Is it time to
pull out all the stops when it comes
to fghting back against plaintiffs’ at-
torneys, or is this an overreaction on
Zimmer’s part?
—Thomas Blair
OrthoSensor’s knee trial integrates
microelectronics and sensors.
ORT1109 015 15 9/27/11 3:47:10 PM
16 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Materials Characterization
3-D optical microscopy provides improved wear characterization,
especially when assessing scar depth and volume removal.
ROGER POSUSTA AND MATT NOVAK, PHD
M
aterial selection can be a chal-
lenge for hip implant manufac-
turers. A major factor in long-
term success for implant procedures is
limiting the gradual and progressive
shedding of material from the implant
surfaces. This wear and the resulting
presence of particulates in the body
can lead to bone resorption, granuloma
formation, loosening of the joint, and,
ultimately, implant failure.
This failure mechanism is driving im-
provements in biometric materials that
provide several options for hip replace-
ment surgery. Today’s top-performing 3-D
optical microscopes provide quantitative
evaluation of materials prior to implanta-
tion to determine the wear characteristics
of surfaces in a variety of preparations
(uncoated, coated, polished, etc.). This
evaluation enables the manufacturer to
make implants with improved wear and
that are more comfortable, have increased
fexibility, and last longer.
Technology-Driven Solution
Three-dimensional microscopy uses
white light interferometry (WLI) and
is one of the most accurate, repeatable,
and versatile methods of precision sur-
face metrology. Systems based on this
technology successfully measure ma-
terials in research and production line
environments in subnanometer vertical
resolution for a wide range of indus-
tries, including medical, automotive,
aerospace, electronics, solar, MEMS,
data storage, and general manufactur-
ing and precision machining inspection.
A 3-D microscope offers a noncontact
advantage over contact stylus systems
that have mechanical fltering due to tip
radius, which can also damage a surface
during measurement.
In WLI microscopy, light from a
source is focused on a sample and simul-
taneously refected from a reference mir-
ror in the instrument (see Figure 1). The
light refected from the sample is pre-
cisely compared with the light refected
from the reference mirror. Local height
Determining Material
Characteristics of Hip
Implants: 3-D Microscopy
is the Answer
Laser
Light Source
Beamsplitter
Reference Mirror
Mirror on the Scanner
Mirau
Interferometer
Objective
Sample
CCD
Reference signal
detector(s)
Mirror
Reference Signal Module
Figure 1. Basic design of a 3-D microscope with a self-calibrating helium-neon laser.
ORT1109 016 16 9/27/11 4:00:38 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 17 orthotec.com
information is obtained as a function
of lateral position on the sample. By us-
ing proper fltering and high-brightness
LEDs as source illumination, the mea-
surement conditions can be tailored
to match the application requirements
for a vast array of sample surfaces.
The presence of the helium-neon laser
delivers a self-calibrating reference for
the movement of the scanner in order to
account for changes in the position due
to environmental variations.
Applications for this technology are
being developed outside the traditional
surface measurement realm, specifcally
for areas such as flm thickness metrol-
ogy, environmental response (corro-
sion) studies, and actuated response
studies. Most recently, the technology is
enabling users to examine the behavior
of materials over a range of timescales
as they are worn via cutting or grinding
operations, or where material wear is
produced due to constant contact with
other components. This particular wear
mechanism is prominent in implants—
specifcally hip implants—where there
is necessary contact by device design
and function.
Plastic-on-metal, ceramic, and metal-
on-metal implants have drawn negative
attention for their tendency to produce
friction-created debris, which in turn
causes infammation of the tissues sur-
rounding the implants. This debris can
lead to increased residual presence of
polyethylene or metal components in the
body. The wear and resulting infamma-
tion can lead to osteolysis (bone destruc-
tion), pseudotumors, or in limited cases,
loud frictional squeaking due to ceramic-
on-ceramic stripe-wear patterns. Careful
characterization of the wear and wear
rate for the materials involved is critical
to improving the long-term performance
and stability of these products. This in-
formation is readily attained using 3-D
optical microscopy.
Wear Study Example
The following example is an alternative
method of performing wear studies based
on 3-D microscopic metrology that pro-
vides critical parameters to characterize
the wear scar, in addition to providing
the volume of material removed. This
information can be useful during process
development, material property analysis,
and material selection. It is invaluable to
process development engineers, materials
science engineers, and product develop-
ment engineers because the fnal perfor-
mance of a material in an application
can be correlated to the wear measured
in such a manner. A virgin PEEK sphere
with a diameter measuring 1 in. was used
to simulate a hip joint, and the top of the
surface was mapped using a 3-D micro-
scope. Several felds of view were mea-
sured at 5x magnifcation and combined
to produce an accurate and wide-angle
view of the top portion of the surface. A
photograph of the PEEK sphere and the
corresponding 3-D microscopic image of
the portion to be inspected are shown in
images 1 and 2.
After initial characterization of the
PEEK sphere, a wear mark was made
to simulate wear and volume removal.
After this small volume of material was
removed, the surface was remapped.
Images of the worn surface and the lev-
eled representation of the wear mark are
shown in image 3. By subtracting the
original pristine surface from the second,
worn surface, the material mass displaced
and the volume loss can be precisely cal-
culated. The high vertical resolution and
high lateral resolution achieved by WLI-
based 3-D optical microscopy ensures the
accuracy of this methodology.
The data presented in image 4 are
used to compute the volume displace-
Image 1. This image shows a PEEK sphere
with a diameter that measures 1 in.
Image 2. A 3-D surface map of the PEEK
sphere is made before wear.
Image 3. The worn PEEK sphere surface is
remapped.
Image 4. The wear data is used to compute
volume displacement.
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.55.0 5.56.2
Volume Calculations
Volume Options
Natural Volume
Normal Volume
Negative Volume
Positive Volume
Net Missing Volume
Total Displaced Volume
Normal
1.26e+009 μm
3
24.22 μm
3
652147136.00 μm
3
664661888.00 μm
3
–12514752.00 μm
3
1.32e+009 μm
3
Thresh: 27.32 μm 16.86% of P-V
Pts Below: 99.94% of Total
Vol: 7.88e+008 μm
3
62.33% of Total
6.1
5.5
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
Figure 2. The chart shows 1 mg of
material removed, which correlates to
~7.5x108 μm
3
/mg volume of material and
matches the nominal mass density of PEEK.
ORT1109 017 17 9/27/11 4:00:42 PM
18 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Materials Characterization
ment. The depth and area over which the
material was removed is used to make
a computation of the material density,
which is highly correlated with gravi-
metric machines. The repeatability of
the surface metrology technique is more
than an order of magnitude higher than
the gravimetric method of measurement,
due to the higher uncertainty in measure-
ment of such small mass. The analysis
and volume computation for the initial
wear mark and computation are in Figure
2 on p. 18.
To verify the repeatability of the tech-
nique, a repeated wear mark was intro-
duced, removing approximately 4 mg of
additional material. This material was
removed from the same surface scar
location. and the surface was remapped.
The final volume removed was then
computed based on analysis of the fnal
depth and width of the resulting wear
scar (see Figure 3).
For this second stage of the material
wear and volume removal experiment,
slightly less than 5 mg of total mate-
rial was eventually removed. This mass
removal corresponds to approximately
~3.5x10
9
μm
3
/mg of volume lost due to
wear on the PEEK sphere surface. Be-
cause some of the fnal volume of mate-
rial removed was taken from the sphere
slightly outside the measurement feld of
view, the fnal measurement of volume
lost was slightly less than the theoreti-
cal loss calculation (resulting in a slight
mismatch to nominal mass density). For
an even more accurate representation of
this removal, a large initial map could be
made to accommodate the additional re-
moval volume. Even with this mismatch,
the associated error in mass determina-
tion is on the order of 10 times smaller
than gravimetric means.
Noncontact 3-D Microscope
Metrology
The speed and versatility of 3-D micros-
copy brings accuracy and data-quality
advantages to the user. The filtering
that takes place with a mechanical sty-
lus measurement does not occur with
noncontact imaging. This is because
the sampling of the image is set by a
combination of the magnifcation of the
observing lenses and the charge-coupled
device camera spacing. Lateral resolu-
Label Value Units
Sa
Sku
Sp
Sq
Ssk
Sv
34.796
3.138
111.986
43.379
–1.023
–118.347
μm
μm
μm
μm
X Profile (2861.533 μm)
μm
μ
m
50
0
–50
–100
–150
0 1000 2000 3000 4000 5000 6000
M
R
Y Profile (3734.228 μm)
μm
μ
m
50
0
–50
–100
–150
0 1000 2000 3000 4000 5000 6000
M
R
6
0
0
0
.
0
5
0
0
0
.
0
4
0
0
0
.
0
3
0
0
0
.
0
2
0
0
0
.
0
1
0
0
0
.
0
0
.
0
0.0 1000.0 2000.0 3000.0 4000.0 5000.0 6000.0
μm
μm
μm
85
50
0
–124
–100
–50
Volume Calculations
Volume Options
Natural Volume
Normal Volume
Negative Volume
Positive Volume
Net Missing Volume
Total Displaced Volume
Normal
4.95e+009 μm
3
92.53 μm
3
1.16e+009 μm
3
1.18e+009 μm
3
–15869696.00 μm
3
2.34e+009 μm
3
Thresh: 48.12 μm 14.12% of P-V
Pts Below: 99.85% of Total
Vol: 3.35e+009 μm
3
67.72% of Total
6.1
5.5
5.0
4.5
4.0
3.5
3.0
2.5
2.0
1.5
1.0
0.5
0.0
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.55.0 5.56.2
Figure 3. The 3-D profile (image) reveals a new wear mark, with 4 mg of material removed.
The chart shows the new volume loss calculation.
Figure 4. The data show a listing of various 3-D areal surface parameters measured via 3-D microscopy.
ORT1109 018 18 9/27/11 4:00:53 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 19 orthotec.com
tions at the diffraction limit are achiev-
able in this manner, enabling higher
sampling than is possible with a stylus
of 2, 5, or 10 μm (some typical stylus
tip dimensions). Important 3-D surface
parameters, such as roughness (Sa),
peak/valley (St), and radius of curvature
(RoC), can easily be obtained from the
same data used for the volume calcu-
lations mentioned previously. These
parameters are computed automatically
for the entire field of view (FOV) of
the optical inspection area. The data, if
desired, can also be examined in 2-D,
thus offering the operator hundreds of
equivalent stylus traces for a single FOV.
The speed with which this information
can be collected is an advantage in pro-
duction settings.
Additionally, 3-D parameters of in-
terest (especially when computed in
accordance with ISO 21578 standards,
which are currently scheduled for adop-
tion across a wide range of industries)
provide an accurate and consistent
quantification of important surface
texture characteristics in a well-known,
industry-accepted manner. A few of
these parameters, representing average
3-D roughness, slope, skewness, kurto-
sis, height, and peak-valley information,
are depicted in Figure 4.
Such 3-D parameters allow materi-
als researchers to correlate properties
that are highly quantifable to product
performance in a fast, accurate, and re-
peatable manner. These measurements
exhibit high reproducibility, a hallmark
of good metrology for process and
quality control.
Conclusion
Three-dimensional microscopes provide
versatile and rapid noncontact means
of performing surface finish and tri-
bology measurements in several areas,
including the engineering lab and the
production floor. Fast, accurate, and
repeatable measurements based on the
capabilities of this technology are ideal
for the medical industry. The versatility
of 3-D microscopy enables end users
to measure materials in a range of ap-
plications. The study presented in this
article demonstrates the ability of 3-D
microscopy to deliver highly accurate
wear metrology to the medical implant
industry. The results showed an accurate
computation of wear volume on a hip
implant (a PEEK simulated hip ball) ob-
tained using 3-D microscopy while also
giving form and surface fnish param-
eters as value-added information. These
accurate results and the additional 3-D
surface texture parameters offer implant
materials development and production
teams a signifcant value over traditional
gravimetric approaches to materials
characterization.
Roger Posusta is senior marketing ap-
plications engineer at Bruker Corp.’s
nano surfaces division (Tucson, AZ).
Matt Novak, PhD, is marketing appli-
cations manager at the company.
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ORT1109 019 19 9/30/11 1:53:53 PM
20 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Compression Molding
This cost-effective process has advantages over other methods of
molding orthopaedic parts.
ROBERT BOLAND
C
ompression molding has been
used to make plastic parts since
Leo Baekeland introduced pheno-
lic resins in 1910. It is the oldest process
used to mold plastic parts.
1
A phenolic is
a thermoset resin—when introduced to
heat and pressure, it cures to become a
plastic part. Thermoset parts have an ir-
reversible chemical crosslinking and can-
not be remelted. Thermoplastic materials
are compression molded and commonly
used in the orthopaedics industry. A
thermoplastic material becomes a liquid
when heated and freezes to a hardened
state when suffciently cooled.
Compression molding requires a ver-
tical press that is usually a hydraulically
actuated and an integrated temperature-
controlled mold. The mold usually con-
sists of two halves—an upper force half
and a lower cavity half, or vice versa.
It is precisely machined from tool steel
to form the desired geometry of the
molded part. The press can be up-acting
or down-acting. With an up-acting press,
the hydraulic cylinder is attached to the
lower press platen and moves upward,
guided by four identically machined tie
bars to close the press in a parallel con-
dition (See Image 1). In a down-acting
press, the hydraulic cylinder is attached
to the upper press platen that moves
downward to close the press. In many
cases, a press with two daylights is used
to double the production.
During operation, a preweighed
amount of molding material is placed
directly into the lower cavity of the
temperature-controlled mold. The ma-
terial can be in the form of powder,
granules, pellets, putty-like mass, or pre-
formed blanks. In the case of thermoset
materials, the mold is heated from ap-
proximately 300º to 350ºF. The heat
from the mold softens the material to a
viscosity low enough so that the material
can fow when pressure is introduced.
The press closes at a high speed until
just before the point at which both mold
halves make contact with the charge of
material to be molded. The fnal clos-
ing speed is slower to prevent damage
to the mold and to profle the velocity
of the close as the charge of material
deforms and flls the cavity to achieve
the optimum material fow. Once the
press is fully closed, the molding mate-
rial takes the shape of the cavity (see
Image 2). With the heat of the mold
and the pressure of the press (typically
1–2 tn/sq in. of molded surface area at
the parting line of the mold), there is an
irreversible chemical crosslinking. The
material hardens and in effect becomes a
plastic part. With thermoplastic materi-
als, the mold is cooled to allow the part
to harden. Cycle times can range from
60 seconds to several hours depending
on the material used and the thickest
wall section of the molded part. Upon
cycle completion, the press is opened. In
many cases, ejector pins in the mold are
actuated either mechanically or hydrau-
lically to lift the molded part away from
the cavity, so an operator or a robot can
easily remove it from the mold.
How to Use Compression
Molding to Make Joint
Replacement Parts
Image 1. The compression press is shown
with a preform of the molding material prior
to press closing.
ORT1109 020 20 9/27/11 3:48:10 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 21 orthotec.com
Some typical compression-molded
plastic parts include circuit breakers,
insulators, closures, cookware handles
and knobs, fuel cell plates, appliance
parts, dinnerware, automotive hoods,
fenders and valve covers, and interior
aircraft parts. Materials used for com-
pression molding include epoxies, urea,
melamine, phenolic, polyester, poly-
imide, polyamide-imide, PEEK, and
various fber reinforced thermoplastics.
Many rubber parts are also compression
molded. In the orthopaedics industry,
various knee, hip, and shoulder replace-
ment joint parts are compression mold-
ed out of medical grade ultrahigh mo-
lecular weight polyethylene (UHMWPE).
UHMWPE is a thermoplastic polyeth-
ylene that was frst introduced as an
orthopaedic implant material in 1962.
2

The odorless and nontoxic material has
high impact strength and many desir-
able features that make it the choice
for molding replacement joint parts.
It has low moisture absorption, a low
coeffcient of friction (comparable with
that of Tefon), is self-lubricating, and
is resistant to abrasion. It exhibits good
wear, an important factor in determining
the life span of orthopaedic implants.
2

As one of the lowest-cost methods of
molding, compression molding wastes
little material and has good surface
finish. With joint replacement parts,
a typical part surface fnish might be
equivalent to an SPI B-1 fnish. Fewer
knit lines are produced, and the process
can yield better impact and flexural
strength in the molded part than can
be achieved with injection molding.
Normally, any high-volume part would
be a candidate for injection molding.
However, the high molecular weight of
UHMWPE affects the melt viscosity to
the point that conventional thermoplas-
tic material processing equipment such
as injection molding cannot be used.
A disadvantage of compression
molding is that some material can seep
through the parting line of the mold
(called fash). This fash can affx to the
molded part and must be trimmed from
the part after molding. Another disad-
vantage is that cycle times are longer
than for injection molding.
In many cases, blocks or sheets of
UHMWPE are compression molded
or consolidated, and the desired part is
machined out of the block or sheet of
molded material. This process prevents
excessive tooling costs because replace-
ment joint parts are made in many dif-
ferent sizes. So instead of having 1000
different molds to make various joint
sizes, a machining center can be pro-
grammed with 1000 different programs
to machine the different joint sizes.
In other instances, orthopaedic im-
plants are compression molded to their
net shape. Called direct compression
molding, this process can result in a
fnished or almost-fnished part with a
highly polished part surface directly out
of the mold. In either case, the proper-
ties of the fnal part can be infuenced
by the technology available in today’s
compression molding presses.
Compression Press Construction
A number of factors must be considered
when selecting the correct type of press
construction for an application. With a
heated press, the frst consideration is
thermal growth of the moving and fxed
platen relative to cylinder platen. Be-
cause the cylinder platen stays at room
temperature as the fxed platen rises in
temperature, the press tie bars are no
longer parallel.
Another consideration is the prob-
lem of clearance required between the
guiding and the tie bars, which allows
the moving platen to shift freely out of
parallelism. The next issue to consider
is the possibility of an offset load (the
mold or material is not centered in the
platen) putting a side load into and de-
fecting the tie bars, allowing the moving
platen to go out of parallelism. The last,
but not least, problem is the rigidity of
the frame itself. When the offset load is
transmitted into the tie bars, the cylin-
der platen wants to shift due to the side
loading, making the connection between
the tie rods and platens crucial.
There are two methods for con-
structing presses used for molding joint
replacement parts. The first method
uses round tie rods. Bronze bushings
are inserted into the moving platen and
ride up and down on the tie rods as the
press is opened and closed. The main
problem with this type of guiding is
that it is not adjustable. Clearances for
bushings must consider thermal expan-
sion conducted from the heat platen
into the press platen, as well as manu-
facturing variance of all of the piece
parts and running clearance. To replace
a round bushing, the press frame usu-
ally needs to be taken apart. Initially,
because the bushing diameter is larger
than the tie rod, the bearing area is very
small, which results in much higher
wear until the tie bar wears into the
Image 2. The compression press is closed
and is molding a part.
Image 3. When trying to reduce deflection,
use multiple clamp cylinders to spread the
load out over the press platen area.
ORT1109 021 21 9/27/11 3:48:15 PM
22 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Compression Molding
bushing, creating an undesirable result
of more clearance.
The second method uses rectangular
tie rods or slab sides machined with
45° gib guides. This type of guiding is
more costly but has several advantages.
Contact area is higher and predictable.
When used properly, the 45° angle can
help offset most of the thermal growth
of the fxed and moving platen. The
press can be designed so that when
the moving platen grows from front to
back it increases the guiding clearance
relative to the cylinder platen, which is
offset by the left-to-right platen growth
to maintain good guiding. This type
of guiding is simple to replace and is
adjustable, so that clearances can be
run tight with easy adjustment for
wear. Regardless of the type of con-
struction used, it is important that the
press closes in a parallel condition to
mold high-quality parts. Parallelism
across the platen within 0.002 in. is
desired when molding joint replace-
ment parts.
The construction of the press must
also be robust enough to keep defec-
tion caused by the clamp to a minimum,
which is usually no more than 0.0015
in./ft of platen area. In addition to the
thickness of the press platen, another
way to reduce defection is to use mul-
tiple clamp cylinders to spread the load
out over the press platen area as shown
in Images 1–3 (p. 20–21).
The Compression Molding
Process
The basic theory of compression mold-
ing thermoplastics is that the materials
are heated above their melting points,
formed, and then cooled. When using
medical-grade UHMWPE to make joint
replacement parts, the material comes in
powder form and must be consolidated.
The proper consolidation of the material
is a direct result of the heat, pressure, and
time combination used by the processor.
3

The equipment is commonly located in
a clean and controlled environment to
prevent any extraneous debris from get-
ting molded into the part.
In many cases, because of the long
cycle times, double-daylight presses are
used. A double-daylight press allows
for two molds in the press and doubles
the output of the press. In other cases,
vacuum presses, which can also have
two daylights, are required.
During operation, virgin UHMWPE
powder is loaded into the mold. This can
be done outside the press with the mold
placed onto heating and cooling platens
in the press after material loading. The
press is closed. Pressure and heat are
applied at a controlled rate. After sev-
eral hours, the press is opened and the
molded part or parts are removed from
the mold. The form and structure of the
molded UHMWPE joint replacement
part is greatly infuenced by the rate and
accuracy of the pressure and temperature
applied to the mold during the molding
cycle. This is where the technology in the
modern compression press can be the key
factor in producing high quality parts.
The long molding times are neces-
sary to maintain slow, uniform heating
and cooling rates and pressure ramping
throughout the cycle. The most effective
results are achieved when the ramping
accuracy of the pressure throughout the
entire tonnage range is within 450 lbs. on
a 75-ton press (accuracy within 0.3%).
Until now, such tight pressure accuracy
was unheard of in a hydraulic press. The
hydraulic system must have a number of
features to achieve this accuracy. Among
these features are the following:

Servo valves and a servo controller.

Proprietary programming of the coun-
terbalance valves.

Use of a pressure transducer in the
hydraulic line instead of a load cell
to determine force. Load cells are ex-
tremely sensitive to temperature and
off-center loading of the press.

