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HERE’S WHAT WE SEE
Why the Medical Device Handbook matters
Medical device suppliers are way • Medical doctors “want better • We have a review of the common
beyond the times when they merely performance and improved adhesive materials and their reaction
filled orders to spec for medtech functionality in the catheters and to sterilization processes, courtesy of
OEMs. From incorporating steerability delivery systems they use,” said Christine Salerni Marotta, the North
into catheters to getting validation Anthony Appling, senior director American medical business and
and testing done right, the companies of research and development market manager for Henkel Corp.
serving the medical device industry at Freudenberg Medical, • Patent protection is becoming
have become specialized experts. Minimally Invasive Solutions increasingly important for mobile
Through our annual Medical (Jeffersonville, Ind.). “One of health developers as more devices and
Device Handbook, we seek to the most important parameters applications join the connected world,
harness this expertise for the is the ability to steer a catheter according to David Dykeman, co-chair of
medical device industry. We with confidence and ease Greenberg Traurig’s global Life Sciences
requested articles from medical through challenging anatomies & Medical Technology Group. Dykeman
device designers, outsourcers and and deflect the tip for precise provides insights about how to do that.
consultants that avoided marketing placement at its final target.” • Scaling to high-volume manufacturing
pitches and instead provided useful Appling lists seven principal requires companies to think ahead
information for our community. factors that medical device and prepare for the future early in
Whether medical device developers should consider. the product lifecycle, according to
developers are new to, say, catheters, • Heraeus’s CerMet – an Gavin Wadas, manager of strategic
electronic components or rapid advanced ceramic and metal capital projects for B. Braun Medical,
manufacturing, the nearly 50 articles technology system – creates OEM Division. Wadas lists four things
in this issue should hopefully help the potential for implantable medical device companies should
them dip their toes into these areas. devices with thousands of reflect upon before they scale up.
Here are just a few examples of electrical channels. Think new • “Using a virtual tubing model
the expertise to be had in this year’s options for treating blindness analysis – such as Integer’s proprietary
Medical Device Handbook: and neurological conditions. Virtual Tubing Model software (VTM)
– dramatically decreases the time
and resources needed for physical
prototyping,” said Michael Holt,
technical solutions director at Integer
(Frisco, Texas). Holt listed three ways
the Virtual Tubing Model software
helps speed up catheter design.
• We have a solid roundup of the growing
assortment of 3D printing options
available for medtech development,
courtesy of Jon Eric Van Roekel, 3D
printing process engineering manager at
Proto Labs (Maple Plain, Minn.).
Chris Newmarker | • Medical device makers have the
Managing Editor | opportunity to capitalize on the
Medical Design & strategic priorities and transparency
Outsourcing |
c newmark er@wtwhmedia.com |
initiatives at FDA’s CDRH, according to
Lisa Olson, president of medical device
strategic consulting company RCRI.
“When the totality of FDA actions and
external communications are evaluated,
the agency is still demonstrating a focus
on the strategic priorities set out in
2016,” Olson said. M
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Medical Design
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11 • 2017 Medical Design & Outsourcing 7
Staff page_MDO_11-17_Vs1.indd 7 11/3/17 11:27 AM

CONTENTS medicaldesignandoutsourcing.com ∞ November 2017 ∞ Vol.3 No.6
INSIDE
the medical device handbook
04 54 104
HERE’S WHAT MACHINING REGULATORY,
WE SEE Choosing the right toolholder REIMBURSEMENT
Why the Medical Device AND IP
Handbook matters
58 Intellectual property protection;
Global product registration; FDA;
10 MANUFACTURING Europe; Deciding Class I or Class

II; Protecting mHealth IP
High-volume automation;
CATHETERS
116
Micro-MIM; Heart valves; Global
Steerability; It’s all in the tip; footprint
Virtual Tubing Model
SOFTWARE
68
22 MATERIALS
Multiphysics simulation software;
Middleware
CONSULTING
120
Plasma treatments; Orthopedic
Get the most from coatings; Adhesives; Epoxy
design services
STERILIZATION
78 SERVICES
26 MOLDING Sterile barrier systems; VPA
ELECTRICAL/ Overmolding; Rapid injection
sterilization
ELECTRONIC
124
molding; Gas-assist molding;
COMPONENTS Micromolding; Dip molding
90 TUBING:
CerMet; UVC LEDs;
Stretchtronics; Advanced lithium
batteries COEXTRUSIONS,
MOTION CONTROL HEAT SHRINK,
40 COMPONENTS
Moving plastic components;
MULTILAYER,
MULTILUMEN
FLUID POWER Mitigating heating Kink-resistant tubing
COMPONENTS
LVADs
96 128
44 NEEDLES AND
SYRINGES
VALIDATION &
TESTING BASICS
HIGH- Drug-delivery system design Validation and testing;
PERFORMANCE Cybersecurity; Designing a
POLYMERS
98
successful trial; Torque auditing;
Preclinical CROs
Sustainability; Liquid silicone
RAPID
136
rubber; PEEK formulations
MANUFACTURING
AND PROTOTYPING AD INDEX
3D printing; Prototyping
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CATHETERS
Incorporating steerability into your catheter:

Here’s what you need to know
Here are seven key design and

development considerations you need to
keep in mind for catheters with steerability.
Anthony Appling As medical technology continues to advance, stiffness along the shaft. They start at the proximal
Freudenberg Medical physicians who specialize in minimally invasive end with a relatively stiff design and transition to a
procedures also have advancing expectations. They more supple design at the distal end.
want better performance and improved functionality
in the catheters and delivery systems they use. 3. Reinforcement
One of the most important parameters is the Good reinforcement along the catheter shaft is
(ABOVE) Four-way ability to steer a catheter with confidence and especially important in a steerable, deflectable
steerable multi- ease through challenging anatomies and deflect catheter, because it needs to resist buckling or
lumen catheter the tip for precise placement at its final target. kinking during use. The following traditional
Image courtesy of
Freudenberg Medical Here are some of the principal factors to methods have been used with success to balance
consider: steerability and deflection with the necessary
reinforcement:
1. Understanding the clinical user’s needs
Ask questions and vet the clinical user requirements • Axial pull wires or aramid fibers with distal
up front. Be sure you understand the anatomical anchors or bands
applications, including any necessary interactions • Coaxial rigid tubing that traverses axially
with given structures or tissue. What will the catheter • Compression coils to reduce or prevent
be used for? Where will it need to go in the body? foreshortening of the catheter
Understand the potential tortuosity and assess what
may be the best approach for achieving optimal Some non-conventional methods have also been
trackability and range of motion. developed using shape memory polymers, nitinol
and electromechanical tips, but these methods
2. Shaft design are often cost-prohibitive.
The three key properties of shaft construction are
flexural stiffness, longitudinal stiffness and torsional 4. Lumen vs non-lumen
stiffness. The material chosen, and how it is A lumened catheter may be constructed with a
engineered along the length of the catheter shaft, lubricious multi-lumen or multiple single-lumen
affects each of these properties and is an important layup. In either case, the lumens must be kept
factor in overall performance and functionality. as straight as possible to maintain planarity. The
Composite shafts, for example, feature a graded goal is to minimize twist to prevent off-plane tip
Catheters_11-17_Vs4.indd 10 11/3/17 12:12 PM

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Teleflex 11-17.indd 56 11/3/17 11:03 AM

CATHETERS
deflection. In addition, the central lumen

needs to maintain patency even in the
deflection zone. This can be achieved
using variable coils, braids or laser-cut
hypotubes. Larger catheters are more
difficult to keep round during deflection
due to the higher force needed to deflect.
For diagnostic or therapeutic
catheters that do not require a central
lumen, other methods can be used to
facilitate tip deflection. For example, for
single-plane deflection, the catheter can
be anchored to the actuation components
and moved axially along fixated wires at
the tip and proximal end. A rigid spine
can be incorporated to maintain planarity.
5. Other catheter functions and their

potential impact on design choices
Steerable catheters often include
advanced functionality, and components
that facilitate other functions may impact
your design choices. For example,
consider whether the catheter has sensors,
electrodes or other electronic components
that may need shielding. Carefully select
materials to ensure they do not interfere
with integrated circuits or sensors.
Selecting a different metal alloy is one
example. Dielectric materials and their
locations must be considered as well.
6. Extrusion
All good catheters start with high-
quality tubing. It is important to
understand the compounds and
additives in the tubing material, and
how to process them, to ensure a
stable, high-quality product that will
stand the test of time. High-performing
materials for the outer jacket include
PU and PEBA-based thermoplastics or
other thermoplastic blends. PTFE or
coextruded PEBA/PU with FEP or HDPE
are traditional materials used for sheaths
or guide catheters.
7. Manufacturing
To help prevent unpleasant surprises
late in the process, it’s considered
a best practice to use the same
manufacturing technique and process
technologies during design and
development as you plan to use for
12 Medical Design & Outsourcing 11 • 2017

25678_
final production. Changes in the manufacturing of experience and a deep understanding of
technique mid-point can adversely affect different manufacturing technologies. Ideally,
catheter performance. you want a company with comprehensive design,
A partner with in-house design and development and full device manufacturing
manufacturing capabilities is advantageous to capabilities as well as an understanding of
ensure design for manufacturability. It is also proven methods. A partner with a wide range of
important that your design partner knows the innovative solutions can further “steer” you to a
fundamentals of lean manufacturing. Optimal successful product launch. M
lean manufacturing techniques and design for
manufacturability go hand-in-hand to deliver a Anthony Appling is senior director of research
best in class device. and development at Freudenberg Medical,
Accessing and reaching the target Minimally Invasive Solutions (Jeffersonville,
anatomy accurately is one of the key elements Ind.). He has 18 years of experience in product
of maximizing procedural success. To ensure design, development and manufacturing with an
the success of a steerable catheter system, it emphasis in minimally invasive delivery systems
is critical to choose a partner with a full range and therapeutic devices.
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CATHETERS
How virtual tubing model analysis

can accelerate complex catheter shaft design
Virtual tubing model analysis optimizes catheter

design to help engineers reach final design
freeze faster and shorten time to market.
Michael Holt As medical procedures become more complex,

Integer engineers are challenged to develop smaller,
thinner-walled catheters to keep pace with high-
performance clinical demands. Conventional Maximize kink response in a catheter by performing
catheter prototyping relies on a manual, time- modeling analysis with Virtual Tubing Model software (VTM)
consuming trial-and-error process involving Graph courtesy of Integer
multiple rounds of material procurement, prototype
assembly and bench testing. A virtual simulator
simplifies the catheter design process but is still
time-consuming and has resource challenges.
Using a virtual tubing model analysis – such as
Integer’s proprietary Virtual Tubing Model software (VTM)
– dramatically decreases the time and resources needed
for physical prototyping. With VTM, complex multilayer
braided composite tubes can be modeled in minutes,
compared to using 3D CAD modeling programs that
may take hours and consume valuable time.
VTM is a fast, easy-to-use software modeling
program that predicts the performance of catheter
shafts for single lumen constructions with one or more Maximize torque response in a catheter by performing
modeling analysis with Virtual Tubing Model software (VTM)
material layers, and with or without braid reinforcement. Graph courtesy of Integer
Here are three ways the Virtual Tubing Model
software helps speed catheter design:
1. Rapid design modeling

With VTM, engineers can quickly model design
options to predict kink radius, bending (lateral)
stiffness, linear stiffness, torsional stiffness and hoop
strength. Various design options can be modeled
and overlaid in graphical form for each performance
attribute, allowing engineers to analyze the graphs
simultaneously to determine which design delivers
optimal performance and any tradeoffs.
For example, an engineer may want to maximize
kink response, but doing so may greatly reduce the Model different stiffness zones to see how the stiffness
torque response of the shaft. Knowing the tradeoffs in of the catheter changes along the length and make
advance is crucial to developing a catheter shaft that changes as needed based on the application
delivers optimal performance. Graph courtesy of Integer

IT’S ALL IN THE DETAILS
ONE SOURCE – ENDLESS SOLUTIONS

Freudenberg Medical goes above and beyond to help you create next
generation products. From components – utilizing sophisticated
materials and processes – to sub-assemblies and highly specialized
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and development through mass production.
Innovating Together.
CATHETERS. COMPONENTS. COATINGS.
Freudenberg 11-17.indd
170920 FreuMed 56
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11/3/17 11:40 AM
AM
CATHETERS
2. Adaptable design options

VTM allows engineers to model up to 10 unique layers, both
braided and non-braided. The model can accommodate almost
any polymer and braid material, requiring only the tensile
modulus, Poisson’s ratio and ultimate tensile strength as inputs.
Braid patterns from 4 to 48 wires can be modeled with almost
any braid wire material, including stainless steel, nitinol, tungsten,
platinum, non-metallic monofilaments and many other metals.
3. Design for Manufacturability (DFM) analysis

Utilize VTM to run and graph a series of models at different A series of VTM models can be run and graphed at
pic counts to quickly determine which option delivers different pic counts to determine the best range for
optimal manufacturability. In the flexural stiffness chart, optimal manufacturability
check out how a catheter engineer created an initial design Graph courtesy of Integer
for a microcatheter and requested a pic count of 160 ppi to
minimize the bending stiffness of the catheter shaft. A series
of VTM models were run at different pic counts and graphed.
The data showed that a pic count in the 120 ppi range
delivered optimal flexibility. This lower pic count took less
time to braid and required less braid wire. It also enhanced
overall manufacturability and helped save time and resources.

Based on a 20-year history of optimizing Michael Holt is technical solutions director
catheter designs, Virtual Tubing Model at Integer (Frisco, Texas). Holt has more
software is one of the most effective than 20 years experience in the design
tools available today to predict prototype and development of complex catheter
performance. The ability to create and based devices. He holds a Bachelor of
overlay multiple reports for different design Science in mechanical engineering from
iterations allows engineers to identify the University of Tennessee.
performance patterns and pinpoint an
optimal design more quickly. The result is
significantly fewer prototype iterations to
reach final design freeze and enhanced
speed of new product delivery to market. M
Innovative solutions engineered to your specific requirements.

Realize your vision with the most experienced and dedicated team in the industry. MicroLumen.com
www.medicaldesignandoutsourcing.com 11 • 2017 Medical Design & Outsourcing 17

CATHETERS
Enhancing catheter steerability and deflection
It’s all in the tip when it comes to making catheters

with state-of-the-art steerability and deflection.
Andy Black Steerable catheters period at body temperature. Examples include

Medical Murray Catheters often need to navigate tortuous guiding catheters, endoscopy, imaging catheters
Ta n n e r H a r g e n s anatomy with precise control of the catheter and tissue ablation. For these more challenging
Medical Murray tip. Steerable catheters are often utilized for needs, deflecting the tip into a defined curve
access into side branches from parent vessels can control the catheter tip location.
to introduce guidewires and other devices One of the most common ways to
into desired locations. The ability to steer a deflect the tip of a catheter is by pulling a
catheter is generally measured by how well wire that runs the length of the catheter shaft
torque is transferred from the proximal end and anchors itself within the distal tip of the
of the catheter to the distal end while the catheter. This type of deflectable catheter
catheter retains the desired shape. design usually has a relatively stiff proximal
Sufficient “steerability” can be achieved shaft and a softer distal tip, allowing the distal
by reinforcing the catheter shaft with braided tip to deflect when the wire is pulled. Using
wire to enhance torque transmission various durometers of the thermoplastic outer
and provide kink resistance. A layer, melted onto the braided liner, commonly
common steerable catheter alters the shaft stiffness.
is constructed by braiding Deflectable catheters incorporate a
wire over a lubricious dedicated liner running the entire length of
liner, which serves as the catheter, to allow the pull wire to move
the working channel, freely between the soft distal tip and the
followed by melting stiffer proximal shaft segments when they are
and compressing all joined together. The pull wire is typically
an outer layer of anchored by welding the wire to a ring and
thermoplastic then embedding the ring within the distal end
onto the braided of the catheter. The location of the embedded
liner to create ring will dictate the deflected shape when the
a single, fused wire is pulled from the proximal end.
composite. For catheters that need to deflect in two
Many steerable directions, two pull wires will be used. Separate
catheters have liners will be dedicated to each pull wire, and
a preset shape at the wires will typically be welded to the ring
the distal tip. These embedded in the tip 180° relative to each
preset tip shapes can be other. These pull wires can be connected to a
manipulated with guidewires levered bell-crank mechanism in the handle for
and shaft rotation for access to simple and smooth control of the tip with two
challenging anatomy. There are a large variety directions of deflection.
of preset tip shapes including a slight angle,
cobra, visceral, pigtail, etc. Advanced design considerations
There’s an increasing need for more advanced
Deflectable catheters design and material considerations to alter
Some catheters may be required to place the the steerability and deflection of the catheter.
catheter tip very precisely for a prolonged For example, structural heart implant delivery

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CATHETERS
systems must navigate a tortuous path by varying the outer layer materials, the
and then maintain the intended shape shaft reinforcement and/or the pull wire
while a relatively large, rigid implant is anchor locations. Varying the outer layer
advanced through the catheter. materials typically involves changing
These more advanced catheter the durometer of the material. The
systems often require varying degrees shaft reinforcement may be altered by
of deflection, such as slight deflection in changing the braid pattern, transitioning
one segment with a very tight deflection from braid to coil or encapsulating a
curve in another segment. Straight lasercut hypotube. The pull wires can be
lengths of catheter shaft between anchored at different locations along the
these deflection segments can also be length of the catheter or be radially offset
utilized to create “reach” for optimal tip when welded to the same anchor ring.
location when deploying other devices All of the options above can be
through the catheter. combined for a near limitless variety of
Multiple deflection zones can be desired results. Assembly of catheters
integrated into the length of the catheter that combine these features can require a
surprisingly amount of subtle finesse.
Emerging technologies
New methods of catheter navigation are
emerging. Rather than utilizing a pull wire,
force can be transmitted to the distal tip
IMPACT CAN DESTROY AN OBJECT using concentric tubes or small hydraulic
OR A SINGLE ELEMENT OF THAT OBJECT chambers positioned within the tip of the
catheter. Force can be generated within
the tip by electric or thermal energy.
Magnets can also be integrated into
the tip and then controlled by external
magnetic systems. Any one of these new
technologies may ultimately displace
the current methods of steerable and
deflectable catheters. M
Andy Black heads all product development
INNOVATING
from initial concept to manufacturing and
leads project teams at Medical Murray’s
four facilities nationwide. Tanner Hargens
SHOCK & VIBRATION has extensive expertise in device design
SOLUTIONS
and commercialization and directs Medical
Murray’s sales engineering team.
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CONSULTING
How to best collaborate with a product design firm
There are a number of things that medical device companies can do to ensure
that their partnerships result in well-designed devices. Here are a few tips for
successfully navigating a partnership with a product design firm.
S o n j a Ta k a t o r i So you’ve successfully interviewed, evaluated 1. Communicate your product marketing

Product Creation Studio and selected a design firm to partner with on your strategy
next medical device product development project. Share information about your products, business
Congratulations on finding a team to bring your and marketing strategy with the design firm at the
product to fruition! As a client, you are investing beginning of the partnership and communicate any
your time and money into the partnership, and changes in strategy as they happen. Understanding
you want ensure that working together results in a more about the business, the product and the
successful and fruitful product development effort. market helps the design firm innovative and make
7 SHP_1579.jpg
Your job now is to make sure the combined better decisions throughout the engagement.
team delivers value and meets your needs. Design offers an effective way to differentiate
Here are four key factors that a company’s products, often providing a
will help you ensure the competitive advantage. Empowering the design
relationship begins firm with information about your company and
and ends on market will inform their designs and decisions,
the right resulting in more effective product designs.
track.
2. Understand your target user needs and
desires to create better experiences
Don’t rely on best guesses about your users
to inform your product design team. You can
find out how actual target users behave, how
they might engage with the product you
are developing and what you might do to
improve that user experience so they will
ultimately purchase your product.
The knowledge gap between the
design team and the target users
can be diminished by applying
systematic usability techniques
throughout the design and
development of the product.
Usability data can provide
objective evidence to use as
the basis for making design
decisions and as a way to decide
which ideas are the most viable.
Consulting_10-17_Vs2-BP-FINAL.indd 22 11/5/17 7:13 PM

CONNECTORS FOR MEDICAL DEVICES
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CONSULTING
3. Accept the uncertainty of product

development, but be an active
participant as the project unfolds
Relatively few details about the desired
ISO 9001 ISO 13485 AS 9100 product are known at the beginning of
the project, meaning that a design firm’s
estimates are subject to a degree of
uncertainty. As the design firm engages in
perfection in the project and the product development

effort matures, more knowledge is gained
stainless steel
and the uncertainty about the project and
desired product typically decreases.
But financial and contractual
commitments are agreed upon at the
beginning, based on the proposal – at
the period of highest uncertainty. Once
the design team engages and dives into
product development, creative ideas
emerge that may not have been in scope
of the original proposal. This limits the
design team’s freedom to pursue a better
product.
If not managed appropriately, this
also can lead to contentious discussions
between the client and their design
partner. Working together, however,
P
CNC machining Laser machining the client and design firm can actively
and continuously strive to reduce the
uncertainty level.
Eagle is the supplier of choice for close-tolerance, An adaptive project management
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exactly what you want, when you want it. Call us for – is one approach to dealing with the
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responses from real people ! and the design firm accept that changes
are inevitable, learn from discovery and
update plans to reflect those lessons
and – above all – work together in a
transparent and trusting partnership.
4. Engage continually in the partnership

At Product Creation Studio, we believe
the consulting relationship is an amazing
collaboration built on commitment and
trust in which we become an extension of
our clients’ team. For this to work, both
sides must embrace open communication
and be capable of giving and receiving
frequent, honest, transparent feedback to
avoid unpleasant surprises.
To get the relationship off to a good
Eagle Stainless Tube & Fabrication, Inc. start, clients should be ready to set their
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2016 HALF CNC laser.indd 1 12/15/15 12:21 PM
day involvement in the details to supporting your • The design team’s dedicated project manager
design partners as they execute on the day-to-day should also manage regular updates in the
details. This means communicating what you need at form of meetings and written status reports.
a requirements level, rather than how to do it at an • The client will benefit from being available
implementation level. Understand and identify the key for the meetings as requested, reading the
decision-makers and make sure the design firm knows status reports to make sure the information is
who they are. understood and asking clarifying questions.
As the project progresses, other behaviors become
key to maintaining a successful, lasting partnership: Working together, the client and the design team can
achieve results that are more successful and innovative
• The client needs to be ready and available than what either team could have produced working
to make decisions to keep the team moving on their own. By keeping these four factors in mind,
forward; you’ll be on your way to successfully bringing your
• The design firm should provide the client with product to market with the power of a well-functioning,
options and tradeoffs to help make these multidisciplinary team. M
decisions;
• Resist the urge to micromanage. Let the design Project Manager Sonja Takatori has 29 years of product
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Medical Design & Outsourcing 25

ELECTRICAL / ELECTRONIC COMPONENTS
Bobbin-type LiSOCl2 batteries are

commonly used in bone growth stimulators
and AEDs, and can handle the extreme
temperatures (-80°C to 125°C) of the medical
cold chain and autoclave sterilization.
Image courtesy of Tadiran Batteries
Advanced lithium batteries

enable medical devices to be miniaturized
Lithium batteries are allowing medical devices to become smaller and more
ergonomic without sacrificing power or performance.
Sol Jacobs Modern medical devices are become that require low average daily current along
Ta d i r a n B a t t e r i e s increasingly sophisticated and miniaturized, with extended battery life of up to 40 years.
demanding more advanced battery- Bobbin-type LiSOCl2 cells deliver higher
powered solutions. energy density and higher capacity, along
Lithium batteries are paving the way by with a very low annual self-discharge rate.
powering a wide variety of medical devices, Typical applications include bone healers,
including automatic external defibrillators, oxygen meters and glucose meters.
surgical power tools, robotic cameras, RFID Due to the absence of water and
asset tags, infusion pumps, bone growth the chemical and physical stability of the
stimulators, glucose monitors, blood oxygen electrolyte materials, certain bobbin-
meters and cauterizers. Lithium battery type LiSOCl2 cells can withstand high
chemistry is preferred for delivering the highest temperatures up to 125°C, enabling
specific energy (energy per unit weight) and equipment to undergo routine autoclave
energy density (energy per unit volume) of any or chemical sterilization without having to
battery type, along with nominal open circuit remove the battery.
voltages ranging from 1.7V to 3.9V, enabling A prime example is Awarepoint
products to be miniaturized. battery-powered radio frequency
identification (RFID) real time location
Understanding lithium thionyl chloride systems (RTLS) that continually monitor
chemistry the location and status of medical
Bobbin-type lithium thionyl chloride (LiSOCl2) equipment. Environmental tests
batteries are ideal for medical applications performed by Awarepoint showed
Electrical Components_10-17_Vs3.indd 26 11/3/17 4:11 PM

Sager EEWeb Design News 130 Anniversary.qxp_Layout 1 2/8/17 2:19 PM Page 1
It All Started in 1887 as a

Small Boston Storefront Selling
Speaking Tubes.
130 years later, Sager Electronics has grown into a leading North
American distributor of interconnect, power and electromechanical
electronic components. Acquired 5 years ago by TTI, Inc., a Berkshire
130
YEARS
Hathaway, Inc. company, Sager continues to operate with the same
dedication to its core values – integrity, service and adaptability.
1887 - 2017
Celebrating 130 Years of Distributing Confidence®
© 2017 Sager Electronics, 19 Leona Drive, Middleborough, MA 02346 • 1.800.724.3780 • www.sager.com
Sager PEH 2-17.indd 7 11/3/17 10:48 AM

