[Link].

com December 2023

INSIDE:
Resource Guide and Directory –
Winter 2023 page 31

Designing Medical Devices That

Minimize Healthcare Costs

Design Considerations
for Surgical Robotics

Medical Manufacturing:
Integrating IoT

Selecting USP Class VI

Medical Silicones
Free Info at [Link]
[Link] December 2023

INSIDE:
Resource Guide and Directory –
Winter 2023 page 31

Designing Medical Devices That

Minimize Healthcare Costs

Design Considerations
for Surgical Robotics

Medical Manufacturing:
Integrating IoT

Selecting USP Class VI

Medical Silicones
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Biocompatibility &Analysis
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Finland Italy Switzerland
Switzerland
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France Netherlands United
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Risk Assessment Factors &
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Functionality
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 December 2023
Published by SAE Media Group®

n COLUMN n SPECIAL SUPPLEMENT

4 From the Editor 31–81 Winter 2023 Resource Guide
32 Designing Medical Devices That Minimize Healthcare Costs
n FEATURES 36 Directory of Products and Services
8 From Ventilators to Surgical Robotics: Bearing Design
Considerations for Medical Devices n ON THE COVER
14 How to Integrate IoT Devices to Improve Safety in Medical A novel technique called transcranial temporal interference
Manufacturing Processes electrical stimulation (tTIS) for noninvasive neuromodulation
18 How to Select USP Class VI Medical Silicones in humans can successfully target deep structures and en-
hance motor skill learning in healthy older subjects. A combi-
nation of computational modeling, fMRI studies, and behav-
n TECH BRIEFS
ioral evaluations, have shown, for the first time, that tTIS can
24 MDR: Regulating Devices That Don’t Have an Intended specifically modulate an area deep within the brain called the
Medical Purpose striatum, which is a central processing hub of motor control
25 Forging a New Path with Advances in Electro-Thermal Design and learning. To learn more about this technique for neurore-
habilitation, read the article on page 23.
27 Exploring Overmolding vs. Gluing for Bonding Medical Devices
(Credit: Flyazure/EPFL)

n DEPARTMENTS
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From Ventilators
to Surgical Robotics:
Bearing Design Considerations
for Medical Devices

H
ealthcare is undergoing a great transformation, ing components. Bearings used in medical devices must be
largely driven by the innovation of medical devices. manufactured from rings and balls produced with high-purity
These devices play an increasingly pivotal role in materials. Refined martensitic stainless steel is recommended
diagnosing, treating, and improving the lives of pa- for most medical applications. This alloy, known by the trade
tients worldwide. Reliability is paramount, and names KS440, ACD34, and X65Cr13, offers the same corrosion
many devices depend on the use of precision ball bearings to resistance as conventional AISI 440C but contains lower carbon
operate effectively under demanding conditions. and chromium content.
Surgical power tools, dental drills, pumps, and ventilators This chemistry results in fine, evenly dispersed carbides after
are just a few of the medical applications that require the use of heat treatment, producing lower noise and vibration character-
miniature and instrument ball bearings. Bearings are also criti- istics during bearing operation. This is highly desirable for
cal components in a wide variety of diagnostic and imaging high-speed medical instruments such as dental drills and surgi-
equipment. Material, lubrication, precision level, low noise, cal handpieces. For higher corrosion resistance, nitrogen-­
phonlamaiphoto/AdobeStock

and protection from contamination are key attributes that de- enhanced martensitic stainless steel can be used. This steel is
signers must properly determine to ensure the optimal perfor- more expensive than 440C but offers five times the corrosion
mance of bearings used in medical devices. resistance, which is beneficial for use in environments such as
exposure to blood. This alloy also exhibits extended fatigue life
Materials and very low noise levels.
Direct exposure to patient tissue and bodily fluids, steriliza- Balls produced from ceramic materials such as silicon nitride
tion requirements, and regulatory compliance all drive the provide great benefits for some applications. Ceramic balls are
need for appropriate material selection when specifying bear- lightweight, nonmagnetic, and resistant to attack from most
8 [Link] Medical Design Briefs, December 2023
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Design Considerations

the bearing; it may also be subject to

regulatory requirements. Manufactur-
ers of medical devices are often re-
quired to use NSF-certified lubricants
(e.g., food-grade H1 or H2) or biocom-
Riveted Retainer patible lubricants according to ISO
10993. In surgical tool applications in-
Rubber Seal volving patient contact, medical-grade
silicone or mineral oil-based lubricants
are commonly used. These lubricants
must be able to withstand high speeds
Ball and be resistant to steam and water
washout from the sterilization process.
Solid film lubrication is another op-
tion but is generally used only in sit-
uations where an oil or grease would
Outer Ring likely fail. These include high- or low-­
Inner Ring temperature extremes, exposure to
radiation, or vacuum environments
where outgassing is a concern.
Solid films are highly engineered and
usually added at the component level
Basic components of a sealed ball bearing (lubrication not shown for clarity). (Credit: AST Bearings) prior to bearing assembly. Common ex-
amples of dry films are graphite, molyb-
l­iquids and chemicals. They also greatly in crown-style retainer. For extremely denum disulfide, tungsten disulfide, or
improve the limiting speed of the bear- high-speed rotation, an angular contact gold. Solid films are subject to wear and
ing, which is ideal for handpieces spin- bearing with a full-machined, one-piece therefore should be used in only low-
ning at very high revolutions. While ce- type retainer should be used. This style speed, lightly loaded applications. The
ramic balls have an impressive list of of retainer provides increased stability bearing manufacturer (or a lubrication
beneficial characteristics, contact stress at higher speeds. A wide array of plas- specialist) should be consulted during
is greater due to the high ball hardness tic materials is available for producing lubricant selection due to the large num-
and the fatigue life of the bearing is com- retainers, which are lightweight, resis- ber of lubricants commercially available
promised. Steel balls are a better option tant to temperatures up to 500 °F, and across a wide range of prices.
when the typical bearing failure mode is autoclavable. Phenolic resin cages have
characterized by fatigue. a porous structure and can be impreg- Precision Level
Full ceramic bearings, in which both nated with oil for better lubricity in the The precision level, or tolerance
the rings and balls are manufactured ball pockets. Some materials, such as class, of a ball bearing should be care-
from ceramic material, offer the advan- polyamide-imides, contain additives like fully considered when specifying for
tage of being completely non-magnetic. graphite or PTFE, which improve lubric- use in a medical device. While all bear-
These bearings are ideally suited for use ity properties. ings are extremely precise mechanisms,
in imaging equipment. Full ceramic thought must be given to the different
bearings cannot be produced to the Lubrication precision level options available and
same precision levels of typical steel Proper lubricant selection — meaning their effect on bearing performance
bearings, however, and can be cost pro- both type and amount — is critical to and lifespan. Raceway parallelism, for
hibitive. Titanium and 300 series stain- bearing life and performance but is of- example, can affect bearing torque, so
less steel are considered biocompatible ten overlooked. Operating temperature a nonparallel raceway condition will re-
options but are not commonly used due is the primary consideration when se- sult in torque spikes during rotation. In
to a reduction in load capacity and a lecting a lubricant. Temperature directly high-speed applications, excessive bear-
large increase in cost. affects the viscosity of the lubricant base ing runout can result in an imbalance
The retainer, or ball separator, is oil, which in turn impacts the lubricant’s in the rotating mass. Both conditions
also an important bearing component ability to support application loads. In can lead to unpredictable performance
and its material selection should not medical applications, bearing lubricants and premature failure.
be overlooked. Retainers influence the are subjected to numerous demanding Bearing tolerance classes are specified
speed capability of a bearing, as well as environmental factors including ster- in the United States by the American
the torque and noise levels produced. ilization, temperature extremes, high- Bearing Manufacturers Association
Retainers used in bearings typical of speed rotation, saline wash down or ir- (ABMA) and are defined as ABEC 1,
medical applications are made from rigation, reagents, blood, and exposure ABEC 3, ABEC 5, ABEC 7, and ABEC 9.
300 series stainless steel. In high-speed to radiation. The higher the tolerance class number,
applications, however, it is often nec- Lubricant selection not only de- the tighter the tolerances. ABEC ratings
essary to use a plastic or phenolic res- pends on the operating conditions of specify tolerances of size and form for
10 [Link] Medical Design Briefs, December 2023
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Why do medical professionals have so much confidence in our devices, sets and kits?
It starts with five decades of contract manufacturing. The pharmaceutical industry relies
on us to build custom kits with all the devices necessary to dispense and administer your
drug. Our product portfolio contains hundreds of standard components plus capabilities
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Design Considerations

a function of rotational speed. Vibration

is caused by several factors, including
rough or damaged ring and ball surfac-
es, poor geometric tolerances, contami-
nation, improper lubrication, incorrect
radial play, and improper shaft and
housing fits.
Most manufacturers of miniature and
instrument bearings produce bearings
that operate at very low noise levels,
referred to as EMQ, or electric motor
quality. An EMQ bearing is manufac-
tured by superfinishing the rolling
contact surfaces to a mirror-like finish,
which provides very smooth rotation.
Equally important is maintaining tight
control of the geometric tolerances of
the bearing components. It is import-
ant to note that unlike ABEC tolerance
Cutaway view of a dental handpiece. Bearings can be seen in several locations supporting the shafts. (Credit: classes, EMQ standards are not uniform
AST Bearings) between bearing manufacturers.

the individual inner and outer rings. Tol- fortable for the operator. The downside Contamination
erances of size refer to the basic bound- of using higher precision bearings is Medical devices and instruments are
ary dimensions: the inner and outer di- price: the higher the ABEC level, the often exposed to various contaminants
ameters and the ring widths. Tolerances more expensive the bearing. when in use, such as blood, saline solu-
of form include roundness, taper, tions, and antiseptic fluids. Sterilization
runout, and parallelism. Bearings with Noise and Vibration of equipment can introduce rinsing liq-
higher tolerance classes are intended for Noise and vibration in a rotating bear- uids and high-pressure steam. Diagnos-
use in precision applications that re- ing is an undesirable condition. Bearings tic equipment, such as hematology ana-
quire high running accuracy, high speed manufactured to meet low noise and vi- lyzers, use a variety of fluids and
rotation, and/or low torque. In hand- bration requirements are an important reagents during operation. Miniature
held instruments, such as surgical or consideration, particularly in very high- and instrument ball bearings are avail-
dental drills, higher precision bearings speed applications over 100,000 RPM, able with different types of closures,
help reduce noise, vibration, and heat such as dental or surgical drills. Noise is called shields and seals. Closures can
generation, making tool use more com- the audible component of vibration and extend bearing life by preventing con-
taminants from reaching the critical
surfaces inside the bearing, while at the
same time limiting the loss of lubricant.
The metallic shield is the most common
closure and highly recommended for
almost all applications. It is manufac-
tured from 300 series stainless steel,
which has a maximum operating tem-
perature of 600 °F.
Since a shield makes no contact with
the bearing inner ring, it has no ap-
preciable impact on torque or speed.
Molded rubber seals are recommended
for more highly contaminated environ-
ments. The most common bearing seal
material is nitrile rubber, also known as
NBR or Buna-N. This type of seal is com-
prised of a rubber profile bonded to a
steel insert and has a maximum operat-
ing temperature of 240 °F. A seal is typ-
ically fixed into the bearing outer ring
and contacts the inner ring, providing
better protection than a shield. This seal
Surgical power tools and robotics require precision ball bearings to operate. (Credit: zapp2photo/AdobeStock) contact results in an increase in rota-
12 [Link] Medical Design Briefs, December 2023
tional torque and reduces the maximum
speed capability of the bearing, however.
Still, this limitation is usually seen as a
design trade-off made to improve bear-
ing life. Light contact seal versions are
available if the increased torque from
the seal lip is of concern.
Nitrile rubber reacts negatively with
certain fluids and lubricants and there-
fore may not be suitable for certain ap-
plications. Alternate materials include
fluoroelastomers, such as Viton, which
have good chemical resistance and a
maximum operating temperature of
400 °F. FDA-approved food-grade sili-
cone rubber, which has an operating
temperature range from –80° to 450
°F, is another good option for extreme
temperature applications. One of the
best sealing solutions for bearings used
in medical applications (particularly
those in the surgical suite) is the glass-re-
inforced PTFE or Teflon seal. Like the
molded rubber and Viton seals, this type
of seal contacts the inner ring, providing
better protection than a metal shield
in contaminated environments. These
materials have outstanding chemical
resistance, can withstand high and low
temperatures, and produce less torque
than rubber seals. These seals are not as
robust as those made from other materi-

Go design.
als, however, and therefore may not be
an effective solution.

Summary
Selecting suitable bearings for med-
ical devices is crucial in ensuring their
reliability and performance. Factors
such as material choice, lubrication,
precision and noise levels, and pro-
tection from contamination should be
carefully considered to meet the de- Emerson’s expertise in plastic joining and fluid
manding requirements of the health- control makes complex medical devices more
care industry. By prioritizing these compact and easier to manufacture.
design considerations, manufacturers
can create safe and effective medi- Learn more at [Link]/Medical
cal devices that improve patient out-
comes and enhance the overall quality
of healthcare.
This article was written by Mark Ma-
negold, Technical Marketing Manager,
AST Bearings, Parsippany, NJ. Mane-
gold is a degreed mechanical engineer
with more than 20 years of experience
with application analysis, design, and
new product development in the bear-
ing industry. For more information,
e-mail [Link]@astbearings.
com or visit [Link].
Medical Design Briefs, December 2023 [Link] 13

Print Ad_Go Boldly -Go design_A&M ENUS_4.5x9.625 inch_2023-[Link] 1 2023/4/24 [Link]

How to Integrate IoT Devices
to Improve Safety in Medical
Manufacturing Processes

T
he Internet of Things (IoT) has developed into an Medical manufacturing comes with its own set of challeng-
essential component of the medical manufacturing es, including strict regulatory requirements and the need
sector. The transformation IoT has brought about is for absolute precision. IoT devices offer solutions by deliver-
both astonishing and inspiring. However, integrating ing real-time data and analytics, which facilitate better deci-
IoT devices into medical manufacturing processes sion-making and risk mitigation.
goes beyond following a trend. These devices improve both
process efficiency and worker safety, making them indispens- Enhancing Process Visibility with Real-Time Monitoring
able in today’s manufacturing landscape. This article explores and Predictive Analytics
the challenges and opportunities of using IoT devices in medi- The lack of real-time data in traditional manufacturing meth-
Patrick Helmholz/AdobeStock

cal manufacturing. ods often leads to costly errors and inefficiencies. IoT has filled
this gap, providing immediate insights critical for maintaining
The Importance of IoT in Medical Manufacturing the high-quality standards required in medical manufacturing.
IoT refers to a network of interconnected devices capable The shift from reactive to proactive oversight and control of
of collecting and exchanging data. In the manufacturing the manufacturing environment through IoT is nothing short
sector, these devices offer unprecedented levels of control of revolutionary. Gone are the days when we had to wait for end-
and oversight, particularly beneficial for quality control and of-day reports or manual inspections to gauge performance and
safety measures. identify issues.
14 [Link] Medical Design Briefs, December 2023
 Integrating real-time monitoring and
predictive analytics creates a synergistic
effect across the entire manufacturing
process, elevating it to new levels of effi-
ciency and safety. Real-time data feeds
into predictive models, making them
more accurate over time. Predictive in-
sights ensure immediate action thanks to
real-time monitoring.

The Need for Streamlined Inventory

and Rapid Response
Agility is one of the main prerequisites
in an industry where a delay in produc-
tion can lead to a shortage of essential
medical supplies. Traditional inventory
management systems often struggle to
keep up with the fast-paced demands,
leading to costly overstocking or under-
stocking issues.

“Integrating
real-time monitoring
creates a
synergistic effect
across the entire
Immediate feedback is a crucial pre- Predictive analytics, enabled by IoT, manufacturing
requisite in medical manufacturing. For can prevent potential equipment mal-
example, IoT devices that monitor steril- functions. Avoiding these failures is criti- process.”
ization processes can ensure that all cal for maintaining consistent product
equipment meets the required cleanli- quality and for reducing the risk of costly
ness standards. Such real-time monitor- recalls or regulatory actions.
ing, aside from ensuring compliance, But the benefits extend beyond pre-
directly affects patient safety. vention. Predictive analytics can also IoT has become a powerful tool for
The implications of real-time moni- optimize machine performance by rec- combating these challenges, offering
toring and predictive analytics are far ommending preventive maintenance real-time insights that enable rapid
reaching, affecting everything from the schedules, extending the lifespan of decision-making. It collects data from
manufacturing process to downstream expensive manufacturing equipment. various machines, systems, and sensors
activities such as packaging, shipping, This also ensures that manufacturers to provide real-time insights for rapid
and even surgical procedures. Real-time are meeting production schedules with- decision-making.
monitoring is the first line of defense in out interruption — a critical factor in Automated tracking systems, pow-
a multi-tiered approach to quality assur- an industry where delays can have se- ered by IoT, can monitor both raw ma-
ance and patient safety. vere consequences. terials and finished products. These
Medical Design Briefs, December 2023 [Link] 15
Integrate IoT Devices

systems minimize downtime and opti- A wearable gas sensor can monitor Step 4 — Develop a security protocol:
mize inventory levels, reducing carry- hazardous gas levels and alert a worker Given the sensitive nature of data in medi-
ing costs and waste. and their supervisor if they go out of cal manufacturing, it’s crucial to establish
Smart shelves equipped with weight range, triggering immediate evacua- robust security protocols. This includes
sensors can send alerts when stock tion or remedial action. These wear- data encryption and secure access controls.
reaches a predefined minimum level, ables contribute to a culture of collec- Step 5 — Implement a pilot program:
triggering automatic reordering. This tive responsibility and proactive risk Deploy the chosen IoT devices in the pi-
level of automation ensures that pro- management. lot area and monitor their performance.
duction never has to halt due to a lack Use the collected data to make any nec-
of materials — a scenario that could essary adjustments.
have life-or-death implications in the Step 6 — Evaluate and tweak: After
medical field. running the pilot program, evaluate

“contribute
Wearables
Supply chain disruptions are inevita- its effectiveness in solving the identi-
ble, be it due to geopolitical issues, nat- fied challenges. Make any necessary
ural disasters, or even sudden spikes in tweaks or adjustments before broader
demand. IoT devices offer a real-time implementation.
overview of the entire supply chain, to a culture Step 7 — Scale up: Once the pilot pro-
from supplier lead times to transporta- gram has proven successful, begin the pro-
tion delays. of collective cess of scaling up the IoT integration to
Technologies such as GPS and RFID
tracking can provide instant updates on responsibility and other areas of the manufacturing facility.
Step 8 — Continuous monitoring and
the location and status of inbound ship-
ments, allowing for contingency plan-
proactive risk improvement: The work doesn’t end af-
ter implementation. Continuous moni-
ning and rerouting if necessary. This
time data enables quick adjust-
real-­
ments, minimizing the impact of disrup-
management. ” toring is essential for ensuring ongoing
effectiveness and making improvements
where necessary.
tions on production schedules and ulti- The integration of IoT into medical
mately, patient care. manufacturing is a multifaceted process
that requires careful planning, execu-
Improving Worker Safety: From Practical Solutions for Integration: tion, and ongoing management. How-
Environmental Monitoring to A Step-by-Step Guide ever, the benefits — from enhanced
Wearable Tech Integrating IoT into a medical man- safety measures to increased operation-
Traditional safety measures often rely ufacturing environment is a complex al efficiency — make it an indispensable
on manual monitoring and reactive pro- but rewarding endeavor. The process strategy for any forward-thinking manu-
tocols, which are often inefficient and involves multiple steps, each crucial in facturer in this field.
prone to human error. However, IoT en- ensuring a seamless transition from tra-
ables proactive safety measures that can ditional methods to a more advanced, Conclusion
prevent accidents before they occur. IoT-enabled operation. Below is a step- The role of IoT in enhancing both
This is particularly useful in environ- by-step guide to help device manufactur- safety and efficiency in medical manufac-
ments with hazardous materials and ers navigate this transformative journey. turing is deeply transformative. For in-
high-powered machinery. Step 1 — Conduct a needs assessment: dustry veterans, these advancements sig-
Environmental factors like ventilation, Begin by identifying the specific chal- nify a revolutionary shift in how
temperature, and humidity are often over- lenges and pain points within your man- manufacturing processes are managed
looked but can have a significant impact ufacturing processes that IoT can ad- and optimized.
on worker safety and product quality. IoT dress. This could range from inventory Staying abreast of technological ad-
sensors continuously monitor these con- management to equipment mainte- vancements is not just advisable but neces-
ditions, triggering alerts or even automat- nance and worker safety. sary, especially in a fast-evolving field like
ed adjustments to HVAC systems when Step 2 — Choose a pilot area: Select a medical manufacturing. The stakes are too
parameters go out of predefined ranges. specific area or process within your man- high to risk falling behind, both in terms
For example, in cleanrooms where ufacturing facility to serve as the pilot for of patient safety and worker well-being.
even minor fluctuations in humidity can IoT integration. This allows you to test As the industry continues to evolve,
compromise product integrity, IoT-en- the technology on a smaller scale before manufacturers must prioritize worker safe-
abled dehumidifiers can turn on auto- full implementation. ty alongside productivity. A safe and effi-
matically to maintain optimal conditions. Step 3 — Select appropriate IoT devic- cient workplace is an operational advan-
Wearable technology has developed es: Based on the needs assessment and tage as much as it is a moral imperative.
well beyond fitness tracking and has be- pilot area, choose IoT devices that are This article was written by Eric Whit-
come a vital tool for workplace safety. best suited to address the identified chal- ley, Director of Smart Manufacturing
Devices equipped with biometric sensors lenges. Consider factors like data accura- for L2L, Salt Lake City, UT. For more
can monitor vital signs, fatigue levels, and cy, ease of integration, and compliance information, contact him at editor@
even exposure to harmful substances. with industry standards. [Link] or visit [Link].
16 [Link] Medical Design Briefs, December 2023
How to Select
USP Class VI
Medical
Silicones

U
SP Class VI silicones are bio- ment. This article provides an overview of numbered I through VI. Each USP Class
compatible elastomers that USP Class VI silicones and explains what and its testing requirements are defined
are safe for contact with hu- medical device manufacturers need to in Chapter <88>: Biological Tests, In
man skin. They have low lev- consider when selecting these materials. Vivo. USP Class I has the least rigorous
els of extractables and chemi- testing requirements. USP Class VI has
cals that can migrate from a material at Understanding USP Class VI the most rigorous testing requirements
elevated temperatures or with surface ex- The U.S. Pharmacopeia (USP) defines and includes an acute systemic toxicity
posure. Applications for USP Class VI sili- the testing requirements that plastics, test, an intracutaneous toxicity test, and
cones include seals, gaskets, tubing, a category of materials that include sili- an implantation test. Specifics of the end
o-rings, cable jacketing, and other com- cones, need to meet in order to belong use and contact duration will determine
ponents for medical devices and equip- to one of six individual plastics classes which class of material is required for a
18 [Link] Medical Design Briefs, December 2023
given application. For example, an appli-
cation where contact of under 24 hours
with intact skin is expected will likely re-
quire a material with less rigorous test-
ing than an application where contact
is long-term, over 30 days, or the skin is
breached or compromised.
USP Class VI silicones may meet re-
quirements that are more rigorous than
what you need, but it’s sometimes better
to be safer by overspecifying materials.
ISO-10993, an international standard for
the biological evaluation of medical de-
vices, has testing requirements that are
much more extensive than USP Chapter
<88>. However, testing medical silicones
to ISO-10993 is more time consuming
and costly than is necessary for most
non-implantable applications.

