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Inside the
OEM: Baxter
Cybersecurity:
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www.medicaldesignbriefs.com September 2022

Inside the
OEM: Baxter
Cybersecurity:
Networked Medical
Devices
Using Cobots for
Biomedical Testing
SHOW PREVIEW:
BIOMEDevice Boston
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n COLUMN n APPLICATIONS
4 From the Editor 38 Why Cleanroom Assembly of Plastic Medical and Electronic
Devices Requires Ultrasonic Welding
n FEATURES
n DEPARTMENTS
6 Inside the OEM: Baxter
12 Cobots Offer Advantages for Biomedical Testing 25 R&D Roundup
Applications 40 New Products & Services
16 BIOMEDevice Boston Show Preview 42 Advertisers Index

n TECH BRIEFS n ON THE COVER

27 Tiny Robots Bring Healthcare Closer to Precisely Targeted
Drug Delivery
28 Surface Mount Technology for PCB Assembly Use Case
and SMT in Healthcare Systems
30 Helmet Made of Magnetic Metamaterials Could Improve
Brain Scans
31 Risk Management for Cybersecure Networked Medical
Devices
32 Medical Packaging: Automation of Thermoforming
Processes
34 Researchers Develop Rapid Lab-on-a-Chip for Cancer,
COVID Diagnostics
36 How RFID Can Help Healthcare Maintain an Effective
Working Environment
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 Private Equity Firms Are Driving Medtech M&A Activity in 2022
M edtech M&A volume continued at
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However, while medtech companies
are taking the opportunity to enhance
their portfolios and add capabilities,
the report, “Medical Device Outsourc-
ing Update,” indicates that private eq-
uity buyers are “unquestionably driv-
ing deal activity.”
4/1/22 8:57 AM
“Financial buyers have accounted for
15 out of 17 2022 transactions, with sev-
eral familiar names adding onto existing
platform investments. Private equity
firms have capitalized on healthy valua-
tions, which has been evidenced by suc-
cessful exits of their portfolio compa-
nies,” Capstone says.
The analysts point to several notable
deals, including Altaris Capital Partners
sale of Paramit, a developer and manu-
facturer of complex electronic medical
devices. The company sold for $1 billion
equating to ~20x EBITDA in June 2021.
“Altaris has continued to deploy capital
towards the sector, entering an agreement
to acquire Intricon in February 2022 for
an enterprise value of $221.1 million and
21.8x EBITDA. The strong valuation envi-
ronment is not only applicable to large
companies. Dealmakers have noted
double­-digit EBITDA multiples paid for
highly sought-after targets with less than
$10 million in EBITDA.”
Capstone notes that strong competi-
tion for quality assets in M&A processes
has been reflected in robust valuations.
The report says that “strategics and pri-
vate equity buyers have demonstrated
their willingness to pay premiums for
quality assets.”
The report finds that supply chain dis-
ruptions, labor constraints, and surgical
procedure delays have severely challenged
medical device OEMs through early 2022.
It notes that healthcare delivery organiza-
tions continue to combat significant work-
force shortages that have impacted the
scheduling of elective procedures, a key
revenue driver for OEMs.
Underlying dynamics such as an ag-
ing U.S. population, increasing preva-
lence of chronic diseases, and medical
technological advancements have creat-
ed a robust backdrop of demand for the
medical device and diagnostics seg-
ments. The stringent regulatory land-
scape created a significant incentive for
OEMs to outsource device manufactur-
ing and commercialization to organiza-
tions with expertise in navigating this
environment.
Sherrie Trigg
Editor and Director of Medical Content
For a copy of the report, go to https://bit.
ly/Capstone-medical-device-report-2022.
I T ’ S W H AT ’ S O N T H E I N S I D E T H AT C O U N T S
®

E L E C T R O N I C S C O R P.
Inside the
OEM:
Baxter
H
ow does a 100-year-old med-
tech company evolve yet still
retain its focus on the compa-
ny’s original mission? Baxter
has gone through many dif-
ferent phases and transformations. Now it
is looking forward to its next phase.
“If we think about the phases of trans-
formation of Baxter — how did we get
here ­ — it is worthwhile looking back-
wards to think about how we transformed
Baxter to the Baxter of today,” said José
(Joe) E. Almeida, chairman, president,
and chief executive officer, at the compa-
ny’s shareholder conference in May.
When Almeida joined the company in
2016, Baxter examined the strength of
the financial operations of the company.
“We went after free cash flow, we went af-
ter expenses, we went after cost reduc-
tions. We started to put the foundation in
the most important thing: patient safety
and quality. That became our number
one tenant in the company,” he said.
The New Baxter
To strengthen its financial position, Bax-
ter invested in operations and innovation.
That phase of the transformation set the
company up for the second phase in 2018–
2021, which was to execute on innovation.
6 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
José (Joe) E. Almeida, Chairman, President and
Chief Executive Officer, Baxter
To do that, Baxter created an ecosystem
and put in place medical affairs, clinical
trials, and regulatory affairs teams focused
on developing new products.
“The company was very focused on
pharmaceutical [products], but prior to
2016, very few products were launched
on the market,” said Almeida. “Today, we
have a cadence of new products.”
Almeida said the next step was to de-
termine how to get there. “And that was
when we decided to bring Hillrom into
Baxter. That acquisition was extremely
important to Baxter. We closed in De-
cember [2021], and it is pushing the
company forward, creating innovation
opportunities to expand the markets that
were in. That created the new Baxter.”
He said the new Baxter welcomed
10,000–12,000 employees from Hillrom to
make the company 60,000 people strong.
But, he said, “our mission is so strong. It is
one of the things that I did not change at
Baxter. I spent a lot of time reflecting on
what the mission of the company should
be. The mission of the company was well
established for many decades, and that
mission is to save and sustain lives.”
With the pivoting of the company into
more connected care and understanding
where the markets were going, though,
Baxter had to restate its vision, he said.
“Our vision now says that we’re going to
‘transform healthcare with a customer
focus in improving patient outcomes and
enhancing workflow efficiency.’ That’s
very important because we must create
the future by not only connecting devices
but also by creating intelligence behind
them, enabling cost-effective care. And
cost-effective care is two very specific vec-
tors: The first one is the ability to provide
effective clinical outcomes; the second is

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Inside the OEM: Baxter

[to do that] cost effectively. So that com-

bination becomes more and more im-
Innovation Market Operational Capital
portant as we go forward and pivot the
Expansion Efficiency Allocation
company in a new direction.”
Another way that Baxter broadened its
markets was through the development of
care sites (see Figure 2). Almeida said
Baxter was always strong in both the Connected Care Revenue Synergies Cost Synergies Portfolio Management
acute care market and the home care Core Therapies Geographic Expansion Digital Transformation Debt Repayment
market with peritoneal dialysis and par- Channel Expansion Quality, Safety, and Dividends
enteral nutrition therapies. “We are now Market Development Supply Chain Share Repurchases
Resilience
becoming more present with other busi-
ness such as PSS [patient support sys-
tems] and GSS [global surgical solutions]
and frontline care, which are the legacy Delivering Enhanced Value For All Stakeholders
Hillrom businesses.”
Fig. 1 – Broadened presence across the care continuum. (Source: Baxter 2022 Investor Conference)
The Effect of COVID-19
on Healthcare
“Once we went through COVID-19, we
found that a significant amount of care Hospital Home Alternate
Care Care Site Care
has moved away from the hospital,” said
Almeida, noting that this change will take Emergency, Surgical,
Primary Care, Dialysis Clinic,
Acute & Chronic Ambulatory Surgery Centers,
hold in the next 5–10 years. “You’re going Med Surg, Critical Care,
Home Care Immediate Care, Outpatient
Pharmacy, Care Comms
to see those changes, and Baxter wants to Cardiology, Infusion Clinics

be present. And to be present there, Renal Care

[we’ve] got to have products and innova-
tion that create that opportunity for us to
be a participant in those markets.”
When setting the strategy for the compa-
ny, he said, “The first thing we do is to look
at the trends that are currently in front of
us.” Because of the number of more com-
plex disorders, he said, will accelerate the
digital health transformation post
COVID-19. “I’m not saying that COVID-19
is gone, but looking at the transformation
took place, the circumstances of how care
is delivered today is very different. The era
of 2018–2019 and how healthcare was de-
livered is pretty much behind us. We’ve got
to look forward at the factors that are driv-
ing better healthcare and better access.
How things are reimbursed are changing
significantly as well as shifting from hospi-
tals to lower cost [care] settings. Access to
healthcare is not equal across the globe,
and Baxter is driving to create products
and technologies that are more accessible
in many more countries in the world so
people can get treated more effectively.”
Supply Chain: Putting the Plants
Where the Products Are Sold
One significant change that Almeida
said the company never spoke about in
the past was implementing an integrated
supply chain and how supply chain plays
a role in product development. In the
past, the company always looked at the
8 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
Pharmaceuticals & BPS
Medication Delivery
PSS & GSS
Frontline Care
Advanced Surgery
Clinical Nutrition
Acute Therapies
Fig. 2 – Compelling strategy for value creation. (Source: Baxter 2022 Investor Conference)
supply chain to deliver patient safety and
quality first and then addressed the
cost-effectiveness in making products to
“get the right product at the right cost at
the right time.”
“Things have probably most radically
changed in this area more than any-
where else. We grew up with putting
manufacturing locations [in areas] to
drive lower costs and taxes effectively.
When you look at the trend going for-
ward, it’s that you’ve got to put the plants
where you sell the product,” said Almei-
da. “And you’ve got to buy the compo-
nents where you have your plants be-
cause of the supply chain cost of moving
things around the world.
During Goldman Sachs’ annual global
healthcare conference in June, Almeida
noted Baxter’s philosophy is to “make
where you sell.”
“That [philosophy] will guide us in the
future on where to locate plants to alleviate
some transportation issues. You always have
this fragility that you as a company cannot
avoid, so how you prevent that is by maxi-
mizing the locations versus putting the
plants [in locations] that may be the most
advantageous for labor or tax rates.”
Four Strategic Pillars for Growth
Baxter’s strategies for value creation
are innovation, market expansion, oper-
ational efficiency, and capital allocation.
Its innovation will focus on connected
care and core therapies (see Figure 1).
Market expansion will encompass reve-
nue synergies, geographic expansion,
channel expansion, and market develop-
ment, while operational efficiency will
involve cost synergies and digital trans-
formation, as well as quality, safety, and
supply chain resilience. Finally, its capi-
tal allocation will entail portfolio man-
agement, debt repayment, dividends,
and share repurchases (see Figure 4).
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Inside the OEM: Baxter

fied a good M&A target (see Figure 5).

“We have done this in the past when we
Sites of Care:
Hospital Home Alternate found that Hillrom and Baxter would
Care Care Site Care make a powerful combination. If you think
about these strategies derived from our
Innovation Connected Care Core Therapies market dynamics, how does that affect our
Focus: market growth and what markets we are in?
Devices or software that can connect, Core therapies and essential products
communicate, and/or analyze data to help designed to address patient and provider
What we found in the acquisition of Hill-
transform healthcare needs rom is an uptick of our weighted average
market growth rates (WAMGR). So today
we have a sustainable market growth of 3–4
Analytics
percent,” said Almeida. “The opportunities
“Smart” Devices Communications

and the CAGR [compound annual growth

rate] growth of our businesses are dispro-
Generating ~$800M In Anticipated Incremental New Product Revenue By 2025
Generating ~$1 In Anticipated New Product Revenue Through 2025
1 portionately allocated to the Hillrom busi-
Fig. 3 – Innovating with connected care and core therapies. (Source: Baxter 2022 Investor Conference) nesses that came into Baxter because the
markets are shifting into more connected
health rather than solely capital products.
In the total market of $130 billion, we have
a WAMGR of 3–4 percent in each our busi-
nesses today. In every single market, Baxter
Revenue Synergies Geographic Expansion Channel Expansion Market Development growth is above or at market growth.”
To achieve this growth, Almeida says
✓ Utilizing Baxter ✓ Prioritizing targeted ✓ Broadening access to ✓ Increasing adoption the company will focus on connected
geographic footprint geographies new customers of underpenetrated care and then core therapies (see Figure
to introduce Hillrom therapies
portfolio
✓ Introducing products ✓ Furthering expansion 3). But connected care is not just jargon, he
into attractive with connected ✓ Providing education says. “It is an enablement for better in-
✓ Expanding value- markets devices and advocacy to
added services improve access sight. So how are we going to create
smart devices? We’re planning to con-
nect devices — smart devices and the
Contributing ~$300M Incremental Sales Through Market Expansion Efforts By 2025 ability to communicate and integrate
Fig. 4 – Executing market expansion through focused initiatives. (Source: Baxter 2022 Investor with hospital systems and integrate
Conference) amongst themselves to create sites.”
He says that although there is an advan-
Enterprise-Wide M&A Themes tage to connecting devices and moving
Hospital Automation & Hospital & Remote Point-of-Care (POC) & Home & Alternate Site
data around, the ultimate goal, the aspira-
Connectivity Monitoring Companion Diagnostics Therapies tion, is to create intelligence behind them
with algorithms that help clinicians in
Cardiology such a tough market, particularly as hos-
Workflow
• Prioritizing investments in key adjacencies Optimization Clinical pitals and clinics struggle in terms of hu-
Decision Suppor t
man resources. “The resources in hospi-
• Supplementing the core portfolio with
POC Diagnostics
tals are difficult to come by. Nursing is
strategic bolt-ons & Monitoring Smar t Medication expensive, technicians are expensive.
Management
There is significant overload on nursing
• Investing in transformative technology
through Baxter Ventures portfolio staff. So we’ve got to create a pathway —
Acute POC Acute
Diagnostics Monitoring the opportunity for them to do their jobs
in a more effective way. And that [path-
Fig. 5 – Optimizing Baxter’s profile with strategic portfolio management. (Source: Baxter 2022 Inves- way] is to create alternate site care. It’s
tor Conference)
more so than just connecting devices.”
“We have a phenomenal lineup of new
“Bringing Hillrom into Baxter will give our responsibility and obligation as a mar- products. We will primarily grow with
us really good leverage on synergies. Some- ket leader in healthcare,” Almeida said. revenue synergies, geographic expan-
thing that we do understand is how capital Almeida said the company will allocate sion, channel expansion, and market de-
allocation will drive growth in the future. internally to businesses that are growing velopment — these four driving tenants
The first thing that we think about for cap- faster — businesses that can provide for will create $300 million in incremental
ital allocation is that patient safety and the future and also return money to sales through market expansion efforts
quality are our number one priority when shareholders via dividends. He notes that by 2025,” said Almeida. “You will see an
we allocate capital. We will continue to in- M&A is Baxter’s preferred way to deploy uptick in our R&D expenses because
vest money in facilities where we are the cash and that share repurchasing will be we’re allocating more money to busi-
single source to a market. We will fulfill used only if the company has not identi- nesses that are growing faster.”
10 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
BardyDx was part of the Hillrom acquisition. The
BardyDx CAM patch results in improved ECG
resolution. (Credit: Baxter)