Medical Interconnect Solutions
that the bobbin-type LiSOCl2 battery batteries enable hand-held devices to

could withstand +135°C temperatures become lighter and more miniaturized.
and work continuously for 500 steam For example, the BioAccess portable
sterilization cycles. The battery was small bone drill was powered by an
compact, lightweight and powerful, alkaline battery pack that performed
delivering 0.55Ah capacity @ 0.5mA well and offered excellent reliability. By
while also being completely safe, substituting 6 AA-size TLM-1550HP lithium
U.L.-recognized and considered non- metal oxide batteries for the alkaline
hazardous when shipped. battery pack, BioAccess achieved a 36%
Bobbin-type LiSOCl2 cells can also weight reduction with only 40% of the
be modified to operate at -80°C for use volume. An equivalent alkaline battery
in the medical cold chain, enabling the pack would have required 3x the weight
continuous monitoring of frozen tissue and 2.5x the volume (15 AA-size alkaline
samples, transplant organs, medical batteries vs. 6 AA-size TLM-1550-HP
supplies and pharmaceuticals during batteries). Use of a lithium metal oxide
transportation. battery pack
However, be aware that LiSOCl2 also
batteries are not created equal. A
superior quality cell can feature an
REDEL SP®, Enabling New average annual self-discharge
rate of 0.7% whereas an inferior
Connections
quality LiSOCl2 battery can
have an annual self-discharge
• Ergonomic grip for easy rate of up to 3% per year.
mating and alignment For automatic external
defibrillators (AEDs) – which
• Embedded latching system can remain idle for years
for impact resistance but then need to perform ✓
reliably in a life-saving
• High density contact emergency – it makes sense
to choose a superior-quality
✓
configuration bobbin-type LiSOCl2 battery
• Four keyways to prevent that features the lowest possible ✓
annual self-discharge.
cross connections ✓
Hybrid batteries power high-current
• Plastic material for pulse applications
sterilization A hybrid version of the bobbin-type ✓
LiSOCl2 cell combines a standard battery
• Multiple colors for Awarepoint medical RFID asset tracking
with a patented hybrid layer capacitor tags utilize bobbin-type LiSOCl2 batteries
indentification (HLC) that acts like a rechargeable battery that do not have to be removed prior to high
to deliver the periodic high pulses temperature autoclave sterilization, ensuring
• 4-22 contacts required by external defibrillators. continuous and reliable data.
(crimp or solder) A similar technique is utilized to
create lithium metal oxide batteries enabled the surgical drill to deliver faster
• Cable assembly solutions that can deliver high voltage and high drilling speeds, more active drill time (30
energy density, along with instant to 40 seconds at a time for up to 20 to
activation and extended operating life, 30 cycles), more instantaneous power
even at extreme temperatures. Lithium and greater stall torque, resulting in more
metal oxide batteries deliver an open efficient drilling cycles with less operator
circuit voltage of 4.0 V with high pulses fatigue.
of up to 15A and 5A continuous current
LEMO USA, Inc.
at 3.2V for a limited time. Often utilized Industrial grade rechargeable Li-ion cells
800-444-5366
in hand-held surgical power tools Numerous medical devices are currently
info-us@lemo.com
and cauterizers, these powerful little powered by consumer-grade Lithium-
www.lemo.com
28 Medical Design & Outsourcing 11 • 2017 www.medicaldesignandoutsourcing.com in
Electrical Components_10-17_Vs3.indd 28 11/3/17 12:25 PM Introtek

ion (Li-ion) rechargeable batteries. for growth with telematics and GPS
Consumer Li-ion cells have inherent tracking devices being coupled with
drawbacks, including short operating heart rate, temperature and other
life (maximum 5 years and 500 advanced sensors used to monitor
recharge cycles, a high annual self- the health and location of patients
discharge rate (up to 60% per year) in hospitals, nursing homes, assisted
and a limited temperature range living quarters or remotely. These and
(0°C to 60°C) with no possibility of other emerging medical technologies
recharging or discharging at extreme will benefit from reliable, long-term
temperatures. battery-powered solutions. M
Industrial-grade rechargeable
Li-ion batteries are now available that Sol Jacobs is VP and general manager
feature up to 20-year operating life for Tadiran Batteries. He has more
with 5,000 full recharge cycles, able to than 25 years of experience in
deliver high-current pulses (up to 5A) developing solutions for powering
and offering a much wider temperature remote devices.
range (-40°C to 85°C) with the ability
BioAccess surgical power drills use
to be discharged and recharged at
lithium metal oxide batteries to achieve a
extreme temperatures (10-hour rate). 36% weight reduction with only 40% of the
Industrial grade Li-ion batteries volume of comparable alkaline batteries.
could see dramatic opportunities Image courtesy of Tadiran Batteries
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7:14 PM
Enabling micro-sensors for next-gen interactive implants
CerMet – an advanced ceramic and metal technology system – creates the potential
for implantable devices with thousands of electrical channels. Think new
options for treating blindness and neurological conditions.
Chris Newmarker Only a few years old, Heraeus’ CerMet is upping Heraeus
Managing Editor the game when it comes to sophisticated implantable CerMet micro-
electronic devices. component with
“Medical implants manufactured using the Heraeus internal routing
to simplify the
CerMet technology can be smaller, more efficient and
design of medical
capable of integrating more functions,” Jens Troetzschel, implants e.g.
VP of advanced technologies at Heraeus (Hanau, Germany; implantable sensors
St. Paul, Minn.), told Medical Design & Outsourcing. “We
can now utilize extremely fine circuit paths that are only
0.15 mm thick, as thin as a piece of paper.”
We asked Troetzschel to explain CerMet and the
medical device advances it’s enabling; the following is an
edited transcript of our conversation: A future retina prosthesis, for example, could be
equipped with a significantly increased number of
MDO: What exactly is Heraeus CerMet technology? channels, conveying signals from the implant to the optic
nerve, which results in improved imaging.
Troetzschel: The Heraeus CerMet material is a strong,
high-density and extremely robust ceramic and metal MDO: Where is CerMet being used already?
(CerMet) composite of tiny platinum and aluminum oxide
particles. But ceramic and metal typically do not bond Troetzschel: We have entered into various partnerships
chemically. To manufacture a feedthrough, until now, with leading companies and research teams to develop
individual wires were inserted manually into the ceramic next generation micro-implants. For example, Heraeus is
and soldered with a high-temperature process, which is now working with research teams on new interactive micro-
labor intensive and time consuming. However, when many implants for the treatment of tinnitus, functional disorders
electrical channels are needed, this process quickly reaches of the gastrointestinal tract, and multilocular muscle
its limit, which prevents the development of sophisticated stimulation in the field of bionic implants as part of the
miniaturized devices applied in novel therapies. With [five-year, €13.5 million] INTAKT innovation program, which
CerMet it is possible to realize a density of more than is sponsored by Germany’s Federal Ministry of Education
5,000 electrical channels per square inch, which is a and Research (BMBF) and led by the Fraunhofer Research
substantial improvement compared to current technologies Institute. This network of medical industry, research,
– and this is not the end of the development. science and clinics is now developing new interactive
This CerMet technology offers developers and micro-implants to improve therapies for numerous medical
manufacturers of implants greater flexibility in designing issues and therapies. The INTAKT Program is using the
new devices because the material system allows for Heraeus CerMet technology to enable a significant
the production of more complex three-dimensional miniaturization of novel medical devices.
structures. In the area of feedthroughs, it will now be This program allows us to fine-tune our technology
possible to manufacture angled or branched circuit paths, even more, and the close cooperation with medical
thereby allowing unprecedented design flexibility for the professionals leads to a much deeper understanding of
medical implants of the future. clinical needs.

Tadiran Batteries 1-17.indd 35 11/3/17 10:55 AM
Within the scope of technology studies, we MDO: What is the future of CerMet?
developed technologies to connect Heraeus CerMet
components to electronic circuit boards on the inside of Troetzschel: In general we see a major shift in
medical devices and to lead wires on their outside. technologies ahead of us.
Heraeus currently is developing technologies for the Mathematicians and programmers have developed
integration of CerMet composites in titanium housings. powerful algorithms and software to analyze huge
We are also working with numerous medical device amounts of data to derive information. We’ve got the
manufacturers worldwide to develop next generation computational power to handle these huge amounts
enabling solutions in the fields of neuro stimulation, retina of data in real time in this day and age. Neuroscientists
implants, hearing aids and implantable sensor applications. and researchers are getting a better and more refined
Higher channel count can

give better resolution e.g. to
improve the performance of
next generation retina implants.
(Image a) Shows an 8×8 grey
scale picture of an apple,
illustrating a retinal implant with
64 channels, b) shows a 16×16
resolution equaling 256 channels,
c) shows 36×36 channels
equaling 1296 channels.)
RFID+ : added-value RFID Technology

Standard RFID protocols including additional customized performance
Special performance in Special tag shapes
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temperatures down running on RFID bands
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Tag-on-metal devices Passively LED driving

through frequency tags for fast visual
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Email: info@ixys.es
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MEDICAL
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■ Corrosion resistance ■ Modular or turnkey solution ■ Easy to handle with gloves
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(LEFT) Example of a high channel count

feedthrough element to enable high
resolution therapy e.g. for retina implants
The Greatest Brains In

Magnetic Assemblies
picture of the processes that happen in the
human body.
All this happening in parallel at
the same time creates an enormous
momentum which is used by an entirely
new group of players in the field of
medical devices. Elon Musk’s Neuralink
is an example, as well as Apple’s and
Google’s activities in this arena.
However, these innovations will require
implantable, miniaturized devices able to
interface with the nervous system or more
generally with the tissue of the human
body – and they will have to sense certain
bio-signals (biomarkers), process the data
and/or transmit to systems outside of the
body – which will display the information to
doctors or directly to the patients. Keep your pacemakers, sleep apnea machines and other
Heraeus CerMet technology can magnet-requiring medical equipment healthy with Magnet
open entirely new design options for Applications. Our expert team of engineers deliver
significantly miniaturized devices. At the custom-designed assemblies and magnets that meet your
same time, the CerMet technology can stringent demands for quality and precision, and built to your
allow for a virtually unlimited number of
exacting specifications. So be a brain and contact Magnet
communication channels to interface with
the body, and thus can help feed this Applications today to discuss your next project.
enormous appetite for data.
As a biocompatible and bio-stable • Engineering Design & Analysis Services
material technology system, CerMet will • 3-D Modeling
serve as a means for encapsulation of tiny • Sensor Class Magnetics for Critical
little sensors or stimulators – which can in
• Indexing Features for Alignment & Orientation
combination with flexible electrodes be
placed everywhere in the human body,
exactly at the point where the signal should
be sampled or stimulation is needed.
Hundreds of channels will be used
to feedthrough signals in retina implants
as well as in brain readers or wearable
general purpose recorders for neuro
signals – just everywhere where a higher
MADE IN
resolution yields a better “picture.”
CerMet will enable a new quality
of delivering the therapy to exactly the Only North American Manufacturer
of Compression Bonded Magnets
right point. M
Jens Troetzschel, Vice President

Advanced Technologies, Heraeus Medical
Components (800) 437-8890
eMail: Sales@MagnetUS.com
magnetapplications.com

Why Flex is betting on stretchtronics for medtech
Stretchtronics is flexible circuitry that could be implanted

into clothing and could offer both worn or implanted USUALLY WHEN
opportunities for body monitoring. YOU THINK ABOUT
HEALTHCARE,
Heather Thompson The wearable lab at Flex (formerly Flextronics) says it was featured
YOU PICTURE
Senior Editor it’s making strides when it comes to creating devices in U.S. Olympic A PERSON IN
A BED WITH
that are transparent and seamless. Athletes’ light-up
“Usually when you think about healthcare, clothing designed
WIRES RUNNING
you picture a person in a bed with wires running by Ralph Lauren.
all around. We think healthcare should be as easy And it could go
ALL AROUND.
as putting on a T-shirt,” John Carlson, president even further, such
of health solutions, told Medical Design & as be threaded
Outsourcing.
WE THINK
into conductive
In Flex’s San Jose innovation and early yarn, noted
HEALTHCARE
technology labs, Anwar Mohammed shared one Mohammed.
of the most intriguing technologies with medical The stretchable
SHOULD BE AS
applications. Mohammed is senior director at the technology has
advanced engineering group at Flex and provided been used in
cuffs in the NFL. In EASY AS PUTTING

some insight into the technology during a press tour sweat monitoring
in September. (Note: None of the devices MDO
was shown are FDA cleared or approved. They were
strictly proof of concept.)
terms of medical
applications, ON A T-SHIRT.
Stretchtronics is flexible circuitry that could Carlson said that
be implanted into clothing and could offer both the sweat cuffs
worn or implanted device opportunities for body monitor glucose levels, as well as lactate and electrolyte levels.
monitoring. You might recognize the technology— Those data could be practical for a therapeutic or diagnostic
application. In orthopedics, the sensors could be embedded in
shoes or socks to measure activity rates post-surgical patients.
Another valuable area of therapy the technology
can be used in is wound care. Flexible electronics could
incorporate antibacterial technology, with hydrophobic
and oleophobic properties.
Sensors that measure O2 levels can play a role in
monitoring the progress of a wound. Mohammed also
mentioned a theoretical ability to predict pressure ulcers.
Wound monitors placed on at-risk areas of the body could
contain sensors that warn caregivers of changes that could
lead to ulcerative conditions.

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Mohammad noted that the material has significant

applications in implantable devices, because of its
flexibility. The electronic components won’t rupture or
delaminate even after hundreds of use cycles.
Devices that use the flexible electronics have a unique
opportunity to function alongside tissue, rather than be
isolated from it.
“When the bodies’ cells identify foreign objects, and
start to reject them, one of the first indications [is that they
push on them],” Mohammad said. “Thanks to work being
done at MIT and Johns Hopkins, they’ve been able to show
that it can take up to 19 days for the body to recognize
stretchable electronics as a foreign object. That is 19 days
in which you can monitor and treat severe trauma.”
Stretchable electronics in medical applications is still
nascent, Mohammed noted. As the technology advances
new applications could be revealed. M

Three ways to integrate UVC LEDs into

medical equipment and devices
Adding disinfection with UVC LEDs is a viable alternative to chemicals, according to

Crystal IS. Here are three examples of how they can make a difference.
Rajul Randive In 2017, the Centers for Disease Control & Prevention been less dramatic. Disinfecting the hub of a central line
Crystal IS (CDC) reported significant progress in many areas commonly is a manual process that relies on friction and time. It
associated with hospital acquired infections (HAIs). However, takes up to 60 seconds when executed properly and there
on any given day about one in 25 people who visit a is no way to verify compliance. A handheld LED device
healthcare facility in the U.S. will still contract an HAI. attached to an infuser could be aimed at the hub and within
Infection reduction depends on combating pathogens seconds deliver a UVC dose capable of a 4-log reduction
that are becoming increasingly resistant to chemical of common pathogens like MRSA. The result is that a
disinfection methods. Adding disinfection with UVC LEDs consistent disinfection dose is applied to a common site of
is a viable alternative to chemicals because it disrupts the pathogen transport in far less time.
DNA of harmful microorganisms and destroys their ability
to reproduce, thereby eliminating the spread of MRSA, C. 3. Preventing ventilator-associated pneumonia
diff. and many other pathogens that have no known natural UVC LEDs can also be used to address ventilator associated
defense mechanism to UVC energy exposure. Although pneumonia (VAP). Though it occurs in only 1% to 2%
there are many ways to integrate UV disinfection with LEDs percent of patients using mechanical ventilators, VAP
throughout the hospital, the following cases offer the most mortality rates are greater than 50%. Focused UVC energy
opportunity for near term impact on the rate of HAIs. from a LED-enabled device could disinfect complex
passageways, in-vitro components and even nebulizer
1. Preventing C. diff Infections on high-touch surfaces equipment in-situ without heating the target surfaces.
Clostridium difficile (C. diff.), one of the most-reported HAIs,
causes nearly 500,000 illnesses per year. It’s a remarkably Considerations for selecting a UVC LED
resilient pathogen that’s easily transported on high-contact When working with LEDs, there are number of parameters
devices including mobile phones, stethoscopes, workstations designers need to consider. The primary factor centers
and diagnostic tools. These devices are
usually cleaned with chemicals such as
isopropyl alcohol – but alcohol wipes do not
kill C. diff. UVC LEDs provide a method for a
quantifiable and trackable UVC disinfection
dose via handheld or countertop devices
to combat the superbug. In addition,
integration directly into portable
workstations and diagnostic equipment
allows surface disinfection as hospital staff
transition between patient rooms.
2. Quantifiable hub disinfection for

CLABSI reduction
The CDC reported a 50% reduction in
central-line-associated blood stream
infections (CLABSI) between 2008 and
2014, but recent improvements have Graph courtesy of Crystal IS

around the desired log reduction, or required over a given time to achieve
disinfection rate, of the specific target the disinfection target – this is known
microbe in the application. This defines as dosage. To achieve a high dosage
the UV dosage required which designers in a short amount of time to address
need to achieve while balancing the other CLABSI, the application would require
variables like UV intensity, disinfection high intensity. For applications that have
time and uniformity of the UV radiation more time for disinfection like high-
pattern in the design. touch surfaces or VAP applications, lower
Each target microbe has a unique intensity LEDs can be used.
radiation absorption, or “fingerprint,” Healthcare providers, medical
meaning they absorb UV photons device OEMs and disinfection equipment
differently at different wavelengths manufacturers have every reason to
based on their cell structure. The embrace smaller, portable devices that
accompanying graph shows the employ solid-state technology like UVC
absorption spectra for a few common LEDs. Doing so will significantly bolster
microbes found in healthcare settings. what’s projected to be a long and difficult
The absorption curves show that there fight against the spread of infectious
is a significant drop in microbe sensitivity diseases and the ongoing emergence of
at wavelengths shorter than 255 nm and chemical resistant super bugs. M
greater than 275 nm. To ensure maximum
disinfection performance, design engineers Rajul Randive is director of application
select a UVC LED that offers the greatest development at Crystal IS (Green Island,
overlap of the target microbes absorption N.Y.), responsible for designing, building
spectra, most typically with a peak in the and testing various prototype applications
260 nm–270 nm range. that use Crystal IS UVC LEDs.
Once an LED is selected with the
optimal peak emission, designers then
consider the amount of UV intensity
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FLUID POWER COMPONENTS
Imagining the future of heart pump technology
Since its introduction more than 50 years ago, the left ventricular assist device
has evolved from being a temporary solution to a long-term option for patients
recovering from heart failure. Now, companies are engineering the LVAD of the
future to be smaller and more adaptable for individual patients.
D r. J o h n O ’ C o n n e l l For more than 50 years, left ventricular assist

Abbott devices (LVADs) have helped to extend and improve
heart failure patients’ lives by assisting their hearts
in pumping blood. Originally, LVADs enabled
physicians to save patients’ lives for only short
periods of time – they were considered a temporary
solution for those that needed heart transplants.
Now, advances in design and functionality allow
LVADs to be used long-term. With an eye toward
progress, clinical and engineering communities are
exploring where the technology is headed over the
next decade.
Previous generations: Pulsatile pump to

continuous flow
First introduced in the 1960s, the LVAD was initially
intended to support patients pending myocardial
recovery, or heart failure reversal. Although they
were huge advances, early LVAD models featuring
a pulsatile pump had some limitations: Battery life
(an hour or two at most) and patient mobility. In
fact, the device was so cumbersome that patients
struggled to eat a full meal because the pump
encroached on their digestive space.
The next generation of LVAD devices, such

as Abbott’s HeartMate 3 pictured here, usher
in a new wave of patient care.
Fluid Power_10-17_Vs3.indd 40 11/3/17 12:31 PM

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how extreme, talk to The Lee Company. We’ve been solving complex engineer will be happy to discuss your application, and develop a
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SO LENOI D VALV E S
The second-generation LVADs, blood and allows variable speeds to
which debuted in the early 2000s, generate a “pulse” of 30 beats per
were continuous axial-flow devices that minute. This flushes the pump out to
improved on the pulsatile devices but reduce stasis and the risk of thrombosis.
posed a risk of blood clot formation and The latest model also extends battery
driveline infection where the LVAD motor life, reducing the patient burden of
connects to its external power source. recharging and swapping out batteries.
Patients also exhibited
nonphysiologic flow
(minimal pulse pressure,
if any); combined with WITH AN EYE TOWARD
the high shear forces
generated, this played PROGRESS, CLINICAL
a role in increased GI
bleeding. To combat these AND ENGINEERING
negative side effects,
scientists and engineers COMMUNITIES
worked to develop a pump
that would not clot and ARE CURRENTLY
would be more compatible
with a patient’s natural
EXPLORING WHERE THE
bloodstream.
TECHNOLOGY IS HEADED
Today’s LVAD:
Centrifugal pump
OVER THE NEXT DECADE.
What makes this
generation unique is its centrifugal Engineers are taking the next major
pump, which spins in a circular fashion, step forward by creating a smaller pump
ensuring blood does not become static that requires less wattage – allowing
to reduce the chance of clotting. The for total battery implantation and safer
rotor is suspended magnetically to recharging, less-invasive implantation
ensure it remains centered regardless of procedures and greater patient freedom
speed. Due to its large gaps, magnetic – and that’s more compatible with a
suspension is less traumatic to the heart that has experienced failure.
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Looking ahead: Designing the LVADs of the future
Engineers and clinicians envision a device that’s more
invisible to the patient and adaptable to the unique
physiologic demands of each person. This next-
generation LVAD will be designed to be fully implantable
(to reduce infection risk) on both the left and right sides
of the heart, with multiple feedback mechanisms to
automatically regulate pump functions.
Twenty years ago, helping an advanced heart failure
patient live for more than a year was considered a medical
feat. Today the majority of patients live an average of two
years with an LVAD as they await transplantation. Thanks
to the hard work of today’s clinicians and engineers, that
number will continue to improve in years to come. M
Dr. John O’Connell was named VP, Medical Affairs &

Medical Director, Mechanical Circulatory Support for
St. Jude Medical (now Abbott) as part of the Thoratec
acquisition in October 2015. Prior to joining Thoratec in
October, 2013, Dr. O’Connell served as a heart failure
cardiologist for 33 years.
If point A is your
design concept
and point B your
finished product,
then you can consider
this the straightest line
for pumps and compressors.
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The advantages
are pointed:
• Exceptional reliability
• Only one moving part
• Low noise & vibration
• Long service life
• Very low power consumption
mption

HIGH-PERFORMANCE POLYMERS
PEEK formulations for new implantable devices
Since the late 1990s, polyether ether ketone has become a go-to material for
companies that manufacture orthopedic implants, thanks to its radiolucent and
anatomical properties. Now, custom formulations of PEEK are enabling new
potential applications for the polymer.
Lawrence Acquarulo Polymers have always played a role in modern In contrast, unreinforced PEEK has an
Foster Corp.
implantable medical devices. But until the late elastic modulus of 3.7 GPa (540 ksi) and a tensile
1990s, many suppliers limited availability for long- elongation of 45%. This provides a semi-rigid, yet
term implants due to potential litigation liability tough implant that reduces stress concentration
in an inherently low-material-volume market. As on adjacent bone. Implants have also been
such, metals remained the materials of choice developed that are made of PEEK compounds
through the end of the century. reinforced with chopped carbon fiber, resulting in
Several factors changed the implantable device rigidity equal to that of bone for greater
polymer paradigm, including passage of the structural continuity.
Biomaterials Access Assurance Act in 1998,
which limited the civil liability of material
suppliers. Suppliers also began developing
business models to provide adequate returns on
low-volume sales. As a result, polymer supply
and innovation for implantable medical devices
surged in the 21st century. No polymer
represents this dynamic growth more than
PEEK – polyether ether ketone.
In less than two decades, PEEK
has become the material of choice
for some orthopedic implants, such
as intervertebral fusion cages. This
has been attributed, in part, to the
anatomical compatibility of PEEK and
its inherent radiolucency.
Many traditional orthopedic
implants, including fusion cages,
were manufactured from titanium
and stainless steel. These materials
are extremely rigid, with elastic
moduli of 100 GPa (14,500 ksi) and
193 GPa (28,000 ksi), respectively.
By comparison, the elastic modulus
of cortical bone is approximately 18
GPa (2,610 ksi). This disparity in rigidity
can cause stress concentration on the
skeletal structure adjacent to the implant.
Polymers_10-17_Vs2-BP-FINAL.indd 44 11/3/17 12:34 PM

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Furthermore, metal implants implantable devices, the availability

are inherently opaque to X-rays of custom formulations designed to
(radiopaque), which limits the enhance key properties will expand.
postoperative visibility necessary for At the forefront of consideration for
some procedures. A major advantage suitable additives will be the elevated
of PEEK over metal intervertebral compounding and component processing
spinal fusion cages is inherent X-ray temperatures of the polymer. M
transparency (radiolucency) for
postoperative evaluations. Lawrence Acquarulo is the founder
Success in intervertebral cages led & CEO of Foster Corp., a developer
to increased interest in PEEK for other and manufacturer of critical polymer
applications, including orthopedic compounds for medical devices and
trauma fixation, spinal stabilization, drug delivery.
dental implants and ligament anchors.
Whereas the inherent radiolucency
of PEEK is suitable for spinal fusion Table 1: Typical Properties of Implantable Materials
procedures, some of these new devices
must be radiopaque. Stainless PEEK
Radiopaque fillers can be Property Units Steel Titanium (30% carbon fiber PEEK
compounded into PEEK to enhance (316) (Grade 4) reinforced) (natural)
x-ray visibility. Selection of the
appropriate filler and loading is based Tensile ksi 125 80 37.7 14.5
on clinical requirements, component Strength MPa 860 550 260 100
size and location within the body.
The most common additives used to Elastic ksi 28,000 14,5000 3,6000 540
enhance the radiopacity of medical Modulus GPa 193 100 25 3.7
polymers are bismuth subcarbonate,
bismuth trioxide, bismuth oxychloride Elongation % 12 15 1.7 45
and barium sulfate. The high melt
temperature of PEEK, which exceeds
335°C (635°F), limits several of these
radiopaque filler options.
Table 2: Common Radiopaque Fillers for Plastics
Bismuth subcarbonate is limited
to melt processing temperatures up to
Specific Heat Particle
205°F (400°C), beyond which it becomes Radiopaque Gravity Stability Size Characteristics
unstable and turns from white to yellow; Filler (gm/cm3) (°F) (μm)
bismuth trioxide tends to turn from
white to brown at PEEK processing
Barium 4.4 700 0.5-2 White powder, medium bulk
temperatures. Bismuth oxychloride can be Sulfate density, compacts,
processed at elevated temperatures, but it semi-free flowing with assist
reduces the melt flow of PEEK, which can Bismuth 8.0 400-450 1-2 Pale white powder, free
impact molding or extruding quality parts.
Subcarbonate flowing, dusty, low to
Barium sulfate is the most
common additive for radiopaque
medium bulk density
PEEK formulations. It disperses well Bismuth 8.9 400* 1-2 Yellow powder, high bulk
in the polymer and can withstand Oxychloride density, free-flowing
the processing temperatures without *turns brown at
color change. Barium sulfate is also
approximately 400°F
biocompatible and has been used in
minimally invasive devices (<30 days) Bismuth 7.8 500 2-12 White to light gray powder,
and long-term implants (>30 days), such Trioxide very dusty, low to
as bone cements. medium bulk density,
As PEEK continues to expand semi-free flowing
into new temporary and long-term

STAMPING
PROBLEMS?
Need Parts? Talk to Bill!
The trouble with tooling Call or text my cell
liquid silicone rubber (920) 328-4974
and how to get molding costs down or cheese.head@cadenceinc.com
Liquid silicone rubber is great for medical device

applications, but is the tooling worth the trouble?
Dave Theiss Liquid silicone rubber (LSR) is a sought-after material for

Robin Industries medical applications. But there are tooling challenges and
expenses associated with LSR that need to be understood by
medical manufacturers looking to use the material.
What’s so great about LSR?