Key Considerations
The USP is not a regulatory agency,
but its standards inform decision-making USP Class VI silicones are safe for contact with human skin. (Credit: Specialty Silicone Products)
at the FDA. In Europe, medical devices
are regulated under the Medical De-
vice Regulation (EU 2017/745), which
requires that materials used in certain
types of devices are free of chemicals
considered to be carcinogenic, muta-
genic, or toxic to reproduction (defined
in Annex VI of (EC) 1272/2008), or are
considered to be endocrine-disruptors
(defined either in the REACH SVHC list
— Article 59 of (EC) 1907/2006 — or
Annex VI of (EC) 1272/2008).
Medical device manufacturers need
to meet regulatory requirements, but
it’s also important to find the right bal-
ance between material prices and per-
formance. When selecting USP Class
VI silicones, consider the ingredients
and certifications, colors and curing
systems, material tolerances, sizes, and
lead times. The durometer, or hard-
ness, of a USP Class VI silicone is also
important because it determines the
elastomer’s compressibility, which sup- USP Class VI silicones are naturally translucent, but a compounder can add pigments. (Credit: Specialty Silicone
ports sealing. Finally, consider vendor Products)
value.
who stopped using certified compounds the formula for a USP Class VI silicone
Ingredients and Certifications without giving notice. changes, a COC from a supplier’s quality
Material manufacturers may substi- To mitigate these risks, medical device department may contain out-of-date or
tute ingredients because of shortages, manufacturers need to ask suppliers for inaccurate information.
discontinued inputs, cost pressures, or certificates, or certs. It’s also important
supplier consolidation. If the formula to understand the difference between a Colors, Durometers, and Curing
for the end-product changes, the elasto- Certificate of Analysis (COA) and a Cer- Systems
mer may no longer meet all USP Class tificate of Conformance (COC). COAs USP Class VI silicones are naturally
VI test requirements. There are also report the test results for a specific batch translucent, but a compounder can add
instances of materials that were never of materials. By contrast, COCs sim- pigments to support distinctive product
validated by a third party and vendors ply attest to a material’s compliance. If designs. What medical manufacturers
Medical Design Briefs, December 2023 [Link] 19
Class VI Medical Silicones

need to consider, however, is that pig- consistent in terms of appearance. In Vendor Value
mented grades need separate testing addition, platinum-cured silicones USP Class VI silicones can provide the
per color by the end user and advance show less degradation of properties right balance between cost savings and
communication with the pigment sup- under sterilization by autoclaving, irra- patient protection, but medical man-
pliers to prevent the use of pigments diation, and ethylene oxide. This com- ufacturers need to protect themselves
that may cause failures in biocompat- bination of high purity, which translates against supplier cost-cutting that can in-
ibility testing. In addition, a supplier to lower toxicity, and superior proper- validate compliance. It’s also important
that makes silicones in different durom- ty retention under sterilization makes to evaluate all of a material’s attributes,
eters, such as from 10 to 80 (Shore A), platinum-cured silicones preferable for such as color and durometer, and to
may have all of the required USP Class medical applications. choose USP Class VI silicones that have
VI testing for a single durometer rath- passed third-party testing.
er than for all durometers. If that is the Material Tolerances, Sizes, and Whether it’s for sheets, rolls, or ready-
case, USP Class VI equivalency in these Lead Times to-mold compounds, it pays to partner
other durometers may still be sufficient Finally, it’s important to consider with a supplier whose products are truly
for the application. the tolerances, sizes, and lead times USP Class VI compliant. It’s also worth
The curing system for USP Class VI of USP Class VI silicones. When sheets picking a partner that is willing to answer
silicones is especially important. Addi- are compression molded, they come in questions about chemical compliance
tional curing through the use of plati- standard sizes based on available tool- and that will facilitate additional testing
num catalysts produces no by-products. ing. Continuous roll technology can if necessary. By sourcing USP Class VI
By contrast, peroxide-cured silicones produce 10 times as many sheets per silicones from the right vendor, medical
contain by-products in the form of or- hour, and with tight tolerances. Im- device manufacturers can mitigate risk
ganic acids. For this reason, platinum-­ portantly, rolls can also be converted and get greater value.
cured silicones have inherently high- to custom sheet sizes. For applications This article was written by Dominic ­Testo,
er purity than their peroxide-cured where a medical device manufactur- Business Development Manager, Specialty
counter­parts. Platinum curing can also er needs a ready-to-mold compound Silicone Products, Bollston Spa, NY. For
offer greater control over cure rates and instead, compression molding can be more information, contact dtesto@sspinc.
cross-linking for silicones that are more used for parts production. com or visit [Link]

Available on Demand!

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What Really Changed: A Look at the Updated
FDA Guidance Document for ISO 10993-1

In September 2023, the FDA released a new revision to its guidance document on the use of ISO 10993-1, which focuses on the
evaluation and testing of medical devices within a risk management process. This 60-minute Webinar will review the changes to the
FDA’s guidance document — including a look at the information provided in the FDA’s explanatory webinar given in October 2023 —
as well as how to assess the revision’s impact on different situations.
Speakers:
Audrey Turley Helin Räägel, Ph.D.
Director and Biocompatibility Expert, Senior Biocompatibility Expert,
Expert Advisory Services, Expert Advisory Services,
Nelson Labs Nelson Labs

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 n Drug-Delivery n Microfluidic Chip
System Improves Tests Drug Sensitivity
Cancer Treatment Researchers have de-
A hydrogel-based de- veloped an integrated
livery system balances microfluidic chip (BSI-
the acidic environment AST chip) for rapid AST
in a tumor and greatly from positive blood cul-
enhances the cancer-­ tures (PBCs). Using the
fighting activity of the chip, the process from
chemotherapeutic drug bacteria extraction to
it encapsulates in lab getting AST results takes
­experiments. less than 3.5 hours, thus
The hydrogel system, which is injectable, acts as a buffer promising to be a power-
to the drug doxorubicin and directly delivers it to malignant ful new tool in managing
tumors, helping to reduce unwanted side effects that occur bloodstream infections.
when the drug isn’t released directly in the targeted site. In a proof-of-concept study, the BSI-AST chip demonstrated
The researchers say the hydrogel, which was designed to bal- its effectiveness by conducting direct AST on artificial PBCs
ance pH levels, has the potential to substantially improve containing E. coli, testing against 18 antibiotics, with results in
chemotherapeutic treatments and reduce the risk of aggres- less than 3.5 hours.
sive cancers spreading in the body by neutralizing acid levels Moreover, the integrated chip was applied to the diagnosis of
in tumors. clinical PBCs, showing a categorical agreement of 93.3 percent
Doxorubicin is toxic and when administered through the with standard clinical methods. The reliable and rapid AST re-
current practice of intravenous delivery, it doesn’t discriminate sults of the chip highlight its great potential in clinical diagno-
between cancer cells and non-cancerous healthy cells, leading sis. The researchers achieved rapid extraction and enrichment
to significant side effects. Compounding these challenges is of bacteria from PBCs by introducing a separator gel to the
that there is no current method to directly balance acidic pH microfluidic chip for the first time. Centrifugal microfluidic en-
levels in cancerous tumors. (Image credit: Vikas Srivastava/ richment technology also was central to the process. (Image
Brown University) credit: Liu Yang)
For more information, visit [Link]/ For more information, visit [Link]/
roundup/1223/hydrogel. roundup/1223/microfluidic.

n Eye Implant n Magnetic Gel

Treats Diabetes Improves Wound
A microscale device Health
for implantation in An innovative mag-
the eye presents new netic wound-healing gel
opportunities for cell- promises to accelerate
based treatment of the healing of diabetic
diabetes and other dis- wounds, reduce the rates
eases. The 3D printed of recurrence, and in
device aims to encapsu- turn, lower the incidents
late insulin-producing of limb amputations.
pancreatic cells and Each treatment in-
electronic sensors. volves the application
The device is de- of a bandage preload-
signed as a wedge, ed with a hydrogel con-
about 240 µm long, taining skin cells for healing and magnetic particles. To max-
allowing the structure to be mechanically fixed at the angle imize therapeutic results, a wireless external magnetic device
between the iris and the cornea in the anterior chamber of is used to activate skin cells and accelerate the wound healing
the eye (ACE). The work demonstrates the first mechanical process. The ideal duration of magnetic stimulation is about
fixation of a device in the anterior chamber of the eye. It is one to two hours.
designed to hold living mini organs in a micro-cage and in- Lab tests showed the treatment coupled with magnetic
troduces the use of a flap door technique to avoid the need stimulation healed diabetic wounds about three times faster
for additional fixation. than current conventional approaches. Furthermore, while
In tests on mice the device maintained its position in the liv- the research has focused on healing diabetic foot ulcers, the
ing organism for several months, and the mini organs quickly technology has potential for treating a wide range of complex
integrated with the host animal’s blood vessels and functioned wounds such as burns. (Image credit: National University
normally. (Image credit: David Callahan) of Singapore)
For more information, visit [Link]/ For more information, visit [Link]/
roundup/1223/eye-implant. roundup/1223/magnetic-gel.
22 [Link] Medical Design Briefs, December 2023
 n Diamond Quantum n Noninvasive DBS Enhances
Sensors Improve Motor Learning
Magnetic Imaging Researchers have implement-
A research team has de- ed a novel technique called
veloped diamond quantum transcranial temporal interference
sensors that can be used electrical stimulation (tTIS) for
to improve resolution in noninvasive neuromodulation
magnetic imaging. In or- in humans to successfully target
der to test the method, the deep structures and enhance
scientists placed a micro- motor skill learning in healthy
chip with microscopic wa- older subjects.
ter-filled channels on the The scientists combined com-
diamond quantum sensor. putational modeling, fMRI stud-
This allowed the research- ies, and behavioral evaluations,
ers to simulate microstruc- to show, for the first time, that tTIS can specifically modulate an
tures of a cell. They were able to successfully analyze the dif- area deep within the brain called the striatum, which is a central
fusion of water molecules within the microstructure. processing hub of motor control and learning. Unlike other
In the next step the researchers want to develop the method deep neuromodulation techniques, tTIS was able to reach the
further to enable the investigation of microstructures in single striatum without the need for invasive procedures.
living cells, tissue sections, or the ion mobility of thin-film ma- The scientists applied bursts of electrical pulses in a specific
terials for battery applications. pattern (theta burst) to modulate brain activity in human sub-
The ability of NMR and MRI techniques to directly detect jects. This pattern has been shown to induce changes in neural
the mobility of atoms and molecules makes them absolutely excitability and neuroplastic properties with large potential as
unique compared to other imaging methods. (Image credit: A. an application for cognitive enhancement and neurorehabili-
Heddergott/TUM) tation. (Image credit: EPFL)
For more information, visit [Link]/ For more information, visit [Link]/
roundup/1223/quantum-sensor. roundup/1223/motor-learning.

n Soft Robotic System

Streamlines Brain Surgery
Researchers have laid the
NON-CYTOTOXIC EPOXY
groundwork for a soft robotic
tool and control system that
for MEDICAL DEVICES
could grant surgeons an un-
precedented degree of ma- Adhesive System
neuverability within the brain.
A recent study demonstrates that the new system is both intuitive EP62-1HTMed
and highly accurate. The early results suggest that, with further
development, the robot could one day speed up and improve
the efficacy of minimally invasive surgeries for life-threatening
brain aneurysms and other serious conditions.
The researchers designed an air pressure operated — or
pneumatic — catheter tip that they 3D printed using a soft and
flexible resin. The design includes two hollow channels running
HIGH TENSILE STRENGTH
in parallel along the length of the tip, which, if pressurized in-
of 10,000-11,000 PSI
dividually, causes the tip to deflect to either the left or the right. SERVICEABLE FROM
While the catheter tip itself was inspired by existing designs, -60°F TO +450°F
the authors sought to address a need that those previous robot-
ic systems had not yet tackled — a control system that would fit RESISTANT TO:
well into the current clinical workflow.
→ REPEATED STERILIZATION
The team developed a hand dial that allows for precise ad-
justments of the tip’s position, providing more control than → AUTOCLAVING
rotating a pre-bent tip. Additionally, the dial offers haptic feed- → ETHYLENE OXIDE AND STERRAD®®
back that indicates when the tip is bent. With this system, the
researchers grant the ability to simultaneously move a catheter
forward with one hand while adjusting the angle of the tip with
the other. (Image credit: Noah Barnes, PhD Student, depart-
ment of mechanical engineering, Johns Hopkins University) Hackensack,
Hackensack, NJ
NJ 07601,
07601, USA
USA ∙∙ +1.201.343.8983
+1.201.343.8983 ∙∙ main@[Link]
main@[Link]
For more information, visit [Link]/ [Link]
roundup/1223/soft-robotic.
Medical Design Briefs, December 2023 [Link] 23
MDR: Regulating Devices That Don’t Have an Intended
Medical Purpose
Products with only fronts manufacturers with a comprehen- purpose falling under the scope of the
sive regulatory act that needs to be first MDR, both in their functions and in terms
aesthetic purposes will understood, and then complied with. of potential complications and side effects.
also be assessed. Products or product groups that now This was reason enough to expand con-
TÜV SÜD need a certificate of conformity are list- sumer protection to cover these devices.
Munich, Germany ed in Annex XVI. They include: Given the rapidly growing market for
1. Contact lenses or other items intended aesthetic surgeries and aesthetic applica-
to be introduced into or onto the eye, tions in general, the expanded scope of
In late 2022, the EU Medical Device e.g. contact lenses in different colors. the MDR means that many manufactur-
Regulation (MDR) was expanded by the 2. Products intended to be totally or par- ers now have to address the strict provi-
addition of the common specifications tially introduced into the human body sions of the regulation for the first time.
(CS) 2022/20346. The spe00cifications through surgically invasive means for
describe the aspects that must be exam- the purpose of modifying the anatomy n Common Specifications
ined for devices without an intended med- or fixation of body parts, e.g., silicone The common specifications govern the
ical purpose. These aspects apply in addi- implants. Excluded from this category safety regulations and risk management
tion to the classical MDR requirements are tattooing products and piercings. applicable to devices without an intended
and include certain aspects of risk man- 3. Products used for facial or other der- medical purpose as listed in Annex XVI. In
agement. In other words, even products mal or mucous membrane filling that view of the diversity of products in this cat-
that only serve aesthetic purposes, such as are introduced by injection, also re- egory, the EU only released the require-
colored contact lenses, will be assessed in ferred to as dermal fillers. ments in late 2022 after a long process of
accordance with the strict MDR regula- 4. Equipment intended to be used to re- discussions. In accordance with these re-
tions and, in addition, will have to fulfill duce, remove, or destroy adipose tis- quirements, manufacturers must proac-
the requirements laid down in the CS sue, such as equipment for liposuction. tively address and arrange for the assess-
2022/2346. 5. High-intensity electromagnetic radiation ment and certification of conformity of
Annex XVI to the MDR precisely speci- emitting equipment intended for use on their devices. As their first step, they should
fies which devices without an intended the human body, including coherent always contact a Notified Body. As the com-
medical purpose fall under the scope of and non-coherent sources, monochro- mon specifications also apply to existing
the MDR. The foremost consideration for matic and broad-spectrum light, e.g., la- products, all manufacturers of products
manufacturers at this stage is to know what sers used for tattoo or hair removal. listed in Annex XVI must prove that their
they need to know or do now. As a notified 6. Equipment intended for brain stimu- devices are in conformity with the MDR.
body, TÜV SÜD also provides certification lation that applies electrical currents
of conformity with the MDR for devices or magnetic or electromagnetic fields n What To Do
without an intended medical purpose. that penetrate the cranium to modify In the run up to the assessment, com-
Before the MDR came into effect, many neuronal activity in the brain. panies first need to fulfill some internal
devices and items of electrical equipment The backdrop to this change in perspec- requirements, such as: There must be
without an intended medical purpose had tive is the fact that many products without both technical documentation and, for
not been subject to the applicable EU- an intended medical purpose are similar example, for Class III devices, a clinical
wide criteria. However, the MDR now con- to the devices with an intended medical evaluation for every device. The business
as a whole must have an appropriate
quality management system.
Within the scope of postmarket surveil-
lance, manufacturers must accompany
and continuously monitor their devices on
the market. And manufacturers must also
have appropriate insurance cover in the
interest of consumer protection. The im-
plementation of these preparations alone
takes a lot of time, particularly for compa-
nies that have no previous experience of
these requirements.
The extended approval process of the
common specifications is already leading
to long waiting times in the processing of
Even products that only serve aesthetic purposes, such as colored contact lenses, will be assessed in accordance applications for conformity certification.
with the strict MDR regulations. (Credit: kichigin19/AdobeStock) Although manufacturers have certain
24 [Link] Medical Design Briefs, December 2023
transition periods until they need to pres- appear a baffling bureaucratic obstacle TÜV SÜD has prepared for the antici-
ent the certificates, they should take action at first glance, it is actually an important pated surge in demand and has provided
immediately. The length of the individual element of consumer protection for time slots and other resources. Neverthe-
deadlines depends on various factors, in- products with a nonmedical purpose. less, waiting times will be unavoidable, pri-
cluding prior certification in accordance The MDR very clearly specifies which marily due to the repeated delays in ap-
with the Medical Device Directive (MDD) documents are necessary for presenting proval of the common specifications.
or fundamental changes in the product. the safety and performance require- Manufacturers should also make use of the
ments of devices with an intended medi- many sources of information, including
n Dual-Use Devices cal purpose. However, if these products question and answer documents, official
Special attention should be given to are also used for aesthetic purposes, websites, checklists and best practice
products that can be used both with and manufacturers must provide additional guidelines, in order to prepare for confor-
without an intended medical purpose. A documents that fulfill that requirement, mity assessment as thoroughly as possible.1
good example are silicone implants. such as documents that furnish evidence
They are used, for example, after a mas- of the manufacturer’s risk management. Reference
tectomy — surgery performed to remove If medicinal products are incorporated 1. 
Q&A on Transitional Provisions for Products
Without an Intended Medical Purpose Covered
a breast, most often used to treat breast in a device, they too require additional by Annex XVI of the MDR,” European Commis-
cancer — and thus for a very clear medi- assessment by a notified body. sion, September 2023, [Link]
eu/system/files/2023-09/md_new-reg_annex-
cal purpose. However, if an identical im- xvi_q-n-a_transition-[Link].
plant is used for breast modification for n Conclusion
purely aesthetic reasons, the implant is Neither the MDR nor Annex XVI are This article was written by Christian
considered a product without an intend- new. Nevertheless, the entry into force of Götz, Head of Department Non-Active
ed medical purpose and is thus subject the common specifications now presents Medical Devices, and Dr. Jara Brenke,
to additional provisions. a new situation for manufacturers of de- Product Specialist Non-Active Medical
With respect to certification and the vices without an intended medical pur- Devices, TÜV SÜD Product Service
required documentation, manufacturers pose. OEMs must prove that their prod- GmbH, Munich, Germany. For more
may thus have to treat the same item as ucts are in conformity with the MDR and infor­
mation, contact [Link]@
two different products. While this may the common specifications. [Link] or visit [Link].

Forging a New Path with Advances in Electro-Thermal

Design
A new electro-thermal and complex interplays of these parts systems in various industries. Unfortu-
within the broader system framework. nately, thermal SPICE has not proven to
design process captures be the answer given its many limitations.
accurate characteristics n Emerging Challenges
from a 3D thermal The dependency between component n BCI-ROM: A Game-Changing
analysis. manufacturer (the SPICE model provid- Technology
er) and OEM (the SPICE model con- Fortunately, a game-changing technol-
Siemens DISW sumer) has worked for many decades; ogy is revolutionizing the electro-thermal
Plano, TX however, that relationship is showing sig- design process. Boundary Condition In-
nificant signs of strain. dependent Reduced Order Model (BCI-
To meet the functional requirements of An increasing number of traditionally ROM) captures accurate characteristics
a circuit under design, electronics engi- analog components are becoming more from a 3D thermal analysis, ready for use
neers meticulously select components, digital — adding programmability, state in a 1D circuit simulation. The BCI-ROM-
evaluating them based on their electrical machines, and other advanced features based thermal design/analysis approach
attributes, performance benchmarks, and that are beyond the capabilities of exist- is applicable to both components and en-
rated capacities. The selected components ing SPICE-based analog design tools. tire PCB/enclosure and systems. BCI-
must all work harmoniously together to Component manufacturers and their ROMs can simply be connected in a ther-
provide the desired circuit characteristics. OEM customers in medical electronics mal circuit, i.e., functional schematic,
To support the OEM design communi- increasingly battle thermal design issues with the heat-flow conservation principle
ty, electronic component manufacturers during design-in. The interactions be- governing the interaction, in the identi-
have furnished models in the widely used tween electrical and thermal effects can cal way Kirchhoff’s Current Law (KCL)
SPICE format. In hand, these models em- lead to unexpected behaviors and fail- underpins electronic circuit simulation.
power customers to simulate their appli- ures if not properly managed. As a result, This technology offers a lifeline to
cation circuits, thereby enhancing their effective electro-thermal analysis, model- electronics designers grappling with for-
comprehension of the intricacies encom- ing, and design are becoming essential to midable thermal obstacles driven by the
passing the capabilities, the potential, ensure that the reliable performance of unrelenting pursuit of smaller, lighter,
Medical Design Briefs, December 2023 [Link] 25
 harnessing the language’s capacity to ar-
ticulate the interconnected differential
equations, expressed in matrix form, es-
sential for capturing dynamic thermal
characteristics.
A thermal BCI-ROM implemented in
VHDL-AMS seamlessly interfaces with
electrical circuit components. To illus-
trate, the thermal circuit depicted below
establishes a bidirectional communica-
tion channel for temperature exchange
with the electrical circuit element,
while the electrical circuit reciprocates
by supplying power. It’s important to
note that this isn’t a traditional back
and forth co-simulation methodology.
Instead, thermal and electrical circuits
are addressed in parallel, solving for the
electrical and the thermal concurrently,
BCI-ROM captures accurate characteristics from a 3D thermal analysis, ready for use in a 1D circuit simulation. an advantage made available given both
(Credit: Siemens) models are described in the same VH-
DL-AMS language.

