www.medicaldesignbriefs.

com July 2022

Insights: Improving Device Manufacturing

Trends in Extruded Engineering
Adhesives Testing for
Wearables

SPECIAL SECTION:
Technology Leaders in
Motors & Motion Control
 

 

 

   
 
  

 
 
   

  

 

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©2019 Intuitive
Surgical, Inc.

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 July 2022

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n COLUMN n SPECIAL SECTION

4 From the Editor Technology Leaders in Motors & Motion Control
21 Advanced Motor Technology Enables Medical Exoskeleton for
n FEATURES Rehabilitation
6 Finding a Manufacturing System Upgrade to Match In-House 23 How to Select Motors to Address Biologic Drug-Delivery
Innovation Challenges
14 How These Engineered Extrusion Trends Can Improve
Device Design and Patient Experience
39 How Automation Can Improve Tubing Manufacturing n ON THE COVER
Hoses and tubes are extensively used within the
n TECH BRIEFS healthcare and medical industry in a variety of appli-
cations, from wound drains and catheters to drug
33 ‘Bionic’ Pacemaker Reverses Heart Failure delivery and feeding tubes. Technology has moved
34 Peeling Back the Layers: Adhesives Testing for Wearables far beyond the production of single, hollow tubes to
36 Joystick-Operated Robot Could Help Surgeons Treat Stroke multilumen extrusions that can incorporate stops,
Remotely bumps, and varying thicknesses in a single design.
Significant benefits can be achieved by taking advan-
tage of innovative manufacturing processes and the
n DEPARTMENTS latest material options. To facilitate the specifica-
31 R&D Roundup tion of these streamlined yet complex extrusions, key factors need to be
considered. Read the article on page 14 to learn how these factors and
41 New Products & Services material options can reduce device developers’ total cost of ownership
44 Advertisers Index while increasing component integrity.
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2 www.medicaldesignbriefs.com Medical Design Briefs, July 2022

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 Spurred by Post-COVID Slump, Zall says that the digital health sector — “During the height of the pandemic,
­Digital Health Firms Dive Into M&A which includes mobile health apps, wear- there was a lot of investment in biotech
able devices, telehealth technologies, and and digital health technologies, which

A s global markets cool, there are signs

that a new round of consolidation may
be starting in the digital health sector, ac-
electronic health records — has slumped
this year after a robust period during the
height of the COVID-19 pandemic. That
cording to Richard Zall, chair of law firm slump, he says, is spurring a trend of smaller
King & Spalding’s healthcare transactional digital health companies seeking M&A op-
and regulatory practice. portunities with larger players.
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were viewed as being very important when
people couldn’t go to a doctor’s office or
hospital due to COVID,” says Zall. “That
led to a wave of innovation — the use of
telehealth, for example, dramatically in-
creased. Many digital health companies
were raising money easily, growing quickly,
and spending their money quickly.”
But in 2022, he says, those valuations
have come back down to earth, and “a lot
of companies and investors are pleased to
see it because some of the valuations
weren’t realistic. While there is still a lot of
activity and interest in digital health tech-
nology, the capital investment environ-
ment has been impacted, so that the sourc-
es of capital — the public markets or
private equity or venture capital — have
definitely slowed, both in the number of
deals and the amount of investments.”
Zall says that smaller digital companies
are saying, “let’s cut our burn rate or we
may not get the capital we need to contin-
ue or expand. Or rather than expand to 10
markets, let’s go out to three markets, or
let’s perfect 2.0 of this product and not go
so fast to 3.0 because we don’t have the
money to go to market and hire people,
and the like.” The cooling market hasn’t
led to these companies going out of busi-
ness, but it has led to there being a slower
growth and more M&A, says Zall. The
companies that are well funded are being
approached by the smaller companies that
might have a product or two but only
raised $5 million or $10 million and are
running out of money and may not have a
runway to be cash-flow positive and com-
mercialize their product. They are starting
to look to join forces as they’re not sure
they’ll make it through 2022. That is spur-
ring some smaller digital health compa-
nies, as they burn through cash, to seek al-
liances with larger players in the field.
Despite this, Zall says interest in this sec-
tor remains. “There are many start-ups and
growth companies sprouting up offering
VascuLathe new digital technologies. And there’s still a
fundamental belief that digitizing is a wel-
come development in healthcare. It is
viewed as a way to reduce costs, make
healthcare more accessible, and give con-
sumers more information and more sway
in deciding what works for them,” he says.

Sherrie Trigg
Editor and Director of Medical Content
4 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
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dical Design Briefs Laserturn Vasculathe Halfpg Island Ad 1.2022.indd 1 1/20/2022 8:58:25 A
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 Finding a
Manufacturing System
Upgrade to Match
In-House Innovation

Elekta, headquartered in
Sweden, pioneered
precision radiation
medicine for cancer care
with precise and
individually tailored
radio­therapy treatments.
(Credit: Shutterstock/
Mark Kostich)

R
adiation medicine pioneer Elekta is
growing fast. In anticipation of regula-
tory changes requiring more docu-
mentation and labeling, the company
implemented a manufacturing execu-
tion system (MES) at three of its sites, one each in
Europe, the UK, and China. The company imple-
mented a manufacturing execution system (MES)
at the three sites before regulatory changes went
into effect that required more documentation
and labeling. One facility is processing nearly 35
percent more manufacturing order lines per
Elekta’s Priorities
Elekta, headquar-
tered in Sweden, pio-
neered precision radiation
medicine, revolutionizing can-
cer care with precise and individually
tailored radiotherapy treatments. As a leading
innovator for equipment and software used to im-
prove, prolong, and save the lives of people with
cancer and brain disorders, Elekta focuses on im-
proving access to high-quality, cost-effective can-
cer care and advanced treatments for patients
Name/Shutterstock.com

month than it did four years ago, without increas- worldwide.

ing the number of employees. They have already The company’s products include a compre-
saved $85,000 in archiving costs over four years hensive range of advanced treatment delivery
and expect $850,000 in savings over the 20-year systems for personalized radiation therapy and
storage period. Elekta has also reduced its time to radio­surgery. With nearly 4,000 employees world-
implement an engineering change to a work in- wide, it has products operating in more than
struction by about 97 percent. 6,000 medical facilities.
6 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
 Elekta’s Crawley factory. (Credit: Elekta)
In 2017, Elekta looked into the busi-
ness benefits of implementing a modern
MES. It used the simple equation that
to increase the value of the devices
it provided, it needed to raise
quality while reducing costs (see
Figure 1). Elekta already had
strategic priorities defined for
its business, including:
• Elevate customer
experience.
Name/Shutterstock.com
• Act as an innovation
leader.
• Continuously improve
its processes.
• Sustain a competitive
cost base.
• Live its values.
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 7
Obstacles Between Elekta and Its
Goals
Prior to implementing the new MES,
Elekta’s existing production systems pre-
vented the company from reaching its
potential and presented risks for the fu-
ture. The company used paper-based de-
vice history records (DHRs), manual
checks for compliance, and paper work
instructions with no electronic process
validation.
Audits, and the interruption to pro-
duction they create, were a top concern.
The manual audit process was costly,
prone to human error, and reduced pro-
duction efficiency. One product, a medi-
cal linear accelerator called Linac, re-
quired some 800 manual signatures and
Manufacturing System Upgrade

Mark Kaak, Elekta’s vice president

of global manufacturing, says, “We re-
How to drive value? viewed several MES suppliers. We se-
lected Critical Manufacturing, [an MES
provider based in Portugal], because
• Adherence to guidance they have excellent reporting. The com-
• Outcome measurement pany is flexible and willing to partner
Quality • Automation and standardization to ensure we get the solution we need
over the long term. It also scored highest
Value = overall in our evaluations.”
Other requirements Elekta specified
for the MES included:
Cost • Process management
• Internet accessibility.
• Performance metrics • User-friendly, configurable graphical
• Actionable insights user interface (GUI).
• Automation • Ability to interface with other business
systems, including enterprise resources
management (ERP), product life cycle
Fig. 1 – Elekta’s equation for MES value focused on quality and cost improvements management (PLM), and customer
life cycle management (CLM).
• Data flow to Elekta data warehouse.
• Easy updates to system programming
that could be performed by Elekta per-
sonnel for rapid changes.

MES Integration Rollout

Because of the MES, Elekta can now make products to order, optimize inventory, and readily share
best practice business processes. (Credit: iStock/Nikolai Mentuk)
produced 1,200 folders a year that the
company needed to store for 21 years.
Further, manual methods and paper
records did not provide visibility into
processes and inhibited data analysis for
continuous process improvements. As a
result of these inefficiencies, products
had long lead times.
Evaluating Modern MES Options
Elekta envisioned a new MES to sup-
port its business priorities. Specific im-
provements were needed in quality con-
trol, manufacturing lead times, supply
chain performance, lean manufacturing,
and employee engagement (see Table 1).
Elekta’s “must have” criteria for MES
solutions included:
• Rapid and faultless execution of
production processes.
8 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
• Electronic device history records
(eDHR).
• FDA compliance.
• Complete tracking and traceability.
•F lexible and configurable process/
line setup with easy adjustments.
• Copying of configurations.
•D igital work instructions in multiple
formats, not just PDF.
• Integration of employee certification.
• Manufacturing process records.
• Localization, such as the ability to
use Chinese characters for the plant
in China.
•A single solution and interface for one
way of working across all sites.
Elekta conducted a thorough evalua-
tion of several MES providers to the
medical device market to meet these
requirements.
Elekta rolled out the new MES across
three sites: Veenendaal in the Nether-
lands, Crawley in the UK, and Elekta Bei-
jing Medical Systems in China. As part of
the project requirements, the implemen-
tation needed to be agile for phased intro-
ductions. The modularity and scalability of
the MES allowed Elekta to deploy a single
instance at the three sites over time at a
rate to suit the company’s business goals.
The total elapsed time from specifications
to the third site’s go-live date was one year.
“We started with Veenendaal because
it has a complex, job-shop-style produc-
tion layout with 1500 different products
moving across 50 stations. The project
went exceptionally well. Critical Manu-
facturing met all of the project sprints
on time. We implemented the first plant
in eight months, the second in nine
months, and the third plant in China in
12 months. In fact, it was hard for us to
keep up with testing all the delivera-
bles,” says Kaak (see Figure 2).
Engineers spent over a year configur-
ing the system for each product, includ-
ing entering all the work instructions
into the MES. However, maintaining
those configurations in the MES requires
less than two people who also have other
responsibilities, so those employees re-
ported a noticeable decrease in frustra-
tion and improved user experience with
the new system.
 Start Finish
19.06.2017 13.07.2018

Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
2017 2017 2017 2017 2017 2017 2018 2018 2018 2018 20180 2018 2018

Veenendaal

Crawley

EBMS

MES Requirements MES Core Integration VN Ready for VN Crawley Crawley EBMS Ready for EBMS
Specification Concepts Specification UATs Go Live Ready Go Live UTAs Go Live
Review Training for UATSs

Fig. 2 – The one-year implementation timeline for the three sites: Veenendaal, NL (VN); Crawley, UK; and Beijing, China (EBMS). UAT = user acceptance tests.