Many LSR materials are biocompatible, with some grades
approved for implants. Devices made from LSR are temperature-
stable and can withstand harsh cleaning and disinfectants. Further,
LSR resists discoloration from UV exposure, is scratch-resistant and
retains a cosmetic attractiveness throughout a product’s lifecycle.
The material comes in an array of durometers, available at
5–90 durometer, that can be mixed to match any color. It can
also be made optically clear, and it is second only to glass in light
transmission.
LSR has a low viscosity that can be molded into components
with thin walls or small features. Once cured, the material is
flexible and can be easily removed from a mold form, even
with undercut shapes. Some grades of LSR materials will bond
to specific substrates during overmolding, thus eliminating the
prepping step required by other overmolded materials.
In addition, LSR parts can be fully cured in seconds rather
than minutes, compared with HCR silicone, which speeds up
cycle times.
STAMPING EXPERT
Trouble with tooling
LSR tooling is expensive and building molds requires high TOOLING MANAGER
precision and expertise beyond what’s needed for rubber and
thermoplastics. PROBLEM SOLVER
The liquidity of the material means that the cavity inserts
must be absolutely precise to prevent flash extension. For PACKERS FAN
example, tooling for many LSR processes will flash with fits as
tight as 0.0002–0.0003 in.
Ejector pins can be used in LSR molds, but they must have
a tapered shutoff and can’t invade the parting-line shutoff area.
Typically, ejector pins are avoided because any amount of debris
or rubber that builds on the ejector valve seat will cause flash.
www.medicaldesignandoutsourcing.com 11 • 2017 Medical Design & Outsourcing 47 Made in Sturgeon Bay, WI

LSR molders will likely use a vacuum components are mixed. Therefore, the
in most tooling to get rid of outgassing, process requires flowing coolant to control
because the venting used in other the temperature up to the cavity.
thermoplastic processes doesn’t work as Shutting down an LSR process is time-
well. LSR comes in two parts and must go consuming and generates material waste.
through a chemical curing process before The dosing system requires disassembly and
being injected into the mold. Depending on each component must be cleaned with a
the final part needs, venting might need to solvent. The A and B hoses are removed and
be ten-thousands-of-an-inch deep to control the static mixer completely disassembled
flash for tight specifications. and also thoroughly cleaned with solvent.
Curing LSR also requires a precise hand. System clean-out can take up to four hours;
The molds are usually heated to 270-360°F to disassembling and cleaning tools will take the
cure and require strategically placed electrical rest of the work day.
Image courtesy of Robin Industries cartridge heaters in the mold. Heating
molds to these temperatures will start the Overcoming tooling issues
cure process in seconds. LSR also begins to Molders with LSR expertise are aware of these
cure at room temperature once the reactive challenges and can adjust by simplifying mold
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construction. Some use cavity inserts
that go into standardized mold frames.
These frames will have a hot or cold
runner system that can adapt to the cavity
inserts, eliminating the need to build a
frame for each part.
Miniature material dosing systems
can minimize set-up and material waste.
Table-top dosing systems use short hoses
or attach directly to the injection unit to
simplify priming and cleanout process.
A pressure pot is a sealed reservoir that
uses air pressure to force the LSR into the
injection unit. The pressure pot requires
premixing the LSR as part of the set-up,
but eliminates the need to prime and
clean out static mixing units. Further, the
pots are easily removed from the machine
THIS IS HIGH
and can be refrigerated to extend the life
of the pre-mixed LSR.
These adaptations will not cut out
all costs, but they do simplify set-up and
THROUGHPUT
shutdown procedures. Because of the
need for a high level of precision, and
the risks of waste, expenses can add up
quickly. It is important to work with a
molding house that has LSR experience
and can offer part design consulting early
in the process. M
Highest Flow To Size Ratio
Dave Theiss is technical director at Simplified Instrument Design
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How to add recyclability and sustainability

into medtech plastics
Recyclability and sustainability have become very

important across the medical device marketplace, and
some companies are taking note.
Jason Middleton, Some implement sustainability to appeal to consumers; sweet spot is making high-quality, aesthetically pleasing
Ray Products others look to cut costs or align their business practices parts in quantities from the low hundreds to the mid-
with their company mission. Whatever the motivation, thousands.
13% of CEOs see sustainability as their top priority, while Easily recyclable processes include pressure forming,
another 36% view it as a “top 3” priority. vacuum forming, injection molding and blow molding.
What role does plastic manufacturing have in the Processes that are non-recyclable or impractical to recycle
realm of sustainability? Quite a large one – at least are RIM, fiberglass and other thermoset processes.
potentially. More than 300 million tons of plastic are
manufactured every year and this number is growing Recycled materials options in thermoforming
significantly. Globally, it’s estimated that less than 3% of The most sustainable plastic manufacturing process uses
that plastic is recycled. recycled materials and creates a recyclable product.
Thermoforming can check both boxes.
Picking the right process On the materials side, thermoforming projects
Planning for recyclability starts with the process you can be made from any combination of virgin and
choose. Some processes, like thermoforming, are easily recycled materials. It helps to think about it in terms of
100% recyclable. Other processes, a percentage. A project could use any percentage of
like fiberglass or thermoset recycled materials — from 0% all the way up to 100%.
manufacturing processes An experienced thermoforming engineer can
such as RIM, are either help you balance your performance, aesthetics and
non-recyclable or can certification requirements with the availability of
only be downcycled recycled materials.
into other materials.
Beyond Zero-waste manufacturing
sustainability, Pressure-forming and vacuum-forming also offer a zero-
thermoforming waste manufacturing process. During the thermoforming
is particularly process, after a part is formed and removed from the
popular in mold, the excess material is trimmed. However, none
medical device of that material need end up in a landfill. Instead, the
manufacturing material can be collected, ground and sent back to the
because its plastic suppliers for reprocessing.
Image courtesy of Ray Products.

Proto Labs 11-17.indd 56 11/3/17 10:36 AM
Design considerations for The future of sustainability in plastic

thermoforming recyclability manufacturing
When you’re planning a thermoforming To the average consumer, the words
project, what you do after your parts “sustainability” and “plastics” might
are thermoformed has a lot to do seem out of place in the same
with their recyclability. Every piece of sentence. But the truth is that plastics
thermoformed plastic is, by definition, manufacturing can play a critical role
recyclable, but the process can be made in creating sustainable products and
more challenging by additions such as product life cycles. As more and more
bosses or other attachment hardware, companies embrace sustainability as a
painting, silk screening or other coatings. core objective and as more and more
These are not insurmountable consumers demand sustainability,
obstacles, but they do require a more understanding and utilizing sustainable
specialized and labor-intensive recycling plastic manufacturing processes
procedure. becomes more important than ever. M
Designing for a sustainable end of life Jason Middleton is VP of sales &

It’s strange to think that the products we development at custom heavy-gauge
create today will someday be discarded, thermoforming manufacturer Ray
but nothing lasts forever. If you’re Products (Ontario, Calif.).
concerned about sustainability, you
must consider and plan for the day your
products are disposed of.
No matter what process you use,
consider the following key factors when
designing for a product’s entire lifecycle:
Key Design Characteristics Consideration

Materials selection Are your individual materials commonly recyclable, or can they only be
downcycled or recycled through specialized processes?
Number of materials Generally, the more materials that exist in a single piece of equipment, the
more complex it is to recycle
Size Smaller pieces of equipment can be more easily transported to recycling facilities
Ease of disassembly Products typically have to be disassembled and separated into individual
components before they can be recycled
Cleanliness Under typical usage, will your product be contaminated with other
materials that will need to be removed before the product can be recycled?
Design and technology cycle How long do you expect this product to be on the market before it’s
made obsolete by a new design or technology?
Durability How long will this product last before it needs to be replaced?
Hazards Does your product contain hazardous materials that will need to be dealt
with in specialized ways?
Chart courtesy of Ray Products.

METAL COMPONENTS
FOR MEDICAL DEVICES
E N D -TO - E N D M E TAL CO M P O N E NT SU PPLI E R S
TO TH E M E D I C AL I N DUS TRY
MW Medical Solutions is focused on designing and manufacturing highly engineered precision

metal components and assemblies for medical OEM and medical device contract manufacturers.
Fluid Delivery | Dispensing | Drug Delivery

Surgical | Diagnostic | Implantable Products
w w w. mwm e d ical s o l ut io ns .co m
MWI-MedDesOut-Nov17.indd
Industries 11-17.indd 561 10/20/2017 9:53:30 AMAM
MW 11/3/17 10:29
MACHINING
Why high-speed machining

demands a high-end toolholder
In high-speed machining for medical equipment manufacturing,

choosing the right toolholder is the key to greater precision,
longer tool life and decreased machining costs.
Jeff Elliott As any machinist will tell you, when it comes Decreased tool life and damage to the workpiece
C o l l i s To o l h o l d e r to precision machining the importance of a Using a less-precise or imported toolholder for high-
toolholder cannot be overstated. The quality of speed machining can also decrease tool life or cause
the toolholder plays an even greater role when damage to the workpiece.
precision machining at higher speeds. “If the toolholder is not concentric or is a little
High-speed machining is typically utilized off-center, you will have rubbing, wear and more
for medical equipment manufacturing, in which friction, which decreases the life expectancy of the
machinists often work with exotic alloys and tools,” explained Bart Fellin of Fellin Industrial Sales
harder metals like titanium. (Flemington, N.J.), a company that represents a variety
However, with speeds reaching 20,000 RPM, of machine tools and toolholders.
30,000 RPM or even higher, the precise and secure When machining exotic alloys and hard metals,
seating of a properly balanced toolholder in the cutting tools already must be changed out more
spindle becomes even more critical. At these frequently as they dull or break. The cost of tool
rates of speed, even minor flaws in toolholder replacement, not to mention loss of production time due
manufacturing can lead to less-precise machining, to frequent changeover, can add up quickly.
reduced tool and
spindle life and
even damaged
workpieces.
THE HIGHER-END TECHNICAL CARBIDE
This is why
it’s important
INSERTS REALLY DEMAND A HIGH-PRECISION
to understand
the crucial role
TOOLHOLDER. IF YOU END UP BREAKING
of a quality
toolholder,
A TOOL IT COULD CAUSE HUNDREDS OF
which for
tapered
DOLLARS’ WORTH OF DAMAGE.
varieties boils
down to two key factors: Fit and concentricity. “The higher-end technical carbide inserts really
Without any holding or locking demand a high-precision toolholder,” Fellin explained.
mechanism, self-releasing toolholders must “If you end up breaking a tool it could cause hundreds
precisely fit within the spindle with only the of dollars’ worth of damage.
smallest allowance to maintain accurate “Not only is the tool expensive, but you have to change
location, repeatability and proper hold. it out more often, and that takes time,” he added. “So when
The other factor, concentricity, refers to you cost out a job, you may find you are over budget rather
the amount of wobble that can occur when the than making a profit. It can make or break a deal.”
toolholder is rotating or spinning. In machining, Less-precise or imported toolholders can also cause
this is called “the whipping effect” and can lead damage to the workpiece, which would then have to be
to inconsistent results and out-of-tolerance parts. repaired or thrown out.
Machining_10-17_Vs2-BP-FINAL.indd 54 11/3/17 12:36 PM

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will provide the peace of mind and control you deserve to deliver your medical components or has over 45 years of medical device
devices to market on time and cost-effectively. Simplify your supply chain by choosing the DSC team experience, with a tried-and-true reputation
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Design Standards 9-17.indd 56 11/3/17 10:13 AM

MACHINING
Image courtesy of Collis Toolholder “You could be spending hundreds of

hours designing a tool and then find out
that it’s cutting slightly oversized holes, as
an example, because the toolholder could
not hold the tool properly,” Fellin said.
e
s at Jos 36 Quality assurance
6
e u an # Fellin cautions against purchasing less-
Se d S oth expensive, imported toolholders based
e Bo
ioM -7! on price alone.
B .6 “There’s a lot of competition
c
De from imports and a lot of misleading
information where they claim their
toolholder is just as good,” he said. “But
‘time is money,’ so when you have to get
a quality part out and you don’t want it
getting rejected, then you want to make
sure the accuracy is going to be there.”
One way to ensure you’re buying
a quality toolholder is to look for its
certification, which should be “AT3 or
better.” AT3 refers to the tolerances related
to the fit of the toolholder in the spindle.
Collis Toolholder touts itself as the
only manufacturer to certify products
as AT3 or better. It also places special
emphasis on accurate concentricity. To
prevent the aforementioned wobble
or “whipping effect” from occurring,
manufacturers often specify the level of
unbalance by a G number with units in
Medically precise Metal millimeters per second (mm/sec). This is
coMponents, when you

why machine-tool spindles and machine-
tool parts usually are specified with
need theM Most vibration levels of G2.5 and G6.3. This is

also why Collis toolholders are balanced to
the higher G2.5 standards.
Fotofab is focused on delivering the best in photo-etched By producing tapered toolholders
with a superior fit and greater balance,
and stamped metal parts. With the industry’s tightest their toolholders can run at higher RPMs
tolerances, print-to-prototype-part in 1 day, and expert with less fretting, resulting in more
customer service, we should be your go-to source. accurate work and better surface finishes.
According to Fellin, in the medical
We are specialists at producing precision medical device industry, OEMs are looking for
components from an extensive list of metals. repeatability in each toolholder as well.
“Being able to know that from the
first toolholder they purchase to the fifth to
Contact us to discuss your project, and request a the 20th, they are going to get the same
free sample kit today! quality is very important,” he said. M
Jeff Elliott is a Torrance, Calif.–based

technical writer. He has researched and
written about industrial technologies
and issues for the past 20 years. Collis
Toolholder (Clinton, Iowa) has been
Free Medical Design Guide at manufacturing high-quality products for
www.fotofab.com/medicalguide more than 100 years.
Call 773.463.6211 • sales@fotofab.com • www.fotofab.com
Machining_10-17_Vs2-BP-FINAL.indd 56 11/3/17 12:37 PM

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MANUFACTURING
High-volume Using a "design for

manufacturing" approach
helps ensure your products can
manufacturing: be manufactured efficiently
over the entire product life
Four points to
cycle. You must consider the
equipment and processes
that will be required should a
consider before you device be designated for high-

volume manufacturing.
Image courtesy of B. Braun Medical
scale up
Scaling to high-volume manufacturing requires companies to think

ahead and prepare for the future early in the product life cycle. Here are
four points to reflect upon before your company scales up.
G a v i n Wa d a s High-volume manufacturing typically manufactured efficiently over the entire

B. Braun Medical, Inc. — OEM Division involves the introduction of automation product life cycle. That means taking
into the medical device fabrication and into consideration the equipment and
assembly process. A number of benefits processes that will be required should a
usually follow: Repeatability, higher quality device be designated for high-volume
and lower (and more predictable) long-term manufacturing. After all, the automated,
costs of operation. However, many medical high-volume processes could be
devices begin their life cycle below the slightly or significantly different than
high-volume threshold, sometimes with the benchtop or prototype equipment
manual procedures. Successfully scaling used for producing lower volumes. Early
to high-volume manufacturing requires discussion with the manufacturing team
foresight and planning to streamline the is critical to understand how high-speed
production process and minimize changes automation may affect the design
that could make your move to high-volume so provisions can be made to avoid
manufacturing more lengthy and expensive. problems when scaling up.
Weigh these important considerations early
in the product life cycle: 2. Material selection: A crucial part of
designing for manufacturing is ensuring
1. Design for manufacturing: Device that the materials selected are acceptable
design needs to encompass more than for high-volume processes. Devices with
end-user specifications. It’s essential injection-molded components are a perfect
that devices are designed to be example. Lower cavitation might be more
Manufacturing_10-17_Vs2-BP-FINAL.indd 58 11/3/17 12:49 PM

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Carlisle 11-17.indd 56 11/3/17 10:10 AM

MANUFACTURING
A crucial part of
designing for
high-volume
manufacturing
forgiving with a given material (such as a supplier can cut is ensuring your
polycarbonate) than a high-speed system into the cost materials are
acceptable for
producing components in a 96-cavity mold. efficiencies of
high-volume
Some materials that are suitable for manual a high-volume, processes. Devices
assembly might be incompatible with automated with injection-
automated processes such as sonic welding process. molded components
or mechanized high-speed clamping. The are a perfect example.
solution is to select materials that you’ve 4. Team approach Select materials that
already qualified for manufacturing with to optimize efficiency: you’ve already qualified for
different processes at various volumes. The move to high-volume manufacturing with different
processes at various volumes.
Otherwise you’ll need to burn time and manufacturing isn’t a once-and- Image courtesy of B. Braun Medical
money adjusting and potentially updating done event. There are many opportunities
regulatory applications. to continue learning and improving after
the process has been established. That and anticipates future demand. After
3. Supply chain and procurement demands involving the entire team, from long-term volume parameters have been
confidence: Given the importance of engineers to machine operators; each established to complement product
material selection – and the obvious need brings a unique perspective. And with specifications, the team can determine
for higher quantities of materials when high-volume manufacturing, even a small how to meet both short-term and long-
producing higher volumes – it’s important improvement in cost or efficiency can be term volumes – and have a road map to
to work closely with strategic procurement significant when extended over millions scale and realize the benefits of high-
to ensure that the suppliers selected at of pieces. The team approach should also volume manufacturing. M
the outset of a device’s product life cycle incorporate suppliers critical to the capacity
will be able to continue supplying with the to upgrade to high-volume manufacturing, Gavin Wadas is Manager, Strategic
same quality and reliability when volumes such as custom machine builders and Capital Projects for B. Braun Medical,
increase. Will the suppliers be able step mold manufacturers. The more they know Inc., OEM Division. He has more than
up when you ask them? Do they have a about the long-term project expectations 15 years of experience in project and
long-term commitment to producing the and objectives, the better they can supply program management, operations,
material or component? Will they have equipment that will meet the design intent capital planning and product
the financial resources and management and match the product’s intended life cycle. engineering within the life sciences
stability to continue supplying you once you Overall, high-volume manufacturing industry and is involved in managing
invest in automated processes? The time, requires a product life-cycle approach medical device product life cycles.
expense and uncertainty of qualifying a new that looks beyond immediate needs

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MANUFACTURING
Best practices for selecting a micro-MIM supplier
Smaller medical devices mean extremely tight tolerances. Here’s how to

identify the best supplier and manufacturing method to meet them.
R a g h u Va d l a m u d i With the development of increasingly Image courtesy of Donatelle

Donatelle smaller medical devices comes the
challenge of identifying the best
supplier and manufacturing method
to meet extremely tight tolerances.
Millimeter-sized components
with micron-sized features are
pushing the limits of traditional
machining methods. As tolerances
become tighter, machining is
less consistent and supplier costs
increase. Suppliers understand
that micro-metal injection molding
(micro-MIM) is becoming a go-to
process for micro metal parts.
Micro-MIM can be a viable
manufacturing alternative for such parts
as metal connectors in implantable
pulse generators and gear pump
components. It’s also an alternative for
components for the cardiac rhythm disease management, 1. Using scientific principles to develop manufacturing
dental, ophthalmic, orthopedic, drug delivery and processes
surgical ablation markets. Perhaps the most important consideration in choosing
As components become smaller, weighing less a micro-MIM supplier is finding one who understands
than a few milligrams, the challenge with conventional manufacturing process variability and the controls needed
machining is maintaining the extremely tight tolerances to minimize the variation throughout the manufacturing
necessary to efficiently produce high-quality medical process. The process needs to be developed using data
components at high volume. to understand the relationships between process inputs
Machining processes are unable to consistently (e.g., material, melt temperature, mold temperature, hold
produce micro-features. Different types of cutting tools pressure) and process outputs (e.g., dimensions, surface
are needed to machine different features to produce a finish) to create predictable manufacturing processes.
single part and there may be a need to use more than This level of understanding the MIM process helps
one machine tool – making the manufacturing process minimize the risk of releasing non-conforming product
expensive and inconsistent. into the field.
When considering micro-MIM suppliers, be aware of
the critical capabilities needed to produce quality parts. 2. Materials expertise
Based on our work with medical device companies, Materials play a critical role in the success of micro-
Donatelle identified four areas in which micro-MIM MIM. Understanding the feedstock composition
suppliers can fail – causing delays, added costs and determines the success of any micro-MIM project.
often the need for a new supplier: Metal particle size distribution and binder type are

important variables in determining the As medical devices continue
manufacturing cost and feasibility of to become smaller, conventional
consistent feature production. metal cutting processes are limited in
Material sourcing is often a challenge producing micro-features and meeting
because of the limited number of material tight tolerances. If you have a high-
manufacturers for micro particle size in the volume product with tight tolerances
United States. Selecting the right material or micro-features, micro-MIM may
for each part is critical. be a solution. Even though the initial
In some cases, a unique material investment cost may be high, micro-
may need to be developed to meet the MIM offers better accuracy, consistency
performance and visual requirements of and cost advantages for high-volume
the component. This requires a supplier manufacturing. M
with the expertise to identify needs and to
work with material compounders to create Raghu Vadlamudi is the chief research &
the right material. If the correct material technology director at Donatelle (New
is not sourced, and if it doesn’t meet the Brighton, Minn.). He has more than 20
requirements or standards, the resulting years of experience in the medical device
product will be inconsistent. manufacturing industry managing process
Donatelle has developed proprietary development groups.
materials to produce parts with specific
corrosion resistance and electrical
properties, mimicking a commonly used
material in the medical device industry.
Custom System Solutions

3. Equipment and technology expertise
In addition to material control, equipment
selection plays an important role in
from
producing parts with minimal variation.
With micro-MIM, building molds for
part sizes of less than a millimeter is
a challenge. It requires specialized
machinery, innovative techniques,
knowledge and experience in machining
— all at the micro size.
HaydonKerk Pittman specializes in the design and
The supplier should not only be able
manufacturing of customized motion control
to identify the right size equipment to
mold the micro components, but have solutions utilizing our broad portfolio of
expertise in designing the manufacturing linear and rotary products.
process as a whole system. They need to You can trust in our 85 years of meeting our
consider downstream operations with the customer’s quality requirements and challenging
customer’s end requirements in mind. application needs by utilizing our capabilities in:
4. Understanding the product • Mechanical, electrical, software

requirements and application engineering
Identifying the proper requirements for
the product in terms of strength, surface • Certified lab testing
finish, feature sizes and dimensional • Global manufacturing
tolerances will help in selecting the • Rapid prototyping
correct feedstock, in addition to process
parameters to mold, debind and sinter.
Micro features demand specialized
Contact us now so that we can
handling procedures through molding,
collaborate with your project teams
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11 • 2017 Medical Design & Outsourcing 63 © 2017 by AMETEK Inc. All rights reserved.
Manufacturing_10-17_Vs3.indd 63 11/5/17 7:35 PM

MANUFACTURING
Is this the key to rapidly manufacturing heart valves?
Harvard researchers developed a manufacturing method

that could help create heart valves in a short amount of time,
opening the potential for rapid manufacturing.
Danielle Kirsch Nanofiber fabrication may be the key to rapidly directly deposited a regenerative layer of complex ECM
Assistant Editor manufacturing heart valves with regenerative and growth on biodegradable scaffolds shaped as heart valves and
potential, according to new research from Harvard University’s vessels. The living cells were eliminated from scaffolds,
Wyss Institute for Biologically Inspired Engineering. leaving an off-the-shelf human matrix-based prosthesis
A research team led by Kevin Kit Parker created that was ready to be implanted.
a valve-shaped nanofiber network that replicates the “That’s kind of taking electrospinning one step further,”
mechanical and chemical properties of the native valve Rowe said. “It’s a pretty cool technology, but it’s pretty far
extracellular matrix (ECM). They used the Parker lab’s from being commercial-ready. It’s exciting nonetheless.
proprietary rotary jet spinning technology – essentially I think they’ve shown some early feasibility that’s
a rotating nozzle that thrust an ECM solution into the encouraging, but remember that a lot of people want their
nanofibers. The nanofibers could then wrap themselves heart valve to last a long time – like their [entire] lifetime.”
around any heart-valve-shaped mandrels. Normal heart valves can take anywhere from six to
“Our setup is like a very fast cotton candy machine 12 hours to assemble, according to Rowe. Additionally,
that can spin a range of synthetic and naturally occurring the valves that the Harvard research team developed
materials,” Parker said in a press release. “In this study, were pulmonary valves. Aortic valves are more commonly
we used a combination of synthetic polymers and ECM replaced in heart valve replacement procedures.
proteins to fabricate biocompatible JetValves that are “The pressures and the requirements of the aortic
hemodynamically competent upon implantation and support valve are substantially higher and more demanding than
cell migration and repopulation in vitro. Importantly, we can the pulmonic valve,” Rowe explained.
make human-sized JetValves in minutes – much faster than The current method for making heart valves involves
possible for other regenerative prostheses.” creating a biomaterial through a process that’s been
The JetValve method is similar to another method perfected over the years.
known as electrospinning. “You take a biological substance and process it into
“You take a polymer and put it into a controlled ionic a biomaterial to remove proteins and cross link it to form
field, you sputter this through a nozzle and it forms a long an implantable material. That process has been around
fiber and orients on the far side in a random for 30 years and has been refined over 30 years
orientation, and it creates a fiber-like mesh,” to produce a really strong, biocompatible
explained Stan Rowe, VP of advanced material that people trust,” he said.
technology & chief scientific officer at The Harvard team implanted
Edwards Lifesciences. JetValves into sheep using a
The Harvard team tested minimally-invasive procedure and
JetValves in collaboration with were able to show that the valves
researchers at the University of could function properly and
Zurich in Switzerland, led by regenerate new tissue.
Simon Hoerstrup, co-director “In our previous studies, the
of the recently founded Wyss
Translational Center Zurich.
Hoerstrup and colleagues recently Harvard’s Wyss Institute of
Biologically Inspired Engineering has
developed regenerative, tissue-
created a rotary jet spinning technology
engineered heart valves designed to spin nanofibers and create heart valve-
to replace mechanical and fixed-tissue shaped mandrels.
heart valves. He used human cells that Image courtesy of Wyss Institute at Harvard University.