Vendor Supplied Models Thermal BCI-ROM

n Additional Resources
QFN
To learn more about BCI-ROM tech-
nology and the tools to create these ac-
curate thermal models, read the white
Thermal Electrical Electrothermal paper, “Electro-thermal design break-
BCI-ROM Spice Functional Schematic through: Enabled by new BCI-ROM ther-
QFN
BOARD mal modeling technology.”1
To understand the power of electro-­
thermal simulation using BCI-ROM
technology, read additional articles that
Fig. 1 – Functional schematic representation of electro-thermal behavior. include interactive, functional simula-
tion examples.2,3
All electro-thermal simulations were
conducted using Siemens’ cloud-based
MOSFET - QFN PartQuest Explore, a complete design,
Power modeling, simulation, and analysis envi-
ronment for electronic and mechatronic
TC Thermal
Electrical
Circuit circuits and systems.4
Circuit

Temperature
References
1. “Electro-thermal design breakthrough: Enabled by
new BCI-ROM thermal modeling technology,” Sie-
mens, [Link]
white-paper-electro-thermal-design-break-
FET_Electrical_Model FET_Thermal_BCI_ROM through?ref=EBS_blog.
2. Mike Donnelly, “Introducing BCI-ROM For Elec-
tro-Thermal Design,” Siemens, March 1, 2021,
[Link]
Fig. 2 – BCI-ROM in circuit simulation environment connecting thermal and electrical circuit modeling. BCI-ROM-For-Electro-Thermal-Design.
3. Mike Donnelly, “Electro-Thermal Design: Using
more cost-effective, faster, and feature-­ n Tackling Electro-Thermal Design BCI-ROMs For Switch-Mode Power Electronics,”
Siemens, March 15, 2021.
rich designs. These pursuits collectively Challenges 4. “Cloud-Based Simulation Tool,” PartQuest, Sie-
exacerbate the challenge of dissipating BCI-ROM revolutionizes collabora- mens, [Link]
heat efficiently. With BCI-ROM emerg- tion between component manufacturers
ing as a pivotal technology for higher and OEM electronics and thermal engi- This article was written by Matt Walsh
accuracy thermal models, a parallel sup- neers, empowering them to jointly tackle Product Marketing, Electronic Board
ply chain is developing, especially in VH- intricate electro-thermal design chal- Systems, Siemens DISW, Plano, TX. For
DL-AMS format. This compliments the lenges with heightened efficiency. The more information, [Link]@siemens.
functional electronic models such as resultant BCI-ROM models adhere to com contact or visit [Link].
SPICE, VHDL-AMS, and IBIS. the IEEE Standard VHDL-AMS format, com/en-US.
26 [Link] Medical Design Briefs, December 2023
Exploring Overmolding vs. Gluing for Bonding Medical
Devices
One benefit of overmolding
is improved patient safety.
Pelham Plastics
Pelham, NH
In the medical device industry, the suc-
cess of a lifesaving operation may depend
on the integrity of a bond between compo-
nents of varying materials. For instance, an
overmolded luer hub on a catheter must
have a strong bond with its shaft to ensure
that fluids may be successfully transferred
into or out of a patient’s body without risk
of leakage or contamination. In this sce- Typically, when a part is overmolded, the substrate is made up of a more rigid plastic or metal, while the overmolded
nario and many others, it is crucial that the material is softer and provides additional function to the part. (Credit: Pelham Plastics)
device manufacturers understand the ad-
vantages and disadvantages that accompa- many manufacturers might choose glu- much adhesive is applied to a catheter
ny different bonding processes. ing methods for several reasons. extrusion, the glue may migrate inside
Overmolding. Overmolding is a pro- For instance, an injection molding ma- the extrusion or into the tip of the cath-
cess by which plastic is injection molded chine is expensive; not every company eter. These critical variables are not pres-
on top of a prefabricated component of can afford to make this kind of invest- ent during overmolding.
similar or different material type. Typical- ment, even if it may increase profits down In addition to the increased integrity
ly, the substrate is made up of a more rig- the road. These are also complex pieces of components, overmolding is a more
id plastic or metal, while the overmolded of equipment, and with this comes great efficient and cost-effective bonding op-
material is softer and provides additional responsibility for engineering and main- tion. Not only are fewer operators (if
function to the part. There are two main tenance personnel. Molding is a more any) required to run an overmolding
overmolding methods: pick and over- niche area of expertise, and companies process, but the process itself is quick-
molding and two-shot overmolding. Both interested in overmolding may have trou- er. Despite the initial expenses incurred
methods accomplish the same task. ble finding a team of personnel who are by owning injection molding machines,
In pick and place overmolding, the not only capable of designing and over- the savings achieved through minimiz-
substrate is manufactured as part of a seeing processes, but also troubleshoot- ing labor hours ultimately justify these
subassembly process (either using a dif- ing and repairing machinery. costs. Further, the rapid production of
ferent machine/mold or by a third-party overmolded parts makes meeting deliv-
supplier) and is manually loaded into n Why Overmolding? ery deadlines more manageable, to the
the mold by an operator or automation. Safety of patients is the most crucial point where it may be possible to take on
Plastic resin is then melted and injected goal for any medical device manufactur- larger lot sizes if desired by the customer.
into the mold, where it adheres to the er. There is perhaps no better way to en- For medical device manufacturers,
substrate. The substrate can also be stra- sure success of equipment than by mini- there are certainly risks to choosing
tegically designed so that it creates a me- mizing the opportunity for human error overmolding over gluing, with the added
chanical interlock with the overmolded during manufacturing. Overmolding re- difficulty of finding competent person-
component, allowing for even greater quires operators to load and remove nel to keep processes running smoothly.
bond strength. In two-shot overmolding, components, at least during the pick and Because of these factors, gluing tends to
the substrate is manufactured and then place method; however, if process pa- be used more often than overmolding to
immediately moved to a separate mold rameters are tested and in place, the bond medical devices. However, over-
or another injection station within the bond itself will have a level of strength molding offers a number of advantages
same mold, where overmolding occurs. and consistency that is nearly impossible from providing a more secure bond of
This transfer is completed mechanically to achieve through gluing. components to an increasing process ef-
by the machine itself, without the need Gluing procedures, by contrast, re- ficiency. Manufacturers, customers, and
for operators to intervene between shots. quire operator attention and manipula- most importantly patients, can all bene-
Gluing. Gluing, a simpler and more tion of parts throughout the entire pro- fit greatly from these advantages.
traditional method of bonding compo- cess. Several factors such as amount of This article was written by Kevin Crow-
nents, requires a manual application of adhesive applied, application location, ell, Technical Writer, Pelham Plastics,
adhesive followed by curing through and cure time are subject to operator er- Pelham, NH. For more information,
heat and light. In many cases, this can be ror and could result in a medical device contact [Link]@pelhamplastics.
just as effective as overmolding, and failing in the field. For example, if too com or visit [Link].
Medical Design Briefs, December 2023 [Link] 27
 PRODUCT OF THE MONTH
n Flexible Biomed Resins
Formlabs, Somerville, MA, has introduced three healthcare-focused materials to its library. BioMed Elastic 50A
Resin, BioMed Flex 80A Resin, and IBT Flex Resin are designed to streamline workflows and reduce labor time. The
two BioMed materials will expand the applications for 3D printing in healthcare, reducing the time and costs associ-
ated with traditional production methods, such as molding. These materials are suited for long-term skin contact and
short-term mucosal membrane contact for flexible patient-matched medical device components, comfortable medi-
cal devices, as well as tissue medical models for surgeons to reference in the operating room. IBT Flex Resin is designed with tear-resistant, accu-
rate, and transparent properties for dental applications, including 3D printed direct composite restoration guides and indirect bonding trays.
[Link]

Product Focus: Test & Measurement

n Digital Caliper n High-Resolution Oscilloscope

Mahr, Providence, RI, has re- New oscilloscopes from RIGOL,
leased a digital caliper line that Portland, OR, have a compact, por-
features an extended measuring table design that is flexible to use for
range of 800 mm. The MarCal both on-site and desktop testing. The
18 EWR(i) enables users to mea- DHO800/900 oscilloscopes feature
sure larger components without requiring larger 1,000 mm cali­ true 12-bit resolution with low noise for
pers, which are often cumbersome and challenging to handle. In- excellent signal fidelity and analysis. They are available in 125–250
tegrated wireless data transmission with an internal wireless chip MHz bandwidths, four channels, 1.25 GSa/sec sampling, 1,000,000
seamlessly communicates with Mahr’s iStick receiver. The caliper wfms/s waveform capture rate, and 50 MPts of memory standard.
confirms via a message on the display whether the data is trans- DHO800 scopes offer 70–100 MHz bandwidths, four channels, 1.25
ferred correctly. GSa/sec sampling, 1,000,000 wfms/s waveform capture rate, and
[Link] 25 MPts of memory standard. Both series feature 12-bit resolution,
a 7 in. intuitive touch screen display, and support type-C power.
n 3D Measuring System [Link]
A high-performance 3D measuring
system from Marposs, Auburn Hills, MI, n Digital Pulse Generator
is ideal for noncontact surface measure- Spectrum Instrumentation has re-
ment. The STIL Micromeasure 2 features leased a digital pulse generator (DPG)
chromatic confocal sensing technology option for its lineup of high-resolution,
that measures dimensional attributes, sur- medium speed, digitizer and arbitrary
face roughness, three-dimensional shapes waveform generator (AWG) products. The option allows the units to
and microtopography, and displacement of part features relative produce digital pulses, and pulse streams, on up to four front panel
to datums and other features, even in challenging materials like multipurpose I/O connectors while simultaneously performing their
glass and polymers. It comes equipped with high-resolution motors regular tasks of acquiring, or generating, analog signals and waveforms.
in the X, Y, and Z axes, 3D processing software, a computer and The new feature is ideal for a variety of automated test and measure-
programmable motion controller, and three sizes of measurement ment applications. All the DPG functionality is implemented by using
stage – 100 × 100, 200 × 200, and 300 × 300. the onboard FPGAs of the PCIe-cards or LXI/Ethernet-instruments.
[Link] [Link]

n Workpiece Holders n Morphing Technology

Dillon Manufacturing, Springfield, OH, Mesh-morphing technology from RBF
offers claw jaws designed to securely grip a Morph, Rome, Italy, is now being fully inte-
workpiece to enable more aggressive turn- grated into the Ansys software portfolio.
ing. The jaws feature an optimized contour The two simulation tools — Ansys RBF
that — along with the jaws weight, center of Morph Fluids and Ansys RBF Morph Struc-
gravity, and cutting forces — combine to se- tures — can help companies optimize their
curely grip workpieces by minimizing jaw clamping force losses. Avail- products and achieve optimal efficiency within the Ansys simulation
able for most commercial chucks, the claw jaws provide increased platform. Ansys RBF Morph Fluids is an add-on that allows for auto-
clamping pressures on both OD and ID of the workpiece. Clamping mated shape optimization studies entirely within Ansys Fluent, lever-
depth can be varied using workpiece stops, providing flexibility in ma- aging morphing of the existing mesh. Ansys RBF Morph Structures is
chining. Many standard sizes are stocked. Custom designs are available an ACT extension that allows for automated shape optimization stud-
with no engineering fees. The claw jaws are manufactured from 8620 ies entirely within Ansys Mechanical and Ansys Workbench by morph-
steel for durability and long service life. ing the existing mesh.
[Link] [Link]

28 [Link] Medical Design Briefs, December 2023

n Post-Market Surveillance n HEC Connector
An eQMS from Sierra Labs, Los Angeles, CA, is de-
signed to strengthen data security and ensure that digital
infrastructure stays secure amidst changes. The Sierra
QMS’s risk management solution enables manufacturers
to track your test findings, tasks, and action items to pre-
pare for audits. It maintains full traceability at each stage of
production and seamlessly tracks product information and
traces it throughout its entire life cycle.
[Link]
A harsh environmental connector from
n Stopcock Manifold binder, Camarillo, CA, has been engineered
Qosina, Ronkonkoma, NY, has introduced a stopcock manifold that for maximum efficiency and versatility. The
provides a serial sequence of incompatible drugs and enables flushing series 696 connector’s hybrid design allows
fluid in between. The RondelO are available in 2-, 4-, or 6-luer inlet simultaneous high- and low-voltage power
ports with a through line for flushing fluid. Each luer port is ISO supply and reliable signal transmission with
80369-7 compliant. They are suitable for in the bioprocess industry for a single mating. Its compact size and bayonet
easy sampling, either manually or automatically from a bioreactor. Ad- quick-locking mechanism offer additional flex-
ditional luer-to-barb connectors may be needed to attach tubing to the ibility. The connector is also highly resistant
stopcock manifold. The automation aspect streamlines the sampling to chemicals, corrosion, and UV light, provid-
process using only one motor turn of its handle. ing robust performance in conditions from
[Link] extreme temperatures, dust, and vibration to
submersion and high-pressure cleaning.
n Polycarbonate Copolymers [Link]
A family of polycarbonate copolymers from SABIC, Hous-
ton, TX, can help prevent stress cracking and mitigate crack n Vision Inspection
propagation. LNP™ ELCRES™ CRX, which are amorphous
and semi-crystalline blends, can potentially serve as offset
solutions in existing injection mold tools for a variety of ma-
terials. Options include LNP ELCRES™ CRX1314TW copo-
lymer or its bio-based equivalent, LNP ELCRIN™
CRX1314BTW copolymer, which offers up to a 42 percent
reduction in carbon footprint based on life cycle assessment
(LCA). Both grades feature limited biocompatibility accord-
ing to ISO 109931. A bottle vision inspection system from
[Link] Norwalt, Randolph, NJ, integrates standard-
ized vision components with custom-made el-
n Sustainable Coating ements and deep learning tools. The Vue In-
Surface Solutions Group, LLC (SSG), Chicago, IL, has re- spection System can monitor gaging defects
leased a sustainable, compliant coating. GlideMed is a water-­ as minuscule at 10 thousandths of an inch
based, low-friction coating for medical devices. Available in No on a translucent surface. It accomplishes this
PTFE and Low PTFE formulations, it is free from any PFOS, by using shape transformation on the sloped
PFOA, solvent, and hexavalent chromium (hex chrome) com- areas of bottles.
pounds. Developed using established, proven coating technolo- [Link]
gy, it is a biocompatible, environmentally friendly coating that is
REACH and RoHS compliant. Available in a variety of colors, it can be applied to multiple wire
configurations, lengths and types, including nitinol, stainless steel alloys, and titanium, and med-
PRODUCT SPOTLIGHT
ical devices such as needles, guidewires, coils, cables, mandrels, hypotubes, and continuous wire. OPTICALLY CLEAR
[Link]
MEDICAL-GRADE
EPOXY
n Design Platform
Master Bond EP30-4Med is a
Zuken, Westford, MA, has released a design platform for
two-part epoxy system with a
ECAD and fluid design. The [Link] release includes en- fast setup time that cures at
hancements in 3D functionality for control panel design, cir- room temperature, or even
cuit diagram generation, and an improved user experience. more rapidly with a bit of heat.
This low viscosity system meets the requirements of ISO
The software’s enhanced 3D functionality allows for more
10993-5 testing and is therefore considered to be non-­
accurate and efficient design. Enhancements to the 3D func- cytotoxic. [Link]
tionality in the control panel design applications meet the
need for designing control panels in increasingly limited
spaces. Elements such as mounting panels can now be ar- Master Bond
ranged and edited at any angle. The 3D geometries from me-
chanical CAD systems can be imported in a single operation.
[Link]

Medical Design Briefs, December 2023 [Link] 29

 The 2023 Nominees Are:

Advanced Photonix
Surface-Mount Devices
ETCO
Connectors for Medical Robotics

NewTek Sensor Solutions

Autoclavable Medical Sensors

Schurter
PCAP Touchscreens

Advantech
Scalable Computing Platform

Each issue, the editors of Medical De-

sign Briefs choose a Product of the Month
that has exceptional technical merit and Arnold Magnetic Technologies
practical value for MDB’s design engi- Thin-Rolled Titanium
neering readers.
Now that these have been selected, Times Microwave
we’re asking readers to help choose the Medical Interconnect Cables
Readers’ Choice Product of the Year
Awards. You’re invited to cast your vote
for the one product among the 11 Prod-
ucts of the Month that you feel was the
most significant new product introduced
to the engineering community in 2023.
The product receiving the most votes will
be named Medical Design Briefs’ Readers’
Choice Product of the Year. Datwyler
Winners will be announced in Medical Film Coating Technology Trelleborg
Design Briefs and on our Web site at www. Single-Use Materials and Services
[Link].

Find out more about the 11 nominated

products and cast your vote by visiting:
[Link]/mdb/poy-2

KNF Neuberger Formlabs

High-Performance Pump Biomed Resins

Only one vote per person will be counted. All votes must be submitted by January 17, 2024.

30 [Link] Medical Design Briefs, December 2023

Designing Medical
Devices That Minimize
Healthcare Costs
page 32

Resource Directory
page 36
Cover image supplied by Tom/AdobeStock

2023 RESOURCE GUIDE

WINTER

[Link]
Designing Medical Devices That
Minimize Healthcare
Costs

Because AEDs are often used by a novice in

emergency situations, it is critical to simplify
the interface, instructions, and operations,
which are all key considerations in the design
process. (Credit: BlackHägen Design)

T
oday’s necessity to reduce regulatory aspects of medical electronics Wearable electronic medical devices
healthcare costs is generating and provides a case study involving auto- for at-home use are expanding in the
a greater demand for medical mated external defibrillators (AEDs). breadth of applications. For instance, a
electronics equipment that wearable electrocardiogram (ECG) de-
improves and expands patient Enhancing Electronic Medical vice can detect atrial fibrillation through
diagnostics inside and outside healthcare Device Capabilities the electrode pads. Designed with com-
facilities. For instance, portable medi- Most medical devices for use by the munication capabilities, these ECG devic-
cal instruments such as glucose meters, public or at home are being designed es send readings to the patient’s doctor.
blood pressure monitors, oxygen meters, with communication capabilities to pro- While these electronic medical devices
and automated external defibrillators vide continuous information to caregiv- hold the potential to deliver better-quality
(AED) have undergone many design con- ers almost anywhere, which can further care, they require a lot of user research
siderations to be developed for doctors, help decrease healthcare costs. Hand- in the initial design process. Interactive
paramedics, public use, and at home with held devices are also improving various discovery methods identify latent user
at-risk patients. This article delves into the diagnostic procedures in medical offices needs and characterize usage scenarios
design considerations, challenges, and and for at-home use. such as at-home use, in public or by an
32 [Link] Winter 2023 Resource Guide
 MEDICAL & BIOTECH
MANUFACTURING
ISO 13485:2016 FDA Registered

Headquartered in West Michigan, Medbio is a contract manufacturer

offering innovative manufacturing solutions for the medical and
biotechnology industries. We specialize in precision injection
molding, assembly, and packaging.

Our facilities include certified ISO Class 8 & Class 7 cleanrooms for
molding, along with several certified Class 7 cleanrooms for
assembly. Our six manufacturing facilities allow us to serve you with
increased capacity to handle any project and accelerate your
speed-to-market.

With over 300 combined years in the medical device industry, our
team has the knowledge, passion, and experience to deliver quality
solutions to our most complex manufacturing challenges.

FULL-SERVICE INJECTION QUALITY &

CONTRACT MOLDING METROLOGY
MANUFACTURER • Medical Grade Thermoplastics • ISO 13485:2016 Certified
• Implantable Thermoplastics • FDA Registered
• Product Development • Silicone • Fully Capable Metrology Lab
• Project Management • Insert & Over Molding • Full Annual Internal Audit Schedule
• Precision Injection Molding • Two-Shot Molding • Tailored Quality and Validation
• Cleanroom Molding • Micro Molding Programs
• Cleanroom Assembly • Thin- Walled Parts/Coining
• Cleanroom Packaging
• Flexible Capacity
• Hand-Loaded Cores to Full AUTOMATION
Automation
• Rapid Turnaround • Scientific Process Development • Robots
• Prototype Plus (RMT) • End-of-Arm Tooling
• Kistler Cavity Pressure Sensors • Cavity Separation
• In-house Tooling • Automated/Packaging

[Link] (616) 245-0214 info@[Link]

Designing Medical Devices

safety and performance, for example, Elec-

tromagnetic Disturbances (IEC 60601-1-2).
HV-Board Internal Particular standards are published with
Charging
Power Capacitor H-Bridge Discharge requirements for specific types of medical
Circuit
Supply Inner Selector Circuit devices. Designing medical devices that
incorporate electronics can become com-
plicated due to the maze of regulations.
Connector Connector Observation of processes in the IEC-60601
Patient documents is instrumental in becoming
Battery
Outer Selector compliant.1
High-Voltage Board
A Case for Discussion: Automated
PSOC External Defibrillators
C-Board
Power There are key requirements for the
I/O
basic safety and essential performance of
Supply
Control Board
electrocardiographs and cardiac de-
fibrillators, for instance, the spacings for
Fig. 1 – The electrical subsystems required to detect and analyze ECG waveforms and deliver up to a 2000 V shock high voltage traces (referred to as creep-
to the patient when required. age and clearance) must be maintained.
RF emissions and susceptibility must be
EMT or practitioner. When conducting ance regulations can substantially affect verified and tested to ensure that the
the discovery phase with the design pro- the design, including mechanical, elec- electromagnetic compatibility (EMC) re-
cess, it requires a team of analytical re- trical, and graphical user interface quirements of the collateral standard
searchers and designers knowledgeable (GUI). The use of empirical methodolo- IEC 60601-1-2 are met.
in the usage environment (either contex- gy, one of the foundational building The challenges of designing porta-
tual inquiry or ethnography). blocks of good usability engineering, es- ble medical devices involve reducing
tablishes testable usability inputs for weight and size while continuing to
Compliance downstream formative studies, culminat- meet the requirements of a complex
Bringing a new electronic medical ing in an FDA-required human factors therapy. In this use case, the study ex-
device of any kind through all the steps engineering report. amines a portable AED for use in air-
for FDA approval is a complex and very Medical device compliance also re- ports, schools, and other public set-
time-intensive process. Making sure de- quires unique disciplines in the design tings. Due to the use by a novice in
sign engineers and the R&D team take all to meet approvals from a notified body, emergency situations, it is critical to
practical steps to shorten the product de- such as UL, TUV, Intertek, or any other simplify the interface, instructions, and
velopment cycle often requires time and of the internationally recognized agen- operations, which are all key consider-
resource investments in the conceptual cies while the FDA requires strict adher- ations in the design process.
design process, including usability testing. ence to IEC guidance documents. In the case of the AED, Figure 1 de-
Medical devices need to meet a com- Collateral standards (numbered 60601- picts the electrical subsystems required
plex set of safety requirements. Compli- 1-X) publish requirements for essential to detect and analyze ECG waveforms

Fig. 2 – As shown here, visual prompting that flashes colored lights indicates that the power to the AED is on.

