Medical Design Briefs June 2021

www.medicaldesignbriefs.
com June 2021
Welcome to Wearables:
Next-Generation
Diagnostics
your Digital Edition of

Medical Design Briefs
June 2021
Evaluating Chemical
Resistance of Copolymers 2021 Resource Guide
and Directory
Adapting Additive page 35
Manufacturing for Medical Outsourcing: Transitioning

from Aerospace to Medical
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www.medicaldesignbriefs.com June 2021
Wearables:
Next-Generation
Diagnostics

Evaluating Chemical
and Directory

www.medicaldesignbriefs.com June 2021
Wearables:
Next-Generation
Diagnostics
Evaluating Chemical
and Directory

2
Conceptual rendering of the
multi-jointed robotic arm of a
surgical system.
Giving robots
QTA143
1 Micro Reaction Torque Sensor
a sense of touch
Dimensions: 14 mm × 10 mm × 26 mm
Provides closed-loop feedback on torque measurement.
FUTEK's miniaturized sensor technology LSB205

2 Miniature S-Beam Jr. Load Cell
allows surgeons to perform as if they had
Dimensions: 19 mm × 18 mm × 6.6 mm
virtual fingertips. The sensors’ precise Provides critical force feedback.
measurement and feedback allow the

machine to emulate the dexterity and
QLA401
haptics of human hands. 3 Load Cell Built for Autoclave
Dimensions: Ø 14 mm × 3.28 mm
go.futek.com/medtech Designed to withstand the autoclave sterilization process.
QLA414
4 Nano Force Sensor
Dimensions: 4mm × 5mm
ANSI ISO ISO ISO Enables direct measurement that eliminates any drift
Z540-1 17025 9001 13485 U.S. Manufacturer in the output.

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June 2021
MINIATURE Solenoid-Operated
Pinch & PTFE Isolation Valves
1 Published by SAE Media Group
COLUMN
6 From the Editor
1 Pinch & Media Isolation Valves FEATURES

8 Impact-Modified Acrylic Copolymers: Evaluating Chemical
2 2 Pneumatic Pinch Valves Resistance
14 Next-Gen POC Diagnostics: Electronic Measurement
3 NEW! Electronic Proportional Technology Driven by Global Demand for COVID-19 Testing
Pressure & Flow Controls
32 AM: Quickly Adapting in Tandem with Medical Innovation
4 NEW! ”Eclipse” Proportional
TECH BRIEFS
Isolation Valves
22 Cohesive Circuit Protection for Wearable Electronics
5 “DR-2” Miniature Precision 24 Tiny Wireless Implant Detects Oxygen Deep Within the
Regulators Body
26 Tiny Implantable Tool for Light-Sheet Imaging of Brain
3 6 Electronic Valves Ideal for Oxygen Activity
Applications 28 E-health Patches Monitor Pulse and Blood Pressure
30 Surgical Sutures Inspired by Human Tendons
30 Exosome-Coated Stent Heals Vascular Injury, Repairs
Damaged Tissue

DEPARTMENTS
20 R&D Roundup
34 Global Innovations
More Precision Control Solutions 97 New Products & Services
100 Advertisers Index
■ SPECIAL SUPPLEMENT
4 5 35–96 2021 Resource Guide
36 Coping with the Pandemic: Transitioning from Aerospace
psi!
bility of ±0.15 to Medical
Repeata
40 Directory of Products and Services
ON THE COVER

The in vitro diagnostic home point-of-care (POC)
product landscape will look very different over the
coming years as new products to detect the COVID-
19 virus are launched. These new IVD products will
use the latest in sensor technologies, ultra low
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cessing, and they will be highly portable, including
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tions. They will also harness the enormous comput-
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4 Free Info at http://info.hotims.com/79414-788 Medical Design Briefs, June 2021