We’re
predictable Because your success relies on it.
— Raghu Vadlamudi
Chief Research and
Technology Director
At Donatelle, we do what it takes to help make sure you get

access to the greatest medical device knowledge and technology.
Let us be your predictable partner for critical industry and
market understanding. Learn more at donatellemedical.com.
Donatelle 11-17.indd 56 11/3/17 2:47 PM

MANUFACTURING
cell-derived ECM-coated scaffolds could recruit cells from regenerating heart valves could have tremendous impact
the receiving animal’s heart and support cell proliferation, on patients’ lives across age, social and geographical
matrix remodeling, tissue regeneration and even animal boundaries,” said Donald Ingber, Wyss Institute
growth,” Hoerstrup said. “While these valves are safe founding director. “Once again, our collaborative team
and effective, their manufacturing remains complex and structure that combines unique and leading expertise
expensive, as human cells must be cultured for a long in bioengineering, regenerative medicine, surgical
time under heavily regulated conditions. The JetValve’s innovation and business development across the Wyss
much-faster manufacturing process can be a game- Institute and our partner institutions, makes it possible
changer in this respect. If we can replicate these results in for us to advance technology development in ways not
humans, this technology could have invaluable benefits in possible in a conventional academic laboratory.”
minimizing the number of pediatric re-operations.” Although the JetValve technique is encouraging,
The Wyss Institute and the University of Zurich there’s still a lot to be done to be able to test in
recently announced that they’re also collaborating humans.
to create a functional heart valve replacement with “It takes a really long time to validate the
the capacity to repair, regenerate and grow. They durability of a heart valve,” Rowe said. “[Harvard] has
also intend to create a GMP-grade version of the done some of the early steps of that, which are really
manufacturing process that is already customizable, encouraging, but they still have a long way to go.”
scalable and cost-effective – enabling the creation of The study was published online in the journal
a high number of prostheses. Biomaterials. M
“Achieving the goal of minimally invasive, low-cost

Why a global footprint is a business imperative, not a buzzword
A global manufacturing footprint can help companies capture value by accessing

talent and reducing costs. Here’s how to successfully execute this strategy without
falling into a reactionary offshore initiative.
Oscar Ford In the last two decades there was an undeniable shift in depending on the speed with which companies decide to
Preh IMA Automation the U.S. toward offshoring manufacturing for all types pursue that strategy and the market conditions that make
of goods, medtech and medical devices included. One one method more or less favorable. A global footprint can
of the primary drivers of that trend was the pursuit of be achieved via internal growth, which could mean the
increased profit margins by reducing operating costs; in creation of new facilities or expansion of current facilities.
many cases, specifically reducing labor costs. It can be achieved via outsourcing, such as the utilization
Now companies seem to be making adjustments of contract manufacturers. It can also be achieved via joint
from the short-term benefit of offshoring to considering ventures, partnerships, or mergers & acquisitions (M&A).
broader strategic plans that maximize resources and Each method has individual and unique pros and cons.
align the enterprise for long-term, sustainable goal At Preh IMA Automation we have been on the
achievement. Some companies have stopped chasing offensive, taking a very aggressive approach toward
low labor rates, as lower-cost countries increase their achieving our global footprint goal, by acquiring
middle class and labor rates increase. That leaves the complementary companies in strategic locations while
enterprise with a manufacturing facility in a country far expanding current facilities. Our keys to success include
from its core team and market without the benefit of the complexity reduction, clear allocation of responsibilities,
once-disproportionately low labor rates. enterprise-wide development and deployment of the
The difference between a well-executed global plan – and, above all, communication.
manufacturing footprint strategy and a reactionary offshore As a manufacturing and assembly automation
initiative usually comes down to which global market equipment builder, we must have the same thought
drivers are being considered, how the risks-versus-benefits process as the manufacturing companies with which
are analyzed and how frequently these drivers or trends are we partner. For us, a global footprint is not only about
monitored. Trends must be monitored closely and forward- being aligned geographically, but philosophically as well.
thinking decisions made when it comes to creating a global As we do business with multi-national companies with
manufacturing footprint. For example, less than a decade manufacturing facilities in many countries, we too must
ago executives were stressing the importance of the BRIC be able to address different regulatory environments
markets (Brazil, Russia, India & China). The emphasis on and regulations, overcome the existence of cultural
the BRIC markets as high-priority targets has changed differences, navigate import/export obstacles and
significantly, driven by a variety of global market conditions: alleviate communication barriers, to name a few, all while
operating and appearing as one company worldwide.
• The reversal of economic progress with multiple A good global manufacturing footprint strategy is
years of recession, as well as ongoing political executed pursuing cost reduction, incentives, improved
corruption scandals in Brazil logistics, access to talent, vendor/supplier alignment
• The slumbering economy and general uncertainty and any other pertinent opportunities to capture value
regarding Russia for your business. All of these need to be analyzed,
• The impact of rising income levels of workers along considered and balanced, instead of taking a singularly
with a slowing economy in China focused, reactionary approach. M
• Increased interest in manufacturing opportunities in
countries including South Africa, Turkey, Vietnam, Oscar Ford is Business Development Manager for Preh
Poland and Saudi Arabia IMA Automation, responsible for the strategic direction
driving customer diversification and market expansion,
There are a variety of ways to achieve a global footprint, focused on the Healthcare/Medical market.
Manufacturing_10-17_Vs3.indd 67 11/3/17 4:32 PM

MATERIALS
Repeat sterilization for adhesives

in reusable and non-disposable devices
Here’s a review of the common adhesive materials and

their reaction to sterilization processes.
Christine Marotta
Henkel
Loctite medical device

adhesives offer strong and
flexible bonds for a range of
flexible medical devices.
Image courtesy of Henkel
Intricate medical devices are often constructed epoxy and urethane adhesives are commonly used
of thermoset and other engineered plastics, which for the assembly of medical devices.
require advanced adhesive technology. In addition
to considerations of bonding, sealing, gap filling • Cyanoacrylate adhesives are polar, linear
and manufacturability, developers need to consider molecules which undergo an anionic
the sterilization plan that all materials – including the polymerization reaction. A weak base, such
adhesives – will need to withstand. as moisture present on essentially all surfaces,
The challenge is high, particularly for reusables triggers the reaction causing the linear chains
and non-disposables. These devices are often to form. The products are maintained in their
sterilized by steam autoclave, hydrogen peroxide liquid form via the addition of weak acids which
and chemical immersion because these methods act as stabilizers. A variety of cyanoacrylate
are conducive to quick turn around and are formulations are available with varying
considered low toxicity. viscosities, cure times, strength properties and
Autoclaving, the sterilization method for a temperature resistance. Cyanoacrylates form
high percentage of these categories of medical thermoplastic resins when cured.
devices, presents the greatest challenge to Testing of cyanoacrylate adhesives with
device manufacturers due to its combination of a number of sterilization methods has yielded
temperature, pressure and moisture. Manufacturers varying results, depending on formulations.
must seek substrates and joining methods that are In general, however, cyanoacrylate adhesives
versatile and easy to use, yet still hold up in the have been shown to withstand up to 50
most rigorous environments. cycles of liquid sterilization immersion as well
Cyanoacrylate, light-curing cyanoacrylate, light- as hydrogen peroxide. In addition, select
curing acrylic, dual UV/moisture-curable silicone, cyanoacrylate adhesives have exhibited
Materials_10-17_Vs2-CN-FINAL.indd 68 11/3/17 12:52 PM

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MATERIALS
moderate resistance to autoclave exposure – • Silicone adhesives are similar to

with some specialty ethyl grades maintaining polyurethane adhesives in that they form
nearly 100% of their initial strengths following flexible polymers when cured. Silicones,
exposure to 50 autoclave cycles. A critical however, possess no rigid segment and
factor in maintaining bond strengths with therefore exhibit lower cohesive strengths
cyanoacrylate adhesives following autoclave – the strength of the polymer itself. The
exposure is the selection of substrates that sterilization resistance of silicone adhesives
offer moderate to high initial strengths as well is typically measured on the bulk polymer
as substrates capable of withstanding the rather than on assembled specimens due to
rigorous temperature, pressure and steam the low cohesive strength of the polymers.
environment of the system. Testing of dual light cure/moisture silicone
adhesives following exposure to fifty
• Light-curing acrylics cure via a free radical autoclave cycles indicated a slight effect on
reaction to form thermoset resins when the percent elongation of the adhesives, but
exposed to light of the appropriate an approximate 60% drop in tensile strength.
wavelength and intensity. Like cyanoacrylates,
light-curing acrylic adhesives are available in • Epoxy adhesives, like the previously
a range of viscosities. In addition, light-curing mentioned light-curing acrylic adhesives,
adhesives vary in final cured form from hard, cure to form thermoset plastics. Like
glasslike resins to soft, flexible resins. several previously mentioned chemistries,
As with cyanoacrylate adhesives, light- polyurethane adhesives form thermoset resins
curing acrylics vary in bond strength retention when cured, thus exhibiting good chemical
following exposure based on formulation, and environmental resistance. It is important
substrates selection and initial strengths to note, however, that the overall thermal
achieved. Testing has indicated that, in general, resistance of cured polyurethanes is less than
light-curing acrylic adhesives maintain that of cured epoxies.
from 50% to 100% of initial strengths
following 50 autoclave cycles. • Polyurethane adhesives are substrate versatile
but do, on occasion, require the use of a
• Light-cured surface primer to increase the reactivity
cyanoacrylates are ethyl- of the surface to be bonded. Epoxy and
based products with urethane adhesives are often selected for
photo-initiators added applications due to their enhanced chemical
to the formulation. and thermal properties. Such resistance makes
The end result is fast the adhesives suitable candidates for sterile
fixturing (like that of reusables and non-disposables. With the
a traditional light- potential of repeated autoclaving exposure, it
curing acrylic) and is critical that reusable/non-disposable device
cure in shadowed manufacturers select adhesives which have
areas. Light-curing the ability to withstand high temperatures and
cyanoacrylates high steam pressure conditions. M
would be expected
to perform similarly Christine Salerni Marotta is the North American
to standard ethyl medical business and market manager for
cyanoacrylates Henkel Corp.
following sterilization
exposure including
autoclave.
Loctite medical device adhesives are used for

high speed and high strength needle assembly
Image courtesy of Henkel

How plasma treatments are
driving up the value of plastic labware
By altering the surface properties of polymer labware through plasma

treatments and coatings, manufacturers are improving the quality of test
results while increasing the value of products they create.
Jeff Elliott Each year, billions of multi-well plates, pipettes, bottles, flasks, vials, Eppendorf
P VA Te P l a A m e r i c a tubes, culture plates and other polymer labware items are manufactured for use
in research, drug discovery and diagnostic testing.
Although many are simple, inexpensive consumables, an increasing
percentage are now being surface treated using gas plasma or have functional
coatings specifically designed to improve
the quality of research and increase the
sophistication of diagnostics.
Surface modification can improve
adhesion and/or proliferation of
antibodies, proteins, cells and tissue and
improve signal-to-noise ratio so testing is
more precise with less target material or
markers required.
Altering the properties of these devices
can also make sense from a business
perspective. In a market dominated by
several large labware manufacturers,
more specialized offerings can create a
competitive edge and drive up the value of
each consumable.
“With polystyrene or polypropylene
labware, if you can add a functional coating
or use plasma to alter the surface properties,
you can turn a $2 item into a $50 item,”
explained Mic Barden of PVA TePla America
(Corona, Calif.), a leading system engineering
firm that designs plasma systems for surface
activation, functionalization, coating, ultra-
fine cleaning and etching.
Plasma treatment
Plasma is a state of matter. When enough
energy is added to a gas, it becomes
ionized into plasma. The collective
properties of these active ingredients
can be controlled to clean, activate,
chemically graft and deposit a wide range
of chemistries.

MATERIALS
Image courtesy of PVA TePla America
Most plasma applications using plasma to become

for plastic labware can be more hydrophilic.
categorized as “simple” Treating the surface
treatments, such as O2 in this manner has many
or argon for cleaning the benefits, including
substrate at the molecular improved analyte wetting of
level. The use of plasma wells, greater proliferation
is also well established for of cells without clumping,
surface conditioning to make reduced amount of serum,
polymers more hydrophobic urine or reagents required for
(water repellent) or hydrophilic testing and lower risk of overflow
(affinity to water). and cross-well contamination.
But in vitro diagnostic substrates
may require more selective chemistries for Improved antibody adhesion for bio assays
the selective adhesion promotion and conjugation Microtiter plates are commonly used for bioassays
of bio active molecules. such as the enzyme-linked immunosorbent assay
This can be achieved by providing particular (ELISA). Performing an ELISA involves at least one
chemical functionality at the surface, allowing antibody with specificity for a particular antigen.
covalent coupling of biochemical species to To improve the bond and function of the
occur. Amino, carboxylic, hydroxyl and epoxy antibody, plasma coatings can be applied to orient
functionalities are important examples of the the Y-shaped IgG proteins utilized in the majority
chemistries that are readily obtainable using a gas of these types of tests. Failure to do so can mean
plasma surface treatment. some antibodies face down or deform and become
essentially unavailable for bonding with antigens.
Multi-well plates “With most uncoated polymer surfaces you
Multi-well, or microtiter, plates are a standard tool in can’t control how the Y-shaped ‘capture’ antibodies
analytical research and clinical diagnostic labs. Most are oriented,” Barden said. “However, a functional
plates come with 96, 384 or 1,536 sample “wells” coating can be used to favor the proper upward
that function as small test tubes. orientation so the entire surface is available for the
Polystyrene is the most common material assay. In this way, we can improve the signal-to-
used to manufacture microtiter plates, because noise and dynamic range of an assay.
“Amine coatings are commonly used
because they have a middle surface energy,
THE COATING IS HYDROPHILIC ENOUGH with water contact angles of approximately
60 degrees,” he said. “So the coating is
THAT THE LIQUID DISPERSES WELL AND hydrophilic enough that the liquid disperses
well and hydrophobic enough to facilitate
HYDROPHOBIC ENOUGH TO FACILITATE bonding of the material.”
Other alternatives include linker
BONDING OF THE MATERIAL. molecules such as epoxides or carboxylic
acids or applying a quartz-like surface
using plasma-enhanced chemical vapor
it’s biologically inert, has excellent optical clarity deposition. According to Barden, these approaches
and is tough enough to withstand daily use. Most provide a similar surface energy, but have functional
disposable cell culture dishes and plates are also differences that may be important, depending on
made of polystyrene. the application. The issues of adhesion that apply to
Other polymers such as polypropylene and proteins used for ELISA can also apply to cells and
polycarbonate are also used in applications that tissue cultures, he added.
must withstand a broad range of temperatures,
such as polymerase chain reaction (PCR) for DNA Pipette tips
amplification. Pipettes are another common lab tool. Often
Untreated synthetic polymers, however, are constructed of high-density polyethylene or
extremely hydrophobic and so provide inadequate polypropylene that tends to be hydrophobic,
binding sites for cells to anchor effectively to their pipettes can still have difficulties with liquids sticking
surfaces. This means they must be surface modified to the surface – particularly on or around the tip.

Some pipette manufacturers
add fluorinated polymers within the
polypropylene during the injection-molding
process, but there can still be issues such as
phase separation or leaching.
To ensure pipette tips “sheet”
off any aqueous solution more
effectively, companies like PVA TePla
NEW ENGLAND WIRE
can utilize nanotechnology to create a
superhydrophobic surface. One technique
TECHNOLOGIES
involves etching the surface to trap gases
in the recesses, allowing the liquid to float
on the top in a “lotus effect;” another
involves applying a more hydrophobic
coating to the pipette tip.
Minimizing leaching
Since plastic labware is susceptible to
leaching from plasticizers, stabilizers
and polymerization residues, plasma is
sometimes used to coat the inside of
the containers with a quartz-like barrier
material. These flexible coatings are
polymerized onto the plastic by plasma
enhanced chemical vapor deposition.
The resulting coating can be very thin
(100–500 nm), highly conformal, non-
crystalline and highly flexible (180o ASTM
D522) coating.
R&D assistance
Custom Wire & Cable

Plasma treatment is common enough
that leading equipment providers are
able to modify existing, mature tools
and technology, complete with fixturing,
to deliver what are essentially drop-in for medical device &
solutions, according to Barden.
Some even provide access to on-site
R&D equipment and engineering expertise.
electronics manufacturers
PVA TePla, for example, often invites labware
manufacturers to visit its lab in Corona, Calif., designed to your unique
to run parts and conduct experiments on in-
house equipment. These technical customer/
supplier meetings often produce the best
performance requirements!
experimental matrices and ideas.
“The elegance of these [plasma
treatment] solutions is that they leverage
existing technology and know-how, as
opposed to creating something that is
completely new,” Barden said. “Access
to this knowledge base facilitates new
entrants into the market.” M www.newenglandwire.com
603.838.6624
Jeff Elliott is a Torrance, Calif.–based
technical writer.

MATERIALS
What are orthopedic coatings?
Medical device designers need to know the facts about orthopedic coatings.
An orthopedic (RBM), anti-wear and sintered. Each coating serves a

coating is used unique function when applied to implants:
on implants to
help improve the • Proprietary HA coatings are bone-like coatings
functionality of an and can be applied to cobalt-chrome, titanium or
implant. Usually, stainless steel implants to accelerate bone growth.
the coatings can TPS improves mechanical fixation with porous and
help define the rough coatings.
geometry and the • TPS coatings, when applied to titanium or cobalt-
mechanical strength chrome substrates, allow the coating to exceed the
of an implant, ASTM requirement while eliminating cracking of the
according to Orchid implant.
(Holt, Mich.). • RBM coatings create a rough surface without
Image courtesy of Orchid
Coatings can be leaving embedded debris. On titanium implants,
applied to different RBM coatings create a roughened surface that is
implants for a number comparable to a 100 mesh aluminum oxide finish
Danielle Kirsh of applications. These applications can include hip without leaving embedded debris behind.
Assistant Editor components, knee components, shoulder components, • Anti-wear coatings enhance the wear properties of
cones, sleeves, wedges, extremities and spinal implants. implantable components. These coatings are a tough
Orthopedic coatings are designed to last as long ceramic coating that has enhanced wear properties
as the implant is in the body, which can be anywhere for implantable components.
between 20 and 30 years. They are made of the same • Sintered coatings create a smooth or rough surface that
materials that an implant is made from, such as titanium is porous enough to allow bone and tissue ingrowth.
or cobalt-chrome, and serve a variety functions.
Particles in coatings were much bigger 25 years ago There is still room for more innovations when it comes
than they are now, when sizes can range from 88 microns to implant coatings, including enabling increased the
to 707 microns. lifetime of an implant, avoiding implant loosening, use
In the design process, coatings can be customized of cementless implants and hypoallergenic implants.
for specific needs. The particle sizes, number of coating Having been used since the 1970s, orthopedic
layers, and whether a tight or loose pack is needed can coatings have some limitations as well. High-
all be configured, according to Orchid. temperature sintering of coatings reduces strength. Also,
These functions include promoting bone growth, specific metal coatings have to be used with specific
improving the anchoring of cells with porous structures, metals. For example, a titanium coating can’t be used
avoiding infection by using anti-infective coatings and with a stainless steel implant.
reducing implant wear. A medical device company’s decision to coat an
The different types of coatings include orthopedic implant is up to the needs of the doctors,
hydroxylapatite (HA), titanium plasma spray (TPS) rough patients and insurance companies involved in the
coating, TPS porous coating, resorbable blast media procedure. M

Accumold 3-17.indd 56 11/3/17 10:08 AM
MATERIALS
How a versatile epoxy is

enabling brain stimulation
In but another example of how useful and critical

EVERY SUCCESSFUL epoxies can be, researchers in Israel used a two-
MEDICAL DEVICE part epoxy to construct a magnetic coil to stimulate
animal brain neurons via a magnetic field.
BEGINS WITH THE
RIGHT MATERIAL Rohit Ramnath
Master Bond
Designers of medical electronics assemblies have many
options to choose from when selecting one or more compounds
for bonding, coating, potting and encapsulating components.
While manufacturers can control many of the properties of
these compounds, the underlying polymer
chemistry is a critical factor to consider.
Each family of compounds –
epoxies, silicones and UV/
LED light curables – offers a
The leader in custom polymer different set of performance
parameters and processing
formulations for medical devices, requirements.
Epoxies are among
implants and drug delivery applications the most versatile
polymer compounds
used in medical
• Radiopaque electronics. They offer
excellent cohesion and
resistance to chemicals
• Low Friction and adhere well to a
variety of materials.
• Antimicrobial Some specialty systems
can operate over a wide
range of temperatures from
• Bioresorbable cryogenic (4K) to more than
550°F. Because they are 100%
reactive, epoxies produce no
• Drug Eluding volatiles during cure and exhibit little or
Master Bond
no shrinkage during polymerization.
EP29LPSP epoxy
Image courtesy of Epoxies are also showing promise in the rapidly
Master Bond growing field of brain stimulation.
P 860.928.4102
Magnetic coils for brain stimulation
info@fostercomp.com Transcranial magnetic stimulation (TMS) is a non-invasive way
to stimulate the motor cortex and other parts of the brain. A
coil energized by a pulse generator is placed near the head
www.fostercomp.com of a human or animal, creating a pulsed magnetic field which
induces small electric currents in the part of the brain just under
the coil. By observing the resultant motor activity of the patient
or subject, medical professionals can assess the damage from a
brain injury or disorder, such as a stroke or multiple sclerosis.
Materials_10-17_Vs4.indd 76 11/3/17 3:47 PM

Scientists at israel’s Bar-Ilan University designed a In an earlier study – published in 2011 in volume 194 of
study to explore exactly how magnetic stimulation acts the Journal of Neuroscience Methods – researchers at the
on nerve cells in the brain (their work is described in the same university fabricated a custom-made mini coil for use in
June 3, 2014 issue of Frontiers in Cellular Neuroscience). a TMS experiment on an awake monkey. In this case, the coil
Thin slices of the somatosensory cortex of rats’ brains were was immersed in a saline solution and placed inside a chamber
prepared for use in the study. A common-used procedure designed to record brain activity via multiple micro-electrodes
for studying the electrical activity of neurons, known as the attached to various regions of the monkey’s brain. A wet-winding
patch-clamp technique, was modified to facilitate magnetic technique was used to build the coil, which included 32 turns
stimulation of individual neurons. The main component of of standard copper wire. Again, the coil was impregnated
the modification was a custom-made magnetic coil. with Master Bond EP29LPSP epoxy mixed with 25 μm alumina
Standard lacquer-coated copper wire was used to make particles during the winding process. For this application,
the coil, consisting of 14 turns of wire in each of two layers. electrical insulation of the coil and its windings was especially
The coil was constructed using a wet-winding technique, important in order to minimize the risk of electric breakdown.
in which the coil is impregnated with an epoxy compound The insulated mini-coil was tested to voltage levels up to 1200V.
during the winding process. The researchers selected low- The studies out of Israel once again demonstrate that
viscosity Master Bond EP29SPLP epoxy for the wet-winding the success of any engineered product depends on the
process. The epoxy was mixed with 25 μm alumina particles performance of all its parts – and that includes any chemical
to enhance heat transfer, increase electrical insulation and compound/epoxy used to join or protect one or more parts. M
strengthen the coil. The magnetic coil was positioned below
the neuron under test during the experiment, which gave Rohit Ramnath is a senior product engineer for Master Bond
researchers important insights into how TMS affects neurons. (Hackensack, N.J.), a custom formulated adhesives manufacturer.
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m www.medicaldesignandoutsourcing.com 11 • 2017 Medical Design & Outsourcing 77
Materials_10-17_Vs4.indd 77 11/3/17 3:48 PM

MOLDING
Dip molding medical device products:

What you need to know
When it comes to dip molding products with emulsions of liquid

rubber, it is necessary to complete a series of process steps to assure
proper formation, vulcanization and finish treatment to meet the
customer’s needs in the final application.
Mark Agee Dip molding can enable the creation of durable The dipping process can be characterized as a
Kent Elastomer Products medical device parts in a variety of shapes, sizes conversion sequence: The rubber is converted
and wall thicknesses, including probe covers, from a liquid to a solid and then chemically
bellows, neck seals, surgeon gloves, heart converted into a vulcanized network of molecules.
balloons and other unique parts. More importantly, the chemical process converts
Natural rubber has outstanding resilience the rubber from a very fragile film into a networked
and high tensile strength, but also carries a group of molecules that can stretch and deform –
protein that can cause an allergic reaction in and still return to their original shape.
humans. Synthetic neoprene and synthetic
polyisoprene, in contrast, are non-allergenic. Coagulation: Changing a liquid to a solid
Neoprene stands up against a multitude of The coagulation process is not always necessary
factors; it’s resistant to flame, oil (moderate), for all “dip” processing but is critical to our
weather, ozone cracking, abrasion and flex processing sequence. The rubber can be
cracking, alkalis and acids. Polyisoprene is a close allowed to change from a liquid to a solid
replacement to natural rubber when it comes through air drying, but that will take much time.
to feel and flexibility, with better resistance to Some-thin walled parts are produced in this
weather than natural rubber latex. Polyisoprene, manner. The coagulation process uses chemicals
though, does sacrifice some tensile strength, tear to force this physical state change.
resistance and compression set. The coagulant is a mixture or solution of
The term “dipping” is associated with the salts, surfactants, thickeners and release agents
manipulation of the dip form. In fact, the forms in a solvent, typically water. Alcohol can also be
are dipped into the materials as the sequence used as the solvent in some processes. Alcohol
is performed. It is important to ensure rubber evaporates quickly and leaves very little residue.
recipes meet FDA medical device guidelines Some water-based coagulants will require help
and requirements. from an oven or other means to dry the coagulant.
Here’s what the process looks like: The main component of the coagulant is the
salt (calcium nitrate), an
inexpensive material
Coagulant Rubber Dip Leach Cure or vulcanization Finish that provides the best
uniformity of coagulation
over the dip form.
Surfactants are used to wet out the dip
form and assure a smooth, uniform coating of
coagulant onto the form.
Release agents such as calcium carbonate are
used in the coagulant formula to aid in the removal
of the cured rubber part from the dip form.
Molding_10-17_Vs3.indd 78 11/3/17 1:04 PM

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MOLDING
Keys to coagulant performance include What is removed? The leach process

uniform coating, fast evaporation, material removes residual salts, surfactants and water
temperatures, entrance and retrieval speeds, based proteins.
and easy change or maintenance of the Main material components include
calcium concentration. the coagulant (calcium nitrate) and rubbers
(natural (NR); neoprene (CR); polyisoporene
The rubber dipping step (IR); nitrile (NBR)). Inadequate leaching can
This is the stage in which result in “sweating,” a sticky film on the
the rubber is converted finished product, as well as adhesion failure
from a liquid to a solid. and increased risk of allergic reactions.
The chemical agent The keys to leaching performance
which facilitates the include water quality, water temperature,
solidification, the dwell time ad water flow rate.
coagulant, is now
applied to the dip Cure stage
form and is dry. This step is a two-step activity. The water in
The form is the rubber film is being removed and the
“dwelled,” or temperature of the oven along with time is
held immersed activating the accelerators starting the cure
in the tank of or vulcanization process. Cure time and
liquid rubber. As cure temperature are key when it comes to
the rubber makes optimizing the best physical properties of the
physical contact with different types of rubbers.
the coagulant, the
calcium from the Finish
coagulant causes Several options are available to treat the
the rubber to surface of a dipped part so that the part
destabilize and does not stick to itself. Options include a
turn from a powder part, urethane coating, silicone rinse,
liquid state to chlorination and soap wash. This is about
a solid state. what the customer wants or needs for their
The longer product to be successful. M
the form is
immersed, Mark Agee, is Manager of Customer Dip
the thicker Operations at Kent Elastomer Products
the wall will (Kent, Ohio).
develop. This
chemical reaction
will continue until all
the calcium is consumed
from the coagulant.
Keys to latex dipping include entrance
and exit speeds, temperature of the latex,
uniformity of coagulant coating, and
controlling pH, viscosity and total solids of
the rubber.
The leach dip

The leach process is the most effective stage
to remove unwanted, water-based chemicals
which are not wanted in the final product.
The most opportune time to remove the
unwanted materials from the dipped film is
the leach before cure.