34 [Link] Winter 2023 Resource Guide

and deliver up to a 2000 V shock to the As shown in the graphic in Figure 2,
patient when required. there is visual prompting that flashes
Some of the components are signifi-
cant in size, such as the battery and the
colored lights indicating that the power
is on. Other lights flash to let the user MEDICAL
SOLENOID
capacitor required to charge, store, and know an analysis is being done as well as
deliver up to a 220 Joule pulse to the pa- which button to push to deliver the
tient’s chest and heart. Modern lithium shock. Both the audio and visual in-

VALVES
batteries help reduce weight, but battery structions coincide to assist the novice
capacity and size are always a compro- user through the entire process from
mise. Miniaturized packaging must allow start to finish.

DESIGNED &
close proximity of highly sensitive analog Also, correct pad placement is import-
circuits amplifying infinitely weak signals ant for the effective delivery of energy

BUILT-TO-SPEC
from the patient’s heart. A massive jolt of through to the heart. Usability studies
energy must be delivered in synchro- indicate that there are users who did not
nized timing to safely bring a patient’s remove the clothes covering the chest
heart back to a normal beat. and instead adhered the pads to the • FREE Design
Today’s modern devices can meet the clothing. Other users did not peel the
stringent requirements for EMC in med- protective backing off the pads. This & Engineering
ical devices, but the overall system design causes problems because the pads must
becomes more challenging. Plastic enclo- be affixed to the bare skin. • FAST Quotes
sures allow form-fitting, colored, and tex- & Prototypes
tured surfaces to idealize the interfaces Conclusion
to the user. Adding metal coatings inside This is only one example of countless
plastics often becomes complex and cost potential scenarios that could occur re-
prohibitive. Typically, a traditional metal garding the risks from novice users im-
enclosure that provides Faraday shielding properly operating an electronic medi-
is no longer available to block electro- cal device.
magnetic [Link]-layer printed circuit Experienced design teams that have
boards (PCB) can be designed to contain the expertise in the regulatory aspect
emissions and be immune to susceptibili- of device design during the R&D pro-
ty from external RF challenges. Cabling cess (involving UX/UI design, human
needs to be minimized and interfaces must factors engineering, user research,
be protected and filtered from noise to be proto­typing) will be coveted, especial-
successful in meeting these challenges. ly with the growth that is occurring in
Connectivity by wireless communication is the home medical equipment market,
oftentimes required and needs to be an in- which was valued at US $12.23 billion in
tegral part of the overall design to ensure 2021 and projected to reach US $21.13
antenna position is optimal and that EMC billion by 2030.2
test results are not compromised. Couple this growth with the shortage
In designing portable public-space of skilled R&D staff, expect many more
AEDs, preventing accidental shocks to device manufacturers to rely on consul- Ideal for:
individuals who don’t require them is a tancies to direct their design processes, Air Beds,
critical requirement. Ensuring ease of especially compliance. With this growth Exam Chairs,
operation in emergencies with a straight- and an expected shortage of skilled R&D O2 Devices,
forward power button that triggers voice staff, many more medical device devel- Sterilizers, Compression
prompts is pivotal. AEDs need to provide opers can expect to rely on experienced Therapy and many
both audio and visual cues throughout consultants to help support their design
more applications!
the process to reinforce user guidance. and compliance processes.
NEW Cryogenic Valves
Audio and Visual Prompting Design References
Considerations 1. IEC 60601-1:2023, International Electrotechnical
Commission, [Link]
Besides voice instructions, AEDs use 2. “U.S. Home Medical Equipment Market Size to
other sounds to help users. There is a Surpass US$ 21.13 BN By 2030,” BioSpace, July 12,
sound that specifies a shock is indicated, 2022.
and that the AED is “charging” up to de-
liver a shock. Another distinct sound alerts This article was written by Brian Lau-
[Link]
the user that the AED is ready to deliver a man, Senior Systems Engineer, Black- 814.838.3190
shock. These sounds coincide with specif- Hägen Design. For more information,
ic voice instructions such as “shock indi- contact info@[Link]
cated” and “press the shock button.” or visit [Link].
Winter 2023 Resource Guide [Link] 35
 Medical Design Briefs Winter 2023 Resource Directory

3D Printing/Prototyping....................36 Materials/Plastics/Metals.................43 H.B. Fuller Company

Adhesives/Coatings...........................36 Mechanical Components/ [Link]/medical
Assembly........................................... 37 Hardware...........................................43
Cleanroom......................................... 37 Molding.............................................43 Halco Fasteners Inc.
Connectors/Interconnects/ Motion Control/Motors......................44 Biocoat Inc.
[Link]
Switches............................................ 37 Optics/Optical Components...............44 215-734-0888
Consulting/FDA Compliance...............38 Packaging..........................................45 sales@[Link] Hydromer, Inc.
Contract Manufacturing....................38 Power Supplies & Batteries...............45 [Link] [Link]
Disposables.......................................39 Product Research/
Electronic Components.....................39 Design/Development.........................45 Chroma Color Innovative Surface
Electronics Manufacturing................40 Robotics/Automation.........................46
Sensors/Detectors/
[Link] Technologies, Inc.
Filter & IV Components..................... 41 [Link]
Fluid Handling/Pumps & Valves......... 41 Data Acquisition................................46
Software............................................46 Coatings2Go
In Vitro Diagnostics........................... 41 [Link] Jaro Corp.
Sterilization......................................47
Laser Cutting/Marking...................... 41 [Link]
Test Services.....................................47
Life Sciences..................................... 41 Cotronics Corp.
Test/Inspection/Metrology................47
Machining/Stamping.......................... 41 [Link] Mactac
Manufacturing Equipment..................42 Tubing & Extrusion............................48
[Link]
Dunmore
[Link]
Materialise
3D PRINTING/ [Link] Dymax
[Link]
PROTOTYPING Nano Dimension, Inc. Master Bond Inc.
Electronic Materials, Inc.
[Link] [Link] 201-343-8983
3D Systems
[Link] Nanoscribe GmbH & Co. KG info@[Link]
Endura Coatings
[Link] [Link] [Link]
3DEO Inc.
[Link] Proto Labs Epoxy Technology MicroCare
[Link] [Link] [Link]

Renishaw EPOXYSET Nanolayr

[Link] [Link] [Link]

Schmit Prototypes Panacol

Accumold [Link] [Link]
515-964-5741
micromolding@[Link] Para-Coat Technologies
Shapeways – Otto Software [Link]
[Link] [Link] Excelitas Technologies
905-821-2600 Permabond Engineering
Axis Prototypes Inc. Turner Medtech omnicure@[Link] Adhesives
[Link] [Link] [Link]
[Link]
B9 Creations Xometry [Link]/ Polymer Science
[Link] [Link] rd223/excelitas [Link]
Boston Micro Fabrication Fluoramics, Inc. PPG
[Link] [Link] [Link]
Diverse Optics
[Link]
ADHESIVES/ Precision Coating
[Link]
COATINGS
EOS PVA TePla
[Link]/en 3M Formacoat [Link]/en
[Link] 952-895-0200
ExOne Röhm
[Link] info@[Link] [Link]
AccuCoat, Inc.
[Link] [Link]
Fathom Scapa Healthcare
[Link] [Link]
Aculon
[Link] Solar Atmospheres
Forecast 3D
[Link] [Link]
Adhesives Research
[Link] Fort Wayne Metals
260-747-4154
Avantor info@[Link]
[Link]
[Link]
Avery Dennison Medical [Link]/ Specialty Coating Systems
Hobson & Motzer rd223/fortwaynemetals
[Link] 317-244-1200
860-349-1756
SCSsales@[Link]
abracale@[Link] Avient General Magnaplate
[Link] [Link]
[Link] [Link] [Link]/
[Link]/ rd223/scscoatings
rd223/hobsonmotzer

36 [Link] Winter 2023 Resource Guide

 Winter 2023 Resource Directory

Adhesives/Coatings continued

Surface Solutions Group Haumiller Engineering HEMCO Corporation

[Link]. [Link] [Link]
com
Herrmann Ultrasonics, Inc. Man & Machine, Inc. Interpower Corporation
[Link]/ [Link]
en-us 800-662-2290
sales@[Link]
Kahle Automation [Link]
[Link] [Link]/
Zeus rd223/interpower
803-268-9500
support@[Link] MICRO
[Link] 732-302-0800
sales@[Link]
[Link]
MICRO
732-302-0800 Keystone Electronics Corp.
sales@[Link] 800-221-5510
ASSEMBLY [Link] kec@[Link]
[Link]
American Standard Circuits
[Link] MicroLumen LEMO USA
813-886-1200 [Link]/en
Arthur G. Russell Company sales@[Link]
[Link] [Link] LifeSync
MicroLumen [Link]
Bosch Rexroth 813-886-1200
[Link]/en/us Static Clean International, Inc. Mill-Max Manufacturing Corp.
sales@[Link] [Link] [Link]
[Link]
Minnesota Wire
Promex Industries [Link]
[Link]

Viant Medical
CONNECTORS/ Nicomatic
Cadence, Inc. [Link]
540-248-2200
[Link] INTERCONNECTS/
sales@[Link] Visumatic Industrial Products SWITCHES NKK Switches
[Link]
[Link] [Link]
[Link]/ Advanced Interconnections Corp. NorComp
rd223/cadenceinc [Link] [Link]
EIS Fabrication Solutions Ametek Engineered Northwire, Inc.
[Link]/fabrication/ CLEANROOM Interconnect & Packaging [Link]
medical [Link]
AdvanceTEC binder USA ODU USA
[Link] [Link]/us-en [Link]

C&K
[Link]
Excelitas Technologies
905-821-2600 Caton Connector Corp.
[Link] Omnetics Connector
omnicure@[Link] Cadence, Inc.
[Link] CPC Corporation
540-248-2200
[Link]/ [Link] 763-572-0656
sales@[Link]
rd223/excelitas sales@[Link]
[Link] EAO Corporation [Link]
[Link]/ [Link]
rd223/cadenceinc
ERNI USA Phoenix Contact
[Link]/en [Link]/en-us
Chemtronics
Filmecc USA, Inc. [Link]
949-756-8252 ETCO
Clean Air Products [Link]
davidz@[Link]
[Link] [Link] Fischer Connectors
[Link]
Qosina
Heilind Electronics 631-242-3000
[Link]
info@[Link]
High Speed Interconnects [Link]
Fort Wayne Metals Flexan [Link] [Link]/
260-747-4154 847-644-6068 rd223/qosina
info@[Link] salesinfo@[Link] Hirose Electric
[Link] [Link]/us
[Link]
[Link]/ [Link]/
rd223/fortwaynemetals rd223/flexan

Winter 2023 Resource Guide [Link] 37

 Winter 2023 Resource Directory

Connectors/Interconnects/Switches continued

Reed Switch Developments Corp. Regulatory Compliance Biomerics Hammill Medical

[Link]. Associates, a Nelson Labs [Link] [Link]
com company
[Link] C-Axis Inc.
SAB North America [Link]
[Link] RJR Consulting, Inc.
[Link]
Smiths Interconnect
[Link] Hobson & Motzer
RQM+ 860-349-1756
[Link]
Steute Meditech, Inc. abracale@[Link]
Cadence, Inc.
[Link] [Link]
540-248-2200
[Link]/
Times Microwave Systems sales@[Link] rd223/hobsonmotzer
[Link] [Link]
[Link]/ Integer
Teleflex Medical OEM rd223/cadenceinc [Link]
800-474-0178
oeminfo@[Link] Command Medical Products Jabil
CONSULTING/FDA [Link]. [Link] [Link]
COMPLIANCE com
Confluent Medical
TÜV SÜD [Link]
Accorto Regulatory Solutions [Link]/en-us
[Link] Dravon Medical, Inc.
[Link]
Anthrotech, Inc. Keystone Electronics Corp.
[Link] 800-221-5510
kec@[Link]
CMIC CONTRACT [Link]
[Link] MANUFACTURING
KMC Systems
Emergo by UL Filmecc USA, Inc. [Link]
[Link] Able Electropolishing 949-756-8252
[Link] davidz@[Link] Linemaster Switch Corporation
EMMA International Consulting [Link] [Link]
Group, Inc.
[Link] Flex Mack Molding Co.
[Link] [Link]
Icon, plc healthcare
[Link] Accumold Marshall Manufacturing
515-964-5741 Company
Innovatum [Link]
[Link] micromolding@accu-mold.
com
Kontron [Link]
[Link] Flexan
Admedes GmbH 847-644-6068
McCormick LifeScience [Link] salesinfo@[Link]
Consultants, LLC [Link] maxon
[Link] Aptyx [Link]/ 508-677-0520
[Link] rd223/flexan [Link]@[Link]
Argon Medical Devices [Link]
[Link] [Link]/
rd223/maxon
Autocam Medical
mdi Consultants Inc. [Link]
516-482-9001 Formacoat
info@[Link] 952-895-0200
[Link] info@[Link]
[Link]
Nelson Mullins
[Link] B. Braun Medical Inc. Freudenberg Medical Medbio
484-240-8301 [Link] 616-822-3284
Noblitt & Rueland info@[Link] info@[Link]
[Link] [Link] Gerresheimer Peachtree City [Link]
[Link]/ (USA), L.P.
Parexel [Link]
[Link] rd223/bbraunoem Medical Manufacturing
Technologies, Inc. (MMT)
Baker Industries, a Lincoln [Link]
QMS Consulting, Inc. Electric Company
[Link] [Link] Medical Murray
Qpharma Bihlermed [Link]
[Link] [Link] Halkey Roberts
727-471-4200
sales@[Link]
[Link]

38 [Link] Winter 2023 Resource Guide

 Winter 2023 Resource Directory

Contract Manufacturing continued

MeKo MedTech Stellartech Research Corp. Nordson Medical Crystal IS

[Link] [Link] [Link] [Link]

MH Manufacturing Teamvantage Poly-Pipets, Inc. CUI Devices

[Link]/divisions/ [Link] [Link] [Link]
mh-manufacturing
Tegra Medical
[Link]

Qosina
MICRO 631-242-3000 DATA IMAGE
732-302-0800 info@[Link] 407-478-4064
Teleflex Medical OEM [Link] heldred@[Link]
sales@[Link]
800-474-0178 [Link]/ [Link]
[Link]
oeminfo@[Link] rd223/qosina
Minnetronix [Link] Data Modul, Inc.
[Link] Super Brush LLC [Link]
Tessy Plastics [Link]
MME Group [Link] Diamond Systems
[Link] [Link]
Timbercon
Model Solution USA [Link] embeddedTS
[Link]
Trelleborg Healthcare & Medical
ELECTRONIC [Link]

New Concept Technology, Inc. [Link]/healthcare COMPONENTS Feig Electronics, Inc.

[Link] [Link]
Triangle ACCES I/O Products, Inc.
NextPhase Medical Devices [Link] [Link] First Sensor, Inc., part of TE
[Link] Connectivity
Tricor Systems, Inc. Accu-Glass Products, Inc. [Link]
Nolato [Link] [Link]
[Link] Fujitsu
UFP MedTech Advanced Circuits, Inc. [Link]
Orchid Orthopedics [Link] [Link]
[Link] Gowanda Electronics
Vantedge Medical Alpha Wire [Link]
Palomar Technologies, Inc. [Link] [Link]
[Link] Heatron, Inc.
Ametek Coining [Link]
Paragon Medical [Link]
[Link] Hightec MC AG
Amperite Co., a division of [Link]
Phillips-Medisize Corp. Olympic Controls Corp.
[Link] [Link] IEI Technology USA Corp.
Zeus [Link]
PLITEK 803-268-9500 Analog Devices, Inc.
[Link] support@[Link] [Link] InfraTec
[Link] [Link]
Pro-Tech Design & BitFlow, Inc.
Manufacturing [Link] Innophase
[Link] [Link]
Byora U.S.A.
International Manufacturing
PTI Engineered Plastics Inc.
[Link]
DISPOSABLES [Link]
Services, Inc.
Caddock Electronics, Inc. [Link]
Pulse Technologies, Inc. Elcam Medical [Link]
[Link] [Link]
Coilcraft CPS
Q Medical Devices IntelliTECH, Inc. [Link]
[Link] [Link]
Components Corporation
RBC Medical Innovations [Link] Interpower Corporation
[Link] 800-662-2290
Congatec sales@[Link]
RepExact, LLC [Link] [Link]
[Link] MICRO [Link]/
Cornell Dubilier Electronics rd223/interpower
Saint-Gobain Medical 732-302-0800 [Link]
[Link] sales@[Link]
[Link] Coto Technology, Inc.
SMC Ltd. [Link]
[Link]

Winter 2023 Resource Guide [Link] 39

 Winter 2023 Resource Directory

Electronic Components continued

Johanson Technology Peerless Electronics, Inc. Telerex

[Link] [Link] [Link]

Kemet Pelonis Technologies Inc. THine Solutions

[Link] [Link] [Link]
Hunter Products Inc.
Pressure Profile Systems TTI, Inc. 908-230-0800
[Link] [Link] hunter@[Link]
[Link]
Princetel, Inc. UTE Microwave, Inc.
Keystone Electronics Corp. [Link] [Link] IEC Electronics
800-221-5510 [Link]
kec@[Link] Renesas Electronics Corp. VersaLogic Corporation
[Link] [Link] [Link] JADAK, a Novanta Company
[Link]
Knowles Precision Devices Review Display Systems Voltage Multipliers, Inc.
[Link] [Link] [Link]

Kyocera AVX Rolec VRG Components

[Link] [Link] [Link]

Laird Rowebots Watlow Keystone Electronics Corp.

[Link] [Link] [Link] 800-221-5510
kec@[Link]
Schott Wavelength Electronics, Inc. [Link]
[Link] [Link]
Kimball Electronics
Sensirion Zippertubing [Link]
Master Bond Inc. [Link] [Link]
201-343-8983
Molex Incorporated
info@[Link] Servoflo Corporation [Link]
[Link] [Link]
NEO Tech
Micro Crystal AG Skyworks Solutions, Inc.
[Link]
ELECTRONICS [Link]
[Link]
MANUFACTURING NexLogic, a Naprotek LLC
Micro Systems Technologies company
[Link] A2e Technologies [Link]
[Link]
Microchip Technology, Inc.
[Link] Axiomtek
Solenoid Solutions, Inc. [Link]
Microtips Technology 814-833-5439
[Link] info@solenoidsolutionsinc. Cirtronics Corporation
com [Link] Omnetics Connector
Minco Products, Inc. [Link] Corporation
[Link] [Link]/ Creation Technologies 763-572-0656
rd223/solenoidsolutions [Link] sales@[Link]
Mouser Electronics [Link]
[Link]
PalPilot
[Link]

DATA IMAGE PCBCart

Statek Corporation [Link]
714-639-7810 407-478-4064
New England Wire heldred@[Link]
Technologies sales@[Link] Precision Assembly
[Link] [Link] Technologies, Inc.
603-838-6624
[Link]
info@[Link] East West
STMicroelectronics
[Link] [Link] [Link] QoSTronics
[Link]
Sunnex
[Link] RPC
[Link]
TDK Electronics Inc.
Omnetics Connector [Link] Schurter Inc.
Corporation [Link]/en/home
TE Connectivity Excelitas Technologies
763-572-0656 905-821-2600 Sony Electronics
[Link]
sales@[Link] omnicure@[Link] [Link]
[Link] Tech-Etch, Inc. [Link] healthcare
[Link] [Link]/
Omron rd223/excelitas Tri-Star Design, Inc.
[Link] Teledyne Lumenera [Link]
[Link]
ON Semiconductor
[Link]

40 [Link] Winter 2023 Resource Guide

 Winter 2023 Resource Directory

TriContinent by Gardner Denver MECCO

FILTER & [Link] [Link]
IV COMPONENTS Watson-Marlow Pumps Group Micron Laser Technology
Emerson [Link] [Link]
AG Industries
[Link] 314-553-2000
[Link]/medical MKS Spectra-Physics
[Link]
Ark-Plas
[Link] Fabco-Air, Inc.
[Link] IN VITRO Resonetics
[Link]
Gore
Fairchild DIAGNOSTICS
[Link] Roland DGA
[Link]
BSI [Link]
Injectech, LLC [Link]
[Link] Fluid Metering Inc.
[Link] Sprinter Marking Inc.
NanoComposix [Link]
Halkey Roberts [Link]
[Link] TouchMark
[Link]
Industrial Specialties Mfg.
Qosina [Link] Trotec Laser, Inc.
[Link]
631-242-3000
info@[Link] IVEK Corporation
[Link] The Lee Company TRUMPF
[Link] 860-399-6281 [Link]/en_INT
[Link]/ Iwaki America inquiry@[Link]
rd223/qosina [Link] [Link] VitalPath
[Link]
Porex Corporation KNF Neuberger, Inc.
[Link] [Link]
Röchling Group KOGANEI International
[Link]/us America, Inc. LASER CUTTING/ LIFE SCIENCES
[Link] MARKING
Aranca
Parker Precision Fluidics ACSYS Lasertechnik [Link]
[Link]/ppf [Link]
FLUID HANDLING/ Cerion Nanomaterials
PUMPS & VALVES [Link]

Corgenix
Air Logic [Link]
[Link]
Qosina AMADA WELD TECH INC. Creative Diagnostics
Antylia Scientific 631-242-3000 626-303-5676 [Link]
[Link] info@[Link] info@[Link]
[Link] [Link] Eitan Medical
Arnold Magnetic Technologies [Link]/ [Link]
[Link] [Link]/
rd223/qosina rd223/amadaweldtech IPM
AW-Lake Company [Link]
[Link] ArcRev
[Link] Pharmalex
Backer Hotwatt Inc. [Link]
[Link] Bold Laser Automation, Inc.
Solenoid Solutions, Inc. [Link] West Pharma
Beswick Engineering Co., Inc. 814-833-5439 [Link]
[Link] FOBA
info@solenoidsolutionsinc. [Link]
Bimba Manufacturing com
[Link] [Link]
[Link]/
Clippard rd223/solenoidsolutions MACHINING/
[Link] STAMPING
Cole-Parmer Hobson & Motzer
[Link] 860-349-1756
abracale@[Link]
Diener Precision Pumps [Link]
[Link]. The Lee Company
[Link]/
com 860-399-6281 rd223/hobsonmotzer AMADA WELD TECH INC.
inquiry@[Link] 626-303-5676
Dispense Works [Link] Laser Impressions
[Link] info@[Link]
[Link] [Link]
Thomas Division
[Link] Lighteum [Link]/
[Link] rd223/amadaweldtech

Winter 2023 Resource Guide [Link] 41

 Winter 2023 Resource Directory

Machining/Stamping continued

Autosplice, Inc. Graham Engineering Company

[Link] MANUFACTURING [Link]

Batten & Allen EQUIPMENT Greenerd Press & Machine Co.