Richard Eweg, manufacturing engineer
and MES champion at Elekta, reports:
“Getting new products into the system is
quite positive. It went from 20 hours over a
few months to five hours in one day. You
can build up the work instructions and
flow structure, prepare it completely, and
do a dry run to test it. When it looks right,
and we’re ready to switch from an old to a
new one, everything is ready. Once it’s live,
we can easily see which steps are in the
flow and the work instructions for that step
for that item.”
Engineers are one of the five groups of
users for the MES, which also includes

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Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 9

Manufacturing System Upgrade

managers, operators, planners, and quali- products, processes, specifications, and at- The MES also provides a flexible, con-
ty personnel. Managers and quality per- tributes. In a single window with real-time, figurable dashboard to report on key
sonnel are particularly pleased with the up-to-date data, operators and engineers performance indicators (KPIs). For
new level of information, control, and can click to go deeper and gain new in- Elekta, real-time KPIs include:
visibility into the factory. Operators faced sights. Advanced analytical capability trans­ • Number of units to produce.
a few challenges at first that the engineers lates masses of real-time shop floor data • Actual value-added time versus planned
corrected. Now, operators also see bene- into accurate intelligence to enable them cycle time.
fits of the system. to optimize and make strategic decisions • Standard hours per the ERP versus ac-
in manufacturing, quality, and for the wid- tual labor hours.
A Single Truth er business. For example, Elekta can now • Production capacity in working em-
Elekta saw benefit from the new MES in confidently price products to ensure prof- ployees and available employees.
having a single system collating and contex- itability without making products too • On-time, in full (OTIF) completion of
tualizing data from all manufacturing areas. ­expensive. orders — MES cannot close incom-
Prior to using the MES, the company had a Eweg reports, “Before, we made a plete orders.
dashboard to see operations; however, that guess and measured with a stopwatch to • Cost of quality.
view was not based on real-­time informa- see how much time a step takes. Now • Wait time between steps.
tion, and operators could not “dig deeper” MES keeps track of everything, and it is
into any collected data. easy to report out the detail of how much Broad-Based Visibility
By installing the new MES, Elekta gained time it takes for each step and produc- Kaak says, “The Critical Manufactur-
enhanced visualization and control of tion order.” ing MES offers user-friendly interfaces
with graphical overviews of processes per
item with cycle times and standard
hours. The system provides comprehen-
sive process control and early issue alerts,
so we can respond before quality issues
arise. Flexible reporting and full eDHR
make it easy to see what is happening
and report on areas we are most interest-
ed in as a business. The solution is scal-
able and gives us the platform we need
to stay at the forefront of medtech man-
ufacturing into the future.”
The MES acts as a digital twin of the
production supply chain, according to
Elekta. Data from real-world, physical en-
tities such as equipment, workers, and
workstations flows into the virtual copy,
Fig. 3 – Elekta’s digital twin view and performance metrics in real time on one display. providing a correct understanding of
their state (see Figure 3). The current sta-
Row Labels Average of Test Result Count of Paremeter
Count of Parameter Average of Test Result
tuses of the plant and specific work cen-
33.0 20
17/Jan/19 32.9 11 18 ters are visible and color-coded in the
18/Jan/19 33.0 18 33.0
16
14
Critical Manufacturing FabLive module.
21/Jan/19 33.0 12 12 The MES addressed many of Elekta’s
32.9
28/Jan/19 33.0 6
10
8
needs (see Figure 4). The system’s config-
4/Feb/19 33.0 6
32.9
6 urable GUIs provide operators with clear
4
5/Feb/19 32.9 6 2
work instructions and a view of only what
Grand Total 33.0 59.0 32.8
17/Jan/19 18/Jan/19 21/Jan/19 28/Jan/19 4/Feb/19 5/Feb/19
0 matters to them, including future tasks
and performance data.
6.00

Data for Traceability Without Paper

5.00
Before implementing the MES, Elek-
4.00 ta’s manufacturing execution used “bills
of process” and paper work instructions.
3.00
Employees manually checked and signed
2.00 paper-­based DHRs. Implementing the
1.00
MES transformed the company’s opera-
tions into a completely self-auditing elec-
0.00
32.75 32.80 32.85 32.90 32.95 33.00 33.05 33.10 33.15 33.20 33.25
tronic system.
Quality is now built into the manufac-
Fig. 5 – The MES quality module shows results and trends in several ways. turing process, and the system automat-
10 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
ically enforces the procedures. Instead of inspecting or check-
The MES streamlines compli- ing process and product data af-
ance with FDA’s Title 21 CFR Live Data ter a manufacturing step, the
Acquisition
Part 11 for Electronic Records system facilitates these functions
and Electronic Signatures. It Product Maintenance at the time of processing. As
Management
also includes a quality module, Traceability measurements are collected, the
which shows trends and results MES enables instant adjustment
graphically (see Figure 5). of processes or flags issues to pre-
The MES imports picked lot vent errors. Elekta can also re-
or serial numbers automatically Personnel Document
move any non-value-adding steps
from the ERP, so the operator Management MES Management and waste to increase overall op-
only has to confirm a match to erating efficiency by analyzing
materials assembled. As the MES process data.
collects data from throughout Eweg says, “I really like how in-
the shop floor, it provides con- Live formation from MES generates
Quality
text as well, creating complete Control
Performance [unique device identifier] labels,
Analysis
traceability with all information, thus effectively ruling out any
Process
measurements, and meta data Management human errors.”
attached to the eDHR.
The MES also enables Elek- Planned System
ta to ensure that its personnel Fig. 4 – Elekta’s view of what MES could do for it was broad and compel- Enhancements
always have correct work in- ling, and the implementation is fulfilling that vision today at three sites. Automating labels. Elekta is
structions, calibrated tools, working to integrate the MES
and appropriate and up-to- Eweg states, “Before, if we wanted to with their ERP to automate the
date training. All of these system fea- change the laser engraving procedure, for entire labeling process for MDR. This
tures improve quality, compliance, and instance, we needed to change about 50 workflow will better accommodate the
productivity. instructions. With the MES, it’s only one.” varied regulatory requirements that

Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 11

Manufacturing System Upgrade

control capabilities (see Figure 4). Qual-

8000
17/18 18/19 19/20 20/21
ity is up and costs in terms of wasted time
and other resources are down.
7000
Optimization. The MES displays steps
6000
and enforces that the operator follows
5000 them. In rolling out the MES, engineers re-
4000
alized that the processes they believed to be
best practices were not always. The MES
3000
forced a new level of process understanding
2000
that allows them to optimize procedures.
1000 Engineering efficiency. Fortunately, cor-
0
recting a work instruction now takes only
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr
an hour when it might have taken three
Fig. 6 – Manufacturing work orders are up each year at the Veenendaal plant in the Netherlands, yet months in the past. The work instruction
Elekta has not had to add administrative headcount to manage this increase. process needs 50 percent less labor and is
no longer dependent on other depart-
ments. Now, everyone can work true to
best practices as a standard approach.
Administrative efficiency. The compa-
ny has nearly doubled revenue over the
five years. Manufacturing orders (MOs)
are up almost 35 percent over four years
Variables
in one of the plants with MES (see Figure
coming 6). Yet, the company has about the same
from MES number of employees. Eweg estimates
they no longer need four FTEs just for ad-
ministrative action work.
Audit efficiency. Using electronic re-
cords and signatures makes audits
Fig. 7 – A typical MDR label, showing where the MES feeds critical information into labels. MES en- much easier and more cost- effective.
ables Elekta to generate many labels automatically. Eweg reports, “For audits, it’s a really
big benefit. Quality assurance is very
happy to get an eDHR from five years
ago in 20 seconds. Before, we had a pro-
cess in place. But the main fears during
an audit were finding the DHR and
checking that it’s OK.”
Agility. Elekta can now make products
to order, optimize inventory, and readily
share best practice business processes. Re-
al-time information helps minimize re-
work and exceptions and optimize manu-
facturing steps to reduce lead times.

Insight to Improve
The system provides comprehensive process control and early issue alerts, enabling the company to The new MES, rolled out across three
respond before quality issues arise. (Credit: Shutterstock/Gorodenkoff) global Elekta production facilities, gives
Elekta enhanced visibility, deeper under-
these cancer-fighting products have in point, and the scheduling module was a standing of manufacturing processes, and
countries around the globe. It will also significant capability Elekta wanted in the tools it needs to enhance quality.
support custom orders. selecting the MES. Elekta builds some assemblies in both the
Scheduling. The latest upgrade Elek- UK and China. The MES enables easy
ta did for the MES in the fall of 2020 Benefits and Payback knowledge transfers as work instructions
includes enhancements to scheduling. Quality. Per the original vision, Elekta and flows can be cloned and then only
With some new planners on board, us- has significantly reduced the cost of translated.
ing this module fully may happen later poor quality. Using the MES interface to Collating and contextualizing masses
in the cycle, yet it is a goal to ensure ef- collect specific measurements provides of shop floor and broader business data
ficiency by using the best resources for the fuel for statistical process control to form valuable business intelligence,
each manufacturing order. Resource (SPC). This MES also includes a quality Elekta is reaping the benefits of in-
scheduling has historically been a pain module including SPC and other quality creased production efficiency, reduced
12 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
costs, and ensuring easier, ongoing
compliance with future regulations.
Costs. The system has dramatically
reduced the overhead associated with
manual actions needed for regulato-
ry compliance. With eDHR and easily
searchable data, Elekta can prepare for
and go through audits with far less time
and effort. The company also enjoyed
archiving cost savings from the first day.
Elekta estimates archiving cost savings
from printing, internal, and external
storage to be $85,000 after four years
and over $850,000 over 20 years.
Kaak says, “This is the start of a new
future for Elekta. The payback on the
MES is already coming from cost sav-
ings, increased efficiency, and easier
compliance. We also benefit from free-
ing up resources to enable our business
to innovate more and greater agility to
respond to our customers’ demands.” As part of the project requirements, the implementation needed to be agile for phased product
Coherent device data. Creating the introductions. (Credit: iStock/izusek)
DHR is not that different in terms of
time and effort. However, in the previous Objective Description
approach using folders, not everything
from a manufacturing order was in the Increase • E nsure using correct work instructions, trained people and
same folder. So, the team had to find Compliance calibrated tools
them in an external warehouse Besides, • Use electronic (fire resistant) DHR
it’s far easier to check a label now that it’s
attached to the eDHR than when it was Improve Quality • Reduce inflow non-conformances (NCs)
separate. • Force processes/procedures
Unexpected benefits. Elekta expect- • Force calibrated tools and trained people
ed to reduce production lead times with • Ability to trace back issues and improve quality/reduce human error
the MES, but according to Eweg, “That’s
Increase Efficiency • No paper (1200 folders a year reduced )
not where we found the real benefits.
• Use data to reduce waste in process
Those are shaping up to be projects
• Improve accuracy and remove checks
that are not directly for MES but use
data from MES. The big benefits and Reduce Lead Time •R
 educe actual lead time for Linac by 50 percent (33 CDs to 15
cost savings are in improving the quality CDs) through visibility and process optimization
of our processes.”
Reduce Cost • No physical signatures anymore
MDRs and Labeling Compliance • Automatic checks
Medical device records (MDRs) re- • MES is FDA proven, so audits are much easier and more cost-effective
quirements have become dramatically • Improve readiness to adapt to future regulations
more complex since the implementa-
tion. Country-specific labeling and Table 1. Elekta expected the MES to help meet its operations performance objectives in various ways.
translations for equipment manuals,
once needed only for China, are now to measure. Eweg says, “We could never through a surge in demand for new small-
required for shipping to an ever-grow- have done it without MES. We connect- er applicator products.
ing number of countries (see Figure 7). ed the label solution to the MES so we MES has already supported Elekta’s
Checking the volume of specialized la- can no longer make mistakes.” healthy growth. By radiating the MES
bels for lot and serial numbers could data throughout the business, Elekta is
have led to improperly labeled items in Remote Work gaining benefits not only in the three
the field. Each month, Elekta’s process Another unexpected event was the plants using it but across disciplines and
triggers 2,000 label print jobs, most of COVID-19 pandemic. With MES in place, the enterprise.
them automatically, and the number is the engineering and operations teams This article was provided by Critical Manu-
growing. have been able to collaborate seamlessly, facturing, Austin, TX, an MES provider head-
As that was not a requirement pre- im- even when working from home. This ease quartered in Portugal. For more information,
plementation, the benefits are difficult of working has also supported Elekta visit http://info.hotims.com/82323-342.
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 13
 How These
Engineered Extrusion Trends
Can Improve Device Design
and Patient Experience
H
oses
and tubes
are extensively
used within the health-
care and medical industry
in a variety of applications, from wound
drains and catheters to drug delivery and
feeding tubes. Technology has moved far
beyond the production of single, hollow
tubes to multilumen extrusions that can
incorporate stops, bumps, and varying
thicknesses in a single design.
Silicone tape, sheet, and ribbon can be extruded up to 152 mm/6 in. in width with a thickness down
to 0.13 mm/0.005 in. (Credit: Trelleborg Healthcare & Medical)
14 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
Significant benefits can be achieved by
taking advantage of innovative manufac-
turing processes and the latest material
options to reduce device developers’ total
cost of ownership while increasing com-
ponent integrity. At the same time, manu-
facturing processes can improve patients’
quality of life by facilitating reduction in
device size and weight, as well as incorpo-
rating multifaceted geometries, multiple
substrates, and active pharmaceutical in-
gredients (APIs). Such improvements can
enhance treatment in terms of safety and
comfort and make wearable medical de-
vice options more appealing.
To facilitate the specification of these
streamlined yet complex extrusions, key
factors need to be considered. These fac-
tors will be outlined in this article along
with material options concentrating on
silicone extrusion technologies and ap-
plication examples.
A Look at the Market
Why is the medical device market
growing? Reasons for a predicted growth
in the medical device market include:
• Fast aging populations and increasing
life expectancy.
• More people looking for improved
quality of life.
• Growing incidences of chronic disease.
• Rapid increase in the prevalence of in-
fectious diseases.
• Rise in obesity.
• An increase in the number of surgical
procedures and complex surgeries.