What is micromolding?
Micromolding is a very specialized art

form. It’s the tiny-scale molding form
of injection molding that entails building
a cavity to match the shape of the part you
want to make, sort of like the plastic molding that
makes Lego bricks.
Danielle Kirsh Very small, high-precision plastic molding goes space is needed to get the plastic where it needs
Assistant Editor into micromolding for medical devices, according to go. The size of the runner system in relation to
to Aaron Johnson at Accumold (Ankeny, Iowa). the size of the part is waste. According to Johnson,
There are three different things to keep in you don't want to make a tiny part and have a lot
mind with micromolding: of waste. True micromolding is efficient in relation
to the part size and the runner system.
1. Micro means the size of the part. It’s the Some companies have set their largest
most common definition when dealing with micromolding to half an inch and some have
micromolding. sizes as small as 800-by-300-by-380 microns.
2. Micro-features are the tiny parts of a larger Micromolded parts can also have a part volume of
piece. As a whole, the part can be big, but its 0.005 cubic inches or less, according to Accumold.
components can be smaller micro-features. The level of detail and expertise required for
3. Micro intolerance is how the parts are measured building microparts is unique. While the task of
and how close to the needed measurement making a small part can be daunting, the parts
the part has to be to be considered a good can be simple to make as long as the company is
or usable part. When a part is molded, it has equipped to build high-precision parts. The process
to measure within the needed measurement of micromolding differs with each company. M
(the tolerance), which could be as small as a
thousandth of an inch. Small parts that are
simple to make have tolerances that are not as
tight and would be considered regular molding.
Micromolding uses a variety of commonplace

thermoplastic moldable materials including polyether
ether ketone (PEEK), polyether imide (PEI), liquid
crystal polymer and nylon. Some micromolding parts
can be made of durometer or elastomeric as well.
They can also be made of optical-grade and medical-
grade materials for medical device parts. The types
of materials used allow for the size of molds to be
smaller than the size of a dime.
To make a part, there is a runner system that
is the vessel for plastic to get from its melting
point to the cavity to make the desired shape. The
runner can be really long in some cases; that extra

MOLDING
Overmolding silicone onto thermoplastics:

What you need for success
Overmolding silicone onto thermoplastics can be challenging,

but offers advantages over TPEs that include chemical resistance,
tensile strength and compression set. Here are some best practices
to maximize your success.
David Mulera Overmolding has become a fundamental technique However, the challenge can be even greater with LSR.
MedPlast for medical component manufacturers in recent years. It Here are some best practices to maximize your success:
reduces assembly costs, improves quality and expands the
limit of what’s possible for medical device designs. 1. Select your materials properly
The most common type of overmolding involves Many plastic substrates require glass transition temperatures
thermoplastic elastomers (TPEs) over thermoplastics. lower than that of LSR to properly cure. When possible,
However, a growing number of medical molders are select a substrate material with a glass transition
expanding the use of overmolding for liquid silicone rubber temperature above 300°F to ensure proper curing. Also
(LSR) because it offers a number of superior performance consider using newer “primerless” or “self-adhesive” grades
characteristics. of LSR. These are formulated to bond well to thermoplastics
LSR acts as a protective cover against dust, water, on their own.
impact, heat and electrical shock. For implantables, silicone
creates a bio-friendly barrier between the medical device 2. Avoid resin additives and mold releases
and the patient. Steer clear of substrate thermoplastics that have additives or
Typical applications for LSR overmolding include: mold releases that can create an adhesion problem. External
mold releases are a definite no-no because they can also
• wearable devices interfere with adhesion. Avoid additives with sulfur or
• mechanical reinforcement amines (including amine-based antistats), as they can inhibit
• gaskets the cure of LSR.
• seals
• fluidic components 3. Test your material combination
• medical catheters To understand how well your substrate material will bond
• medical implants to a particular grade of LSR, it’s a good idea to send a
representative part or sample plaque to the LSR supplier
In many applications, overmolding LSR onto thermoplastics for testing. Most suppliers will perform this testing at no or
offers advantages compared with TPEs, including better: minimal charge and it’s a good insurance policy before you
invest in molds.
• tensile strength
• chemical resistance 4. Keep your thermoplastic substrates free of
• compression set contamination
• heat resistance Any contamination can interfere with adhesion, so it’s
• extreme low-temperature flexibility important to keep substrates clean before overmolding.
• elongation This is less of an issue if the substrates are molded with
• inherent lubricity the LSR in a two-shot mold, rather than molded separately
and transferred from one machine to another. This is why
Achieving good long-term adhesion can be difficult when it’s better to use a two-shot overmolding technique over
overmolding TPEs onto rigid thermoplastic substrates. transfer overmolding when possible.

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Helical 11-17.indd 56 11/3/17 10:21 AM

MOLDING
5. Consider pretreating the substrate in a transfer overmolding process, it’s a good

(transfer molding only) idea to preheat it in a conveyor oven or on a
Preparing the substrate surface with chemical hot plate.
primers, plasma or a UV treatment can
increase adhesion. This is typically not 7. Design in a mechanical interlock when
possible with a two-shot overmolding process possible
but can be done on transfer overmolding if Even if you follow the recommended practices
adhesion is a major concern. for optimal LSR adhesion, it never hurts to
incorporate into the part design some form of
6. Keep your substrates warm mechanical interlock between the materials.
It’s vital for substrate parts to be hot because Allowing LSR to penetrate through-holes onto
the bonding of LSR to the thermoplastic is the back side of the part is a good example.
a chemical reaction; it needs a combination A rough finish on the overmolding interface
of time, temperature and pressure. Typical area can help, but isn’t required with a good
mold temperatures for LSR are 300°F to self-bonding material.
400°F. The hotter the temperature, the
shorter the cure cycle. Temperature is less 8. Avoid aggressive demolding
of an issue if the substrates are molded in a Avoid pulling or stretching the LSR when
two-shot mold, because the residual heat left demolding because it may not be fully
in the substrate from the first shot helps cure adhered and cured. Consider a PTFE coating
the LSR. If the substrate is molded separately on the mold to help with demolding.
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9. Maintain a consistent cycle time
With transfer molding using two machines, it
definitely helps to use automated (robotic) transfer
from one to the other. (This is not usually an issue
with two-shot molding.) This will ensure that the
substrate temperature is consistent for overmolding
and also avoids any contamination from a human
operator handling parts.
Overmolding LSR onto thermoplastics can be more

challenging than overmolding TPEs, but the benefits
in terms of device performance characteristics make
this specialized process well worth it. Looking ahead,
innovations such as UV-curable silicone will likely allow
medical molders to further drive down cycle time and
increase adoption of this overmolding technique. M
David Mulera is corporate VP of engineering

at MedPlast (Tempe, Ariz.), responsible for
engineering, processing and new technology
development. Images courtesy of MedPlast.
Components thru Mechatronics

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• Compact,
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• Stepper, Servo, and
Smart Motor options
SIMO Series
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MOLDING
Expanding design horizons with gas-assist molding
Gas-assist molding, the process of using nitrogen gas pressure to fully form a part,
increases design and manufacturing options for injection molded components.
Scott Rishell Traditional plastic processing brings design and Examining external gas-assist
Mack Molding manufacturing benefits through repeatable, high-volume In external gas-assist, a micro-thin layer of nitrogen gas is
and high-quality part production coupled with cost introduced during the packing phase on the non-aesthetic
reductions, but its versatility can be expanded in certain side of the part, after the part is filled with plastic but not
scenarios by the introduction of gas-assist molding. There yet fully packed out. This process packs the part evenly,
are two methods – external and internal – with both allowing replacing the more traditional holding phase. The gas is
for improved flatness and the packing out of atypically- held at a high pressure, forcing the uncured resin onto the
thick geometry. The external process can also reduce press opposite side of the tool. The aesthetic side ends up with a
tonnage, leading to cost savings, while internal gas-assist clean, uniform appearance, while the gassed side will have
can form a lighter part that may benefit the end application. a wavy or “sinky” appearance.
External gas allows designers to modify
traditional molded-part design parameters, such
as rib-to-wall ratio. Generally held below 50% to
70% to avoid creating sink marks on the aesthetic
side, external gas designers can increase this ratio
up to and even above 100% depending on the
part and resin requirements.
This process also allows for thicker ribs,
offering a key part advantage by reducing
differential shrink – a primary culprit in causing
part distortion – between the nominal wall and
the ribs. In components with critical flatness
specifications this can be a game-changer.
In typical molding the required pressure to
fully pack a part out can be extremely high, due
to pressure loss from gate to end of fill. Because
external gas molding replaces some press work
with evenly distributed nitrogen gas pressure, less
clamp force is required – molding pressures of 1-2
tons/inches squared can be achieved leading to
lower part costs. Some considerations, however,
include the fact that sealing gas from the external
environment requires more intricate tool and part
design, leading to increased tool cost, and the
gassed side of the tool needs to be unseen in the
final application if aesthetics are a factor.
Investigating internal gas-assist

Internal gas-assist, on the other hand, is used
specifically to mold very thick sections in parts.
In general the process is similar to the external
method, except the gas is introduced inside the
part geometry – creating a hollow channel through

the thick region of the part and forcing the
resin against the external walls to create a
packed-out appearance in the thick section.
When the resin is evacuated from
the center of the thick section, it leaves
a cavity that can be 20% to 30% of the
cross section. This can result in significant
part-weight savings that could be critical to
product performance. Additionally, getting
this resin out of the part means the cooling
time can be reduced in comparison to
molding the thick geometry as a solid.
Press cycle times are typically dependent
on the thickest part’s geometry.
Internal gas-assist allows extremely
thick sections to be molded with high
aesthetics; however, as with external gas-
assist, the more intricate tool design and
increased tool cost must be considered
when determining the best course of
action for the application. M
Scott Rishell is the technical lead on

several programs at Mack, developing
part designs for production processes
with a focus on diagnosing and
implementing solutions for design for
manufacturability (DFM) issues, as well as
reduce manufacturing costs through part
simplification and process improvements.

MOLDING
Rapid injection molding: 5 things you need to know
Here are five things you should consider when deciding to use rapid
injection molding as part of your development process.
As every custom injection Your development partner should have

molder will tell you, broad experience with injection molding
“There’s no such thing of medical devices and should be able to
as an easy part.” When conduct design reviews to recommend the best
you add in the need for technology for your part. If you go into your DFx
speed the trade-offs start process with the bias that the parts needs to be
to multiply, because you molded, you might not consider alternatives that
are now considering how will meet your desired outcome that could be
close the part needs to faster and less expensive.
be to production versus
willingness to invest in 2. Materials are important
tooling that might not be Material selection has an impact on everything
production-worthy. from device performance, to testing and
Another factor includes sterilization methods, to cost and profitability.
working with supply chain When designing a new device, manufacturers
– which ideally wants to often prefer to use materials that they already
qualify vendors that can have biocompatibility data for, since this simplifies
help you with prototypes the qualification process. In addition, the shrink
and transfer to production. rate of the chosen material is an important factor
Rapid injection molding is that should be considered when determining the
more than just speed and manufacturing process for your product.
cost; it is about the ability Coming back to DFx and how it relates
to deliver a part that meets to rapid injection molding, you still need to
your desired outcome. ask whether the product needs to be of the
With that in mind, here production material. Or can you accept a tradeoff
are five things you should of something that is close enough to quickly
Roger Spurrell consider when deciding to use rapid injection meet your user needs, for lower cost.
Va u p e l l R a p i d S o l u t i o n s molding as part of your development process:
3. Change is expensive
1. DFM has become DFx Design freeze is that mythical place that most
What was traditionally termed “design “built-to-print” shops are looking for from a
for manufacturability” (DFM) has evolved designer. But you cannot get to design freeze
(ABOVE) Precision
molded ferrules into “design for manufacturability, test, without building a few parts and, many times
used for dental laser clinical evaluation, investor presentations or during this process, parts that are critical to
procedure production readiness” (DFx). In other words, function need to be built in the exact design and
DFx is a comprehensive approach to design intended material of the final part. Of course,
that requires consideration of both the you want to do this inexpensively and have the
product and the business objectives, including flexibility to change when design inputs change,
reliability, regulatory requirements, cost and without breaking the bank.
supply chain. One way to reduce the costs associated with
To choose the right manufacturing changes is to adopt a “steel safe” approach to
technology to meet your DFx objectives, you the mold design. “Steel safe” or “metal safe”
must evaluate the cost, timeline and product refers to the practice of leaving a small amount
output capabilities of each technology. of extra material on the mold – for example, an

inner diameter that should be 0.250 in. might
initially be left at 0.255 in. This allows the mold
to be modified (removing material is generally
easy; adding material is nearly impossible) as
the mold and product design are evaluated
and “dialed-in.”
4. Validation
There is a lot of complexity to the decision
of whether to validate a component or the
entire assembly of a device. The decision
is risk-based, depending on the criticality
of the device and your FMEA (failure
modes and effects analysis). It is typically
prudent to consider the validation criteria or
validation path for your product early in the
development process.
If the use of the product does not require
validation for component delivery or future
use of the same tool, certain trade-offs
can speed up the process. As part of the
design review, knowing the intended use of
components and whether there is budget
to build production tools will allow your tool Pipette tips that require injection molding with
designer to offer trade-offs that reduce cost tolerances to +/- .0001 in.
and speed delivery.
Surgical handle 5. How many parts do you need?

component We started this article talking about DFx. becomes the limiting factor. Working with
with insert One of the outputs of the effort should be a vendor that can offer multiple solutions
whether your development project is far to meet your goals allows you to see and
enough along to justify investment understand the tradeoffs. Technologies such
in injection molding. Injection as machining, cast urethane and 3D printing
molds are expensive and all have their place in the development of a
increase cost of change. plastic part based on how many parts you
Understanding need.
how many parts you Completing DFx on your project with
might need allows product intended use and volume is critical in
your manufacturing making a manufacturing decision. By having
partner to suggest this clear understanding, the options available
tooling investment to meet your needs may expand significantly.
that is appropriate One of your goals should be to identify a
for the life of the product development firm that can help you
tool and other make the right manufacturing choice for your
technologies that product development needs. M
might be a better fit.
Roger Spurrell has 20 years of experience
There is a tipping point working with customers to meet their time
with every technology to market and technical needs for product
where the total cost of development. He is currently senior program
ownership, which includes manager and tooling manager at Vaupell
the tooling and part costs, Rapid Solutions located in Hudson, N.H.

MOTION CONTROL COMPONENTS
How Igus moving plastic components

are enabling medtech innovation
Advanced plastic components maker Igus sees more medical

sector opportunities. Here’s how its e-chains, bearings and
linear systems are enabling innovation.
Chris Newmarker Igus – maker of advanced plastic components agents. They’re also easy to clean and can be
Managing Editor including e-chain cable carriers, bearings and linear produced with FDA and E.U. compatible materials.
systems – has its main medical customers in Europe. Both Igus e-chains and bearings are also finding
But that could soon change. uses in 3D printers, with potential opportunities in
The company plans to sell to more medical medical device manufacturing.
customers in the U.S., Harald Nehring, Igus’s VP and Here are three ways Igus components are
head of global industry management, recently told already enabling innovation in the medical sector:
Medical Design & Outsourcing.
“At the moment, we have one industry manager 1. Speedy robot arms to store and retrieve
on medical technology, and we are looking for more medications in seconds
like that so we extend the range. We want to offer It’s not difficult to see hospitals and pharmacies
the special medical technology consulting worldwide challenged by dispensing thousands of drugs with
[and] more in-depth,” Nehring said. (Igus hosted trade speed and accuracy. As the number of drugs rises, so
press on an October visit to its Cologne, Germany, do security issues. To address both, the Rowa Division
headquarters and manufacturing facility – as well as of BD in Germany has introduced two machines.
side trips to highlight innovative uses of its products.)
When it comes to Igus’s e-chains, they can
The Vmax robot arm with a gripper (not shown) takes
provide a customized solution for any moving
scanned medication packages and places them where space is
piece of medical equipment (or medical device available. The arm is driven in this left and right direction by an
manufacturing equipment) attached to multiple Igus Dryspin nut on an Igus lead screw with about a 1-in. pitch.
cables. Think MRIs, X-ray systems and more. They Image by Paul Dvorak
reduce downtime because they increase the service
life of cables and hoses, can be customized for
various types of motions and installations and are
cleanroom-suitable.
“Our e-chain systems you can find in every
device where a big linear or rotary movement is
needed. We have a big advantage because we are
non-magnetic with all materials, compared to metal
competitor products, which in MRI equipment is a big
advantage,” said Nehring, adding the caveat that the
company so far does not offer systems that come into
contact with blood or tissue below the epidermis in
the long term, e.g. implants.
Igus bearings and linear systems also offer
advantages because they have smooth movement
and are durable and self-lubricating – enabling easy-
to-adjust hospital beds, surgery tables and more.
They’re resistant to acid, alkaline and alcohol cleaning
Motion Control_11-17_Vs2-BP-FINAL.indd 90 11/3/17 1:06 PM

Off-The-Shelf-Custom SM
It’s Not An Oxymoron.

Conventional thinking would suggest that getting a
medical-grade foot control that is customized to your
unique specifications requires investments in NRE and/
or tooling… and months of development. 1
2
This need not be the case. Many OEM requirements can
effectively be addressed using our broad
array of field-proven foot control elements … 5 3
e.g. platforms, actuator styles, selectable actuating
4
forces, graphic options (colors, icons, logos), cable styles,
strain reliefs, handles/foot rests, and floor contact pads.
1. Exam Chair Control 4. Bone Saw Control
Our design team has combined these and other 2. HF Generator Control 5. Eye Surgery
elements to satisfy medical device OEM needs 3. CT Scanner Control System Control
worldwide. (A few solutions are shown above.) Each
design is optimized for functionality, user comfort, ease- For more details, please view the 2-minute video on
of-use, and aesthetic appearance. And each is certified our home page at www.steutemeditech.com. Or,
to meet all relevant medical Standards Directives and contact us to discuss receiving a complimentary
Regulatory requirements. sample for evaluation.
(203) 244-6302 www.steutemeditech.com info@steutemeditech.com
Steute 9-17.indd 56 11/3/17 10:53 AM

The Rowa Vmax provides for the

automatic storage and retrieval of boxed
pharmaceuticals while the Smart System
can collect and blister-pack a daily dose
of medications for individual patients.
The rapid storage and retrieval are
possible because of an Igus lead screw
and nut. Stefan Niermann, the Igus
head of business unit dryline linear &
drive technology, says BD engineers
had looked for a lead screw with
a long pitch and low friction and
selected the Igus products in
part because the nut operated
with less than half the friction of
competing products.
2. Wheelchair wheel with

speedy shock absorption
Softwheel (Tel Aviv) boasts
impact-absorbing wheels for
wheelchairs. Wheel designers
used Igus Iglide W300 plain
bearings 18 times because the
plastic bearings had so many benefits.
The W300 bearings were robust,
wear-resistant, lightweight, corrosion-
resistant, suitable for linear and oscillating
applications and maintenance-free.
The Acrobat wheelchair One would never know just glancing
wheel from Softwheel at the wheel that Igus plastic bearings
Image courtesy of Softwheel were playing such an important role. “The
problem with the bearings is that they’re
always hidden,” joked Patrick Carl, head
of international sales for Iglide bearings.
3. Taking friction out of

OUR E-CHAIN SYSTEMS YOU CAN FIND a mechanical gurney
A and A Co. (Tokyo)
IN EVERY DEVICE WHERE A BIG LINEAR had a mechanism for
electrical gurneys used
OR ROTARY MOVEMENT IS NEEDED. in operating rooms. But
the mechanism had a
problem: Friction from
the rotating shaft created a metal powder
that was unacceptable for hygiene
regulations for medical areas. Igus’s Iglide
plain bearings solved the problem. Plus,
the bearings don’t require lubrication,
further promoting hygiene. M
Founding editor Paul Dvorak

contributed to this report.

FAST DELIVERY, PRECISION
AND PROVEN RESULTS.
MONOCARRIER™ QUICK SHIP PROGRAM
Automated medical and diagnostic applications demand repeatability to achieve
consistent, accurate results. Through NSK’s Quick Ship Program, Monocarrier™
actuators are available within 4 weeks. Customize your order and add accessories,
such as K1™ Lubrication Units, covers, sensors, rails and brackets for select models.
This program is ideal for small volume purchases with quick turnaround needs.
Backed by precision and proven results, choose NSK Quick Ship.
www.nskamericas.com
Quickship 11-17.indd 56 11/3/17 10:45 AM

How to mitigate heating in a handheld surgical tool
There are two main sources of power loss, and hence heating, when it
comes to hand-held surgical tool motors.
Urs Kafader Motors operated at the rated torque limit can get very drills that operate at several ten-thousand rpm. Such high-
Maxon Motor hot. In continuous operation, the winding can reach 155°C, speed motors need special design precautions to limit eddy
resulting in a housing temperature of some 120°C. No current heating. Typically, they are made with a low number
surgeon would like to operate with a hand-held tool at even of magnetic poles, a slotless winding and ultra-thin back iron
half of that temperature! Neglecting friction, there are two foils made of special low-hysteresis materials.
main sources of power loss, and hence heating, in motors.
Source 2: PWM driver and inductance
Source 1: Joule power and iron loss It turns out that heating is not only a question of torque, speed
The Joule power losses are linked to the current, i.e. the and design, but also of the driver. Some users have experienced
required torque load. As is well known, these losses increase high motor temperatures (80°C and more) even when driven
with the square of the current. High currents close to the at no-load conditions. In those cases, the driver and supply
nominal value will result in temperatures unbearable for voltage often have a major effect.
humans to touch; running the motor at currents of about half Slotless windings have a very low inductance, resulting in
the nominal current results in moderate temperatures (typically a very low electrical time constant. The current will react very
below 50°C) that match sensitive human skin. quickly; that’s good for dynamic behavior. However, when
For motor selection, this essentially means you should driven with pulse-width modulated (PWM) power stage (as
go for an oversized motor! Be aware, however, that we most controllers are) the motor current is able to follow these
consider here continuous operation in which the maximum rapid voltage changes, giving rise to a considerable current
temperatures will only be reached after some 10 minutes. In ripple. Be aware that the PWM voltage and the current ripple
hand-held tools, one usually has intermittent operation that have no effect on the mechanical response of the motor. The
can expand to 30 minutes and more. The heating is according motor reacts according to the average current and voltage
to RMS average load including dwell times. values.
The iron losses are related to speed. Eddy current The current ripple peaks, however, heat up the motor.
losses increase with the square of speed, heating up the Counter-measures for minimizing the current ripple are:
motors simply when rotating – even in a no-load condition.
In hand-held tools, this can be a problem for grinders and • Reducing the supply voltage of the PWM driver, if
possible, by the speed requirements of the application;
• Increasing the PWM frequency to allow less time for the
current ripple to build;
• Adding an extra inductance – a motor choke – in series
to the motor lines in order to increase the electrical time
constant and to dampen the current reaction.
Maxon controllers take the low inductance of Maxon motors

Image courtesy of Maxon Motor into consideration. They work at high PWM frequencies of
50 to 100 kHz and are equipped with sufficient additional
inductance for most motors.
The heating problem might be easily resolved by replacing
the old over-dimensioned controller with a controller made for
lower power with a larger built-in inductance that operates at
a higher PWM frequency. The largest effect on temperature,
however, is gained by reducing the supply voltage close to the
minimum value needed. M
Urs Kafader is head of training for Maxon Motor.

maxon product range
The solution is always a matter

of the right combination.
If versatility and intelligent drive solutions are called for, the maxon pro- maxon precision motors
duct range provides the answer: A wide range of brushed and brushless 101 Waldron Road
DC motors up to 500 watts complemented by gearheads, sensors, brakes, Fall River, MA 02720, USA
positioning controllers and accessories offer a consistent modular system Phone 508-677-0520
to realize whatever you have in mind. info@maxonmotorusa.com, www.maxonmotorusa.com
Maxon Motors 11-17.indd 56 11/3/17 10:24 AM