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applications where performance and reliability are paramount.
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8 6 0 - 3 9 9 - 6 2 8 1 | 1 - 8 0 0 - L E E - P L U G | w w w. t h e l e e c o . c o m
W E S T B R O O K • L O N D O N • P A R I S • F R A N K F U R T • M I L A N • S T O C K H O L M
M c e n e F 2 . d
n
i d l i r s B 2 n 1
FROM
THE EDITOR
New Innovative Technologies One such innovative company, for in funding. BlowFISH has now successful-
Continue to Emerge in the Fight example, is Medivolve, which seeks out ly cleared the first milestone in a series of
Against COVID-19 disruptive technologies and exclusive clinical tests targeting application of an
partnerships to develop technologies to Emergency Use Authorization (EUA)
E ven as the world inches foward to

achieving a fully vaccinated population
against COVID-19, innovators are working
help combat COVID-19. The company
teamed with Marvel Diagnostics, the
developer of the noninvasive exhaled
from FDA to test for the COVID-19 virus.
During the clinical trial, BlowFISH’s
proprietary technology, designed to effi-
hard to develop new technologies that diag- breath diagnostic technology called ciently collect a substantial liquid sampling
nose and treat this awful virus. The disease BlowFISH. Medivolve announced its directly from deep within the lungs, suc-
continues to thrive in many parts of the investment in Marvel Diagnostics in cessfully detected the COVID-19 virus in
world, and new variants are still a concern. January 2021, providing up to $1 million three test samples. Developed by Marvel
Diagnostics and funded by Medivolve, the
technology offers the potential for a sim-
ple, inexpensive, noninvasive, massively
deployable, rapid diagnostic system for
detecting respiratory illness and airborne
viral threats in approximately 10 minutes.
“This is an exciting and important
milestone in advancing BlowFISH toward
achieving EUA status in testing for
COVID-19, and providing a noninvasive,
cost-effective, and scalable testing alterna-
tive to nasal swab solutions currently in
market,” says David Preiner, CEO of
Medivolve. “Making testing more accessi-
ble to populations such as children and
the elderly, where it may be difficult to
administer a nasopharyngeal swab test,
will become important in our transition
to resuming daily life in the new normal.
Data obtained from BlowFISH-powered
testing will also further Medivolve’s mis-
sion to use innovation and artificial intel-
ligence to close the loop in health man-
agement for every American.”
Marvel Diagnostics is partnering with
a research team from Louisiana State
University Health Shreveport (LSUSH)
to conduct clinical trials. With the sec-
ond phase of testing now in progress,
BlowFISH is currently on the right track
to seek EUA approval from FDA.
“BlowFISH’s detection of the COVID-19
virus brings us one significant step closer
to changing the future of diagnostics for
not only COVID-19, but for a wide range
of respiratory illnesses,” says Dr. Pirouz
Kavehpour, UCLA professor and Marvel
Diagnostics co-founder. “We are moving
forward with urgency through proof-of-
concept clinical trials, as these studies are
a critical next step in making respiratory
testing more comfortable, convenient and
accessible for all ... one breath at a time.”
Technologies like this are changing
the future of the healthcare landscape,
providing diagnosis faster and with more
accuracy than ever before.
Sherrie Trigg
Editor and Director of Medical Content
6 Free Info at http://info.hotims.com/79414-790 Medical Design Briefs, June 2021

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Impact-Modified
Acrylic Copolymers:
CYROLITE® with balanced optical

transmission and mechanical robust-
ness offers chemical resistance to
IPA, lipids, blood, disinfectants, and
oncology drugs, necessary for safe
BPA-free, infusion therapy applica-
tions such as filter housings.
Evaluating
Chemical Resistance
previous article discussed cally environmental stress cracking.
A
Evaluating Environmental Stress
acrylic-based medical Here in Part 2, the key parameters for Crack Resistance (ESCR) in
copolymers that are de- evaluating chemical resistance, under- Medical-Grade Polymers
signed through extensive standing industry-wide testing discrep- Leading resin manufacturers offer
R&D to carefully balance ancies, and identifying opportunities for products designed for ESCR applica-
properties and perform- a unified and regulated approach for tions in medical devices. They support
ance for healthcare applications.1 More material evaluation are presented. A performance metrics to quantify chemi-
importantly, it emphasized the key role case study on chemical resistance testing cal resistance and cross reference mate-
of polymer mechanical behavior in gov- of CYROLITE acrylic-based medical rial endurance with chemical agents.2–6
erning the chemical resistance of copolymers is presented following these These compatibility matrices are insight-
CYROLITE® and delivered an under- key considerations against various chem- ful in understanding their material spe-
standing of the chemical attack, specifi- ical agents.2 cific performance but could be highly
8 www.medicaldesignbriefs.com Medical Design Briefs, June 2021