[Link] Keystone Electronics Corp. [Link]
3DT LLC
Big Daishowa Inc. 800-221-5510 [Link] Haas Multigrind LLC
[Link] kec@[Link] [Link]/en
[Link] Adelbert Haas LLC
[Link]/en Hines Industries, Inc.
Lyons [Link]
[Link] Advanced Cooling Technologies
[Link]/markets/medical JULABO USA
M3 Precision LLC [Link]
Cadence, Inc. [Link]
540-248-2200 Kinefac Corporation
sales@[Link] M&K Engineering, Inc. [Link]
[Link] [Link]
[Link]/ Kurt Manufacturing Company
Medical Equipment Repair AMADA WELD TECH INC. [Link]
rd223/cadenceinc 626-303-5676
Associates (MERA)
Camozzi Automation, Inc. [Link] info@[Link] Madison Company
[Link]/products/ [Link] [Link]
life-science Metal Cutting Corporation [Link]/
[Link] rd223/amadaweldtech Marubeni Citizen-Cincom Inc.
Cretex Medical CDT [Link]
[Link]/cdt Microcision
[Link] AZCO Corp.
Criterion Tool & Die [Link]
[Link] Norman Noble, Inc.
[Link] Behringer Saws, Inc.
CSS
[Link] [Link]
OKAY Industries maxon
[Link] 508-677-0520
Disposable Instrument
Company Inc. [Link]@[Link]
[Link] Orbel Corporation [Link]
[Link] [Link]/
Biocoat Inc. rd223/maxon
Penn United Technologies Inc.
[Link] 215-734-0888
Mikrotron
sales@[Link] [Link]
Quest International [Link]
Formacoat [Link] Milacron
952-895-0200 Comco Inc. [Link]
rms Company [Link]
info@[Link] [Link]
[Link] Norton | Saint-Gobain
Cool Clean Technologies [Link]
Sandvik Coromant [Link]
GMI Corp. [Link]
[Link] OK Sealer
Delta ModTech [Link]
Swiss Automation [Link]
[Link] On Line Controls, Inc.
Emuge-Franken USA [Link]
[Link]
Lehnen Industrial Services
[Link]

Hobson & Motzer The Lee Company

860-349-1756 860-399-6281
abracale@[Link] inquiry@[Link] Excelitas Technologies
[Link] [Link] 905-821-2600
[Link]/ omnicure@[Link] The Lee Company
rd223/hobsonmotzer Twin City EDM & Mfg., Inc. [Link] 860-399-6281
[Link] [Link]/ inquiry@[Link]
K.S. of West Virginia rd223/excelitass [Link]
[Link] Vanpro Inc.
[Link] FPZ Inc. Thermal Care
Kemac Technology, Inc. [Link] [Link]
[Link] Vaupell
[Link] Glebar Z-Laser
Kenmode [Link] [Link]
[Link] Xact Wire EDM
[Link]

42 [Link] Winter 2023 Resource Guide

 Winter 2023 Resource Directory

Tiodize Co. Inc. John Evans Sons, Inc.

MATERIALS/ [Link] [Link]
PLASTICS/METALS Toray JW Winco
[Link] [Link]
Achilles USA Fort Wayne Metals
[Link] 260-747-4154 Lampin
info@[Link] [Link]
Anomet Products [Link]
[Link] [Link]/ Loos & Co.
rd223/fortwaynemetals [Link]
Bally Ribbon Mills Ulbrich Stainless Steels &
[Link] Foster Corporation Special Metals, Inc. Medicoil
[Link] 800-243-1676 [Link]
Banner Industries info@[Link]
[Link] Greene Tweed [Link] Microlap Technologies, Inc.
[Link] [Link]/ [Link]
Banner Medical Innovations
[Link] rd223/ulbrich
NBK America LLC
[Link]/en-US
BASF
[Link] Rotor Clip
[Link]
Boston Centerless Hobson & Motzer MECHANICAL
[Link] Schaffner USA
860-349-1756 COMPONENTS/ [Link]
abracale@[Link]
Boyd
[Link] [Link] HARDWARE
Senior Metal Bellows
[Link]/ [Link]
rd223/hobsonmotzer Acme Monaco Corporation
[Link]
Indium Corporation
[Link] Bal Seal Engineering By Kaman
[Link]
CHT USA International Polymer
804-517-0656 Engineering (IPE) Carl Stahl Sava Industries Solenoid Solutions, Inc.
[Link] [Link]
[Link]@[Link] 814-833-5439
[Link] Carlisle Medical Technologies info@solenoidsolutionsinc.
Lubrizol LifeSciences com
[Link]/ [Link]/health [Link]
rd223/cht [Link]
Coherent [Link]/
Curbell Plastics, Inc. [Link] rd223/solenoidsolutions
[Link]
Designatronics Inc. Southco
MicroLumen [Link] [Link]
813-886-1200
sales@[Link] Electri-Flex Company Steinmeyer
[Link] [Link]/en/home-
[Link] page
DDL Ewellix
952-283-9226 Momentive [Link] Stock Drive Products/Sterling
ddlinforequests@ddltesting. [Link] Instrument
com [Link]
Omniseal Solutions
[Link] [Link]/ Teamsworld Innovation Inc.
industries/life-science [Link]
Dow
[Link]/en-us Poly-Med Inc. Filmecc USA, Inc.
[Link] 949-756-8252
DuPont
[Link] davidz@[Link]
RTP Company
[Link] [Link]
Eastman
[Link] The Lee Company
SABIC 860-399-6281
[Link]
Edge International inquiry@[Link]
[Link] Sekisui Kydex [Link]
[Link]
Elkem Hobson & Motzer
[Link]/silicones SINTX Technologies 860-349-1756
[Link] abracale@[Link]
EMS-GRIVORY
[Link]
[Link] MOLDING
Supra Alloys [Link]/
[Link] rd223/hobsonmotzer
Evonik Aberdeen Technologies, Inc.
[Link] SWM International [Link]
[Link]

Winter 2023 Resource Guide [Link] 43

 Winter 2023 Resource Directory

Molding continued

ProMed Kollmorgen Sepac

[Link] [Link] [Link]

PSI Molded Plastics LM76 Southern Gear

[Link] [Link] [Link]
Accumold
515-964-5741 RenyMed Ludl Electronic Products Ltd. Telco Intercontinental Corp.
micromolding@accu-mold. [Link] [Link] [Link]
com
[Link] Seaway Plastics Engineering Thomson Industries
[Link] [Link]
Advanced Molding Technologies
[Link] Silcotech North America Inc. Tolomatic Inc.
[Link] [Link]
Beaumont maxon
[Link] Simtec Silicone Parts, LLC 508-677-0520 Velmex, Inc.
[Link] [Link]@[Link] [Link]
BMP Medical [Link]
[Link] [Link]/
rd223/maxon
Carclo Technical Plastics
[Link] Molon Motor & Coil Corporation OPTICS/OPTICAL
[Link]
Crescent Industries Teleflex Medical OEM COMPONENTS
[Link] 800-474-0178
Moog Components Group
oeminfo@[Link] [Link] Access Optics
Currier Plastics, Inc. [Link] [Link]
[Link] Moticont
VEM Medical [Link]
Diversified Plastics, Inc. [Link]
[Link] Nexen Group, Inc.
Westfall Technik [Link]
Empire Precision Plastics [Link]
[Link] Nippon Pulse America, Inc. Accumold
[Link] 515-964-5741
Eptam Precision micromolding@accu-mold.
[Link] NSK Americas com
MOTION CONTROL/ [Link] [Link]
MOTORS Optimal Engineering Systems, Archer OpTx, Inc.
Inc. [Link]
ABM Drives [Link]
[Link] ASML
Flexan Parker Hannifin – [Link]
847-644-6068 Aerotech, Inc. Electromechanical & Drives Div.
salesinfo@[Link] [Link] [Link] Avo Photonics
[Link] [Link]
[Link]/ Allied Motion PBC Linear
rd223/flexan [Link] [Link] BEA Lasers
[Link]
Custom Machine and Tool Co. PI
Husky [Link]
[Link] [Link] C-Flex Bearing Co. Inc.
[Link]
ICO Mold Del-Tron Precision, Inc.
[Link] [Link] Chroma Technology
[Link]
Matrix Plastic Products, Inc. Destaco
[Link] [Link]
Portescap
Moldamatic, LLC ebm-papst, Inc. 404-877-2534
[Link] [Link] [Link]@regalrexnord.
com
Festo DATA IMAGE
MTD Micro Molding [Link]
[Link] [Link] 407-478-4064
[Link]/
rd223/portescap heldred@[Link]
Nypromold GAM Enterprises [Link]
[Link] [Link]
Power-Packer
[Link] Delta Optical Thin Film
Pelham Plastics H2W Technologies [Link]
[Link] [Link]
QuickSilver Controls, Inc.
[Link] Edmund Optics
Plastic Design International, Hanning Elecktro-Werke [Link]
Inc. [Link]
Schneeberger, Inc.
[Link] [Link] Enable Inc.
Haydon Kerk Pittman [Link]
Premold Corp. [Link]
Sensata Technologies
[Link] [Link]
IKO International Inc.
[Link]

44 [Link] Winter 2023 Resource Guide

 Winter 2023 Resource Directory

Optics/Optical Components continued

Epix, Inc. Tek Pak Inc.

[Link] PACKAGING [Link] PRODUCT
Fiber Optic Center, Inc. Accu Seal Corporation
RESEARCH/DESIGN/
[Link] [Link] DEVELOPMENT
Gray Optics
[Link]
Amcor POWER SUPPLIES & 42 Technology
[Link] [Link]
BATTERIES
Hamamatsu Corporation Atlas Vac Machine. LLC Accurate Medical Systems, Inc.
[Link] [Link] Absopulse Electronics Ltd. [Link].
[Link] com
IMPERX, Inc. Autajon Group
[Link] [Link]/en Advanced Energy Industries Applied Design Technologies Inc.
[Link] [Link].
Innofiber Brentwood Medical com
[Link] [Link] Astrodyne TDI
[Link]/ [Link] Ascential Technologies
Innovations in Optics packaging [Link]
[Link] Autec Power Systems
Caplugs [Link] BB7, Inc.
Jenoptik Optical Systems [Link] [Link]
[Link] Bel Power Solutions &
Colimatic USA, Inc. Protection
Kugler of America, Ltd. [Link] [Link]
[Link]/en
Cretex Medical – QTS Cell-Con, Inc
Laser Components USA, Inc. [Link]/qts [Link]
[Link] Biocoat Inc.
Custom Case Group COSEL USA Inc. 215-734-0888
Lighthouse Imaging [Link] [Link] sales@[Link]
[Link] [Link]
Daburn Electronics and Cable
Marktech Optoelectronics [Link]/ Boston UX
[Link] [Link] [Link]
Micro Laser Systems, Inc. GlobTek, Inc. Cambridge Consultants
[Link] DDL [Link] [Link]
952-283-9226
Mirrorcle Technologies Inc. ddlinforequests@ddltesting. Inspired Energy LLC CCS Cooper Consulting Service
[Link] com [Link] [Link].
[Link] com
Modulight, Inc. Jasper Electronics
[Link] [Link] Celestica
Dorner by Columbus McKinnon [Link]
Novanta Photonics [Link]
Littelfuse, Inc.
[Link] [Link] Charles River
DuraTech Industries [Link]
OFS [Link]
MEGA Electronics Inc. Cyient
[Link]/medical [Link]
Gel-Pak [Link]
Optikos Corporation [Link]
Mike Doherty Designs, LLC Daedalus
[Link] [Link]
Millstone Medical [Link]
Photron, Inc. [Link]
Minmax Power Inc. DCA Design International
[Link] [Link]/en
OKW Enclosures, Inc. [Link]
Precision Glass & Optics [Link]
Murata Power Solutions
[Link] [Link]
Pixus Technologies
Reynard Corporation [Link]
Quail Electronics, Inc.
[Link] [Link] DDL
Placon
[Link] 952-283-9226
RPMC Lasers, Inc. RRC Power Solutions
[Link] ddlinforequests@ddltesting.
Prent Corporation [Link] com
Toptica Eagleyard [Link] [Link]
Totex Manufacturing
[Link] [Link]
QuickPouch Delve
Xenon Corporation [Link] [Link]
Triad Magnetics
[Link] [Link]
Sonoco TEQ Design Catapult
Zeiss [Link] [Link]
XP Power
[Link] [Link]
Technipaq, Inc. DW Product Development, Inc.
Zygo Corporation [Link] [Link]
[Link]
Eclipse Product Development
[Link]

Winter 2023 Resource Guide [Link] 45

 Winter 2023 Resource Directory

Product Research/Design/Development continued

Sagentia Innovation Tekscan Honeywell Safety and

[Link] [Link] Productivity Solutions
[Link]
Filmecc USA, Inc. StarFish Medical THK
[Link] [Link] Innovative Sensor Technology,
949-756-8252 USA Division
davidz@[Link] Start Medical Product Universal Robots [Link]/en-us
[Link] Development [Link]
[Link] Introtek/Ametek
Wittenstein/High Integrity [Link]
Sunrise Labs Systems
[Link] [Link]

Syprosoft Engineering
Formacoat [Link]
952-895-0200
maxon
info@[Link] TecMed Incorporated
[Link]
SENSORS/ 508-677-0520
[Link]
DETECTORS/DATA [Link]@[Link]
ACQUISITION [Link]
[Link]/
Advanced Photonix, a Division rd223/maxon
of OSI Optoelectronics
Fort Wayne Metals Teleflex Medical OEM [Link] Micronor Sensors
800-474-0178 [Link]
260-747-4154
info@[Link] oeminfo@[Link] AMS AG
[Link] OmniVision Technologies, Inc.
[Link] [Link]. [Link]
[Link]/ com
Basler AG
rd223/fortwaynemetals [Link] Opto Diode Corp., an ITW
Vantage Medtech Company
HDA Technology [Link] [Link]
Canon Medical Components
[Link] USA, Inc. – Video Sensing
Worrell OSI Optoelectronics, Inc.
[Link] Devices
HS Design [Link] [Link]
[Link]
Ximedica RJG
[Link] CAS Dataloggers
Idneo [Link] [Link]
[Link]
Sensor Scientific Inc.
IEEE Engineering in Medicine [Link]
and Biology Society
[Link] ROBOTICS/ Strain Measurement Devices
[Link]
Instrument Technology, Inc. AUTOMATION DATA IMAGE
[Link] TSI Incorporated
ATI Industrial Automation 407-478-4064 [Link]
Ion Design [Link] heldred@[Link]
[Link] [Link]
DENSO Robotics
[Link] ENM Co.
[Link]
DeviceLab
SOFTWARE
[Link] Evergreen Telemetry
[Link] ANSYS
MicroLumen Intel [Link]
813-886-1200 [Link] Eyecloud
sales@[Link] [Link] Arena Solutions
[Link] Kinova [Link]
[Link] Framos Technologies
[Link] ARM
Nemera Insight PD [Link]
[Link]
FUTEK Advanced Sensor
Nortech Medical Solutions [Link]
[Link]
Gems Sensors & Controls
maxon [Link]
Northeast Biomedical
[Link] 508-677-0520
HBK Cadence, Inc.
[Link]@[Link]
[Link] 540-248-2200
Novo Engineering [Link]
[Link] sales@[Link]
[Link]/
rd223/maxon HBM, Inc. [Link]
Omnica [Link] [Link]/
[Link] Nissha Medical Technologies rd223/cadenceinc
[Link] Heraeus Sensor Technology
Orthogone USA Check Point
[Link] NVIDIA [Link] [Link]
[Link]

46 [Link] Winter 2023 Resource Guide

 Winter 2023 Resource Directory

Software continued

Clariant Plastics & Coatings OnScale Tovatech Ultrasonic F2 Labs

[Link] [Link] [Link] [Link]

Cognition Open Mind Technologies AG Gilero

[Link] [Link] [Link]

Photon Engineering LLC

[Link]
TEST SERVICES Hexagon Manufacturing
Intelligence
[Link]
Precision Systems, Inc. Advanced Inspection Services
[Link] [Link] Intertek Allentown
COMSOL, Inc.
[Link]/analytical-­
781-273-3322 Promenade Software Inc. Akron Rubber Development laboratories/allentown
info@[Link] [Link] Laboratory, Inc.
[Link] [Link] Laboratory Testing Inc.
Propel [Link]
Critical Manufacturing [Link] Anderson Materials Evaluation
[Link] [Link] Microtest Laboratories, Inc.
Razorleaf [Link]
Cytellix [Link] Boston Analytical
[Link] [Link] NAMSA
Siemens Digital Industries [Link]
Dassault Systèmes SolidWorks Software Cambridge Polymer Group, Inc.
Corp. [Link]/en-US [Link]
[Link]
SpiderOak CertifiGroup - Eurofins
[Link] [Link]

Stat-Ease, Inc. Compliance West USA Nelson Laboratories, LLC

[Link] [Link] 801-290-7500
sales@[Link]
DATA IMAGE Tietronix Medical Consumer Product Testing Co.
[Link] [Link]
407-478-4064 [Link]
heldred@[Link] Oneida Research Services
Volume Graphics CSZ, a Weiss Technik company
[Link] [Link] [Link]
[Link]
EMIDS Stress Engineering Services
[Link] Wibu-Systems USA [Link]
[Link]
ETQ TUV Rheinland of North
[Link] Zontec Inc. America, Inc.
[Link] DDL [Link]
Geisel Software, Inc. 952-283-9226
[Link] ddlinforequests@ddltesting. UL LLC
com [Link]/healthcare-and-
Grand Avenue Software life-sciences
[Link] STERILIZATION [Link]
ViVitro Labs Inc.
Green Hills Software EdgeOne Medical [Link]
Andersedn Sterilizers [Link]
[Link] [Link]
WESTPAK, Inc.
Honeywell/Sparta Systems Element [Link]
E-Beam Services, Inc. [Link]
[Link] [Link]
WuXi AppTec
ICS HIGHPOWER Validation Testing [Link]
[Link] & Lab Services [Link]
[Link]
LDRA Zaxis
[Link] Life Science Outsourcing, Inc. Eurofins Medical Device [Link]
[Link] Testing
Maplesoft
[Link] 717-656-2300
Nordion, a Sotera Health Co. medical-device@[Link]
[Link]
Master Control
[Link]
Noxilizer, Inc. [Link]/medical-­
device
TEST/INSPECTION/
[Link]
METROLOGY
Steri-Tek Exact Metrology
[Link] [Link] 4D Technology Corporation
[Link]
Sterigenics
[Link] Actco Metrology Services
maxon [Link]
508-677-0520 Sterilucent, Inc.
[Link]@[Link] [Link] Bristol Instruments, Inc.
[Link] Formacoat [Link]
[Link]/ STERIS Applied Sterilization 952-895-0200
rd223/maxon Technologies info@[Link] Chroma Systems Solutions, Inc.
[Link] [Link] [Link]

Winter 2023 Resource Guide [Link] 47

 Winter 2023 Resource Directory

TEST/INSPECTION/METROLOGY continued

Cincinnati Test Systems PVI Systems Inc. Polygon Company

[Link] [Link] [Link]
Creaform Q-PLUS Labs Interpower Corporation Proterial Cable America
[Link] [Link] [Link]
800-662-2290
The L.S. Starrett Co. sales@[Link] Putnam Plastics
[Link] [Link] [Link]
[Link]/
Werth, Inc. rd223/interpower
[Link]
DDL Judson A. Smith Company
952-283-9226 Zarbeco, LLC [Link]/
ddlinforequests@ddltesting. [Link] judson-a-smith
com Qosina
[Link] Junkosha 631-242-3000
[Link]/en info@[Link]
ED&D [Link]
[Link] TUBING & [Link]/
rd223/qosina
Excel Technologies EXTRUSION
[Link] Raumedic
1 Medical Extrusion [Link]
[Link] Medical Extrusion
Technologies Seisa Medical
A.P. Extrusion 800-618-4346 [Link]
[Link] info@[Link]
Fort Wayne Metals [Link] SiMEDEx Inc.
ATW [Link]
260-747-4154 [Link]
info@[Link] Spectrum Plastics Group
[Link] Axis Medical Extrusion [Link]
[Link]/ [Link]
rd223/fortwaynemetals Sunlite Plastics
CUUMed MicroLumen [Link]
in-phase technologies [Link] 813-886-1200
[Link] Superior Tube/Ametek
sales@[Link]
Duke Extrusion [Link]
[Link] [Link]
Teel Plastics
Exalt Custom Tubing [Link]
[Link]
Instron Tekniplex Medical
800-877-6674 [Link]
web@[Link] Microspec Corporation tekni-plex-medical/
[Link] 603-924-4300
[Link]/ info@[Link]
rd223/instron Filmecc USA, Inc. [Link]
949-756-8252
Labcorp davidz@[Link]
[Link] Teleflex Medical OEM
[Link] Midwest Interventional Systems
Lenox Instrument Company [Link] 800-474-0178
[Link] oeminfo@[Link]
MRPC [Link]
Mahr Inc. [Link]
[Link] Trelleborg
Flexan [Link]/
Marposs healthcare
[Link] 847-644-6068
salesinfo@[Link]
MB [Link] [Link] Vanguard Products Corporation
[Link] New England Wire [Link]
[Link]/
rd223/flexan Technologies
MSI-Viking Gage Xponent Global
603-838-6624
[Link] [Link]
info@[Link]
NI, part of Emerson GenX Medical [Link]
[Link]/[Link] [Link]
NewAge® Industries, Inc.
Nikon Metrology Guill Tool & Engineering Co., [Link]
[Link] Inc.
[Link] Optinova Zeus
Pfeiffer Vacuum [Link] 803-268-9500
[Link] HandyTube Corporation support@[Link]
[Link] PBS Plastics [Link]
PPT Group Corp dba Mecmesin [Link]
[Link]

48 [Link] Winter 2023 Resource Guide

 Sponsored Content

B. Braun Medical Inc.

861 Marcon Blvd.
Allentown, PA 18109
Phone: 484-240-8301
Fax: 610-691-1785
E-mail: info@[Link]
[Link]

About Our Company Target Markets

B. Braun’s OEM Division services all areas of the medical

device and pharmaceutical space.