NEEDLES & SYRINGES
How to ensure patient centricity

in drug-delivery system design
Now more than ever, it’s critical for drug-delivery systems to address usability
needs and patient safety. Here are three key takeaways to ensure that
patients stay central to the development process for drug-delivery devices.
Kennedy Clark For the treatment of many chronic road maps and habits and ideal scenarios.
West Pharmaceutical Services conditions, such as Crohn’s disease, diabetes, • Identifying ergonomics: Human error and
multiple sclerosis and rheumatoid arthritis, risk analysis, usability testing and heuristic
drug administration continues to move from analysis (encouraging a person to use the
a doctor’s office to self-administration in device on his/her own).
the patient’s home. As a result, the market
demand for patient-centric delivery platforms Device usability
has increased dramatically. If patients are not Once human factors are identified, it’s crucial
comfortable with – or have difficulty using – to gain a deeper understanding of how
the technology, adherence levels can drop. appropriate a drug-delivery platform is for
It’s more critical than ever for drug-delivery patients. Typically, the most impactful data is
systems to address patient safety and usability gathered through interviews and observations
needs. Therefore, drug-delivery platform in the proper context. Seeing the user in the
providers are more vigorously exploring midst of daily distractions – such as caring
innovation and technology to build patient for an aging parent and interacting with
centricity into the design of self-administration children, pets, ambient noise, temperature and
systems and stay ahead of market demand. lighting – all help human-factors experts better
This requires conducting extensive research understand how the patient will use a device.
into three patient-facing areas: Human factors, Testing can be broken down into four major
device usability and patient needs. components:
Human factors • Physical abilities: Anthropometry (the

To design a drug-delivery system that will measure of bodies, such as height or the
truly resonate with patients, the first step is size of hands), biomechanics (what can
understanding their behaviors and motivations. be accomplished physically) and sensory
This requires conducting research that will drive abilities (vision, hearing and tactile sense).
innovation in the design and development • Cognitive abilities: How people process
processes, creating a solution that works in a information, the capabilities of memory, the
variety of situations. Methods for pinpointing manner in which humans learn new things
behaviors and motivations include: and how habits are developed.
• State of being: The general health of the
• Collecting qualitative data: Interviews, expected user, disease states and co-
ethnographic observations, contextual morbidities, mental and emotional states
inquiries and concept evaluation. and motivation for learning new things.
• Gathering quantitative data: • Experiences: Educational background,
Questionnaires, in-person surveys and user- knowledge of a particular disease state
based performance testing. and lifelong experiences with objects that
• Analyzing and synthesizing outputs: will guide behavioral interactions with any
Affinity diagramming, product adoption delivery system.
Needles_Syringes_10-17_Vs3.indd 96 11/3/17 1:09 PM

Patient needs
A third critical aspect to developing
a patient-centric self-administrative
platform is defining what they need out
of the technology, beyond successfully
delivering the therapy. Research can
uncover information that will personalize
the system and help increase adherence.
NEW ENGLAND CATHETER
Those needs include:
• Expected needs: Meaningful to
Custom Medical Extrusions

patients; direct observation inside the
user's environment is an effective way
to document them.
• Expressed needs: Simple for users
to articulate; “think-alouds” and
other narrative techniques are best to Braid or Spiral Reinforced Tubing
determine expressed needs.
• Exciting needs: Typically delights
patients; they often do not think about
Multi Lumen & Hybrid Tubing
the features as technically possible.
Value Added & Post Processing Services
Taking human factors, device usability and
patient needs into account is critical to
designing delivery systems that patients
can and want to use. In doing so, drug-
delivery platform providers will not only
meet the unique needs of pharmaceutical
partners, but more importantly, also
ensure the device’s user interface is safe
and effective for the intended population
and environments. M
Kennedy Clark is a Senior Director

leading the Global Market Development
team for West proprietary devices. He
has earned both MBA and Bachelor of
Science in Industrial Technology degrees.
www.necatheter.com
603.838.2261
Needles_Syringes_10-17_Vs3.indd 97 11/3/17 1:09 PM

RAPID MANUFACTURING & PROTOTYPING
Complete 3-D printing

Form 2 package by Formlabs
Image courtesy of Formlabs
How have company launches and prototyping

evolved with 3D printing?
Here are three basic ways that 3D printing can help you
get your medical device project off the ground.
Jim Medsker Additive manufacturing, commonly referred to hobbyists. Today there are several 3D printer
Keystone Solutions Group as 3D printing, began to surface in the 1980s. options in the sub-$1,000 range, and many in the
Since then, the technology has quickly become $3,000–$10,000 range, that produce high-quality,
a valuable tool for creating plastic prototype structurally capable parts.
parts in a rapid fashion. Like many emerging In the early days of the technology,
technologies, however, the early days of 3D materials were limited to specialized plastics
printing had drawbacks. with limited mechanical and thermal properties.
The equipment and materials were Today materials, processes and resulting parts
prohibitively expensive for most companies, are wide-ranging, including:
thus creating the initial demand for 3D printing
service firms. Many of the first printers on the • Many plastic resins
market came with a price tag close to $300,000. • Elastic and dual durometer components
Further, the parts created were primarily for • Metals
visual purposes only and typically did not have • Fabrics
the surface finish, strength or other properties • Biocompatible scaffold materials to promote
necessary to make them a fully functional part. tissue growth
Roll the clock forward to the present day and • Synthetic food products
the technology is not only capable of creating
fully functional parts in many applications, This advance led to the capability to produce
it’s also accessible for small companies and everything from organ tissue to full-size
Rapid Manufacturing_10-17_Vs2-BP-FINAL.indd 98 11/3/17 1:12 PM

Propel your
business into
the future.
HP Jet Fusion 3D Printing
delivers design flexibility fast.
hp.com/go/3Dprint
HP 3D 11-17.indd 56 11/3/17 10:21 AM

Design World Print Ad v2.indd 2 7/5/17 10:25 AM
vehicles and just about anything one

can imagine in between.
For medical device startups, this
means additive manufacturing is now a
key asset for not only creating parts, but
also in launching companies. The following
provides a few brief examples of how this
technology can help you get your medical
device project off the ground:
1. Design cycle frequency

Many additive manufacturing processes
produce parts with near net shape
and physical properties that parallel
components made with standard
production processes. This allows
YOUR IDEA
the 3D-printed parts to go beyond
boardroom presentation and into the lab
for testing. At times, they can even go
realized
into the field for voice-of-customer and
validation studies.
Data from the lab and feedback from
the field can then be fed back to the design
team and the next iteration design can
be produced quickly. This means project
schedules and budgets are minimized and
design integrity is optimized.
Comprehensive and scalable medical 2. Funding

Funding is often the primary barrier for
device solutions from development entrepreneurs and department heads
when it comes to getting ideas off the
through manufacturing ground. While PowerPoint presentations
and detailed pro formas can be impactful in
the fundraising effort, there is nothing like
Complete product development services a production-intent product in the hands of
Contract assembly, packaging, and distribution investors to help close the deal.
With today’s additive
Durable goods and single-use products manufacturing technologies, this is
not only possible – it’s becoming an
ISO 13485 Certified expectation in many cases. High-quality
FDA Registered prototypes deliver the message effectively
and increase investor confidence.
3. Production
Moving to full-scale production often
requires a significant capital outlay for
tooling, fixturing and minimum volume
commitments – potentially meaning
months of lead time. The cost as well
as the time required for custom tooling
often puts the program’s finances and
schedule at high risk. Fortunately, with
LEARN MORE AT the production quality output of many of
keystone-pd.com
MS1048
today’s additive manufacturing processes accessibility will undoubtedly help an
and materials, many companies are ever-increasing number of initiatives get
forgoing the burden of expensive off the ground. M
tooling and are now using 3D printing
for production runs. Jim Medsker founded Keystone
Depending on the product, Solutions Group (Kalamazoo, Mich.)
using 3D printing for production may be in 1998 with the vision of creating a
limited to the initial pilot runs. However, turnkey resource for helping people and
it is becoming increasingly common companies with product ideas get their
to use this technology for long-term products commercialized.
ongoing production.
The exciting news is that the technology

continues to evolve and progress at
an amazing pace. As the quality of
parts and variety of materials produced
with additive manufacturing continues
to improve, the equipment and
material costs continue to fall. These
combined advancements and improved
MS1048_Half_Page_Ad_Dev_(v1).indd 1 4/10/17 11:47 AM

How 3D printing options are growing for medtech development
The new Multi Jet Fusion process out of HP is but the latest 3D printing technology to
up the game for medical device development. Here’s a roundup of what’s available.
J o n E r i c Va n R o e k e l The medical device industry continues to be driven The technology uses an inkjet array to selectively
Proto Labs by innovation. Some sources, including medical market apply fusing and detailing agents across a bed of
research firm Kalorama Information, say that medtech nylon powder, which are then fused by heating
companies this past year will have spent an average of 7% elements into a solid layer. After a layer is built, a
of revenue on R&D, which is higher than most industries. fresh layer of powder is distributed on top of the
As those innovations are brought to market in previous layer and the next phase continues until the
the form of new products and services, medtech build is complete. The process uses an engineering-
companies will look to rapid manufacturing processes grade nylon 12 powder, so parts are durable and
for prototyping, functional and regulatory testing and, suitable for functional testing and end use.
ultimately, end-use production. Proto Labs was one of a handful of sites that tested
Fittingly, our manufacturing industry generally – the technology before it hit the market.
and 3D printing specifically – is driven by innovation. “As far as what we’re testing in, it is definitely
Indeed, key technological developments and new becoming a faster way to build parts compared to some
applications in industrial-grade 3D printing, or additive other 3D printing processes,” applications engineer Joe
manufacturing, continue to advance this technology, Cretella told Medical Design & Outsourcing.
which has only been around for about 30 years. Indeed, as a part of this testing, we worked closely
AS FAR AS WHAT WE’RE TESTING IN, IT IS DEFINITELY

BECOMING A FASTER WAY TO BUILD PARTS
COMPARED TO SOME OTHER 3D PRINTING PROCESSES.
Medtech companies are already using 3D printing with HP’s R&D team to fine-tune the process in order to
in an impressive variety of ways: Vertebra replacements consistently produce high-quality parts.
for the human spine; prosthetic components; surgical In August, following the testing phase, we added
instruments; operating room equipment; hand-held this process to our production capabilities. With the
devices; clear (transparent) options for braces, aligners addition of MJF we offer five industrial-grade 3D
and retainers in dentistry; and so on. printing processes that can produce plastic, metal
and elastomeric parts and components. This array
Multi Jet Fusion joins the 3D printing lineup of platforms is a prime example of how additive
One notable additive manufacturing newcomer manufacturing continues to advance and grow.
is Multi Jet Fusion (MJF), launched last year by
technology giant HP and recently adopted by So what 3D printing technologies are available?
multiple 3D printing service bureaus. MJF is a Designers and engineers can now choose from several
production-grade 3D printing technology that distinct classes of 3D printing technologies. Your choice
builds fully functional plastic prototypes and of “tool” just depends on what you’re designing and its
production parts faster than comparable processes final application. Here’s a brief roundup of some of the
and with detailed precision and improved isotropic main industrial-grade 3D printing options:
mechanical properties.

• Stereolithography (SL) uses an • Continuous Liquid Interface
ultraviolet laser that draws on the Production (CLIP), used by a
surface of a liquid thermoset resin company named Carbon, builds
to create thousands of thin layers parts from the top down, unlike
until final parts are formed. SL is other additive technologies that work
used to create concept models, from the bottom up. Final plastic
cosmetic prototypes and complex parts exhibit excellent mechanical
parts with intricate geometries. properties and surface finishes.
• Selective laser sintering (SLS) • Multi Jet Fusion (MJF) selectively
uses a CO2 laser that lightly applies fusing and detailing agents
fuses nylon-based powder, across a bed of nylon powder,
layer by layer, until final which are fused in thousands of
thermoplastic parts layers by heating elements into a
are created. SLS solid functional component. Final
produces accurate parts exhibit improved surface
prototypes roughness, fine feature resolution,
and functional and more isotropic mechanical
production parts. properties when compared to
• Direct metal processes like SLS.
laser sintering
(DMLS) uses a Ultimately, choosing the right process
fiber laser system for your next project is a multi-faceted
that draws onto decision because it depends on project
a surface of requirements and a multitude of
atomized metal variables. Our application engineering
powder, welding teams work with customers every day to
the powder into help them determine the best 3D printing
fully dense metal process for their particular needs. M
parts. DMLS builds
fully functional metal Jon Eric Van Roekel is 3D printing
prototypes and production process engineering manager at Proto
parts and works well to Labs (Maple Plain, Minn.).
reduce metal components in
Image courtesy
of Proto Labs multipart assemblies.
• PolyJet uses a jetting process
in which small droplets of liquid
photopolymer are sprayed
from multiple jets onto a build
platform and cured in layers to
form elastomeric parts. PolyJet
produces multi-material prototypes
with flexible features at varying
durometers and is often used to
concept overmolding designs.
• Fused deposition modeling
(FDM) works by feeding a filament
or spool of plastic into a heated
nozzle, which then extrudes
successive layers of thermoplastics
onto the workpiece. FDM offers
a wide thermoplastic material
selection and is leveraged for
iterative prototyping.

REGULATORY, REIMBURSEMENT AND IP
Protecting
intellectual property
All companies begin with an idea. The details of protecting that

intellectual property can be daunting, especially if your idea is in the field
of medical technology.
N. Scott Pierce Starting a medical device company 2. Copyrights: These offer protection
Alexander Adam requires a vast array of knowledge, for works of authorship and visual
Hamilton, Brook, Smith & Reynolds PC
including knowledge about almost art. Copyright protects an expression
every type of technology, an immense of an idea in a tangible form, rather
amount of regulatory requirements and than the idea itself. In most medical
intellectual property protection strategies. technology-based startups, copyright
So how can you establish a legal protection applies to publications
framework that fulfills the promise of and other written materials, such as
an advance in medical technology internal manuals, product literature
while rewarding you for your and company announcements.
contribution to society? Computer software, such as the
Medical devices and methods programming of robotic components,
of treatment that employ them are is also subject to copyright
protectable as intellectual property. The protection, often as an alternative to
most advantageous type of intellectual or in addition to patent protection.
property will depend on the exact nature of
the technology. In any case, it’s imperative 3. Trade secrets: These can include
before any action is taken that at least initial almost any type of information
steps are taken to protect their work. generated within a company that’s
not known or readily ascertainable by
Types of intellectual property the public. Trade secrets can include
Each form of protection has its own technology generated by the company,
advantages and limitations: employee know-how and customer
lists and can be maintained indefinitely,
1. Trademarks and service marks: These usually through the use of employment
are intended to indicate the source agreements and confidentiality
of a product or service and generally agreements with third parties.
take the form of brands or logos. Technology that is kept confidential,
Trademarks and service marks can but can be reverse-engineered if
be registered with the U.S. Patent & disclosed, should be protected by
Trademark Office (Patent Office) and patents before any public disclosure,
are usually indicated by the symbol TM such as during fundraising efforts or by
or SM or, if the mark is registered, ®. the commercial launch of a product.
Regulatory_10-17_Vs3.indd 104 11/3/17 1:18 PM

4. Patents: These are by far the most common means application can be filed on the improvement. Very
for protecting innovative medical technology. Most often this is critical because the improvement may
relevant to medical technology are “utility patents,” end up as the most important – or only – protectable
which protect the way an article is used; less relevant IP. Startups should be sure to have any employees
are patents for a design or a plant. assign their rights to the company when they become
employees, lest they independently license or assign
Six things you need to know about patents: their rights to a third party. Even if inventors agree
to assign rights to the company, failure to record the
1. Provisional patents: A common form of initiating assignment with the Patent Office may still allow them
patent protection for medical startups is to file a to assign the rights to a third party.
“provisional” patent application, especially for
companies with limited funds – the cost of filing can 5. Multiple parties: Medical technology is often
be very low, typically only a few hundred dollars. multidisciplinary and startups based on medical
Provisional patent applications are not examined by technology frequently collaborate with outside
the Patent Office and automatically expire after a year. parties, meaning that patent applications and patents
They never mature into enforceable patents and are may be jointly owned. Assignments of rights by
maintained in secret by the Patent Office, unless used in inventors with obligations to different companies will
a subsequently published “non-provisional application.” cause the resulting application or patent to be jointly
owned by both companies.
2. Filing early is important: Filing dates for provisional
and non-provisional patent applications are important 6. Associated agreements: Medtech startups often use
because prior right is given to the first inventor to file several types of agreement for their IP. Nondisclosure
a patent application, not the first person to invent to a agreements can be important in protecting confidential
system. Therefore, it’s critical to file a patent application, information before patents are filed. It’s strongly
even a provisional application, as soon as possible recommended that, regardless of any confidentiality
– preferably before speaking to potential investors. agreement, a patent application be filed before
Many “seed” or “angel” investors require that a patent disclosing the invention to a third party; it’s not
application be filed as a prerequisite to discussing a new uncommon for vendors to file applications after meeting
venture based on any emerging medical technology. with inventors to discuss new technology. Another
common instrument is a material transfer agreement,
3. Wording of claims: The intellectual property of any often associated with samples of proprietary subject
nonprovisional patent application or patent is defined by matter sent to prospective customers.
its claims, which appear at the end of any application or Patents and patent applications can also
issued patent. Each claim includes a “preamble” and a be licensed, either exclusively or nonexclusively,
“body,” wherein a combination of so-called “elements” with “exclusive” licenses for a single licensee and
of the body of the claim outline the exclusionary rights “nonexclusive” licenses for multiple licensees. In any
of the patentee. Any process, machine, manufacture or enforcement action against a potential infringer, all
composition of matter that includes all of the elements parties, including licensees, must take part.
of the claim is said to “infringe” the claim and the patent
owner has the right to exclude the public for the limited Intellectual property protection is vital in any medical
period of enforceability of the patent from making, technology-based startup and it is relatively easy and
using, selling, offering to sell or importing the infringing inexpensive to establish a filing date in the Patent Office for
subject matter. The wording of claims is extremely an invention. Obtaining an early filing date is often critical in
important and it’s strongly advised that medical enabling an organization to attract the capital necessary to
technology startups use a patent agent or attorney become established and proceed with its vision. M
registered with the Patent Office.
N. Scott Pierce is a principal and Alexander Adam is
4. Inventorship: This is determined by the claims of a an associate at Hamilton, Brook, Smith & Reynolds PC
patent application; any individual who contributed to (Boston). Pierce practices in biotechnology, chemistry,
the complete mental conception of any claim must be chemical engineering, electronics, medical devices and
named as an inventor. Inventorship should be assessed pharmaceuticals. Adam helps startups advance their
before any patent application is filed to mitigate issues innovations in medical devices, computer systems,
over patent rights. In addition, if improvements are not electronics, imaging software, control systems, mechanical
described in an application or patent, a new patent devices, telecommunications and clean energy.

Mobile health innovations need protection for success
Patent protection is becoming increasingly important for mobile health

developers as more devices and applications join the connected world.
David Dykeman The emergence of medical mobile device apps Control to assist first responders during the recent
G r e e n b e r g Tr a u r i g and wearables is revolutionizing healthcare. Home Ebola outbreak. Other mHealth apps provide
monitoring, big data, the Internet of things (IoT) continuous blood glucose monitoring, nutrition
and personalized medicine are putting mobile analysis and personal fitness tracking to allow
health (“mHealth”) apps at users’ fingertips. With individuals to monitor their own health. Analysts
connected health and point-of-care diagnostics estimate that there are approximately 259,000
becoming more common in clinical settings, patent health-related apps for mobile devices. Consulting
protection is crucial for developers of mHealth firm PwC forecasts that mHealth apps will have been
innovations and wearables used to downloaded 1.7 billion times by the end of the year.
diagnose and monitor medical In this rapidly growing market, medtech companies
conditions, prescribe drugs or need to maintain a competitive edge through a
order laboratory tests. strategic patent portfolio that focuses on protecting
mHealth apps can be core technology, exploring new patent areas and
used on a large scale, such establishing worldwide patent protection.
as the apps provided by
the Centers for Disease Drive growth with strong patent strategy
A strategic patent portfolio protects a company’s
core technology, which in turn helps secure funding
and establishes a competitive advantage in the
marketplace. A recent study found that a startup has
about a 2.5-times greater chance of achieving success
within 10 years of venture capital investment if it
holds patents before the investment.
Patents are extremely important for
companies of all sizes with innovations in
mHealth. For early-stage companies, patents are
often the only way for investors to place a value
on its technology. In this way, patents make up
a significantly greater portion of enterprise value
for early-stage mHealth companies. As a company
grows, patents become the currency that secures
financing through venture capital or private equity
investment. Patents can also lead to collaborations,
joint ventures and licenses with strategic partners.
For early-stage mHealth companies, the
key is to develop a strategic patent portfolio that
has comprehensive patent coverage around the
company's innovations. The core technology must
have adequate patent protection to provide flexibility
and room to operate in a desirable market. To obtain
broad patent protection, companies should file an
Graphics by Matt Claney initial patent application covering the core technology,

followed by additional patent applications covering key From innovation to market
improvements. A company should consider both current mHealth innovations present some unique concerns.
and future business objectives and analyze ways that FDA is issuing new guidance on how to best regulate
competitors may attempt to design around its patents. medical mobile apps. To limit potential liability,
mHealth apps should include a disclaimer that the app
Navigating the patent thicket does not provide medical advice.
A major challenge for mHealth companies is the Medical mobile device apps and wearables are
complex and often multifaceted nature of mobile changing medicine at the forefront of healthcare
technology. Many traditional medical device companies innovation. With strategic patents that focus on key
are now creating mobile apps for existing products. innovations, medtech companies can maintain a
Such innovations frequently incorporate or combine competitive edge in the burgeoning mHealth industry. M
multiple technologies; each component of the
device must be protected. Where applicable, patent David Dykeman is a registered patent attorney with more
claims should be directed to the entire device, key than 20 years of experience in patent and intellectual
components, control systems, disposables, mobile property law and co-chair of Greenberg Traurig’s global
applications, methods of treatment, manufacturing Life Sciences & Medical Technology Group. He can be
methods and any other aspects of the invention. Design reached at dykemand@gtlaw.com or (617) 310-6009.
patents can also provide protection for the ornamental
features of mHealth products. As companies continue
to improve their core technology, they should patent
incremental changes to form a "picket fence" of patent
mdi Consultants, Inc.

protection around that core tech. By filing patent
applications covering incremental improvements,
mHealth companies can grow their patent portfolio and THE FDA REGULATORY CONSULTANTS
expand their presence in the market.
It’s important to work with a patent attorney Internationally Recognized Consulting Company to the Medical
who understands the interplay of programming, Device/IVD/Pharmaceutical Industry/Food Industry – Since 1978
healthcare, detection and processing with hardware
to ensure that the app qualifies as patentable subject
matter. A patent attorney can also file copyright • OVER 38 YEARS SERVICING THE MEDICAL DEVICE
applications covering the software. AND PHARMA INDUSTRIES
• FDA compliance –SPECIALIZE in responding to the
Protect IP ownership in developer agreements 483 and Warning Letters/3rd party audits conducted
Medtech companies that outsource the development by former US FDA Investigators with extensive
of apps to third-party developers need to protect the International experience
ownership of their intellectual property (IP), including • SET UP and AUDIT QSR/cGMP systems for FDA
software code. When an mHealth company hires an Compliance (Device/Drugs)
independent contractor to create and develop code for • NEW MDSAP Understand and assist with the audit
an app, the company must have a written agreement preparation!!
stating that any code the independent contractor • Official Correspondent and U.S. Agent
creates is a “work-for-hire” under copyright law. In a (for non-U.S. companies)
work-for-hire arrangement, that mHealth company will
own any code developed by the contractor. Including Main Office:
this specific language in a written developer agreement 55 Northern Blvd,
allows the mHealth company to retain ownership of the Great Neck,
copyrighted source code that runs the mobile app. NY, 11021
Tel: 1-516-482-9001
As a practical matter, mHealth companies should Fax: 1-516-482-0186
also be sure that third-party developers transfer website Info@mdiconsultants.com
passwords upon completion of projects. Thus, a company Visit: http://mdiconsultants.com/
can access and improve mobile apps and websites even
if the developer is no longer involved.

MDIconsultants_10-17_Vs1.indd 1 10/26/17 3:57 PM

How can sponsors respond to and benefit from the

complex challenges the new EU regulations present?
New regulations are coming to the European Union and it’s up to developers to
implement changes that will help them thrive in the new environment
Vicki Anastasi The new European Medical Devices
Graphic by Matt Claney

ICON Regulation (MDR) and the In Vitro
Diagnostic Medical Devices Regulation
(IVDR) represent one of the most wide-
ranging and disruptive changes to recently
affect the world’s second-largest medical
technology market.
With just a three- to five-year transition
period before full compliance is required
in 2020 for MDR and 2022 for IVDR, the
scope and complexity of this legislation will
require significant changes in areas such
as product development, data reporting,
quality assurance and manufacturing
processes. Manufacturers will need to
identify which of their products will be
affected by the new classifications to ensure
they remain compliant. For IVD organizations that have not previously run
Additionally, the role of Notified Bodies (NBs) will be clinical trials, developing this capability requires a lot of
restricted by the European Commission to certifying only time and resources. In addition, review of certification
specific classes and types of medical devices and in vitro applications by NBs will take time, since NBs must develop
diagnostic devices (IVDs) for which each NB can demonstrate the capacity to review IVDs.
expertise. This will reduce the number of NBs available to So, for MDR and IVDR, early transition will give your
certify many devices for some time and, in combination with products an advantage in the market by providing buyers
the larger volume of clinical data that NBs will be reviewing with credible performance information. Also, it gives early
for each device, we expect long delays in certification reviews movers an edge in squeezing out other manufacturers
as deadlines approach. Finally, IVD manufacturers will be competing for the same limited NB resources.
particularly impacted, as NB review will be required for
approximately 90% of products, up from about 10% today. Will it be worthwhile to conduct clinical testing on existing
products?
What steps should manufacturers take to prepare for the Yes, it’s worth the investment. Developing strategies that
new EU regulations? demonstrate effectiveness will help you gain and press your
Early planning is key. As challenging as product testing and market advantage.
reporting requirements may be, the new regulations could The best way to know whether your products are
present an opportunity to get ahead of the competition. worth the investment is to conduct a “gap analysis” of your
Complying with the new MDR and IVDR will require pipeline and existing product portfolio. For each product,
significant lead time, especially when preparing clinical first determine the category under which it will be certified
studies to certify new devices – and to recertify existing – MDR or IVDR – and what additional evidence, clinical
ones. Moreover, you’ll need extra time for expanded NB testing, production process, technical file documentation or
reviews and any backlog that may develop. other changes will be required to conform.