Acrylic Copolymers
subjective when screening through strained environments and evaluating

industry-wide choices. Foremost, the test 8 tensile property retention.9
methods to quantify compatibility Percent Strain Loading and Chemical
against a chemical agent show discon- 7 Agents for Exposure Parameters. ESCR
nect and widespread practices across testing measures the tensile property
suppliers. Therefore, the medical device 6
retention of material upon simultaneous
industry should combine input from exposure to a controlled strain and a
resin producers, medical device manu- 5
chemical agent. The test assembly is
Stress,σ
Ductile
facturers, and the application environ- designed to mimic the mechanical loads
4
ment to define a regulated approach for Brittle in use and simulate the internal stresses
measuring ESCR and corroborating the material undergoes in the health-
3
material comparisons. As a result, the care environment. Figure 3 shows con-
different resin solutions available for a trol strain jigs at 0.5 percent, 1 percent,
2
given application would be assessed or 1.5 percent strain, with tensile bar
through the same metrics and ranked held in place and exposed to chemical
1
for performance/resistance against agent. Notice the increase in curvature
these chemicals. Key aspects to consider as the strain is increased from 0.5 to 1.5
0
for universal harmonization and evaluat- 0 2 4 6 8 percent. Depending on the application,
Strain,ε
ing ESCR are discussed below. chemical exposure to numerous chemi-
Preconditioning. Foremost, polymer Fig. 1 – Typical tensile stress-strain curve of cal agents is tested for the duration of
mechanical response to applied mechan- plastic material showing ductile and brittle fail- exposure (typically ranging from 5 to 24
ure behaviors. ASTM-D543-14, Section 12 and
ical stress or strain depends on its chem- ASTM D638-14 recommend ESCR testing hours), to evaluate material response in
ical structure and morphology during using tensile testing. a controlled environment.
polymer processing. Test specimens Evidently, a material is likely to show
should be annealed to minimize the material along with modulus and elonga- different response against variable
effect of molded-in stress (i.e., part tion at break properties (see Figure 2). strain, chemical agents tested, and to the
design/geometry and external factors For tensile testing, ASTM-D618 lists ten- extent of exposure. More importantly
that are application dependent). An- sile bar dimensions and tolerances for these are critical variables in context to
nealing and preconditioning are prac- standard tensile specimens with regard to the application, whether it is short-term
tices to establish comparable testing con- size and geometry. Moreover, the test use as in the case of disposables, or long-
ditions and to eliminate specimen histo- parameters such as extensometer capaci- term medical devices as in equipment
ry (storage, processing). It is also critical ty and crosshead speed for testing require housings. The current data reports don’t
to bring the material into equilibrium by rigorous attention specific to a material shed much insight on the selection of
establishing controlled temperature and tested.8 ASTM D543-14 provides guide- strain percent or the chemicals in con-
humidity conditions before testing. De- lines for chemical exposure under text of the application and do not
pending on the polymer, crystalline or address the medical device manufactur-
amorphous, controlled conditioning er’s unmet needs.
ensures reproducibility and repeatability 12.4 R Chemical Exposure Method and
of analysis. Polymer-specific standards Duration of Exposure. ASTM D543-14
should be followed for conditioning be- lists the wet patch method for ESCR test-
fore testing. For example, ASTM D-4066 ing against various chemical agents. The
stipulates the need for testing to be car- wet patch method allows for exposing
ried out on dry as-molded specimens for the strained tensile bar to the chemical
hygroscopic materials such as nylon. 6.2 R agent periodically — for example, every
ASTM-D 618-13 specifies precondition- 30 minutes for a maximum duration of
ing the test bars for >40h, at 23 ± 2 °C, 50 the test exposure. Resin manufacturers
± 5% relative humidity before strain are discussing three approaches for
exposure.7 exposure: periodic wipe method, wet
Measuring Mechanical Properties. Me- patch exposure by periodic saturation,
chanical strength of medical plastics can 4.1 R and continuous immersion by creating
be expressed using tensile, compressive, an isolated environment. Method com-
flexural, impact, fatigue, weathering, and parisons are enlightening, revealing the
other similar metrics, depending on the Radius of Jig, R (in inches) % Strain = (T/(2R+T)*100 potential variability in mechanical re-
targeted application. For ESCR evalua- 12.4 0.5 sponses and property retention.
tion of medical plastics, the mechanical A periodic wiping test is reported to
test type studied is varied, e.g., tensile or 6.2 1 be more aggressive than continuous im-
impact or flexural, etc.3–6 However, the 4.1 1.5 mersion for polycarbonate (PC) and PC
property retention upon chemical agent Fig. 2. – ASTM tensile type 1 exposed to three blends and linked to the added stressors
exposure to establish compatibility is an different strains at 0.5 percent, 1.0 percent, from the concentration build of high-
industry-wide practice. The stress-strain and 1.5 percent. The strain is determined pri- boiling chemicals in the formulations.4
marily by the thickness of the tensile bar type,
curves as part of tensile testing provide T, and the radius of curvature of the strain jig, However, this does not guarantee the
the ductile or brittle response of the R, as shown in the expression. same mechanical behavior for all materi-