Products/Services Offered

B. Braun’s OEM Division delivers complete contract manufac-

turing capabilities focusing on fluid administration and admix-
ture products, kits,
valves, catheters and
interventional acces-
sories. In-house ser-
vices include product
de­velopment, labora-
tory, design, proto-
typing, tooling, mold-
Whether you are looking for a solution, medical device, fluid ing, validation, manu-
administration set, custom kit or individual components, we can facturing, packaging,
provide the products and capabilities to meet your needs. sterilization, quality
A division of one of the world’s leading healthcare compa- control, private labeling, regulatory guidance, and supply chain
nies, our dedicated project management teams have the exper- management services.
tise to turn your ideas into reality. With in-house capabilities
that include everything from design and assembly through
packaging and sterilization, we are an OEM partner in the most
complete sense of the word.

[Link]

Winter 2023 Resource Guide [Link] 49

 Sponsored Content

Eurofins Medical Device Testing

2425 New Holland Pike Target Markets
Lancaster, PA 17601
Phone: 717-656-2300 From implants and instruments, to single-use and combination
Fax: 717-656-3772 products, as well as active electronic devices, Eurofins Medical
E-mail: medical-device@[Link] Device Testing works with medical device companies to provide
[Link]/medical-device the optimal testing strategy for all types of class I, II, and III
medical devices.

About Our Company

Products/Services Offered
With extensive knowledge of commercialization processes,
regulatory requirements and scientific trends in the Industry,
Eurofins Medical Device Testing offers regulatory compliance
expertise and experienced GMP/GLP/ISO 17025 testing to
ensure rapid turnaround times with the highest level of service
and advanced technologies for your analytical chemical,
microbiological, biocompatibility, electrical, mechanical, and
package testing needs.
Our team has been assisting companies with developmental
testing for over 40 years; and our global network of >20
laboratories in North America, Europe and Asia Pacific the highest
level of instrument technology with a full scope of testing services.
Eurofins Medical Device Testing can develop and execute your
test plans and navigate the regulatory pathway to market • Analytical Chemistry —
anywhere in the world. Our laboratories maintain quality systems Our chemistry labora–
compliant with cGMP, GLP, and ISO 17025, and conduct testing in tories are equipped
accordance with ISO, ASTM, ANSI, AAMI standards, and custom with nearly 400 HPLCs
test methodologies to meet the unique needs of our customers. and 100 GCs with more
than 600 detectors.
• Microbiology — We offer
validations for terminal
sterilization, reprocess-
ing of re­usable devices,
and environmental mon­
itoring to support your
clean manufacturing
facilities.
• Biocompatibility Testing
— Our global biocom-
patibility team includes a
vast group of certified
veterinarians, path­olo­
gists and toxicologists.
• Electrical & Mechanical Testing — We perform testing of active
medical devices for compliance to electrical requirements of
ISO 60601.
• Package Testing — We provide the full range of testing
required to assess every aspect of product packaging, from
sterile seal integrity through pallet-level transit testing, to
label durability and UDI compliance.
• Stability Testing & Storage — Our laboratories contain over
187,000 cubic feet of environmental chamber space for
accelerated and real-time stability and aging studies.

[Link]/medical-device

50 [Link] Winter 2023 Resource Guide

 Sponsored Content

Flexan
500 Bond St.
Lincolnshire, IL 60069
Phone: 224-543-0003
E-mail: salesinfo@[Link]
[Link]

About Our Company Target Markets

Flexan is a full-service global contract design and manufac- Class I, II, and III Medical Device manufacturers
turing organization specializing in high-precision medical-grade
silicone, rubber, and thermoplastic components. With more 70+
years of experience, five locations globally and over 2,400 Products/Services Offered
SKUs, Flexan delivers world-class molding, extrusion, assembly
and packaging solutions for leading medical device and health- The company specializes in: Design for manufacturability
care technology companies worldwide. (DFM); process validation (IQ, OQ, PQ); molding; extrusion/tub-
ing (thermoplastic and silicone); rapid prototyping; secondary
operations, including hole drilling; assembly; logistics and distri-
bution; manufacturing management and sustainability; and lean
Six Sigma methodologies.

[Link]

Winter 2023 Resource Guide [Link] 51

 Sponsored Content

Formacoat LLC
2960 Chaska Boulevard Products/Services Offered
Chaska, MN 55318
Phone: 952-895-0200 Formacoat provides a “one-stop shop” with a wide range of
Fax: 952-895-6020 coating technologies from different coating vendors that are
E-mail: info@[Link] beneficial for various applications. Some newer capabilities include:
[Link]
• Matrix-entrained liquid coatings
• Heparin coatings
• Soft touch coatings
About Our Company
• Grafting coatings (OD and small IDs)
• Non-Drug Antimicrobial materials
Formacoat is a creative biomedical company that can coat
• Opaque colored coatings (fluidized bed)
your product with hydrophilic, hydrophobic or other custom
• Precision coating application (micro-spray, ultrasonic spray)
coatings as a contract manufacturing service. The company
• Encapsulation
offers coatings from the full range of different brands,
• Surface blocking (peptide)
chemistries, and types of coatings. Formacoat draws from its
• Specialized PTFE
extensive coating and device experience and this array of
• Coating OLED with volatile scavenger coatings (Getter coatings)
different technologies and coating vendors to help its customers
• ID coatings
find the best, most cost efficient and technologically appropriate
• Gel encapsulation
coating for their application, all at single efficient source:
• Stent coatings
Formacoat.
• Drug delivery coatings
Formacoat is ISO 13485 certified.
• Heatable coatings
• Conductive polymers
• Production scale plasma
• 3D printing of sample parts with biocompatible polymers
• Dynamic particle count stress testing (particle shedding rates)
• IOL cartridges
• Spectrophotometric method development and analysis of
reagents

Formacoat is building a brand new 38,000+ square foot

facility, which will include 6000+ square feet of ISO Class 7
cleanrooms to designated uses. This will allow the company to
greatly expand its already extensive capabilities.

Target Markets

Medical Device Industry, as well as other industries with

products that may benefit from a medical device coating

[Link]

52 [Link] Winter 2023 Resource Guide

 Sponsored Content

Hobson & Motzer

30 Airline Drive Target Markets
Durham, CT 06422
Phone: 860-349-1756 Medical Device • Endo Mechanical • Electro Surgical • Surgical
E-mail: abracale@[Link] Stapling • Robotic Surgery • Drug Delivery • Custom Electrical
[Link] Contacts

About Our Company Products/Services Offered

A passion for excellence, innovative spirit, attention to detail, Hobson & Motzer offers a
collaboration, and a dedicated workforce have all contributed to broad range of capabilities,
Hobson & Motzer’s steady growth over our 111 years of manufac- manufacturing precision
turing experience. We are a vertically integrated manufacturer of metal components and as-
precision metal components and assemblies serving the needs of semblies, excelling at preci-
the medical device market and other advanced industries. The sion metal stamping and
ability to excel and innovate in our field requires a strong commit- coining — 30T to 660T —
ment to technology; we invest in the most advanced manufactur- coined wire, and has more
ing and metrology equipment available. For 25 years, we have than 100 high-precision,
maintained a deep commitment to lean manufacturing and con- multi-axis CNC machines. We
tinuous improvement; in recent years pursuing enterprise excel- design and build complex
lence through the Shingo model. Hobson & Motzer operates two progressive dies and offer a
manufacturing plants with primary operations — and headquar- full complement of in-house
ters — centrally located in Durham, CT; the Advanced secondary operations, all
Manufacturing Center is just a few miles away in Wallingford, CT. supported by our internal en-
Hobson & Motzer is built on the pillars of integrity, humility, a gineering team and 50-per-
passion for excellence, and a culture of innovation. son toolroom. Vertical inte-
gration is a strategy, but lis-
tening to the needs of our
customers has truly been the
driving force behind our manufacturing depth. This inspired First
Step, our project-based rapid precision prototyping program, a
radical new approach to new product development. With each
move into a new technology or capability — whether precision CNC
machining, robotic automation, or PECM — our approach, like our
parts, is consistent. Our infrastructure assures that parts and
critical projects will remain on quality, on schedule, and on time.

[Link]

Winter 2023 Resource Guide [Link] 53

 Sponsored Content

Interpower Corporation
P.O. Box 115
Oskaloosa, IA 52577-0115
Phone: 800-662-2290
E-mail: sales@[Link]
[Link]

About Our Company Target Markets

Interpower® electrical designs . . . easy . . . fast. Interpower • Medical

makes it easy to design, build, and maintain electrical products
for North American and international markets — that’s our mis-
sion on a global scale. We provide customers with world-class Products/Services Offered
electrical products and industry knowledge. As the premier
supplier of AC power system components, Interpower manufac- All of Interpower’s North American and international cords,
tures and ships hospital-grade products designed for medical cord sets, and components are manufactured and shipped with
settings throughout the world. This includes cords, cord sets, the correct country-specific approvals.
plugs and sockets, IEC 60320 inlets, outlets, connectors, plug With no minimum order or dollar requirements, order just
connectors, and power entry modules and an array of value-­ what you need — 1 cord or 5,000 cords with 1-week lead-times.
added services. Interpower provides an industry-unique 1-week Specialized labeling is available — mark your cords with labels
U.S. manufacturing lead-time on non-stock Interpower products containing specific information, such as identifying a certain
while in-stock products ship the same day with no minimum hospital, clinic, or office locations (e.g., “Operating Room 1,” “ER
order or dollar requirements! Interpower manufactured prod- 2”). Value-added services, in addition to specialized labeling,
ucts are made in Iowa, U.S.A., and are standards tested through- include optional cord lengths, colors, cord clips, special packag-
out the production process prior to shipping. Interpower also ing, barcode labeling, serial numbering, and made-to-order as-
offers free technical support. Contact Customer Service about semblies. Contact Customer Service for more information re-
products, pricing, and technical issues. garding our North American and international hospital-grade
products for worldwide markets.

[Link]

54 [Link] Winter 2023 Resource Guide

 Sponsored Content

Keystone Electronics Corp.

55 South Denton Avenue
New Hyde Park, NY 11040
Phone: 800-221-5510
Fax: 516-328-1080
E-mail: kec@[Link]
[Link]

About Our Company

For more than 75 years,

Keystone Electronics Corp.
has been manufacturing
precision electronic in-
terconnect components
and hardware, supplying
quality products worldwide.
Whether you are de­
veloping Ultrasound De­
vices; Defibrillators; Im­
plantable Pacemakers;
Portable Medical Monitors or Electro-surgical Instruments, Keystone
products are engineered specifically for use by OEM Designers and
Engineers who create and develop state-of-the-art electronic
products such as medical devices, instruments and systems.
All Keystone facilities are fully integrated with 3D/CAD model-
ing and CAD/CAM to produce precision tools and production
parts. Keystone is an ISO 9001:2015 certified company and com-
plies with RoHS and
REACH di­rectives. It is
our policy to continu-
ously im­prove our prod-
ucts to better satisfy
the needs of our cus-
tomers and to deliver
quality products, every
time and on time. All
pro­ducts are available
through our global dis­ Product Categories include:
tribution network. • Battery Clips, Contacts & Holders
• Fuse Clips & Holders
• Terminals & Test Points
Target Markets • Spacers & Standoffs
• Panel & Computer Hardware
Medical, Automotive, Electronics, Aerospace, Defense, Solar, • Pins, Plugs, Jacks & Sockets
Appliance and Consumer Products • PC Board Hardware
• Multi-Purpose Hardware
While our Dynamic Catalog of products meets most standard
Products/Services Offered requirements, modifications as well as custom fabrications can
be manufactured to meet your special needs. Keystone’s Design
Keystone has a diverse manufacturing base of equipment includ- and Engineering specialists and our responsive customer service
ing progressive dies, four-slide, wire forming, in-die tapping and team are all vital in-house resources which constitute our
high-speed blanking along with automated and semi-automatic as- Custom Manufacturing Division’s capabilities that are available
sembly procedures including eyeleting, riveting, staking, swaging, to support standard and customer specific requirements.
crimping, and screw insertion. Services to support the thousands of Request our new Product Design Guide M70.
standard products you will find in Product Design Guide M70 and
Keystone’s Dynamic Catalog on-line.
[Link]

Winter 2023 Resource Guide [Link] 55

 Sponsored Content

KNF Neuberger, Inc.

2 Black Forest Rd Products/Services Offered
Trenton, NJ 08691
Phone: 609-890-8600 One size doesn’t fit all. We collaborate closely with our cus-
E-mail: knfusa@[Link] tomers throughout the entire development process to create
[Link] the best solution for each specific application while balancing
required performance, product lifetime, and cost.
By understanding customers’ applications and specifications,
KNF engineers strive to optimize not only our pump, but to also
About Our Company
assist customers in optimizing their overall system. Our job is to
fit the pump to your application — not the application to a pump.
KNF is an independent, family-owned company comprised of
In fact, customers often send us problematic systems for test-
24 global locations. As a technology leader with over 300 pat-
ing. Whether the issue is related to the pump or other system
ents, we are dedicated to providing tailor-made solutions with
components, we’ll provide a full report with analysis and recom-
reliable diaphragm, solenoid, swing piston, and smooth-flow
mendations.
pump technologies. Drawing on our expertise in various fields of
We have solved thousands of design challenges for a variety
engineering, from mechanics, materials, and fluidics to elec-
of application tasks, including fluid supply, liquid waste han-
tronics and software, KNF strives to find the smartest solutions
dling, washing, recirculation, and metering/dosing; aspiration,
for every application — not just for today but innovated over
degassing/debubbling, chamber evacuation, and vacuum rough-
time to continuously serve evolving needs.
ing/backing; gas transfer and pneumatics.

Target Markets

KNF’s applications experience extends across diverse indus-

tries, including medical devices, clinical diagnostics, environ-
mental/industrial hygiene, laboratory equipment, printing, se-
curity, and defense, semiconductor, energy, and various process [Link]
industries.

56 [Link] Winter 2023 Resource Guide

 Sponsored Content

Medbio
5346 36th St., SE
Grand Rapids, MI 49506
Phone: 616-245-0214
Fax: 616-245-0244
E-mail: Info@[Link]
[Link]

About Our Company Products/Services Offered

Located in Michigan, Medbio is an ISO 13485:2016-certified The Medbio management team averages over 25 years of
contract manufacturer offering innovative man­ufacturing solu- experience in the medical device industry. We have experience
tions for the medical device and biotech industries. We special- with most medical-grade thermoplastics and im­plantable-grade
ize in precision injection molding, as­sembly, packaging, proto- resins. We currently mold products for the major OEMs in
typing, and design support. Building strategic partnerships and Orthopedics, Cardio­ vascular, Ophthalmology, Neurological
conducting business with integrity allows Medbio and our cus- Surgery, General Surgery, Wound Care, Biotech (Diagnostics &
tomers to achieve growth, success, and profitability. cell growth), and Dental. From components to full assemblies,
Medbio will tailor our manufacturing services to meet your
needs, taking your medical device from design to completion.
We have the knowledge, passion, and experience to solve your
most difficult manufacturing challenges.

Target Markets [Link]

Medical

Winter 2023 Resource Guide [Link] 57

 Sponsored Content

New England Wire Technologies

130 N Main St. Target Markets
Lisbon, NH 03574
Phone: 603-838-6624 We currently serve a full range of industries including medi-
E-mail: info@[Link] cal device and electronics, aerospace, defense, robotics and
[Link] automation, power generation, and alternative energy.

About Our Company Products/Services Offered

Founded in 1898, New England Wire Technologies has been

the premier supplier of custom wire and cable products for 125
years. We currently serve a full range of industries including
medical device and electronics, aerospace, defense, robotics
and automation, power generation, and alternative energy to
name just a few. Our capabilities include custom Litz wire, min-
iature, micro-miniature, single and multiconductor cables, low
noise, high temperature, coaxial and hybrid cables. New England
Tubing Technologies designs custom braid or spiral reinforced
tubing, lined catheter shafts, multi-lumen, multi-durometer, and
hybrid tubing.
Our facilities consist of 400,000 square feet of manufactur-
ing, quality/testing, tooling/machine fabrication, and office
space. Manufacturing processes include wire drawing, plating,
stranding, braiding, cabling, insulating, and extrusion services.
We are an ISO9001:2015 registered company with over 400 New England Wire Tech­
employees operating three shifts, five days a week. We develop, nologies specializes in prod-
and manufacture the most technologically advanced wire, cable, uct development, concurrent
and tubing products in the industry. engineering, design for man-
ufacturability, and quick-turn
prototyping. We work with
customer supplied specifica-
tions or performance re-
quirements to design a cus-
tom cable specific for each
application. With our verti-
cally integrated manufactur-
ing capabilities and expertise
in cable design, we are proud
to offer some of the shortest
lead times in the industry.
Our products include custom
Litz wire, miniature, mi-
cro-miniature, single and
multiconductor cables, low-
noise, high temperature, co-
axial, and hybrid cables.
Our subsidiary, New England Tubing Technologies, occupies a
14,000 square foot state-of-the-art facility adjacent to New
England Wire manufacturing. Working directly with clients in
the medical electronics and device industries, as well as with
other custom industrial and commercial projects, we design and
manufacture custom braid or spiral reinforced tubing, lined
catheter shafts, multi-durometer and multi-lumen tubing, hy-
brid tubing configurations, as well as medical braid.

[Link]

58 [Link] Winter 2023 Resource Guide

 Sponsored Content

Teleflex Medical OEM pany looking for a development partner to collaborate with
3750 Annapolis Lane N. from concept development to device delivery or a large com-
Plymouth, MN 55447 pany with the idea but doesn’t have the internal resources to
Phone: 800-474-0178 or 508-964-6080 bring the product to market, Teleflex Medical OEM has the expe-
E-mail: oeminfo@[Link] rience and expertise to get the job done.
[Link]

Products/Services Offered
About Our Company
TELEFLEX MEDICAL OEM is a team of seasoned engineers,
Teleflex Medical OEM is a leader in the medical device devel- material and polymer experts, and skilled technicians that func-
opment and manufacturing space. It’s our vertically integrated tion as an extension of your R&D and operations staff.
capabilities, deep industry expertise, and decades of device de- Capabilities include:
velopment experience that make us our customer’s most-valued • Product concept development
development partner. Partner with us for custom-engineered: • Engineering
• Extrusion • Design for manufacturability
• Micro-diameter tubing • Material selection and formulation
• Diagnostic and interventional catheters • Prototyping, testing, and validation
• Balloons and balloon catheters • Custom tooling
• Medical conductors • Production process development
• Insulated fine wire • Manufacturing
• Coated mandrel wire • Finishing operations
• Sheath/dilator sets • Assembly
• Special sutures and performance fiber materials • Packaging and labeling
• Bioabsorbable sutures, yarns, and resins User-needs driven medical device development is the Teleflex
Medical OEM solution. Our decades-long experience designing
for manufacturability allows us to provide the right solution for
optimal performance.
At EPIC Medtec Centers we:
• Utilize the multi-stage IDEA Medtec® Process incorporating
requirements early in the concept stage
• Apply data-driven decision making utilizing our proprietary
analytic tools
• Develop intelligent device designs and refine for optimal per-
formance
• Focus on design for manufacturability at each stage of device
development
• Determine device viability with quick-turn demonstrative pro-
totypes
• Provide access to in-house laboratories for testing and valida-
tion of device concepts

Target Markets

As one of the leaders in medical device development, we

partner with large and small companies across the globe to help [Link]
deliver their devices to the market. So whether it’s a small com-

Winter 2023 Resource Guide [Link] 59

 Sponsored Content

The Lee Company

2 Pettipaug Road
Westbrook, CT 06498
Phone: 860-399-6281
E-mail: inquiry@[Link]
[Link]

Products include high quality miniature solenoid valves (con-

About Our Company ventional and chemically inert models), high speed micro dis-
pense valves, atomizing and dispense nozzles, fixed and vari-
Since its founding in 1948, The Lee Company has pioneered able volume pumps, micropumps, integrated fluidic manifolds,
the development of miniature fluid control components for au- inert tubing and fluid control components, and custom engi-
tomated fluid handling in medical and scientific instrumenta- neered designs.
tion, analytical/clinical chemistry, and medical disposable appli-
cations. In response to the ever-increasing demands of the
medical and scientific industries, The Lee Company continues to
redefine miniature fluidics by integrating new and more ad-
vanced technology into smaller packages.
The Lee Company employs more than 1100 people at its
Technical Centers in Connecticut, U.S.A., and Cambridge, U.K.
We have built our reputation over many decades as a preferred
supplier to every major Tier 1 and Tier 2 company in the indus-
tries we serve. Our worldwide network of Technical Sales
Engineers is ready to work with you on an engineer-to-engineer
level — helping you find the best components to solve your fluid
control problems.