Five mistakes
that can turn your product
registration into a money drain
Medical device registration may seem

straightforward, but it’s actually prone to
Next, estimate the cost of these
potentially costly mistakes.
changes, assess how they’re likely to affect
profitability and reconfigure your portfolio
accordingly. Your analysis may indicate it’s
time to drop marginal products with a lot Heather Thompson Medical device organizations are required to register
of competition and focus on preparing Senior Editor medical devices with notified bodies in all countries
packages for new, more profitable medical where they sell those products. This process is fairly
devices where there are fewer marketplace well understood and expected.
competitors or IVDs with strong evidence However, there are pitfalls in the practice of
showing they support clinically beneficial compiling the dossiers to register; mistakes can end
treatment decisions. up costing a company money, according to Carl Ning,
Clinical tests for IVDs differ from those director of global solutions architecture for Sparta
of pharmaceuticals or medical devices Systems (Hamilton, N.J.).
primarily in their endpoints. Although Ning highlighted the common errors medtech
drugs and medical devices generally can companies make in thinking about product registration
be evaluated based on how they directly and offered some solutions:
affect a disease or condition, IVDs must be
evaluated based on how the information 1. Your regulatory department is understaffed.
they provide affects treatment decisions. The global registration process is time-consuming.
Consider that the new regulations For the most part, medical device organizations
require uniform performance data only keep a few regulatory professionals on staff.
reporting to a central database, which will That means that only a few people are dealing with
make it easier for health system buyers to the hundreds, if not thousands, of SKUs marketed
compare product performance head-to- globally. They are working lean and they can’t get
head. As a result, any product that shows ahead of the transactional volume.
a clear performance edge could gain a
decisive market advantage. 2. You think of your regulatory department as being
CROs can help assess portfolios pigeonholed as a cost center, not a revenue
for product viability under the new generator. Regulatory folks are responsible for a
regulations and in creating the real-world wide range of tasks, spanning pre-market approval
evidence needed to conform to the new activities to post-market surveillance. But thinking
regulations. M that your team is only perceived as a cost center is an
underestimation of the value of your regulatory staff.
Vicki Anastasi is Vice President & Global The perception couldn’t be further from the truth.
Head, Medical Device & Diagnostics Consider that if a product isn’t properly registered in
Research for ICON plc. She has more than a country, the cost to the company can be enormous.
25 years of experience in the medical Consequences could range from potential civil
device industry, with more than 15 years penalties levied against the organization to top-line
specifically focused on global medical revenue impact if the sales team cannot gain timely
device strategic consulting. and lawful access to the product for sales execution.

3. Your regulatory How to fix or avoid these mistakes

personnel is using Of course, there are ideal situations. Regulatory
home-grown leaders would love to have more staff, but adding
spreadsheets or technology may suit more organizations. An end-to-
even paper tracking. end management system offers both scalability and
The “cost center” cost containment.
misconception can lead To make internal changes, regulatory leadership
to a lack of investment can help to educate the C-level teams on investing
in the department. in technologies that can integrate the product
As such, many registration process into the other critical pillars
regulatory staffers within an organization’s technology stack – such as
use homegrown ERP systems for product holds or QMS by linking
spreadsheets to product registration process to quality processes;
manage global e.g., a systemic issue requiring a CAPA that leads
registration. Tracking into change management, which in turn initiates
something as complex the necessary product (re-)registration process
as global product automatically.
registration with a One of the key tenets is data integrity. If your
spreadsheet is the regulatory staff is using outdated solutions, a “single
regulatory equivalent source of truth” may be difficult to reach. That means
of bringing a knife to getting answers to simple questions takes too long.
Image courtesy of istockphoto.com a gunfight. These complex spreadsheets are A good tracking system will introduce data integrity,
often updated by multiple people, so the real- ensuring all users are consuming consistent and up-
time accuracy becomes questionable as the to-date data across the organization.
staff continuously plays catch-up. Further, such The right technology also provides a way to
“systems” do not integrate with enterprise resource manage registration schedules and (recurring)
planning solutions. Companies have often invested commitments, so that regulatory teams get ample
heavily in an ERP, but fail to make the connection lead time, and can work quickly to ensure deadlines
for product registration. This non-integrated are met. An organization can benefit tremendously
landscape perpetuates the operational redundancy by having a collaborative platform to enable sales,
organizations face today, but it doesn’t have to. marketing, product management and regulatory to
work in unison to define, build, launch and sell the
4. You are in reactive mode all the time. Without product. Finally, do ensure that the solution provides
a comprehensive (and integrated) registry system, the proper alignment to your organization’s IT strategy
the regulatory staff is reacting to information rather (cloud versus on-premises). M
than getting ahead of it. That means that keeping
up with changes takes longer than it should. And
producing even simple reports for a leadership
team – reports that could be generated in a few
hours – can take two to three days.
5. Your regulatory department may be viewed as

a new product introduction/sales launch blocker
rather than an enabler. With outdated technology
in hand and a lean team to boot, regulatory teams
trudge on fighting the good fight. While they may
be able to contain a blaze, the time it took to fix
the problem was likely borrowed from impending
sales launch efforts. Any delay in new product/sales
launch puts the responsible party under intense
scrutiny; no regulatory team intentionally protracts
the launch timeline.

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Smart Products 11-17.indd 56 11/3/17 10:49 AM
How to work with the new FDA
Here’s how medical device makers can capitalize on the strategic priorities and
transparency initiatives at the FDA’s Center for Devices & Radiological Health.
Lisa Olson Dr. Scott Gottlieb has now settled into his role as the FDA’s one can extrapolate that interactions with the agency may
RCRI new commissioner and is putting his stamp on the agency. become more highly formulaic. Standardized evaluations,
Interestingly, Gottlieb started with some very specific reliance on checklists and uniform responses from the agency
points of focus that have bubbled to the surface in the are going to become common. This can present both a
political arena, including the drug approval process and benefit and a challenge for the device industry. On the
tobacco and opioid addiction. positive side, interactions with the agency should become far
On the working level, Gottlieb’s appointment has not more predictable. Evaluating warning letters, blogs, Twitter
interrupted the momentum of the agency as a whole. When feeds, inspection reports and quarterly reports to Congress
the totality of FDA actions and external communications are will tell manufacturers a lot about FDA expectations. On the
evaluated, the agency is still demonstrating a focus on the negative side, reviewers are going to be more stringent about
strategic priorities set out in 2016. Although the recently exactly meeting guidances without deviation.
signed fourth iteration of the Medical Device User Fee Act On the surface, this standardization should help expand
(MDUFA IV) has several new points, all of the changes serve the FDA’s capacity and provide a more uniform approach
to support the 2016 initiatives. to review and feedback. Looking deeper, this could also
drive the agency to be potentially less flexible in accepting
Strategic priorities alternative or novel approaches. Expect submissions to be
The initial priorities set forth in 2016 focused on three main closely held to the published requirements. Policies such as
topics: Establishing a national evaluation system; partnering with RTA, allowable interactions, number of review cycles, etc., will
patients; and promoting a culture of quality and organizational be closely followed. Pre-submission meetings will have more
excellence. For 2017, the agency went deeper by defining how importance than ever to ensure that planned approaches will
they intended to support those initiatives with the Regulatory meet agency expectations.
Science Priorities document. These priorities ranged from the Despite the drive towards metrics, there is a clear
use of Big Data in decision-making to the development of new initiative to be accessible. Both the pre-submission meeting
evaluation tools. There are tactical points for safety evaluations program and the interactive review process should be used
and controlling the microbial risks in reprocessed and sterile to your advantage. However, every interaction with the FDA
devices. Notably, these are all externally facing initiatives. should be very carefully planned. When engaging in a pre-
However, the FDA is honoring its commitment to improvement, submission meeting, have your strategy as well-developed as
transparency and accountability through its highly detailed possible. Have a list of questions that are specific, detailed
quarterly reports. and designed to gather agency expectations. Submissions
must not only be thorough, correct and detailed but also
MDUFA IV commitments well-constructed to lead a reviewer through the review
Important commitments that will fundamentally impact how the process to a clear and compelling case for device safety and
FDA works have been included in MDUFA IV. Laying out the efficacy. Any novel approaches in your submission should be
pilot program for laboratory accreditation, as well as actually well-justified and clearly defended.
accrediting laboratories, may not be revolutionary but will We are in a time of complex and continual change.
dramatically impact how review of submissions are done (as However, the FDA is providing multiple indicators of their
well as how submissions are constructed). Furthermore, MDUFA expectations. Use all of these indicators to smooth your
IV formally commits the FDA to accepting third-party review. regulatory pathway. M
Although the agency has been regularly reporting to Congress,
the new requirement is far more explicit in linking performance Lisa Olson is president of RCRI, a Twin Cities–based medical
and activities to monies appropriated. device strategic consulting company. Olson has more than 20
years of experience in the medical device industry providing
Capitalizing on the information contract research services to startup through Fortune 100
Basically, Regulatory Science Priorities and MDUFA IV are companies. She has extensive technical experience in pre-
about measurable performance and accountability. With clinical research, including in vitro and in vitro biocompatibility,
an understanding that the FDA is being driven by metrics, genotoxicology and toxicology models.

Navigating the FDA for connected devices
As connectivity features become increasingly prevalent, developers are tasked

with accounting for regulatory implications in increasingly long-term plans.
Aidan Petrie Let’s imagine a product that dispenses a drug for

Ximedica eczema. At its most basic, the dispenser is little more
than a package for the primary drug container and
so falls under some medical packaging and labeling
standards, with some scrutiny as to what materials or
pathways are in contact with the drug.
But add intelligence to the product and now it
knows how much was dispensed and at what time;
perhaps it has a reminder function that lets the patient
know when they should take the treatment. We could
then send the use patterns to the cloud and have
analytics compress the data so that a caregiver or
physician could look at the patient’s adherence to the
regimen and make proper recommendations.
Everything described in this scenario is already
happening with some medications, providing real
benefits to the patient and potential benefits to
the health system as a whole. Although some of
these features cost little to implement and bring to
market, others will require years of development,
validation, usability and cost-benefit trials – and
cost an order of magnitude more to develop.
Preemptively planning and managing this process
can give clarity to the entire team and allow
development teams to effectively to meet deadlines,
plan resources and budget accurately.
Connectivity and classification

Connected medical devices offer huge value to
healthcare systems and services with their ability to
transmit and analyze data, remotely monitor patient
conditions, manage multivariable disease states and
more. Navigating feature sets that keep a device within
the FDA’s Class I exempt designation or trigger a
higher classification is critical, as it has vast implications Class I and
on development cost and timeline. Class II triggers
Almost every device we work on now has some From a development perspective, the cost and time
form of connectivity. Often, the classification on the variant between a Class I exempt and Class II device
device has been defined by the clinical purpose and is huge. With the higher risk profile of Class II comes a
risk profile of the device and the FDA has an existing mass of additional requirements for the development
categorization. Other times, determining the effect of and manufacturing process. Device development
connectivity on classification can make abiding by pre- now follows a process outlined by ISO 13485 and
existing regulations difficult. As more digital products the FDA’s Quality System and cGMP regulations.
are being developed with capabilities, analytics and These rigorous standards incorporate user needs and
processing outside of the physical product, growing requirements, specifications, hazards analysis and a
risks and ambiguity exist alongside the benefits. full risk-management process, design history files,

documentation practices and a myriad It is also worth noting the advantages

of other controls that ensure that the to pursuing features that will move the
device is developed safely. The device app into Class II or higher territory. These
or system must also demonstrate its richer, more impactful features and
efficacy through validation studies and functions enable a digital health product
predicate equivalency. The ISO and FDA to separate itself from the pack. Class I
quality system requirements call into apps are everywhere, are not distinct from
play a plethora of general and specific each other and, although they offer some
product safety standards, including the value, don't take real advantage of the
IEC 60601 series, 62366, 62304 (software power of digital devices.
validation), ICH Q6 and Q9 and more. Regulatory, marketing and
Risk management (ISO 14971) cuts development leads should work through
across all these standards, laying out a matrix set that ’line items’ individual
a development process infused with features desired and then categorizes
attention to safety and risk mitigation. them as ‘no implication,’ ‘it depends,’
Connected devices, particularly or ‘triggers a higher classification.’
those used at home, draw from many Proper input from respective leads about
already available or easily developed whether a particular feature will affect
technologies to deliver value to their the development schedule or regulatory
diverse users. But how does the considerations in this rapidly evolving
entrepreneur know what features might area can help to ensure that a device is
trigger a benign product Class I exempt successful in its first market entry and
device to suddenly require adherence to a make it easier to build in new features as
Class II standard? they are ready. M
Evaluate each feature, present or future In 1985, Aidan Petrie co-founded an

The ‘tail should not wag the dog,’ in that IP development firm today known as
classifications should not determine the Ximedica. In his role as Chief Innovation
success of a product. To that end, we Officer, Emeritus, Petrie drives innovation in
recommend an exercise that evaluates Ximedica’s core markets of medical device
individual features against the regulatory development and consumer healthcare.
implications and against the development
consideration. This trifecta gives the
developer the ability to offset the market
value of features against the likely impact
to cost and to take a strategic approach
to deploying feature sets. Developing
a multigenerational plan in which MVP
meets FDA strategy allows a product to
come to market with a low regulatory bar
and introduce new features over time.

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Ruland_MSHandbook9-16.indd 11/3/17 AM
SOFTWARE
Four ways
multiphysics
simulation
can boost medical
device design
From the simulation expert to

the device designer, it’s never
been easier to access the power
of multiphysics simulation.
Va l e r i o M a r r a Because the human body is such an extraordinarily a physical prototype or in the human body is greatly
COMSOL complex system to model and such a hostile appreciated. Design challenges can be surpassed
environment for medical devices, their design must with ease when thousands of ideas are tested and
push the limits of technology. The adoption of measured before the first physical prototype is built.
multiphysics simulation can help bring devices to the The human body is an inherently multiphysics
market more efficiently while promoting innovation system where multiple physical effects influence each
and collaboration among specialists. other. Hence medical devices have to be designed
One of the key advantages simulation offers in that context to function properly and effectively.
is the ability to reduce physical prototyping. Multiphysics simulation allows for a high-fidelity
Challenging designs and new ideas can be built and modeling of devices and the systems they operate in.
tested in the virtual world of numerical simulation A real-world example involves a tissue ablation
without having to be physically constructed. In an problem. (See model above.) To successfully design
industry where safety is of paramount importance, such an ablation system, engineers have to take into
the capability to investigate different scenarios by account different electrical conductivities of tissues,
specifying boundary conditions, material properties optimize the delivery of electromagnetic energy within
and physiological mechanisms allows for early and the radio frequency and microwave range, and include
harmless correction of design mistakes. perfusion to predict the temperature distribution inside
Additionally, simulation measurements of and around the tissue being ablated. Multiphysics
any variable, such as temperature or flow velocity, simulation ensures successful device design by
can be taken at any point in a model, enabling a accounting for all of the important variables.
better interpolation of available experimental data. Designers, who have simulation expertise, often
Especially for medical devices, the fact that simulation find themselves in unique positions. In addition to
results can be accessed in locations where it would being able to simply adjust definitions of variables and
be impractical if not impossible to place sensors on values and rerun the simulation, they can also make
(ABOVE) Multiphysics simulation of tumor ablation. The localized heating of malignant tissue is achieved through the insertion
of a four-armed electric probe. This model couples the bioheat and electric field equations, and models the temperature field in
the tissue. Simulation example made using COMSOL Multiphysics software and provided courtesy of COMSOL.
Software_11-17_Vs4.indd 116 11/3/17 1:42 PM

This packaged simulation application published
through COMSOL Server allows users to calculate the
trajectories of platelets and red blood cells in a blood
sample as they travel through a filtration device. Results
show the electric potential, fluid flow distribution in
the filtration system, and the particle locations. App
example created with the Application Builder available
in COMSOL Multiphysics software and provided
courtesy of COMSOL.
experts in other disciplines, like physiology

and healthcare compliance.
Democratizing the use of numerical
simulation software for anyone through
the deployment of apps is another way
multiphysics simulation helps achieve the best
design possible. This lets specialists from a
variety of disciplines share their perspectives
and skills during the design process of the
next breakthrough technology in healthcare.
Multiphysics simulation can boost
your device design in many ways, the four
we discussed here are: 1) reduced need
for physical prototyping, 2) availability of
significant modifications to the model, even measurements of any modeled variable at
if they were to realize a phenomenon had not any point in a device and its surroundings, 3)
been included or a new material or condition high-fidelity modeling by taking into account
needed to be specified. However, with the any physical interactions as they happen in
shortage of simulation specialists, often the the real-world, 4) facilitating the collaboration
designer is an expert in the device being between simulation specialists and experts in
designed but not in the numerical methods and device design and other disciplines through
software needed to run a multiphysics model. apps. Multiphysics simulation has a lot to offer
Simulation specialists then find themselves the medical device industry, especially through
creating a bottleneck for innovation. the adoption of simulation apps bringing its
To remove this bottleneck and foster predictive power into the hands of simulation
a culture of collaboration, the simulation experts and device designers alike. M
specialists could build a user interface that
simplifies the use of a multiphysics model Valerio Marra is the marketing director at
by including only the input and output fields COMSOL in Burlington, Mass. He received
and reports needed by the device designer. his PhD in fluid machines and energy systems
Such a packaged simulation application, as engineering and his MSc in nuclear engineering,
shown above, would hide all of the modeling focusing on numerical methods for CFD.
details and show only the inputs needed for
the simulation to provide accurate results.
The app would only present the results and
reports that the designer is interested in and
could be shared with a large group of users
within an organization or even customers
worldwide. Such a group can go beyond the
device designer and include, for example,

SOFTWARE
How middleware is changing medtech
Medtech developers can take advantage of middleware

technology to gain a competitive advantage.
Two macro trends are affecting how medical devices development methodologies. This rapid time-to-
Tim Gee and systems are designed: adoption of off-the-shelf market translates to substantially lower overall product
Medical Connectivity (OTS) computing technology to extend the power and development costs.
Consulting
capabilities of traditional embedded system medical By integrating feature-rich modules into an overall
devices, and the evolution of software architectures that architecture, it’s possible to launch an initial product with
greatly extend the ability to reuse software. Both of these a substantially greater set of features. Once the modules
trends have driven adoption of messaging middleware in are integrated, virtually all product functionality comes
the design of medical devices and systems. from how the various modules are configured, rather than
As medical devices are transformed into networked adding to or changing the source code of the underlying
information appliances, medtech manufacturers look architecture. Consequently, product changes and
to these two trends when designing central stations, enhancements require less time and skill.
remote surveillance, data analysis & diagnostic report The trade-off for these benefits centers on changes
generation and information gateway products. Rather required by the manufacturer to effectively support
than design these products as embedded system the development of a product based on a messaging
devices, industry best practice is to use OTS hardware middleware architecture. These changes hit the engineering,
and commercial IT software architectures. A common quality and regulatory departments. The degree of these
architecture is messaging middleware. changes depends on how far along a company is on
Messaging middleware is an amalgam of various the journey to adopt commercial software development
software modules that use an enterprise service bus (ESB) methodologies for their non-embedded system products.
to integrate and manage the modules. Key modules The development tools and engineer skillsets differ
include a messaging engine, rules engine, interface substantially between embedded system software
engine, database, a web server and a data acquisition development and development using the commercial
module to integrate the manufacturer’s medical device computing platform software approach required by
data. The selection of specific modules – there are many messaging middleware. This change can require
to chose from – and the inclusion of any additional investment in tools, engineer training, and perhaps,
modules depends on the project’s market requirements. bringing in engineering resources with new skills.
A common example of this architecture is the Mirth The quality department will see new verification
Connect interface engine, which is designed around its testing requirements for messaging middleware
own ESB and includes messaging, rules, database and compared to embedded systems devices. Due to the
web server modules. A competitive patient monitoring substantial functionality available in these types of
central station has been developed using architectures, automated software testing, commonly
messaging middleware architecture. This used for commercial software, will have a big impact
product was developed in less than 12 on minimizing the common testing bottleneck for
months with seven engineers and received manufacturers’ product development process.
FDA clearance in less than 100 days using The final opportunity for change driven by
mostly open-source software. messaging middleware lies in regulatory affairs. There
Both commercial and open-source are several potential levers where messaging middleware
modules are available for building this based products can foster competitive regulatory
software architecture. Vendor support strategies, especially impacting sustaining engineering
is available for most of the open source (development after initial product introduction).
modules. Because messaging middleware is a mature
This approach impacts manufacturers technology, this transition is more about navigating
in a number of important ways. By successful organizational change across multiple
leveraging messaging middleware departments than it is about the technology itself. M
architecture, manufacturers can come
to market in a much shorter period of Tim Gee is principal and founder of Medical
time compared to conventional software Connectivity Consulting.

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STERILIZATION SERVICES
Comparing EO and VPA sterilization
As medtech advances, device makers need to consider sterilization methods

that won’t compromise electronics, drugs or biologics.
Matt Conlon The medical device industry has undergone syringes or drug-coated stents, the drug
REVOX Sterilization Solutions an impressive transformation over the last is also at risk. Heat can affect the active
several years, resulting in new and innovative pharmaceutical ingredient (API) or biologic
devices and solutions. As companies continue and impact the stability or pH, which
to innovate, they are finding that commonly threatens its overall functionality.
used sterilization methods impose limitations
in terms of efficacy, quality or production 2. Patient and employee safety
processes of many of the newer device The limitations outlined in the ISO 10993-
components (electronics), coatings (drug), or 07 standard set guidelines on how much
contents (drugs or biologics). New approaches EO can be left on medical devices. This
have the potential to overcome the constraints amount varies depending on the intended
of legacy sterilization methods. use of the device. There has been
particular attention to this issue in France,
The challenges of ethylene oxide where 85% of single-use sterile devices
Proper and thorough sterilization of medical in neonatal wards are sterilized using EO.
devices is critical. One of the most commonly Because of this, stricter regulations are
used sterilization methods is exposure to in the ISO proposal process to further
ethylene oxide (EO) to kill microorganisms. discourage the use of EO by requiring that
Though other methods come with their own manufacturers provide documentation
challenges, EO presents the greatest risk in of the rationale for choosing EO for
terms of patient and worker safety – and costs sterilization (as opposed to an alternate
associated with risk mitigation requirements. method) and quantifying and limiting
The following three areas are where aggregate (multiple products) potential
EO presents its most serious challenges to exposure to special patient populations,
medical device manufacturers: such as neonates. Due to the difficulty of
making these calculations (with potentially
1. Materials compatibility multiple products by the manufacturer
New materials for medical device being used on a single patient), most
manufacturing, such as biosensors, would prefer a “risk versus benefit”
bioabsorbables and electronics, are not approach. This enables the continued use
able to withstand heat- and humidity- of EO sterilization processes on critical life-
inducing sterilization methods such as EO. saving devices for which there is no other
Also, any chemical reactions that might commercially feasible sterilization method.
occur at higher temperatures and with The other side of this issue is the
humidity could create adverse chemical danger of EO to the health and safety
reactions that speed up degradation of the employees in the manufacturing
and corrosion of the device. In situations facility using it for sterilization. OSHA
where a drug or biologic is present has strict regulations around exposure to
during sterilization, such as with prefilled EO, which medical device manufacturers
Sterilization_11-17_Vs2-BP-FINAL.indd 120 11/3/17 1:30 PM

have to adhere to when using it in their facilities. If a manufacturer wants to switch to one of
For example, EO chambers must use blast- these novel methods, the change requires the
proof containment facilities and employees are product and sterilization process to be resubmitted
required to take extensive health and safety for 510(k) clearance. However, it makes the most
precautions. While protective measures are sense to consider these alternative methods if a
standard operating procedures whenever a company is designing a new product, is going
process/material presents danger to employees, through changes that will need to be submitted for
these precautions can become costly. Few FDA 510(k) clearance anyway or is planning new
manufacturers that do not already have manufacturing processes/sites.
experience with the risk and cost of on-site EO VPA can improve material compatibility
processing are willing to take on the regulatory and enable integration of less costly designs
and safety hurdles it brings. and materials by eliminating the use of heat for
sterilization, which can damage newer, heat-sensitive
3. Manufacturing efficiency materials such as sensors and biologics. Instead
While the sterilization process time itself varies of using heat, a proprietary peracetic acid (PAA)
greatly in accordance with the product being biocide is injected into a vacuum chamber at room
sterilized, every EO process requires temperature (18°C to 30°C) in vapor form, gently
pre-sterilization conditioning sterilizing the product with a total processing
and post-processing aeration time of two to four hours. The VPA process is
periods. This can add noncarcinogenic, nonexplosive/flammable, requires
significant time to no external ventilation and breaks down to H20,
the overall process, CO2, and O2 within hours.
ranging from several Additionally, although newer sterilization
days to weeks. methods, such as gas plasma and vaporized
Because of the hydrogen peroxide (VHP), have proven efficacy and
risks and costs utility for various applications, they do not offer
associated with commercial feasibility in the industrial sterilization
on-site EO space in terms of their throughput capabilities. With
sterilization, chamber capacities of up to eight pallets and short
roughly 75% processing times, VPA is now a commercially feasible
of medical alternative that may help manufacturers further
devices are sent reduce the risk in the risk versus benefit decision
out to contract tree. VPA can also be used as a valuable tool for
sterilization bioburden reduction for preterminal sterilization,
service companies. eliminating pre-sterilization bioburden fluctuation
Depending on and enabling lower terminal sterilization exposure to
the location of the whichever method is being used. M
sterilization facility and
the distribution logistics Matt Conlon is vice president and general manager of
of the product itself, this REVOX Sterilization Solutions.
can also add significant
transportation time and inventory
The REVOX 3000L VPA
requirements that will impact the cost
Machine could be an option of goods sold. On-site EO operations bring the
for medical device products associated costs of required risk mitigation.
that incorporate sensitive
electronics, drugs or biologics. VPA as an alternative
Novel methods of sterilization can include high-
intensity light/pulse light, microwave radiation,
sound waves, ultraviolet light and vaporized
peracetic acid (VPA).