• Adoption of advanced technologies.
• Rising healthcare expenditure globally.
• Strong economic growth and increas-
ing access to healthcare facilities in
emerging countries.
Global market for medical devices.
According to The Business Research
Company, the global medical device
market reached a value of nearly $456.8
billion in 2020. The market is expected
to grow from $456.8 billion in 2020 to
$662 billion in 2025 at a rate of 7.7 per-
cent. The medical devices market is
then expected to grow at a CAGR of 5.5
percent from 2025 and reach $863.2.4
billion in 2030.1
This decline was mainly anticipat-
ed due to lockdowns imposed by gov-
ernments across the world related to
the COVID-19 pandemic, which hin-
dered global supply chains, including
in the medical device manu­f acturing
industry. 1
Global market for hoses and tubing.
The medical device market’s overall
growth is causing an increase in de­mand
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 15
Silicone tape, sheet, and ribbon can be extruded up to 152 mm/6 in. in width with a thick-
ness down to 0.13 mm/0.005 in. (Credit: Trelleborg Healthcare & Medical)
Silicone tape, sheet, and ribbon can be extruded
up to 152 mm/6 in. in width with a thickness
down to 0.13 mm/0.005 in. (Credit: Trelleborg
Healthcare & Medical)
for med-
ical tub-
ing. Accord-
ing to Grand
View Research,
the global medical
tubing market was esti-
mated at $11.39 billion in
2020 and has an expected
CAGR of 7 percent from 2020
to 2028. Additionally, tubing’s
growth can be attributed to the avail-
ability of cost-­competitive medical-grade
plastics; a surge in demand for sin- Silicone
gle-use or disposable devices due to tubes can be
growing awareness of hospital-acquired reinforced in a
variety of ways, from
infections and efforts to prevent them; polyester and stainless-steel
and developing countries having in- braids for expansion-, elongation-
creased access to healthcare supplies. and burst-resistance to spiral
reinforcement with nylon monofilament
Key trends. To help detect diseases in for kink- and crush-resistance to keep fluid
the initial stages and mitigate treatment paths open. (Credit: Trelleborg Healthcare
costs, a trend toward further develop- & Medical)
ment of diagnostic equipment is gaining
Engineered Extrusion Trends

momentum. An emphasis on preventing
the spread of infection from one patient
to another also is increasing.
Continuous innovation in drug-­
delivery systems is expanding demand
for customizable tubes. In addition, in-
novations, such as intra cochlear drug
delivery and photothermally triggered
drug delivery, are expected to lead to
growth in nano medical tubes.
Less-invasive medical procedures of-
fer the advantages of lower cost, as
well as quicker recovery times and
shorter hospital stays for patients.
These procedures are therefore in-
creasing in importance compared to
conventional surgical procedures,
which in turn is increasing the market
for tubing used to make such proce-
dures possible.
The trend toward less-invasive pro-
cedures also places technical demands
on the devices to be designed in in-
creasingly smaller and complex ways.
Medical tubing applications. In
terms of applications, the medical
tubing market is categorized into
bulk disposable tubing, drug-delivery
systems, catheters, biopharmaceuti-
cal laboratory equipment, and other
categories.
Stent tubes and implant-grade
tubes are anticipated to boost market
growth. Advancements in wound
therapy, in which tubes are used to
remove infectious materials and flu-
ids, also is expected to drive growth
in the sector.
Market by material. The medical tub-
ing market is categorized in terms of
materials into polyolefins, silicone,
polyvinyl chloride (PVC), fluoropoly-
mers, poly­carbonates, and others. PVC
is the most widely used thermoplastic
material in medical tube manufactur-
ing, but silicone is seeing significant
growth.
The demand for PVC tubing is
anticipated to increase owing to the
rising demand for single-use prest-
erilized medical devices, which are
transparent, biocompatible, and of-
fer high resistance to chemicals. PVC
led the market and accounted for
29.5 percent of the global revenue
share for tubing in 2020 while sili-
cone, with its inherent suitability, in
particular for implantable devices,
is estimated to be the second-fastest
growing segment.

Application Examples
Bioprocessing Flow Tubing
Application: Tubing to give a high-flow-rate discharge through a
large-volume bottom outlet disposable biobag.
Issues:
• Desired flow rates were not being achieved.
• Tubing was collapsing due to large suction pressure.
Solution: Tubing wall was increased to 0.48 mm/0.188 in. from 0.32
mm/0.125 in., while maintaining the same inner diameter. The thicker
wall prevented the tubing from collapsing, and the specified flow rates
were met.
Central Vascular Access Catheters
Application: Multilumen tubing and liquid-injection overmolding
connectors for central vascular access catheters.
Issues:
• Maintaining orientation of feeding lines.
Solution: Multilumen tubing and overmolded connectors utilized a
combination of high-precision, liquid-injection molding and extrusion
production techniques.
Orthopedic Tubing
Application: Extrusion used in an orthopedic additive-eluting medical
device.
Issues:
• Outer diameter less than 0.012 in. required.
• Precisely control a specific elution curve of consistent concentration
over a lengthened release time.
Solution: Close collaboration that started with the elution concept.
Using a single material resulted in a narrow two-layer extrusion with
the core serving as an eluting rod and an outer concentric layer that
precisely regulates elution in MIS procedures. The entire cross section
was under 0.012 in. Customer measurement fixtures were developed
and validated with the process.
Implantable Neurostimulator
Application: Electrical pulses to the brain and spinal cord are used for
chronic pain therapy and to treat disorders such as epilepsy, Parkin-
son’s, and Tourette syndrome.
Issue:
• Leads must be very small while maintaining insulation properties to
deliver the neurostimulating signals to precise locations.
Solution: Extremely tight tolerances were met with a microextrusion
made possible with advancements in quality process control and monitor-
ing systems. Diameters of ≤0.030 in. and required tolerances of 0.001
in. inner diameter, outer diameter, wall thickness, and concentricity to
allow for assembly of the conductor ensure sufficient and consistent
insulation along the length of the lead and minimize the overall size.
Pacemaker Lead
Application: Insulating, biocompatible extrusion carrying multiple
conductors for a pacemaker lead.
Issues:
• A strain relief method was needed to mitigate risk of breaking due to
dynamic loading.
• The multilumen extrusion design included more that 30 dimensions
with tolerances of 0.002 in. or less.
Solution: Employed continuously twisted tubing process technology with
custom tooling and measurement fixtures to validate the process
capability of all required dimensions.
Heart Pump
Application: Cable jacketing.
Issue:
• Provide a biocompatible, protective layer to a cable assembly including
several conductors, insulators, and strength members.
Solution: Developed and validated custom extrusion tooling in conjunction
with a precise cure parameter window to apply a silicone jacket around the
outside of the cable assembly without damage to internal cable components.