Social Responsibility
While social responsibility has become
increasingly important in the medtech
market, Almeida says that Baxter has
been committed to social responsibility
for many years. The company has pro-
grams to support and protect the planet,
its patients, and its people and communi-
ties. “Our commitment is to carbon foot-
print neutrality, clean water, to being not
only environmentally conscious but envi-
ronmentally protective of what we do,
Plastic Material Changes
and to making sure that the communities Require Latest Plastic Welding
that we work in are protected.”
Also important, he said, is empowering Technologies
patients to understand the best therapies
available and improving the company’s Market pressures are driving medical device
capabilities and quality core products, designers away from PVC and PC, yet replacements
noting that Baxter is “championing our like PE and PP do not respond well to traditional
people and creating an environment plastic joining methods. Reliable assembly requires
where people want to come to work.”
advanced BransonTM ultrasonic and laser welding
The Future for Baxter systems from Emerson. They produce ultra-clean,
“We are going to grow through inno- aesthetically superior welds for today’s preferred
vation. We are increasing our spending NBUFSJBMT
XIJMF
BMTP
EFMJWFSJOH
EFTJHO
¼FYJCJMJUZ

in innovation. We want to have the best QSPDFTT
FG»DJFODZ
FOFSHZ
TBWJOH
BOE
TVTUBJOBCJMJUZ

place to work. We want employees to advantages.
feel that this company socially responsi-
ble, that this is an inclusive company Learn more at: Emerson.com/Branson
that values diversity and equality, that
[employees say] ‘Baxter has all the in- $PNF
BOE
TQFBL
XJUI
BO
FYQFSU
BU

gredients to make this a place that I K-Show, Hall 11 Booth F55, 19-26th Oct 2022.
want to go to work.’ If we do those things
right, if we fulfill our mission with ethics
and compliance, we will deliver on the
results — and the results are conse-
quences. The results are a consequence
of a good company with 60,000 great
The Emerson logo is a trademark and a service mark of Emerson Electric Co. © 2022 Emerson Electric Co.
employees that wake up every day with
one mission: save and sustain lives.”
This article was written by Sherrie
Trigg, Editor and Director of Content
for MDB. Contact: sherrie.trigg@
saemediagroup.com.
Medical Design Briefs, September 2022 11
Cobots Offer
Advantages
for Biomedical
Testing
Applications

A
collaborative robot, or cobot, is an automation tool that can be adapted for use in
mechanical testing laboratories. Cobots are robotic arms designed to work alongside
humans and are adaptable to a variety of applications. They are intended to bridge
the gap between manual system operation and full industrial automation, offering
the benefits of automation without the additional complexity of a fully robotic test-
ing system. Cobots are particularly suited for use in the biomedical industry, where full-scale
automation is often not possible but where lab efficiency, safety, and data integrity are critical.
Cobots and robots can perform very similar tasks: Both are designed to remove a system
operator from a task or operation by automating part or all of the testing process.
Because of the overlap in functions, both options can be appropriate for a given
application; however, there are some key differences that make one solu-
tion preferable over the other in certain circumstances.
Robot systems are best suited for repeating the same task at
a high speed for 24/7 operation. These systems are not
Name/Shutterstock.com

always equipped with force control features and

struggle with tasks that require varying degrees of
sensitivity. Because these robots are designed for high
speed, the possibility for damage or injury is high if

12 www.medicaldesignbriefs.com Medical Design Briefs, September 2022

 these ­systems are not properly im-
plemented. Making changes to the
movements of the robot or adding a
new task requires someone with a ro-
botics or software engineering back-
ground to implement.
Cobots are generally more flexible
and easier to use than robots. The
average cobot will operate at a lower
speed with a smaller reach and lesser
payload than an average robot. It will
also typically have a smaller footprint
and be more lightweight than a ro-
botic system.
Cobots come equipped
with software that makes
Name/Shutterstock.com
Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 13
changes to movements and tasks easy.
Anyone with basic programming ex-
perience will be able to make chang-
es quickly and efficiently, and the
learning curve to make changes to
the software is much less steep than
it is with the average
robot.
The cobot’s light weight makes it
easy to transport or relocate within a
facility. In terms of safety, the force-­
controlling sensors greatly reduce the
risk to operators or devices, and de-
pending on the risk of the particular
task, a cobot may be able to operate
with no physical guarding.
Lab Efficiency
Most mechanical testing —
particularly biomedical and
medical device testing — is
performed manually. A lab em-
ployee sets up the initial test and
then loads and unloads individ-
ual specimens until the sample
batch is completed. In this
time-consuming process, many
tests take between 3 and 5
minutes to complete while
only requiring about 30
Custom specimen racks can
be 3D printed and mounted
to the workstation for the
cobot to pick from.
(Credit: Instron)
Cobots
Cobots can be added to a new or existing universal testing system to automate the loading and un-
loading of specimens while the system performs tests without the operator present. (Credit: Instron)
A cobot mounted on an autoinjector testing system capable of performing all required testing of in-
jection devices in a single test. (Credit: Instron)
seconds worth of operator interaction
per test. For example, if a test takes 3.5
minutes to complete, a test frame can
run a batch of 30 specimens in 2 hours.
A technician is required to be pres-
ent for this entire period, while only
needing to interact with the system for
a total of 15 minutes in order to load
and unload specimens every 3.5 min-
14 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
utes. This inefficient process presents
an enormous opportunity to recoup
lost time, especially as high-value, ex-
pensive labor resources are frequently
responsible for running the testing in
many biomedical testing labs. Freeing
up the operator to perform other valu-
able tasks would bring significant bene-
fits to the lab.
Many medical device companies could
benefit from automation but are not a
good fit for a fully automated robotic sys-
tem. Companies might not need a fully
automated system if, for example, their
test volume isn’t high enough to warrant
a robotic system because they require
a system with more flexibility. For labs
where fully automated testing is not pos-
sible or desirable, cobots offer a promis-
ing new solution.
Safety and Ergonomics
When using a cobot, the operator is not
required to load and unload specimens
by hand into the frame, greatly improv-
ing ergonomics by reducing repetitive
movement. When testing high-risk items
such as syringes with needles, cobots also
improve safety by reducing sharps han-
dling by the system operator. In order
to completely eliminate the need for the
operator to handle sharps, systems can be
configured with a tap removal.
Cobots also have an advanced control
system designed to reduce the risk of in-
jury to the test operator and damage to
the cobot or its surroundings. The force
on each axis is constantly monitored,
and the cobot will stop if it comes in con-
tact with an unexpected object. Guard-
ing, or protective shielding, for the co-
bot is dependent on the application and
the specific risks associated with moving
and testing the specimen. For example, a
cobot testing syringes with exposed nee-
dles will likely require different guarding
than a system performing residual seal
force testing on vials.
Data Variance and Integrity
Data spread between operators is a
common issue in medical testing. Each
person loads specimens into the test sys-
tem in a slightly different way, which lim-
its repeatability. Adding alignment devic-
es can improve this issue but cannot fully
eliminate it. The cobot removes any vari-
ance in specimen loading. Most cobots
are repeatable to within a fraction of a
millimeter, which yields results that are
vastly more repeatable than those from
a system being manually loaded. Addi-
tionally, any time an operator is manu-
ally transferring data between a testing
system and a production database pres-
ents the possibility for errors to be made.
By using a cobot system to automate that
transfer, human error can be removed.
Test Applications use that isn’t possible with traditional umes to justify the purchase of a fully ro-
Autoinjector Testing. Manufacturers robotic automation systems. For the bio- botic system. These devices are also suit-
of autoinjectors and other needle-based medical industry, a cobot installed on a able for labs that see a high changeover
injection systems are ramping up pro- mechanical testing system can greatly in testing needs and fixturing.
duction to meet the rising global de- improve lab efficiency, operator safety, This article was written by Richard Spie-
mand for safe and convenient forms of and data variance and integrity. Cobots gel, Product Manager, Instron, Norwood,
drug delivery. Bringing these devices are particularly well suited for test labs MA. For more information, visit www.
from development to production is a that are looking to improve efficiency instron.com. Contact: richard_spiegel@
long process with strict requirements for but do not have high enough testing vol- instron.com.
both functional and usability testing of
the devices at each of stage of product
development. A test frame with cobot au-
tomation is ideal for testing various de-
sign iterations of a product with minimal
changeover time, reducing the burden
on highly technical design engineers to
stand in front of a system. Technicians
can simply place the test specimens in
the system’s production tray and the co-
bot will load and unload them while the
machine runs the necessary tests.
Syringe Testing. Break-loose and glide-
force testing constitutes the bulk of sy-
ringe testing and is used to determine the
real-world forces required to operate the
syringe. Pre-filled syringes are combina-
tion devices requiring device verification
testing before a New Drug Application
can be submitted. For syringe testing
applications, cobots can be placed sepa-
rately or in-line to improve throughput
and efficiency. Fully integrated manu-
facturing systems can even use measured
break/loose glide force data to modify
production settings in real time to correct
for any out-of-tolerance values.
Luer Connector Testing. ISO 80369 is
the global standard used by device man-
ufacturers to evaluate the mechanical
and pressure-related properties of the
connections. When used in conjunction
with a torsion-enabled universal testing
system, a cobot can be extremely benefi-
cial for lab productivity, essentially func-
tioning as a pick-and-place operation to
reduce operator influence.
The repeatability of automated speci-
men insertion is also ideal for improving
device alignment, a significant contrib-
utor to data spread. Since luer connec-
tions can be found on a wide array of
devices, the sample racking can be cus-
tomized to accommodate all potential
device geometry.