Frictionless seals in the hydraulic
cylinders.
The pressure accuracy of the hydrau-
lic clamp is calibrated with portable
load cells at ambient temperature. The
pressure works in conjunction with the
temperature to achieve the optimum
molded part. Because UHMWPE is a
thermoplastic material, it must be heated
and then cooled. With orthopaedic parts,
the mold is not normally equipped with
direct heating and cooling. The heating
and cooling is done with heating and
cooling platens in the press. Each day-
light has top and bottom heating/cooling
platens that conduct the temperature
into the mold. The press is equipped
with a separate, dedicated controller
that specializes in heating and cooling.
This dedicated controller communicates
with the programmable logic controller
and human interface of the press, so
the heating and cooling values can be
input on the color touch screen and
are a part of the recipe set up for a
particular mold. Heating in the platens
is done with electric Calrod heaters
that are ftted tightly into holes drilled
in the platen. The dedicated temperature
controller senses the platen temperature
Four double-daylight presses operate from a common hydraulic power pack and control
system.
ORT1109 022 22 9/27/11 3:48:21 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 23 orthotec.com
with thermocouples in the platen and
sends the proper amount of current to
the heaters to achieve the desired heat.
The heat platen is typically heated to
450ºF. The wattage and arrangement
of the Calrod heaters in the platen must
be calculated to achieve heating that is
within ±10ºF across the surface of the
platen. The platens are heated from ambi-
ent temperature to 450ºF at a controlled
rate. The platens are also gun-drilled with
passages for cooling air and water. To
start the cooling cycle, the electric heat-
ers are turned off. Cooling begins with
the dedicated heating/cooling controller,
sending a signal to the compressed air
and water solenoid valves to send the
proper amount of air into the cooling
passages. Then based on the desired rate
of cooling, it is followed by an air/water
mix, and then water. With the accuracy
of the controller, the rate of cool down
can be controlled to the optimum rate
that is most beneficial to the molded
UHMWPE part.
Vacuum Molding
During the past several years, vitamin E
has been blended with UHMWPE pow-
der for molding orthopaedic insert parts.
Vitamin E is an excellent biocompat-
ible stabilizer for UHMWPE as it goes
through the molding process.
4
However,
exposure to oxygen during the molding
process can break down vitamin E. To
eliminate this problem, the material is
molded in vacuum presses. A vacuum
press can have all of the features of a con-
ventional press except that is constructed
with solid-steel side plates (slab sides).
These take the place of the tie rods. The
moving platen rides up and down the slab
sides on 45º gib guides. Front and back
sealed doors are attached to the slab sides
to create an air-tight chamber (see Figure
1). A vacuum pump draws down the
press/platen chamber to a programmed
Torr value that is best for the molded
part. The vacuum can be maintained for
the entire length of the cycle.
Press Controls
In addition to controlling press move-
ment, pressure, and temperature, there
are other valuable tools on modern press
control systems, such as real-time graph-
ing, data collection, and Ethernet ca-
pability. Real-time graphing (RTG) is
a Windows application that displays a
graph of process data in real time and
collects and archives process data for
every machine cycle. When the machine
cycle begins, a real-time graph collects
each data point (i.e., position, pressure,
and temperature) 20 times per second
and saves the information when the cycle
ends. A new data fle is created for each
machine cycle. RTG allows the operator
to see exactly how the press is performing
at any time during the cycle. The user can
go back and observe the data collected if
there is ever a perceived problem with a
molded part.
Conclusion
Compression molding joint replacement
parts is a time-consuming and technically
demanding process. To mold high-quality
orthopaedic parts, it is essential that the
selected compression-molding press has
all of the necessary features to meet pro-
cess challenges. Those features include
very fne pressure control, accurate tem-
perature control, tight parallelism, and
low defection. Other helpful features that
will enable the user to keep track of the
manufacturing process include real-time
graphing, Ethernet capability, and data
collection. There may be other features
required of your press. It is a good idea to
work closely with the press manufacturer
to discuss the properties you will require
in the fnished molded parts. Choosing
a press manufacturer with experience
building presses for joint replacement
parts can help. Their knowledge can assist
in designing and building a press that will
produce high quality joint replacement
parts for many years.
References
1. B Davis et al., Compression Molding (Cincinnati:
Hanser Gardner Publications 2003), 1–18.
2. M Allen, “Perplas Medical UHMWPE Processing
Techniques and Problems,” (paper presented at
UHMWPE meeting, University of Torino, Italy,
September 19, 2003).
3. MB Turell et al., “New Processes to Improve the
Mechanical Performance of UHMWPE,” (Harvard
Medical School, March 18, 2005, presented at
UHMWPE meeting, University of Torino).
4. P Bracco, “Stabilisation of UHMWPE with Vita-
min E Chemical Mechanisms,” (paper presented at
Fourth UHMWPE International Meeting, 2009).
Robert Boland is sales director at Law-
ton Machinery Group (De Pere, WI).
Hot Plate Heater
Vacuum Seal
Bronze Gib
Figure 1. By using a double-daylight vacuum press, manufacturers can press two molds and
double their output.
ORT1109 023 23 9/27/11 3:48:27 PM
24 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Intellectual Property
To weather the patent storm, orthopaedic device companies must
carefully navigate a new world of patent reform and build a strategic
patent portfolio.
DAVID J. DYKEMAN AND DANIELLE T. ABRAMSON, PHD
T
he orthopaedic device industry
has flourished in recent years
with the orthopaedics market
slated to produce more than $4.6 bil-
lion in revenue by 2015.
1
Orthopaedic
devices are typically categorized into
diagnostic, prosthetic, and surgical cat-
egories. This industry boom is largely a
response to the increase in healthcare
issues facing America’s aging popula-
tion. Currently, 40.3 million Ameri-
cans are over the age of 65, and this
number will nearly double by 2030.
2

Seniors are the primary patients in
need of reconstructive products such as
hip and knee replacements. Given the
shifting population dynamics and the
ensuing health problems, the orthopae-
dics industry is pressured to advance
technology that can diagnose and treat
age-related orthopaedic conditions.
In addition, the need for minimally
invasive surgical devices has recently
skyrocketed, leading to the develop-
ment of innovative devices and new
surgical methods.
Patents are the currency of the
orthopaedics industry. In order to sur-
vive, orthopaedic device companies
must distinguish themselves from their
competitors through their intellectual
property (IP) portfolios. These patent
portfolios are the key to success. They
should embody a well-reasoned busi-
ness strategy in which each patent is a
single building block in a larger portfo-
lio that refects present and future busi-
ness objectives. A strong patent port-
folio is also important in the current
orthopaedic device investment climate.
Venture capital funding often depends
on whether a company has secured its
IP assets, which validates a company’s
technology and demonstrates its com-
mercial potential. Although building
and maintaining a strong patent port-
folio is important for all orthopaedic
device companies, it is most critical
for start-up frms. Patent portfolios are
often the driving force for major events
in the life cycle of an orthopaedic de-
vice company, including mergers and
acquisitions, public offerings, venture
capital investment, strategic collabora-
tions, joint ventures, and litigation.
There have been recent measures
taken by Congress, the U.S. Patent and
Trademark Office (USPTO), and the
Supreme Court to reform the current
Patent Reform: Navigating
the Changing Patent
Landscape
B
a
c
k
g
r
o
u
n
d
:

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l
i
n
t

S
p
e
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c
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r
/
i
S
T
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;

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v
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:

N
i
c
k
S
/
i
S
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O
C
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H
O
T
O
.
C
O
M
ORT1109 024 24 9/27/11 3:49:38 PM
www.MDEAwards.com
VISIT OUR WEB SITE FOR COMPLETE INFORMATION.
Transforming Healthcare—
One Innovation at a Time
PRESENTED BY:
ENDORSED BY:
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Early-bird Deadline
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Standard Deadline
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ORT1109 025 25 9/27/11 3:49:46 PM
26 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Intellectual Property
patent system. Orthopaedic device
companies must respond with strong
patent strategies that take these new
reforms into account while establish-
ing a competitive edge in the market.
Such comprehensive technology strate-
gies must maximize patent coverage of
a company’s current core technology
and future improvements, monitor the
patent landscape, and explore ways
to patent white space, while also con-
sidering crosslicensing opportunities
with competitors. Companies will then
be able to withstand patent reform
and ensure their success in today’s
competitive and rapidly changing IP
environment.
Congress Passes
Major Patent Reform
Major changes to the U.S. patent sys-
tem are brewing, with Congress’s patent
reform legislation, the USPTO’s pro-
posed changes in patent examination
processes, and the Supreme Court’s is-
suance of far-reaching opinions. These
changes will affect how orthopaedic
device companies develop and manage
their patent portfolios.
After years of anticipation, President
Obama signed the America Invents Act
into law on September 16, 2011. This is
the frst major legislative change to the
U.S. patent system since 1952.
The most signifcant changes include
switching the U.S. patent system from a
frst-to-invent to a frst-inventor-to-fle
system and introducing postgrant op-
position review. These changes, slated
to become effective 18 months and 12
months after enactment, respectively,
will dramatically affect current pat-
ent fling strategies in the orthopaedic
device industry. For example, the frst-
inventor-to-fle rule will cause inven-
tors to err on the side of fling strong
provisional applications as quickly as
possible. As a result, inventors may end
up prematurely fling patent applica-
tions, before they understand the full
capabilities of an innovative technol-
ogy. Inventors will also need to write
more detailed patent applications, to
minimize opportunities for third parties
to block improvement patents. Further-
more, eliminating the much relied–upon
one-year grace period under the current
frst-to-invent system may hamper the
natural scientifc review process, where
ideas are shared and discussed by col-
leagues, particularly in university and
research settings.
Meanwhile, the postgrant patent
opposition review will increase the
number of challenges to patents based
on both novelty and obviousness
grounds. Orthopaedic device compa-
nies should monitor the issued patents
of key competitors to determine if they
want to challenge their competitor’s
patents. This change favors major
medical technology players that have
resources to challenge patents in an
increasingly complex and time-con-
suming process. Orthopaedic device
companies must carefully adjust to
these congressional reforms to main-
tain a strong patent portfolio that
protects their core technology.

U.S. Patent Office Proposes
New Rules
According to data from the USPTO, the
current backlog of unexamined patent
applications is at nearly 700,000.
3
As
a result, the average processing time,
from fling an application to receiv-
ing a frst USPTO action, is at least
two years. Further, it takes more than
three years, on average, for a patent to
be issued. In an effort to reduce this
logjam, the USPTO is advancing its
own patent reform by proposing new
programs that could lead to faster pat-
ent allowances.
First, the USPTO has implemented
an accelerated examination program
to address the lengthy turnaround pro-
cess regarding the allowance or denial
of patent applications. Accelerated ex-
amination promises that final deci-
sions on patentability will be rendered
within 12 months of fling. A quicker
turnaround time not only allows in-
ventors to protect their products from
infringement, but also attracts inves-
tors who want the certainty of an is-
sued patent.
Another USPTO program designed
to facilitate the patent process is the
Full First Action Interview Pilot Pro-
gram. An expansion of earlier success-
ful examiner interview programs, the
program includes all technology areas,
including classes that cover diagnostic,
prosthetic, and surgical devices. Under
this program, applicants have the right
to an interview with the patent exam-
iner before the frst offce action on the
merits in a utility patent application.
This interview resolves patentability
issues at the beginning of the process,
thereby advancing prosecution of a
patent application. The program is
scheduled to run through May 16,
2012 and may be extended.
Finally, the USPTO has joined the
Patent Prosecution Highway (PPH), an
international program that speeds up
examination by relying on prosecution
in a corresponding foreign applica-
tion filed in one of 15 participating
countries, including Canada, Austra-
lia, those represented by the Euro-
pean Patent Office, and Japan. The
PPH reduces time spent on examina-
tion because patent examiners reuse
the search strategies of their foreign
counterparts. The PPH also shortens
the wait time prior to examination.
A granted PPH request will result in
patent applications being examined
within two to three months, accord-
ing to the USPTO. Once examined,
PPH patent applications enjoy a sur-
prisingly high allowance rate—more
than 90% of PPH cases are allowed,
compared to only 50% of standard,
non-PPH cases.
4
In an industry where a well-developed
IP portfolio is indicative of success,
In order to survive, orthopaedics
companies must distinguish
themselves from their competitors
through their IP portfolios.
Dykeman
ORT1109 026 26 9/27/11 3:49:50 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 27 orthotec.com
orthopaedic device companies should
take advantage of the USPTO’s pro-
grams to expedite patent prosecution.
Doing so allows a company to estab-
lish a strong patent portfolio that re-
fects current innovation and industry
developments.
The Supreme Court Weighs In
The U.S. Supreme Court recently issued
far-reaching opinions that affect pat-
ent prosecution and licensing strategy.
In 2007, it ruled on one of the most
challenging questions in patent law:
what makes an invention “obvious”
and thus unworthy of a patent? In
KSR International Co. v. Telefex, the
Supreme Court affrmed the invalidity
of Telefex’s U.S. patent no. 6,237,565.
5

The Court found that the patent claim
merely combined obvious elements in
the prior art and rejected a narrow
application of the “teaching, sugges-
tion, or motivation” test for assessing
obviousness. KSR particularly affects
orthopaedic device companies whose
products tend to comprise incremental
improvements and combine established
devices and techniques. It may bar their
patentability and characterize them
as predictable variations of already
existing art and devices. To survive
obviousness challenges post-KSR, pat-
ents should clearly state the product’s
new features, discuss the challenges of
altering the design of the product, and
identify how its combining features are
not predictable in light of prior art.
The Supreme Court addressed the
patent eligibility of a process in Bilski
v. Kappos, one of the most anticipated
U.S. Supreme Court decisions of 2010.
6

Although the claims of the Bilski U.S.
patent application relate to fnancial
services, the Supreme Court’s inter-
pretation in Bilski of the “machine or
transformation” test is applicable to
the patentability of medical diagnostic
and personalized medicine methods.
The Bilski decision states that the ma-
chine or transformation test is not the
sole test for determining the patent
eligibility of a process, but rather a
useful and important clue or tool for
investigation.
After the Bilski decision, the Su-
preme Court granted judicial review,
vacated the decisions of the U.S. Court
of Appeals for the Federal Circuit, and
remanded to the federal circuit for re-
consideration two cases related to med-
ical diagnostics: Prometheus Laborato-
ries Inc. v. Mayo Collaborative Services
and Classen Immunotherapies Inc. v.
Biogen Idec. In Prometheus, the patent
claims were again found patentable
under the machine or transformation
test. In Classen, an opposite decision
was issued in which two of the three
Classen patents were patent-eligible,
while one patent was not. Previously,
all three patents at issue in Classen
were held invalid. Thus, medical device
companies must work closely with
their patent counsel to draft patent
claims that conform to the decision in
Bilski and its aftermath.
These Supreme Court rulings in-
dicate a trend in recent years of the
Court’s willingness to address perceived
problems in the U.S. patent system. To
build and maintain a strong patent
portfolio, orthopaedic device compa-
nies will need to implement patent
strategies that account for these major
Supreme Court decisions.
Protecting Core Technology
Developing a strategic patent portfolio
that addresses Congress’s reforms and
the frst-inventor-to-fle rule means es-
tablishing patent protection for a com-
pany’s core technology. One or more
patent applications should be filed
providing the broadest possible patent
protection covering the core technol-
ogy. When drafting patent applications,
an orthopaedic device company should
teach current and future technology
innovations, as well as alternative em-
bodiments that competitors may at-
tempt to design around the company’s
core technology. Where applicable,
patent claims should be directed at
diagnostic, surgical, prosthetic, and
combination devices; kits; methods of
manufacturing, treatment, or use; and
any other aspects of the invention. As
the core technology evolves, incremen-
tal improvements should be patented to
form a picket fence of protection.
Another key to broad patent protec-
tion is an offensive strategy that pre-
vents competitors from infringing on
(making, using, or selling) a company’s
invention. Companies need to patent
aggressively—they need to fle quickly
and frequently. Filing aggressively en-
sures that a company will claim own-
ership of the technology frst and can
block competitors by fling patent ap-
plications that cover improvements to
a competitor’s product to effectively
limit product enhancement options.
Meanwhile, companies should monitor
their competitors’ portfolios to identify
potential patent infringement.
Filing international patent appli-
cations further strengthens a patent
portfolio by expanding a company’s
presence in the global marketplace. A
company should consider fling in spe-
cifc countries with a large target mar-
ket for the product—countries where
competitors’ manufacturing facilities
are located and countries that export
products to other countries through
channels of distribution. Having pat-
ents in these countries will protect the
company against potential infringers
around the world.
Finally, a company should conduct
frequent audits of its patent portfolio
to ensure its patent strategy adapts to
Building a Patent
Portfolio to Endure
Change
Devel opi ng and mai ntai ni ng a
strong patent portfolio is critical to
an orthopaedic device company’s
growth and survival. Given the re-
cent furry of patent reform mea-
sures initiated by Congress, the
USPTO, and the Supreme Court, or-
thopaedic device companies must
effectively address reform through
a three-pronged approach:
Filing strong patent applications •
to protect a company’s current
core technology and future
improvements.
Monitoring the patent landscape •
and exploring ways to patent
white space.
Considering crosslicensing •
opportunities.
ORT1109 027 27 9/27/11 3:49:54 PM
28 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Intellectual Property
changes in the legal landscape and the
marketplace. A patent audit allows a
company to assess strengths, weak-
nesses, and gaps in its patent portfolio
and identify opportunities to enforce
patents against competitors. Conduct-
ing periodic patent audits ensures that
a company’s patent portfolio achieves
broad and cost-effective coverage of its
discoveries.

Finding Freedom to Operate to
Patent White Space
Exploring white space is another
method for obtaining a strong patent
portfolio. The amount of white space
measures the crowding of a particular
technology area with patents and pat-
ent applications. If the patent landscape
is relatively clear, there is room to stake
meaningful new patent claims. Given
the USPTO’s recent programs to ad-
dress the patent application backlog
and provide accelerated examination
procedures, companies pursue patent
applications in clear patent landscapes
before they become crowded with com-
petitor patents.
Before patenting white space, a com-
pany should undertake a freedom-to-
operate analysis to avoid infringing on
patents owned by third parties. After
conducting a thorough search of patent
and scientifc literature databases and
identifying third-party patents, a com-
pany should maximize its patent pres-
ence within that particular commercial
area. It can accomplish this by identi-
fying potential patent design-around
opportunities that a competitor might
use and blocking these opportunities
by seeking new patents or modifying
current patent applications.
Combination products and therapies
provide another means of exploring
white space and anticipating industry
developments. A combination prod-
uct pairs biologics, drugs, and medi-
cal devices to provide a targeted and
specialized treatment that minimizes
side effects. Examples of combination
products in orthopaedics include bone
fracture fxation devices combined with
an antiinfection coating and implants
combined with bone growth factors.
To avoid issues regarding ownership
of combination products (one company
may claim ownership of a device and
another company may claim ownership
of a drug or biologic), patent rights can
be assigned either entirely to one party
or jointly between the parties. Or, an
exclusive or nonexclusive license may
be established among the companies.

Crosslicenses and Competition
Crosslicensing with competitors is an-
other way to bolster a patent portfolio
and address challenges to the patent-
ing system.
7
A crosslicense is a mutual
sharing of patents between compa-
nies without exchanging a license fee.
Companies enter into crosslicenses
when they have overlapping patents,
and practicing one patent would mean
infringing on another. The companies
pool the relevant patents together
and divide the patent rights amongst
themselves so that each party takes
exclusive or nonexclusive rights to a
particular area of use covered by the
combined patents. A crosslicense is also
accompanied by a promise not to sue.
Therefore, each party in the agreement
can practice its patent rights without
infringing on another’s, thereby avoid-
ing expensive and time-consuming pat-
ent litigation.
Crosslicensing agreements are in-
creasingly important given a recent
rise in patent infringement cases in the
orthopaedic device industry, especially
among key industry players. To counter
this trend in court filings and avoid
costly litigation, companies should
consider crosslicensing strategies with
competitors to further bolster and pro-
tect their patent portfolios.

Conclusion
Orthopaedic device companies must
build and maintain high-value patent
portfolios to be successful in today’s
competitive and rapidly changing pat-
ent environment. These patent portfo-
lios face numerous challenges in the
patent reform storm from Congress,
the USPTO, and the Supreme Court.
By aggressively protecting core tech-
nology, optimizing the patenting of
white space, and seeking crosslicensing
opportunities with competitors, ortho-
paedic device companies can achieve a
strong patent portfolio. This will secure
a company’s competitive advantage in
the marketplace by maximizing patent
protection, securing funding, enhanc-
ing revenue, and increasing marketing
value. It will also be broad and fexible
enough to withstand the changing pat-
ent landscape.

References
1. “US Orthopaedics Extremity Market to Grow to
$4.6 Billion by 2015,” Millenium Research Group
Inc., January 17, 2011.
2. “The Demographics of Aging…” Transgenera-
tional Design Matters (2009); available from
Internet: http://transgenerational.org/aging/
demographics.htm.
3. B Stoll, “First Office Action Backlog Dips Be-
low 700,000,” USPTO Director’s Forum: David
Kappos’ Public Blog (July 12, 2011); available
from Internet: www.uspto.gov/blog/director/entry/
frst_offce_action_backlog_dips.
4. USPTO, PPH-Fast Track Examination of Ap-
plications, PPH Brochure; available from In-
ternet: www.uspto.gov/patents/init_events/pph/
pphbrochure.pdf.
5. KSR International Co. v. Teleflex, 550 U.S. 398,
127 S.Ct. 1727 (2007).
6. Bilski v. Kappos, 130 S. Ct. 3218, 561 U.S. __
(2010).
7. S Qualters, “Cross-Licenses Grow; Legal Work
Follows,” The National Law Journal 29, No. 36
(May 14, 2007).
David J. Dykeman is a patent attor-
ney and cochair of the IP department
at Greenberg Traurig LLP (Boston).
Danielle T. Abramson, PhD is a patent
agent at the frm’s offce in Florham
Park, NJ.
Abramson
Conducting periodic patent audits
ensures that a company’s patent
portfolio achieves broad and cost-
effective coverage of its discoveries.
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Testing
Effcient test protocols remove excess cost and complexity from the
product design equation.
DANIEL SANTOS
Test Protocols: Accelerate
the Process and Keep
Customers Happy
C
reating effective test protocols
can pose many challenges for
medical device design engineers.
It’s critical to establish test protocols
that verify a device will operate safely
and reliably from its frst through its
1000th use. However, in the competi-
tive world of medical devices, speed
to market is important. Test protocols
must consider a device’s entire life
cycle in the shortest amount of time
possible.
Determi ni ng whi ch tests wi l l
accelerate design evaluation, analy-
sis, and verifcation can make a design
engineer’s head spin. Overthinking
the parameters can delay product
release and result in added cost for
the customer. Taking short cuts with
certain tests can lead to failures late
in the process, requiring the team to
start over—or worse, it can lead to
failures in the feld.
However, creating test protocols
that verify and validate that a device
meets a customer’s specifcations and
performance requirements doesn’t
have to be as complex and costly
as it might seem. This article dis-
cusses tips and insights that can help
design teams avoid unnecessary test-
ing, shorten the development process,
prevent nonessential spending, and,
most importantly, increase customers’
satisfaction by meeting their needs.
Customer and Crossfunctional
Collaboration
How a medical device company applies
its process to designing, developing, and
manufacturing an orthopaedic device
greatly affects the accuracy and effec-
tiveness of test protocols.
Firms will often assemble key
people—especially those involved in
testing—in the same room at a kick-
off meeting with the customer. At this
stage, variables that affect the design
should be explained.
For example, after it’s clear where
the product will be released (i.e., the
United States or Europe), the regu-
latory affairs and quality assurance
(RA-QA) team can offer insight on
relevant sterilization parameters. The
procurement group might have unique
knowledge about what materials are
available, and the manufacturing team
can give input as to whether the compo-
nents, dimensions, and materials being
considered will withstand high produc-
tion levels. Without the early collabora-
tion between all involved departments,
it is diffcult for a design engineer to
create expeditious and comprehensive
test protocols that account for these
diverse variables.
Siloed processes whereby phases of
the project are handed off from one
department to another (i.e., business
development to design engineering to
RA-QA) tend to limit the scope and
Solving a Rubik’s cube is
a good example of design
of experiment. To align
all the colors, you must
factor in how multiple
variables interact and
affect one another.
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ORT1109 030 30 9/27/11 4:04:21 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 31 orthotec.com
effectiveness of test protocols. For ex-
ample, if design engineers don’t know
the orthopaedic device will be released
in Europe, they aren’t likely to take
higher pH levels into account during
the design or testing of that parameter.
As a result, the device could fail in the
feld or during clinical trials, requiring
design engineers to start from the begin-
ning of the process. In such case, time-
lines are pushed back, costs increase,
and customers are left unhappy.
Had the RA-QA group been present
during the design and testing process, it
could have given the engineers impor-
tant insight about the types of steriliza-
tions required or performed in Europe.
More upfront testing could have been
done, resulting in nominal design issues
later in the project. Early communica-
tion, comprehension, and collaboration
about what the customer wants among
all departments can signifcantly reduce
cost, time delays, redundancies, and
failures in testing, and minimize cus-
tomer frustrations.
Understand Application and
Environment
In addition to bringing crossfunctional
team members together at the begin-
ning of a project, it is important to
understand how an orthopaedic device
will be used in all aspects of a surgical
procedure. This greatly infuences which
test protocols are established.
If how a device will be operated and
handled is unclear to a design engineer,
many important parameters will be
overlooked in the testing process. For
instance, if limited knowledge leads a
designer to mistakenly think that a de-
vice will be turned on and off and then
placed directly into an autoclave for ster-
ilization, test protocols are more likely to
refect only those limited parameters—
especially if timelines are tight.
However, if that design engineer
had continuously communicated with
the customer—from the beginning of
the project onward—they would have
learned the full extent of the intended
sterilization process, which in this case
is much harsher. Rather than simply be-
ing sterilized after the device is turned
off, it is frst handed to a nurse or surgi-
cal technician who rinses it with water,
Siloed processes whereby phases of the
project are handed off from one department
to another tend to limit the scope and
effectiveness of test protocols.
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32 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
Testing
scrubs it with a brush, dips it into a
cleaning chemical, and then puts it into
the autoclave. Having full knowledge
of how the device will be used early on
enables design engineers to create rigor-
ous test protocols that accurately verify
and validate safety factors. Customers
should divulge how an orthopaedic de-
vice will be handled, along with any po-
tential misuses that can result in failure,
because engineers can’t always decipher
such factors on their own.