16 www.medicaldesignbriefs.com Medical Design Briefs, July 2022

Tubing Technologies pigmented if required. Care must be tak- more layers of silicone to precision toler-
Different processing options have led en to verify that the mechanical proper- ances. Such products can be supplied on
to groundbreaking ways of producing ties of reinforcing materials are not com- spools or cut to length. Like reinforced
tubing. When customers partner with promised by the heat required to cure the tubing, care must be taken to verify that
medical device component manufactur- silicone. the mechanical properties of reinforcing
ers that utilize the latest capabilities and Jacketed wires and cables. Wire and ca- materials are not compromised by the
technologies, they can create solutions ble assemblies up to 5.08 mm/0.2 in., heat required to cure the silicone.
that optimize the performance and us- such as those used to power implantable Custom profiles. Custom profiles of-
ability of medical devices. heart pumps, can be jacketed with one or ten do not include lumen and are used
High-precision microextrusion and
thin-walled tubing. Microextrusion
processing performing below the sub-
millimeter (0.1 mm) range employs
modified equipment featuring inno-
vations in extrusion head, tool, and
screw designs. Microextruded, thin-
walled tubing can be manufactured
down to 0.05 mm/0.002 in. and with
outside and inside diameters down to
Expanding production capacity
0.25 mm/0.004 in., potentially for use To meet your medical device needs
in minimally invasive surgical (MIS)
procedures.
Multicomponent extrusion. Multiple
materials can be simultaneously extrud- For over 75 years, MICRO has continually
ed within the same tube to account for expanded our capabilities in order to provide
differing properties and media interac- our customers with the finest in full service
tions. The most common example of
Medical Device contract manufacturing.
this capability is the inclusion of a radio­
paque stripe, which typically incorpo- The latest addition to our global footprint
rates a barium sulfate-loaded silicone as
the stripe used to locate the device in an is a newly facilitated 32,000 sq. ft. location
x-ray or fluoroscope, but this inclusion in Costa Rica featuring clean room
can also be used to vary hardness of spe- assembly and light manufacturing.
cific contact surfaces or to facilitate
downstream assembly through color This recently added piece of the puzzle will
coding of lumen. continue to allow us to fulfill our Vision:
Extruded ribbon and film. Silicone
tape, sheet, and ribbon can be ex-
"To Help Our Customers Save Lives"
truded up to 152 mm/6 in. in width
with a thickness down to 0.13
mm/0.005 in. Such ribbon can be
supplied in spools with carriers and
slip sheets or as punched seals or dia-
phragms to support sealing applica-
tions in devices such as pacemaker
generator housings.
Reinforced and kink-resistant tubing.
Silicone tubes can be reinforced in a vari-
ety of ways, from polyester and stain-
less-steel braids for expansion-, elonga-
tion-, and burst-resistance to spiral
reinforcement with nylon monofilament
for kink- and crush-resistance to keep fluid
paths open. Reinforcement is customiz-
able, and tubes can be made to specific
precision tolerances.
Contact us today to discuss your next project: sales@micro-co.com
Silicone tubing reinforced with polyes-
FDA Registered • ISO 13485 • ISO 9001 • ISO 14001
ter braid can also be used to resist abra-
MICRO 140 Belmont Drive, Somerset, NJ 08873 USA • Tel: 732 302 0800 • www.micro-co.com
sion under cyclic loading, such as in pac-
ing leads. The outer covers can be
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 17
MSC-3161- Micro print ad 4.5x7.25.indd 1 4/1/22 8:57 AM
Engineered Extrusion Trends
Platinum-cured silicones can eliminate the need for a secondary post-cure process, which is required
for older peroxide-cured silicone systems. (Credit: Trelleborg Healthcare & Medical)
to seal housing assemblies or in heart
valve repair applications. Being nonsym-
metrical, such cross sections can require
longer development cycles and can be
more difficult to measure while trying to
maintain the extrusion’s free state.
Twisted extrusions. This extrusion pro-
cess produces continuously twisted tubing
for use in applications in which implanted
power or sensing cables require strain re-
lief from repeated flexing and bending,
such as with pacemaker leads.
The tube cross section typically consists
of a center lumen and multiple outer lu-
mens, with the twisting process causing
the outer lumen to become spiraled
around the center lumen. In this struc-
ture, wires fed through the outer lumen
are less prone to dynamic flex failures be-
cause stresses are distributed more evenly
to the multiple wires.
The process does not require the tub-
ing to have a round outer diameter. And
features, such as grooves, can be incorpo-
rated on the outer surface. Accurate veri-
fication of the spiral pitch requires trans-
lucent tubing and custom measurement
techniques.
Bump tubing. Bump or tapered tubing
is created by stretching the tube at a vary-
ing rate to produce tubing with a larger
diameter at one end and a significantly
smaller diameter at the other end. The
process can be applied to plastics and
elastomers, including silicone. The geom-
etry is limited by the Poisson’s ratio of the
18 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
material during stretching in the green
state.
Formed extrusions. Extruded tubing
is designed to create complex paths,
such as sinusoid shapes for flex and
strain relief and to fit tortuous anatomy,
or spiral shapes that might be used to
soften contact within the bladder, for ex-
ample. Measurement of such geometries
in the extrusion’s free state can be chal-
lenging and require custom manufactur-
ing methods.
Bonded or overmolded stops. Stops
can be bonded or molded onto tubing
to lock it in place and keep it from ro-
tating. The stops are typically added to
peristaltic pumps for infusion, internal
feeding, laboratory equipment, diag-
nostic equipment, and bioprocessing
fluid transfer. The key advantage of
peristaltic pumps is their disposable
pump tubing. Only the tubing’s inner
diameter comes into contact with the
fluid; therefore, there is no need to
clean or flush the pump between uses.
Multilumen extrusion. Using this tech-
nology, numerous lumens or channels
are produced as a single extrusion. More
lumens mean more dimensions to con-
trol and measure, including the inner di-
ameters and the walls between diameters.
High-precision vision systems with cus-
tom programming are often required to
ensure quality. Downstream molding can
incorporate overmolded connectors to
separate the lumen into individual tubes.
Typical applications include catheters,
electronic medical devices, analytical
equipment, fluid transfer, drug delivery,
and medical instrumentation.
Geometric transitioning extrusion.
Geometric transitioning, or GeoTransTM,
allows for silicone tubing to change the
cross section during the extrusion pro-
cess to eliminate molding and secondary
bonding steps. Reducing the number of
components and the bonding joints be-
tween them allows for a more hygienic
design.
The GeoTrans technology is applied to
custom applications with precision toler-
ances. To facilitate the development cycle
for these highly customized extrusions, it
is fastest to identify one cross section as
critical and allow flexibility of other cross
sections. Typical changes include:
• Changing the tubing inner diameter,
outer diameter, or both to create tub-
ing with two or more different cross
sections.
• Bifurcation or converting a dual lumen
extrusion into two single lumen tubes.
• Inclusion of channels to open internal
fluid paths at locations along the extru-
sion length.
• Stopping one of multiple lumens to
avoid the need for backfilling, such as
when the lumen will be used for bal-
loon inflation.
• Thinning a tube wall for a short section
to drive specific balloon inflation, loca-
tion, and shape.
Geometric transitioning single lumen.
This technology, also called off-ratio bump
tubing, creates two distinct tube cross sec-
tions with a near-step transition between
them.
Tubing lengths are available in single
transition (cross section A to B) or double
transition (cross section A to B to A) op-
tions. Applications include custom-end as-
semblies, such as accommodation of con-
nectors or fittings, and peristaltic pumps.
Foam extrusion. Closed-cell silicone
foam offers custom mechanical charac-
teristics by lowering effective durome-
ter and providing additional cushion
space. Silicone foam extrusion can be
customized in a variety of sizes and
cross sections with precision toleranc-
es. Cell pore size and foam density can
also be adjusted. Silicone foams are
made from medical-grade HCR, plati-
num-cured silicone.
Measurement of foam materials can be
less precise due to the natural variation of
surfaces caused by cell formation that cre-
ates the lower density foam.
Tubing Materials
Depending on the application, medical
hoses and tubing are produced in a variety
of materials, including plastics such as flu-
orinated ethylene propylene (FEP), Ny-
lon, PVC, polyetheretherketone (PEEK),
polytetrafluoroethylene (PTFE); thermo-
plastic elastomers (TPE); and elastomers,
in particular, silicone.
Silicone. Silicone is a key tubing mate-
rial for medical devices, especially for
implants. The unique characteristics of
high-consistency rubber (HCR) silicones
offer an uncured, green strength that al-
lows for a variety of custom and complex
processing techniques. Additional ad-
vantages include the following:
• It is proven to be inert and biostable,
making it the gold standard in terms of
biocompatibility.
• It is nonreactive with other elements.
• It can be platinum-cured for the highest
degree of purity.
• Durometers can be easily altered.
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 19
• It allows for extended post-cure for low-
est level extractables.
• I t does not utilize leaching plasticizers.
• Certain formulations are suitable for
long-term surgical implant.
• I t is odorless, tasteless, and nontoxic.
• It possesses favorable physical and haptic
attributes.
• It can be manufactured with a variety
of textures.
• It can be sterilized by radiation, EtO,
steam: 30 psi/2 bar at +123 °C/+253 °F.
• It resists temperature extremes with flex-
ibility retention: from –54 ° to +204 °C/
from –65 ° to +400 °F; brittle point: –73
°C/–100 °F.
• It is processable in numerous ways, in-
cluding molding, overmolding, sheet-
ing, dipping, and extrusion, as well as
in combination with other materials
and substrates.
• It can include different fillers for specific
applications.
• It offers exceptional permeability, allow-
ing absorption of APIs.
Drug eluting. Silicone is often used for
catheters, respirators, and implants due to
its biocompatibility and biostability bene-
fits; however, silicone is not immune to
bacterial colonization.
One option to prevent tubing from
transmitting bacteria is to impregnate vul-
canized silicone with APIs. The silicone is
immersed in the drug solutions, which can
be absorbed into the material.
The APIs do not interfere with the cure
chemistry of the silicone and are uni-
formly impregnated through the matrix
of the silicone. Customizing the API con-
centration and adding release mem-
branes enables a drug to be released at a
constant rate. APIs can also be used to
release a variety of drugs slowly, over lon-
ger periods, and focused at the site of
need. For example, hormones and can-
cer treatments can elute through silicone.
Platinum-cured silicone. Platinum-­
cured silicones can eliminate the need
for a secondary post-cure process, which
is required for older peroxide-cured sil-
icone systems. Platinum-cured silicone
contains fewer volatile organic com-
pounds and can be formulated to have
faster cure times at lower temperatures.
Engineered Extrusion Trends
Using this technology, numerous lumens or channels are produced as a single extrusion. More lumen facturers are looking to innovative process-
means more dimensions to control and measure. (Credit: Trelleborg Healthcare & Medical)
Platinum-­cured silicones can be for-
mulated to bond with metals used in im-
plants, such as titanium, stainless steel,
and nitinol, and with plastics such as
polycarbonate, polyester, and PEEK.
Factors to Be Considered Before
Specifying Tubing and Hoses
Before designing tubing and hoses
for medical devices, engineers should
consider factors such as size, hardness,
tear strength, elongation, surface fric-
tion, transparency, and visibility.
Size. Size is increasingly becoming a criti- like stents and balloons, or to facilitate
cal factor in the design of tubing as medical
device developers seek to produce ev-
er-smaller devices and less-invasive drug-de-
livery systems. Shrinking geometries and
tolerances can push the limits of process
control and create downstream challenges
with testing, measurement, and assembly.
Hardness. Extruded silicone is com-
monly available in durometers from Shore
A 20 to Shore A 80. As the durometer in-
creases, tensile strength decreases, making
it an important factor to prevent break fail-
ures in wound drains, for instance, which
are put under significant tensile load when
removed from the body.
Tear strength. Tear strength influenc-
es, for example, how difficult it is for a
nick in a tube to propagate and is a con-
sideration in situations in which the tube
might be exposed to a sharp edge or for
geometry with small internal radii. Low-
er-durometer silicones have significantly
lower tear strength.
20 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
Elongation. Elongation properties
relate to the elasticity of the tubing,
which is a significant factor for bal-
loon devices, for instance. Lower-­ these new developments and improve
durometer silicones have higher elon-
gation properties.
Surface friction. When it is import-
ant for a tube to have minimal surface
friction, the tube can be coated to de-
crease the material’s inherent sticki-
ness. For instance, a coating can reduce
the forces required for deployment of
an implanted or interventional device,
assembly of tight fits in devices like pac-
ing leads.
The coating or surface finish must
be biocompatible if it is likely to come
into contact with the body. Several
coatings are available that bond well
to silicone and meet compatibility re-
quirements.
Transparency. Visibility to verify flow
of media through a tube is important
for certain types of devices, such as
those carrying fluids into or out of the
body. Silicone, for instance, is naturally
translucent. However, certain silica fill-
ers that increase durometer, as well as
fillers such as barium sulfate (BaS04)
and titanium dioxide (TiO2), can re-
duce or eliminate transparency.
Visibility. Designers may wish to
make a tube more visible within the
body, to aid in guiding a device through
the body when viewing it using an x-ray
or fluoroscope, for example.
Barium stripes can be added to a tube
to make it visible within soft tissue, while
still enabling the fluid to be viewed to ver-
ify flow. A higher percentage of barium
additive can be used to ensure that a tube
can be seen through bone, such as to
help a surgeon place a catheter in the
spine.
There is a limit to the amount of
radio­paque additive that can be incor-
porated and still render silicone pro-
cessable by extrusion, however. Even the
smallest additive amount can make sili-
cone visibly opaque without offering suf-
ficient radiopacity.
Tubing’s Role in Enhancing Device
Design
Responding to rapid growth in the med-
ical device market, medical device manu-
es to enhance their products and meet
patients’ needs, including miniaturization
and wearability.
Hoses and tubing manufacturing
techniques are helping to support
patient quality of life with increased
function and enhanced integrity and
by enabling the incorporation of
APIs.
To facilitate manufacturing these
complex extrusions to client specifi-
cations and with user experience in
mind, designers and manufacturers
should work with an expert in hoses
and tubing who can help identify and
prioritize critical features relevant to
the application and who can employ
progressive technologies and pro-
cesses to revolutionize medical de-
vice design.
References
1. “Medical Devices Market 2021 - By Type Of De-
vice,” Global Forecast to 2023, The Business Re-
search Company, accessed Jun 1, 2022, http://
www.thebusinessresearchcompany.com/report/
medical-devices-market
2. “Medical Tubing Market Size, Share & Trends
Analysis Report,” 2020–2-28, Grand View Re-
search, accesses Jun 1, 2022, http://www.grand-
viewresearch.com/industry-analysis/medical-­
tubing-market
This article was written by Dan Sanchez,
Product Manager, Trelleborg Healthcare &
Medical, Paso Robles, CA. For more informa-
tion, visit http://info.hotims.com/82323-340.
A detailed white paper can be downloaded at
https://www.trelleborg.com/en/healthcare/
tools-and-media/technical-librar y/
advanced-extrusion-whitepaper.
TECHNOLOGY LEADERS Motors/Motion Control

Advanced Motor Technology Enables Medical

Exoskeleton for Rehabilitation

T
he primary aim for Harmonic Bi- puts from users instead of the position chanically isolated from any extraneous
onics is to empower patients and setpoints typical of most robotic arms. loads. The result is that each load cell can
care providers by designing intel- To assist patients with exercises, it is sense the force exerted by only the joint of
ligent technology that facilitated much more important for the robot to the robot it is mounted to, while being iso-
a data-driven treatment protocol when apply exact forces to patients rather than lated from the forces being applied to oth-
dealing with neurological and musculo- to position them accurately (see Figure ers, thus maximizing the sensing accuracy
skeletal movement impairments. To this 1). The robot has been designed with of the load cell. ESCON controllers, man-
end, the company was responsible for compliance in mind so that even small ufactured by maxon, were compact in size
the complete design and assembly of its forces applied to the robot can cause the and easy to integrate electrically and phys-
Harmony SHR™ bilateral upper extrem- robot to move out of the way, to slow ically (see Figure 2). Harmonic Bionics
ity exoskeleton. down, or to stop completely. This feature found that the software was straight­
By enabling early intervention, func- makes the robotic exoskeleton extreme- forward to use. The motors include infor-
tional repetition, and intent-based thera- ly safe to be in and around. mative datasheets, making them simple to
py, Harmony SHR delivers users the abil- This force sensitivity necessitated a rede- integrate. According to Harmonic Bionics,
ity to improve the efficiency and sign of typical robotic actuators. Harmonic motor selection was rarely revised because
ef­fectiveness of upper-body rehabilita- Bionics has developed a patented robotic the datasheets enabled the company to se-
tion. As the company’s flagship product, actuator, which uses a load cell that is me- lect the correct motor the first time.
the Harmony SHR is designed to pro-
vide unique value in three areas of prac-
tice: neuroscience and movement sci-
ence research, movement disorder
assessment, and rehabilitation.
Harmonic Bionics has selected com-
mercial off-the-shelf (COTS) compo-
nents to integrate into their various ro-
botic actuators according to each
actu­ator’s requirements to simplify prod-
uct design efforts. The company did
have to make minor trade-offs in the de-
sign phase, at times, such as between ac-
tuator size and load capacity/weight,
and between maximum torque and
torque sensitivity. The end product is
strong enough to assist with physical ex-
ercises while not being too heavy or
cumber­some to use.
Typically, in robotic arm applications,
people must be separated from the ro-
botic arms so that the robot cannot in-
jure a person while moving. Most robotic
arms on the market are not designed to
interact with humans safely — they can-
not detect a person in their way or move
around a person while performing the
programmed task. Because of this, typi-
cal robots could be very dangerous for
people to interact with, especially in a
physical therapy application. This is not
a problem with the Harmony SHR,
which has been designed to be force sen-
sitive and to be controlled by force in- Fig. 1 – Accuracy is less important for rehabilitation, particularly during exercising.

Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 21

TECHNOLOGY LEADERS Motors/Motion Control
Fig. 2 – maxon’s ESCON controller provided a compact and powerful addition to the Harmony SHR exoskeleton.
Actuators used in the Harmony SHR
exoskeleton are either rotary actuators
with torque and angle sensing output
used to assist with patient motion, or
linear actuators with position feedback
used to resize the robot to fit a patient.
The exoskeleton is designed to provide
objective assessment of a patient’s
movement capabilities. The system in-
corporates more than 80 sensors that
record measurements 2,000 times per
second, allowing it to precisely mea-
sure multiple parameters, including
range of motion, force generation, and
number of repetitions.
The motion system uses several motors
designed and manufactured by maxon,
which supplied motors to address a wide
variety of unique needs of the system. For
example, EC Flat motors provided the
high torque output needed in a compact
package that fit the exoskeleton’s compact
size (see Figure 3). The flat motors could
also be supplied with angle sensors.
An EC 60 Flat motor was selected be-
cause the outer diameter was similar to
that of the harmonic drive and because
this motor is axially compact. The shaft
of a maxon EC 60 DC Flat motor is at-
tached to a wave generator of a size 17
harmonic drive, which was selected for
its compact axial size and high torque
22 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
capacity. Harmonic drive gear reducers
offered the high reductions, low back-
lash, and high torque capacity the com-
pany needed for the design.
The stator of the motor is mounted to
the circular spline of the harmonic drive.
The flex-spline of the harmonic drive is
attached to an output shaft supported by
a crossed roller bearing, which supports
all loads that are not the torque output
of the actuator. Because the crossed roll-
er bearing supports the other loads, the
only load that acts on the load sensor is
the torque output of the load sensor.
The motor, output shaft, and harmon-
ic drive assembly are free to rotate in the
crossed roller bearing. A bracket is at-
tached to the circular spline of the har-
monic drive and to the stator of the mo-
tor. A load sensor is attached to the
bracket so that output torque of the
overall assembly can be measured
through the load sensor.
The alignment of the harmonic drive
to the shaft of the motor is critical to the
life of the actuator. Even a minor mis-
alignment can cause premature wear
or failure of the mechanism. Therefore,
the machined components are manufac-
tured to be parallel to within about 20
µm while concentricity is maintained
within about 30 µm to align the circular
Fig. 3 – maxon EC 60 Flat motor provides high torque
in a compact package.
spline to the motor. The overall foot-
print of the actuators inside the robot
is approximately 80 mm in diameter
and 90 mm in length. The machined
components that go into each actuator
are made from various fatigue-resistant
aluminum alloys, and grade 5 titanium
where stresses are high.
The output torque of the overall actua-
tor is approximately 30 Nm, and the actua-
tor can output over 100 Nm peak. The ac-
tuator is attached to an extremely sensitive
load cell, which has a resolution of less
than 10 mNm. Each actuator is designed
to have a life of over 3 million revolutions.
Conclusion
The actuators used in the Harmony
SHR are of a mature design and are ex-
pected to need few improvements in the
future. According to the company, it is
unlikely that they will be changing any of
the COTS components during future re-
visions, particularly the maxon compo-
nents. The maxon DC motors were highly
configurable, and low backlash versions
of gear reducers were used in the rotary
actuators. In addition, small diameter
brushed dc motor and planetary gearbox
combinations were used to create com-
pact rotary actuators. The leadscrew gear
reducers were also available to use in lin-
ear actuator applications. The goal
achieved was to provide an intelligent,
data-driven treatment therapy for dealing
with neurological and musculoskeletal
movement impairments.
This article was written by Biren Patel,
Sales Engineer, maxon Group, Taunton, MA.
For more information, visit http://info.
hotims.com/82323-343.
TECHNOLOGY LEADERS Motors/Motion Control

How to Select Motors to Address Biologic

Drug-Delivery Challenges

B
iologic drugs change the way
the human immune system re-
sponds to numerous diseases
and conditions. These drugs
have revolutionized disease treatments
and offer hope to many patients who
previously had no effective remedies
for their illnesses. That’s good news for
patients, but biologics present drug-­
delivery challenges for device designers.
Recently developed biologics are char-
acterized by high molecular weights —
as much as 150,000 daltons (Da). For
designers of biologic drug-delivery devic-
es, such weights create different chal-
lenges than conventional synthesized
drugs. The higher molecular weights Fig. 1 — Drug molecules for biologics (left) and traditional drugs (right).
also means that biologics have high vis-
cosities, which influence the injection
profile of the drug-delivery device and,
ultimately, the device’s effectiveness. Intravenous Subcutaneous Intramuscular
These challenges make the motor system • Milti-drug delvery • Medium viscosity drugs • High-med. viscosity drug delivery
• Large flow rate ranges • Low flow rates • Flow rates fixed
a significant element in biologic delivery • Long term treatment • 1 day to 3 years treatment • One time use
device development.

Biologic Drug Administration Methods

Of the three methods for administering
a drug into a patient’s body (see Figure 1),
biologics use subcutaneous and intramus-
cular delivery methods, including:
• Intravenous. This technique, often ab-
breviated as IV therapy, delivers the
medication directly into a patient’s
vein.
• Subcutaneous. Drugs intended for slow
absorption are often injected into the
subcutaneous tissue between the fat
layer just under the skin and over the
top of the muscles.
• Intramuscular. Because muscles have
larger and more numerous blood ves-
sels than subcutaneous tissue, intra-
muscular injections are preferable for
faster drug absorption.
Technical Considerations for Biologic
Drug-Delivery Devices
Three main types of devices are used
to deliver biologic drug injections: dis-
posable, limited-use, and reusable bio-
logic pumps. How these devices are used
Epidermis
Dermis
Subcutaneous tissue
Muscle tissue
Fig. 2 — Methods and devices for injecting biologics.
— along with their technical consider-
ations and the motors or motion compo-
nents available to address them —
­include the following:
Disposable biologic devices. Single-­
use devices are designed to cost-­
effectively deliver a specific drug, with
delivery time ranging from a few sec-
onds to a few days. Examples include
mechanical injectors and disposable
patch pumps that are worn directly on
the body and have a reservoir, pump-
ing mechanism, and infusion set inside
a small case.
Various motors and drives can be a
good fit for this application. The most
suitable motor technologies are can stack
stepper and brush DC. Both motor types
offer a mature technology with advantag-
es over some alternative actuators that,
although they may also be appropriate,
require complex drive electronics.

Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 23

TECHNOLOGY LEADERS Motors/Motion Control
Limited-use devices have both a disposable drug unit and a separate, reusable pump unit. (Credit: Portescap)
Reusable pumps can handle drugs of various viscosities for a broad range of therapies. (Credit: Portescap)
The duty cycle for disposable applica-
tions is limited, ranging from a few seconds
to a few hours. Based on the application
requirements, a reliable, cost-­ optimized,
motor-driven system serves these devices
well.
Limited-use biologic devices. A motor-
ized device can accept multiple biologic
drug cartridges over the course of a ther-
apy. Limited-use devices offer the advan-
24 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
tage of having both a disposable drug
unit and a separate, reusable pump unit.
They also provide flexible performance
as well as a lifetime that is relative to the
pump price. Limited-use devices are
generally designed for use with a single
biologic drug or limited drug offerings,
so the force and size requirements for
the motors may be different than those
of reusable devices.
A motor that can meet a force range
of 50–80 N is typically sufficient. These
devices are battery driven, so efficiency is
important to the pump design. Coreless
brush DC motors with precious metal
commutators are well suited to meet
these higher battery life requirements,
providing high power density and reli-
ability. A spur compound gearbox or
custom gearhead are ideal for limited-­
use biologic applications.
Reusable biologic pumps. Robust, rug-
ged, and long-lasting reusable drug-­
delivery pumps can handle drugs of vari-
ous viscosities for a broad range of
therapies. This type of delivery device
presents particularly demanding mo-
tion requirements, however; the higher-­
viscosity biologics make a high axial
force output up to and higher than 100
N necessary.
When supporting various biologics
as a platform, the pump must be able
to deliver the highest viscosity drug
while also accurately delivering the
lower viscosity ranges. Reusable pumps
are portable, so their size and weight
are important criteria. Outside diame-
ters for a premium biologic device mo-
tor typically range from 10 to 12 mm
(see Table 1).
A reusable pump must also be robust
and reliable. Product warranties can range
from two to five years, so the motors and
drives have to be properly sized to deliver
the same accuracy from day one to the end
of the pump’s life. For a motor-driven sys-
tem, the designer confirms a confidence
factor of greater than 90 percent to ensure
that it lasts the required lifetime.
Feedback, repeatability, and storage
conditions are additional factors in drive
system selection. An encoder confirms
that the motor has provided the needed
drug delivery, ensuring that the therapy
is successful. It also ensures that every
delivery increment is met each time. If
the biologic requires cold storage, a mo-
tor and gearhead that can withstand low-
er temperatures and humidity over peri-
ods of time are necessary.
Overall, brushless DC motors (BLDC)
or coreless brush DC motors with pre-
cious metal commutators are best suit-
ed for reusable biologic pump devices.
A spur gearhead or a custom-designed
gearhead can provide a great torque-to-
TECHNOLOGY LEADERS Topic

force density within the smallest avail-

able size.

Current Challenges in Biologic Drug-

Delivery Systems
Like biologic drugs, biologic delivery
devices are relatively new to the market
and are continuously improving. Because
biologics are more complex with higher
molecular weights and viscosities than
small-molecule chemical drugs, biologic
drug devices face the following challenges:
• Accommodate high-viscosity drugs.
• Deliver a large volume of a drug.
• Delivery accuracy.
• Cost optimization in order to reach a
larger population.
Some of these challenges can be sup-
ported by motor-driven systems (see Ta-
ble 2):
• Brushless and brushed motors have Biologics are drugs made of proteins and/or derivatives that modulate the immune system. (Credit: Portescap)
higher power densities, which, in com-
bination with higher reduction ratio
Biologic Drug Device Parameters Disposable Applications Limited-Use Applications Reusable Applications
gearheads, can handle high-viscous
Device lifetime + ++ ++++
drugs greater than 50 cP.
• Power density helps to accommodate Packaging + + ++
larger drug volumes in a smaller device Battery operating time (hrs) + ++ +++
size, ranging from 10 to 50 mm. Various drugs based
Ability to handle drugs Specific drug Specific drug
• A bsolute encoders can help precise- on viscosity
ly monitor drug delivery at 3–5 µm Drug cartridge capacity (mL) ~3 3–10 3–10
resolution. Separate from Separate from
Driving unit of device Disposable
• Reliable motors and gearheads provide disposable unit disposable unit
long life for safe, home-based therapies. Needle system (patch type) Automated insertion Automated insertion Automated insertion
and retraction and retraction and retraction

Motor and Gearhead Options for Biologic Refrigeration Not applicable Possible Possible
Drug-Delivery Devices Sterlization Not applicable Not applicable Possible (based
Because powering the delivery mecha- on design)

nism is a crucial part of a drug-delivery Table 1 — Key performance characteristics for different biologic drug-delivery devices.
device, design engineers must evaluate a
variety of motors and gearheads to find Motion Solution Parameters Disposable Applications Limited-Use Applications Reusable Applications

the most appropriate component for Drive Technologies Stepper/Brush DC/Others/ Stepper/Brush DC Brush DC/BLDC
Mechanical
their application. To complete this selec-
tion process effectively, engineers can Wide range
Performance (Torque/Force) Limited range Limited range torque/Force
consider the following list of key perfor-
Performance (Force), N Up to 50 Up to 120 Up to 200
mance elements of drug-delivery devices
and the different motor technologies Output linear speed 1–3 mL dispensing Up to 10 mL in up Up to 10 mL in up to
in <10–100 seconds to 20 minutes 2 to 4 hours
that can handle them:
• Torque/power. All motor technologies Efficiency + ++ +++
offer the ability to produce torque, but Input voltage , V DC 1.5–3.6 3.6–7.2 3.6–7.2
their internal designs present different Encoder needs, LPR 1–16 lines 1–16 lines 16–128 lines
output capabilities. BLDC slotted de- Weight + + ++
signs deliver higher output torque
Size/Packaging ++ ++ ++
than BLDC slotless designs, based on
the higher amount of copper and mag- Life + ++ ++++
nets in the motor. When considering Reliablity +++ +++ ++++
stepper motors, hybrids provide the Table 2 — Technologies and key performance characteristics of motor-driven systems used for biologic
highest torque. drug-delivery devices.

Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 25

TECHNOLOGY LEADERS Motors/Motion Control

Performance Parameters Brush DC Brushless DC Stepper

Iron Core Coreless Slotted Slotless Can Stack Disk Magnet Hybrid
Torque +++ ++ ++++ +++ + ++ +++
Speed + ++ +++ ++++ + +++ +
Power +++ ++ +++ ++ + ++ +++
Efficiency + +++ ++ +++ + ++ +
Reliability + ++ ++++ ++++ ++ ++ +++
Weight (Inertia) + ++++ ++ ++ ++ ++ +
Cost (low) +++ ++ + ++ +++ ++ +++
Cogging + +++ ++ +++ ++ ++ ++

Table 3 — Comparison of key performance characteristics of different motion technologies.