Bridging the Automation Gap

Cobots present new automation solu-
tions in a variety of potential applica-
tions. They offer flexibility and ease of

Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 15

MDB maxon Digital Ad 0922.indd 1 8/4/22 1:11 PM

SHOW PREVIEW
BIOMEDevice Boston 2022
www.biomedboston.com • Boston Convention & Exhibition Center, Boston, MA
BIOMEDevice Boston 2022: Bringing Innovation to Life
BIOMEDevice Boston brings engineers, business leaders, disruptive companies, and innovative thinkers from the region’s top
startups and medical device OEMs together to inspire the next life-changing medical devices. BIOMEDevice bridges the gap be-
tween the present and the future. The event is designed so that attendees can source the solutions needed today, and also gain
access to medtech technology changing the trajectory of the industry.
CONFERENCE SCHEDULE, SEPTEMBER 28–29 (all times EDT)
WEDNESDAY, SEPTEMBER 28
TIME SESSION
9:15 AM–10:15 AM KEYNOTE
Erika Cheung, Theranos whistleblower and executive director of Ethics in Entrepreneurship, empowers future tech leaders
to recognize and act when ethical problems arise within the industry. Hear from a medical researcher, turned technology
and innovation ecosystem builder, on her experience at Theranos and how we, as an industry, can use it as a cautionary
tale to improve ethics in entrepreneurship.
10:30 AM–11:00 AM Q&A with Erika Cheung in the Start-up Stadium
10:30 AM–11:15 AM Robots
Extending Surgical Robotics into Microsurgery
Galen Robotics is developing a single-platform solution to aid surgeons across several disciplines with minimal distur-
bance to existing workflows.
Speakers: Dave Saunders, Chief Technology Officer & Taylor Leverage, Product Manager, Galen Robotics
11:30 AM–12:15 PM Digital Health
Medtech Insights Podcast — Live at BIOMEDevice Boston!
Enabling New Virtual Care Models by Creating the Clinical Grade Digital Health Tools They Demand
Healthcare delivery has dramatically changed over the last three years, with telemedicine, remote patient monitoring,
hospital at home, asynchronous care, and even virtual first. But the digital health tools like the Fitbit and Apple Watch,
have not kept up, being initially designed for the consumer market. These new healthcare care models need more clinical-
grade tools to meet the digital health demands that have the same rigor of quality, reliability, and trust as typical clinical-­
grade medtech. Be sure to join us with some leaders in new care models and digital tools to discuss this urgent market
need for clinical-grade digital health tools.
Speaker: Jennifer Joe, MD, CEO, AMPLIFY for Healthcare CMO, BrightMarbles US Digital Health Researcher, VA Bedford
Hospital
12:30 PM–1:15 PM KEYNOTE
Dean Kamen, inventor and cofounder of the Segway, is an innovation expert. Hear from Dean as he recounts his experience
bringing inventions to market and the steps he took to overcome challenges along the way. From working with large indus-
try partners to securing over 1,000 patents, receiving FDA approval and building companies from the ground up, Dean
will share how the path to market is far from linear but can result in a commercialized product that can revolutionize the
industry.
1:30 PM–2:15 PM Materials
MedTech Materials Selection for Better Sustainability
Join Vipul Dave, leading industry expert and Fellow/Head of Materials at Johnson & Johnson, as he talks about the latest
materials transforming medical devices into commercial products. He’ll share the latest innovations in new materials, and
how they can improve product life cycle, hospital, and home waste streams, and offer better end use sustainability. In this
session, we’ll look at material trends in polymers, adhesives, plastics, and soft materials, so you can keep up with the
latest.
4:00 PM–5:00 PM Welcome Reception with special guest, Erika Cheung

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

 THURSDAY, SEPTEMBER 29
TIME SESSION
9:15 AM–10:15 AM KEYNOTE At the Cutting Edge of Digital Health (Sponsored by MedExec Women)
Digital health solutions are entering clinical practice, and while they may have shorter development cycles than physical medical
devices, the path to adoption can be just as arduous and long. Our panel of experts, all brought together by the MedExecWomen
organization, will discuss the keys to driving adoption of SaMD and digital solutions into medical practice.
Moderator:
Maria Shepherd – President of Medi-Vantage and Co-Founder of MedExecWomen
Panelists:
Jill Dooling, VP Strategic Accounts, Vapotherm
Sara Kehoe, Senior Director, Clinical Insights, Danaher Diagnostics
Teresa Prego, Chief Commercial Officer, Nile
Mira Sahney, President, Pelvic Health, Medtronic
Jill Schiaparelli, CEO, Avation Medical
10:30 AM–11:15 AM Materials
. Panel: Next-Gen Surgical Implants – Improved Design with Novel Materials & Manufacturing Methods
There are numerous novel materials, to include alloys and polymers, being considered that offer a range of properties in terms of
performance attributes for surgical implants like coronary stents and joint replacement. These materials help design teams man-
age expectations for demographic characteristics and provide for personalized solutions for patients. This panel will discuss de-
velopments arising in both the material domains, as well as the flexibility provided by additive manufacturing for creativity in design
and structure for increased functionality and superior performance
12:30 PM–2:15 PM Start-ups
Panel: What Entrepreneurs Need to Know About Investment Funding for the Medtech Sector
All start-ups require financing, and the sources of that financing vary depending on the need, stage, and type of enterprise. This
panel brings together a spectrum of investors including angels, traditional VC and corporate VC to discuss the challenges and
opportunities unique to the medical device space.
Panelists:
Bruce Lichorowic, President, Galen Robotics
Salvatore Viscomi, MD, Chief Medical Officer, Goodcell
David Voge, Managing Partner, Kayon Partners
1:30 PM–2:15 PM KEYNOTE
Christopher Gates, Cybersecurity: Unworkable Today, Hope for Tomorrow
The current process of including cybersecurity in a medical device system is broken. This is mostly due to the huge shortfall of
embedded cybersecurity experts. So manufacturers are left with staff engineers making mistaken assumptions about secure
designs that don’t align with regulatory expectations, standards, project goals, or attackers’ capabilities. Christopher will present
one approach for abandoning this current broken model for secure design and adopt a new approach to designing security into
your next medical device. This new approach aligns with the intent of regulatory standards, doesn’t require staffing up with expen-
sive and hard-to-find embedded cybersecurity experts, and improves the overall speed of the development process

MASTER CLASS START-UP SERIES

SEPTEMBER 28–29
TIME SESSION
11:15 AM–12:00 PM State of Medtech Investments
The last few years saw a tremendous influx in available capital and investments into medtech startups. As the market corrects
and investments become more competitive, what does this mean for available capital? This session will examine today’s shifting
fundraising marketplace with an eye for trends to be aware of and how best to prepare for the year ahead.
12:00 PM–1:00 PM Lunch & Learn Session: The State of M&A – Partnering with Strategics
As the market corrects, how does this impact the way larger medtech companies think about capital allocation to M&A and licens-
ing? Do short term dynamics matter in these initiatives? This session will feature the heads of M&A from leading industry OEMs
who will discuss their companies’ perspectives on investments today and in the next 18 months.
1:00 PM–1:15 PM BREAK
1:15 PM–2:00 PM Fundraising: Planning Your Attack
Successful entrepreneurs know the value of a well-coordinated effort when fundraising. From timing and messaging to prepping
documents to lining up contacts, strong planning is key to strong results. In this session, attendees will hear from leaders of
emerging companies who have recently closed successful funding rounds and will share lessons learned and tips for success.
2:00 PM–2:15 PM BREAK
2:15 PM–3:00 PM Fundraising: Thinking Outside the Box
The finance industry is growing in dynamism. As such, vehicles and players that are sometimes less prominently advertised may
be attractive avenues for companies in various circumstances. In this session, we’ll discuss debt financing, family offices, and
online investment platforms, and the pros and cons of each.
3:00 PM–3:15 PM BREAK
3:15 PM–4:00 PM Fundraising: Raising with VCs
Venture capital financing is all about return on investment. In this session, we’ll hear from VCs who will share how they develop
valuations and how today’s marketplace is impacting what they do and how they do it. We’ll also dive into the differences between
independent financial VCs and those who sit in-house at strategics to understand what each may be looking for to better prepare
you to create the right profile for your next pitch.

Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 17

BIOMEDevice Boston 2022

BUILD YOUR KNOWLEDGE

BIOMEDevice features three areas located on the expo floor where attendees can learn from industry thought leaders, watch
demonstrations, ask questions, and get answers from leading subject matter experts. Join the MedTech community looking for
new technology, inspiration, and innovation. Explore the content offerings taking place on the show floor including, Center
Stage, Tech Theater, and Start-Up Stadium.

Center Stage Tech Theater

Center Stage will feature educational sessions focused on Gain a deeper technical insight from the experts in 30-minute
high-growth areas in medtech, including: supplier-hosted sessions on the latest industry topics and trends.
• Robotics
• Digital Health Start-Up Stadium
• Materials Featuring live pitches from MassMEDIC’s 2022 IGNITE co-
• AI & Machine Learning hort of medtech innovators, an exclusive Q&A session with
• Start-ups BIOMEDevice’s keynote speaker, Erika Cheung, and podcasts
• Device Cybersecurity recorded live, hosted by Project Medtech and Medical Device
Success.

MASTER CLASS START-UP SERIES

BIOMEDevice is teaming up with MassMEDIC to bring attendees the Master Class Start-up Series. This
conference program will feature finance focused content tailored to what growing companies need to know
in this evolving marketplace. Join us in the Master Class Start-up Series to receive an overview of the med-
tech investment landscape, an inside look at various funding vehicles – from strategics, to venture capital –
and everything in between, and connect with those who have done it to hear their tips for success.

KEYNOTE SPEAKERS
Erika Cheung
Erika Cheung is the Executive Di-
rector of Ethics in Entrepreneurship,
a nonprofit organization with the mis-
sion to embed ethical questioning, cul-
ture, and systems in start-up ecosystems
worldwide.
Cheung began her career working
as a medical researcher in the bio-
technology industry and is most famously known for being a
key whistle-­blower reporting the medical-diagnostic company
Theranos to health regulators.
Cheung went on to help launch a technology accelerator
in Hong Kong supporting early-stage technology investments
across the Asia-Pacific (APAC) region. She continues to advise
and support the development of biotechnology and healthcare
initiatives across the APAC region.
Christopher Gates
Christopher Gates is director of
product security for Velentium, a pro-
fessional engineering specializing in
the end-to-end design, development,
and manufacturing of therapeutic and
diagnostic active medical devices.
Gates has over 30 years of experi-
ence developing and securing med-
ical devices and works with numerous industry-leading
device manufacturers. He frequently collaborates with reg-
ulatory and standard bodies including the NTIA, MITRE,
Bluetooth SIG, IEEE, the U.S. Department of Commerce,
and the FDA to present, define, and codify tools, tech-
niques, and processes that enable the creation of secure
medical devices.
18 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
He promotes the “secure development lifecycle,” the
industry-­leading approach that ultimately eases the burden on
developers and ensures high-quality products that work as in-
tended to save and improve lives.
He joined Velentium in 2017 because he had previously
collaborated with the company as a contractor and had seen
firsthand that its values are exemplified by its founders. “In a
world where most companies are only motivated by financial
interest, Velentium routinely has moral discussions about the
best approach for its clients, its staff, and the world. Every em-
ployee engages each project with the mindset that the equip-
ment we’re designing might one day be used to save our own
loved ones.”
This motivation is not a mere thought exercise. When his first
grandchild was born prematurely, before the baby’s lungs could
fully close, Christopher visited him in the NICU. There, he no-
ticed that a handful of the machines allowing his grandson to
breathe were among the devices he himself had helped design.
Dean Kamen
Dean Kamen is an inventor, an en-
trepreneur, and a tireless advocate for
science and technology. His roles as
inventor and advocate are intertwined
— his own passion for technology and
its practical uses has driven his person-
al determination to spread the word
about technology’s virtues and by so doing to change the cul-
ture of the United States.
As an inventor, he holds more than 1000 U.S. and foreign
patents, many of them for innovative medical devices that have
expanded the frontiers of health care worldwide. While still
a college undergraduate, he invented the first wearable infu-
sion pump, which rapidly gained acceptance from such diverse
medical specialties as oncology, neonatology, and endocrinolo-
gy. In 1976, he founded his first medical device company, Auto­
Syringe, Inc., to manufacture and market the pumps. Then,
working with leading diabetes researchers, Dean pioneered
the design and adoption of the first portable insulin pump. It
was quickly demonstrated that using a pump could much more
effectively control patients’ blood glucose levels. At age 30, he
sold AutoSyringe to Baxter Healthcare Corporation.
Following the sale of AutoSyringe, Inc., he founded DEKA
Research & Development Corporation to develop internally
generated inventions as well as to provide research and de-
velopment for major corporate clients. Kamen led DEKA’s
development of the HomeChoice™ peritoneal dialysis system
for Baxter International Inc. The HomeChoice™ system al-
Medical Design Briefs, September 2022
MDB Instron Ad 0922.indd 1
www.medicaldesignbriefs.com 19
lows patients to be dialyzed in the privacy and comfort of their
home. It quickly became the worldwide market leader. Kamen
also led the development of technology to improve slide prepa-
ration for the CYTYC (now Hologic Inc.) ThinPrep® Pap Test.
Kamen-led DEKA teams have also developed critical compo-
nents of the UVARTM XTSTM System, an extra­corporeal pho-
tophereisis device marketed by Therakos, a unit of Johnson
& Johnson, for treatment of T-Cell lymphoma. An advanced
prosthetic arm in development for DARPA should advance the
quality of life for returning injured soldiers. Other notable de-
velopments include the Hydroflex™ surgical irrigation pump
for C.R. Bard, the Crown™ stent, an improvement to the orig-
inal Palmaz-Schatz stent, for Johnson & Johnson, the iBOTTM
mobility device, and the Segway® Human Transporter.
The medical device and biomaterials
industries undergo continual
innovation and change. Instron® test
systems are available in both
standard and custom configurations
to help ensure that every new design
can be fully evaluated.
TO LEARN MORE VISIT
go.instron.com/bio
or scan the QR CODE
8/11/22 12:03 PM
 Sponsored Content

Medbio
5346 36th St., SE
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Phone: 616-245-0214
Fax: 616-245-0244
E-mail: Info@medbiollc.com
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About Our Company Products/Services Offered

Located in Michigan, Medbio is an ISO 13485:2016-certified
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We have the knowledge, passion, and experience to solve your
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Target Markets BIOMEDevice Boston Booth 921

Medical

20 www.medicaldesignbriefs.com Medical Design Briefs, September 2022

 Sponsored Content

Target Markets

Component, subassembly, or full assembly of catheters, deliv-

ery systems, access systems in cardiovascular, peripheral,
Filmecc USA, Inc. neuro, abdominal, endoscopic, orthopedic, ENT specialties.
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 Sponsored Content