Align Customer Wants and
Needs
More often than not, customers come
to medical device manufacturers with
a vague idea of what they want and
need from their orthopaedic device.
They may need their device to contain a
motor with 60 in.-oz of torque, but they
want it to be the size of a highlighter.
Because test protocols are only as good
as the customer specifcations, the de-
sign team and the customer must be on
the same page as to what the customer
wants and what they actually need.
Without clear and detailed specifca-
tions, protocols can miss the mark for
performance, safety, functionality, and
reliability testing.
An effective strategy to ensure cus-
tomer needs are established before the
design and test protocols are developed
is to create a functional prototype—a
bare bones, primitive model of what
the customer is requesting—while still
in the feasibility stage. If the manufac-
turer has the capability, it can create this
mock-up in-house. If not, leveraging the
resources of the production foor or an
outside prototype house is worth the
effort because this preliminary model
ultimately saves time and money.
Returning to the motor example, the
design engineer may intrinsically know
it isn’t feasible for a highlighter-sized
orthopaedic device to generate 60 in.-oz
of torque and may be overkill, consid-
ering what the customer really needs.
However, providing the customer with a
rudimentary sample that demonstrates
why alternatives must be considered is
often more effective than just dismissing
the request out of hand. If the customer
can see and feel that the device must be
the circumference of a baseball to meet
their power requirement, they’re more
likely to compromise between what
they want and what they need.
The sooner the customer and manu-
facturer can nail down feasible product
parameters, the faster the engineer can
design the device and focus on testing
variables.
Understand Variables
Associated with Design of
Experiment
Design of experiment (DOE) is a sta-
tistical tool for creating effective and
efficient test protocols. It takes into
account multiple variables simultane-
ously before test protocols are actually
written and carried out. It is important
to use DOE during process validation.
“In DOE all the factors of interest can be
investigated in a single trial, minimizing
the size of the experimental schedule re-
quired and providing information on key
process interactions...This latter aspect is
of importance since optimal conditions
may occur when one factor is high and
another low. This type of information on
interactions between factors cannot be
easily obtained by investigating the effect
of each factor separately.
A DOE approach permits efficient use of
resources (personnel time, machine time,
materials, etc.), provides detailed analysis,
gives information on reproducibility and
errors, and provides a predictive capabil-
ity...Applying DOE reduces the size and
hence the cost of process validation trials.
It is a regulatory requirement to run suf-
ficient trials to demonstrate the statistical
significance of results, and DOE can assist
in this procedural aspect.
1

Device and process specifications
must be established before a piece of
equipment can be validated because
this information is used to write the
protocol.
2
Table I illustrates an example of
DOE process limits for how a sealant in
an orthopaedic bone drill might hold up
in an autoclave. This DOE process gives
a design engineer a holistic understand-
ing of how multiple variables interact
with each another in an autoclave envi-
ronment. Evaluating multiple variables
at the same time (rather than evaluating
one variable at a time while all others
are held constant) reduces the number
of iterations required, which accelerates
the design and development process.
Balance Functional Testing and
Sterilization Testing
It is both an art and a science to en-
sure you’ve adequately tested a device’s
functionality and its ability to withstand
harsh sterilization environments. Con-
ducting sterilization tests between every
functional test takes time, and that’s
something many medical device makers
can’t afford. To accelerate the process,
many testers separate functional and
sterilization testing methods, which,
unfortunately, causes many important
variables to be disregarded.
For example, some testers might
verify that an orthopaedic handpiece
meets autoclave testing standards, but
they won’t run its duty cycle. Sterilizing
the device hundreds of times without
running it doesn’t test the functionality
of the handpiece. The seals are essen-
tially being tested over and over again
without being subjected to the rigors
of regular use, which is an unlikely
scenario in the feld.
On the other hand, some may test
device functionality by running it 500
times to ensure that the motor, seals,
and internal components are work-
ing properly without testing its abil-
ity to withstand sterilization. If they
aren’t running the device through an
autoclave, it’s not being exposed to
moisture as it would in a real-world
application.
In fairness, there is no single easy
answer that balances these two im-
portant testing needs. It helps to have
experience conducting other tests and
FACTOR
LOW
LEVEL
HIGH
LEVEL
Temperature
(ºC)
115 135
Time (min) 5 20
Pressure (psi) 20 60
Table I. The high and low limits for
temperature, time, and pressure of the
autoclave are hypothetical examples for
these ranges. The levels of each factor
selected are based on knowledge of the
system being tested.
ORT1109 032 32 9/27/11 4:04:24 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 33 orthotec.com
verifying past failures because there
are some similarities in how certain
variables in each handpiece interact.
However, if historic data or previous
experience is lacking, it is important to
at least do the following:

Clearly understand how the device
will be used in the feld.

Conduct component level testing and
subsystem testing early.
As noted previously, understand-
ing the operation and handling of an
orthopaedic device makes it easier to
set up test protocols that replicate the
conditions of actual feld usage. You
can run a motor all day, not stopping
until it burns up (fails), but if that’s not
how it will be used in the feld, you’re
wasting valuable testing time and caus-
ing unrealistic failures. However, if
you conduct a test that closely mimics
feld usage, verifes that the device lasts
through all testing cycles, and verifes
that the device will cause no unintend-
ed consequences, you’ve determined a
good testing protocol framework.
It is crucial to conduct component
and subsystem-level testing. These
tests should be started early in the
development phases—long before a
product is completed. Component-
level testing analyzes individual as-
pects of the device. For example, it
can involve testing a shaft to verify
that it meets strength requirements,
testing gear teeth to ensure they can
withstand torque load, or analyzing
material properties to assess how they
withstand high pH levels.
After verifying that individual com-
ponents will survive real-world use,
subsystem testing can begin. Subsystem
tests bring different components togeth-
er to evaluate how they interact. Take
the example of a motor. You would test
the motor separately before putting it
into a system to determine its limits
and ensure that it functions properly.
Testing the motor frst reduces unin-
tended consequences that could make
the entire handpiece fail in later testing
phases. Once the motor is tested using
realistic testing parameters, add another
variable, such as the cable, to see how
the two interact. If these two variables
interact successfully, the next step is to
add other handpiece components or
subsystems to the test. This process can
make it easy to pinpoint failures. After
you’ve determined that the motor and
cable tested well together, you know
any issue or a failure must be caused
by an interaction between other com-
ponents or subsystems.
Subsystem testing is a key part of
product design. Verifying that each
subsystem can handle the rigors of the
feld eliminates much of the variable
testing later on, further accelerating the
speed of reliability testing.
Recreate Realistic Usage
Environments In-House
Another way to accelerate reliability
testing is to create a real-world, real-
time testing environment in-house. This
method provides more control over
how a device is tested. Testers have the
ability to see how the orthopaedic de-
vice is tested, hear how it sounds, and
experience how different variables are
interacting.
This in-house environment might
include dishwashers for pH testing,
machines for autoclaving, a simulated
cadaver lab to test bone density, and a
prototype shop to quickly create func-
tional prototypes. If a design engineer
doesn’t have adequate in-house capa-
bilities to test components and subsys-
tems, it’s diffcult to recreate realistic
applications. They must rely on the
material specifications—hoping they
are correct—or farm out tests to verify
failures, gaining little understanding of
why the failures occurred.
In addition to keeping the whole
testing process under one roof, devel-
oping proprietary testing equipment
specific to the orthopaedic medical
device helps create an authentic test-
ing environment. Equipment that isn’t
specifc to the device often won’t pro-
vide an accurate prediction as to how
the device will hold up in the feld. For
example, using an oven to replicate the
autoclave temperature thermal cycling,
which reduces testing time, may seem
adequate. In actuality, the lack of steam
and pressure cycling eliminates crucial
variables that the device will likely
encounter in the feld.
Proprietary testing equipment can
also save a lot of time compared with
manual testing. For example, creat-
ing an automated panel system to test
multiple orthopaedic surgical drills
eliminates the need for an operator
and increases a manufacturer’s ability
to test more than one unit at a time. De-
veloping proprietary testing equipment
to mimic operative handling enables
the manufacturers to meet the strictest
customer specifcations.
Conclusion
There’s no one-size-fits-all approach
to creating effective, proprietary test
protocols, especially when it comes to
accelerating reliability testing. How-
ever, overlooking key fundamentals will
delay processes. The most important
starting point is to ensure all individu-
als involved in testing or testing-related
activities are on the same page and
understand the customer’s parameters
and the device’s intended feld use. This
makes developing accurate, legitimate
test protocols an intriguing process of
discovery, rather than one of uncer-
tainty and adversity.
References
1. D Dixon et al., “Application of Design of Experi-
ment (DOE) Techniques to Process Validation in
Medical Device Manufacture,” Journal of Valida-
tion Technology 12, no 2 (2006).
2. GHTF/SG3/N99-10:2004 Edition 2, (PDF)
“Quality Management Systems—Process Vali-
dation Guidance.”
Daniel Santos is engineering manager
at Pro-Dex Inc. (Irvine, CA).
The design team and the customer must be
on the same page as to what the customer
wants and what they actually need.
ORT1109 033 33 9/27/11 4:04:28 PM
Products & Services
Find new equipment, components, and supplies for orthopaedics here.
34 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
PPSU Resin
A polyphenylsulfone (PPSU) resin is suited for medical devices such as a
positioning support for orthopaedic trauma surgery. Radel PPSU is strong
and chemically resistant, and can withstand up to 1000 cycles of
autoclaving without losing toughness or impact resistance. It is a tough,
transparent thermoplastic with a heat distortion temperature of 207°C.
Another performance attribute is its processability.
Solvay Specialty Polymers
Houston, TX, 713/525-6000
www.solvayplastics.com
Swiss Clamp System
A Swiss clamp system is used with machine tools in the
manufacture of orthopaedic instruments and
components, including bone screws and implants. The
EZR Swiss Clamp System ensures increased torque
by achieving proper settings and enables fast, positive
ER collet clamping. It
eliminates wrench slippage
and prevents the loss
of clamping nuts in the
machine sump-chin bin.
Operators’ hands are
kept clear of the sharp
tools in the tooling zone.
The system also prevents
accidental breakage
of ID microtooling. The
Swiss clamp nuts can be
tightened using standard
box wrenches or a
3
⁄8-in.
drive ratchet wrench with the EZR wrench adaptor or the
EZR torque adaptor. Both adaptors engage and lock to the
clamping nut with a specialized cam system on the face,
delivering positive torque to the nut.
Genevieve Swiss Industries, Inc.
Westfield, MA, 413/562-4800
www.genswiss.com
Machining Vise
A company is replacing a currently avail-
able model of machining vise with an
upgraded version of an older model. The D688
features an 8.8-in. jaw opening and repeatability to
within 0.001 in. It is replacing the D675. The new
model produces up to 7968 lb of clamping force with
80 ft·lbf input torque. The D688 has a jaw capacity
that is 25% greater than that of the D675 model, and
its clamping torque is greater by 36%. The distance
from the keyway to the stationary jaw is identical in the
two models, so they can be easily aligned on a vise
table. The vise is designed with an alloy steel screw
mechanism and high-precision roller bearings. The
vise has a porosity-free ductile iron body, which is
designed to provide overall vise rigidity while absorbing
machining vibration.
Kurt Manufacturing Co.
Minneapolis, MN, 877/226-7823
www.kurtworkholding.com
Laser Ablation Machine
A five-axis laser ablation machine is designed for 3-D machining.
LaserSmart is suited for extra-fine 3-D laser machining of super-hard
materials, such as PCD and CBN. Surfaces do not have to be flat; the
machine can handle surfaces with an arbitrary geometry. It can be used to
apply logos and tool numbers to PCD, CBN, or CVD silicon carbide inserts.
Rollomatic Inc.
Mundelein, IL, 847/281-8550
www.rollomaticusa.com
ORT1109 034 34 9/27/11 3:51:27 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 35 orthotec.com
Grinder
A specialty grinder can be used to grind
multifaceted cannulae, trocars, and
other specialized surgical tools. Fanuc
CNC servo-programmable controls
enable the grinding of multiple axes.
They control profle and angle, as well
as the length and depth of cut and the
number of facets. The controller can
store individual programs for grinding
different products. Machine technicians
who know the g-code language used
by Fanuc machine controls can use the
grinder immediately. Operators are able
to quickly change the parameters of a
given program. Canned programs are
also provided.
Concep Machine Co.
Northbrook, IL, 847/498-9740
www.concepmachine.com
Blast Machine
A blast machine can clean substances
such as hydroxyapatite and titanium-
coating overspray from equipment
such as cup-and-stem implant fxture
masks, which can become encrusted
with coating when medical implants are
vacuum plasma sprayed. The Multiblast
RSB machine is ftted with a 14-station
planetary component drive and two
vertically traversing pressure-fed blast
nozzles. The objects to be cleaned are
manually loaded into component hold-
ers on the turntable, in the center of
the rubber-lined blast chamber. The
door is closed and the turntable begins
rotating clockwise, while the 14 com-
ponent holders rotate on their own
axes. The objects rotate at a controlled,
adjustable speed and are blasted from
the two blast nozzles, which vertically
traverse the component, aiming at a
prepositioned angle and from a prepo-
sitioned distance. After the blast cycle
is fnished, an integral air knife blows
the residual dust from the components.
The system is ftted with a PCL-HMI,
enabling full operational control over
all machine variables. A simple menu
system enables recipes to be entered and
recalled as needed.
Guyson International Ltd.
Skipton, North Yorkshire, UK
+44 1756 799911
www.guyson.co.uk
Online Bone Database
An online information resource covers
the properties of human bone. The Hu-
man Biological Materials data module
is part of an expanded materials infor-
mation system for orthopaedic device
designers and manufacturers. It can
help them make informed decisions
regarding the selection, substitution,
qualifcation, regulation, and biocom-
patibility of materials. The module is
an authoritative collation of data on the
mechanical properties of primary load-
bearing bones gathered from various
publications. It can serve as a reference
for a designer working on an implant-
able device that must complement or
mimic human body performance. In
its frst release, the searchable resource
presents the tensile, compressive, fexur-
al, and general properties of the femur,
tibia, vertebrae, and acetabulum.
Granta Design
Mason, OH, 800/241-1546
www.grantadesign.com
Optical Inspection System
Relying on the white-light axial chro-
matism technique, an automated op-
tical inspection system is capable of
stand-alone operation or in-line in-
tegration. Featuring a stage that can
move as fast as 1 m/sec, the HS100
provides both speed and resolution. At
maximum speed, the unit can measure
one point every 32 μm. Scan rates range
from 31,000 points per second with
nanometer accuracy up to 324,000
points per second when a line sensor is
employed. The x-y measurement area is
IMPLANT COMPONENTS
Implantable Biomedical Fabrics
Custom implantable biomedical fabric structures made of Zeniva PEEK fber
are for OEM use in therapeutic devices that have applications in orthopae-
dics and general surgery. The PEEK material, manufactured in conditions
compliant with ISO 13485 and GMPs and tested in an accredited laboratory
compliant with ISO 17025, has a modulus similar to that of bone and exhib-
its good biocompatibility, toughness, and fatigue resistance. The fabrics for
implantable devices are woven, knitted, or braided from the fbers for use in
high-strength sutures; bone-anchoring devices; rotator cuff and arthroscopic
joint repair; spinal stabilization and disk repair and replacement; textile-based
heart valves and vascular grafts; and mesh structures for tissue reinforcement
and wound support in surgery. The PEEK is supplied by Solvay Advanced
Polymers through a partnership.
Secant Medical LLC
Perkasie, PA, 877/774-2835
www.secantmedical.com
ORT1109 035 35 9/27/11 3:51:46 PM
Products & Services
36 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
400 × 600 mm. The system features a
range of automated options for measur-
ing such surface characteristics as pro-
fle, dimension, roughness, shape and
form, flatness and planarity, volume
area, step-height depth, and thickness
values.
Nanovea Automated Optical Inspection
Irvine, CA, 866/333-4674
www.nanovea.com
Carbon-Fiber Composites
Exhibiting mechanical strength and
heat-distortion properties, thermoplas-
tic carbon-fber composites consist of
a thermoplastic matrix and a woven
fabric made of carbon-fber bundles. Ac-
cording to the manufacturer, the Tecatec-
series provides higher tensile and fexural
strength than fiber-reinforced extru-
dates. Supplied in standard plate thick-
nesses of 3–40 mm and in other dimen-
sions upon request, the lightweight,
chemical-resistant materials are also
radiolucent, making them suitable for
external fxation devices and surgical
instruments. One of the composites—a
PEEK-matrix polymer compressed with
laminated woven-carbon fabric mats
constituting 50% of the composite—
provides torsional stiffness and resists
warping even after multiple sterilization
cycles. The other composite is a PEEK
matrix laminated with a 60%-carbon-
fiber fabric. Capable of undergoing
steam sterilization, this carbon-fiber
component ensures dimensional stabil-
ity and stiffness.
Ensinger Inc.
Washington, PA, 724/746-6050
www.ensinger.co.uk
Laser Processing and
Cable Assembly
A company partners with medical de-
vice OEMs to provide diverse laser
processing services, including laser
welding of stainless steel and titanium
components for bone screws. The ISO
13485:2003–certified company of-
fers precision laser machining, cutting,
drilling, and welding of surgical imple-
ments and implantable devices from
many materials, including stainless
steel, titanium, platinum, borosilicate,
quartz, ceramic, and silicone. Lasers
incorporating the latest technology,
along with high-output production
equipment, enable the service provider
to concentrate on medical device ap-
plications involving small component
features and requiring high precision.
Laserage Technology Corp.
Waukegan, IL, 847/249-5900
www.laserage.com
Turning Center Software
A supplier of precision machine tools has
developed software for its line of turning
centers. CAMplete TruePath Turn-Mill
software is an integrated suite of g-code
editing, optimization, analysis, and veri-
fcation tools for use with Nakamura-
Tome multitasking turning centers. The
software can enable a range of turn and
mill functions. It was designed to com-
bine g-code from CAM systems and
hand-coded g-code into a set of programs
that could be simulated, fne-tuned, and
optimized using 3-D machine models.
Methods Machine Tools Inc.
Sudbury, MA, 978/443-5388
www.methodsmachine.com
Miniature Medical Parts
A contract medical device manufacturer
has acquired a Tornos 7 Swiss turn-
ing center to facilitate the machining
of miniature medical parts. Suited for
the high-precision machining of very
small surgical instrument and medical
implant components, the machine can
produce parts as small as 0.030 in. in
IMPLANT COMPONENTS
ePTFE Materials
Used to manufacture orthopaedic implant coverings, an ePTFE material is
chemically inert, hydrophobic, and gas permeable. Available in a range of
tubular diameters, lengths, and
wall thicknesses, the material is
suitable for a variety of implant-
able medical device applications.
In addition to displaying con-
formability, temperature stabil-
ity, and gas permeability, the
ePTFE material can be made
thin and strong using the com-
pany’s high-density microwall
technology. This process can
produce fat sheets with thick-
nesses as low as 0.1 mm.
Bard Peripheral Vascular OEM
Products
Tempe, AZ, 800/655-8722
www.bardpvoem.com
ORT1109 036 36 9/27/11 3:51:57 PM
The Medical Device Industry’s Most
Comprehensive Project Acceleration
Resources Comes to Texas!
MD&M Texas is your gateway to
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For information on exhibiting or attending, please visit
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ORT1109 037 37 9/27/11 3:52:16 PM
Products & Services
38 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
diameter and length, with tolerances
of ±0.0002 in. As a Swiss machining
center, the system minimizes defection
and supports attainment of very close
dimensional tolerances by machining
the area of the part immediately adja-
cent to the collet. The Swiss machin-
ing center, according to the company,
enables the more precise and effcient
production of smaller parts than is pos-
sible with computer-aided machining.
This advantage can, in turn, translate
into higher-quality parts at a reduced
cost, according to the company.
MicroGroup Inc.
Medway, MA, 800/255-8823
www.microgroup.com
Modular Workholding
System
A modular workholding system uses
compact clamp, power clamp, and
microclamp technology to hold small
and midsize parts. The system, which
enables parts to be changed easily, is
designed for machining medical prod-
ucts. The clamping designs minimize
interference, ensuring machine spindles
have full access to the workpieces. Ep-
oxy mineral tombstones have the char-
acteristics of cast iron with the weight
of aluminum.
Triag
Allenwinden, Switzerland,
+41 41727 2727
www.triag.ch
Laser Welding Workstation
Capable of joystick-controlled deposit
welding and high-precision CNC-
controlled welding processes, a system
is equipped with functions to support
process validation for medical device
manufacturing. The Select laser weld-
ing workstation enables the observation
of crucial welding parameters, includ-
ing yielding gas monitoring, to ensure
process reliability.
Rofin-Baasel Lasertech
Starnberg, Germany, +49 8151 7760
www.rofin.com
Biomedical Materials
A company provides a range of biomed-
ical materials for minimally invasive de-
vices, orthopaedic implants, and surgi-
cal instruments. The frm also maintains
a cleanroom facility for developing
and manufacturing custom formula-
tions. These include PEEK compounds
for long-term implants and bioresorb-
able polymer compounds with such
additives as tricalcium phosphate and
hydroxyapatite.
Foster Corp.
Putnam, CT, 860/928-4102
www.putnamplastics.com
Precision Machining
A manufacturer is repositioning its
precision medical machining services
to include device design assistance,
prototype development, component
device validation, and volume precision
machining. The company specializes
in the process design and manufac-
ture of high-precision Swiss-machined
components. End-use products include
surgical tools and spine implants.
Marshall Manufacturing
Minneapolis, MN, 800/321-6727
www.marshallmfg.com
Lubricious Coating
Lubricious coatings can prevent medi-
cal devices from shedding wear parti-
cles inside patients’ bodies. Baymedix
CL 100 is a polymer coating that is
grown directly from a material sur-
face, enabling it to bond to a substrate
through strong covalent linkages. This
bond enhances the coating’s durability
and its ability to resist particle genera-
tion. The company says the technology
gives its coating an advantage over
other lubricious coatings, like hydro-
philic coatings, which are weakened by
the water they absorb.
Bayer MaterialScience LLC
Pittsburgh, PA, 412/777-2000
www.baymedix.bayermaterialscience.com
Microabrasive Blasting
Platform
A microabrasive blasting platform
can fulfill the surface modification
and cleaning needs of medical device
manufacturers. ProCenter Plus is a
freestanding workstation and dust col-
lection unit in one platform. The con-
sole swiftly evacuates spent abrasive
from the blaster’s chamber, keeping the
work area clean. Unlike conventional
dust collectors that require frequent
cleanings, this HEPA flter–equipped
unit can handle a large amount of
spent abrasive in its oversized stor-
age hopper without any infuence on
blasting performance. The system has
built-in silencers and features quiet
operation. Other design highlights in-
clude advanced downdraft technology
and a large, well-lit work chamber
to maximize operator comfort. ESD
control features and a magnifer are
also available.
Comco Inc.
Burbank, CA, 818/841-5500
www.comcoinc.com
ORT1109 038 38 9/27/11 3:52:20 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 39 orthotec.com
Supplier Beat
Recent news about suppliers to the orthopaedics industry.
OrthoWorx (Warsaw, IN),
an industry, community, and
education initiative promot-
ing the orthopaedic device
sector in the Warsaw region,
has hired David K. Floyd as
its CEO.
Formerly the president of
DePuy Orthopaedics (War-
saw), Floyd is also a founding
member of the OrthoWorx board of
directors, where he served until this past
April, and chaired the organization’s
transportation and logistics initiative.
“We are delighted that Da-
vid has agreed to join our or-
ganization as chief executive
offcer,” Cheryl R. Blanchard,
chair of the OrthoWorx
board of directors, said in
a statement. “David’s indus-
try experience as the global
head of a multi-billion dollar
orthopaedic enterprise, his
leadership in the creation and launch of
OrthoWorx, and his deep connections
to the Warsaw community make him
ideally suited for this position.”
In addition to his tenure at DePuy
Orthopaedics, Floyd served as presi-
dent of Abbott Spine (Austin, TX),
president of Centerpulse Orthope-
dics (Austin), and president and CEO
of AxioMed Spine Corp. (Garfield
Heights, OH).
“I am delighted to join OrthoWorx
and to be able to draw on my experi-
ences in leadership and in the ortho-
paedic industry in a different way—to
help the Warsaw region continue to
thrive as the orthopaedic capital of the
world,” Floyd said in a statement.
OrthoWorx Taps Former DePuy
Executive for CEO Position
UL Expands
Capabilities with
Acquisitions
Product safety testing company UL (Camas, WA)
has acquired test laboratory MDT Medical Device
Testing (MDT; Ochsenhausen, Germany) and MD
Registration Support (MDRS; Ochsenhausen), an
advisory frm that helps medical device manufac-
turers achieve CE marking for their devices.
The acquisition is designed to enable UL to
reach more medical device manufacturers, in-
cluding makers of orthopaedic, ophthalmic, and
cardiovascular implantable devices.
“The deepening of our service offerings will
put the UL brand in front of a wider variety of
customers—including some of the biggest com-
panies in the medical and health feld,” Anil Patel,
general manager of UL Health Sciences, said in a
statement. “From sterile gauze and bandages to
more complex devices such as bone screws, contact
lenses, orthopaedic, dental, and other implantable
devices, UL’s testing capabilities will help manu-
facturers develop products that will keep patients
healthy and mobile.”
MDT and MDRS are joining UL’s life and
health business unit and will expand its services,
including testing, to help medical device manufac-
turers improve the safety of their products.
Floyd
Marshall Manufacturing
Increases Services
Medical components manufacturer Marshall Manufacturing (Min-
neapolis) has broadened its service offerings to better serve OEMs
that have downsized their in-house engineering departments.
The company now offers in-
creased medical device design as-
sistance, prototype development,
component device validation,
and volume component preci-
sion machining.
“Simply being a precision parts
manufacturer in today’s medical
device industry is not enough,”
Michael Burchill, president of
Marshall Manufacturing, said in
a statement. “We will be mak-
ing more of our experience and
resources available to assist cus-
tomers with the development and
manufacturing of their products.
As the engineering outsourcing trend has grown, it has been a challenge
and opportunity for our talented staff to step up and play a greater role
in our medical customers’ innovation.”
Marshall Manufacturing specializes in the design and manu-
facture of high-precision, Swiss-machined components; machined
needles; 2-D and 3-D contouring; and bending machined wire and
tubes. Its components are used in products including trocars, surgical
tools, and spine implants.
ORT1109 039 39 9/27/11 3:54:27 PM
Supplier Beat
40 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
University Purchases EOS Laser-Sintering System
eCustoms
Launches Service
for Export Law
Compliance
International trade services provider
eCustoms (Buffalo, NY) has added a
service to help orthopaedic device com-
panies comply with export laws gov-
erning restricted or denied parties. The
company’s Easy List-Check service helps
clients achieve continuous compliance
without the use of IT resources or ad-
ditional employee training.
“Few companies have people who
are trained in the complete ins and outs
of country-specifc trade regulations or
customs compliance,” Jackson Wood,
eCustoms corporate business manager,
said in a statement. “We wanted to make
it easy. That’s why we’ve created the
Easy List-Check service. It provides a
simple way for orthopaedic companies
to address their compliance needs.”
Easy List-Check takes less than one
working day to implement, according
to the company. It provides eCustoms
with a list of names or companies to be
checked and creates a compliance report
summarizing the results of the review.
The process is protected by encryption
and security technology, and users are
charged per record. Easy List-Check can
be used on a regular basis to help compa-
nies maintain long-term compliance.
EOS (Krailing, Germany) has an-
nounced that the Centre for Additive
Layer Manufacturing (CALM) at the
University of Exeter in the United King-
dom has purchased one of its EOSINT
P800 laser-sintering systems.
With its ability to process tempera-
tures up to 385°C, the EOSINT P800
can process high-performance poly-
mers, such as polyether ether ketone
(PEEK), a material used in medical im-
plants. The system, which is the frst of
its kind in the United Kingdom, will be
used “to research applications across
industry and to provide services for
universities and companies,” according
to a spokesman for the company.
“Partnering with the University of
Exeter to provide additive manufactur-
ing facilities for the southwest of the UK
will further help to raise awareness for
a technology that is currently shifting
paradigms in design and manufactur-
ing,” Hans J. Langer, founder and CEO
of EOS said in a statement. “We are also
looking forward to expanding the use
of the PEEK material, which is being
processed on the P800, in the aerospace,
medical, and motorsports arena.”
Millstone Medical Outsourcing
Hires VP of Operations
Precision Medical Technologies
to Expand Instrument Business
Precision Medical Technologies (War-
saw, IN), a contract manufacturer
specializing in spine, trauma, and
sport medicine devices, plans to open
a second facility in 2012.
The site will be an extension of the
company’s instrument manufacturing
division. It will be located in Rome
City, IN, which the company owners
believe is “a highly desirable location
from which to attract skilled machin-
ists and CNC programmers,” accord-
ing to a press release.
The facility will feature at least $1
million in new equipment and is ex-
pected to create at least 10 new jobs.
Millstone Medical Outsourc-
ing (Fall River, MA), an out-
sourcing company serving or-
thopaedic OEMs, has named
Karl Neuberger vice president
of operations at its Memphis
facility.
Neuberger, who has served
in executive positions for vari-
ous companies, including a durable
medical equipment supplier, will be re-
sponsible for managing the facility, run-
ning programs, and ensuring effcient
loaner kit processing and distribution.
“Karl is a veteran operations pro-
fessional,” Chris Ramsden, Millstone
CEO, said in a statement. “We are
excited to have his experience and
expertise in place as we grow to meet
the needs and expectations
of our customers. At Mill-
stone, we are committed to
continuous improvement,
and I am confdent that Karl
will help us maintain and
then exceed the high level of
quality with which we oper-
ate in Memphis.”
Neuberger’s expertise includes devel-
oping and implementing programs, im-
proving sales and marketing, strength-
ening infrastructure, and streamlining
operations. He is charged with scaling
operations to meet the demands of
Millstone’s customers. Millstone pro-
vides inspection, cleanroom packaging,
loaner kit processing, and distribution
services for medical device OEMs.
Neuberger
ORT1109 040 40 9/27/11 3:54:34 PM
ORTHOTEC | SEPTEMBER/OCTOBER 2011 41 orthotec.com
Contributors
Ad Index
Roger Posusta is senior marketing ap-
plications engineer in the stylus and op-
tical metrology business unit at Bruker
Nano Surfaces. Posusta has experience
in engineering, R&D, electronics, and
optical metrology. He has provided ex-
pert applications support for 3-D opti-
cal microscopy. Send him an e-mail at
roger.posusta@bruker-nano.com.
Pierfrancesco Robotti is responsible for scientifc market-
ing at Eurocoating (Italy), an international service vendor
that manufactures porous structures for bone integration.
Robotti has 15 years of experience working with orthopae-
dic companies. He received his MSc in biomedical engineer-
ing at Milan Polytechnic University, in Italy. Reach him at
francescorobotti@eurocoating.it.