Adding a gearbox can increase output torque, and

• Speed. The drug dictates the duration
and flow for the therapy, so the device
speed will be set. BLDC stepper motors
can meet higher speed requirements.
Brush DC motors can satisfy medium
speed requirements, whereas steppers
can handle lower speed requirements.
To increase output torque, you can add
a gearbox and thereby increase the
There are several types of devices that are used to
deliver drugs. (Credit: Portescap)
Ultra EC™ mini motor platform is a 16 ECP brushless
motor, designed specifically to provide an economic
motor solution for high-performance applications.
(Credit: Portescap)
speed requirements on the motor by
the corresponding ratio.
• Efficiency. Biologic drug-delivery de-
vices rely on battery power, so an effi-
cient system will keep the battery size
low. Brush DC coreless and BLDC slot-
less motors have a rotor-based design,
making them the optimal choices for
system efficiency.
• R eliability. The device has a specific
life requirement based on the num-
ber of therapies to be delivered to
the patient. Motor life is deter-
mined by the commutation and
bearing systems. Brush DC motors
have a mechanical commutation,
meaning the motor life is dictated
by brush wear. BLDC and stepper
motors have electrical commuta-
tion, which provides a potentially
longer motor life. Bearings also af-
fect motor life, with ball bearings
providing longer life than sleeve
bearings. Motor technologies offer
both bearing versions, with some
Athlonix™ DCP high-power-density brush DC mini
motors feature an energy-efficient coreless design.
(Credit: Portescap)
thus increase the speed requirements on the motor
by the corresponding ratio. (Credit: Portescap)
providing them as standard and
others requiring customization.
• Weight. Because biologic drug-delivery
devices are portable, weight can signifi-
cantly affect patient comfort. Brush DC
coreless motors are the lightest option.
• Cost. Each motor technology has a cost
profile based on its design. The device
and accompanying therapy mandate a
cost profile for market acceptance, so
engineers need to understand the cost
drivers for each motor type.
Comparing the various motor technolo-
gies and how they function in different
drug-injection devices is a necessary part of
device design (see Table 3). Referencing a
checklist like the one above can help de-
sign engineers assess motor options for
their impact on device cost, efficiency, and
user experience more effectively.
Partner With a Motor Supplier Early in
the Design Process
As biologic drug treatments contin-
ue to increase in the market, each ap-
plication presents its own challenge in
terms of biologic therapy require-
ments. Connecting with a motor sup-
plier early in the development process
can help designers and manufacturers
identify the best motor technology and
accessories to create an optimal drug-
delivery device.
This article was written by Jigar Fulia, Divi-
sional Manager, Product Design and Develop-
ment, and Kanti Vala, Research and Develop-
ment Manager, Product Design and Development,
Portescap, West Chester, PA. For more informa-
tion, visit http://info.hotims.com/82323-346.

26 www.medicaldesignbriefs.com Medical Design Briefs, July 2022

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For more information, visit www.medicaldesignbriefs.com/
roundup/0722/IVF.
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 31
n Understanding Titanium’s
Biocompatibility
Scientists used photoelectro-
chemical measurement and x-ray
photoelectron spectroscopy to
clarify the source of titanium’s
biocompatibility when implanted
Band gap energies of the pas- into the body, as with hip replace-
sive film on Ti are relatively ments and dental implants. They
small that is one factor gener- find that its reactivity with the
ating the excellent biocompati-
bility. (Credit: Tokyo Medical correct ions in the extracellular
and Dental University) fluid allows the body to recognize
it. This work may lead to a new
generation of medical implants that last longer.
The researchers tested thin disks of titanium in a solution
containing ions meant to mimic the extracellular fluid of the
body, as well as in saline. They measured how much photoelec-
trical current was generated when light of various wavelengths
was illuminated on the disks. They also performed x-ray photo-
electron spectroscopy to characterize the passive films that
were naturally present on the surface of the titanium.
Passive films consisted of a very thin TiO2 layer containing
small amounts of Ti2O3 and TiO, hydroxyl groups, and water.
The reactivity of titanium with high corrosion resistance, as re-
vealed in this experiment by its electronic band structure, is
one of the primary reasons for its excellent biocompatibility
among metals. This research may lead to safer and less-­
expensive implants for hip replacements or dental implants,
because titanium is relatively rare and expensive.
For more information, visit www.medicaldesignbriefs.com/
roundup/0722/titanium.
n Rapid Sensor Chip for
Real-Time THO Monitoring
Scientists have developed a dis-
posable, paper-based THO sen-
sor consisting of an electrode
made of molecularly imprinted
graphite. Since MIPs are de-
signed using the target molecule
A low-cost sensor chip with
graphite-based molecularly im- as a template, the team used
printed polymer as the electrode THO as a template when devel-
for detecting and monitoring
theophylline levels. (Credit: Ya- oping the sensor’s carbon-based
suo Yoshimi/SIT, Japan) electrode paste. The synthesized
paste was then loaded onto a
printed sensor chip and its THO detection abilities were tested.
The sensor was found to be highly sensitive (meaning it
could detect even small amounts of THO) and showed great
selectivity toward the drug. In fact, the sensor could identify
THO even in samples with THO concentrations as low as 2.5
µg/mL. The sensor needs only 3 seconds to detect THO.
The portable, low-cost, reliable, and rapid sensor has long-
term stability and can be used for the real-time detection of
drugs like THO without depending on sophisticated equip-
ment. The fabrication strategy provided in this study can be
used to develop efficient electrochemical sensors for various
other clinical interventions
For more information, visit www.medicaldesignbriefs.com/
roundup/0722/sensor.
 n Deep UV Lasers for
Device Sterilization
Engineers have created a
deep-ultraviolet (UV) laser us-
ing semiconductor materials
that show great promise for im-
proving the use of UV light for
sterilizing medical tools, among
A lab setup used to operate a
deep-ultraviolet laser-emitting de- other applications. The alumi-
vice. (Credit: Cornell University) num gallium nitride-based de-
vice is capable of emitting a
deep-UV laser at sought-after wavelengths and modal line widths.
The team used molecular beam epitaxy, a crystal growth tech-
nique, to grow a high-quality crystal of aluminum nitride.
The second challenge was to create an optical cavity from the
stacked layers that could be used to trap the emitted light and
promote stimulated emission, which is necessary for the laser.
The cavity was created in the form of a small, micron-scale res-
onator on an aluminum nitride chip.
The laser was able to achieve peak gain at a wavelength of
284 nm and modal line widths on the order of 0.1 nm. The line
width is an order of magnitude more precise than similar devic-
es and demonstrates the growth method’s applicability toward
improved ultraviolet light emitters.
For more information, visit www.medicaldesignbriefs.com/
roundup/0722/lasers.
n Pulse Signal Sensor Patch
Uses Inkjet Printing Technology
Researchers have developed a
wearable sensor patch thinner than a
hair strand that can measure pulse
wave signals with high precision. The
patch was printed using inkjet print-
Pulse signal map created ing. Using this technology, wearable
by ultrathin wearable sen-
sors with 100 sensing electronic devices can be made by
pixels. (Credit: POSTECH) simply printing conductive ink on a
very thin substrate.
The team fabricated a pressure sensor that mimics skin’s
tactility and used it to enable physical pulse waves to be de-
tected by the patch just as they are detected by the fingers.
The researchers also used a patch-type device with 100 sen-
sor pixels to obtain a two-dimensional (2D) pressure map on
the wrist.
The researchers successfully created a 2D pressure map to
accurately obtain the pulse wave signals and analyzed their
strengths to locate the invisible arterial blood vessels. More-
over, they developed sensor patches of various sizes by taking
age, gender, and body sizes into consideration.
The newly developed technology allows for at-home diagno-
sis of diseases that are usually performed only at hospitals.
For more information, visit www.medicaldesignbriefs.com/
roundup/0722/patch.

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32 www.medicaldesignbriefs.com Medical Design Briefs, July 2022

‘Bionic’ Pacemaker Reverses Heart Failure
The pacemaker
re-establishes the A Heart Rate (bpm)
heart’s naturally 120
irregular beat. 110
Cardiac output
(L/min)
University of Aukland
100

Aukland, New Zealand RSA 0.1 Blood pressure

0.0 (mmHg)
RSA -0.1
Pacemaker
A revolutionary pacemaker that
Diaphragmatic EMG (mv)
re-establishes the heart’s naturally ir-
regular beat is set to be trialed in New B
Zealand heart patients this year, fol-
lowing successful animal trials. acclim. embolizations develop HF acclim. surgery recovery baseline pacing off-pace
“Currently, all pacemakers pace the 1 week 3-4 weeks 8-10 weeks 1 week 1-2 weeks 1 weeks 4 week 1 week
heart metronomically, which means a
very steady, even pace. But when you C D
record heart rate in a healthy individu- 90 Control animal 120 Heart failure
DEMG (mv) HR (bpm)

DEMG (mv) HR (bpm)

al, you see it is constantly on the
move,” says Prof. Julian Paton, a lead
researcher and director of Manaaki 70 100
Manawa, the Centre for Heart Re- 0.1 0.1
search at the University of Auckland.
Manaaki Manawa has led the re-
search and the results have just been -0.1 -0.1
2 secs 2 secs
published in leading journal Basic Re-
search in Cardiology. E F
“If you analyze the frequencies with- 120 Monotonically paced 120 RSA paced
DEMG (mv) HR (bpm)

DEMG (mv) HR (bpm)

in your heart rate, you find the heart

rate is coupled to your breathing. It
goes up on inspiration, and it goes
down on expiration, and that is a natu-
ral phenomenon in all animals and
humans. And we’re talking about very
ancient animals that were on the plan-
et 430 million years ago.”
Twelve years ago, Paton was a mem-
ber of a group of scientists who decided Schematic representation of the experimental setup. (Credit: Shanks, J., Abukar, Y., Lever, N.A. et al. Re-
to investigate the function of this vari- verse re-modeling chronic heart failure by reinstating heart rate variability. Basic Res Cardiol 117, 4, 2022)
ability. They made a mathematical
model that predicted it saved energy. That
made them question why a metronomic
heartbeat was used in heart-failure patients
who lacked energy. They asked, “Why ar-
en’t we pacing them with this variability?”
All cardiovascular disease patients lose
the heart rate variability, which is an early
sign that something is going wrong.
“People with high blood pressure, peo-
ple with heart failure, their heart rate is
not being modulated by their breathing.
It may be a little bit, but it’s very, very de-
pressed, very suppressed,” Paton says.
“We decided that we would put the
heart rate variability back into animals
with heart failure and see if it did any-
thing good,” says Paton.
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 33
100 Avg. HR 110 bpm
0.1
-0.1
2 secs
Following positive signals in rats, the
latest published research was on a large
animal model of heart failure, per-
formed by Dr. Julia Shanks and Dr. Ro-
hit Ramchandra.
“And the big news is that we believe we
have now found a way to reverse heart
failure,” Dr. Ramchandra says.
Dr. Shanks, the research fellow who car-
ried out the research, explains, “There’s
nothing really on the market that will cure
heart failure. All the drugs will do is make
you feel better. They don’t address the is-
sue that you’ve got damaged tissue that’s
not contracting as efficiently as it was.
“Our new pacemaker brings back
this variability, which of course is natu-
100 Avg. HR 107 bpm
0.1
-0.1
2 secs
ral, in a way you could call it ‘nature’s
pacemaker.’”
Dr. Ramchandra adds, “Currently,
pacemakers trigger a metronomically
steady beat, but this study shows intro-
ducing a natural variation in the heart-
beat improves the heart’s ability to pump
blood through the body. The other big
news is that we get a 20 percent improve-
ment in cardiac output, which is effec-
tively the ability of the heart to pump
blood through the body. And 20 percent
is a big number.”
“The pacemaker is almost like a bion-
ic device,” says Paton. “It understands
the signals from the body that tell the
device when we’re breathing in and
when we’re breathing out. And then
the device has to communicate back to
the body and pace the heart up during
breathing in and down during breath-
ing out.”
On seeing the results, interventional
cardiologist Dr. Wil Harrison from Mid-
dlemore Hospital says, “Very interesting
study. We do recognize clinically that
permanent pacing is non-physiological
to a certain degree, and pacing-induced
cardiomyopathy is a well-recognized
phenomenon. It will be exciting to see if
the findings translate over to humans.”
Dr. Martin Stiles, a cardiologist from
Waikato Hospital, who will lead the trial,
adds, “We typically see improvements in
heart function with current pacemakers,
but this bionic pacemaker has far exceed-
ed our expectations. This discovery may
revolutionize how heart failure patients
are paced in the future.”
The next steps are well under way, with
plans to recruit patients into a trial
planned for later this year in New Zea-
land. The trial will be supported by Ceryx
Medical, a start-up company that owns
the IP on the unique electronics within
the bionic pacemaker.
The study was funded by the Health
Research Council of New Zealand.
For more information, visit www.auckland.
ac.nz.