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Major advances in medical devices have been made over the last few decades, keeping thousands of people alive and improving the quality
of life for others. At the same time, these devices (e.g., implants, catheters, in-dwelling devices, and contact lenses) can be the source of
serious or life-threatening infections caused by the adherence and establishment of biofilms on the surface of the device.
Due to the unique nature of a biofilm’s structure and its resistance to antimicrobial agents, minimizing the risk of biofilm formation poses
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8/17/22 10:10 AM
 n Breath-Driven Concept
Could Transform
Prosthetics
Researchers have devel-
oped a hand prosthesis pow-
ered and controlled by the
user’s breathing. The sim-
Researchers have developed a new ple, lightweight device offers
breath-driven concept set to trans-
form access to hand prosthetics. an alternative to Bowden
(Credit: University of Oxford) cable-driven body-powered
prosthetics initially devel-
oped in the early 19th century — particularly for those too
young or anatomically unsuited to an uncomfortable har-
ness and cable system.
The new approach provides an alternative body-powered
device for users in situations where cost, maintenance, com-
fort, and ease of use are primary considerations. By regulat-
ing their breathing, users power a small purpose-built Tes-
la turbine that can accurately control the prosthetic finger
movements. The volume of air needed to power the unit can
be achieved by young children, and the gearing in the unit
determines the speed of the grasping action.
Cable and harness free, the device is suitable for children
and adolescents who are still growing. Minimal maintenance
and training are needed for ease of use in comparison to
other prosthetic options.
For more information, visit www.medicaldesignbriefs.com/
roundup/0922/prosthetics.
n Copper Nanowires
Combat Spread of
Diseases
An ancient metal used
for its microbial prop-
erties is the basis for a
materials-­based solu-
tion to disinfection. A
Left: Scanning electron microscopy im-
age of the network on a copper-sprayed
team of scientists has
surface. Right: Up-close image of nano­ developed an antimi-
wire. (Credit: Ames National Laboratory) crobial spray that de-
posits a layer of copper
nanowires onto high-touch surfaces in public spaces.
The spray contains copper nanowires (CuNWs) or copper-­
zinc nanowires (CuZnNWs) and can form an antimicrobial
coating on a variety of surfaces. This research was initiat-
ed by the COVID-19 pandemic, but the findings have wid-
er-reaching applications.
First the surface needs to be cleaned and disinfected,
then the reformulated copper ink solution can be applied.
The ideal coating should be thin enough to be transparent.
The ink can be diluted with water or alcohol to make it
sprayable, and it works on plastic, glass, and stainless-steel
surfaces.
The team tested two types of copper ink: CuNW and CuZn-
NW. Compared to a plain copper disk, both inks were just as
effective at disabling the virus. The nanowires worked faster
because of their greater surface area.
For more information, visit www.medicaldesignbriefs.com/
roundup/0922/nanowires.
Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 25
n ‘Smart’ Necklace May
Track Health Through Sweat
A team of researchers has
demonstrated a battery-free, wire-
less biochemical sensor that detect-
ed the blood sugar — or glucose
— humans excrete from their skin
when they exercise.
Participants rode on stationary
The team fabricated a smart
bikes to produce enough sweat
for the study’s sensor to ana- necklace — complete with a
lyze. (Credit: Getty Images) functional clasp and pendant —
which, once placed around their
necks, was used to monitor the glucose level of study partici-
pants as they exercised.
Instead of a battery, it works using a resonance circuit, which
reflects radiofrequency signals sent out by an external reader sys-
tem. After engaging in indoor cycling for 30 minutes, participants
took a 15-minute break, during which they drank sugar-sweetened
beverages, before resuming cycling.
The results showed the sensor tracked the glucose levels suc-
cessfully, which suggests it will work to monitor other important
chemicals in sweat. Additionally, the smart necklace requires only
a minimum amount of sweat for the interface to work due to the
miniaturized structure of the sensing interface.
For more information, visit www.medicaldesignbriefs.com/
roundup/0922/necklace.
n Electrospinning Advantages
for Wearable Technology
Researchers have shown that
electrospun materials have many
advantages over conventional bulk
materials for the development of
wearables. Electrospun materials’
high surface-to-volume ratio endows
Electrospun nanofibers boast them with enhanced porosity and
numerous advantages over breathability, which is important for
conventional bulk materials
long-term wearability. Also, with the
for the development of
wearables. (Credit: Sameer appropriate blend of polymers, they
Sonkusale) can achieve superior biocompatibility.
Conductive electrospun nanofibers
provide high surface area electrodes, enabling both flexibility and
performance improvements, including rapid charging and high
energy storage capacities. Also, their nanoscale features mean
they adhere well to the skin without need for chemical adhesives.
Electrospinning is considerably less expensive and more user-­
friendly than photolithography for realizing nanoscale transistor
morphologies with superior electronic transport. The researchers
are confident that electrospinning will further establish its claim
as a versatile, feasible, and inexpensive technique for the fabrica-
tion of wearable devices in the coming years.
They note that there are areas for improvement to be consid-
ered, including broadening the choice for materials and improv-
ing the ease of integration with human physiology. They suggest
the aesthetics of wearables may be improved by making them
smaller and, perhaps, with the incorporation of transparent ma-
terials, almost invisible.
For more information, visit www.medicaldesignbriefs.com/
roundup/0922/wearables.
 n Device Measures Vitals n Smartphone Clip-On
from Ear Canal Detects Zika in Blood
A new device, called MedSENS, Researchers have devel-
measures various vital parameters oped an instrument that can
from the ear canal. The instru- be clipped on to a smart-
ment consists of a probe about the phone to rapidly test for
size of an ear plug, which contains Zika virus in a single droplet
innovative measuring sensors. It is of blood.
MedSENS consists of a probe The development team holding the
pushed it into a victim’s ear, then instrument and the cartridge. (Cred- A cartridge that contains
about the size of an ear plug.
(Credit: Eurac Research/Mar- covered with an outer ear pad that it: University of Illinois) reagents required to detect
tina Jaider) insulates against heat and cold. the virus is inserted into the
The device incorporates a small instrument to perform the test while the instrument is clipped
screen that shows the measured values in real time. In addition to onto a smartphone. Once the patient adds a drop of blood,
body temperature, it also measures heart rate and oxygen satura- one set of chemicals break open the viruses and the blood
tion and gives a complete picture of essential vital parameters. The cells within five minutes. A heater below the cartridge heats it
data can then be sent wirelessly to any other connected device. up to 65 °C. A second set of chemicals then amplifies the viral
It is designed for emergency situations, such as when the vic- genetic material, and the liquid inside the cartridge fluoresc-
tim is suspected to be hypothermic, knowing their core tempera- es bright green if the blood sample contains the Zika virus.
ture as accurately as possible is essential for proper triage. During The entire process takes 25 minutes.
simulations of interventions between –10° and 20 °C, rescue The clip-on device uses the smartphone’s rear camera, which
workers had to apply the device. The “victims” were monitored looks at the cartridge while the amplification occurs. When
both through the MedSENS device and a traditional esophageal there’s a positive reaction, little green blooms of fluorescence
probe, which had previously been inserted in the clinic. eventually fill up the entire cartridge with green light.
For more information, visit www.medicaldesignbriefs.com/ For more information, visit www.medicaldesignbriefs.com/
roundup/0922/vitals. roundup/0922/zika.
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26 www.medicaldesignbriefs.com Medical Design Briefs, September 2022

Tiny Robots Bring Healthcare Closer to Precisely
Targeted Drug Delivery
The multifunctional
wireless robots maximize
health outcomes and
minimize invasiveness of
procedures.
Stanford University
Stanford, CA
If you’ve ever swallowed the same round
tablet in hopes of curing everything from
stomach cramps to headaches, you already
know that medicines aren’t always de-
signed to treat precise pain points. While
over-the-counter pills have cured many ail-
ments for decades, biomedical researchers
have only recently begun exploring ways to
improve targeted drug delivery when treat-
ing more complicated medical conditions,
like cardiovascular disease or cancer.
A promising innovation within this
burgeoning area of biomedicine is the
millirobot. These fingertip-sized robots
are poised to become medicine’s future
lifesavers — to crawl, spin, and swim to
enter narrow spaces on their mission to
investigate inner workings or dispense
medicines.
Leading research in this field, Stan-
ford University mechanical engineer Re-
nee Zhao is working on many millirobot
designs at once — including a magnetic
crawling robot, which was recently seen
worming its way through a stomach on
the cover of Science Advances. Powered by
magnetic fields — which allow for con-
tinuous motion and can be instantly ap-
plied to generate torque and change the
way the robots move — her robots can
self-select different locomotive states
and overcome obstacles in the body. Just
by shifting the strength and orientation
of the magnetic field, Zhao’s team can
send the robot sailing across the body at
distances in a single leap that are 10
times the robot’s length.
A key aspect of her research, the mag-
netic actuation also provides untethered
control for noninvasive operation and
separates the control unit from the de-
vice to allow for miniaturization. Zhao
says their most recent robot, featured in
Nature Communications, is “the most ro-
bust and multifunctional untethered ro-
bot we have ever developed.”
Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 27
Origami millirobot with spinning-enabled propulsion. (Credit: Zhao Lab)
This new “spinning-enabled wireless
amphibious origami millirobot” is as mul-
tifunctional as its name implies. It’s an el-
egantly conceived single unit that’s able
to speedily travel over an organ’s slick,
uneven surfaces and swim through body
fluids, propelling itself wirelessly while
transporting liquid medicines. Unlike
pills swallowed or liquids injected, this ro-
bot withholds medicine until “it reaches
the target, and then releases a high-­
concentration drug,” says Zhao, who is an
assistant professor of mechanical engi-
neering. “That is how our robot achieves
targeted drug delivery.”
n Reshaping Drug Delivery
What’s groundbreaking about this par-
ticular amphibious robot, according to
Zhao, is that it goes beyond the designs of
most origami-based robots, which only
utilize origami’s foldability to control how
a robot morphs and moves.
On top of looking at how folding
could enable the robot to perform cer-
tain actions — imagine an accordion
fold that squeezes out medicine —
Zhao’s team also considered how the di-
mensions of each fold’s exact shape in-
fluenced the robot’s rigid motion when
it was not folded. As a result, the robot’s
unfolded form inherently lends itself to
propulsion through the environment.
Such broad-minded considerations al-
lowed the researchers to get more use
out of the materials without adding bulk
— and in Zhao’s world, the more func-
tionality achieved from a single structure
within the robot’s design, the less inva-
sive the medical procedure is.
Another unique aspect of the design of
the robot is the combination of certain
geometrical features. A longitudinal hole
into the robot’s center and lateral slits an-
gled up the sides reduced water resistance
and helped the robot swim better. “This
design induces a negative pressure in the
robot for fast swimming and meanwhile
provides suction for cargo pickup and
transportation,” Zhao says. “We take full
advantage of the geometric features of this
small robot and explore that single struc-
ture for different applications and for dif-
ferent functions.”
Based on conversations with Stanford
Department of Medicine experts, the
Zhao Lab is considering how to improve
upon current treatments and proce-
dures by building new technologies. If
this work goes Zhao’s way, her robots
won’t just provide a handy way to effec-
tively dispense medicine but could also
be used to carry instruments or cameras
into the body, changing how doctors ex-
amine patients. The team is also working
on using ultrasound imaging to track
where robots go, eliminating any need to
cut open organs.
n The Smaller, Simpler, the Better
While we won’t see millirobots like
Zhao’s in real healthcare settings until
more is known about optimal design and
imaging best practices, the lab’s first-of-
its-kind swimmer highlighted in Nature
Communications is among their robots
that are furthest along. It’s currently in
the trial stages that come before any live
animal testing that proceeds human clin-
ical trials.
In the meantime, Zhao’s team contin-
ues combining a variety of novel smart
materials and structures into unique de-
signs that ultimately form new biomedical
devices. She also plans to continue scaling
down her robots to further biomedical
research at the microscale.
As an engineer, Zhao strives to devel-
op the simplest structures with the most
Surface Mount Technology for PCB Assembly Use Case
and SMT in Healthcare Systems
SMT assembly eases the
constraints of the board
space.
TechnoTronix
Anaheim, CA
Surface mount technology (SMT) is
widely accepted as the ideal process for
electronic products that are compact,
lightweight, and high speed. Both
through-hole and surface mount assembly
techniques have their own merits and de-
SURFACE MOUNT TECHNOLOGY
A secure product requires effective security measures and a clear set of requirements. (Credit: Pix-
abay/VIN JD)
28 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
functionality. Her amphibious robot ex-
emplifies that mission, as it inspired her
team to more fully consider geometric
features not yet commonly prioritized by
other origami robot researchers. “We
started looking at how all these work in
parallel,” Zhao says. “This is a very
unique point of this work, and it also has
broad potential application in the bio-
medical field.”
Additional Stanford co-authors of this
paper include postdoctoral scholars Qiji
Ze and Gentaro Ikeda; doctoral student
Shuai Wu; Phillip C. Yang, who is a profes-
sor of medicine in the School of Medi-
cine; and Gianluca Iaccarino, who is a
professor of mechanical engineering and
director of the Institute for Computation-
al and Mathematical Engineering. Other
co-authors are from The Ohio State Uni-
merits. To understand the wide usage of
SMT in printed circuit board (PCB) as-
sembly, this article discusses the SMT pro-
cess, benefits of SMT assembly, major dif-
ferences compared with the through-hole
technology (THT) method, and suitable
applications in the electronics industry.
While the THT process involves mount-
ing electronic components by inserting
their leads in the holes drilled on the
PCB, the SMT process directly solders
the components onto the surface of the
PCB. These components are called surface
FOR PCB ASSEMBLY
versity. Iaccarino is also a member of Stan-
ford Bio-X and an affiliate of the Precourt
Institute for Energy and the Stanford
Woods Institute for the Environment.
Yang is also a member of Stanford Bio-X,
the Cardiovascular Institute, and the Wu
Tsai Human Performance Alliance. Zhao
is also a member of Stanford Bio-X, the
Cardiovascular Institute, the Wu Tsai Hu-
man Performance Alliance, and the Wu
Tsai Neurosciences Institute.
This research was funded by the Na-
tional Science Foundation and the Amer-
ican Heart Association.
This article was written by Ashley Be-
langer, Stanford. Contact: Jill Wu, Stan-
ford University School of Engineering:
386-383-6061, jillwu@stanford.edu. For
more information, visit https://news.
stanford.edu.
mount devices (SMDs). They are smaller
in size compared to through-hole devices
and are suitable for high-routing density
and compact designs.
SMT benefits include:
• Supports assembly automation and
helps in quicker bulk production.
• Reduces manufacturing costs due to
smaller PCBs. SMDs have smaller foot-
prints, and a small board can offer
more functionalities as well.
• Supports high-speed design because it
can produce densely packed PCBs.
• Produces fewer assembly defects be-
cause the SMT process easily adapts to
required modifications and upgrades.
• Improves signal integrity and reduces
electromagnetic interference because
the traces become shorter between
closely placed components.
• Increases the reliability of SMT assem-
bled PCBs. The application of solder
paste instead of molten solder highly
reduces the possibility of component
failure due to false solder joints.
• Offers flexibility because combining
SMT with THT assembly methods pro-
vides greater functionality.
There are several differences between
through-hole and surface-mount technol-
ogies that make each suitable for some
specific applications. SMT, however, has
penetrated almost all the electronics do-
mains and will continue to add more fea-
tures to the PCB assembly process.
SMT assembly eases the constraints of
the board space when compared to the
THT assembly method. Through-hole
components require preparations such
as lead bending and trimming before in-
serting in the holes. These steps increase
the assembly cost of the PCB. SMDs do
not have leads and are directly soldered
on the surface of the PCB. Higher pin
count packages are also available. How-
ever, SMDs do require advanced assem-
bly skills and experienced staff to handle
the production line.
SMT assembly is capable of mounting
fine-pitch components, which is not pos-
sible using the THT method. In applica-
tions where space is premium, this SMT
feature is surely the front-runner. With
the SMT assembly process, PCBs that re-
quire a mixed build of both through-
hole and surface-mount components
can be attained. Although SMT reduces
production costs, the capital investment
required on machinery is quite high
compared with the through-hole pro-
cess. The THT method is best suited for
applications where the final product is
exposed to continuous vibration or peri-
odic mechanical stress.
In applications where high-speed cir-
cuits are required, SMT PCBs are the best
choice. Stray capacitance and inductance
issues are reduced in SMT PCBs because
there are fewer holes drilled on the PCB.
The automation of the SMT assembly
method drastically reduces the cost, and a
compact design provides small, light-
weight PCBs. Thus, SMT PCBs are used
extensively in applications such as wear-
able consumer products and implantable
medical devices.
SMT assembly has made it possible to
choose flexible substrates for PCB fabri-
cation. Flex and rigid-flex PCBs are in-
troduced only because of the SMT as-
sembly process. The improved efficien-
cy of PCB assembly is attributable to the
automation of the entire process, which
eliminates the scope of manual errors.
Pick-and-place equipment speeds up as-
sembly of the PCB and reduces process-
ing time significantly.
Although SMT assembly offers multi-
ple advantages in the PCB manufactur-
ing process, there are few disadvantages
also. Surface mounting is not recom-
mended for harsh environment applica-
tions. SMDs can easily get damaged in
high-thermal operations. Due to the
dense component placement on an
SMT PCB, there may be insufficient
space for a detailed silkscreen. Manual
debugging and identifying components
for any rework may become complex in
such PCBs.
To decide which assembly technology
is suitable for a given application, it is
essential to consider factors such as the
product usage, the environmental con-
ditions and stress applied, power re-
quirements with associated heat dissipa-
tion, performance based on the
com­ponent’s package, assembly quality
and ease of rework, price benefits, and
component lead time. In most of the
conditions, SMT will be the best option
for PCB assembly.
SMT assembly is widely used in appli-
cations like consumer electronics, medi-