Daniel Santos is the engineering man-
ager at Pro-Dex Inc. (Irvine, CA), which
designs, develops, and manufactures
surgical devices, components, and sub-
assemblies for leading medical device
OEMs. He has a master’s degree in engi-
neering from UCLA, with specialization
in design and manufacturing. His previ-
ous experience includes design and development of various
types of orthopaedic and surgical devices. Contact him at
daniel.santos@pro-dex.com.
Danielle Abramson, PhD, is a registered
patent agent in the New Jersey offce
of Greenberg Traurig LLP. Abramson’s
practice focuses primarily on patent
prosecution in the area of biomedical
sciences, with particular expertise in
orthopaedic devices, medical devices,
and pharmaceuticals. She received her
PhD in medical sciences from Brown University. E-mail her
at abramsond@gtlaw.com.
Robert Boland is the sales director for
Trinks Inc. (De Pere, WI), with respon-
sibility for both domestic and foreign
equipment sales. Boland has worked as a
consultative representative involved with
the sale of compression, transfer, and
injection molding machines to various
industries, including the medical indus-
try. He graduated from Temple University with a bachelor’s
degree in business administration. Reach him at rboland@
lmgpresses.com.
David Dykeman is cochair of the intellec-
tual property department in the Boston
offce of the law frm Greenberg Traurig
LLP. Dykeman’s practice focuses on se-
curing strategic worldwide intellectual
property protection for high-tech clients,
with particular expertise in orthopaedic
devices, medical devices, biotechnology,
and healthcare IT. He can be reached at dykemand@gtlaw.
com.
Leo Glass founded Surface Dynamics
(Chelsea, MI) after 23 years at APS Ma-
terials Inc., where he served as executive
vice president and vice president of sales
and marketing. During his time there, he
held various positions in sales, engineer-
ing, and regulatory management. Glass
has a bachelor’s degree in chemical en-
gineering from the University of Cincinnati. Get in touch
with him at lglass@sdbiocoatings.com.
Matt Novak is the marketing applica-
tions manager in the stylus and opti-
cal metrology business unit of Bruker
Nano Surfaces (Tucson, AZ). Novak
has 15 years of experience developing
metrology products and systems across
a range of applications, including opti-
cal inspection, surface characterization,
and thin flm flter characterization. He can be reached at
matt.novak@bruker-nano.com.
Lowell Inc...........................................................31
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Master Bond Inc. ................................................19
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Orchid Orthopedic Solutions ... Inside Front Cover, 11
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Pro-Dex Inc. ......................................7, Back Cover
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Rösler ................................................................13
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ORT1109 041 41 9/30/11 1:55:06 PM
Ortho Scope
42 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.com
The pie chart shows the breakdown of net
sales for 2010, which reached $519 million.
During the second quarter, net sales
increased 4% over last year’s Q2.
A full profle of Wright Medical is at
orthotec.com/article/wright-medical-
profile
Online
Extremities
and Biologics
(International) 7%
Other
2%
Orthopaedic Reconstruction
(United States) 27%
Orthopaedic Reconstruction
(International) 32%
Extremities and
Biologics
(United States) 32%
N
e
t

S
a
l
e
s

(
$

m
i
l
l
i
o
n
s
)
133
132
131
130
129
128
127
Q2 2010 Q2 2011
126
Wright Medical Group Inc.
Leadership

Robert J. Palmisano, president and
CEO

Lance A. Berry, senior vice president
and CFO

Timothy E. Davis, Jr., senior vice
president, corporate development

William L. Griffin, senior vice presi-
dent, global operations

Karen L. Harris-Coleman, senior vice
president, sales and marketing, Ja-
pan, Latin America, and Pacifc Rim

Edward A. Steiger, senior vice presi-
dent, human resources

Eric A. Stookey, senior vice presi-
dent and chief commercial offcer

John T. Treace, senior vice president,
global marketing and U.S. sales
Highlights

September 2011: Names Robert J.
Palmisano president and CEO.

September 2011: Reaches agree-
ments with U.S. Attorney’s Offce of
New Jersey and the OIG.

July 2011: Announces exclusive deal
with ArthoCare for foot and ankle
products.

April 2011: Appoints chairman David
D. Stevens as interim CEO following
the resignation of Gary Henley.

January 2011: Expands relation-
ship with Kinetic Concepts to sup-
ply Graftjacket regenerative tissue
matrix through December 2018 for
orthopaedics markets.
Focus Going Forward

Implement first phase of cost re-
structuring plan over the next nine
months.

Continue to strengthen compliance
program.

Transition from interim to permanent
senior management while operating
under the terms of the DPA and the
surveillance of the federal monitor.
“With a solid portfolio and strong pipeline
of new products, the company is well
positioned for success.”
—ROBERT J. PALMISANO, president and CEO
I
n the span of just a few days, Wright Medical Group Inc. (Arlington, TN)
announced a cost-restructuring plan, extended its deferred prosecution agree-
ment (DPA), and named a new president and CEO. It’s a lot to swallow for
a company that has seen one executive after another leave this year following a
scandal involving its compliance program.
The problems began in April with the abrupt resignation of then-CEO Gary
Henley, which came prior to a board meeting that planned to discuss management’s
handling of the company’s ongoing compliance program. The company also received
a letter from the U.S. Attorney’s Offce for the District of New Jersey, stating that it
had “knowingly” violated provisions of the DPA. The scandal snowballed and led to
several executive resignations.
In September, the company announced a cost-restructuring plan in the hopes of
improving cash fow and shareholder value. The plan will cost between $25 million
and $30 million, with the frst phase occurring over the next nine months. As part
of the initiative, the company will lay off 80 employees, or 6% of its workforce.
Wright Medical also hopes that the steps it takes to improve operating effcien-
cies will boost the company to an adjusted earnings per share of about $0.05 to
$0.06 next year and about $0.08 thereafter. The company also agreed to extend
the terms of its DPA for 12 months.
The fnal twist came a day later with the appointment of Robert J. Palmisano
as the new company president and CEO. “In recent months, we have taken many
positive steps to better position the company for success, including strengthening
our compliance program and implementing a plan to reduce operational costs,”
said interim president and CEO David Stevens in a company statement. “We be-
lieve Bob is the right person to continue building on this progress.” The company
has temporarily suspended its sales and earnings outlook to allow Palmisano to
transition into his position. —Maria Fontanazza
Trying to Right the Ship
ORT1109 042 42 9/27/11 3:55:56 PM
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Contents
September/October 2011 • Volume 2 • Issue 4 Cover Story

8

IMPLANT MANUFACTURING

Surface Manufacturing
Plasma spray coatings and additive manufacturing technology offer orthopaedic device manufacturers big benefits.

BY LEO GLASS AND PIERFRANCESCO ROBOTTI

14
Features

16
Columns

20

16 Materials Characterization

42 Ortho Scope
Wright Medical restructures following the departure of several executives.

3-D Optical Microscopy Solves Material Selection Challenges
This method of precision surface metrology provides improved characterization of implant materials.

BY ROGER POSUSTA AND MATT NOVAK, PHD

Departments

20 Compression Molding

Joint Replacements Fit The Mold
Compression molding offers cost benefits over other methods of molding joint replacement parts.

BY ROBERT BOLAND

24 Intellectual Property

How to Weather the Patent Reform Storm
Orthopaedic device companies are entering a brave new world of IP and patent reform.

6 14 34 39 41 41

From the Editor Blog Teasers Products & Services Supplier Beat Contributors Advertisers Index

BY DAVID J. DYKEMAN AND DANIELLE T. ABRAMSON, PHD

30 Testing

On the Cover
The backside of a femoral condylus has been coated with hydroxyapatite. Image courtesy of Eurocoating s.p.a. (Ciré-Pergine, Italy).

Testing Protocols Keep Customers Happy
Find out how to create efficient test protocols throughout the product life cycle.

BY DANIEL SANTOS
orthotec.com ORTHOTEC | SEPTEMBER/OCTOBER 2011 3

Online Contents
Monkeys Walk with Spinal Implant; Humans Next

EDITORIAL STAFF
DIRECTOR OF CONTENT, MEDICAL DEVICE BRANDS

ACCOUNT MANAGERS

www.orthotec.com

Matthias Gasser
Tel: +41 32 6663090 France

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EDITOR-IN-CHIEF

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Tel: +49 911 93976442 Germany, Eastern Europe

Heather Thompson
EDITOR, ORT

Hermann Jordi
Tel: +41 32 6663090 Austria, Switzerland

Maria Fontanazza
MANAGING EDITOR

The once-paralyzed CEO of InVivo Therapeutics designed his own physical therapy program and regained the ability to walk. Not all patients with spinal cord injuries (SCIs) are so lucky. Frank Reynolds wants to save as many of them as possible from life in a wheelchair with an implant that protects the spinal cord from inflammation, further bleeding, and cell death following SCI. Check out the top OrthoTec’s news story of the summer at

Brian Buntz
ASSOCIATE EDITOR

Laura Polidori
Tel: +39 086 1737255 Italy

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ASSISTANT EDITOR

LIST RENTALS

Statlistics
Tel: 203/778-8700

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DIRECTOR OF SALES

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Tel: 781/879-4642 New England, MA, NY, FL, RI, Canada

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ART DIRECTOR

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PUBLICATIONS PRODUCTION DIRECTOR

orthotec.com/article/invivo-implant

SOUTHEAST TERRITORY SENIOR ACCOUNT EXECUTIVE

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Tel: 480/699-7196 AR, AZ, CO, KS, NV, OK, TX, UT

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VICE PRESIDENT AND EXECUTIVE DIRECTOR

New Implants, Components, and More
Recently given FDA 510(k) clearance, DePuy’s Trumatch Personalized Solutions system (right) uses technology that customizes the fit of a knee replacement. CT scans and software create femoral and tibial cutting blocks that match the bone surfaces of a specific patient. These scans are quicker, cheaper, and provide better imaging than MRIs. Get more product and company updates at

Andrea Marmalstein
Tel: 310/445-3737 MO, NE, NM, WI Special Projects (Nationwide)

Stephen Corrick
SENIOR VICE PRESIDENT, EVENTS DIVISION

Kevin O’Keefe
VICE PRESIDENT, OPERATIONS, PUBLICATIONS DIVISION

BRAND DIRECTOR, QMED

Tim Simone
Tel: 310/445-3767

Roger Burg
VICE PRESIDENT, DIGITAL MEDIA

ACCOUNT EXECUTIVES, QMED

Nicole Welter
Tel: 310/445-3754 Tel: 310/445-3747

Jason Brown
VICE PRESIDENT, PEOPLE AND CULTURE

Alison LeBoeuf
CLIENT SERVICES, QMED

Harris Grayman
VICE PRESIDENT, MARKETING

Renee Bernabe
Tel: 303/254-4758

Kieran Hannon

INTERNATIONAL
INTERNATIONAL SALES DIRECTOR

Andrew Porter
Tel: +44 2075 604029 Benelux, Ireland, Israel, Scandinavia, UK
ORT/OrthoTec (ISSN 2153-9782, print; ISSN 2153-9790, online) is published quarterly by UBM Canon, 11444 W. Olympic Blvd., Los Angeles, CA 90064; 310/445-4200; FAX 310/445-4299. SUBSCRIPTIONS—Free to qualified subscribers as defined on the subscription card. Basic subscription price $50 (one year). Delivery outside United States by air service. For telephone inquiries regarding subscriptions, call 763/746-2792. CHANGE OF ADDRESS—Notices should be sent promptly to P.O. Box 47461, Plymouth, MN 55447. Please provide old mailing label as well as new address. Allow two months for change. EDITORIAL CONTRIBUTIONS—Electronic submissions in Microsoft Word are preferred. Submissions may be e-mailed to maria.fontanazza@ubm.com, faxed to the attention of ORT at 877/743-6688, or mailed to Editor, ORT, 30 Two Bridges Rd., Ste. 227, Fairfield, NJ 07004. NOTICE—Every precaution is taken to ensure accuracy of content; however, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein. POSTMASTER—Send address changes to ORT/OrthoTec, P.O. Box 47461, Plymouth, MN 55447. Canadian Post International Publications Mail Product (Canadian Distribution) Sales Agreement No. 40612608. Canada Post return address: BleuChip International, P.O. Box 25542, London, ON N6C 6B2, Canada. Printed in U.S.A. ©2011 by UBM Canon. All rights reserved. Reproduction in whole or part without written permission is prohibited.

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But times are difficult now. We’re seeing a lot more partnerships and acquisitions that are generating new business.com 6 SEPTEMBER/OCTOBER 2011 | ORTHOTEC . the company has experienced a compound annual growth rate of more than 20%. As we talk to OEMs about what type of suppliers they want. we’ve seen the opposite. is looking at where the industry is headed but is doing so from the standpoint of what OEMs want. “OEMs have maintained supplier bases that are unmanageable because they’re so large and diverse. Implant manufacturers are being hit especially hard. and so far. executive vice president and general manager at Oberg. how are you turning challenges into success stories? Let me know what’s going on at your company.S. Stryker. T he business of manufacturing anything isn’t easy. First. which leads me to another part of the equation—the supplier. —MARIA FONTANAZZA maria. Following a partnership announced with Stryker in August. FL) was founded four years ago. PA) has been around for more than 60 years.fontanazza@ubm. That being said. I often wonder how a company can not just survive but also thrive in this hostile economic environment. medical device business has recently exploded. but right now. according to David Bonvenuto.” Operating in harmony with what OEMs need has been the key to Oberg’s recent growth.S. Biomet. and Wright Medical have cut or announced plans to cut jobs. “Contrary to the unemployment rates and the focus on jobs [in] a stalling economy over the last several years. During the past three years. Most of these jobs will be in sales because the company outsources its manufacturing. (Sunrise. He thinks his company’s technology will be a disruptive force in orthopaedics. the company is planning to continue its upward trajectory. this strategy is leading to success. Manufacturers and suppliers must think and operate strategically at all times. Sometimes it’s easier to get caught up in the negative news. too. they seek to improve quality.” says Bonvenuto. let’s look at a young company. I think we need to talk about the positive things happening in our industry. Zimmer. Is it luck or smart business practices and strategic thinking? In most circumstances I’d say that it’s a little bit of both. and the company recently held its first job fair to find candidates.com orthotec. and CEO Jay Pierce is directing the company right where he sees orthopaedics headed—into an era of smart technology that integrates electronics and sensors into implants. “[OEMs] are looking to consolidate their supply chains. and pricing [while working] with fewer top tier–type suppliers. Oberg. delivery. OrthoSensor Inc. workforce. Seasoned supplier Oberg Industries (Freeport. Within the orthopaedics segment. Its U.” he says. people who have lost their jobs aren’t going to pay for elective hip or knee surgeries. Pierce told the South Florida Business Journal that OrthoSensor is planning to hire up to 40 people during the next year. In 2011 alone. Looking ahead to 2012 and 2013.From the Editor What’s Your Success Story? Focusing on the future and listening to what customers want will help manufacturers keep a strategic eye on the prize. Oberg wants to add more than 50 positions to its U.

proprietary six-phase product development cycle consisting of the following phases: Product Feasibility. document controls and CAPA systems. state-of-the-art. Coupled with our full Quality Management System compliance. prototyping. Pro-Dex also operates an ISO 2001 facility in Nevada that manufactures custom motors for the aerospace and medical markets and a facility in Oregon that produces multi-axis motion control products for leading research labs.pro-dex. Irvine Ca 92614 Phone: (800) 562-6204 e-mail: info@pro-dex. every time. develops. and manufactures custom electric. or a fully-designed product. has introduced its new 13485-certified contract manufacturing division. at a lower total cost.ADVERTISEMENT CORPORATE PROFILE Pro-Dex. Prior to its move in 2008. 2361 McGaw Ave. Post-Production Evaluation. Pro-Dex took two years to design and architect a 30. Pro-Dex is focused on getting customers to market faster. semiconductor. Pro-Dex delivers a powerful solution for your surgical products including: Detailed Design Product Feasibility Proof of Concept Prototyping and Production Program Management Pro-Dex Inc. with facilities in Oregon and Nevada. This is why Pro-Dex. Whether your are starting with a “napkin” concept. foot. with a safe and reliable product. manufacturing facility with a focus on concurrent engineering. Product Transfer and Release. designs. Pro-Dex’ headquarters. Inc Pro-Dex. Safe and effective products are paramount to our clients’ success.com Website: www. reliable contract manufacturing capabilities to leading Medical Device Manufacturers. Proof of Concept . Inc. is an ISO 13485-certified manufacturer of cutting-edge powered surgical devices to leading OEM’s. reliable and delivered on time. Headquartered in California.000 sq. based in Southern California. At the start of every project. This thorough approach guarantees that the end product will be safe. air and battery-powered surgical devices for leading Medical Device OEMs. in-process inspection and lean manufacturing cells in order to deliver highly reliable and safe products while compressing their customer’s time to market. and medical diagnostics applications. Pro-Dex implements a process that incorporates a proven. 13485-Certified Contract Manufacturing offers an unmatched level of competency and excellence to controlling manufacturing processes. Design Verification and Validation. Pro-Dex understands how important it is to keep up with the ever-changing regulatory guidelines.com Advanced Validation and Verification Testing Post-Market Surveillance Contract Manufacturing Custom Motors Multi-Axis Motion Control Marketing contact: Tricia Rodewald Sales Contact: Jim McKenney . Product Design and Process Development . focused on providing responsive.. Inc.

safe. automated and controlled to prevent the application or transfer of excessive energy—specifically heat—to the substrate.000°C. plasma spray was a special process technology that was not easily 8 SEPTEMBER/OCTOBER 2011 | ORTHOTEC verifiable without destructive testing.Implant Technology Macromanagement: Surface Manufacturing for Implants Plasma spray coatings and additive manufacturing technologies offer significant value to orthopaedic device manufacturers. Powder metal or ceramics are injected into the plasma stream internally or externally and are then melted and accelerated An acetabular at the substrate. In today’s world. A dc arc is maintained. the technology has proven itself reliable. Inert gases (argon-nitrogen) flow over a cylindrical copper anode and a tungsten cathode. can accomplish this mission. The molten or semimolten droplets attach to the roughened substrate and splats of particles. Controlled atmospheric plasma spray (CAPS) or vacuum plasma spray (VPS) is used to process metallic powders that exhibit oxygen-sensitive properties. Unlike many technologies in use during the 1980s. with new engineered process controls and automated equipment that is all validated as a complete system.com Image courtesy of ADLER ORTHO . the plasma spray process depends on thermal conditions (the temperature must be at the melting point) and kinetic energy. which are used to manufacture macroporous surfaces for orthopaedic implants. HA is a naturally occurring mineral form of calcium apatite with the formula Ca10 (PO4)6 (OH)2. The material melted in the plasma is simultaneously accelerated by high-velocity plasma-gas stream. OEMs must consider using technologies to make products that prove their relevance based on both increased regulatory scrutiny and a costbenefit ratio. The material is synthetically derived into a powder form and applied using an air plasma system (see Figure 1).manufactured for cess is carefully clinical use in Europe. and effective. LEO GLASS AND PIERFRANCESCO ROBOTTI T he practical application of a technology that differentiates a product from its competition isn’t always the most novel approach. Plasma spray and additive manufacturing technologies. Another breakthrough came later that decade with the introduction of hydroxyapatite (HA) coatings for dental implants. In the orthopaedics market. However. When applied to a substrate. The air plasma spray is used to process an HA coating but is not typically used for processing titanium metal powder. cup is serially The entire pro. Part 1: Plasma Spray Coatings The use of plasma spray coatings in the manufacture of medical devices began in the early 1980s with Biomet’s introduction of the titanium porous plasma spray coating. plasma-sprayed titanium coatings are commonly used to make titanium alloy hip im- orthotec. which creates gas plasma with a core temperature that can reach up to 30. within the past five years.

which in turn gives a service manufacturer more flexibility on delivery times and overall cost. shoulder. volume. Titanium is extremely sensitive to oxygen pick-up in high-temperature environments. Advances in process control have enabled the application of thick coatings (up to 1000 μm). Both processes can successfully produce porous coatings that are beneficial for bone up-growth and in-growth. Overall Capability PPM < LSL 0. ORTHOTEC | SEPTEMBER/OCTOBER 2011 9 . The thickness of the coating determines the predictable amount of pore size. which allows for high porosity and interconnecting porosity that is suitable for joint replacement components. This process normally requires the use of metallic hard masking to protect parts and can raise the overall cost of production.03 PPM > USL * PPM Total 0.01 PPM > USL * PPM Total 0. The ease of manufacturing allows for greater overall output. swer is multifaceted and depends on the device market. The CAPS coating process maintains a low-temperature coating substrate interface that avoids metallurgical bonding or elemental migration. Figure 2 shows the results that can be obtained with tight process control over the application of a porous titanium coating onto PEEK implants. Titanium coatings are being applied to knee. This chart shows the resulting data from the tight process control of a porous titanium coating onto PEEK implants. Within Performance PPM < LSL 0.65 Within Overall Potential (Within) Capability Cp * CPL 1. Ti-Growth is a VPS coating that eliminates the pore-size advantage of sintered beads. The search for a process that improves the uses of this material has led OEMs to work with a variety of surface-modification technologies. PEEK is used in fusion devices that are designed to be inert. This means that bone treats the polymer as inert but does not want to attach to it mechanically or chemically. elbow. The CAPS unit processes the coating and the implant in a positive-pressure inert atmosphere. Process Capability of CP-Ti on Peek Tensile (PSI) LSL Process Data LSL 3190 Target * USL * Sample Mean 5290. H2 Water Figure 1. though the material does have one limitation. high strength.Plasma Spray Process Powder Powder Spray Film Plasma Jet Substrate Arc + Anode Cathode Water Ar.1.80 PPU * Ppk 1. However.68 Sample N 34 StdDev(Within) 370. the VPS coating process introduces considerable heat. and radiolucent. and overall porosity that can be achieved. plasma-sprayed titanium coatings exhibit the minimum pore size characteristics needed to be defined as a porous coating. and ankle implants. Bone will not grow into pores that are less than 100 μm.80 Cpm * 3500 4000 4500 5000 5500 6000 6500 Observed Performance PPM < LSL 0.218 StdDev(Overall) 388. The porosity profile is not an ordered structure like porous beads but instead is a completely random structure that is rough and porous. especially when applied to fusion-type devices.89 Overall Capability Pp * PPL 1.01 Exp. Molten Particle Splat plants.00 Exp.03 Tight Process Control What are the distinct advantages to plasma-sprayed titanium porous coatings. Although noted for its bioinert properties. PEEK has little direct bone attachment. along with other products made from titanium and cobalt-chromium-molybdenum alloys.2 Today. It offers mechanical performance benefits and allows for parts to be moved in and out of the chamber. A porous coating is defined as one that exhibits bone in-growth into the coating. and how do we understand how to best use the technology? The anorthotec. The basic concept is simple. This application fits into many of the uses for PEEK. CAPS and VPS methods process titanium powder using plasma spray technology but perform the same process in a different manner with different equipment. while the VPS unit processes at a controlled low-vacuum pressure. Apply a bioactive coating to a bioinert material to enhance bone up-growth or osseointegration.89 CPU * Cpk 1.00 PPM > USL * PPM Total 0. The spinal device market will continue to use PEEK in a range of applications.com Figure 2. The plasma spray process must be controlled to avoid excessive heat transfer to a surface.