Peeling Back the Layers: Adhesives Testing for Wearables

As wearable devices
become more widespread,
mechanical testing methods
must develop in parallel.
Instron
Norwood, MA

Trends in wearable technology follow

those of the broader biomedical and elec-
tronics industries — devices are getting
smaller, smarter, and easier to use. Specifi-
cally, wearables in healthcare have moved
toward solutions that reduce the device
profile, provide more integration with
smartphone apps, and most importantly
enable patients to receive their treatments
at home, outside of a doctor’s visit. These
wearable devices range from on-body
drug-­delivery systems for cancer treatment
to electrical nerve stimulation patches or
simply sensors to monitor vitals. All treat-
ments increase patient autonomy and are
rapidly increasing in popularity.
As this trend continues, manufactur-
ers are working to develop robust testing
methods to mechanically evaluate all as-
pects of these devices and ensure that
they are performing as expected. In ad-
dition to testing the injection device
components, manufacturers face chal-
Instron’s 6800 Series universal testing system is used to perform a 90° peel test to ASTM D3330.
lenges in evaluating and selecting the This test establishes baseline properties for adhesives and can also be used to evaluate adhesives
adhesives for their products. after they have undergone conditioning to simulate real-world stresses. (Credit: Instron)

n Challenges in Adhesive Selection
Innovation in the field of medical
adhesives has been ongoing since
Band-Aids® were invented in 1921.
Medical adhesives have long been used
in ECG sensors, medical tapes, and
bandages. However, the rise of wear-
ables and more specifically on-body
drug-delivery systems has intensified
34 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
the need for standardization and test-
ing of adhesives that must stay on the
body for extended periods of time.
Scientists have long understood that
designing adhesives for use on skin is
uniquely challenging. Skin regenerates
approximately every 27 days, and its sensi-
tivity to different adhesives is dependent
on biocompatibility factors such as age,
allergens, hair, moisture/sweat levels, and
how the adhesive itself performs over
time and under different environmental
conditions. Adhesives used on skin must
be able to withstand products like soap or
lotion and not degrade or react to contact
with these substances. Additionally, a
wearable device designed for extended
use needs to withstand the motions and
forces of day-to-day life while ensuring pa-
tient comfort.
Most medical pressure sensitive ad-
hesives (PSAs) are made of either rub-
ber, acrylic, or silicone-based adhe-
sives. Each type is best suited to meet
different challenges, including length
of adhesion time, possible allergic re-
actions, and patient comfort upon ap-
plication/removal.
ASTM D3330 Methods A and F mea-
sure the peel strength required to re-
move pressure-sensitive adhesives from
a standard steel panel or from another
surface of interest at 90° or 180°, re-
spectively. The adhesive is carefully
­applied to the test panel using a me-
chanical roller of specified require-
ments. The specimen is then peeled
away from the substrate at a set rate,
and the average adhesion force is re-
corded over the course of the test.
The peel adhesion value is reported in
N/10 mm. This test mimics removing
an adhesive patch from a patient’s skin
and can also serve as a baseline test to
compare back to after a specimen is
conditioned.

n Adhesives Testing for Wearables

ISO 11608 is the internationally recog-
nized standard for testing needle-based
injection systems (NIS) for medical use.
In 2021, a new section of ISO 11608-6 fo-
cused on on-body delivery systems was
released as a draft. While this new sec-
tion establishes standard practices for
testing many aspects of these novel drug-
delivery devices, it is still vague in how it
recommends testing the adhesives used
for these devices.
ISO 11608 points toward established
standards like ASTM D3330 for character-
izing the fundamental adhesive proper-
ties of the material. However, it does not
provide recommendations for how to test
the more functional aspects such as the
torsional, shear, and peel forces encoun-
tered by these devices in practice.

Instron’s 6800 Series universal testing system

with a Torsion Add-On is used to apply both axial
and torsional loads to adhesives and other materi-
als. It is used to simulate loads that a wearable
device may experience while being worn by a pa-
tient. (Credit: Instron)

Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 35

 Tack tests are another functional test
used to demonstrate how quickly an ad-
hesive bond is formed. A pressure-­
sensitive adhesive is put in contact with a
known substrate at a given load for a set
amount of time in order to determine
the load required to separate the two.
One way to achieve this is by using an au-
tomatic XY translation stage. The adhe-
sive patch is secured to the stage, and an
upper probe with a flat surface is used as
the substrate surface. The stage automat-
ically moves between test points and
runs the same test procedure on each,
providing the adhesive strength across
the full contact area of the patch.
Additionally, preconditioning materi-
als under temperature, moisture, or oth-
er conditions can also provide useful in-
formation about how an adhesive’s
properties might change. Temperature
or environmental chambers set to mimic
body temperature, or slightly elevated or
lower temperatures, provide other use-
ful test circumstances under which to
evaluate these materials.
n Conclusion
As wearable devices become more
prevalent, innovation and standard-
ization of their mechanical testing
continues to develop. Manufacturers
of testing equipment must work with
global biomedical companies to en-
sure that these developing testing needs
can be met.
This article was written by Meredith Bern-
stein, Applications Engineer at Instron, Nor-
wood, MA. For more information, visit
http://info.hotims.com/82323-341.

Joystick-Operated Robot Could Help Surgeons Treat

Stroke Remotely
The system could provide
teleoperated endovascular
treatment to patients
during the critical
time window after a
stroke begins.
MIT
Cambridge, MA

A telerobotic system helps surgeons

quickly and remotely treat patients ex-
periencing a stroke or aneurysm. With a
modified joystick, surgeons in one hos-
pital may control a robotic arm at an-
other location to safely operate on a
patient during a critical window of time
that could save the patient’s life and
preserve their brain function.
The robotic system, whose movement
is controlled through magnets, was de-
signed by MIT engineers to remotely as-
sist in endovascular intervention — a
procedure performed in emergency situ-
ations to treat strokes caused by a blood
clot. Such interventions normally re-
quire a surgeon to manually guide a thin
wire to the clot, where it can physically
clear the blockage or deliver drugs to
break it up.
One limitation of such procedures is
accessibility: Neurovascular surgeons are
often based at major medical institutions
that are difficult to reach for patients in
remote areas, particularly during the
golden hour — the critical period after a
stroke’s onset, during which treatment
should be administered to minimize any
damage to the brain.
36 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
MIT engineers developed a telerobotic system to help surgeons remotely treat patients experiencing
stroke or aneurysm. With a modified joystick, surgeons may control a robotic arm at another hospital to
operate on a patient. (Credit: MIT)
The MIT team envisions that its robot- ing, neurosurgeons were able to remote-
ic system could be installed at smaller ly control the robot’s arm to guide a wire
hospitals and remotely guided by trained through a maze of vessels to reach target
surgeons at larger medical centers. The locations in the model.
system includes a medical-grade robotic “We imagine, instead of transporting a
arm with a magnet attached to its wrist. patient from a rural area to a large city,
With a joystick and live imaging, an oper- they could go to a local hospital where
ator can adjust the magnet’s orientation nurses could set up this system. A neuro-
and manipulate the arm to guide a soft surgeon at a major medical center could
and thin magnetic wire through arteries watch live imaging of the patient and use
and vessels. the robot to operate in that golden hour.
The researchers demonstrated the sys- That’s our future dream,” says Xuanhe
tem in a phantom, a transparent model Zhao, a professor of mechanical engi-
with vessels replicating complex arteries neering and of civil and environmental
of the brain. With just an hour of train- engineering at MIT.
 Endovascular surgery is a specialized,
Real-time Teleoperaton of system minimally invasive procedure that in-
volves carefully twisting and guiding a
Remote Control thin medical wire through the body’s ar-
of Robot Arm teries and vessels to a target location, in
a way that avoids damaging vessel walls.
The procedure typically requires years of
training for a surgeon to master.
Joystick Robotic systems are being explored as
Knob
assistive technologies in endovascular
Magnet surgery. These systems mainly involve
motor drives that advance and retract a
wire while twisting it through the body’s
vasculature.
Neurovascular “But having a robot twist with the same
Phantom
level of sophistication [as a surgeon] is
challenging,” Kim notes. “Our system is
based on a fundamentally different
mechanism.”
The MIT team envisions that its robotic system could be installed at small hospitals and be remotely The team’s new system builds on work
guided by trained surgeons at larger medical centers. (Credit: MIT) from 2019, in which they demonstrat-
ed steering a magnetically controlled
Zhao and his team have published er, Robert Regenhardt, Justin Vranic, thread through a life-sized silicone mod-
their findings in Science Robotics. Adam Dmytriw, and Aman Patel at el of the brain’s blood vessels. They did
MIT co-authors include lead author Massachusetts General Hospital (MGH), so at the time using a handheld magnet,
Yoonho Kim, Emily Genevriere, and and Marcin Balicki of Philips Research about the size of a soup can, that they
Jaehun Choe, along with Pablo Hark- North America. manually manipulated.

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 They have since affixed the magnet to
the end of a medical-grade robotic arm,
which can be steered using a small joystick
knob on a mouse. By tilting the joystick, re-
searchers can tilt the magnet in an orienta-
tion that a magnetic wire can follow. But-
tons on the mouse control a set of motorized
linear drives, which advance and retract
the wire to make it move forward and back.
The wire is as thin and flexible as a
conventional neurovascular guidewire,
with a soft, magnetically responsive tip
that follows and bends in the direction
of a magnetic field.
n Finding a Path
The team tested the robotic system in
MGH’s Catheter Lab — an operating
room with standard medical imaging
equipment used in endovascular proce-
dures. The researchers installed the robot-
ic arm in the lab, along with a life-sized sil-
icone model of blood vessels. They set the
joystick, along with a monitor displaying a
live video of the model, in a control room.
From there, an operator watched the vid-
eo while using the joystick to remotely
steer the wire through the vessels.
The team trained a group of neurosur-
geons to use the robotic system. After
just one hour of training, each surgeon
was able to successfully operate the sys-
tem to guide the wire through complex
vessels that are difficult to navigate with
a manual guidewire.
The team also used the robotic system
to clear simulated clots in difficult-­ to-
reach areas in the model. They steered
the guidewire through vessels, and
around sharp corners and turns, to reach
regions where the researchers simulated
clots. Once they guided the wire to the
clot, the surgeons proceeded with stan-
dard endovascular methods to thread a
microcatheter along the wire to the site of
the clot. They retracted the wire, leaving
the catheter, which they then applied to
successfully remove the clot.
“The primary purpose of the magnetic
guidewire is to get to the target location
quickly and safely, so that standard devic-
es like microcatheters can be used to de-
liver therapeutics,” Kim says. “Our sys-
tem is like a pathfinder.”
He hopes that the teleoperated system
can help more patients receive time-­
critical treatment. He also sees benefits
for surgeons, who typically perform such
vascular procedures in the same room as
the patient, while being exposed to radi-
ation from x-ray imaging.
“The neurosurgeons can operate the
robot in another room or even in anoth-
er city without repeated exposure to
x-rays,” Zhao says. “We are truly excited
about the potential impact of this tech-
nology on global health, given that
stroke is one of the leading causes of
death and long-term disability.”
This research was supported in part by
the National Science Foundation, the
National Institutes of Health, and Phil-
lips Research of North America.
This article was written by Jennifer Chu,
MIT. For more information, visit https://
news.mit.edu. A video of the technology is
available at https://www.youtube.com/
watch?v=IYlHl6h8lm4&t=1s.

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38 www.medicaldesignbriefs.com Medical Design Briefs, July 2022

How Automation Can Improve Tubing Manufacturing

A s the cost of shrink tubing used in the production of

catheters has increased, and supply chain issues caused
delivery delays, FEP shrink tubing, for example, has become
a very expensive throw-away item for medical device manu-
facturers. Engineering Resources Group (ERG), a product
and process development company that specializes in auto-
mated processes for fabrication, assembly, inspection, and
testing operations, works closely with clients to determine
the best ways to meet their tubing manufacturing needs.
ERG provides solutions designed to improve client process-
es and reduce costs. Some medical device manufacturers
have turned to ERG for machinery to enable them to make
the tubing in house. It can be a painstaking process working
with a delicate feedstock. ERG engineers, however, have de-
veloped a fully automated, self-contained process that is sim-
ple to operate. One key to this development is a unique
puller assembly that deftly handles the fragile tubing as it
enters and exits, facilitating the system’s automation.

n How the System Works

ERG has developed a way to create shrink tubing from
regular tubing through a process that includes pressuriza-
tion, lubrication, heating, expansion, cooling, washing, and
drying. The first step of the process employs a Versa Cater-
pillar puller with pneumatic belt closure, pulling the tubing
from a spool in a controlled way and presenting it to the A Versa Caterpillar puller with pneumatic belt closure pulls the tubing from a
system. Powered by servo motors with planetary reduction spool in a controlled way. (Credit: Versa Machinery)
gearboxes, the model C-22 pullers are well suited for the
task because they provide uniform pressure and consistent
feed rates. ERG uses a, FDA-approved 40-durometer Neo-
prene belt; however, a variety of belt material options are
available to choose from. Although this model puller can
handle speeds of up to 450 ft per minute, the ERG process
generally runs at between 10 and 20 ft/min. Maintaining
that speed is critical so that the tubing isn’t stretched or
­deformed.
After passing through the first Versa puller, the tubing is
lubricated to ease its journey through the other system stag-
es. It is heated and then pressurized with nitrogen, which
allows the pressurized tubing to expand. Then the tubing
passes through a water bath for a controlled cooling process
where it freezes in the stress of expansion. Next it enters a
drying chamber before it is pulled by another Versa C-22
Caterpillar Puller on the back end, which presents the fin-
ished tubing to a special automated cutter that produces the
desired lengths while maintaining the pressure in expan- Versa model C-22 pullers provide uniform pressure and consistent feed rates.
sion process. (Credit: Versa Machinery)
The C-22 pullers apply just enough pneumatic pressure to
convey the tubing through the system without deformation. This adjustable, uniform pressure moves the tubing through
The input and output puller speeds are controlled by the ma- the process without any elongation or other deformation.
chine controller with the output puller being primary and the Compact C-22 pullers fit nicely within the machine’s overall en-
input puller speed offset as needed to prevent the tubing from closure, as well.
stretching.
The caterpillar design applies uniform pressure over the en- n Pneumatic Actuation Is Key
tire traction length. Pressure is adjustable, allowing a different In addition to the uniform pressure and compact size, a key
grip on tubing with thicker or thinner sidewalls, for example. aspect of the puller design is its pneumatic actuation. ERG
Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 39