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cal devices, telecom applications, auto-
motive, etc. Rapid production, higher
circuit speed, assembly automation, low-
er cost, higher density, design flexibility,
and improved performance are the im-
portant features of the SMT assembly
process that support the extensive usage
of SMT PCBs in electronic applications.
SMT Assembly for Healthcare
Systems
Healthcare systems have grown tre-
mendously in the field of patient care.
Monitoring devices like blood pressure
monitors and pulse oximeters are com-
pact and lightweight because SMT PCBs
are used in such medical equipment. In-
creasing demand for consumer products
Helmet Made of Magnetic Metamaterials Could
Improve Brain Scans
The wearable
metamaterial could help
make MRI scans crisper,
faster, and cheaper.
Boston University
Boston, MA
It may look like a bizarre bike helmet,
or a piece of equipment found in Doc
Brown’s lab in Back to the Future, yet this
gadget made of plastic and copper wire is
a technological breakthrough with the
potential to revolutionize medical imag-
ing. Despite its playful look, the device is
actually a metamaterial, packing in a ton
of physics, engineering, and mathemati-
cal know-how.
It was developed by Xin Zhang, a Col-
lege of Engineering professor of me-
chanical engineering, and her team of
scientists at BU’s Photonics Center.
They’re experts in metamaterials, a type
of engineered structure created from
small unit cells that might be unspectac-
ular alone, but when grouped together
in a precise way, get new superpowers
not found in nature. Metamaterials, for
instance, can bend, absorb, or manipu-
late waves—such as electromagnetic
waves, sound waves, or radio waves.
Each unit cell, also called a resonator, is
typically arranged in a repeating pat-
tern in rows and columns; they can be
designed in different sizes and shapes,
30 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
like smartphones and smartwatches are
driving growth in the telecom industry.
Compact and flexible products are also
possible because of the development of
the SMT PCB assembly process.
Several growing trends in the SMT pro-
cess include building fast and flexible as-
sembly lines, efficient and easily upgrad-
able assembly setup, etc. But assembly
service providers are also focusing on de-
veloping environmentally friendly PCB
manufacturing units. There are compli-
ance requirements included in the SMT
assembly process to develop a green line
for PCB assembly.
SMT for PCB assembly makes miniatur-
ization, versatility, and extended opera-
tions possible in the PCB industry. Elec-
Ke Wu, a PhD student in BU’s department of me-
chanical engineering, demonstrates a new magnetic
metamaterial device intended to be used in conjunc-
tion with MRI machines to boost the quality of brain
scans. (Credit: Cydney Scott)
and placed at different orientations, de-
pending on which waves they’re de-
signed to influence.
Metamaterials can have many novel
functions. Zhang, who is also a professor
of electrical and computer engineering,
biomedical engineering, and materials
science and engineering, has designed
an acoustic metamaterial that blocks
sound without stopping airflow (imagine
quieter jet engines and air conditioners)
and a magnetic metamaterial that can
improve the quality of magnetic reso-
nance imaging (MRI) machines used for
medical diagnosis.
tronic design automation tools have
improved the design for manufacturabili-
ty (DfM) software that helps PCB design-
ers to build industry-standard products.
The PCB assembly process of complex
circuits has become faster and easier due
to the automated SMT assembly lines.
Customer satisfaction has been achieved
by consistent and high-quality SMT PCB
manufacturing, and contract manufac-
turers have built cutting-edge assembly
units to capture the growing market of
SMT PCB products.
This article was written by Ken Ghad-
ia, Senior Sales Engineer, TechnoTronix
Inc., Anaheim, CA. For more informa-
tion, visit www.technotronix.us. Contact:
keng@technotronix.us.
Now, Zhang and her team have
taken their work a step further with
the wearable metamaterial. The
dome-shaped device, which fits over
a person’s head and can be worn
during a brain scan, boosts MRI per-
formance, creating crisper images
that can be captured at twice the
normal speed.
The helmet is fashioned from a se-
ries of magnetic metamaterial reso-
nators, which are made from 3D
printed plastic tubes wrapped in
copper wiring, grouped on an array,
and precisely arranged to channel
the magnetic field of the MRI ma-
chine. Placing the magnetic meta-
material — in helmet form or as the
originally designed flat array—near
the part of the body to be scanned,
says Zhang, could make MRIs less
costly and more time efficient for doc-
tors, radiologists, and patients — all
while improving image quality.
Eventually, the magnetic metamaterial
has the potential to be used in conjunc-
tion with cheaper low-field MRI machines
to make the technology more widely avail-
able, particularly in the developing world.
This work is supported by the National
Institutes of Health.
This article was written by Jessica Co-
larossi, Boston University. For more in-
formation, visit https://www.bu.edu.
Contact: jrcola@bu.edu.
Risk Management for Cybersecure Networked
Medical Devices
Comprehensive and
complete security risk
management helps
develop efficient
countermeasures.
TÜV SÜD Product Service
Munich, Germany
For developers and manufacturers of
networked medical devices, IT security is
increasingly becoming a challenge. While
the number of cyber threats is growing sig- one attack in 2019. Telemedicine and re-
nificantly, companies often lack experience mote care were the most affected.
and clear guidelines for medical security. A
comprehensive and complete security risk
management plan helps to meet existing
requirements in the best possible way and
helps develop efficient countermeasures.
The healthcare sector is more in the
public eye than ever before during the
MDB Nelson pandemic.
coronavirus Labs Ad 0622_ADAM.qxp_1/2
The sector has Page
been doubly affected: On the one hand,
intensive care had to be stretched to the
limit at times, and politicians and the me-
dia everywhere are calling for medical and
epidemiological expertise. On the other
hand, cyber threats in the healthcare sector
increased massively. According to the
“2021 Global Threat Intelligence Report”
of the technology service company NTT,
the number of cases in the healthcare sec-
tor tripled in 2020 compared to the previ-
ous year.1 Four out of five medical device
manufacturers were the target of at least
Nearly one in four medical devices is
connected to the Internet or otherwise
connected to a network. While there were
already around 337 million devices in 2017,
the number is estimated to rise to 125 bil-
lion by 2030.2 This also includes digital
health applications, whose development is
Horizontal by
encouraged 5/18/22
several5:49 PM Page
European 1
initiatives
like the German “Digital Healthcare Act.”3
In times of pandemic, when care should be
as contactless as possible, they receive spe-
cial attention.
n Little Experience and Serious
Consequences
The attacks range from extortion at-
tempts (ransomware) to industrial espio-
nage. Besides pharmaceutical companies
and clinics, research institutions are also
targeted. In the worst case, manipulations
in sensitive medical areas endanger the
safety of patients and users. However, the
affected manufacturers and institutions
must also reckon with considerable and
lasting economic consequences in less seri-
ous cases — for example, due to the loss of
brand image if critical security vulnerabili-
ties or safety deficits become public.
A secure product requires effective se-
curity measures and a clear set of require-
ments. However, many manufacturers

Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 31


A secure product requires effective security measures
and a clear set of requirements. (Credit: Pixabay/VIN JD)
have little experience with cybersecurity,
and there are no clear guidelines, for ex-
ample on how to implement “security by
design” for medical devices. In addition,
there are only a few industry-specific
standards, such as the technical report
IEC TR 60601-4-5 (“Medical electrical
equipment – Part 4-5: Guidance and in-
terpretation – Safety-related technical se-
curity specifications”).
n Risk Management from Design
to Decommissioning
To identify all risks and threats, cyberse-
curity should be a key consideration at ev-
ery stage of development. Because many
security vulnerabilities only become appar-
ent after a product is on the market, risk
management must encompass the entire
Medical Packaging: Automation of Thermoforming
Processes
Automation facilitates
higher, more predictable
throughput.
GN Thermoforming Equipment
Chester, NS, Canada
The medical packaging market has
quickly embraced the use of automa-
tion for the thermoforming process.
Automation has enabled adherence to
stringent quality requirements and has
addressed the need for high levels of
repeatability. Automation has also fa-
cilitated higher and more predictable
throughput.
32 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
life cycle, all the way through to de-
commissioning. This means that
even if the product is already dis-
tributed, it must be continuously
monitored. This includes a report-
ing system, a problem resolution
process, and regular updates. It
should be borne in mind that med-
ical devices are designed for a sig-
nificantly longer operating life
than, for example, household elec-
tronics or software for private use.
The European General Data
Protection Regulation (GDPR) al-
ready defines high requirements
for data security. Regulations EU
2017/46 (In-vitro Diagnostic De-
vice Regulation, IVDR) and EU
2017/745 (Medical Device Regula-
tion, MDR) set cybersecurity requirements
and demand, among other things, IT secu-
rity measures in accordance with the “gen-
erally accepted state of the art.” Depend-
ing on the product class of a medical
device, based on the classification by the
MDR, extensive safety and performance
requirements are the result for European
market access.
Useful guidance exists for some sub­
areas. The MDCG 2019-16 guide, for exam-
ple, specifies the requirements for security
risk management throughout the entire
product life cycle. In its “Postmarket Man-
agement of Cybersecurity in Medical Devic-
es” guide, the U.S. Food and Drug Admin-
istration (FDA) highlights the cybersecurity
aspects of products already placed on the
n What Is Different About Medical
Packaging?
Thermoformed medical packaging is
designed to protect a wide variety of items
ranging from implantable medical devices
to surgical instruments, to disposable cath-
eters and syringes. The selection of materi-
als and the forming and sealing processes
are crucial to ensuring that the integrity of
the sterile barrier system is maintained
during shipping and handling until the
product is opened by the user.
Medical items are often delicate. There-
fore, the packaging must protect the
products from damage during shipping
and handling, securely holding each item
market. This is also helpful for manufactur-
ers outside the U.S. market.
n Continuous Monitoring
and Testing
A comprehensive risk management
and a security life cycle form the basis
for a secure medical device. In addition,
ongoing controls such as vulnerability
scans, penetration tests, and fuzzing are
necessary to ensure safe functioning —
even during the operational phase.
With the implementation of existing
standards and specifications, manufac-
turers and developers ensure that their
medical product corresponds to the
technical state of the art. Proof of cyber-
security of the medical device must be
provided to the regulatory authorities
or notified bodies as part of the certifi-
cation process.
References
1. 2021 Global Threat Intelligence Report, https://
hello.global.ntt/en-us/insights/2021-global-­
threat-intelligence-report
2. T
 he Internet of Things: A Movement, Not a Market,
https://cdn.ihs.com/www/pdf/IoT_ebook.pdf
3. “Driving the digital transformation of Germany’s
healthcare system for the good of patients,”
(“Digitale-­
Versorgungs-Gesetz”, DVG) https://
www.bundesgesundheitsministerium.de/digi-
tal-healthcare-act.html
This article was written by Dr. Abtin Jam-
shidi Rad, Global Director Functional
Safety, Software and Digitization, TÜV
SÜD Product Service GmbH, Munich,
Germany. Contact abtin.jamshidirad@
tuvsud.com or +49 (0)89/50084-388.
in place and separating multiple items
packaged together from damaging each
other. For sharp objects, such as needles,
screws, and drills, the packaging must be
designed to protect the safety of the peo-
ple handling and opening the package.
n Considerations
Material Selection. Ensuring an effec-
tive and durable sterile barrier starts with
material selection. Polyethylene tereph­
thalate glycol-modified (PETG) and
high-impact polystyrene (HIPS) are of-
ten selected for medical packaging appli-
cations. PETG is created by adding a gly-
col modifier to PET, making it slightly
softer for tighter seals and also more suit- Form/cut/stack systems are usually en- Investment in automation offers many
able for withstanding high-­temperature closed in a protective envelope, protect- advantages in medical packaging manu-
sterilization processes. ing the process and the product from facturing. More precision and control
In addition to the polyethylene family of ­airborne particulates and ambient temp­ result in much higher repeatability,
plastics, HIPS is also commonly used for erature and humidity. They can be more which means higher quality products as
thermoforming in medical packaging. fully automated and, therefore, more pre- well as fewer defects and less waste. The
HIPS plastics are impact-resistant and clear, cisely monitored and controlled, especial- process improvements achieve faster cycle
and they have excellent hygienic qualities. ly machines with 100 percent servo motors times and predictable output, for higher
Strong Flange and Complex Geome- and drives. throughput and scalability.
tries. The shape of the packaging typi-
cally differs for medical products. The
entire package must withstand the
temp­erature and pressure extremes of
the sterilization process. The flange
must have the required thickness and
rigidity — and smooth surface — to ac-
cept and maintain a hermetic seal to a
Tyvek lid. The sidewalls must also have
adequate and consistent strength and
thickness to prevent cracking and leak- Medical-grade tubing —
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The most challenging aspect of medi-
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Elimination of Airborne Particulates. • Choose from more than 150 options!
Most medical packaging applications call • Conveniently packaged small coils
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n Increasing Automation • DEHP-free PVC • FEP

All of these special requirements for
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Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 33

Medical packaging must protect the products from damage during shipping and handling, securely holding
each item in place and separating multiple items packaged together from damaging each other. (Credit:
GN Thermoforming)
Precise control and repeatability are
also critical to the calibration and produc-
tion consistency required by the strict stan-
dards and government regulations for
medical packaging, such as ISO 11607:2019
and Title 21 CFR Part 11. Automation may
also include vision systems and other in-
spection technology that provide automat-
ic, continuous real-time quality control. In
general, the more automation, the greater
the opportunity to collect data for process
improvement and for traceability.
n Ease of Operation
Automation addresses workforce issues
in several ways. Obviously, automated sys-
tems are less labor-intensive. Instead of
requiring one or more operators per pro-
Researchers Develop Rapid Lab-on-a-Chip for Cancer,
COVID Diagnostics
The technology for medical
tests has received $6.6
million in continued NIH
funding.
University of Kansas
Lawrence, KS
A research center based at the Universi-
ty of Kansas that develops rapid next-­
generation tests for a host of human ail-
ments like cancer, stroke, and COVID-19
34 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
duction line, a single operator can cover
multiple lines. This requires that the ma-
chines autonomously perform the form-
ing, cutting, and stacking processes with
little or no hands-on engagement by the
operator. For high-volume production,
robotics are increasingly employed to au-
tomatically perform downstream packag-
ing and palletizing functions. But the au-
tonomous operation of these functions is
only one element of automation.
The procedures for changing tooling be-
tween SKUs and for replacing roll stock also
need to minimize human error and effort.
The right tooling needs to be installed in
exactly the right way, for every production
run, and roll stock can weigh 1500 lbs.
Thermoforming equipment should be de-
recently earned $6.6 million in continued
funding over the next five years from the
National Institutes of Health’s National In-
stitute of Biomedical Imaging and Bioen-
gineering (NIBIB) as a National Biotech-
nology Resource (P41) Center.
The Center of BioModular Multi-Scale
Systems for Precision Medicine, dubbed
CBM2, takes small plastic chips made of
the same material as a compact disc and
transforms them into marvels of engineer-
ing and chemistry that quickly can detect
hard-to-diagnose human diseases using sa-
signed with procedures and tools for
streamlining these processes and prevent-
ing errors and with ergonomic aids for lift-
ing and correctly positioning heavy objects.
n Intuitive HMI
Moreover, the human-machine inter-
face (HMI) must be designed to be intu-
itive and easy-to-learn for new employees
while also being very efficient and easy-
to-use during production every day. The
latest HMI systems employ large high-­
resolution displays that support multi-
touch gestures, taking advantage of the
skills new employees now universally
bring with their years of smartphone ex-
perience. Like smartphones apps, these
new interfaces should require little train-
ing and no paper documentation.
n Looking Forward
The whole concept of a form/cut/stack
thermoforming machine is to integrate
and automate multiple functions in a sin-
gle system. Medical packaging manufac-
turers have been at the forefront of the
trend toward automation, initially driven
by the need for high quality, repeatability,
and traceability. Automation also in-
creased scalability and throughput. The
third driver of automation is the need to
address labor shortages and high turnover
by making processes more productive and
less labor-intensive and easier to learn.
This article was written by Brian Gold-
en, Sales Director Americas, GN Ther-
moforming Equipment, Chester, NS,
Canada. For more information, visit
www.bmg-solutions.com/gn. Contact: 902-
275-3571.
liva, urine, or blood from a patient. The
liquid biopsies can detect circulating tu-
mor cells, cell-free DNA, viruses, and vesi-
cles that are released by biological cells as-
sociated with a particular disease.
The technology honed at KU and part-
ner institutions is pushing forward the
boundaries of precision medicine, improv-
ing and extending the lives of patients,
and creating commercialization partner-
ships as well as new training and education
opportunities in the Lawrence-Kansas City
region and beyond.
 “We develop little $2 widgets made
from a plastic by injection molding that
can take a liquid biopsy sample and
search for different types of markers that
can help a physician manage disease,”
says CBM2 director Steven Soper, Foun-
dation Distinguished Professor of Chem-
istry, Mechanical Engineering and Bio-
engineering, who brought the center to
KU when he was recruited from the Uni-
versity of North Carolina in 2016. “To
give you an example, this little chip is
used to isolate tumor cells out of the
blood of cancer patients. A physician will
very small vesicles — the presence of
which indicates early stage of cancer that
will provide better survival compared to
current diagnostic methods.
“The CBM2 is an essential component
of our collaborative efforts to develop a
stand-alone Precision Medicine Institute
at the University of Kansas,” Godwin
says. “I’m pleased to serve as the codirec-
tor for this P41 Center and have been
excited to work with an extremely talent-
ed and creative team of bioengineers at
KU, LSU, UNC and Wake Forest who are
developing cutting-edge technologies to
help advance the future of health care.”
The medical advances developed at
CBM2 already are helping patients through
commercial partnerships with private firms

F
take a sample of blood from the patient,
put it into the chip to enrich the tumor
cells from the blood sample — there’s

SIC K O
GS?
very few of them, maybe about 10 or so

RIN
— and then we open those cells to look
at the genetic composition to help de-
cide: does the patient have a disease,
how to treat the disease, is the patient
responding to therapy?” COIL SP
Of the 50 P41 centers, CBM2 is the only
one based in an NIH IDeA (Institutional
Development Awards) state — a designa-
tion for states that historically have re-
ceived lower amounts of NIH funding.
“Most of these biotechnology resource
centers, as with all big projects, are on ei-
ther coast,” Soper says. “We’re the only bio-
technology resource center that’s funded
in an IDeA state, so that’s a big hooray for We were too.
Kansas and KU — all major NIH centers
have high visibility, so we have a very im- That’s why we invented
portant mission because we’re the only
center of these 50 that has these technolo- the wave spring.
gies, and we’re filling an important niche
within the NIH community.” • Optimize Application Space & Weight
Much of the work of CBM2 takes place • Industry-Specialized Design Support
in collaboration with partners that include • Large Selection from Stock
KU Medical Center (Andrew Godwin, • Easy to Customize
CBM2 co-director), University of North
Carolina-Chapel Hill (Dr. David Kaufman,
CBM2 co-director), Louisiana State Uni-
versity (professors Sunggook Park and Mi-
chael C. Murphy) and the Wake Forest
School of Medicine (professor Adam Hall).
For instance, at KU Medical Center,
Godwin — who also serves as deputy di-
rector of The University of Kansas Can-
Crest-to-Crest® Wave Springs
cer Center and director of Kansas Insti-
9LVLWX
XVD %,20('%
DW% %RRWK

tute for Precision Medicine COBRE
— and Soper are working to develop a
handheld instrument to spot viruses giv-
ing rise to COVID-19 and to detect ovar-
ian cancer early in women with a high
family risk. This kind of cancer detection
uses a few blood drops placed on a plas- Request Free Samples at 847-719-5900 or smalley.com
tic chip created by the center to look for
Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 35
like San Diego-based BioFluidica, culating tumor cells are secured
which markets instruments for the from a blood sample using a plastic
isolation and analysis of liquid biopsy microchip pioneered by the CBM2
markers. Some of these products al- and marketed by BioFluidica.
ready are in use at the KU Cancer Other important research initia-
Center to improve outcomes of can- tives include a project with Dr. Ali-
cer patients in Kansas as well as those son Baird of SUNY Downstate Medi-
across the U.S. cal Center in New York City on a test
“I want to congratulate Drs. Soper using small vesicles as markers for a
and Godwin for the renewal of the point-of-care test for diagnosing
CBM2 P41 grant,” says Dr. Roy Jen- ischemic stroke. The test can be
sen, director of the KU Cancer Cen- The Center of BioModular Multi-Scale Systems for Precision completed in about 30 minutes to
ter. “This funding provides critical Medicine takes small plastic chips made of the same mate- help decide how best to treat pa-
infrastructure support to our re- rial as a compact disc or DVD, then transforms them into tients with stroke. In another effort,
marvels of engineering and chemistry that quickly can detect
search efforts focused on develop- hard-to-diagnose human diseases using saliva, urine, or CBM2 is developing a new nanotech-
ing new and improved detection blood from a patient. (Credit: CBM2) nology platform for sequencing RNA
systems for biomarkers in cancer and DNA to detect changes to the
and other diseases. This renewal For example, CBM2 is working with RNA genome of viruses that give rise
will go a long way toward further en- KUMC’s Dr. Anup Kasi on clinical trials to variants, such as those associated with
hancing our correlative science capa- at the KU Cancer Center to evaluate COVID-19.
bilities and places us at the cutting new therapeutics for pancreatic cancer, For more information, visit https://
edge of molecular diagnostics and pre- which accounts for 7 percent of cancer today.ku.edu. Contact: Brendan M.
cision medicine research.” deaths across the United States. The cir- Lynch, blynch@ku.edu.