AM has created a loyal following among suppliers.2 Max 0.3 This image and table are an example of atomized Ti-6Al-4V powder and its chemical composition. Starting materials are in liquid or powder form and are subjected to consolidation upon local energy supply.5–4.16 0. It can also withstand structural degradation at high temperatures.97 4. Improved software and process controls enable these technologies to produce devices with porous structures that compete directly with those produced by alternative machining and porous coating methods of manufacturing. 10 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec. These coatings can be applied to almost any material and geometry. In addition. Thus. m a n u f a c t u r e s f a c e challenges when applying thermally sprayed materials to PEEK. The physical and thermal properties of polymeric materials are very different from those of metallic or ceramic materials. there has been technology that can build up solid parts from 3-D computer-aided design models.Implant Technology H o w e v e r. AM has created a loyal following among suppliers.5 Max 0. The chemical structure of PEEK exhibits outstanding chemical and radiation resistance.015 Max 0.5–6.05 Max 0. Part 2: Additive Manufacturing For at least two decades. the material must be kept at a temperature By eliminating several manufacturing steps and inventory costs. The plasma spray process has evolved from a misunderstood technology method to a mainstream technology for manufacturing porous coatings.01 0. rapid or additive manufacturing (AM) technologies.75 3.01 0. are showing they can compete with traditional coating technologies in manufacturing porous titanium surfaces and offer the added benefit of a complete near-net part construct.013 0. To address the challenges related to these characteristics. the titanium coating can be applied using specially developed air or vacuum plasma spray processes that provide low-temperature stability during processing. the plasma spray process is used extensively in the device market.0025 0. Nevertheless.08 Max 0. By eliminating several manufacturing steps and inventory costs. although not new to the world. CAPS has also shown superior capability in enabling a Human mesenchemal stem cells proliferate onto a titanium additive-manufactured macroporous surface. that does not exceed the glass transition temperature of 143°C. stimulating a specific chemical or ELEMENT WEIGHT (%) ISO 5832-3 Ti Al V O N C H Fe Balance 5.com .056 Balance 5. porous titanium coating on PEEK without chemical or mechanical deterioration during the plasma-spray process.

implant manufacture. Orchid’s key mission is to be the leader in contract medical design and manufacturing by compressing time to market. dental and cardiovascular markets. MI 48842 Phone: (517) 694-2300 Fax: (517) 694-2340 Sales@orchid-orthopedics. Orchid Orthopedic Solutions’ contract design and manufacturing divisions offer the following products and services: contract design and development (e. joint and bone replacement components. Orchid Orthopedic Solutions has more than 900 skilled employees at locations throughout the United States. near-net forging (e. The company meets the ISO 13485:2003 international standard for medical devices and related services that consistently meet customer requirements and regulatory requirements. implants. extremities.com www. instruments and innovative technologies for the following markets: reconstruction. implants.. spine. spine. plates and extremity parts).. sports medicine. screws. The company provides unparalleled customer service through innovative design and development. dental and medical devices. nails.. products. TPS and RBM. trauma.. forging. porous and bead coatings and surface treatments (e.orchid-orthopedics. design troubleshooting. providing new technology and being the best total supply-chain value. Orchid’s purpose is to provide an opportunity for people to live a better life. implant and instrument systems. and gage design and fabrication). customs and specials. dental and medical devices.com . New technologies.g. implants). plastics and coatings. trauma. Major Markets Served Orchid Orthopedic Solutions specializes in implants. Orchid Orthopedic Solutions 1489 Cedar Street Holt. and HP. instruments and innovative technologies for the following markets: reconstruction. medicalgrade precision-machined and molded plastic products (e. implant coatings and surface treatments and packaging for the medical device industry. surgical instruments. Facilities & Capabilities Headquartered in Holt. medical devices. advanced machining.. The company offers an array of implants and instruments within five core capabilities: design. extremities.and design innovations are constantly being developed for Orchid customers. plastic technology. Michigan. plates and joint replacement parts).g. components and delivery systems).g. machining. orthobiologics.g. quality and regulatory. Products/Services Orchid Orthopedic Solutions specializes in implants. instrument manufacture. advanced machining (e.g. sports medicine.02_55565598 OT1004 re ADVERTISEMENT CORPORATE PROFILE Orchid Orthopedic Solutions Corporate Description Orchid Orthopedic Solutions is a worldwide leader in contract design and manufacturing solutions for the orthopedic. orthobiologics.

One critical concern is that titanium is chemically prone to oxidation. Results revealed a high capability to maintain the material within HA and titanium coatings were applied to this PEEK Motis implant. as manufactured. when high dimensional accuracy is required for coupling components.com 12 SEPTEMBER/OCTOBER 2011 | ORTHOTEC . Each layer can be as thin as 30 μm.9 Studies also showed that Ti alloy macroporous structures that were EBM-manufactured and surgiorthotec.7 If porous structures are manufactured on the pieces. The production cycle of Ti-6Al-4V alloy-based parts presents challenges. chining. such as thermal treatments.8 Once components with their porous coating surface are additive manufactured. < 0.2%. the partial sintering of the powder.3..e.5.4 The second part of this article focuses on two specific AM technologies —electron beam melting (EBM) and direct metal laser sintering (DMLS). which holds it in place during the subsequent melting. Such data has been proven successful through in vitro and animal testing. and second. A typical layer thickness is 70–100 μm. Productivity for the DMLS process as defined (melted material per hour) is lower when compared with the high-energy EBM process. it may decrease material ductility. When additional mechanical work is applied. These technologies can produce parts made of implantable metals such as titanium alloy (Ti6Al4V). The common feature of these AM technologies is that they melt and rapidly solidify portions of a metal powder layer according to the specific drawing being replicated. and chemical etching. it is crucial to avoid or remove contaminants such as emulsions and lubricant residuals from porous structures. specification when the processes are performed correctly.Implant Technology physical reaction. per ISO 5832-3). The ultimate goal of porous titanium structures is to host living bone tissue in a manner that guarantees device fixation by osseointegration. The process leads to improved resolution and accuracy in the pieces manufactured compared with those made via EBM. However. This process has two effects: first. the high temperature (about 600°C) maintained during the process reduces the thermal gradient between the just-melted layer and the already built-up body of the part. Under specific process conditions. This approach substantially reduces residual stresses.5 A DMLS machine for titanium alloys uses a laser beam with a higher focus capacity than EBM. they may be subjected to further critical postprocess steps. an electron beam gun preheats the powder layer using a relatively low beam current and a relatively high scan speed. If the oxide content in the manufactured parts exceeds standard requirements (i. sandblasting. and it is necessary to remove these particles.1 mm and are a long way from typical values obtained by ma- An HA coating is applied via the plasma spray process onto a femoral hip stem. Part of the powder loaded into the equipment that is not melted to form the solid parts will eventually be reused in the next manufacturing cycle. hipping. or machining. In an EBM machine. Properly engineered and EBM-manufactured surface structures allow human mesenchemal stem cells to attach to the structures and spread. solidification results in a fully dense solid body. The powder feeder tanks are also routinely refilled with new powder so that a blend between reused and new powder is permanently in place. contain a number of loosely adhered surface beads. Numerous analyses were performed to obtain a statistical picture of the oxygen and carbon rate variation against powder reuse. The most practiced particle-removal methods are thermal treatments. a number of studies have demonstrated how the mechanical properties of the titanium alloy obtained by AM may fully satisfy the applicable standards and fatigue resistance requirements.6 When using AM technologies. It does not find a correspondence in the international standard dealing with titanium alloy microstructures for biomedical applications (ISO 20160). a critical postprocess step such as titanium debris cleaning may be required. both for the powder in the tanks and for the final parts. Both technologies release the Ti6Al-4V alloy with a specific acicular microstructure that cannot be modified by heat treatment and can be considered a building process fingerprint. tolerances against nominal design are about 0. or a combination of these methods. Nevertheless. a number of different topographic structures can be achieved with excellent performances.6 Designing and Manufacturing Macroporous Surfaces When a contract manufacturer uses both EBM and DMLS technologies in serial production. The porous structures. Technologies that produce components according to this strategy are categorized under AM. it can establish a process surveillance strategy.

“The Effect of E-Beam Engineered Surface Structures on Proliferation and Differentiation of hMSCs.” Proceedings of the Second International WLTConference on Lasers in Manufacturing (Munich. “Frictional and Bone Ingrowth Properties of Engineered Surface Topographies Produced by E-Beam Technology. Applying Additive Manufacturing AM has a host of possibilities. June. Stress Shielding. It enables the delivery of intricate geometrical components completed with designed lattice surface topography in one manufacturing step.a (CiréPergine.” British Bone and Joint Surgery 69-B. References 1.. “Porous-Coated Hip Replacement. 7. LLC is the leader in mass finishing. The main advantage is design freedom.” Rapid Prototyping Journal 16. and 3D Imaging Conferences (Anaheim. Facchini et al. no. Our system solutions provide precise.made in the USA. May 18–20.rosler. E Magalini et al. 5 (2011):711–718. Visit www. no. 10 These results show favorable conditions to enable device fixation. 2010). Italy). 2003). JE Biemond et al.” Proceedings RAPID 2010 and 3D Imaging Conferences (Minneapolis. 2011). repeatable processes to meet the strict requirements of the medical device industry. Leo Glass is president of Surface Dynamics (Cincinnati). June. “The Optimum Pore Size for the Fixation of Porous-Surfaced Metal Implants by the Ingrowth of Bone.” Proceedings of the Second International WLT-Conference on Lasers in Manufacturing (Munich.” Clinical Orthopaedics 150.” Rapid Prototyping Journal 15. (1980):263–70. CA. So who do you trust to provide the exact finishes your OEM requires? Rosler has specialized in superior surface finishing equipment and consumables for over 60 years. L. The method enables complex surface components to be manufactured in a costeffective and timely manner. 3 (2009): 171–178. 9. The method can also be used in the rapid manufacture of complex-shaped custom implants and thousands of acetabular components for hip arthroplasty. Rosler Metal Finishing USA.. 3. The Factors Governing Bone In-Growth. AM technologies are proving to be the way of the future.. 6.” Proceedings RAPID 2010 Artificial joints get pretty personal and need very specific finishes.p. E Magalini et al. which improves device fixation strength.. C Over et al.” Archives Orthopaedic and Trauma Surgery131. CA Engh et al.cally placed in immediate stable conditions promoted a bone in-growth of about 1. T Wirtz et al. 8.” Proceedings at ORS 2010: Orthopaedic Research Society (Louisiana March 6–9... no. no. Using the process with titanium produces orthopaedic components with a surface trabecular (porous) structure that promotes bone colonization and in growth. JD Bobyn et al. JE Biemond et al.. “Industrialization and Validation of RM Process. 2003). Pierfrancesco Robotti is responsible for scientific marketing in Eurocoating s. “Microstructure and Mechanical Properties of Ti64 Produced by EBM of PreAlloyed Powders. “New Possibilities for the Design and Manufacturing of Bone Implants with External and Internal Functional Architecture. These could be your knees... (2010): 450–459. “Effect of the Microstructure on the Ductility of a Ti-6Al-4V Alloy Produced by SLM of Prealloyed Powders.. shot blasting.1 (January 1987). 10. 2010). orthotec.com ORTHOTEC | SEPTEMBER/OCTOBER 2011 13 . “Porous Titanium Foams with Additive Manufacturing Technologies.. automated processes and media .5 mm after six weeks of implantation time in goats. Facchini et al. 5.. May 24–26.us or call 269-441-3000. and Clinical Results. 4. 2. Implant makers are examining ways to meet inventory volume needs while adhering to regulatory requirements. “Rapid Manufacturing of Metal Parts and Tools Using Laser Melting.

com Bionic Leg Integrates Man and Machine Advanced electronics technology is boosting the power of a lower-limb prosthetic. ■ Operation time on a single charge: Three days of normal activity/13–14 km of continuous walking. Fast facts about Vanderbilt’s bionic leg: ■ Weight: 9 lb. 42. ■ Better hardware design: The hardware has endured seven designs. sitting. we have validated our hypothesis that the right technology was available to make a lower-limb prosthetic with powered knee and ankle joints. users who were equipped with the device walked 25% faster on level surfaces then they did when they used passive lower-limb prosthetics. EMEA commercial operations. Visit orthotec. etc. Palmisano CEO and announced a signficant restructuring plan. and secretary.) that many take for granted. Developed at Vanderbilt University’s Center for Intelligent Mechatronics (Nashville). CEO. John Knighton. Professor Michael Goldfarb (right) stands with amputee Craig Hutto.com Photo courtesy of JOHN RUSSELL/VANDERBILT UNIVERSITY . which includes layoffs. Wright Medical is trying to get back on track. it lifts the leg to get away from the obstruction and plants the foot on the ground. and the electronics board has been revised 15 times. standing. “With our latest model.”. Raymond Kolls. the following executives have left Wright Medical: ■ ■ ■ ■ ■ ■ Gary Henley. The development of the device came after seven years of research and was funded by the National Science Foundation and the National Institutes of Health. vice president. CA) exclusive rights to make the device. Vanderbilt University patented parts of the design and has given prosthetic manufacturer Freedom Innovations (Irvine. compliance director at the company. Alicia Napoli. It is designed to simplify the daily movement (walking. Lisa Michaels. clinical and regulatory affairs. Fort Flowers professor of mechanical engineering at Vanderbilt. who is wearing the new bionic leg developed at Vanderbilt University. will 14 SEPTEMBER/OCTOBER 2011 | ORTHOTEC fill in for now. which tend to drag or have a lag in motion. general counsel. senior vice president and chief technology officer. who directed the research. Cary Hagen. 2012. senior vice president. However. Sensors monitor the prosthetic’s motion.Blog Teasers OrthoTec’s blog covers the latest development in the orthopaedics industry. orthotec. The company also voluntarily extended its deferred prosecution agreement until September 29. vice president and chief compliance officer. vice president and chief compliance officer. —MF Since April. According to studies. It has named Robert J. “Our device illustrates the progress we are making at integrating man and machine. Read more about this news on p. Microprocessors take the data to predict the user’s desired movement and act accordingly. So what’s next? The Center for Intelligent Mechatronics is working on an anthropomorphic prosthetic arm project and an exoskeleton for use in physical therapy. ■ Antistumble routine: If the leg senses that the user is about to stumble.” said Michael Goldfarb. The company’s board of directors plans to hire a recruiting firm to find Michaels’ replacement. the device is an improvement over traditional prosthetics. H. senior vice president. Frank Bono. —Maria Fontanazza Will Wright Medical Straighten Out Compliance Issues? The compliance scandal at Wright Medical continued during the summer with the resignation of Lisa Michaels. enabling simultaneous knee and ankle joint use.

while struggling procedure volume growth combined with steady price degradation is the sign of the times. There is generally a rough-andtumble flavor to most product liability litigation.” said Doug Leach. Zimmer is accusing the attorneys of being dishonest about the safety records of the knee implants in their zeal to recruit potential plaintiffs.5 million in revenue. “The single-radius design philosophy of Stryker knees is a perfect complement to OrthoSensor’s innovative technology. which tend to cost less than imported implants. An article in Bloomberg provides a snapshot of just how contentious this fight has been.com .” The latest confusion surrounds joint reconstruction volumes. Surgeons use this information to alter the position of an implant. which it says is progressing according to plan. which enjoyed a strong second quarter. FL) was positioning itself to be a disruptive force in orthopaedics through its strategy of integrating electronics and sensors into implants. The OrthoSensor Knee Trial has embedded sensors and microelectronics that give surgeons real-time feedback about ligament balance and joint kinematics during knee arthroplasty procedures. Neither the aggressive campaigns from plaintiffs’ attorneys nor the aggressive response from Zimmer are particularly surprising. to say the least. according to the analysts. the legal wrangling over Zimmer’s NexGen knee implants has been contentious. in a statement. (Sunrise. According to the article.S. it’s not all bad news. detailing how Zimmer has begun suing plaintiffs’ attorneys. or is this an overreaction on Zimmer’s part? —Thomas Blair ORTHOTEC | SEPTEMBER/OCTOBER 2011 15 OrthoSensor’s knee trial integrates microelectronics and sensors. The company is beginning to put this plan into action. Roger Williams University law professor David Logan stated that it “opens up a new front in the product-liability wars. the company is providing its OrthoSensor KneeTrial system for use with Stryker’s Triathlon Knee System. “The days of lavish spending on surgeons and consulting agreements are a thing of the past. The company sold 12 of its RIO systems during the quarter. because the medical insurance companies prefer to reimburse domestic implants. Kanghui also has an advantage in competing against multinational companies in China.” Do you think he’s right? Is this tactic something other orthopaedic and medical device companies can use in future product liability defense efforts? Or is it going to backfire? Is it time to pull out all the stops when it comes to fighting back against plaintiffs’ attorneys. —MF the gradual improvement of business in orthopaedics. Biomet saw its sales fall in Q4 2011.6 million. change leg alignment. launched a kyphoplasty system earlier this year and could be entering the joint implant segment next year. at Stryker Orthopaedics. sales. KangHui’s growth will be driven by the eight trauma and spine products that it released in 2009 and 2010. orthotec. They noted that business should get better with the economy— but the question is when. which accounted for $9. However. —MF Zimmer Fights Back Against Plaintiffs’ Attorneys by Suing Them As is true of most product liability litigation. As part of this agreement. However. Last year. Mako Surgical reported second quarter revenues of $18. The company. forming a partnership with Stryker Orthopaedics. Robotics manufacturer Mako Surgical and China-based KangHui Medical could experience better-than-expected results this year. right on the heels of the previous quarter’s flat U. And the fallout from the metalon-metal hip controversy has yet to be fully realized. campaigns the company says have unfairly maligned its reputation. The data is wirelessly transmissed onto a graphic display.Smart Idea: Glory Days of Stryker Embeds Orthopaedics Are Microelectronics Over from OrthoSensor Although analysts are positive about At the start of 2011. “We expect medtech investors to play the waiting game for many of these stocks until consistent growth and subsequent leverage opportunity returns. knee reconstruction. an 81% increase over Q2 2010.” analysts with investment research firm Canaccord Genuity wrote in its assessment of the market. and optimize soft tissue balance. the article makes it clear that Zimmer’s move is innovative. the company began an orthopaedic surgeon preference evaluation following the clearance of its Makoplasty system for the hips. several firms have launched campaigns to attract clients. OrthoSensor Inc. vice president of global R&D. they say the industry will never be the same.

ultimately. granuloma formation. Local height orthotec. electronics.com . especially when assessing scar depth and volume removal. This wear and the resulting presence of particulates in the body can lead to bone resorption. Systems based on this 16 SEPTEMBER/OCTOBER 2011 | ORTHOTEC technology successfully measure materials in research and production line environments in subnanometer vertical resolution for a wide range of industries. have increased flexibility. and general manufacturing and precision machining inspection. This evaluation enables the manufacturer to make implants with improved wear and that are more comfortable. coated. ROGER POSUSTA AND MATT NOVAK. The light reflected from the sample is precisely compared with the light reflected from the reference mirror. Today’s top-performing 3-D optical microscopes provide quantitative evaluation of materials prior to implantation to determine the wear characteristics of surfaces in a variety of preparations (uncoated.Materials Characterization Determining Material Characteristics of Hip Implants: 3-D Microscopy is the Answer 3-D optical microscopy provides improved wear characterization. light from a source is focused on a sample and simultaneously reflected from a reference mirror in the instrument (see Figure 1). PHD M aterial selection can be a challenge for hip implant manufacturers. including medical. and versatile methods of precision surface metrology. loosening of the joint. aerospace. which can also damage a surface during measurement. Technology-Driven Solution Three-dimensional microscopy uses white light interferometry (WLI) and is one of the most accurate. automotive.). solar. etc. data storage. and. This failure mechanism is driving improvements in biometric materials that provide several options for hip replacement surgery. implant failure. CCD Reference Signal Module Mirror Reference signal detector(s) Laser Beamsplitter Reference Mirror Light Source Mirror on the Scanner Objective Mirau Interferometer Sample Figure 1. and last longer. In WLI microscopy. A 3-D microscope offers a noncontact advantage over contact stylus systems that have mechanical filtering due to tip radius. Basic design of a 3-D microscope with a self-calibrating helium-neon laser. MEMS. A major factor in longterm success for implant procedures is limiting the gradual and progressive shedding of material from the implant surfaces. repeatable. polished.

or in limited cases. ORTHOTEC | SEPTEMBER/OCTOBER 2011 17 . The wear data is used to compute volume displacement. A virgin PEEK sphere with a diameter measuring 1 in.5 5. After initial characterization of the PEEK sphere. was used to simulate a hip joint. A photograph of the PEEK sphere and the corresponding 3-D microscopic image of the portion to be inspected are shown in images 1 and 2. and the top of the surface was mapped using a 3-D microscope. a wear mark was made to simulate wear and volume removal.5 5.94% of Total Vol: 7. and metalon-metal implants have drawn negative attention for their tendency to produce friction-created debris.0 3. Images of the worn surface and the leveled representation of the wear mark are shown in image 3.5 6.5 4. in addition to providing the volume of material removed. Image 3.22 μm3 Normal Volume 652147136.0 4.2 Wear Study Example The following example is an alternative method of performing wear studies based on 3-D microscopic metrology that provides critical parameters to characterize the wear scar.32 μm 16.com Plastic-on-metal. Thresh: 27. The worn PEEK sphere surface is remapped.5x108 μm3/mg volume of material and matches the nominal mass density of PEEK. Image 2. which correlates to ~7. the measurement conditions can be tailored to match the application requirements for a vast array of sample surfaces.5 1. information is obtained as a function of lateral position on the sample. ceramic. This information can be useful during process development.86% of P-V Pts Below: 99. By using proper filtering and high-brightness LEDs as source illumination.0 2. Most recently. After this small volume of material was removed. worn surface.0 0. the surface was remapped.33% of Total Figure 2. and actuated response studies. Careful characterization of the wear and wear rate for the materials involved is critical to improving the long-term performance and stability of these products. By subtracting the original pristine surface from the second.00 μm3 Total Displaced Volume 1.26e+009 μm3 Natural Volume 24.00 μm3 Negative Volume 664661888.5 0. material property analysis. This image shows a PEEK sphere with a diameter that measures 1 in. or where material wear is produced due to constant contact with other components.32e+009 μm3 6.0 2. A 3-D surface map of the PEEK sphere is made before wear.Image 1. Image 4.0 0.88e+008 μm3 62. This information is readily attained using 3-D optical microscopy.1 5. The wear and resulting inflammation can lead to osteolysis (bone destruction). The data presented in image 4 are used to compute the volume displace- Volume Calculations Normal Volume Options 1. loud frictional squeaking due to ceramicon-ceramic stripe-wear patterns.0 5.0 0. The presence of the helium-neon laser delivers a self-calibrating reference for the movement of the scanner in order to account for changes in the position due to environmental variations. Several fields of view were measured at 5x magnification and combined to produce an accurate and wide-angle view of the top portion of the surface. which in turn causes inflammation of the tissues surrounding the implants. specifically for areas such as film thickness metrology.5 1. This particular wear mechanism is prominent in implants— specifically hip implants—where there is necessary contact by device design and function. The chart shows 1 mg of material removed. environmental response (corrosion) studies.0 1.5 2. orthotec. and product development engineers because the final performance of a material in an application can be correlated to the wear measured in such a manner.0 4.00 μm3 Positive Volume Net Missing Volume –12514752. and material selection. This debris can lead to increased residual presence of polyethylene or metal components in the body.5 3. the technology is enabling users to examine the behavior of materials over a range of timescales as they are worn via cutting or grinding operations.5 2.0 1. the material mass displaced and the volume loss can be precisely calculated. pseudotumors. Applications for this technology are being developed outside the traditional surface measurement realm.5 3.0 3.5 4. materials science engineers. It is invaluable to process development engineers. The high vertical resolution and high lateral resolution achieved by WLIbased 3-D optical microscopy ensures the accuracy of this methodology.