STERILIZATION SERVICES
How to select a sterile barrier system

for a reusable medical device
Sterile barrier systems are key components in medical device
sterilization, so selecting the right barrier is essential.
Jason Pope Reusable medical devices, prior to use in healthcare takes advantage of the optimal sterilization offered by the
Nelson Laboratories facilities, must undergo validation testing to demonstrate barrier manufacturer; that’s because the manufacturer’s
the effectiveness of the cleaning instructions and the choice to include a 510(k)-cleared SBS in the medical
microbiocidal instructions that will be provided to the device sterilization instructions means the packaging
health care facility. Often, the microbiocidal process was subject to tests demonstrating the maintenance of
that’s validated for a reusable medical device is a set of sterility following exposure. That testing takes into account
sterilization instructions. Those instructions tell personnel any degradation that may result from exposure to the
performing the reprocessing how the device must be damaging effects of the sterilization process (e.g. the high
processed to correctly sterilize the device. The sterile barrier heat of steam sterilization or potential chemical reactions
systems that may be used to contain the device during with a gaseous sterilization process).
sterilization and storage after sterilization are an important When choosing an SBS cleared for the sterilization set-
part of the sterilization instructions. Medical device points to be used in the validation of the device instruction
manufacturers must choose an appropriate sterile barrier for use, we also are ensuring the use of a barrier that will
system (SBS) for the device prior to sterilization instruction allow for effective residue removal or package drying. Being
validation testing to ensure that the highest level of patient able to sterilize the device is not enough; to ensure patient
safety can be built into the reprocessing instructions. safety we must also be able to remove all toxic residues left
A sterile barrier system must allow for the following behind by the sterilant. In the case of steam sterilization,
activities during reprocessing: effective drying must be obtained to reduce the possibility
of an event occurrence that may compromise sterility.
• Achieve the appropriate sterility assurance level Finally, when choosing an SBS to contain a medical
(SAL): The SBS chosen to contain the device must device during and after sterilization, it’s important to consider
allow the sterilant to reach all areas of the device. the needs of the healthcare facility and personnel who will
• Prevent microbes from reaching the product use the sterile barrier. The medical device manufacturer
following sterilization: An SBS must allow for the can validate their sterilization instructions with an SBS
device to be safely stored by the healthcare facility that’s easy for healthcare personnel to use, which can
until the time when it is needed for use on a patient. improve the aseptic presentation of devices into the sterile
• Allow for residual sterilant removal prior to field. Additionally, by talking with healthcare facilities and
handling: Sterilant residues may be toxic (e.g. personnel, the medical device manufacturer can determine
residues from ethylene oxide sterilization) or may which barrier systems are cost-effective for the facility to use.
compromise the barrier properties of the SBS (e.g. There are many types of SBS, including wraps,
the resultant moisture of a steam sterilization process pouches, bags and rigid containers, so take the time
can compromise the SBS if not properly removed). to find one that’s the best fit for the medical device in
• Facilitate easy aseptic presentation: An SBS that question. By looking at these necessities and concerns,
allows for easy aseptic presentation reduces the the medical device manufacturer, when selecting an
possibility of contamination prior to patient contact. SBS to contain the medical device during and after
sterilization, can improve the safety to the patient and
Sterile barrier systems receive 510(k) clearance for specific help contribute to positive health care outcomes. M
sterilization parameters, making it important to choose an
SBS with clearance for the sterilization set-point required Jason Pope is a certified quality auditor and specializes
for validating the medical device. in providing consultations for clients about sterilization of
For example, an SBS cleared only for dynamic air reusable medical devices, endoscopes and pharmaceuticals
removal steam sterilization would be a poor choice for a and general sterilization validation process development.
device to be sterilized in a gravity displacement steam He has over 19 years of experience working in research
sterilization cycle. Choosing a system that’s cleared for and development, validation, and routine control of various
the sterilization cycle appropriate for the medical device sterilization processing modalities.

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TUBING
How to make kink-resistant tubing work

in smaller medical devices
Today’s implantable medical devices require bio-friendly

silicone that keeps fluids flowing even when space is tight.
Dan Sanchez Combining highly biocompatible silicone adding radial strength and reducing the
Tr e l l e b o r g S e a l i n g S o l u t i o n s with the elasticity and durability of nylon likelihood the tube will compress or kink.
creates a class of durable, crush- and KRT is ideal for long-term implantable
kink-resistant tubing that’s ideal for today’s devices, allowing fluid to flow from the
small yet highly complex medical devices. device into the body regardless of bodily
That’s because small is the name of the movement. The tube will stay open even
game when it comes to today’s implantable when the body moves and muscles flex,
medical devices, and tubing has to shrink keeping fluid transfer consistent in all
to fit them. The challenge is that silicone positions.
– the most biocompatible, durable and The tubing is also very useful in
flexible material for tubing – tends to kink implantable devices involving electrical
when produced in small sizes. connections, such as pacemakers. The
The solution is reinforced tubing, wires that carry the electrical impulses can
which allows significant reduction of the be safely placed inside the reinforced tube
bend radius of small silicone tubes. This with no concern that the tube will become
opens up design possibilities for long- compressed at the point of connection
term implantable devices, drainage tubes with the device.
and tubes that resist collapse under higher Tubes that deliver fluids such as drugs
vacuum pressures. into the body – or remove them from the
body (blood, spinal fluids, urine) – can also
What is kink-resistant tubing (KRT), and benefit from reinforcement. For example,
how is it used in medical settings? cerebral spinal-fluid shunt systems involve
In the medical world, silicone tubes are a tube that must go straight into the skull
made kink-resistant by reinforcing them but take a sharp turn after leaving the
with nylon 66 monofilaments in a double- body. Reinforcement can ensure consistent
helix configuration. The monofilaments fluid flow and improve the surgeon’s ability
are embedded within the wall of the tube, to push the tube into the cranial opening.
Tubing_11-17_Vs2-CN-FINAL.indd 124 11/3/17 1:34 PM

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TUBING
Finally, reinforced tubes are an excellent Combining highly biocompatible silicone

choice for wound drainage involving a with the elasticity and durability of nylon
vacuum (negative-pressure wound therapy). creates a class of durable, crush resistant,
The same nylon configuration that creates kink resistant tubing that is ideal for today’s
kink resistance makes silicone tubes resistant small yet highly complex medical devices. M
to collapsing under pressure.
Dan Sanchez is a product manager for
What design considerations are relevant Trelleborg Sealing Solutions – with 19
to KRT? years of experience in silicone component
There are four main concerns when manufacturing for the healthcare and
considering KRT in a small medical device: medical industry, specializing in process
development of silicone extrusions.
1. Silicone is highly biocompatible, but
the nylon used in KRT is not. In some
instances, the manufacturer may need
to prove that the reinforcement will not
come into contact with the body in order
for the tubing to be used.
2. The nylon monofilaments used to create
KRT are encapsulated in the silicone
walls but not chemically bonded to
them. Thus, if the tube is unattached
at one end, that end may need to be
sealed (using a secondary process) to
ensure the relatively sharp ends of the
monofilaments don’t come into contact
with the body.
3. Nylon can degrade when exposed
to high heat, so KRT is not an option
for devices that will be subjected to
an autoclave or used during ablation
procedures.
4. The potential length of reinforced
silicone tubing depends in part on its
diameter. Current technology allows
reinforced silicone tubes to be produced
in sizes from 1⁄16 in. to 1/8 in. inner
diameter. The tube wall must be built on
a mandrel while the nylon spiral is being Image courtesy of Trelleborg Sealing Solutions
created, after which the mandrel can be
removed. This step is difficult for long
tubes, particularly those with large inner
diameters. The surface area’s contact
with the silicone enlarges significantly as
the mandrel increases in size, increasing
friction and the difficulty involved in
removing the mandrel.
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VALIDATION & TESTING
Validation and testing:

What you need to know
In an increasingly competitive medical device industry, it’s still important that

validation and testing is done right. Here are four things to keep in mind.
James Woods Medical device industry leaders these days are driving actual use conditions. It is also generally
Jordi Labs results at an ever-increasing pace. Amid patent limitations, good practice to go a little on the stronger
intense competition and acute regulatory scrutiny, there’s a side of the simulated use condition with
rush to get results that demonstrate safety and efficacy. temperature, time or solvent to effect a
Jordi Labs (Mansfield, Mass.) is a contract research lab greater margin of safety. Additionally, to
that’s frequently tasked with meeting these needs while simulate the use conditions, it may be
maintaining a high degree of confidence and scientific necessary to design custom extraction
certainty. Here are four basic recommendations we have equipment and validate novel analysis
when it comes to validation and testing: techniques to ensure results are the best in
terms of accuracy and scientific certainty.
1. Understand the testing regulations and guidance
Validation and testing, particularly for regulatory 2. Pay attention to details
studies, is best prescribed by carefully considering the Sometimes simple things like the wet
regulations and guidance relevant to your test article. chemistry required for sample preparation
Each project has unique requirements, whether the are overlooked while using advanced
test article is a medical device, a bioprocess system or instrumentation. Whether it’s digestion for
a combination device. Additionally, understanding the ICP-MS, volatiles analysis or concentrating
relevant background information is critical. Two key a sample, the steps immediately prior to
questions are 1) What is the test article composition? the analysis often play a critical role in the
and 2) How is the test article going to be used? veracity of results. What seems like a slight
Answering these enables you to conduct testing modification to the sample preparation may
in a way that produces results representative of the pivotally alter the accuracy of an assay. This is
why any modifications should be validated for
accuracy, precision and intermediate precision.
Image courtesy of Jordi Labs

3. Choose your instrumentation wisely
Although sample preparation is the foundation
of any good analysis, it’s also important to
use the latest advanced instrumentation,
such as high-resolution mass spectrometers.
High-resolution mass spectrometers, in
conjunction with comprehensive compound
libraries, allow unambiguous identification of
chemical species. Once a chemical species
is correctly identified, accurately quantifying
the species is the next concern. Species
like oligomers, reaction intermediates and
process degradants can be particularly
challenging to quantify – especially when
they’re not commercially available. When
they are commercially available, or when
Validation_Testing_11-17_Vs2-CN-FINAL.indd 128 11/3/17 1:38 PM

using a surrogate standard, consideration should a careful understanding of the applicable regulatory
also be afforded to selecting the right detector framework for a medical device.
for a compound. When you’re trying to maximize
a method’s accuracy, it is important to remember In summary, there are a few key features we’d like
that there are tradeoffs between detectors like to emphasize in a successful validated analysis.
UV/Vis, CAD, ELSD, IC and QTOF or QqQ MS. Understanding the background information for your
These tradeoffs can drastically affect validations for medical device is the foundation of study design. Pay
parameters like specificity, accuracy and precision. attention to details as you perform your analysis because
minor changes frequently have a significant effect
4. Understand the regulatory framework on your results. Using advanced instrumentation can
Regulatory guidance providers – including ICH, the reduce unanswered questions, but it’s also important to
FDA, the EC as well as standards providers such as understand the limitations of your instruments. A firm
ISO, USP, and ASTM – have some general consensus understanding of the regulatory guidance is required to
on concepts. But there are frequently significant avoid analysis pitfalls and potential costly regulatory delays.
differences in details. One set of guidances could Finally, a strong focus on patient safety should be the
spell out minutia like the number of replicates, bedrock upon which all decisions are made. M
extraction ratios, and acceptable time, temperature,
and solvents while another may leave them nebulous James Woods is a senior research scientist at Jordi
or open to selection. Navigating this guidance to Labs (Mansfield, Mass.). He has a demonstrated history
determine parameters like precision, intermediate of working in the chemicals industry, with a PhD in
precision, accuracy and robustness frequently requires chemistry from Carnegie Mellon University.

How to work with a

preclinical contract research organization
When outsourcing medical device laboratory testing, knowing

what the regulatory and business requirements are up front is
critical to the success of your testing program.
Amy A. Schade Requests such as unusual application of technical the intended use of the data (e.g. are you
Felice Randi LaMadeleine or regulatory guidelines, shortened timelines, submitting to a regulatory body?), and reports and
J. Heléne Andersson
To x i k o n nonstandard study designs and custom reports are information from any previous studies performed.
common reasons why medical device testing does not Inform your CRO as soon as possible when there
go as planned. are any changes, particularly in regulatory timelines.
The sponsor can help minimize risk of deviations
and delays by avoiding such requests and by fostering 4. Fulfilling your own responsibilities
a collaborative relationship with the contract research Doing your part is an important element of
organization (CRO) through open communication. ensuring success. The personnel who interact
Here are five basic steps to apply to your with the CRO should be trained in appropriate
outsourced testing programs: technical procedures and regulations. When
information is requested by the CRO, be prompt
1. Selecting the vendor and thorough in your replies. Provide information,
To ensure that you select the right CRO, perform materials and documentation quickly and as
a thorough vendor audit before placing work. agreed. Make sure to review all documents
Schedule a visit to discuss capabilities, meet thoroughly and ask for clarification if there are any
critical staff, understand their quality systems and concerns, before signing.
get comfortable with the new relationship. Ask to
tour the facilities and review the CRO’s standard 5. Listening to the experts you hired
operating procedures in order to ensure their When hiring a CRO, take advantage of their
processes meet your requirements. Request copies expertise and experience. Allow the CRO to use
of certifications and regulatory inspection history their standard procedures as much as possible,
to support compliant testing. as they have been developed to meet technical
and regulatory requirements as well as industry
2. Setting expectations standards. If you require a CRO to use customized
Once you’ve selected a vendor, collaborate to processes, the likelihood of deviations and delays
set expectations. Be clear before starting work may increase.
about items such as expectations for timelines,
report style, data sharing and frequency of In closing, the single most important thing you can
communication between sponsor and CRO. do is to communicate well. Consider the CRO’s
Request sample reports ahead of time to have suggestions and recommendations carefully. Provide
visibility to report content and data interpretation complete information promptly when requested.
expectations. If you have specific requirements Be clear with expectations of quality, access and
for report formatting, analysis or other content, it deadlines. Good communication on both sides of the
should be communicated up front to avoid delays. partnership will help to ensure the success of your
outsourced testing. M
3. Sharing information
Share as much information as possible with Amy A. Schade (RQAP-GLP) is director of corporate
the CRO, particularly when it comes to the compliance, and Felice Randi LaMadeleine (RQAP-
characteristics of your test materials, all GLP) and J. Heléne Andersson (RQAP-GLP) are quality
communication you have with regulatory agencies, assurance managers at Toxikon (Bedford, Mass.).

Simplifying product testing and validation
with fastener torque auditing
Capturing data during a product’s manufacturing process can help

ensure the quality and consistency of that product. Here’s how
that process plays out with fastener torque.
Thomas Moore One of the scariest phases of product design is lead to the premature failure. For instance, a bolt that has
FUTEK testing & validation. That’s when any unknown flaws or too little preload applied will transmit less stress than its
manufacturing defects will see the light of day. As you’ll neighbors, overloading them and leading to premature
see, you can eliminate the unknowns by performing failure. Bolts with too much preload, on the other hand,
something as simple as measuring and recording can damage structures or overly elongate. The latter
fastener torque. effect results in an eventual loss in bolt preload over time.
Ensuring that your product meets An improperly torqued fastener also affects more than
manufacturing standards, operates consistently just load distribution; it can also affect seal integrity.
and does not fail prematurely is no easy task. Gaskets and seals require sufficient bolt preloading
Customers, regulatory bodies and internal quality on the fasteners holding them in place. This ensures the
control each have traceability requirements that gasket meets the desired service life of your product;
must be satisfied. How do you satisfy the needs of otherwise, failures can occur. For instance, too much
these various groups? The answer lies in providing preload will result in premature gasket collapse, while too
data that your product meets specifications. little preload results in a weak or nonexistent seal.
Although there are many design aspects to focus How do bolts receive the incorrect preload? This
Electric
Nut Runner on, for this article we’ll concentrate on the literal issue can be traced back to unexpected friction in the
“nuts and bolts” of your system by addressing the assembly process and the incorrect application of torque.
effects of fastener preload and how to solve the Solving this problem requires you to measure the applied
problems that may arise from incorrect preload. torque and fastener preload and use that to determine
Why focus on the fasteners? Your product’s the friction in your system and calculate the correct
structure relies on its fasteners to distribute amount of applied torque.
loads. An incorrect
preload applied to 1. Capture bolt preload. A complete measurement
a fastener can solution requires two sensors, one to measure bolt
loading and another to measure applied torque.
Measuring bolt loading requires a sensor that allows
Rotary the bolt shaft to pass freely through the sensor
Torque Sensor
while measuring the force the bolt head applies
Computer
as the fastener is torqued down. These sensors
go by different names, such as through-hole load
cells, load washers or donut load cells. The sensors
Load Cell
USB Hub aren’t limited to bolt load auditing; they can also
be permanently installed to monitor gaskets and
seals. This enables the monitoring of the changes
Fastener USB DAQ in preload due to gasket fatigue and hardening,
allowing you to anticipate and replace the gasket
before failure. With this in mind, the next step is to
measure applied torque.

2. Measure applied torque. Torque

measurement can be as simple as using a Medical device cybersecurity –
strategies for verification and
torque wrench with a digital display or a
strain gauge based reaction or rotary torque
sensor. The latter can be connected to a
digital display and data-logging solution to
automatically capture the torque the operator
validation
is applying to each fastener, or integrated into
automated assembly systems for live torque
feedback and monitoring. The sensor that will
work best for you will depend on the accuracy Cybersecurity is becoming an essential pillar
you need and demands of your application.
Once you have a torque and bolt-loading of medical device design, and it’s important
sensor selected, you can derive the friction in
your system to make an accurate calculation to find the right strategies to validate and
of the torque you need to apply. verify your products are secure.
3. Derive fastener friction and determine
appropriate torque values. Friction
derivation is quite simple. You install the
bolt-loading sensor between your structure M i c h a e l Ly n c h The growth of connected environments
and the fastener. The shaft of the fastener Delmar Howard has put medical devices at the forefront of the
Intertek
then passes freely through the sensor with the cybersecurity and patient data movement. As
head of the fastener resting against the active more of these devices are brought online there
sensor area of the transducer. You then torque is an increased risk of hackers looking for targets
the sensor down measuring both the applied that have, in the past, had a very lax standard for
torque and resulting bolt loading. These tests security. As shown by several high-profile exploits,
are repeated until you receive consistent the industry appears to still be catching up when
torque and bolt loading values. To calculate addressing security concerns.
friction for your system, you then input your Fortunately, there are many industry
torque and bolt loading values and use a guidance documents available, but sorting
torque equation such as the Farr Screwjack through them and identifying the most
Equation or Motosh Equation. effective can be daunting. Almost all directives
from the FDA concerning cybersecurity are
Once you have friction calculated, you can then nonbinding, which can make it difficult to
determine the necessary torque required to confidently identify the most effective way to
achieve your requisite bolt loading. You then implement a verification and validation process.
combine this precision torque value with torque The exception is the premarket submission
sensors during manufacturing to verify that process, which requires documentation on how
each fastener has received the correct amount cybersecurity is implemented.
of torque and logging it. The captured data is For many device manufacturers, the
used to ensure the quality and consistency of difficulty is not only in identifying standards
your manufacturing process to your customers, to follow but which apply to their specific
regulatory agencies and any standards bodies you product. Ensuring the chosen framework can
may encounter. With the data in hand, validation scale as the device is updated and changed
and traceability will no longer be a nightmare. M is also a challenge. Updates – or a lack
thereof – can be challenging because of the
Thomas Moore is an aerospace engineer working possibility of introducing new vulnerabilities.
for FUTEK Advanced Sensor Technology. He has Cybersecurity is rarely a rigid checklist that
worked on multiple projects including a miniature applies to all industries. In many cases, third-
CubeSat attitude control system and an air braking party help is required given the large number of
system for small-scale sounding rockets. complementary guidance documents available.

Image courtesy of dreamstime.com
NIST Framework has equal consideration in the

One of the most comprehensive design phase. While IEC 62304
guidance documents available is doesn’t identify specific tools to use;
the Framework for Improving Critical it provides a robust framework for
Infrastructure Cybersecurity published verification and validation throughout
by the National Institute of Standards the software development process.
and Technology (NIST). This is one of Ongoing cybersecurity risk
the most effective documents to lay the assessments and static analysis are key
groundwork for cybersecurity implementation. ways to help mitigate zero-day-style exploits on
The “Identify, Protect, Detect, Response & Recover” hardware and software. This is especially important
framework core is referenced throughout the industry and within environments using Software of Unknown Provenance
allows device manufacturers to consistently identify gaps in (SOUP). When devices enter a hospital environment, they
their processes through risk-based implementation. can be placed somewhere not specifically intended for
Utilizing an Information Sharing & Analysis Organization them to operate. Testing within a mixed interoperability
(ISAO) can help gather and identify industry threats and can environment can help mitigate some of these issues through
be an effective solution for keeping a baseline of security better understanding of various connections and network
throughout the design and post-market cycle by leveraging features common in a real-world environment.
the overall knowledge of the group. Participating with an For example, Intertek has created virtual offices that
ISAO also helps meet the FDA guidance on postmarket include several hundred unique devices that can emulate
cybersecurity. a live hospital environment. With large-scale emulated
environments, it is easier to test patches and identify
Medtech regulations potential limitations without subjecting customers and
There are many regulations that medical devices must adhere patients to potential harm.
to. The E.U.’s General Data Protection Regulation is one of the • Hardware: Addressing hardware security during the design
most stringent, requiring immediate action. Effective May of & development phase goes well beyond simply testing and
2018, the GDPR will change from a directive to a regulation, validating. Hardware has the disadvantage of not being
which is a stronger form of legislation. Some of the key able to be updated easily once delivered to a customer.
considerations for medical devices are breach notification – in To combat this, it’s essential to avoid activating ports that
which users must be notified of a breach within 72 hours – and are not required to function and ensuring each piece of
privacy by design, requiring privacy considerations when a hardware has a unique ID and login implementation.
product is designed. Both requirements align with generally Additionally, it’s critical to make sure features not in use are
effective cybersecurity design practices and should be part of either disabled or removed from the device, prior to it being
the ongoing validation and review process. introduced to a live environment, especially when outsourcing.
In its final premarket guidance, the FDA is now looking for Some hardware chips can be activated using physical access
a cybersecurity plan, as well as data to back it up. Specifically, and, in rare cases, can be activated through software.
device manufacturers must identify cybersecurity risks, provide The UL-2900 standards are a good starting point;
a traceability matrix and give a summary of controls created in however meeting all of the requirements requires already
the design of the device. having an effective documentation and validation process;
it’s a good guideline for internal teams to work toward
Verification & validation before opening up for a third party audit.
After considering the applicable guidance and regulations for
a device, it’s important to conduct verification and validation Increased breaches revealing personally identifiable information
activities to illustrate security is in place. When running have made designing security into medical devices and their
verification and validation on connected medical electrical accompanying software required for all 510(k) submissions to
equipment, it’s important to take a two-prong approach, the FDA in the U.S. and through regulations such as GDPR in the
examining both the software and hardware of a device: E.U. Having an effective validation and verification plan during
the design phase has been a requirement for bringing medical
• Software: Medical device manufacturers spend large devices to the market for 20 years. Adding cybersecurity to that
amounts of time on hardware development, but software plan is essential for any connected device. M
development is less structured. Manufactures should
include robust requirements for validation. The adoption of Michael Lynch is managing consultant and Delmar Howard is
IEC 62304 is a good start to ensure that software validation performance testing program manager at Intertek (London).

How to design a successful

Claret
Medical’s
embolic protection
Sentinel
device,
cleared by the
devices clinical trial
FDA this year,
trapped micro
debris in 99%
of cases.
Image courtesy
Embolic protection devices could reduce risks
of Claret
Medical
of interventional cardiac procedures such as
TAVR, but their efficacy is hard to prove.
David Novotny The embolic protection device (EPD) market is Assessments of valve severity, comorbidities and mortality
Novella Clinical expected to grow into a billion-dollar industry if the risk all must be done prior to the procedure. Knowing
device becomes the standard safety protocol for the dosing of certain medications or existence of carotid
transcatheter aortic valve replacement (TAVR) and other stenosis, for example, is necessary to determine later if
interventional cardiac procedures. However, EPD tech these factors had a role in any post-procedure strokes.
has found limited success in clinical trials. TAVR-EPD study patients must also have had stable
One potential reason is that even with well-designed health for 30 days before undergoing the procedure.
devices, efficacy is difficult to demonstrate. EPDs are
engineered to catch or deflect debris loosened during 2. Have committed site teams. Because EPD trials require
TAVR procedures away from cerebral arteries. By and more time and resources than typical device trials,
large, they do a good job: Claret Medical’s Sentinel device, manufacturers should select sites that have a history of
cleared by the FDA this year, trapped micro debris in 99% dedication to patient enrollment and retention. One
of cases. However, in its pivotal trial, the data did not reason for this is the recent expansion in the U.S. and
conclusively show it improved patient outcomes. the E.U. of TAVR indication to include intermediate-risk
Transcatheter aortic valve replacement, a widely individuals. Sponsors will need to document and evaluate
popular alternative to surgery for high-risk patients, patient health carefully to ensure that study participants
carries a small but serious risk of stroke, cerebral lesions match the characteristics included in the expansion. The
and increased risk for neurological complications team should include not only cardiology and imaging
associated with debris blocking a cerebral artery, specialists, but also geriatricians, heart failure experts,
according to a study published in November 2016 in the stroke neurologists, electrophysiologists, anesthesiologists
American Journal of Cardiology. and behavioral specialists. The best patient outcomes are
Deploying an EPD during the procedure should, in theory, most likely achieved with a committed, organized and
reduce that risk. An estimated 300,000 individuals worldwide multidisciplinary team both in study settings as well as in
have received TAVR, according to Future Market Insights. The post-approval commercial use of the devices.
growth in the TAVR market has, in turn, grown the EPD market
potential. As of August 2017, three EPD devices had E.U. 3. Use precise definitions. In past trials, strokes were often
market clearance and one (Sentinel) achieved FDA clearance. determined based on clinical symptoms alone. However,
To capitalize on this commercial potential, future devices must the Stroke Council of the American Heart Association/
optimize their clinical studies to show their efficacy. American Stroke Association (AHA/ASA) now provides
Here are a few best practices EPD manufacturers must instructions on how to address the inclusion of clinically
apply to design a successful trial that demonstrates the silent brain lesions as endpoints and how to accommodate
lifesaving potential of these technologies: changes in imaging technology. Should a silent stroke that
is captured by magnetic resonance techniques actually
1. Determine appropriate patient populations. TAVR count as a stroke? Including such imaged events, the AHA/
has become a standard option for high-risk patients ASA cautions, could “unnecessarily inflate the assessment
with severe aortic stenosis because it’s equally as safe as of risk of those procedures without a measurable clinical
surgery and minimally invasive. But when determining advantage to doing so.” M
which patients should be chosen for a TAVR-EPD trial,
sponsors must bear in mind that recruitment procedures David Novotny is SVP of the Medical Device & Diagnostics
are more challenging than other cardiac device trials. Division of Novella Clinical (Morrisville, N.C.).

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WHERE MEDICAL DEVICE CONNECTIONS

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How virtual tubing model analysis

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