Target Markets

In vitro diagnostics, scientific instrumentation, drug discov-

ery, and medical equipment such as oxygen delivery, patient
monitoring, dialysis, and compression therapy

Products/Services Offered

The Lee Company’s unique capabilities in miniaturization and

engineering expertise keep the company at the forefront of
fluid flow technology and enable it to work effectively with cus- [Link]
tomers to solve difficult fluid control problems.

60 [Link] Winter 2023 Resource Guide

 Sponsored Content

Zeus
3740 Industrial Blvd. Products/Services Offered
Orangeburg, SC 29118
Phone: 803-268-9500 Our polymer solutions include tubing, heat shrinks, and a
E-mail: support@[Link] range of specialty products such as biomaterials, monofila-
[Link] ments, and many more.
A range of value-add services, including product assembly, drill-
ing, etching, fillers, flaring, flanging, and more, allow customers to
further optimize products to their specific application needs.
About Our Company
Additionally, Zeus services for the medical device industry
extend to contract design and manufacturing, allowing custom-
Zeus is a global leader in advanced polymer solutions, help-
ers a single source for catheter design, rapid prototyping, and
ing customers overcome complex design and engineering chal-
manufacturing. Additional in-house capabilities include laser
lenges since 1966.
cutting, ablation, and welding.
Headquartered in Orangeburg, SC, USA, Zeus employs over
For more than 55 years, customers have depended on our
2,400 people worldwide across its facilities in Aiken, Columbia,
best-in-class quality and technical support, global reach, and
Gaston, and Orangeburg, South Carolina; Branchburg, New
high-volume manufacturing capabilities to gain a critical com-
Jersey; Chattanooga, Tennessee; San Jose, California; Arden
petitive advantage in the market. From concept to commercial-
Hills, Minnesota; Guangzhou, China; and Letterkenny, Ireland.
ization, we are present every step of the way, providing prod-
With our industry-leading expertise in high-performance
ucts, services, and solutions that fuel product innovation.
polymers, we partner with customers to find new ways to
overcome complex design and engineering challenges. We
apply new thinking that challenges the status quo, often
pushing boundaries of what is possible and going beyond
current limitations to deliver breakthrough solutions for our
customers.

NEW — Absorv™ XSE oriented tubing.

NEW — State-of-the-art catheter manufacturing facility in Arden Hills,
Minnesota.

Target Markets

Peripheral vascular, cardiovascular, neurovascular, structural

heart, cardiac rhythm management / electrophysiology, and
endoscopy.

Value-added services.

[Link]

Winter 2023 Resource Guide [Link] 61

 Sponsored Content

Accumold
1711 SE Oralabor Rd. About Our Company
Ankeny, IA 50021
Phone: 515-964-5741 Accumold® has been an expert in micro
E-mail: micromolding@[Link] molding for more than three dec­ ades.
[Link] Our 130,000 sq ft facility is home to our

in-house tooling and production teams.

The company currently operates 155+
molding machines in sev­eral Class 7 and
8 clean room spaces. Accumold is ISO
13485, 9001 and 14001 certified.

Target Markets

• Medical Device
• Micro Optics
• Micro Electronics
• Other Emerging Technologies

Products/Services Offered

Accumold® is a high-tech manufac-

tur­er of precision micro, small and lead
frame injection molded plastic compo-
nents. Utilizing pro­cesses developed from
Accumold’s Micro-Mold® technology, the
company designs, builds and produces
unique molds and parts efficiently for a
wide variety of applications.
Molded components range in size
from 5 cm, with micro features, to parts
that are less than 1 mm in size. These
complex parts often include tight tol-
Your medical cannula can be erances measuring only a few microns.
micro-molded at scale... Processes include: insert molding, clean
room molding, 2-shot molding, and cus-
for less cost. tom automated
manufacturing
cells. Common
materials in-
clude: PEEK,
Ultem, LCP,
and most en-
gineered ther-
moplastics.
Micro Solutions For Big Innovations®

[Link] [Link]

62 [Link] Winter 2023 Resource Guide

 Sponsored Content

Products/Services Offered

Actuonix offers
a complete range
Actuonix Motion Devices of micro linear
Unit 201-1753 Sean Heights ac­tuators, linear
Saanichton, BC, Canada V8M 0B3 ser­ vos and track
Phone: 888-225-9198 ac­tuators to meet
Fax: 206-347-9684 the specifications
E-mail: sales@[Link] of almost any pro­
[Link] ject. Our line of
products features
164 different types
About Our Company of micro linear
ac ­t uators and
Actuonix is a leading manufacturer and innovator in the servos. New models
micro motion marketplace. We strive to offer our clients the are always being developed
most affordable, high-quality micro linear actuators. We pride and added to our lineup. We
ourselves on great service, fast delivery and more models to strive to stock a range of products
choose from than any of our competitors. that will suit any project. We offer
actuators in lengths from 0.4 inches
(10 mm) through to 11.8 inches (300 mm)
with maximum forces of up to 67 lbs
Target Markets
(300 N).
We provide innovative and economical micro motion solutions
for the growing needs of several markets including robotics, [Link]
aerospace, automotive, medical and radio control.

Make your
machine move
MICRO LINEAR ACTUATORS
M
• 10mm-300mm
10mm
1
10m m stroke • 6v-12v power supply
• 25kg+
25kg
5kg+ available force • 15g-100g net weight
kg

[Link]

Winter 2023 Resource Guide [Link] 63

 Sponsored Content

Target Markets

Medical Device, Contract Manufacturing, Machine Builders,

Batteries, Automotive, Aerospace, Electronic Components, and
AMADA WELD TECH General Industrial Manufacturing
1820 S. Myrtle Ave.
Monrovia, CA 91016
Phone: 626-303-5676 Products/Services Offered
E-mail: info@[Link]
[Link] AMADA WELD TECH
is a leading manufac-
turer of equipment
About Our Company and systems for resis-
tance welding, laser
Since 1948, AMADA WELD TECH has worked to achieve one goal: welding, laser mark-
solve our customers’ manufacturing challenges. Knowing there is no ing, laser cutting, laser
one solution that micromachining, her-
fits all, we strive to metic sealing, and hot
provide our medi- bar bonding.
cal device manu- The company also
facturing custom- offers free feasibility
ers with innovative studies, training, and
and reliable manu- applications develop-
facturing technol- ment support.
ogy solutions so
that we may be
their single source [Link]
provider.

SIGMA LS ®

Laser Micromachining Subsystem

s 2EADY TO INTEGRATE s &EMTOSECOND LASERS FOR HIGHEST

s 3ENSITIVE LASER AND OPTICAL COMPONENTS QUALITY AND PRECISION
PRE INSTALLED s -ACHINING OF METALS POLYMERS
s &ULLY OPTIMIZED LASER PROCESS INCLUDED CERAMICS GLASSES

WWWAMADAWELDTECHCOM s (626) 303-5676

64 [Link] Winter 2023 Resource Guide

 Sponsored Content

COMPLEX MIM
PARTS FOR
VARIOUS SURGICAL
Cadence, Inc.
9 Technology Drive
Staunton, VA 24401

APPLICATIONS
United States and Costa Rica
Phone: 540-248-2200
E-mail: sales@[Link]
[Link]

About Our Company

Cadence, Inc. is a full-service contract manufacturing part-

ner for medical device, drug delivery, and diagnostics compa-
nies worldwide. Our services range from initial DFM through
manufacturing and full supply chain management of precision
machined components, value-add sub-assemblies, and fin-
ished devices.

Micro MIM
Complex Geometries
Thin Wall Capabilities
Target Markets Customizable Feedstock
Life Science — Medical, Drug Delivery, and Diagnostics
Debind Versatility

Products/Services Offered High Density

Fro m co n ce p t
through commercial-
ization, Cadence as-
sists its customers
every step of the way Learn More:
– design for manu-
facturing, rapid pro-
totyping, complete
supply chain man-
agement, and pro-
duction of your fin-
ished medical and
drug delivery devices. We offer cleanroom manufacturing and
assembly at our Product Realization CenterTM located just out-
side of Pittsburgh, PA, and at our nearshore facility in Alajuela,
Costa Rica. We are vertically integrated with extensive in-house
metals and plastics manufacturing expertise that includes deep
draw technologies, machining, metal injection molding (MIM),
metal stamping, sharpening/grinding, tube fabrication, preci-
sion laser processing, plastic injection molding, insert molding,
and much more.

[Link]
[Link] 540.248.2200

Winter 2023 Resource Guide [Link] 65

MDB Cadence Ad [Link] 1 11/27/23 10:21 AM

 Sponsored Content

Target Markets

DDL provides testing for the medical device, pharmaceutical,

and consumer products industries.
DDL, Inc.
10200 Valley View Road, Suite 101
Eden Prairie, MN 55344 Products/Services Offered
Phone: 952-941-9226
E-mail: ddlinforequests@[Link] DDL offers pack-
[Link] age testing in its Eden
Prairie, MN; Irvine, CA;
and Edison, NJ loca-
About Our Company tions. Our labs perform
distribution simulation
DDL Inc. is an testing per ASTM D4169
ISO/IEC 17025 as well as the sterile
ac­credited test- barrier system testing
ing lab that pro- for seal strength and
vides packaging, integrity per ISO 11607.
ma­ter­ials, medi- Our laboratories house over 125 continuously monitored en-
cal device, and vironmental chambers providing accelerated aging, real time
container closure aging, stability testing, thermal shock, thermal performance
in­tegrity testing and environmental testing services.
ser­v ices. The Testing of medical devices such as Luer fittings, syringes,
company’s team needles, catheters, guidewires, cannulae and tracheal tubes, is
of en­gineers and done at the Eden Prairie, MN, and Irvine, CA locations.
technical and quality experts is devoted to helping customers
worldwide succeed by taking an independent, involved, and in- [Link]
formed approach to ensuring regulatory compliance.

MEDICAL DEVICE + PHARMA

A Reputation for Extraordinary Packaging,
Product and Materials Testing.
DDL has over 30 years of experience TESTING EXPERTISE
navigating complex testing standards
• Packaging and Materials
and regulations for medical device and
pharma products. Our reliable quality, • Medical Devices
responsive attention, and on-schedule • Combination Products
completion for packaging, product and
• CCIT Testing
PDWHULDOVWHVWLQJVHFXUHFRQÀGHQFHLQ
(GMP Compliant)
performance and safety while achieving
regulatory compliance.

Partner with us and gain a reliable testing expert at your side!

DDL is an ISO 17025 Visit us at [Link] or call us at 1-800-229-4235
accredited laboratory Minnesota | California | New Jersey

66 [Link] Winter 2023 Resource Guide

 Sponsored Content

Target Markets

OmniCure® UV curing solutions are used for a variety of

medical device manufacturing applications including assembly
Excelitas Technologies® Corp. of catheters, blood oxygenators and needles.
Mississauga, ON, Canada L5N 6H7
Phone: 905-821-2600/800-668-8752
E-mail: omnicure@[Link] Products/Services Offered
[Link]
The OmniCure® S2000
Elite is a new generation UV
About Our Company lamp-based spot curing sys-
tem designed for demand-
Excelitas Technologies® Corp., a leading industrial technol- ing manufacturing applica-
ogy manufacturer offers its’ industry recognized OmniCure® UV tions. Offering highest reli-
LED and Lamp-based curing systems. Offering features such as ability and process control
Closed-Loop Feedback, precise irradiance control and wave- for UV curing of adhesives,
length selection, medical device manufacturers can achieve a the S2000 Elite enhances productivity, precision, security, and
controlled and repeatable UV assembly process for improved usability. Proprietary Closed-Loop Feedback and Intelli-lamp®
product yields and maximum reliability. technologies automatically monitor and maintain system opti-
cal output for a highly repeatable curing process. Featuring a
30ms high-speed shutter for precise dose delivery, and user-in-
terchangeable optical filters and lamps for ultimate applications
flexibility. Combining industry-leading precision with advanced
communication technologies and PLC automation capability,
the S2000 Elite tackles the most demanding UV curing applica-
tions in Industry 4.0.

[Link]

Leap into the Future of

UV Spot Curing
The New OmniCure® S2000 Elite UV Curing Solution

Enhanced precision
Industry-leading patented Closed-Loop Feedback
technology, 30ms high-speed shutter, and
irradiance calibration for high precision curing.

Refined usability
Innovative UI with easy access to all system
functions through the touch screen or
physical control panel.

Next-level control
Advanced communication
features to meet changing
demands of Industry 4.0.

[Link]

2023_11
Winter MedResource
2023 Design Briefs half pg_FINAL.indd
Guide 1 [Link] 11/2/23 4:16 PM
67
 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,
3002 Dow Avenue, Suite 216 Structural Heart, EP.
Tustin, CA 92780 Non-medical inquiries welcome.
Phone: 949-756-8252
Fax: 949-756-8165
E-mail: davidz@[Link] Products/Services Offered
[Link]
• Cable Tube OD 0.008 ~ 0.1539”
• Flat Wire Torque Coils and
About Our Company Flexible Shafts to 6 mm
• PTFE SPC MANDRELS from
Filmecc USA, Inc. is 0.45 mm to 2.30 mm. PTFE wall
a leading global medi- thickness (one side can range
cal device manufac- from 0.008 mm to 0.012 mm)
turer [CDMO/CMO] • OEM/ODM Guidewire: Guidewire, Diagnostic catheter, PTCA
and serves its cus- guiding catheter, PTCA balloon catheter, etc
tomers by providing a • Stainless Steel Cables and Assemblies: 0.002” to 3 mm ~ 4 mm.
broad range of solu- • Miniature Coil: round wire OD from .0039”, flat wire OD from .0055”
tions. We specialize in • Torque Transmission Wire: 1x3, 1x7, 1x19 OD from .012” to 0.078”
ODM/OEM solutions, • Torque Transmission Coil: OD from 0.012” to 0.1563”, 2–3 lay-
high-performance components, assemblies, finished devices, ers rotational fidelity/motor, NURD
delivery systems for minimally invasive therapies. Drawing from • Variable Durometer Tubes
our vast experience in the medical device field, our in-house wire
drawing, wire-forming, coating, torque and assembly technolo-
[Link]
gies provide a broad range of options for your device.

Asahi_2023_MDB_printer.pdf 1 7/12/2023 [Link] PM

Best in Class, High Performing Components for Your Medical Devices

Drawing from our IN-DEPTH EXPERIENCE in the medical device field, our in-house wiredrawing, wire-forming,
coating, torque and assembly technologies provide a BROAD RANGE of OPTIONS for your device.
C

Product Design & Development / Contract Manufacturing of Finished Devices CDMO / CMO Services
M
ISO 13485 • 9001
Minimally Invasive
Y Device Solutions
CM
Co-development Opportunities
MY Access, Delivery, & Retrieval Systems
Wire & Catheter Based Devices
CY

CABLES CABLE TUBES

TU COILS MACHINING & PTFE LINERS TUBING & Contract Manufacturing
ASSEMBLY + COATINGS BRAIDING
CMY
Vascular Access Devices
K Guidewires, Therapeutic & Diagnostic
Braided & Coiled Catheter Shafts
Class 8 Clean Room

Filmecc USA,
S Inc. | 3002 Dow Avenue, Suite 216 | Tustin, CA 92780 | Phone: 949.756.8252 | [Link]

68 [Link] Winter 2023 Resource Guide

 Sponsored Content

We’ve got
a wire
Fort Wayne Metals
9609 Ardmore Ave.
Fort Wayne, IN 46809
Phone: 260-747-4154

for that.
Fax: 260-747-0398
E-mail: info@[Link]
[Link]

About Our Company

Fort Wayne Metals

is a leading manufac-
turer of precision
bar, wire, and wire- custom
based components
used in medical de-
mechanical
vices and other criti- assemblies
cal applications. We
routinely work with
stainless steel, super
alloys, commercially pure titanium and titanium alloys, precision
Nitinol, and a range of high-performance alloys.
coatings
and laser
Target Markets ablation
• Cardiac rhythm management
• Endoscopy
• Dental implants
• Orthodontic
• Orthopaedics shape set
• Neurostimulation
• Vascular therapy
Nitinol
parts
Products/Services Offered

Our portfolio of services in-

cludes extrusion coating, laser
ablation, a variety of cleaning
processes, as well as custom
assembly based on customer
designs. When quality matters, look to Fort Wayne Metals
We also offer laboratory ser-
for the world-class, wire-based solutions you need –
vices in our state-of-the-art test-
ing facility, utilizing the most ad- no matter what you need them for.
vanced instrumentation for mate-
rial characterization and develop-
ment. Our Materials Testing 260.747.4154 · info@[Link] · [Link]
Laboratory has been awarded ISO/IEC 17025 accreditation in
both chemical and mechanical testing fields by the American
Association for Laboratory Accreditation (A2LA) and offers a
wide range of services including metallurgy, interstitial gas anal-
ysis, differential scanning calorimetry, corrosion testing, and
mechanical and fatigue testing.

[Link]

Winter 2023 Resource Guide [Link] 69

 Sponsored Content

Target Markets

Drug Delivery Devices and Containers, Medical Consumables,

Medical Packaging, Cardiovascular and Interventional Devices,
Biomaterials, Orthopedic Implants, Dental Implants

Instron®
825 University Avenue Products/Services Offered
Norwood, MA 02062
Phone: 800-877-6674 Instron offers a wide range
E-mail: web@[Link] of testing systems to evalu-
[Link] ate the mechanical proper-
ties of medical devices using
tensile, compression, flexural,
About Our Company fatigue, impact, torsional,
and multi-axis loading. Our
A global leader in the systems can be adapted to an
materials testing industry, extensive scope of applica-
Instron manufactures me- tions through our selection of grips and fixtures designed to
chanical testing systems accommodate the most common devices and meet the most
designed to meet the frequently used ASTM and ISO standards. Instron’s Engineered
needs of the biomedical Solutions Group is also available to develop solutions specific to
industry for performing novel applications within the biomedical space. Instron can sup-
static, fatigue, and impact port the full product development pathway, offering flexible
testing on medical devices, components, and raw materials. As an solutions for R&D and fully automated solutions for production
integral part of our customers’ testing programs, Instron offers or quality environments.
turnkey solutions providing localized service and support, IQ/OQ
documentation, performance verification, system installation and [Link]
calibration, training, and preventative maintenance.

OPTIMIZE YOUR
BIOMEDICAL
DEVICE TESTING
Learn how you can
optimize the repeatability,
efficiency, and safety of
drug delivery device
testing with automation.

SCAN THE QR CODE

TO LEARN MORE

70 [Link] Winter 2023 Resource Guide

 Sponsored Content

maxon closely with you to develop innovative with us on your next project. We have the
125 Dever Dr. product solutions that precisely meet the experience and industry-specific solutions
Taunton, MA 02780 unique operating parameters of your indi- that will get your product to market faster.
Phone: 508-677-0520 vidual system in your industry. But, did
E-mail: [Link]@[Link] you know that we also offer contract man- [Link]
[Link] ufacturing services? Consider partnering

About Our Company

maxon develops and builds high preci-

sion electric drive systems that are among
the best in the world. Specialists in com-
bining electric motors, gears and DC motor
controls into high-precision, intelligent
drive systems that can be custom-made to
fit the specific needs of customer applica-
tions. maxon helps provide innovative
solutions at competitive prices for numer-
ous applications in various markets.

Target Markets

Medical, Industrial Automation,

Aerospace, and e-Mobility

Products/Services Offered

Offering solutions that fit your cus-

tomized needs
maxon’s line of products include DC
brushed and brushless motors, gear-
heads, encoders and controllers — these
products are easily combined into com-
plete mechatronic drive systems. As a
global leader in the design, manufactur-
ing, and engineering services of high
precision drive systems, maxon works

Winter 2023 Resource Guide [Link] 71

 Sponsored Content

mdi Consultants, Inc. years of industry, government, and con-

55 Northern Blvd., Suite 200 About Our Company sulting experience, which we use to as-
Great Neck, NY 11021 sist med­ical device, pharmaceutical, bio­
Phone: 516-482-9001 mdi Consultants is a leader in providing tech­nology, and food companies achieve
Fax: 516-482-0186 consulting services to the healthcare in- compliance with U.S., European, and
E-Mail: info@[Link] dustry worldwide. Our staff has over 200 Canadian regulations.
[Link]

Dr. Anand Akerkar Alan Schwartz

Target Markets

Medical Device Companies, Pharma­

ceutical Companies, Biotechnology
Com­
­ panies, Food Companies, Tobacco
­Com­panies.

Products/Services Offered

mdi Consultants offers a full range of

services focused on assisting compa-
nies across the globe achieve regula-
tory and standard compliance with U.S.,
European, and Canadian agencies and
organizations. Our services include
FDA Com­ pliance services (Regulatory
Strategy Development, Clinical Trial
Development/Management, cGMP com­
pliance, on-site audits, validation (pro-
cess, software, and sterilization)
and 510(k)/PMA/ANDA/NDA submis­
sion services), FDA troubleshooting
ser­v ices, 483 & Warn­ing Letter Re­
sponse services, MDSAP Assis­t ance,
Quality Sys­­t em Com­p li­a nce ser-
vices, CE Mark consulting, ISO Comp­
liance (ISO 9000:2000, ISO 14000,
ISO 13485:2016), Regulatory Con­
sulting, U.S. Agent Services, Auth­
orized Agent Services, Import Agent
Services, Electronic Drug Listing and
Registration, and Health Canada
­Com­p liance.

[Link]

72 [Link] Winter 2023 Resource Guide

 Sponsored Content

Products/Services Offered

Medical Extrusion Technologies offer s full range of consulta-

tion services from material selection to tooling development.
Technical Services:
• Processing technology
Medical Extrusion Technologies • In-house tool design and fabrication
26608 Pierce Circle • Responsive customer service
Murrieta, CA 92562 Common materials:
Phone: 800-618-4346 • Nylons
E-mail: info@[Link] • Polypropylene
[Link] • Polycarbonate
• Polyurethane
• FEP, PFA, ETFE, EFEP
About Our Company • PEEK
• Custom compounds
Medical Extrusion Technologies manufactures custom tubing Extrusion Capabilities:
extrusions to your specification. We produce close tolerance • Single-lumen extrusion
profiles in single and multi-lumen geometries. For over 30 • Multi-lumen extrusion
years, Medical Extrusion Technologies has developed a global • Co-extrusion
reputation for high quality extrusions to meet your most chal- • Tri-extrusion
lenging designs. • Bump tubing
• Profile extrusion
• Ribbon extrusion
Target Markets
[Link]
Medical device

Winter 2023 Resource Guide

MDB Medical Extrusion Technologies Ad [Link] 1
[Link] 73
1/9/23 10:19 AM
 Sponsored Content

MICRO highest qual-

140 Belmont Drive About Our Company ity products
Somerset, NJ 08873 to customers
Phone: 732-302-0800 Established in 1945, MICRO is a contract in the medical
E-mail: sales@[Link] manufacturer that draws on 75 years of device market-
[Link] manufacturing expertise to deliver the place. A truly
global com-
pany, we manufacture and distribute our
products to customers around the world.