0 6000.12% of P-V Pts Below: 99.0 3. Noncontact 3-D Microscope Metrology The speed and versatility of 3-D microscopy brings accuracy and data-quality advantages to the user.0 2000.228 μm) 50 R M Label Sa Sku Sp Sq Ssk Sv Value Units 34.0 2.5 2.0 3.533 μm) 1000.16e+009 μm3 Negative Volume 1. slightly less than 5 mg of total material was eventually removed. Lateral resoluX Profile (2861.0 0. which is highly correlated with gravimetric machines.95e+009 μm3 Natural Volume 92.72% of Total Figure 3.5 2.0 4000.0 0. with 4 mg of material removed. Even with this mismatch.1 5. the associated error in mass determination is on the order of 10 times smaller than gravimetric means.Materials Characterization ment. For this second stage of the material wear and volume removal experiment.5 1.2 Thresh: 48.5 4.5 3. The analysis and volume computation for the initial wear mark and computation are in Figure 2 on p.0 6000. This mass removal corresponds to approximately ~3.5 0.5 4.347 μm 0 μm –50 –100 –150 0 1000 2000 3000 μm 4000 5000 6000 Figure 4.0 2000.0 3000.379 μm –1. 18 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec.0 1. The chart shows the new volume loss calculation.0 Y Profile (3734.0 5000.0 2.85% of Total Vol: 3. To verify the repeatability of the technique. and the surface was remapped.5 1.023 –118. For an even more accurate representation of this removal.796 μm 3.5 6.com .0 μm μm 85 50 0 μm –50 –100 R M 50 0 –50 –150 –100 –124 μm 0. Because some of the final volume of material removed was taken from the sphere Volume Calculations Normal Volume Options 4.12 μm 14. removing approximately 4 mg of additional material.0 1000.0 4000.53 μm3 Normal Volume 1. The depth and area over which the material was removed is used to make a computation of the material density. the final measurement of volume lost was slightly less than the theoretical loss calculation (resulting in a slight mismatch to nominal mass density). This is because the sampling of the image is set by a combination of the magnification of the observing lenses and the charge-coupled device camera spacing. The 3-D profile (image) reveals a new wear mark.5 3.0 0 1000 2000 3000 μm 4000 5000 6000 0.0 4. The data show a listing of various 3-D areal surface parameters measured via 3-D microscopy.5x109 μm3/mg of volume lost due to wear on the PEEK sphere surface. The final volume removed was then computed based on analysis of the final depth and width of the resulting wear scar (see Figure 3). due to the higher uncertainty in measurement of such small mass.34e+009 μm3 6.35e+009 μm3 67. a large initial map could be made to accommodate the additional removal volume.5 5. The repeatability of the surface metrology technique is more than an order of magnitude higher than the gravimetric method of measurement. The filtering that takes place with a mechanical stylus measurement does not occur with noncontact imaging.18e+009 μm3 Positive Volume Net Missing Volume –15869696.0 1.0 0.00 μm3 Total Displaced Volume 2. slightly outside the measurement field of view.5 5.0 3000. This material was removed from the same surface scar location.0 4.0 5.0 5000.986 μm 43. 18.138 111. a repeated wear mark was introduced.

slope. or 10 μm (some typical stylus tip dimensions).rushmachinery. Such 3-D parameters allow materials researchers to correlate properties that are highly quantifiable to product performance in a fast. NJ 07601 USA +1. which are currently scheduled for adoption across a wide range of industries) provide an accurate and consistent quantification of important surface texture characteristics in a well-known. The speed with which this information can be collected is an advantage in production settings. These measurements exhibit high reproducibility.8983 main@masterbond.masterbond.201. and repeatable measurements based on the capabilities of this technology are ideal for the medical industry. is marketing applications manager at the company. accurate. The results showed an accurate computation of wear volume on a hip implant (a PEEK simulated hip ball) obtained using 3-D microscopy while also giving form and surface finish parameters as value-added information. a hallmark of good metrology for process and quality control. if desired. AZ). Matt Novak. and radius of curvature (RoC). including the engineering lab and the production floor.com Email: mail@rushmachinery. These accurate results and the additional 3-D surface texture parameters offer implant materials development and production teams a significant value over traditional gravimetric approaches to materials characterization. are depicted in Figure 4. The versatility of 3-D microscopy enables end users to measure materials in a range of applications. such as roughness (Sa).343. thus offering the operator hundreds of equivalent stylus traces for a single FOV. representing average 3-D roughness. enabling higher sampling than is possible with a stylus of 2.tions at the diffraction limit are achievable in this manner. Roger Posusta is senior marketing applications engineer at Bruker Corp. The study presented in this article demonstrates the ability of 3-D microscopy to deliver highly accurate wear metrology to the medical implant industry. Important 3-D surface parameters. and peak-valley information. NY USA Hackensack. PhD. A few of these parameters. Fast.com ORTHOTEC | SEPTEMBER/OCTOBER 2011 19 orthotec. can easily be obtained from the same data used for the volume calculations mentioned previously. Additionally. The data. accurate.com Toll Free: 800/929-3070 Rushville. industry-accepted manner. peak/valley (St). Conclusion Three-dimensional microscopes provide versatile and rapid noncontact means of performing surface finish and tribology measurements in several areas. can also be examined in 2-D. height. and repeatable manner. These parameters are computed automatically for the entire field of view (FOV) of the optical inspection area.’s nano surfaces division (Tucson. skewness. Do You Grind Medical Parts? ? Rush Has You Covered From Start to Finish! S Serving the Grinding Industry with friendly and g knowledgeable service for over 25 years r Diamond / CBN Wheel Truer Wheel Truing and Dressing Machines Grinding Fluid Filtration Systems Carbide Rod Cut-Off Machines Drill and Tool Grinders PCD Tool Grinders a healthy Balanced Formulations For High Strength Bonding diet Sterilization resistant Adhesive solutions for the assembly of orthopedic devices USP Class VI compliant Contact us Today! O Filtration Oil Filtrat Oil Filtration Web: www.com www. 3-D parameters of interest (especially when computed in accordance with ISO 21578 standards. 5. kurtosis.com .

the press is opened. the mold is heated from approximately 300º to 350ºF. the molding material takes the shape of the cavity (see Image 2). or preformed blanks. of molded surface area at the parting line of the mold). During operation. the mold is cooled to allow the part to harden. The heat from the mold softens the material to a viscosity low enough so that the material can flow when pressure is introduced. guided by four identically machined tie bars to close the press in a parallel condition (See Image 1). orthotec.1 A phenolic is a thermoset resin—when introduced to heat and pressure. In many cases. Once the press is fully closed. The material can be in the form of powder. The final closing speed is slower to prevent damage to the mold and to profile the velocity of the close as the charge of material deforms and fills the cavity to achieve the optimum material flow. It is precisely machined from tool steel to form the desired geometry of the molded part. a press with two daylights is used 20 SEPTEMBER/OCTOBER 2011 | ORTHOTEC C Image 1. The press closes at a high speed until just before the point at which both mold halves make contact with the charge of material to be molded. The mold usually consists of two halves—an upper force half and a lower cavity half. the hydraulic cylinder is attached to the lower press platen and moves upward. In the case of thermoset materials. granules. The material hardens and in effect becomes a plastic part. ROBERT BOLAND ompression molding has been used to make plastic parts since Leo Baekeland introduced phenolic resins in 1910. putty-like mass.Compression Molding How to Use Compression Molding to Make Joint Replacement Parts This cost-effective process has advantages over other methods of molding orthopaedic parts.com . there is an irreversible chemical crosslinking. In many cases. or vice versa. Thermoplastic materials are compression molded and commonly used in the orthopaedics industry. The compression press is shown with a preform of the molding material prior to press closing. Cycle times can range from 60 seconds to several hours depending on the material used and the thickest wall section of the molded part. to double the production. Thermoset parts have an irreversible chemical crosslinking and cannot be remelted. A thermoplastic material becomes a liquid when heated and freezes to a hardened state when sufficiently cooled. so an operator or a robot can easily remove it from the mold. it cures to become a plastic part. The press can be up-acting or down-acting. a preweighed amount of molding material is placed directly into the lower cavity of the temperature-controlled mold. pellets. Upon cycle completion. It is the oldest process used to mold plastic parts. the hydraulic cylinder is attached to the upper press platen that moves downward to close the press. In a down-acting press. With thermoplastic materials. ejector pins in the mold are actuated either mechanically or hydraulically to lift the molded part away from the cavity. Compression molding requires a vertical press that is usually a hydraulically actuated and an integrated temperaturecontrolled mold. With the heat of the mold and the pressure of the press (typically 1–2 tn/sq in. With an up-acting press.

With joint replacement parts. cookware handles and knobs. The first method uses round tie rods. the high molecular weight of UHMWPE affects the melt viscosity to the point that conventional thermoplastic material processing equipment such as injection molding cannot be used. UHMWPE is a thermoplastic polyethylene that was first introduced as an orthopaedic implant material in 1962. the press tie bars are no longer parallel. Some typical compression-molded plastic parts include circuit breakers. blocks or sheets of UHMWPE are compression molded or consolidated. phenolic. PEEK. and shoulder replacement joint parts are compression molded out of medical grade ultrahigh molecular weight polyethylene (UHMWPE). dinnerware. The last. and interior aircraft parts. polyimide. In either case. In other instances. With a heated press. The next issue to consider is the possibility of an offset load (the mold or material is not centered in the platen) putting a side load into and deflecting the tie bars. It has low moisture absorption. compression molding wastes little material and has good surface finish.2 The odorless and nontoxic material has high impact strength and many desirable features that make it the choice for molding replacement joint parts. any high-volume part would be a candidate for injection molding. insulators. fenders and valve covers. polyamide-imide. Clearances for bushings must consider thermal expansion conducted from the heat platen into the press platen. appliance parts. an important factor in determining the life span of orthopaedic implants. this process can result in a finished or almost-finished part with a highly polished part surface directly out of the mold. the properties of the final part can be influenced by the technology available in today’s compression molding presses. The compression press is closed and is molding a part. as well as manufacturing variance of all of the piece parts and running clearance. This process prevents excessive tooling costs because replacement joint parts are made in many different sizes. and the desired part is machined out of the block or sheet of molded material. polyester. This flash can affix to the molded part and must be trimmed from the part after molding. the bearing area is very small. There are two methods for constructing presses used for molding joint Image 3. When trying to reduce deflection. the moving platen to shift freely out of parallelism. Materials used for compression molding include epoxies. urea. Another disadvantage is that cycle times are longer than for injection molding. Another consideration is the problem of clearance required between the guiding and the tie bars. but not least. and is resistant to abrasion. The main problem with this type of guiding is that it is not adjustable.Image 2. the first consideration is thermal growth of the moving and fixed platen relative to cylinder platen.2 As one of the lowest-cost methods of molding. To replace a round bushing. and various fiber reinforced thermoplastics. So instead of having 1000 different molds to make various joint sizes. Because the cylinder platen stays at room temperature as the fixed platen rises in temperature. When the offset load is transmitted into the tie bars. is self-lubricating. Many rubber parts are also compression molded. a machining center can be programmed with 1000 different programs to machine the different joint sizes. A disadvantage of compression molding is that some material can seep through the parting line of the mold (called flash). a low coefficient of friction (comparable with that of Teflon). Fewer knit lines are produced. Compression Press Construction A number of factors must be considered when selecting the correct type of press construction for an application. Initially. the press frame usually needs to be taken apart. Normally. melamine. closures. because the bushing diameter is larger than the tie rod. orthopaedic implants are compression molded to their net shape. making the connection between the tie rods and platens crucial. In the orthopaedics industry. Bronze bushings are inserted into the moving platen and ride up and down on the tie rods as the press is opened and closed. However. orthotec. and the process can yield better impact and flexural strength in the molded part than can be achieved with injection molding. In many cases. which allows replacement parts. allowing the moving platen to go out of parallelism. automotive hoods. It exhibits good wear. hip. which results in much higher wear until the tie bar wears into the ORTHOTEC | SEPTEMBER/OCTOBER 2011 21 .com a typical part surface finish might be equivalent to an SPI B-1 finish. Called direct compression molding. the cylinder platen wants to shift due to the side loading. fuel cell plates. various knee. use multiple clamp cylinders to spread the load out over the press platen area. problem is the rigidity of the frame itself.

the press is opened and the molded part or parts are removed from the mold. A double-daylight press allows for two molds in the press and doubles the output of the press.002 in. 20–21). This dedicated controller communicates with the programmable logic controller and human interface of the press. The press is closed.Compression Molding bushing. it must be heated and then cooled. on a 75-ton press (accuracy within 0. Each daylight has top and bottom heating/cooling platens that conduct the temperature into the mold. The form and structure of the molded UHMWPE joint replacement part is greatly influenced by the rate and accuracy of the pressure and temperature applied to the mold during the molding cycle. When used properly. The heating and cooling is done with heating and cooling platens in the press. creating an undesirable result of more clearance. which is offset by the left-to-right platen growth to maintain good guiding. because of the long cycle times. vacuum presses. The pressure accuracy of the hydraulic clamp is calibrated with portable load cells at ambient temperature. which is usually no more than 0. This is where the technology in the modern compression press can be the key factor in producing high quality parts. Heating in the platens is done with electric Calrod heaters that are fitted tightly into holes drilled in the platen. Proprietary programming of the counterbalance valves. Use of a pressure transducer in the hydraulic line instead of a load cell to determine force. are required. In other cases. Because UHMWPE is a thermoplastic material. This type of guiding is simple to replace and is adjustable. Until now. The second method uses rectangular tie rods or slab sides machined with 45° gib guides. During operation. double-daylight presses are used. the 45° angle can help offset most of the thermal growth of the fixed and moving platen. Among these features are the following: ■ ■ ■ ■ Servo valves and a servo controller. In addition to the thickness of the press platen. Four double-daylight presses operate from a common hydraulic power pack and control system. The construction of the press must also be robust enough to keep deflection caused by the clamp to a minimum. The proper consolidation of the material is a direct result of the heat. dedicated controller that specializes in heating and cooling. the mold is not normally equipped with direct heating and cooling.3 The equipment is commonly located in a clean and controlled environment to prevent any extraneous debris from getting molded into the part. and then cooled. This type of guiding is more costly but has several advantages. virgin UHMWPE powder is loaded into the mold. When using medical-grade UHMWPE to make joint replacement parts. and time combination used by the processor.0015 in. it is important that the press closes in a parallel condition to mold high-quality parts. In many cases. which can also have two daylights. so that clearances can be run tight with easy adjustment for wear. Contact area is higher and predictable.com 22 SEPTEMBER/OCTOBER 2011 | ORTHOTEC . The pressure works in conjunction with the temperature to achieve the optimum molded part. the material comes in powder form and must be consolidated. Frictionless seals in the hydraulic cylinders. The dedicated temperature controller senses the platen temperature orthotec. The press can be designed so that when the moving platen grows from front to back it increases the guiding clearance relative to the cylinder platen. The hydraulic system must have a number of features to achieve this accuracy. is desired when molding joint replacement parts. so the heating and cooling values can be input on the color touch screen and are a part of the recipe set up for a particular mold. This can be done outside the press with the mold placed onto heating and cooling platens in the press after material loading. Regardless of the type of construction used. The Compression Molding Process The basic theory of compression molding thermoplastics is that the materials are heated above their melting points. After several hours.3%). With orthopaedic parts. such tight pressure accuracy was unheard of in a hydraulic press. another way to reduce deflection is to use multiple clamp cylinders to spread the load out over the press platen area as shown in Images 1–3 (p. The most effective results are achieved when the ramping accuracy of the pressure throughout the entire tonnage range is within 450 lbs. The press is equipped with a separate. uniform heating and cooling rates and pressure ramping throughout the cycle. Parallelism across the platen within 0./ft of platen area. Load cells are extremely sensitive to temperature and off-center loading of the press. The long molding times are necessary to maintain slow. pressure. formed. Pressure and heat are applied at a controlled rate.

2005. it is essential that the selected compression-molding press has all of the necessary features to meet process challenges. exposure to oxygen during the molding process can break down vitamin E. “Perplas Medical UHMWPE Processing Techniques and Problems. A vacuum pump draws down the press/platen chamber to a programmed Torr value that is best for the molded part.” (Harvard Medical School. When the machine cycle begins. manufacturing process include real-time graphing. there are other valuable tools on modern press control systems. Real-time graphing (RTG) is a Windows application that displays a graph of process data in real time and collects and archives process data for every machine cycle. Conclusion Compression molding joint replacement parts is a time-consuming and technically demanding process. The platens are also gun-drilled with passages for cooling air and water. 4. Ethernet capability. Hot Plate Heater Vacuum Seal Bronze Gib Vacuum Molding During the past several years. March 18. 2. The platens are heated from ambient temperature to 450ºF at a controlled rate. tight parallelism. position.. Front and back sealed doors are attached to the slab sides to create an air-tight chamber (see Figure 1). It is a good idea to work closely with the press manufacturer to discuss the properties you will require in the finished molded parts. RTG allows the operator to see exactly how the press is performing at any time during the cycle. To eliminate this problem. and low deflection. and Ethernet caorthotec. Their knowledge can assist in designing and building a press that will produce high quality joint replacement parts for many years. P Bracco.e. B Davis et al. 2009). presented at UHMWPE meeting. “Stabilisation of UHMWPE with Vitamin E Chemical Mechanisms. and temperature. M Allen. ORTHOTEC | SEPTEMBER/OCTOBER 2011 23 . A new data file is created for each machine cycle. “New Processes to Improve the Mechanical Performance of UHMWPE. Those features include very fine pressure control. pressure. 1–18. To mold high-quality orthopaedic parts. Compression Molding (Cincinnati: Hanser Gardner Publications 2003).with thermocouples in the platen and sends the proper amount of current to the heaters to achieve the desired heat. such as real-time graphing. pability. There may be other features required of your press.4 However. 2003). A vacuum press can have all of the features of a conventional press except that is constructed with solid-steel side plates (slab sides).” (paper presented at UHMWPE meeting. sending a signal to the compressed air and water solenoid valves to send the proper amount of air into the cooling passages. Vitamin E is an excellent biocompatible stabilizer for UHMWPE as it goes through the molding process. 3. With the accuracy of the controller. The heat platen is typically heated to 450ºF. the rate of cool down can be controlled to the optimum rate that is most beneficial to the molded UHMWPE part. Choosing a press manufacturer with experience building presses for joint replacement parts can help. The user can go back and observe the data collected if there is ever a perceived problem with a molded part. Other helpful features that will enable the user to keep track of the Press Controls In addition to controlling press movement. the material is molded in vacuum presses. These take the place of the tie rods. MB Turell et al. pressure. and then water. References 1. The wattage and arrangement of the Calrod heaters in the platen must be calculated to achieve heating that is within ±10ºF across the surface of the platen. University of Torino). and temperature) 20 times per second and saves the information when the cycle ends. the electric heaters are turned off. WI). To start the cooling cycle. a real-time graph collects each data point (i. accurate temperature control. The moving platen rides up and down the slab sides on 45º gib guides. Cooling begins with the dedicated heating/cooling controller. The vacuum can be maintained for the entire length of the cycle. University of Torino.. Figure 1. vitamin E has been blended with UHMWPE powder for molding orthopaedic insert parts.com Robert Boland is sales director at Lawton Machinery Group (De Pere. By using a double-daylight vacuum press.. data collection. Italy. and data collection.” (paper presented at Fourth UHMWPE International Meeting. it is followed by an air/water mix. Then based on the desired rate of cooling. manufacturers can press two molds and double their output. September 19.

3 million Americans are over the age of 65.2 Seniors are the primary patients in need of reconstructive products such as hip and knee replacements. DYKEMAN AND DANIELLE T.com Background: Clint Spencer/iSTOCKPHOTO. In addition. and this number will nearly double by 2030. A strong patent portfolio is also important in the current orthopaedic device investment climate. the need for minimally invasive surgical devices has recently skyrocketed. Although building and maintaining a strong patent port- folio is important for all orthopaedic device companies. Currently. orthopaedic device companies must carefully navigate a new world of patent reform and build a strategic patent portfolio. venture capital investment. These patent portfolios are the key to success. and surgical categories.S. orthopaedic device companies must distinguish themselves from their competitors through their intellectual property (IP) portfolios. Patent portfolios are often the driving force for major events in the life cycle of an orthopaedic device company.1 Orthopaedic devices are typically categorized into diagnostic. prosthetic. including mergers and acquisitions. and litigation. They 24 SEPTEMBER/OCTOBER 2011 | ORTHOTEC T should embody a well-reasoned business strategy in which each patent is a single building block in a larger portfolio that reflects present and future business objectives. This industry boom is largely a response to the increase in healthcare issues facing America’s aging population. strategic collaborations. the U. ABRAMSON. There have been recent measures taken by Congress. PHD he orthopaedic device industry has flourished in recent years with the orthopaedics market slated to produce more than $4. DAVID J. Given the shifting population dynamics and the ensuing health problems. Patents are the currency of the orthopaedics industry. Venture capital funding often depends on whether a company has secured its IP assets. Patent and Trademark Office (USPTO).6 billion in revenue by 2015. which validates a company’s technology and demonstrates its commercial potential. Gavel: NickS/iSTOCKPHOTO. public offerings. and the Supreme Court to reform the current orthotec.COM . the orthopaedics industry is pressured to advance technology that can diagnose and treat age-related orthopaedic conditions. 40. In order to survive. it is most critical for start-up firms. leading to the development of innovative devices and new surgical methods.Intellectual Property Patent Reform: Navigating the Changing Patent Landscape To weather the patent storm. joint ventures.