How RFID Can Help Healthcare Maintain an Effective

Working Environment
RFID enables workers to
assign each unique
tracking information to
each asset.
Accutronics, Ltd.
Newcastle-under-Lyme, UK
Forty hours is a lot of time — for most
of us, it’s a full working week. Nurses in
healthcare settings, however, spend this
amount of time searching for medical
equipment each month, according to a
NursingTimes survey.1 What’s more, in 16
percent of cases, respondents said that
they had given up the search after fail-
ing to find a piece of equipment. With
increasing demands on the sector for a
more streamlined approach to health-
care, this article explores how radio­
frequency identification (RFID) tag-
ging can be used to locate assets that
healthcare workers need to do their
jobs more effectively.
The underutilization and loss of med-
ical assets costs the healthcare sector
millions of dollars each year. Hospitals
that are particularly susceptible are
those with multiple buildings and
36 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
floors, or that have thousands of assets.
Getting real-time or last-known location
information for these often-critical as-
sets can considerably improve opera-
tional performance. Used at numerous
medical facilities across the United
States, RFID technology enables work-
ers to assign each asset with unique
tracking information, which is stored in
a tag attached to the asset and located
using an RFID receiver.
However, there are several different
types of RFID tags and receivers, so
which are the most qualified for the
job? Passive RFID tags are the cheapest
solution, so these are often used to
track lower value assets or discardable
ones, such as blood vials or test tubes.
These tags have no internal power
source, so they are entirely reliant on
energy transmitted from an RFID re-
ceiver. Consisting of an integrated cir-
cuit and an internal antenna, passive
tags are often embedded into adhesive
labels that are quick and easy to attach,
or sometimes into the device itself.
Alternatively, active RFID tags utilize a
battery, which enables them to transmit a
unique ID and location information every
time they pass an RFID receiver or at pre-
set intervals. To transmit information, ac-
tive RFID tags contain a beacon or tran-
sponder, which is powered by batteries.
Active RFID tags are more expensive than
passive RFID ones, but they can be worth
the cost to ensure more accurate tracking
of higher value items such as medical de-
vices (e.g., feeding devices and infusion
pumps) or other equipment (e.g., wheel-
chairs and beds).
With regard to the battery, size can be a
key consideration. A compact battery can
help to reduce the size of the tag and,
therefore, make it less detectable and
harder to remove from the device. Ultra­
life’s Thin Cells®, for example, are dis-
crete batteries measuring as thin as 1.1
mm. They retain more than 98 percent of
their capacity after one year of storage at
room temperature, meaning they are al-
ways ready to use regardless as to how the
medical devices are stored. This can prove
useful in hospitals where equipment
could be left anywhere after use.
Finally, there is a type of tag that sits
between active and passive, known as
semipassive RFID, which reflects a small
fraction of the power emitted by an RFID
receiver. Because it does not have an on-
board transmitter, the read range of a
 semipassive tag can be limited. There- require different voltages or that have
fore, semipassive RFID tags are best bespoke requirements (size, perfor-
suited for applications where tagged mance, etc.), custom battery packs are
items stay within close range of an also an option.
RFID receiver or can be scanned reg- When it comes to tracking a hospi-
ularly, which may be achievable in a tal’s assets and devices, battery-powered
smaller hospital or clinic but could active RFID offers an excellent choice
prove challenging in a larger one. for real-time or last-known location
Active RFID tags, however, contain tracking. Selecting the optimum non­
a beacon/transponder that can trans- rechargeable battery to power the tags
mit signals to a receiver more than ­20 and rechargeable battery to power a
m away (sometimes up to 150 m), de- handheld reader (if required) is critical
pending on frequency levels and oth- to attaining the desired results.
er factors. To further expand this dis- Ultralife’s Thin Cells® are discrete batteries that measure
tance, in larger hospitals or those as thin as 1.1 mm. (Credit: Ultralife) References
with several buildings, instead of buy- 1.“MGM Solutions: 6000 Hours Per September
Wasted on Nurses Finding Lost Equipment,”
ing multiple receivers, a hospital can Because handheld RFID readers may Healthcare Facilities Today, https://www.health-
utilize its existing Wi-Fi nodes, which not be in continuous use, they are often carefacilitiestoday.com/posts/MGM-Solutions-
6000-Hours-Per-September-Wasted-on-Nurses-
may already cover most of the hospital powered by rechargeable batteries that Finding-Lost-Equipment—17611
grounds and are likely to be networked are charged between use. For these types
together to share data. However, there of readers, pre-engineered­, rechargeable This article was written by Robert Brown,
may be some areas of a hospital that its lithium-­ion batteries, such as Ultralife’s Marketing Executive, Accutronics, Ltd.,
Wi-Fi network does not reach or where Soft Packs, are suitable. The batteries Newcastle-under-Lyme, UK. For more in-
existing nodes may not be compatible come in voltages ranging from 3.7 to 14.8 formation, visit www.ultralifecorporation.
with RFID. In these instances, handheld V and have a long cycle life. For original com. Contact: robert.brown@accutronics.
RFID readers can be a useful option. equipment manufacturers (OEMs) that co.uk or +44 (0) 1782 566 688.
Asahi_2022_MDB_Metal_printer.pdf 1 5/31/2022 9:44:52 PM

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Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 37

Why Cleanroom Assembly of Plastic Medical and Electronic
Devices Requires Ultrasonic Welding Technology
F or years, ultrasonic welding has been used in cleanrooms
where plastic components are assembled to complete medi-
cal and electronic devices. That is unlikely to change. What is
In ultrasonic plastic welding, parts are brought together un-
der pressure by the acoustic stack, which generates a vibratory
motion (amplitude) that is transferred to the part. These vibra-
changing, however —rapidly — is the sophistication and com- tions cause friction at the interface between the parts, creating
plexity of these products and the level of precision and quality heat and localized melting to form the weld. Ultrasonic weld-
required to complete their assembly. ing is an inherently clean process, but it does involve moving
Specialized manufacturers know that cleanliness — especial- parts, and particulate generation is always a possibility. In addi-
ly prevention of particulate contamination — is of paramount tion, quality standards — such as ISO 13485 in medical manu-
importance, and most have already installed the latest in HEPA facturing — demand real-time control, process monitoring,
filtration, air pressure, and temperature control and monitor- data storage, and communication capabilities that may not be
ing systems to comply with all applicable standards. However, it built into older welders.
is equally important for manufacturers to fully understand and
appreciate that today’s applications require higher levels of n State of the Art
performance in welding equipment than they did only a few Today’s advanced ultrasonic welders, such as the Branson™
years ago. Examples of challenging applications include: GSX-E1 model from Emerson, incorporate technology and fea-
• Plastic assemblies containing compressible internal elements, tures that make them ideal for cleanroom applications. For in-
such as elastomeric seals or cores stance, they are built with electromechanical (servo) actuators,
• Small, thin, or complex plastic parts welded onto plastic struc- which are far less likely to generate particulates than pneumat-
tures directly atop sensors or delicate electronics ically actuated units. The new GSX-E1 welder qualifies for an
• Components involving posts or other structural elements that ISO Class 5.5 cleanliness rating, and, if desired, a special
must be ultrasonically swaged or inserted into substrates that cleanroom-­friendly feature package, which includes stainless-­
vary in hardness or structural consistency, such as composites steel exterior surfaces to make wipe down easy, can be added.
• Parts molded from bioplastics and other novel materials with New power supplies that drive and control the welder also
narrow processing windows are drawing interest from cleanroom operators. These have
It is necessary, then, to stay current with available welding transitioned in recent years from analog to fully digital systems
technology. In fact, if ultrasonic equipment is even just seven that offer closed-loop feedback and tighter control of critical
years old, it may not be up to the task, and the consequences in weld parameters. This change is important because, while the
terms of quality and productivity can range from the inconve- welding equipment itself is inherently clean, the specifics of
nient to the catastrophic. each application — size, cycle times, polymer materials in-
volved, and so on — influ-
ence particulate genera-
tion. Suppliers can work
with customers to test ap-
plications and determine
the ideal “recipe” to
achieve high-quality re-
sults while also meeting
cleanliness objectives.
For instance, the Bran-
son GSX-E1 welder takes
advantage of closed-loop
feedback in the actuator
to make split-second ad-
justments to force and
amplitude. Both variables
can be changed in 10-step
increments such that, in a
1-second welding cycle,
for example, the setting
can be changed every 0.1
seconds to ensure optimal
results.
State-of-the-art power
By staying current with available ultrasonic welding technology, manufacturers of medical and electronic equipment find supplies also use web ser-
it easier to maintain the level of precision and quality required in the assembly of plastic components. (Credit: Emerson) vices to enable remote
38 www.medicaldesignbriefs.com Medical Design Briefs, September 2022
connectivity. Medical and electronics manufacturers can con-
trol and monitor welding equipment from just about anywhere
in a given plant or around the world. They can digitally moni-
tor the health of their assembly systems by tracking key process
indicators such as frequency or power draw. Variations in these
and other values can provide early indications of problems in
the acoustic stack. This, in turn, helps users identify near-term
maintenance issues and avoid quality problems and unplanned
downtime on the line.
In addition, the advanced data-gathering capabilities of
these digital power supplies also enable users to monitor pro-
cess parameters in real time, set high/low limits on weld re-
sults, and configure alarms that flag weld cycles of parts that fall
outside process limits. This capability enables automated bad-
part processing and data logging that can be indispensable for
maintaining superior quality as well as the 100 percent trace-
ability required under standards such as the U.S. Food and
Drug Administration’s 21 CFR Part 11.
n Dynamic Mode
Cleanroom applications often involve complex parts with very
tight welding tolerances or high levels of automation. Applica-
tions like these frequently require more advanced welding tech-
nology than older systems that optimize welder performance
around a single factor that is critical to part quality such as ener-
gy (joules per weld), peak power, distance
(part collapse depth), or total weld time.
To overcome the limitations of single-­
factor weld modes, Emerson has devel-
oped a new patent-pending dynamic
mode that is available on the GSX-E1.
Dynamic mode leverages the servo-­
actuation system, combining
computing power and cutting-­
edge algorithms with high-
speed data communications to
monitor, recalculate, and ad-
just the weld process
in real time and
achieve an opti-
mized target result.
When using dy-
namic mode, the
manufacturer se-
lects the single-factor weld
mode — such as energy, distance,
or time — that provides the best re-
sults in a new application. Then,
the user enters two additional
scores, which act as limits for
dynamic mode activity. The
first is a material density
score that essentially charac-
terizes the hardness or resis-
tance of the material that is
to receive the welded, The Branson™ GSX-E1 welder from
staked, or inserted part Emerson qualifies for an ISO Class
(e.g., a low-density score 5.5 cleanliness rating. This rating and
other technology and features make
equates to a harder, more it ideal for cleanroom applications.
resistant material). The (Credit: Emerson)
Medical Design Briefs, September 2022 www.medicaldesignbriefs.com 39
second is a weld reactivity score, which is used to adjust the de-
gree of variability allowed in the target result (e.g., a low reac-
tivity score equals a more homogenous result). Then, dynamic
mode monitors each weld cycle, using the density and reactivity
limits to adjust the cycle in response to specific part-to-part vari-
abilities throughout the production run.
n Getting to the Right Solution
Focusing on challenging applications in medical and elec-
tronic cleanrooms, along with new equipment and technology
available to help ensure meeting quality and standards-­
compliance goals, is critical to advancing applications of new
welding technology; however, not every situation will require
top-shelf features or be best-served by ultrasonic welding.
Working closely with customers, supplier consultants use their
extensive process expertise and consider alternative technolo-
gies — like laser welding, for instance — before recommending
the appropriate equipment. Branson welding solutions, for ex-
ample, are backed by deep technical knowledge, decades of ap-
plication experience, and a global supply chain with sourcing,
manufacturing, and customer-support capabilities.
This article was written by David Devine, Business Develop-
ment Manager, Medical, for Branson Welding and Assembly at
Emerson, St. Louis, MO. For more information, visit www.
emerson.com. With in-depth knowledge of both plastic materials
and assembly technologies, he provides customers with welding
and assembly solutions. Contact: DavidDevine@Emerson.com.
Extend The Life of Tools and
Wear Surfaces Up to 1000%.
Improve and renew Micro-Electronic Tools, Surgical Instruments and Micro-
Laboratory Instruments with the Hunter Carbitron 300. This simple easy-to-
use process applies tungsten-carbide to tools and wear surfaces extending
the life up to 1000%.
The Carbitron 300 system, consisting of an adjustable power supply and
vibrating hand-tool is a heavy-duty unit incorporating the features of units
selling for 5 – 10 times its low price.
Used for Tissue Forceps, Needle Holders, Micro Needle Holders, Micro Pliers etc.
Hunter Products, Inc.
908-526-8440
www.hunterproducts.com
E-mail: hunter@hunterproducts.com
 PRODUCT OF THE MONTH
2022 Product of the Year
Finalist
n DC/DC Converter
A series of high isolation 6 W DC/DC converters suitable for medical applications is available from
Cosel, Tokyo, Japan. Packaged in a single in line (SIP) type 8, the MH6 series has a reinforce isolation of
3k VAC, 4.2k VDC, and complies with medical isolation standard (2MOOP – 250 VAC working voltage).
Three input voltages (4.5–18; 9–36, and 18–76 V) and a large variety of single (MHFS6) and dual output
(MHFW6) options cover a large range of applications. The series has only 20 pF max insulation capaci-
tance, thus reducing noise transfer. It has built-in overcurrent protection circuit, with automatic recovery.
A remote control pin operating as negative logic (L:ON, H:OFF) is available.
For Free Info Visit http://info.hotims.com/82325-340