Target Markets

• General Surgery

Expanding production capacity • Orthopedics

• Cardiology
To meet your medical device needs • Urology
• Women’s Health
• Diabetes Management
For over 75 years, MICRO has continually
expanded our capabilities in order to provide
Products/Services Offered
our customers with the finest in full service
Medical Device contract manufacturing.

The latest addition to our global footprint

is a newly facilitated 32,000 sq. ft. location
in Costa Rica featuring clean room
assembly and light manufacturing.
This facility, located in the Zona Franca
Metro Business Park, achieved ISO
13485:2016 certification for its Medical Full-service contract manufacturer of
Device Quality Management System in medical devices and subassemblies — in-
cluding injection/insert molding, MIMs,
October of 2022.
and fabricated tube assemblies. We offer
pro­duct development and design assis-
This recently added piece of the puzzle will tance — from prototyping and validation
continue to allow us to fulfill our Vision: to full-scale production.
Our modern facilities in New Jersey
"To Help Our Customers Save Lives" are cGMP-QSR compliant and ISO-9001,
ISO-13485, and ISO-14001 certified.
Staffed by highly trained individuals, we
maintain an ISO Class 8 environmentally
controlled cleanroom for surgical instru-
ment assembly.
MICRO’s Costa Rica location
achieved ISO 13485:2016 Certification
for its Medical Device Quality Man­
agement System in October of 2022.
The 32,000 sq. ft. facility located in
the Zona Franca Metro Business Park
features clean room assembly and
light manufacturing.

Contact us today to discuss your next project: sales@[Link]

FDA Registered • ISO 13485 • ISO 9001 • ISO 14001 [Link]
MICRO 140 Belmont Drive, Somerset, NJ 08873 USA • Tel: 732 302 0800 • [Link]

74 [Link] Winter 2023 Resource Guide

MSC-3161-
SC-3161- Micro print ad 4.5x7.25 [Link] 1 1/13/23 1:49 PM
 Sponsored Content

Target Markets

Specializing in Cardiovascular, Neurovascular, Urology,

Peripheral Vascular, and Electrophysiology
MicroLumen
One MicroLumen Way
Oldsmar, FL 34677 Products/Services Offered
Phone: 813-886-1200
E-mail: sales@[Link] MicroLumen manufactures High-Performance Medical Tubing
[Link] and custom tubing for critical applications and minimally invasive
medical devices. Polyimide is a thermoset plastic and has excellent
mechanical, thermal, and chemical properties. Typical applications
About Our Company include cardiovascular & urological catheters, stent deployment,
and drug delivery systems. ID ranges = 0.10 mm to 2.11 mm with
MicroLumen® various wall profiles. Ultrathin PTFE liners are available for reduced
is the interna- surface friction and can be delivered on a mandrel. Braid and coil
tional leader in the reinforced designs are available for added flexibility, torque, and
manufacture of column strength. Pebax and Tecoflex jackets are available, as well
High-Performance as flexible tips, marker bands, value added sub-assembly, and cus-
Medical Tubing tom laser machining. ISO 13485:2016 certified & USP Class VI.
for critical OEM
applications and
minimally invasive
devices for over
35 years. Our en-
gineering team provides a partnership offering innovative solu-
tions in the design of very specialized medical devices. Our tubing [Link]
has excellent mechanical, thermal and chemical properties.

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Winter 2023 Resource Guide [Link] 75

 Sponsored Content

Products/Services Offered

Technical Services:
• Skillful proprietary processing
Microspec Corporation • In-house tool design and fabrication
327 Jaffrey Road • Exceptional customer service
Peterborough, NH 03458 • Product validation services
Phone: 603-924-4300 • Raw material and product testing
Fax: 603-924-4310 • Annealing services
E-mail: info@[Link]
[Link] Most Thermoplastic Elastomers Extruded:
• Polyurethanes •F
 luoropolymers: FEP, EFEP,
• Nylons and PFA
About Our Company • High Heat Polymers: PEEK, •B
 ioabsorbable resins
Polysulfone and PEI •C
 ustom formulations
For 30 years, medical
device companies the Extrusion Capabilities:
world over have turned • New Concepts • Over-Extrusions
to Microspec for medical • Single-lumen Extrusions • Fully-Encapsulated Stripes
tubing that challenges • Multi-lumen Tubing • Coated Wire
the limits of extrusion • Bump Tubing • Profile Extrusions
technology. From con- • Co- and Tri-Extrusions • Balloon Tubing
cept to commercializa- • Multi-Durometer Extrusions • Ribbon Extrusions
tion, Microspec has built a global reputation for extruding some • Multi-layered Extrusions
of the smallest, most complex, and tightest toleranced medical • Micro-Extrusions
parts in the industry.
Microspec’s mission is to supply innovative extrusion technol-
ogy to the technologically advancing and changing medical de- [Link]
vice market and to deliver high quality parts on time.

medical extrusions
customized excellence

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Redefining the limits of extrusion technology...

For over 30 years, Microspec has specialized in advanced medical extrusion services world wide,
extruding most thermoplastic elastomers, including fluoropolymers, engineering resins, and custom compounds.
The precision medical parts we extrude are among the smallest and most complex in the industry,
with some of the tightest tolerances. Contact Microspec with your extrusion challenge – We’ll turn it into reality.

Microspec Corporation
327 Jaffrey Rd. ࠮ Peterborough, NH 03458 <:(࠮࠮924࠮4300 ࠮ info@[Link]
[Link]

76 [Link] Winter 2023 Resource Guide

 Sponsored Content

Target Markets

Defense, Aerospace, Medical, Petroleum, Industrial

Omnetics Connector Corporation

8840 Evergreen Blvd. Products/Services Offered
Minneapolis, MN 55433
Phone: 763-572-0656 Omnetics Connector Corporation has a long history working
E-mail: sales@[Link] with medical applications. We can use this experience to help
[Link] guide you through
the design phase.
Our Manufacturing
About Our Company department is set up
to build samples and
For more than prototypes for initial
30 years, Omnetics test, biocompatibility,
has engineered an and FDA approval. We
extensive portfolio also have the expe-
of innovative prod- rience and capacity
ucts, with a special to support high volume production runs. Omnetics has years
focus on micro and of experience working with many medical grade materials. We
nano-miniature in- have an excellent understanding of the requirements unique
terconnects. Our con­ to the medical industry. We operate a class 10,000 clean room
nectors are a­ mong system as an added value service. Let our experience help you
the smallest on with your application.
the market and deliver exceptional performance in challenging
work environments. As interconnect technologies continue to
evolve, we design next-generation products that help bring [Link]
transformative ideas to life.

When a life is on the line, every second

is crucial, just like every connection.

VISIT [Link] CALL US AT 763-572-0656

Winter 2023 Resource Guide [Link] 77

 Sponsored Content

Target Markets

Medical device engineers, engineering management, product

designers, manufacturing engineers, contract manufacturers/
Qosina kitting personnel, and purchasing personnel in the medical de-
2002-Q Orville Drive North vice and bioprocess industry.
Ronkonkoma, NY 11779
Phone: 631-242-3000
E-mail: info@[Link] Products/Services Offered
[Link]
Qosina helps medical device
engineers get their products
to market faster and more effi-
About Our Company
ciently by offering free samples
of our products; downloadable 3D
Qosina is a
CAD models and technical prod-
leading global
uct documentation; modification
supplier and one-
of existing molds; and new prod-
stop source of
uct design and development.
more than 5,000
Our mission is to provide the
OEM off-the-shelf
best customer experience possible by helping our customers find,
components to
order and receive quality medical components quickly and accu-
medical device
rately. We provide practical solutions to meet the changing needs
and pharmaceu-
of today’s engineers through innovation, technology and continu-
tical manufactur-
ous improvement. If an item is not a stock product in our inventory,
ers. We offer free
we will work to develop the part to your exact specifications.
samples, low min-
imums on orders
and bill of material kitting, all supported by regulatory documen- [Link]
tation and backed by Qosina’s assurance of supply.

Your first source.

Your second source.
The only source you need.
Partner with Qosina and let us help you find
the most suitable component for your project.
We offer many options of similar products to meet
your required specifications. We also provide
downloadable documentation and complimentary
samples for testing and evaluation.

Log on to [Link] today to see our full product offering.

Qosina Corp.: Qosina Europe:

[Link] +1 631 242-3000 info@[Link] [Link]/qosina-europe +39 02 66401337 info@[Link]

78 [Link] Winter 2023 Resource Guide

 Sponsored Content

Specialty Coating Systems barrier properties and play a critical including circuit boards, MEMS, sen-
7645 Woodland Drive role in protecting numerous compo- sors, LEDs, semiconductors and more.
Indianapolis, IN 46278 nents and applications throughout the
Phone: 317-244-1200 medical device, electronics, aerospace,
[Link]
E-mail: SCSsales@[Link] defense and automotive industries,
[Link]

About Our Company

Specialty Coating Systems is a leader

in Parylene, liquid, plasma, ALD and
multilayer coating services and tech-
nologies with more than 50 years of
experience and 21 worldwide locations,
including 9 in the Americas, 5 in Europe
and 7 in Asia.

Target Markets

Medical device, electronics, aerospace,

defense, consumer electronics and
automotive

Products/Services Offered

SCS is a direct descendant of the

companies that originally developed
Parylene and employs some of the
world’s foremost coating specialists,
highly experienced sales engineers
and expert manufacturing personnel.
SCS combines its worldwide resources
and expertise to provide customers
with high-quality coating services and
materials that enable their applica-
tions to succeed.
SCS conformal coatings offer excel-
lent moisture, chemical and dielectric

Winter 2023 Resource Guide [Link] 79

MDB Specialty Coating Systems Ad [Link] 1 11/3/23 10:26 AM

 Sponsored Content

Target Markets

Medical Devices, OEM, Battery, Automotive, Business

Electronics, Home Appliances, Robotics, Packaging, Nonwovens
Branson
120 Park Ridge Road
Brookfield, CT 06804 Product/Services Offered
Phone: A mericas 203-796-0400
Europe +49-6074-497-0 Emerson leads the weld-
Asia +86-21-3781-0588 ing and assembly-­
E-mail: [Link]@[Link] technology market for
[Link]/Medical medical device manufac-
turing by offering the ad-
vanced technology of
About Our Company Branson™ material joining
and precision cleaning
Emerson leads the solutions for healthcare,
medical global as- life sciences and chemical laboratory applications. The breadth of
sembly technology our expertise allows for a process-neutral approach to application
market offering the development, resulting in advantages in product development and
Branson brand of ad- the delivery of robust manufacturing solutions. Our Branson port-
vanced material join- folio offers an extensive array of assembly and joining technolo-
ing and precision gies, including ultrasonic welding, laser welding, PulseStaking and
cleaning sys­tems. precision cleaning equipment. Through the support of global ap-
Customers re­ceive plication engineers and our applications lab, Emerson continues
the most ro­ bust manufacturing solution to address product to introduce Branson plastics joining innovations.
specifications, regulatory, budgetary needs, while providing
competitive advantages in application development and prod- [Link]/Medical
uct design for benchtop or automated processes.

Target Markets

Halkey-Roberts supplies medical OEMs and contract manu-

facturers worldwide. Our components are used in critical appli-
Halkey-Roberts Corporation cations such as cardiovascular, urology, oncology, anesthesia,
2700 Halkey-Roberts Place North respiratory, IV/drug delivery, and surgical devices. Our products
St. Petersburg, FL 33716 are also used in a number of biotech applications.
Phone: 727-471-4200
Fax: 727-578-0450
E-mail: sales@[Link] Products/Services Offered
[Link]
Halkey-Roberts is a global leader in the design and manufac-
ture of valves for medical device companies whose products
About Our Company require precise delivery of fluids and gases. We supply global
medical device companies with off the shelf and custom solu-
Halkey-Roberts manu- tions for their fluid and gas delivery applications. Since 1941, we
factures plastic compo- have been offering innovative solutions like our new Male Luer
nents and subassemblies Valves. Our vertically integrated facility in St. Petersburg,
used in disposable medical Florida, allows us to control the entire development and manu-
devices, including flow de- facturing process of our products: from design, tooling, mold-
vices, medical valves, ing, high speed automation, regulatory support, and product
needle-­free valves, cath­ release. We offer extensive capabilities to customize our prod-
eter and tracheal tube ucts to your specific application.
valves, tubing clamps, clo-
sures, and hand pumps.
Halkey-Roberts is ISO 9001 and ISO 13485 certified and man- [Link]
ufactures to the standards of GMP.

80 [Link] Winter 2023 Resource Guide

 Sponsored Content

every test matters and requires solutions to complex problems

to improve patient outcomes and minimize client risk.

Products/Services Offered

Research & Development • Chemical Characterization

Nelson Laboratories, LLC
• Process Validation • Toxicological Assessments
6280 South Redwood Rd.
• Material Assessment Product Validation
Salt Lake City, UT 84123
Sterilization Validation • Cleaning
Phone: 801-290-7500
• Radiation • Disinfection
E-mail: sales@[Link]
• Ethylene Oxide • Barrier Tests
[Link]
• Steam • Physical Tests
• VHP • Environmental
• STERRAD • Microbiologic
About Our Company • Filtration Lot Release (QC Tests)
Packaging Validation ISO • Bioburden
Nelson Labs is over 500 scientists, technicians and service 11607 • Sterility
specialists diligently performing more than 800 rigorous tests • Stability • Particulates
in 14 global laboratory locations. With decades of foremost • Distribution • Bacterial Endotoxin
scientific expertise, we stand behind the quality of our results • Container Closure • EO Residuals
and the strength of our customer partnerships. • Physical • BI Sterility
Safeguarding Global Health® – with every test we complete. • Aging
• Microbial
Biocompatibility ISO 10993
Target Markets • In Vitro and In Vivo

Nelson Labs performs over 800 rigorous microbiological and

analytical laboratory tests across the medical device, pharma- [Link]
ceutical, protective barriers, and tissue industries. We know that

Target Markets

• Medical Electronics
• Aerospace & Defense
Statek Corporation • Industrial
512 N. Main Street
Orange, CA 92868
Phone: 714-639-7810 Products/Services Offered
Fax: 714-997-1256
E-mail: sales@[Link] Product features:
[Link] • Ultra-miniature & low-profile • Helium impermeable
• Excellent long-term aging • High accuracy & stability
• Low power consumption • Fast start-up
About Our Company • Full medical high-reliability • Full product traceability
testing & screening
In 1970, Statek Corporation was the first to use semiconduc-
tor technology such as photolithography, chemical etching, and • CX16, SMT crystal, available form 32.0 kHz to 100 MHz, in 2.0
micro­ machining to manufacture quartz resonators in wafer mm × 1.2 mm footprint.
form. Today, Statek remains at the forefront of innovation in the de- • CX18, SMT crystal, available from 30 MHz to 100 MHz, in a 1.6
sign, de­vel­op­ mm × 1.0 mm footprint.
ment and man­ • CXOU, SMT crystal oscillator, available from 32.768 kHz to 100
ufacturing of kHz, in a 2.0 mm × 1.2 mm footprint
high­ly reliable,
ultra-mini­ature Statek’s products are used in all classes of FDA approved medical
quartz-based devices in both implantable and non-implantable applications.
frequency con-
trol products.
[Link]

Winter 2023 Resource Guide [Link] 81

 ADVERTISERS INDEX
Advertiser Page Web

Publisher............................................................................................................................Joseph T. Pramberger Accumold........................................ 62...................................... [Link]

Associate Publisher............................................................................................................................. Helene Beck
Actuonix Motion Devices................... 63......................................... [Link]
(908) 300-2538
Sales Director................................................................................................................................. Desiree Stygar AMADA WELD TECH....................... 64...............................[Link]
(908) 300-2539
B. Braun Medical Inc........................ 11, 49...........................[Link]
Editor & Director of Medical Content..................................................................................... Sherrie Trigg
Production Manager................................................................................................................. Adam Santiago Cadence, Inc................................... 65..................................... [Link]
Production Coordinator..........................................................................................................James Rodriguez DDL, Inc......................................... 66....................................... [Link]
Creative Director................................................................................................................................Lois Erlacher
Emerson......................................... 13, 80.......................[Link]/medical
Graphic Designer.......................................................................................................................... John McCarthy
Marketing Director......................................................................................................................Kaitlyn Sommer Eurofins Medical Device Testing......... Cover 2, 50....... [Link]/medical-device
Senior Marketing Coordinator..............................................................................................................Sam Mills
Excelitas Technologies® Corp.............. 67.........................................[Link]
Marketing/Event Coordinator ..................................................................................................Chris Kendrick
Filmecc USA, Inc.............................. 68.......................................[Link]
Audience Development Director............................................................................... Christine Oldenbrook
Audience Development/Circulation Assistant...................................................................... Erykah Davis Flexan............................................. 5, 51.........................................[Link]
Subscription Changes/Cancellations........................................................................MDB@[Link]
Formacoat...................................... 7, 52.................................. [Link]
(866) 354-1125
Fort Wayne Metals.......................... 69........................................ [Link]

SAE MEDIA GROUP® Halkey-Roberts Corporation.............. 2, 80..............................[Link]

261 Fifth Avenue, Suite 1901, New York, NY 10016 Hobson & Motzer............................. 21, 53........................... [Link]
(212) 490-3999
Instron............................................ 70................................... [Link]
Executive Vice President........................................................................................................Luke Schnirring
Technology Director......................................................................................................................Oliver Rockwell Interpower®..................................... 54, Cover 4.........................[Link]
Director of Digital Products................................................................................................................Howard Ng
Keystone Electronics Corp................ 17, 55.....................................[Link]
Digital Media Associate............................................................................................................ Md Jaliluzzaman
KNF Neuberger, Inc.......................... 1, 56.............................................[Link]
Digital Production Associate........................................................................................... Andrew Greenberg
Digital Production Associate..........................................................................................................Symba Wong Master Bond Inc.............................. 23, 29..............................[Link]
Digital Production Assistant............................................................................................. Rowena Pagarigan
maxon............................................ 71....................................[Link]
Digital Production Assistant................................................................................................................Zita Zhang
Budget & Forecasting...................................................................................................................... Felecia Lahey
mdi Consultants, Inc........................ 72............................... [Link]
Accounting/Human Resources Manager............................................................................... Sylvia Bonilla Medbio, LLC.................................... 33, 57..................................[Link]
A/R Clerk............................................................................................................................................... Crystal Ortiz
Medical Extrusion Technologies Inc...... 73............................... [Link]
Office Manager.............................................................................................................................Alfredo Vasquez
Credit/Collection Manager.........................................................................................................Stacie Pointek MICRO........................................... 74........................................ [Link]

MicroLumen Inc............................... 75.................................... [Link]

MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES
Microspec Corporation..................... 76........................[Link]
CT, WI, Europe ...................................................................................................................................... Helene Beck
Nelson Laboratories, LLC.................. 81...................................... [Link]
(908) 300-2538
IN, MI, Europe.................................................................................................................................. Desiree Stygar New England Wire Technologies......... 58, Cover 3................. [Link]
(908) 300-2539
MA, NH, ME, VT, RI, Eastern Canada............................................................................................. Brian Hines Omnetics Connector Corporation....... 77........................................ [Link]
(647) 296-5014
Qosina............................................ 78............................................[Link]
NJ, PA, DE...............................................................................................................................................John Murray
(973) 409-4685 Solenoid Solutions, Inc...................... 35......................... [Link]
TX, OK, LA, AR, MS, AL, TN, FL, SC, NC, GA, DC, WV, VA................................................... Ray Tompkins
(281) 313-1004 Specialty Coating Systems, Inc.......... 79.................................... [Link]
NY, OH...................................................................................................................................................Ryan Beckman
Statek Corporation........................... 4, 81........................................ [Link]
(973) 409-4687
MN, ND, SD, IL, KY, MO, KS, IA, NE, Central Canada.................................................................Bob Casey Teleflex Medical OEM........................ 3, 59...................... [Link]
(847) 223-5225
CA, WA, OR, AZ, NM, Rocky Mountain States..........................................................................Tim Powers The Lee Company............................ 9, 60..................................... [Link]
(908) 892-2838
Zeus, Inc......................................... Cover Flap, 61..........................[Link]
Integrated Media Consultants..................................................................................................Patrick Harvey
(973) 409-4686
Rick Rosenberg Medical Design Briefs, ISSN# 2158-561X, USPS 4865, copyright ©2023 in U.S., is pub-
(973) 545-2565 lished 11 times a year by SAE Media Group, 261 Fifth Avenue, Ste. 1901, New York,
Todd Holtz NY 10016. The copyright information does not include the (U.S. rights to) individual
(973) 545-2566 tech briefs that are supplied by NASA. Editorial, sales, production, and circulation
Jason Setti offices are located at 261 Fifth Avenue, Suite 1901, New York, NY 10016. Subscriptions
(973) 874-0271 for non-qualified subscribers in the U.S. and Puerto Rico, $100.00 for 1 year. Single
copies $30.00 each. Foreign Subscriptions 1 year U.S. funds $195.00. Digital copies:
Daniel Barrett
$60.00. Remit by check, draft, postal, express orders or VISA, MasterCard or American
(973) 409-4762
Express. Other remittances at sender’s risk. Address all communications for subscrip-
tions or circulation to SAE Media Group, 261 Fifth Avenue, Suite 1901, New York,
NY 10016. Periodicals postage paid at New York, NY and additional mailing offices.
POSTMASTER: Send address changes and cancellations to Medical Design Briefs,
P.O. Box 3525, Northbrook, Il 60062.
December 2023, Volume 13, Number 12.

82 [Link] Medical Design Briefs, December 2023

 Since 1898, we have partnered with the most
innovative companies in the world to solve
complex challenges and advance technology.

Our legacy of decades of expertise and

unrivaled reliability makes us the industry
leader in custom wire and cable solutions.

Manufacturing Custom Wire & Cable Solutions Since 1898

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