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After years of anticipation. for a patent to be issued. to minimize opportunities for third parties to block improvement patents. Inventors will also need to write more detailed patent applications. is at least two years. The program is scheduled to run through May 16. monitor the patent landscape. orthopaedics companies must distinguish themselves from their competitors through their IP portfolios. and Japan. Accelerated examination promises that final decisions on patentability will be rendered within 12 months of filing. will dramatically affect current patent filing strategies in the orthopaedic device industry. and surgical devices. The PPH also shortens the wait time prior to examination. 2012 and may be extended.S. those represented by the European Patent Office. including classes that cover diagnostic. Australia. As a result. Further. and the Supreme Court’s issuance of far-reaching opinions. Orthopaedic device companies must carefully adjust to these congressional reforms to maintain a strong patent portfolio that protects their core technology. Another USPTO program designed to facilitate the patent process is the Full First Action Interview Pilot Program.com . the postgrant patent opposition review will increase the number of challenges to patents based on both novelty and obviousness grounds. Meanwhile. A granted PPH request will result in patent applications being examined within two to three months. it takes more than three years. Orthopaedic device companies must respond with strong patent strategies that take these new reforms into account while establishing a competitive edge in the market. compared to only 50% of standard. eliminating the much relied–upon one-year grace period under the current 26 SEPTEMBER/OCTOBER 2011 | ORTHOTEC first-to-invent system may hamper the natural scientific review process. before they understand the full capabilities of an innovative technology. particularly in university and research settings. from filing an application to receiving a first USPTO action. Furthermore. Such comprehensive technology strategies must maximize patent coverage of a company’s current core technology and future improvements. Finally. First. an international program that speeds up examination by relying on prosecution in a corresponding foreign application filed in one of 15 participating In order to survive. This interview resolves patentability issues at the beginning of the process. with Congress’s patent reform legislation. 2011. An expansion of earlier successful examiner interview programs. orthotec. where ideas are shared and discussed by colleagues. and explore ways to patent white space. Companies will then be able to withstand patent reform and ensure their success in today’s competitive and rapidly changing IP environment.Intellectual Property patent system.4 In an industry where a well-developed IP portfolio is indicative of success.000.S. the average processing time. The most significant changes include switching the U. patent system since 1952. while also considering crosslicensing opportunities with competitors. including Canada. These changes will affect how orthopaedic device companies develop and manage their patent portfolios. the USPTO has joined the Patent Prosecution Highway (PPH). A quicker turnaround time not only allows in- countries.3 As ventors to protect their products from infringement. U. Congress Passes Major Patent Reform Major changes to the U. President Obama signed the America Invents Act into law on September 16. patent system from a first-to-invent to a first-inventor-to-file system and introducing postgrant opposition review. This change favors major medical technology players that have resources to challenge patents in an increasingly complex and time-consuming process. Dykeman a result. inventors may end up prematurely filing patent applications. PPH patent applications enjoy a surprisingly high allowance rate—more than 90% of PPH cases are allowed. slated to become effective 18 months and 12 months after enactment. For example.S. This is the first major legislative change to the U. prosthetic. the USPTO has implemented an accelerated examination program to address the lengthy turnaround process regarding the allowance or denial of patent applications.S. Once examined. the current backlog of unexamined patent applications is at nearly 700. patent system are brewing. on average. the firstinventor-to-file rule will cause inventors to err on the side of filing strong provisional applications as quickly as possible. but also attracts investors who want the certainty of an issued patent. applicants have the right to an interview with the patent examiner before the first office action on the merits in a utility patent application. respectively. thereby advancing prosecution of a patent application. In an effort to reduce this logjam. the USPTO is advancing its own patent reform by proposing new programs that could lead to faster patent allowances. the program includes all technology areas. Under this program. Patent Office Proposes New Rules According to data from the USPTO. These changes. the USPTO’s proposed changes in patent examination processes. Orthopaedic device companies should monitor the issued patents of key competitors to determine if they want to challenge their competitor’s patents. The PPH reduces time spent on examination because patent examiners reuse the search strategies of their foreign counterparts. non-PPH cases. according to the USPTO.

orthotec. Companies need to patent aggressively—they need to file quickly and frequently.S. Previously.com vacated the decisions of the U. One or more patent applications should be filed providing the broadest possible patent protection covering the core technology. Court of Appeals for the Federal Circuit. To build and maintain a strong patent portfolio. patent no. Filing aggressively ensures that a company will claim ownership of the technology first and can block competitors by filing patent applications that cover improvements to a competitor’s product to effectively limit product enhancement options.6 Although the claims of the Bilski U. all three patents at issue in Classen were held invalid. When drafting patent applications. In Classen. patent system. and identify how its combining features are not predictable in light of prior art. the Supreme Court’s interpretation in Bilski of the “machine or transformation” test is applicable to the patentability of medical diagnostic and personalized medicine methods. using. the patent claims were again found patentable under the machine or transformation test. the Supreme Court affirmed the invalidity of Teleflex’s U. and remanded to the federal circuit for reconsideration two cases related to medical diagnostics: Prometheus Laboratories Inc. KSR particularly affects orthopaedic device companies whose products tend to comprise incremental improvements and combine established devices and techniques. a company should conduct frequent audits of its patent portfolio to ensure its patent strategy adapts to ORTHOTEC | SEPTEMBER/OCTOBER 2011 27 .S. In Prometheus. Where applicable. and the Supreme Court. orthopaedic device companies must effectively address reform through a three-pronged approach: • Filing strong patent applications to protect a company’s current core technology and future improvements. companies should monitor their competitors’ portfolios to identify potential patent infringement. treatment. it ruled on one of the most challenging questions in patent law: what makes an invention “obvious” and thus unworthy of a patent? In KSR International Co. v. patent claims should be directed at diagnostic. methods of manufacturing. prosthetic. suggestion. To survive obviousness challenges post-KSR. Mayo Collaborative Services and Classen Immunotherapies Inc.orthopaedic device companies should take advantage of the USPTO’s programs to expedite patent prosecution. one of the most anticipated U. After the Bilski decision. as well as alternative embodiments that competitors may attempt to design around the company’s core technology. Supreme Court recently issued far-reaching opinions that affect patent prosecution and licensing strategy. or selling) a company’s invention. Supreme Court decisions of 2010. The Supreme Court addressed the patent eligibility of a process in Bilski v. surgical.S. orthopaedic device companies will need to implement patent strategies that account for these major Supreme Court decisions. 6. but rather a useful and important clue or tool for investigation. It may bar their patentability and characterize them as predictable variations of already existing art and devices.S. The Supreme Court Weighs In The U. Doing so allows a company to establish a strong patent portfolio that reflects current innovation and industry developments. an opposite decision was issued in which two of the three Classen patents were patent-eligible. Having patents in these countries will protect the company against potential infringers around the world. Filing international patent applications further strengthens a patent portfolio by expanding a company’s presence in the global marketplace. Given the recent flurry of patent reform measures initiated by Congress. These Supreme Court rulings indicate a trend in recent years of the Court’s willingness to address perceived problems in the U. patent application relate to financial services. Protecting Core Technology Building a Patent Portfolio to Endure Change Developing and maintaining a strong patent portfolio is critical to an orthopaedic device company’s growth and survival. or motivation” test for assessing obviousness. v.237.5 The Court found that the patent claim merely combined obvious elements in the prior art and rejected a narrow application of the “teaching. Kappos. the Supreme Court granted judicial review. discuss the challenges of altering the design of the product.S. As the core technology evolves. Developing a strategic patent portfolio that addresses Congress’s reforms and the first-inventor-to-file rule means establishing patent protection for a company’s core technology. and combination devices. Thus. an orthopaedic device company should teach current and future technology innovations. incremental improvements should be patented to form a picket fence of protection. A company should consider filing in specific countries with a large target market for the product—countries where competitors’ manufacturing facilities are located and countries that export products to other countries through channels of distribution. patents should clearly state the product’s new features. Biogen Idec.565. Another key to broad patent protection is an offensive strategy that prevents competitors from infringing on (making. or use. Meanwhile. the USPTO. Finally. • Considering crosslicensing opportunities. Teleflex. In 2007.S. v. • Monitoring the patent landscape and exploring ways to patent white space. and any other aspects of the invention. kits. The Bilski decision states that the machine or transformation test is not the sole test for determining the patent eligibility of a process. while one patent was not. medical device companies must work closely with their patent counsel to draft patent claims that conform to the decision in Bilski and its aftermath.

S. Legal Work Follows. NJ. weaknesses. available from Internet: www.7 A crosslicense is a mutual sharing of patents between companies without exchanging a license fee.com . 3.pdf. __ (2010). “First Office Action Backlog Dips Below 700. Or.” USPTO Director’s Forum: David Kappos’ Public Blog (July 12.gov/blog/director/entry/ first_office_action_backlog_dips. and medical devices to provide a targeted and specialized treatment that minimizes side effects. and seeking crosslicensing opportunities with competitors. A patent audit allows a company to assess strengths.gov/patents/init_events/pph/ pphbrochure.000. Dykeman is a patent attorney and cochair of the IP department at Greenberg Traurig LLP (Boston). 2007). No. Therefore. 130 S. thereby avoiding expensive and time-consuming patent litigation. A combination product pairs biologics. a company should undertake a freedom-tooperate analysis to avoid infringing on patents owned by third parties. The amount of white space measures the crowding of a particular technology area with patents and patent applications. available from Internet: http://transgenerational.uspto. Ct. especially References 1. v. Danielle T. Conducting periodic patent audits ensures that a company’s patent portfolio achieves broad and cost-effective coverage of its discoveries. Kappos. the USPTO. 398. companies pursue patent applications in clear patent landscapes before they become crowded with competitor patents.” Millenium Research Group Inc.htm. 4. KSR International Co. S Qualters. January 17. each party in the agreement can practice its patent rights without infringing on another’s.S. Teleflex. To counter this trend in court filings and avoid costly litigation. 2. Given the USPTO’s recent programs to address the patent application backlog and provide accelerated examination procedures. and the Supreme Court. available from Internet: www. It can accomplish this by identifying potential patent design-around opportunities that a competitor might use and blocking these opportunities by seeking new patents or modifying current patent applications. 36 (May 14.” The National Law Journal 29. securing funding. an exclusive or nonexclusive license may be established among the companies. After conducting a thorough search of patent and scientific literature databases and identifying third-party patents.. David J. Conclusion Orthopaedic device companies must build and maintain high-value patent portfolios to be successful in today’s competitive and rapidly changing patent environment. companies should consider crosslicensing strategies with competitors to further bolster and protect their patent portfolios. 7. 5. By aggressively protecting core technology. patent rights can be assigned either entirely to one party among key industry players. enhancing revenue. PPH Brochure. optimizing the patenting of white space. orthotec. Finding Freedom to Operate to Patent White Space Exploring white space is another method for obtaining a strong patent developments. there is room to stake meaningful new patent claims.org/aging/ demographics. Crosslicensing agreements are increasingly important given a recent rise in patent infringement cases in the orthopaedic device industry. 3218. orthopaedic device companies can achieve a strong patent portfolio. These patent portfolios face numerous challenges in the patent reform storm from Congress.Intellectual Property changes in the legal landscape and the marketplace.6 Billion by 2015. Abramson. To avoid issues regarding ownership of combination products (one company may claim ownership of a device and another company may claim ownership of a drug or biologic). Companies enter into crosslicenses when they have overlapping patents. a company should maximize its patent presence within that particular commercial area. Conducting periodic patent audits ensures that a company’s patent portfolio achieves broad and costeffective coverage of its discoveries. “The Demographics of Aging…” Transgenerational Design Matters (2009). 127 S.uspto. Abramson portfolio. Examples of combination products in orthopaedics include bone fracture fixation devices combined with an antiinfection coating and implants combined with bone growth factors. 561 U. 1727 (2007). If the patent landscape is relatively clear. PPH-Fast Track Examination of Applications. Combination products and therapies provide another means of exploring white space and anticipating industry 28 SEPTEMBER/OCTOBER 2011 | ORTHOTEC or jointly between the parties. and increasing marketing value. Crosslicenses and Competition Crosslicensing with competitors is another way to bolster a patent portfolio and address challenges to the patenting system. “Cross-Licenses Grow. 550 U. “US Orthopaedics Extremity Market to Grow to $4. drugs. Before patenting white space. B Stoll. The companies pool the relevant patents together and divide the patent rights amongst themselves so that each party takes exclusive or nonexclusive rights to a particular area of use covered by the combined patents. 2011). 6.Ct. PhD is a patent agent at the firm’s office in Florham Park. and practicing one patent would mean infringing on another. USPTO. A crosslicense is also accompanied by a promise not to sue. and gaps in its patent portfolio and identify opportunities to enforce patents against competitors. Bilski v. 2011. This will secure a company’s competitive advantage in the marketplace by maximizing patent protection. It will also be broad and flexible enough to withstand the changing patent landscape.

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Taking short cuts with certain tests can lead to failures late in the process. the United States or Europe). shorten the development process.. DANIEL SANTOS Solving a Rubik’s cube is a good example of design of experiment. in the competitive world of medical devices. reating effective test protocols can pose many challenges for medical device design engineers. speed to market is important. It’s critical to establish test protocols that verify a device will operate safely and reliably from its first through its 1000th use.e. Firms will often assemble key people—especially those involved in testing—in the same room at a kickoff meeting with the customer. and verification can make a design engineer’s head spin. analysis. and the manufacturing team can give input as to whether the components. This article discusses tips and insights that can help design teams avoid unnecessary testing. 30 SEPTEMBER/OCTOBER 2011 | ORTHOTEC C Customer and Crossfunctional Collaboration How a medical device company applies its process to designing. most importantly.com Photo by FREETRANSFORM/ISTOCKPHOTO. and manufacturing an orthopaedic device greatly affects the accuracy and effectiveness of test protocols.e. and materials being considered will withstand high production levels. it is difficult for a design engineer to create expeditious and comprehensive test protocols that account for these diverse variables.COM . requiring the team to start over—or worse. However. To align all the colors. The procurement group might have unique knowledge about what materials are available. and. Determining which tests will accelerate design evaluation. Without the early collaboration between all involved departments. At this stage. increase customers’ satisfaction by meeting their needs. variables that affect the design should be explained. after it’s clear where the product will be released (i. Siloed processes whereby phases of the project are handed off from one department to another (i. developing. However. Test protocols must consider a device’s entire life cycle in the shortest amount of time possible. the regulatory affairs and quality assurance (RA-QA) team can offer insight on relevant sterilization parameters. prevent nonessential spending. Overthinking the parameters can delay product release and result in added cost for the customer. creating test protocols that verify and validate that a device meets a customer’s specifications and performance requirements doesn’t have to be as complex and costly as it might seem.Testing Test Protocols: Accelerate the Process and Keep Customers Happy Efficient test protocols remove excess cost and complexity from the product design equation. it can lead to failures in the field.. For example. business development to design engineering to RA-QA) tend to limit the scope and orthotec. you must factor in how multiple variables interact and affect one another. dimensions.

This greatly influences which test protocols are established. requiring design engineers to start from the beginning of the process.com Please use Promo Code: AA orthotec. redundancies. resulting in nominal design issues later in the project. As a result. comprehension.com ORTHOTEC | SEPTEMBER/OCTOBER 2011 31 . it is first handed to a nurse or surgical technician who rinses it with water. time delays. Your Gateway to the Education. timelines are pushed back. Had the RA-QA group been present during the design and testing process. However. it could have given the engineers important insight about the types of sterilizations required or performed in Europe. costs increase. Early communication. and customers are left unhappy. which in this case is much harsher. 2012 For information on exhibiting or attending. and collaboration about what the customer wants among all departments can significantly reduce cost. Understand Application and Environment In addition to bringing crossfunctional team members together at the beginning of a project. if design engineers don’t know the orthopaedic device will be released in Europe. and failures in testing. procedure. they aren’t likely to take higher pH levels into account during the design or testing of that parameter. For example. if that design engineer had continuously communicated with Siloed processes whereby phases of the project are handed off from one department to another tend to limit the scope and effectiveness of test protocols. For instance. test protocols are more likely to reflect only those limited parameters— especially if timelines are tight. the device could fail in the field or during clinical trials. if limited knowledge leads a designer to mistakenly think that a dethe customer—from the beginning of the project onward—they would have learned the full extent of the intended sterilization process. please visit MDMwest. More upfront testing could have been done. If how a device will be operated and handled is unclear to a design engineer. Rather than simply being sterilized after the device is turned off. it is important to understand how an orthopaedic device will be used in all aspects of a surgical vice will be turned on and off and then placed directly into an autoclave for sterilization. Tools and Partnerships Needed to Turn Your Big Ideas into Market-Ready Products Exposition: February Conference: February 14–16. and minimize customer frustrations. In such case. 2012 13–16.effectiveness of test protocols. many important parameters will be overlooked in the testing process.

unfortunately. If the customer can see and feel that the device must be the circumference of a baseball to meet 32 SEPTEMBER/OCTOBER 2011 | ORTHOTEC their power requirement. materials. In fairness. Returning to the motor example. which accelerates the design and development process.2 Table I illustrates an example of DOE process limits for how a sealant in an orthopaedic bone drill might hold up in an autoclave. many testers separate functional and sterilization testing methods. This type of information on interactions between factors cannot be easily obtained by investigating the effect of each factor separately. must be established before a piece of equipment can be validated because this information is used to write the protocol. and pressure of the autoclave are hypothetical examples for these ranges.. FACTOR LOW LEVEL HIGH LEVEL Temperature (ºC) Time (min) Pressure (psi) 115 5 20 135 20 60 Table I. along with any potential misuses that can result in failure. On the other hand. but they won’t run its duty cycle. provides detailed analysis.. It is a regulatory requirement to run sufficient trials to demonstrate the statistical significance of results. it can create this mock-up in-house. Evaluating multiple variables at the same time (rather than evaluating one variable at a time while all others are held constant) reduces the number of iterations required. machine time. Balance Functional Testing and Sterilization Testing It is both an art and a science to ensure you’ve adequately tested a device’s functionality and its ability to withstand harsh sterilization environments.. Having full knowledge of how the device will be used early on enables design engineers to create rigorous test protocols that accurately verify and validate safety factors. the design engineer may intrinsically know it isn’t feasible for a highlighter-sized orthopaedic device to generate 60 in.This latter aspect is of importance since optimal conditions may occur when one factor is high and another low.-oz of torque. because engineers can’t always decipher such factors on their own. They may need their device to contain a motor with 60 in.. protocols can miss the mark for performance. Customers should divulge how an orthopaedic device will be handled. time. the design team and the customer must be on the same page as to what the customer wants and what they actually need. considering what the customer really needs. However. Sterilizing the device hundreds of times without running it doesn’t test the functionality of the handpiece. primitive model of what the customer is requesting—while still in the feasibility stage. and reliability testing. there is no single easy answer that balances these two important testing needs. If they aren’t running the device through an autoclave. safety. which is an unlikely scenario in the field. some may test device functionality by running it 500 times to ensure that the motor. dips it into a cleaning chemical. providing the customer with a rudimentary sample that demonstrates why alternatives must be considered is often more effective than just dismissing the request out of hand. A DOE approach permits efficient use of resources (personnel time. An effective strategy to ensure customer needs are established before the design and test protocols are developed is to create a functional prototype—a bare bones. For example.Testing scrubs it with a brush. This DOE process gives a design engineer a holistic understanding of how multiple variables interact with each another in an autoclave environment. some testers might verify that an orthopaedic handpiece meets autoclave testing standards. it’s not being exposed to moisture as it would in a real-world application. which.Applying DOE reduces the size and hence the cost of process validation trials. If not. and that’s something many medical device makers can’t afford. It is important to use DOE during process validation. If the manufacturer has the capability. minimizing the size of the experimental schedule required and providing information on key process interactions. “In DOE all the factors of interest can be investigated in a single trial. Because test protocols are only as good as the customer specifications. gives information on reproducibility and errors. Without clear and detailed specifications. The seals are essentially being tested over and over again without being subjected to the rigors of regular use. It takes into account multiple variables simultaneously before test protocols are actually written and carried out. seals. The sooner the customer and manufacturer can nail down feasible product parameters. etc. Conducting sterilization tests between every functional test takes time. It helps to have experience conducting other tests and orthotec. To accelerate the process. and provides a predictive capability. customers come to medical device manufacturers with a vague idea of what they want and need from their orthopaedic device. and DOE can assist in this procedural aspect. and internal components are working properly without testing its ability to withstand sterilization.-oz of torque and may be overkill. they’re more likely to compromise between what they want and what they need. leveraging the resources of the production floor or an outside prototype house is worth the effort because this preliminary model ultimately saves time and money.).com Understand Variables Associated with Design of Experiment Design of experiment (DOE) is a statistical tool for creating effective and efficient test protocols. The levels of each factor selected are based on knowledge of the system being tested. but they want it to be the size of a highlighter. Align Customer Wants and Needs More often than not.1” Device and process specifications . causes many important variables to be disregarded. The high and low limits for temperature. and then puts it into the autoclave. functionality. the faster the engineer can design the device and focus on testing variables.

rather than one of uncertainty and adversity. especially when it comes to accelerating reliability testing. you’re into a system to determine its limits and ensure that it functions properly. such as the cable. may seem adequate. Equipment that isn’t specific to the device often won’t provide an accurate prediction as to how the device will hold up in the field. Componentlevel testing analyzes individual aspects of the device. and a prototype shop to quickly create functional prototypes. testing gear teeth to ensure they can withstand torque load. it’s difficult to recreate realistic applications. The most important starting point is to ensure all individuals involved in testing or testing-related activities are on the same page and understand the customer’s parameters and the device’s intended field use. Recreate Realistic Usage Environments In-House Another way to accelerate reliability testing is to create a real-world. However. However. but if that’s not how it will be used in the field. Developing proprietary testing equipment to mimic operative handling enables the manufacturers to meet the strictest customer specifications. Subsystem testing is a key part of product design. As noted previously. In actuality. D Dixon et al. Proprietary testing equipment can also save a lot of time compared with manual testing. you know any issue or a failure must be caused by an interaction between other components or subsystems. This in-house environment might include dishwashers for pH testing. This method provides more control over how a device is tested. if historic data or previous experience is lacking. add another variable. machines for autoclaving. After verifying that individual components will survive real-world use. gaining little understanding of why the failures occurred. These tests should be started early in the development phases—long before a product is completed.com subsystem can handle the rigors of the field eliminates much of the variable testing later on. For example.verifying past failures because there are some similarities in how certain variables in each handpiece interact. Conclusion There’s no one-size-fits-all approach to creating effective. creating an automated panel system to test multiple orthopaedic surgical drills eliminates the need for an operator and increases a manufacturer’s ability to test more than one unit at a time. After you’ve determined that the motor and cable tested well together. you’ve determined a good testing protocol framework. “Application of Design of Experiment (DOE) Techniques to Process Validation in Medical Device Manufacture. Verifying that each The design team and the customer must be on the same page as to what the customer wants and what they actually need.. using an oven to replicate the autoclave temperature thermal cycling.” Daniel Santos is engineering manager at Pro-Dex Inc. (Irvine. In addition to keeping the whole testing process under one roof. Take the example of a motor. realtime testing environment in-house. and verifies that the device will cause no unintended consequences. For example. it is important to at least do the following: ■ ■ Clearly understand how the device will be used in the field. to see how the two interact. which reduces testing time. hear how it sounds. It is crucial to conduct component and subsystem-level testing. overlooking key fundamentals will delay processes. This makes developing accurate. the next step is to add other handpiece components or subsystems to the test. Testers have the ability to see how the orthopaedic device is tested. understanding the operation and handling of an orthopaedic device makes it easier to set up test protocols that replicate the conditions of actual field usage. a simulated cadaver lab to test bone density. further accelerating the speed of reliability testing. no 2 (2006). or analyzing material properties to assess how they withstand high pH levels. This process can make it easy to pinpoint failures. You can run a motor all day. the lack of steam and pressure cycling eliminates crucial variables that the device will likely encounter in the field. However. developing proprietary testing equipment specific to the orthopaedic medical device helps create an authentic testing environment. Conduct component level testing and subsystem testing early. For example. it can involve testing a shaft to verify that it meets strength requirements. Subsystem tests bring different components together to evaluate how they interact. Once the motor is tested using realistic testing parameters. If these two variables interact successfully. legitimate test protocols an intriguing process of discovery. ORTHOTEC | SEPTEMBER/OCTOBER 2011 33 . not stopping until it burns up (fails). verifies that the device lasts through all testing cycles. wasting valuable testing time and causing unrealistic failures. (PDF) “Quality Management Systems—Process Validation Guidance. if you conduct a test that closely mimics field usage. They must rely on the material specifications—hoping they are correct—or farm out tests to verify References 1. You would test the motor separately before putting it orthotec. proprietary test protocols. Testing the motor first reduces unintended consequences that could make the entire handpiece fail in later testing phases. GHTF/SG3/N99-10:2004 Edition 2. subsystem testing can begin. CA). and experience how different variables are interacting. failures. If a design engineer doesn’t have adequate in-house capabilities to test components and subsystems.” Journal of Validation Technology 12. 2.

rollomaticusa. The system also prevents accidental breakage of ID microtooling. Inc. Rollomatic Inc.com 34 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec. 877/226-7823 www. The D688 features an 8. It can be used to apply logos and tool numbers to PCD.com Machining Vise A company is replacing a currently available model of machining vise with an upgraded version of an older model.solvayplastics. transparent thermoplastic with a heat distortion temperature of 207°C. so they can be easily aligned on a vise table. Kurt Manufacturing Co.genswiss. The Swiss clamp nuts can be tightened using standard box wrenches or a 3⁄8-in. Mundelein. Genevieve Swiss Industries. MN. components. including bone screws and implants. delivering positive torque to the nut. drive ratchet wrench with the EZR wrench adaptor or the EZR torque adaptor. Surfaces do not have to be flat.kurtworkholding. IL. Solvay Specialty Polymers Houston. Both adaptors engage and lock to the clamping nut with a specialized cam system on the face. Westfield. The EZR Swiss Clamp System ensures increased torque by achieving proper settings and enables fast. 847/281-8550 www. LaserSmart is suited for extra-fine 3-D laser machining of super-hard materials. and its clamping torque is greater by 36%. positive ER collet clamping. The D688 has a jaw capacity that is 25% greater than that of the D675 model.001 in.Products & Services Find new equipment. TX. Minneapolis. It is replacing the D675. jaw opening and repeatability to within 0. MA. The new model produces up to 7968 lb of clamping force with 80 ft·lbf input torque. The distance from the keyway to the stationary jaw is identical in the two models. Radel PPSU is strong and chemically resistant. 713/525-6000 www. or CVD silicon carbide inserts.8-in. the machine can handle surfaces with an arbitrary geometry. CBN. 413/562-4800 www. Another performance attribute is its processability. which is designed to provide overall vise rigidity while absorbing machining vibration. The vise has a porosity-free ductile iron body. and supplies for orthopaedics here.com .com Swiss Clamp System A Swiss clamp system is used with machine tools in the manufacture of orthopaedic instruments and components. Laser Ablation Machine A five-axis laser ablation machine is designed for 3-D machining. It eliminates wrench slippage and prevents the loss of clamping nuts in the machine sump-chin bin. The vise is designed with an alloy steel screw mechanism and high-precision roller bearings. and can withstand up to 1000 cycles of autoclaving without losing toughness or impact resistance. such as PCD and CBN. Operators’ hands are kept clear of the sharp tools in the tooling zone.com PPSU Resin A polyphenylsulfone (PPSU) resin is suited for medical devices such as a positioning support for orthopaedic trauma surgery. It is a tough.