The C-22 is a 2 × 9 in. (50.8 × 228.6 mm) traction length caterpillar extrusion
puller assembly, with timing belts and pulleys. (Credit: Versa Machinery)
chose the Versa Caterpillar pullers because they open and close
pneumatically, allowing the process to be automated for con-
trol and safety.
“Whenever there’s an alarm or an error in the system, the ex-
pander’s controller sends a signal to open the pneumatic cylinders
without stopping the belts,” says Chris Ross, ERG president. “Then,
A unique puller assembly handles the fragile tubing as it enters and exits the system, facilitating the system’s automation. (Credit: Versa Machinery)
40 www.medicaldesignbriefs.com Medical Design Briefs, July 2022
once the situation is attended to, we send another signal to
close the pneumatic cylinders and get back into production.”
Ross highlights the Versa pullers’ functionality and longev-
ity. The C-22 has a 2-in.-wide belt with a 9-in. traction length
and a maximum opening of 2 in., which easily accommo-
dates the tubing that ERG uses. Should ERG opt for a larger
tubing size, the company’s C-44 features a 4-in.-wide belt and
a 4-in. opening, while the model 418 provides 18 in. of trac-
tion length; both are available with pneumatic opening.
Ross began testing the Versa pullers around 2016 and has
been using them ever since. Several other pullers ERG ini-
tially considered use hand cranks to change the distance be-
tween the feed belts. Though functional, these cranks would
not allow the automation that is ERG’s hallmark.
Ross says that Versa Machinery is the ideal companion to
ERG’s process automation. “We’ve used them on every ma-
chine of this type that we build here,” he says . “We use
them exclusively. We looked at others, but even if the form
and fit were right, without the pneumatic belt opening we
couldn’t use them.”
In addition to being ideal for automation, the Versa pull-
ers are designed to be durable. All Versa pullers include
heavy-duty steel tables with a 3/8-in.-thick steel plate and ¼
× 2-in. angle iron. Custom stainless-steel guarding was add-
ed for this ERG medical application. That guarding, along
with a durable powder coat paint, ensures the pullers can
work for years in some of the toughest environments imag-
inable. “We’ve replaced some belts as needed, but we’ve
never had to repair or service a puller,” says Ross.
With this combination of durable, automated machines
from Versa, and ERG’s automation experience and innova-
tion, medical device manufacturers have access to a system op-
tion designed to ensure that their shrink tubing will be made
efficiently and cost-effectively.
This article was written by Logan Montgomery, Versa Machinery,
Elkhart, IN. For more information, visit http://info.hotims.com/
82323-344.
 PRODUCT OF THE MONTH
2022 Product of the Year

n Long-Wear Medical Tape Finalist

A medical adhesive from 3M, St. Paul, MN, has been developed for extended wear devices that require attach-
ment to the skin for up to a 21-day wear time. The Spunlace Extended Wear Adhesive Tape on Liner, 4576, is de-
signed for devices that must be worn by patients for several weeks. The acrylate-based adhesive is flexible and
conformable. With its excellent adhesion to the skin, this new product is said to be ideal for devices that require
continuous extended wear, both in and out of care facilities.
For Free Info Visit http://info.hotims.com/82323-347

Product Focus: Connectors/Wires/Cables

n Barb Connectors n High-Voltage Connector

Qosina, Ronkonkoma, NY, has intro-
duced 25 new tube-to-tube barb con-
nectors to its portfolio. The connectors
available in more than 500 configura-
tions. These connectors accommodate
inner tube diameters as small as 1/32
in. (0.031 in., 0.8 mm) and as large as 1
in. (25.4 mm). Styles include reducing and non-reducing, Y, cross,
elbow, T, straight, and barbs with luer connectors. Available materi-
als include Kynar, PP, and PC.
For Free Info Visit http://info.hotims.com/82323-349
Overmolded Cable
Connectors
Binder, Camarillo, CA, has
launched a series of 8-pin cable
connectors, equipped with molded,
UL-approved PUR or PVC cables.
The series is designed primarily for
use in applications where liquid media are found. The 770 NCC
(not connected closed) series provides level IP67 protection, be-
ing dust-tight and shielded against temporary submersion. Un-
plugged, they are rated IP54, protecting against contact, dust, and
splashing water. A reliable and easy-to-use bayonet locking system
ensures quick and safe mating and unmating, and molded, UL-­
approved PUR or PVC cables make field assembly unnecessary.
The cable cross-section is 8 × 0.25 mm² and the cable jacket diam-
eter is 6.0 mm.
For Free Info Visit http://info.hotims.com/82323-350
LEMO, Rotkreuz, Switzerland,
has introduced a multi-contact
high voltage connector. The RE-
DEL ® 2P Multi-Contact High Volt-
age Connectors are available in 2,
5, and 8 contact configurations.
They are designed for medical applications where compliance
to user safety IEC 60601-1 (Rev. 3) is required, including PFA
(pulsed field ablation) and PEF (pulsed electric field) cathe-
ter and cardiac applications technologies. The connectors
address 2 MOPP/2 MOOP (Means of Patient/Operator Pro-
tection), which increases the air clearance and creepage dis-
tances to guarantee user safety. Building on the 2P series leg-
acy in medical applications, the new connectors are an ideal
solution for PFA and PEF catheter and cardiac applications
technologies.
For Free Info Visit http://info.hotims.com/82323-351
n Coaxial Cables
Coaxial cable as-
semblies from Times
Microwave, Walling-
ford, CT, deliver RF power from the equipment room to the elec-
tromagnetic coils. The LMR®-900 and LMR®-1200 are designed to
meet the high-power demands of magnetic resonance imaging.
The cables’ inherent flexibility allows easy handling during installa-
tion. The high-performance cables are available in flame-resistant
and low-smoke options.
For Free Info Visit http://info.hotims.com/82323-348

Compact Digital Microscope Variable Resistors

Vision Engineering, New Milford, CT, has
launched a new, compact digital microscope for a
wide range of applications. The VE Cam digital mi-
croscope is available in two variants with differing
fields of view (FOV). VE Cam 50 (50 mm FOV)
and VE Cam 80 (80 mm FOV) enable users to do
more within a smaller footprint, making it ideal for
many routine inspection tasks. It is a stand-alone
unit and does not require a PC, keyboard, or
mouse. With Wi-Fi screen sharing, results can be shared wirelessly to smart
devices and displays with screen mirroring. Enhanced productivity fea-
tures include 10 user-programmable presets, six hotkeys for instant one-
touch access to commonly used presets, and a configurable interface that
allows commonly used settings to be shown directly on the screen.
For Free Info Visit http://info.hotims.com/82323-354
TT Electronics, Woking, UK, has added four new
product families to its variable resistor portfolio.
These include three new encoder lines and a new
line of single-turn potentiometers. The EN10 en-
coders feature an insulated hollow shaft and IP40
rating, offering a rotational life of 100,000 cycles
minimum in a 10 mm package. EN16AB includes an
IP51 rating in 16 mm packaging, while EN18AB of-
fers either IP51 or IP67 versions in its 18 mm foot-
print. Both variable resistors provide rotational life
of 30,000 cycles minimum and maintain positional information should
power loss occur. The PHS21 series rotary potentiometers convert rotary
motion into a change of resistance, resulting in a smooth transition of
voltage or current levels.
For Free Info Visit http://info.hotims.com/82323-362

Medical Design Briefs, July 2022 www.medicaldesignbriefs.com 41

n ISTA Certified Testing n Linear Power Supplies
The testing laborato- Custom linear power supplies for a wide range of applications are
ries at TÜV SÜD, Mu- available from Polytron Devices, Paterson, NJ. The P3 and P5 low-
nich, Germany, have re- noise linear power supplies provide multiple output voltages in a
ceived full accreditation single model. Other custom options include programmability, ON-
from the International OFF switches, and a variety of types such as open frame, desktop, and
Safe Transit Association wall plug-in models, in addition to enclosed units for harsh environments. Power capability rang-
(ISTA). Manufacturers es from 30 to 450 W. Evaluation samples and safety-test units are available.
can have their packag- For Free Info Visit http://info.hotims.com/82323-364
ing tested and certified
for transport safety in n Linear Voice Coil Motor
accordance with all A new miniature metric linear voice coil motor is available from Moti-
wide­spread ISTA series. cont, Van Nuys, CA. The LVCM-013-008-02M linear voice coil motor, also
Packaging testing includes simulating the known as a moving coil motor, is only 12.7 mm (0.500 in.) in diameter. The
mechanical and climatic conditions that stroke length is 3.175 mm (0.125 in.) and the length at mid-stroke is just
products may encounter during transporta- 12.7 mm (0.50) in. long. The miniature voice coil motor has a high force-
tion and storage. It explores how the prod- to-size ratio with a continuous force of 0.86 N (3.1 oz) and a peak force of 2.73 N (9.8 oz). The
ucts are shipped, what stresses they are ex- brushless DC linear servo motor features high acceleration/deceleration and low inertia and is ideal
posed to, which requirements of the industry, for haptic feedback in medical/surgical instruments.
and the application in question they need to For Free Info Visit http://info.hotims.com/82323-355
comply with, and which potential (new) mar-
kets are appropriate for the packaged prod- n Linear Motors
ucts. In the case of a positive result, an ISTA Siemens, Munich, Germany, offers three models of linear motors for
test certificate is issued. seamless integration with all Sinumerik or Simotion control systems us-
For Free Info Visit ing Sinamics drives. The new models are 1FN3 peak load motors, 1FN3
http://info.hotims.com/82323-353 continuous load motors, and 1FN6 magnet free secondary motors. 1FN3
peak load motors offer short time, high acceleration/deceleration, and velocity
rates comparable to S3 duty; 1FN3 continuous load motors provide long power-on
duration for horizontal, inclined, or compensated vertical axes. The 1FN6 magnet-
free secondary motors are ideal for long traverse lengths at high acceleration and velocity
EPOXY MEETS rates. They can be used for horizontal, inclined, or compensated vertical axes.
ISO 10993-5 For Free Info Visit http://info.hotims.com/82323-357
CERTIFICATION
Master Bond one-part ep- n Spiral Torsion Springs
oxy, EP4CL-80Med, is an John Evans’ Sons, Lansdale, PA, offers spiral torsion springs that allow
optically clear, very low
viscosity system that cures easily at 80–85 °C. This one- for rotation in two directions as well as a return to center capability. Used
part system possesses excellent dimensional stability in pairs at a right angle to each other, the springs enable a wide range of
and low shrinkage upon curing. EP4CL-80Med of- motion in a two-axis configuration, while preserving the return to center
fers an exceptionally high tensile strength and mod- feature. Spiral torsion springs are normally used in applications requiring
ulus as well as superb light transmission properties.
http://www.masterbond.com/tds/ep4cl-80med less than 360 degrees of rotation. They are generally used to obtain a large amount of torque
through a small amount of rotation. A typical application is a dental x-ray head.
For Free Info Visit http://info.hotims.com/82323-361
Master Bond
n Motion Smoothing
Teknic, Rochester, NY, offers regressive auto-spline (RAS) in its
ClearPath integrated servos. RAS is designed to go beyond tradition-
al motion smoothing algorithms such as S-curving or cosine smooth-
MEDTECH LEADERS ing by limiting the jerk and the jerk-derivative, resulting in smooth
Free annual publication from
www.medicaldesignbriefs.com
motion profiles. It can be configured with just a mouse click. It elim-
Medical Design Briefs features inates vibration with a simple one-click setup.
informative articles and pro- For Free Info Visit http://info.hotims.com/82323-356
files of leading companies
in 10 areas of technology:
Electrical Connectors/Wires/ n Prefilled Syringe Safety Device
Cables, Test & Measurement, A 1-mL safety device for prefilled syringes from Owen Mum-
Medical Robotics, Tubing/ ford Pharmaceutical Services, Oxford, England, has been ap-
Extrusion, Materials/Coatings/
2021
Adhesives, Motors/Motion proved as a combination product in Asia. In Europe, regulatory
Technology Leaders
Control, Orthopedics/Implants/ approval has also been granted for UniSafe 1mL, and the product
Prosthetics, Electronics, Contract Manufacturing/ is now available on the market as a combination product with a
Outsourcing, Gas/Fluid Handling/Pumps. drug for treatment of rheumatoid arthritis. The platform uses unique spring-free mechanism to
prevent accidental activation and drug leakage. The plunger rod has an integrated design so
www.medicaldesignbriefs.com/ that it cannot be pulled out when removing the needle shield or the device from its packaging,
techleaders21 eliminating the risk of accidental drug spillage and compromised sterility.
For Free Info Visit http://info.hotims.com/82323-359

42 www.medicaldesignbriefs.com Medical Design Briefs, July 2022

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