Product Focus: Pumps/Valves

n Mass Flow Controller n Media Isolation Valve

High-performance mass flow controllers and
meters are available from Sensirion, Stafa, Switzer-
land. The SFC5500 mass flow controllers are cali-
brated for multiple gases and come with push-in
fittings, which can be easily swapped out from a list
of compatible parts. They are available in ranges
from 50 sccm to 200 slm. The SFM5500 is a valveless version. The
pressure-­resistant mass flow meters are available in four flow ranges: 50
sccm, 0.5 slm, 2 slm, and 10 slm. The sensor is based on the micro­
thermal measurement principle and uses the company’s CMOSens®
MEMS technology. The mass flow controllers/meters are suitable for
applications such as gas mixing in medical instruments.
For Free Info Visit http://info.hotims.com/82325-341
n Smart Pipette
Festo, Islandia, NY, has developed a closed-loop
smart-pipette for automated, high-speed dispensing
systems. The new DHOP smart pipette with DHAP
low-force-tip family is designed for automated pipette
applications where precision, validation, and process
monitoring are needed. The DHOP’s three pressure
sensors validate the performance of every dispense.
Sensor data can be used to track dispense volumes
and fluid characteristics. The pipettes can alert to clogged tips and
sense liquid levels. The DHOP closed-loop technology and the
DHOE open-loop pipette is based on pressure over liquid technol-
ogy. It allows the operator to program in engineering units (μl, ml),
and the pipette accurately and repeatably dispenses that volume
utilizing multiple pressure and temperature sensors and sophisti-
cated software feedback.
For Free Info Visit http://info.hotims.com/82325-343
A solenoid-operated device from
Clippard, Cincinnati, OH, uses a flex-
ible diaphragm to isolate the actua-
tion mechanism from the fluid path.
All wetted areas of the NIV Series me-
dia isolation valve are either PEEK or
PTFE, making this series ideal for use with corrosive media. A
unique feature of the series is the one-piece valve stem that func-
tions as a sealing membrane while also supporting and centralizing
the poppet in the seating area. This multifunctional poppet/­
diaphragm/stem results in a simplified design with fewer parts
(only two for the 2-way and three for the 3-way), longer life, and
zero dead volume. Four orifice sizes are available as 2-way normally
closed, 2-way normally open, or 3-way selector/diverter.
For Free Info Visit http://info.hotims.com/82325-344
n Fluid Power Systems
Motion Industry, Birming-
ham, AL, offers fluid power, in-
tegrated electronic controls
and electromechanical technologies under a new brand, Mi Fluid
Power Solutions. The new brand comprises more than 65 on-­
demand retail fluid power hydraulic and industrial hose assembly
stores and support facilities, including repair, build, and engineer-
ing capabilities. The brand encompasses hydraulic equipment,
pneumatics, pumps, filtration, motors, and lubrication products, as
well as services that range from barcoded hose assemblies and VMI
delivery services to pressure testing, design of mobile equipment,
hydraulic manifold design, and custom power units with complete
integrated controls and software.
For Free Info Visit http://info.hotims.com/82325-342

n Stretchable Film n Frameless Servo Motors

A stretchable film from Toray, Tokyo, A series of frameless servo motors from Koll-
Japan, builds on the company’s technol- morgen, Radford, VA, are suitable for surgical
ogy to deliver circuit mounts that offer robots. The TBM2G series delivers optimal per-
exceptional resistance value stability. formance in a lighter, more compact package.
­REACTIS™ is designed to provide ex- They are optimized to deliver high torque at rel-
cellent shape recovery and heat resistance. The stretchable film uses a atively low speeds in low-voltage applications
proprietary polymer structure design and film-forming technique that such as robotic joints, mobile robots, and other
combines cross-linked and stretchable components. The flexible film battery-operated machines. Compact and efficient, the series is de-
recovers its shape between –20° and 80 °C. It also maintains heat resis- signed to be directly embedded into a machine using the machine’s
tance even after treatment at 200 °C. own bearings to support the rotor.
For Free Info Visit http://info.hotims.com/82325-352 For Free Info Visit http://info.hotims.com/82325-361

40 www.medicaldesignbriefs.com Medical Design Briefs, September 2022

n Wireless Pressure Sensor n Ductless Hoods
Millar, Houston, TX, offers a transmitter-receiver combo designed HEMCO, Independence, MO, offers duct-
to remove the need for new hardware to operate existing capital less hoods in 24, 30, 35, and 47 in. models.
equipment. The wireless pressure prototypes can be customized in The CleanAire II ductless hoods are de-
catheter size, length, and transmitter shape and size to meet the re- signed to meet DH I
quired application. To measure pressure, the catheter tip is inserted requirements as de-
inside the body at the desired pressure reading location and the transmitter is secured to the fined by SEFA 9. The
patient. Upon activation, the transmitter connects wirelessly to the Bluetooth receiver compati- hoods feature a built-
ble with an existing patient monitor. In this capacity, it can connect to any existing capital equip- in carbon filtration
ment or monitor, reducing the costs of enabling wireless capability. system to adsorb non-
For Free Info Visit http://info.hotims.com/82325-349
toxic fumes and
odors. They are
n Display Modules equipped with an in-
Review Display Systems, Milwaukee, WI, offers of a comprehensive range tegral blower, vapor-­
of industrial specification 10.1-in. TFT display modules that are suitable for proof light, fan, and
use in a broad range of industry sectors, applications, and operating envi- light switches. The hoods’ superstructure is
ronments. Available in a range of resolutions including 800 × 600 pixels constructed of chemical and flame resistant,
(SVGA), 1024 × 600 pixels (WSVGA), and 1280 × 800 pixels (WXGA), the display modules feature nonmetallic, composite resin with a molded
traditional 4:3 and widescreen 16:9 aspect ratios. Brightness specifications of 300 cd/m² up to high one-piece seamless interior fume chamber. A
luminance 1000 cd/m² versions are supported with long-life LED backlights. For extreme operating vertical sliding clear acrylic sash protects
environments, an extended operating temperature range of –30° to +85 °C is also available. the user and contains the process fumes.
For Free Info Visit http://info.hotims.com/82325-350 The carbon filter that is included adsorbs
the fumes and then recirculates the air back
n Pinch Clamps to the laboratory.
Qosina, Ronkonkoma, NY, has introduced a new selection of For Free Info Visit
pinch clamps made from polybutylene terephthalate (PBT), an al- http://info.hotims.com/82325-346
ternative to nylon, which is used in the manufacture of many types of
single-use components. The ¾ in. (19 mm) pinch clamps are now
available in white (#25659), red (#25154), yellow (#25152), blue PRODUCT SPOTLIGHT
(#25156), and black (#25153), making them ideal for color-­coded
sets. The tamper-evident clamps offer easy, one-handed closure and are zip-tie compatible. Materials CUSTOM
meet USP Class VI and ISO 10993 criteria, and the clamps are gamma and autoclave compatible. AUTOMATION
For Free Info Visit http://info.hotims.com/82325-360 EQUIPMENT
The Arthur G. Russell Company
n EMI-RFI Three-Phase Filter designs automatic assembly
A series of metal box three-phase filters is available from KEMET, Ft. Lau- equip­ment for the medical de­
vice industry. We specialize in high-speed, mechani-
derdale, FL. The GTX metal case filters cover three-phase EMC requirements cal systems designed for products like syringes, blood
with a wide variety of characteristics. With a nanocrystalline core, these filters are collection tubes, catheters, and dosage dispensers.
designed to achieve excellent damping and attenuation characteristics in a compact AGR’s manufacturing process adheres to stringent
size, coupled with a broader frequency range. In addition, six different combinations of FDA requirements. http://www.arthurgrussell.com/
Y capacitors can be selected to support various equipment topologies. The lightweight filters are
ideal for use in medical applications where suppressing EMC is critical.
For Free Info Visit http://info.hotims.com/82325-354 The Arthur G. Russell Co.
n Diagnostic Tapes
Mactac, Stow, VA, has expanded its line of diagnostic adhesive tapes.
The Response® line includes 10 new acrylic adhesive tapes that are man-
ufactured with ultra-clean, solvent-free, 100-percent solids UV curing MEDICAL-GRADE
technology. The tapes deliver low levels of outgassing and migration and LED CURABLE
offer excellent optical properties and adhesion performance, typical of SYSTEM
traditional solvent acrylics. They feature precise deposition control, compatibility with many assay Master Bond LED403Med
chemistries, and a wide temperature range, making them ideal for diagnostic device applications. is a one-part LED system
For Free Info Visit http://info.hotims.com/82325-362 that cures fully upon expo-
sure to LED light. In thinner sections, cures can be
achieved in 15–30 seconds or less. Led403Med resists
n Spiral Torsion Springs various sterilization methods and passes the plastics
John Evans’ Sons, Lansdale, PA, offers spiral torsion springs that allow for rota- test for USP Class VI biocompatibility and ISO 10993-5
tion in two directions as well as a return to center capability. Used in pairs at a cytotoxicity requirements. http://www.masterbond.
com/tds/led403med
right angle to each other, the springs enable a wide range of motion in a two-axis
configuration, while preserving the return to center feature. Spiral torsion springs
are normally used in applications requiring less than 360° of rotation. They are
generally used to obtain a large amount of torque through a small amount of rotation. A typical ap-
Master Bond
plication is a dental x-ray head.
For Free Info Visit http://info.hotims.com/82325-348

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

 ADVERTISERS INDEX
Advertiser Page Web

Publisher.....................................................................Joseph T. Pramberger
Associate Publisher..................................................................... Helene Beck Biosensors for
(908) 300-2538
Medical Wearables 2022 ............9....................... biosensors-medical-wear.com
Sales Director.........................................................................Desiree Stygar
(908) 300-2539
Chroma Technology......................Cover 4....................................... chroma.com
Editor & Director of Medical Content.......................................... Sherrie Trigg
­Content Strategist, Audience Development................................... Kendra Smith
Da/Pro Rubber Inc.......................26....................................... daprorubber.com
Production Manager...............................................................Adam Santiago
Production Coordinator......................................................... James Rodriguez
Creative Director....................................................................... Lois Erlacher Emerson.....................................11................................emerson.com/branson
Graphic Designer....................................................................John McCarthy
Marketing Director................................................................ Kaitlyn Sommer
Eurofins Medical Device Testing....Cover 2.................eurofins.com/medical-device
Senior Marketing Coordinator...........................................................Sam Mills
Marketing/Event Coordinator ...................................................Chris Kendrick
Audience Development Director........................................ Christine Oldenbrook Filmecc USA, Inc.........................21, 37.............................asahi-inteccusa.com
Audience Development Coordinator............................................ Stacey Nelson
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(212) 490-3999
Executive Vice President......................................................... Luke Schnirring
Keystone Electronics Corp............5.................................................keyelco.com
Technology Director................................................................ Oliver Rockwell
Director of Digital Products........................................................... Howard Ng
Master Bond Inc..........................41........................................masterbond.com
Digital Media Associate......................................................... Md Jaliluzzaman
Digital Production Associate................................................Andrew Greenberg
Digital Production Associate........................................................Symba Wong maxon........................................15, 21.................................... maxongroup.us
Digital Production Assistant................................................. Rowena Pagarigan
Budget & Forecasting.................................................................Felecia Lahey
Medbio, LLC................................7, 20....................................... medbiollc.com
Accounting/Human Resources Manager...................................... Sylvia Bonilla
A/R Clerk.................................................................................Crystal Ortiz
Office Manager......................................................................Alfredo Vasquez
MICRO.......................................4, 22........................................ micro-co.com
Credit/Collection Manager........................................................ Stacie Pointek
MicroLumen Inc...........................29........................................ microlumen.com
MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES

CT, WI, Europe ......................................................................... Helene Beck Microspec Corporation.................Cover Flap, 22.......... microspecorporation.com
(908) 300-2538
IN, MI, Europe.........................................................................Desiree Stygar
(908) 300-2539 Nelson Laboratories, LLC.............23, 31....................................nelsonlabs.com
MA, NH, ME, VT, RI, Eastern Canada..............................................Brian Hines
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NJ, PA, DE............................................................................... John Murray Qosina........................................23, 33..........................................qosina.com
(973) 409-4685
TX, OK, LA, AR, MS, AL, TN, FL, SC, NC, GA, DC, WV, VA..............Ray Tompkins
(281) 313-1004 Sealevel Systems, Inc...................2................................................sealevel.com
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Integrated Media Consultants.................................................... Patrick Harvey
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42 www.medicaldesignbriefs.com Medical Design Briefs, September 2022

Upcoming...

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Thursday, October 6, 2022 at 11:00 am U.S. EDT
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Pumps play an integral role in medical devices, but there are so many different pumps, what
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