It can serve as a reference for a designer working on an implantable device that must complement or mimic human body performance. A simple menu system enables recipes to be entered and recalled as needed. bone-anchoring devices.concepmachine. IL. They control profile and angle.Grinder A specialty grinder can be used to grind multifaceted cannulae. Concep Machine Co. The module is an authoritative collation of data on the mechanical properties of primary loadbearing bones gathered from various Optical Inspection System Relying on the white-light axial chromatism technique.000 points per second with nanometer accuracy up to 324. 800/241-1546 www. and other specialized surgical tools. and biocompatibility of materials. and acetabulum. The PEEK is supplied by Solvay Advanced Polymers through a partnership. in the center of the rubber-lined blast chamber. regulation. toughness. and general properties of the femur. The system is fitted with a PCL-HMI. UK +44 1756 799911 www. adjustable speed and are blasted from the two blast nozzles. Featuring a stage that can move as fast as 1 m/sec. substitution. Secant Medical LLC Perkasie. rotator cuff and arthroscopic joint repair. Machine technicians who know the g-code language used by Fanuc machine controls can use the grinder immediately. At maximum speed. manufactured in conditions compliant with ISO 13485 and GMPs and tested in an accredited laboratory compliant with ISO 17025. spinal stabilization and disk repair and replacement. knitted. or braided from the fibers for use in high-strength sutures. as well as the length and depth of cut and the number of facets. has a modulus similar to that of bone and exhibits good biocompatibility.secantmedical. Scan rates range from 31.guyson. which vertically traverse the component.com different products.000 points per second when a line sensor is employed.com Online Bone Database An online information resource covers the properties of human bone. The orthotec. The fabrics for implantable devices are woven. 847/498-9740 www. aiming at a prepositioned angle and from a prepositioned distance. enabling full operational control over all machine variables. an automated optical inspection system is capable of stand-alone operation or in-line integration. Canned programs are also provided. while the 14 component holders rotate on their own axes. After the blast cycle is finished. The PEEK material. The controller can store individual programs for grinding door is closed and the turntable begins rotating clockwise. The objects to be cleaned are manually loaded into component holders on the turntable. PA. vertebrae. and mesh structures for tissue reinforcement and wound support in surgery. The Multiblast RSB machine is fitted with a 14-station planetary component drive and two vertically traversing pressure-fed blast IMPLANT COMPONENTS Implantable Biomedical Fabrics Custom implantable biomedical fabric structures made of Zeniva PEEK fiber are for OEM use in therapeutic devices that have applications in orthopaedics and general surgery. Operators are able to quickly change the parameters of a given program. The Human Biological Materials data module is part of an expanded materials information system for orthopaedic device designers and manufacturers. The x-y measurement area is Blast Machine A blast machine can clean substances such as hydroxyapatite and titaniumcoating overspray from equipment such as cup-and-stem implant fixture masks. which can become encrusted with coating when medical implants are vacuum plasma sprayed. Granta Design Mason. tibia. textile-based heart valves and vascular grafts.co.com ORTHOTEC | SEPTEMBER/OCTOBER 2011 35 .com nozzles. Fanuc CNC servo-programmable controls enable the grinding of multiple axes. Skipton. In its first release. North Yorkshire. the HS100 provides both speed and resolution. an integral air knife blows the residual dust from the components. Guyson International Ltd. It can help them make informed decisions regarding the selection. Northbrook. the searchable resource presents the tensile. the unit can measure one point every 32 μm. The objects rotate at a controlled. compressive. OH.uk publications. qualification. trocars.grantadesign. 877/774-2835 www. and fatigue resistance. flexural.

flatness and planarity.bardpvoem. AZ. In addition to displaying conformability. 724/746-6050 www. in orthotec. and gas permeability. Waukegan. the material is suitable for a variety of implantable medical device applications. One of the composites—a PEEK-matrix polymer compressed with laminated woven-carbon fabric mats constituting 50% of the composite— provides torsional stiffness and resists warping even after multiple sterilization cycles. the lightweight. Laserage Technology Corp. and silicone. Methods Machine Tools Inc. CAMplete TruePath Turn-Mill software is an integrated suite of g-code editing. Available in a range of tubular diameters.030 in. the machine can produce parts as small as 0.nanovea. optimization. and welding of surgical implements and implantable devices from many materials.ensinger. The other composite is a PEEK matrix laminated with a 60%-carbonfiber fabric.com 36 SEPTEMBER/OCTOBER 2011 | ORTHOTEC . thermoplastic carbon-fiber composites consist of a thermoplastic matrix and a woven fabric made of carbon-fiber bundles. According to the manufacturer. platinum. the Tecatecseries provides higher tensile and flexural radiolucent.Products & Services 400 × 600 mm. Capable of undergoing steam sterilization.com Miniature Medical Parts A contract medical device manufacturer has acquired a Tornos 7 Swiss turning center to facilitate the machining of miniature medical parts. making them suitable for external fixation devices and surgical instruments. enable the service provider to concentrate on medical device applications involving small component features and requiring high precision. MA. temperature stability. Suited for the high-precision machining of very small surgical instrument and medical implant components.com Carbon-Fiber Composites Exhibiting mechanical strength and heat-distortion properties. The software can enable a range of turn and mill functions. along with high-output production equipment. IL. titanium.com strength than fiber-reinforced extrudates. roughness. including laser welding of stainless steel and titanium components for bone screws. and thickness values. Laser Processing and Cable Assembly A company partners with medical device OEMs to provide diverse laser processing services. hydrophobic. analysis. CA.laserage. lengths. Bard Peripheral Vascular OEM Products Tempe. 847/249-5900 www. This process can produce flat sheets with thicknesses as low as 0. ceramic. cutting. step-height depth. and wall thicknesses. volume area. PA.uk quartz. fine-tuned. an ePTFE material is chemically inert. and optimized using 3-D machine models. the ePTFE material can be made thin and strong using the company’s high-density microwall technology. It was designed to combine g-code from CAM systems and hand-coded g-code into a set of programs that could be simulated. Washington. Lasers incorporating the latest technology. shape and form.1 mm. 800/655-8722 www.com IMPLANT COMPONENTS ePTFE Materials Used to manufacture orthopaedic implant coverings.methodsmachine. 978/443-5388 www. chemical-resistant materials are also Turning Center Software A supplier of precision machine tools has developed software for its line of turning centers. drilling. and gas permeable. Sudbury. Supplied in standard plate thicknesses of 3–40 mm and in other dimensions upon request. The system features a range of automated options for measuring such surface characteristics as profile. 866/333-4674 www. borosilicate. Nanovea Automated Optical Inspection Irvine. dimension. this carbon-fiber component ensures dimensional stability and stiffness. including stainless steel. The ISO 13485:2003–certified company offers precision laser machining.co. and verification tools for use with NakamuraTome multitasking turning centers. Ensinger Inc.

2012 Fort Worth Convention Center Fort Worth. faster and more effectively.com . please visit Produced and managed by UBMCanon.com MDMTexas. networking opportunities.The Medical Device Industry’s Most Comprehensive Project Acceleration Resources Comes to Texas! March 14–15. and up-to-theminute information you need to bring your best ideas to market. innovative solutions. TX MD&M Texas is your gateway to new technology. Co-located with: For information on exhibiting or attending.

Epoxy mineral tombstones have the characteristics of cast iron with the weight of aluminum. The console swiftly evacuates spent abrasive from the blaster’s chamber. 860/928-4102 www. These include PEEK compounds for long-term implants and bioresorbable polymer compounds with such additives as tricalcium phosphate and hydroxyapatite. ProCenter Plus is a freestanding workstation and dust collection unit in one platform. Medway.com Bayer MaterialScience LLC Pittsburgh. is Microabrasive Blasting Platform A microabrasive blasting platform can fulfill the surface modification and cleaning needs of medical device manufacturers. This bond enhances the coating’s durability and its ability to resist particle generation.bayermaterialscience. As a Swiss machining center. Switzerland. +41 41727 2727 www. this HEPA filter–equipped unit can handle a large amount of spent abrasive in its oversized storage hopper without any influence on blasting performance. keeping the work area clean. The system has built-in silencers and features quiet operation.com designed for machining medical products.Products & Services diameter and length. 818/841-5500 www. power clamp. well-lit work chamber to maximize operator comfort. 800/321-6727 www. Baymedix CL 100 is a polymer coating that is grown directly from a material surface.ch Precision Machining A manufacturer is repositioning its precision medical machining services to include device design assistance. CA. translate into higher-quality parts at a reduced cost. End-use products include surgical tools and spine implants. including yielding gas monitoring. The Select laser welding workstation enables the observation of crucial welding parameters. CT.baymedix. +49 8151 7760 www. Unlike conventional dust collectors that require frequent cleanings.marshallmfg. Germany. according to the company. and surgical instruments.comcoinc. 800/255-8823 www. Other design highlights include advanced downdraft technology and a large. enabling it to bond to a substrate through strong covalent linkages.com Modular Workholding System A modular workholding system uses compact clamp.com Lubricious Coating Lubricious coatings can prevent medical devices from shedding wear particles inside patients’ bodies. which enables parts to be changed easily. Triag Allenwinden. Putnam. The firm also maintains a cleanroom facility for developing and manufacturing custom formulations.com Laser Welding Workstation Capable of joystick-controlled deposit welding and high-precision CNCcontrolled welding processes. ensuring machine spindles have full access to the workpieces. to ensure process reliability. like hydrophilic coatings.com . 412/777-2000 www. and microclamp technology to hold small and midsize parts. component 38 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec. enables the more precise and efficient production of smaller parts than is possible with computer-aided machining. MA. MicroGroup Inc. The system. according to the company. This advantage can. PA. Burbank. The company says the technology gives its coating an advantage over other lubricious coatings. with tolerances of ±0. and volume precision machining. in turn. Comco Inc. which are weakened by the water they absorb.microgroup.0002 in. MN. Rofin-Baasel Lasertech Starnberg.triag. The clamping designs minimize interference. prototype development.com Biomedical Materials A company provides a range of biomedical materials for minimally invasive devices. orthopaedic implants. Marshall Manufacturing Minneapolis. Foster Corp. The company specializes in the process design and manufacture of high-precision Swiss-machined components. ESD control features and a magnifier are also available.putnamplastics. manufacturing. the system minimizes deflection and supports attainment of very close dimensional tolerances by machining the area of the part immediately adjacent to the collet. a system is equipped with functions to support process validation for medical device device validation. The Swiss machining center.rofin.

As the engineering outsourcing trend has grown. and volume component precision machining. and his deep connections to the Warsaw community make him ideally suited for this position. surgical tools. his leadership in the creation and launch of OrthoWorx. Blanchard. and other implantable devices. ophthalmic.” In addition to his tenure at DePuy Orthopaedics. orthotec. IN). “We will be making more of our experience and resources available to assist customers with the development and manufacturing of their products. Its components are used in products including trocars. Floyd served as president of Abbott Spine (Austin. said in a statement. including makers of orthopaedic. said in a statement. and president and CEO of AxioMed Spine Corp. community. including testing. “David’s industry experience as the global head of a multi-billion dollar orthopaedic enterprise. component device validation. The acquisition is designed to enable UL to reach more medical device manufacturers. and spine implants.” Cheryl R. it has been a challenge and opportunity for our talented staff to step up and play a greater role in our medical customers’ innovation. an industry. “I am delighted to join OrthoWorx and to be able to draw on my experiences in leadership and in the orthopaedic industry in a different way—to help the Warsaw region continue to thrive as the orthopaedic capital of the world.” MDT and MDRS are joining UL’s life and health business unit and will expand its services. Ochsenhausen). and bending machined wire and tubes. said in a statement. (Garfield Heights. orthopaedic. and cardiovascular implantable devices. to help medical device manufacturers improve the safety of their products. Ochsenhausen. Swiss-machined components. The company now offers increased medical device design assistance. chair of the OrthoWorx board of directors.Supplier Beat Recent news about suppliers to the orthopaedics industry.” Anil Patel. where he served until this past April.” Michael Burchill. OrthoWorx Taps Former DePuy Executive for CEO Position OrthoWorx (Warsaw. Floyd is also a founding member of the OrthoWorx board of directors. contact lenses. dental.com Marshall Manufacturing Increases Services Medical components manufacturer Marshall Manufacturing (Minneapolis) has broadened its service offerings to better serve OEMs that have downsized their in-house engineering departments. general manager of UL Health Sciences. ORTHOTEC | SEPTEMBER/OCTOBER 2011 39 . machined needles.” Floyd said in a statement. prototype development. president of Marshall Manufacturing. and chaired the organization’s transportation and logistics initiative. Formerly the president of DePuy Orthopaedics (WarFloyd saw). TX). Floyd as its CEO. “From sterile gauze and bandages to more complex devices such as bone screws. has hired David K. “Simply being a precision parts manufacturer in today’s medical device industry is not enough. UL Expands Capabilities with Acquisitions Product safety testing company UL (Camas. OH). Germany) and MD Registration Support (MDRS. 2-D and 3-D contouring. WA) has acquired test laboratory MDT Medical Device Testing (MDT. president of Centerpulse Orthopedics (Austin). “We are delighted that David has agreed to join our organization as chief executive officer.” Marshall Manufacturing specializes in the design and manufacture of high-precision. an advisory firm that helps medical device manufacturers achieve CE marking for their devices. and education initiative promoting the orthopaedic device sector in the Warsaw region. “The deepening of our service offerings will put the UL brand in front of a wider variety of customers—including some of the biggest companies in the medical and health field. UL’s testing capabilities will help manufacturers develop products that will keep patients healthy and mobile.

“We are also looking forward to expanding the use of the PEEK material. It provides a simple way for orthopaedic companies to address their compliance needs. NY) has added a service to help orthopaedic device companies comply with export laws governing restricted or denied parties. will be used “to research applications across industry and to provide services for universities and companies. The site will be an extension of the company’s instrument manufacturing division.” Millstone Medical Outsourcing Hires VP of Operations the needs and expectations Millstone Medical Outsourcof our customers. Millstone Millstone’s customers. The facility will feature at least $1 million in new equipment and is expected to create at least 10 new jobs. The process is protected by encryption and security technology.oping and implementing programs. With its ability to process temperatures up to 385°C. according to the company. such as polyether ether ketone (PEEK). eCustoms corporate business manager. IN). who has served Neuberger ate in Memphis. trauma. said in a statement. an outstone. eCustoms Launches Service for Export Law Compliance International trade services provider eCustoms (Buffalo.” Hans J. a contract manufacturer specializing in spine. operations. thopaedic OEMs. run. founder and CEO of EOS said in a statement.” Easy List-Check takes less than one working day to implement. and streamlining loaner kit processing and distribution.” Jackson Wood. the EOSINT P800 can process high-performance polymers. It will be located in Rome 40 SEPTEMBER/OCTOBER 2011 | ORTHOTEC City. which the company owners believe is “a highly desirable location from which to attract skilled machinists and CNC programmers. . “Partnering with the University of Exeter to provide additive manufacturing facilities for the southwest of the UK will further help to raise awareness for a technology that is currently shifting paradigms in design and manufacturing.” in executive positions for variNeuberger’s expertise includes develous companies. in the aerospace.Supplier Beat University Purchases EOS Laser-Sintering System EOS (Krailing. and motorsports arena. said in a statement. IN. medical. “Few companies have people who are trained in the complete ins and outs of country-specific trade regulations or customs compliance. At Milling (Fall River.” Chris Ramsden.operations to meet the demands of fessional. orthotec. quality with which we operNeuberger.” according to a spokesman for the company. The company’s Easy List-Check service helps clients achieve continuous compliance without the use of IT resources or additional employee training.” according to a press release. “We wanted to make it easy. He is charged with scaling “Karl is a veteran operations pro. and ensuring efficient ening infrastructure. “We are vides inspection. Germany) has announced that the Centre for Additive Layer Manufacturing (CALM) at the University of Exeter in the United Kingdom has purchased one of its EOSINT P800 laser-sintering systems. strengthning programs. The system.com Precision Medical Technologies to Expand Instrument Business Precision Medical Technologies (Warsaw. and distribution expertise in place as we grow to meet services for medical device OEMs. excited to have his experience and loaner kit processing. has named and I am confident that Karl Karl Neuberger vice president will help us maintain and of operations at its Memphis then exceed the high level of facility. That’s why we’ve created the Easy List-Check service. which is being processed on the P800. will be re. which is the first of its kind in the United Kingdom.proving sales and marketing. It provides eCustoms with a list of names or companies to be checked and creates a compliance report summarizing the results of the review. imsponsible for managing the facility. and users are charged per record. cleanroom packaging. Millstone proCEO. including a durable medical equipment supplier. we are committed to sourcing company serving orcontinuous improvement. MA). and sport medicine devices. a material used in medical implants. plans to open a second facility in 2012. Langer. Easy List-Check can be used on a regular basis to help companies maintain long-term compliance.

........rosler... orthotec.. Send him an e-mail at roger. with particular expertise in orthopaedic devices..... and healthcare IT..tegramedical. including the medical industry................. Contact him at daniel.com ■ 508/541-4200 ORTHOTEC | SEPTEMBER/OCTOBER 2011 41 ............com....5 www....com ■ 201/343-8983 Orchid Orthopedic Solutions...com ■ 800/929-3070 Tegra Medical ...santos@pro-dex.... Novak has 15 years of experience developing metrology products and systems across a range of applications.. and thin film filter characterization. WI).. in Italy....... (Irvine..Inside Front Cover. Leo Glass founded Surface Dynamics (Chelsea.. he held various positions in sales... biotechnology...pro-dex. David Dykeman is cochair of the intellectual property department in the Boston office of the law firm Greenberg Traurig LLP.... He can be reached at dykemand@gtlaw. components.... Robotti has 15 years of experience working with orthopaedic companies...lowellinc. R&D.....rushmachinery............... develops. Daniel Santos is the engineering manager at Pro-Dex Inc. including optical inspection......7..... medical devices.... Back Cover www.com. E-mail her at abramsond@gtlaw.. Robert Boland is the sales director for Trinks Inc.. and injection molding machines to various industries........ Posusta has experience in engineering. He graduated from Temple University with a bachelor’s degree in business administration. with responsibility for both domestic and foreign equipment sales.com ■ 800/562-6204 Rösler .. and optical metrology.com..com ■ 517/694-2300 Pro-Dex Inc.13 www..com ■ 763/425-3355 Master Bond Inc. Matt Novak is the marketing applications manager in the stylus and optical metrology business unit of Bruker Nano Surfaces (Tucson..... and regulatory management.. CA)....... His previous experience includes design and development of various types of orthopaedic and surgical devices... Get in touch with him at lglass@sdbiocoatings... is a registered patent agent in the New Jersey office of Greenberg Traurig LLP.... Abramson’s practice focuses primarily on patent prosecution in the area of biomedical sciences.... surface characterization... com.com............... .. an international service vendor that manufactures porous structures for bone integration..com....... electronics... She received her PhD in medical sciences from Brown University.. which designs.. Reach him at rboland@ lmgpresses........ ......19 www...us ■ 269/441-3000 Rush Machinery .. Glass has a bachelor’s degree in chemical engineering from the University of Cincinnati.. where he served as executive vice president and vice president of sales and marketing. with specialization in design and manufacturing....novak@bruker-nano... engineering. He can be reached at matt... Reach him at francescorobotti@eurocoating....... PhD.. transfer.....orchid-orthopedics....... Pierfrancesco Robotti is responsible for scientific marketing at Eurocoating (Italy)..... 11 www...... He has provided expert applications support for 3-D optical microscopy...... and subassemblies for leading medical device OEMs....com Roger Posusta is senior marketing applications engineer in the stylus and optical metrology business unit at Bruker Nano Surfaces.Contributors Danielle Abramson..31 www....posusta@bruker-nano......... AZ)... MI) after 23 years at APS Materials Inc......... Dykeman’s practice focuses on securing strategic worldwide intellectual property protection for high-tech clients......... (De Pere............. During his time there. Ad Index Lowell Inc.. and manufactures surgical devices........ medical devices.masterbond. and pharmaceuticals.... He has a master’s degree in engineering from UCLA........... Boland has worked as a consultative representative involved with the sale of compression.it... with particular expertise in orthopaedic devices....com.....19 www. He received his MSc in biomedical engineering at Milan Polytechnic University............

sales Orthopaedic Reconstruction (United States) 27% Other 2% Online A full profile of Wright Medical is at orthotec. April 2011: Appoints chairman David D. The problems began in April with the abrupt resignation of then-CEO Gary Henley.05 to $0. with the first phase occurring over the next nine months. net sales increased 4% over last year’s Q2. which reached $519 million. Stookey. July 2011: Announces exclusive deal with ArthoCare for foot and ankle products. PALMISANO. Transition from interim to permanent senior management while operating under the terms of the DPA and the surveillance of the federal monitor. The pie chart shows the breakdown of net sales for 2010. Wright Medical also hopes that the steps it takes to improve operating efficiencies will boost the company to an adjusted earnings per share of about $0. “In recent months. corporate development William L. the company announced a cost-restructuring plan in the hopes of improving cash flow and shareholder value. or 6% of its workforce. Palmisano president and CEO.com . Continue to strengthen compliance program. president and CEO Lance A. “We believe Bob is the right person to continue building on this progress.Ortho Scope Wright Medical Group Inc. the company will lay off 80 employees. Palmisano as the new company president and CEO. senior vice president. human resources Eric A. stating that it had “knowingly” violated provisions of the DPA. Treace. senior vice president. Attorney’s Office for the District of New Jersey.S. senior vice president. and Pacific Rim Edward A. president and CEO Leadership ■ ■ ■ ■ 133 Orthopaedic Reconstruction (International) 32% Extremities and Biologics (International) 7% ■ Net Sales ($ millions) 132 131 130 129 128 127 126 Q2 2010 Q2 2011 ■ Extremities and Biologics (United States) 32% ■ ■ Robert J. Palmisano. Attorney’s Office of New Jersey and the OIG. extended its deferred prosecution agreement (DPA). Japan. global operations Karen L. Harris-Coleman.com/article/wright-medicalprofile During the second quarter.S. senior vice president. 42 SEPTEMBER/OCTOBER 2011 | ORTHOTEC orthotec. senior vice president and CFO Timothy E. the company is well positioned for success. and named a new president and CEO. September 2011: Reaches agreements with U. TN) announced a cost-restructuring plan. Stevens as interim CEO following the resignation of Gary Henley. The company also received a letter from the U. senior vice president.” The company has temporarily suspended its sales and earnings outlook to allow Palmisano to transition into his position. Steiger. The plan will cost between $25 million and $30 million. The company also agreed to extend the terms of its DPA for 12 months. Latin America. Griffin.06 next year and about $0. Highlights ■ ■ ■ ■ ■ September 2011: Names Robert J. Jr.” —ROBERT J.S. In September. we have taken many positive steps to better position the company for success. It’s a lot to swallow for a company that has seen one executive after another leave this year following a scandal involving its compliance program. The scandal snowballed and led to several executive resignations.08 thereafter. global marketing and U. The final twist came a day later with the appointment of Robert J. Davis. January 2011: Expands relationship with Kinetic Concepts to supply Graftjacket regenerative tissue matrix through December 2018 for orthopaedics markets.” said interim president and CEO David Stevens in a company statement. —Maria Fontanazza Focus Going Forward ■ I ■ ■ Implement first phase of cost restructuring plan over the next nine months. Wright Medical Group Inc. including strengthening our compliance program and implementing a plan to reduce operational costs. (Arlington.. senior vice president and chief commercial officer John T. Trying to Right the Ship n the span of just a few days. As part of the initiative. Berry. which came prior to a board meeting that planned to discuss management’s handling of the company’s ongoing compliance program. “With a solid portfolio and strong pipeline of new products. sales and marketing.

2012 Paris.The World’s Leading Project Acceleration Resources for Medical Device Design and Development North and South America MD&M Texas March 14–15. 2011 Cork. UK MEDTEC China September 26–27. India MEDTEC Southeast Asia November 30 – December 1. 2012 São Paulo. China OrthoTec Europe Fall 2012 Zürich. Japan MEDTEC UK May 23–24. 2011 MD&M West February 14–16. 2012 Philadelphia. 2012 Yokohama. Brazil MD&M Florida March 6–7. PA Europe and Asia MEDTEC Ireland October 5–6. TX MD&M Minneapolis November 2–3.com . 2011 Barcelona. 2011 San Jose. Malaysia MEDTEC Europe March 13–15. 2012 Anaheim. IL MD&M Brazil June 26–27. 2011 Mumbai. 2011 Minneapolis. PA Pharmapack May 22–23. 2013 Orlando. IN MEDevice San Diego Fall 2012 San Diego. Switzerland Pharmapack February 15–16. please visit CanonMed. France BIOMEDevice February 15–16. CA BIOMEDevice December 6–7. 2012 Chicago. 2012 Philadelphia. CA MD&M East May 22–24. 2012 Birmingham. France MEDTEC Japan April 18–19. CA BIOMEDevice April 25–26. MA Diagnostica North America May 22–24. 2012 Shanghai. France MEDevice Spain October 5–6. Germany MEDTEC France April 4–5. 2012 Fort Worth. 2012 Stuttgart. 2012 Boston. MN MD&M Online When Face-to-Face is Not an Option East Edition: December 14–15. 2012 Lyon. 2012 Paris. 2011 Penang. Spain For information on exhibiting or attending. 2012 Winona Lake (Warsaw). Ireland MEDTEC India October 19–20. PA MD&M Chicago June 19–21. 2012 Philadelphia. FL OrthoTec June 6–7.

regulatory. Pro-Dex delivers reliable electromechanical solutions for your medical/surgical products. Inc. Irvine. Offering turn-key design.6204 • www. and manufacturing expertise means no more dropped balls.pro-dex.562. 2361 McGaw Avenue.com Pro-Dex..Powerful Solutions From Concept Through Production & Every Step In Between Whether you’re starting with a napkin concept or a fully-designed product that you’d like to outsource. CA 92614 USA ISO 13485:2003-Certified Facility . Product Feasibility Proof of Concept Detailed Design Validation & Verification Testing 13485 Manufacturing Post-Market Surveillance 800. restarts or finger-pointing .just peace of mind and pure execution.