7 7
Tensile Strain (%) als. Relevance needs to be established
0.5 % strain 1.0 % strain
6 6
on the chemical exposure method with
5
guidelines laid out for the dimensions of
5
the patch, frequency of chemical agent
Tensile Stress (kpsi)

4 4
reapplication, the setup in a controlled
3 3
environment, and duration of exposure
2 2
— all with respect to the chemical agent
1 1
tested. Lack of a standardized methodol-
0 0 ogy leads to inconsistency in data com-
-1
-1 0 1 2 3 4 5 6 7 8 9 10 11 12 13
-1
-1 0 1 2 3 4 5 6 7 8 9 10
parisons between resin manufacturers.
Tensile Strain (%) Tensile Strain (%) Evaluation of Test Results and
7
1.5 % strain Material A – Chemical agent ESCR for (x) hour Tensile Property Retention. The goal is
Tensile property retention (%)
6
to gauge representative behavior of the
Strain Modulus Strength Elongation at Yield Elongation at Break Crazing
5 polymer under investigation. Property
0.5% No
retention can be expressed in terms of
4
1.0% No
3
1.5% No one or a combination of tensile modu-
2 Compatibility Legend lus, strength, elongation at yield, and
1
Property Retention Color break elongation characteristics. Un-
>90% doubtedly, all of these present a unique
0 80-90%
<80%
piece of information about the mechan-
-1
-1 0 1 2 3
Tensile Strain (%)
4 5 6 7
ical characteristics of the material to the
medical device manufacturer.
Fig. 3 – Scenario to evaluate mechanical response of material upon strained exposure to a chemical A unanimous parameter(s) (modulus,
agent. Compatibility assessment showing the stress-strain curves at variable strains (0.5 percent,
1.0 percent, and 1.5 percent) for duration and environment of exposure. The curves in different col- strength, elongation at yield, and break
ors denote stress strain behavior for five test specimens tested from the same sample/product. elongation) should be published for rank-
ing the compatibility matrix against chem-
Strain (%) Modulus Strength Elongation at Yield Elongation at Break Crazing icals tested in line with the geared applica-
tion. Tensile strength and elongation at
0.5% No
yield present closer relevance to materials
1.0% No deformation behavior under mechanical
loads in use.7 Elongation at break meas-
1.5% No ures the materials failure stress but often
is misleading and shows the most scatter
Table 1a. Tensile property retention for CYROLITE® Med 2 after exposure to IPA/water (70 percent)
for 5 hours at strain rates of 0.5, 1.0, and 1.5 percent. Property retention: >90% (green), 80– across the tested pool of tensile bars as
90% (yellow), <80% (red). shown in Figure 4. In addition, visual
observations linked to onset and develop-
Strain (%) Modulus Strength Elongation at Yield Elongation at Break Crazing ment of crazing or stress whitening of
material during exposure should be
0.5% No
recorded (see Tables 1a and 1b). Figure 4
1.0% No and Tables 1a and 1b present the twofold
scenario expressing ESCR output.
1.5% No
Table 1b. Tensile property retention for CYROLITE®

Med 2 after intralipid for 24 hours at strain rates Case Study: Environmental Stress
of 0.5, 1.0, and 1.5 percent. Property retention: >90% (green), 80–90% (yellow), <80% (red). Crack Resistance (ESCR)
Performance Testing
For CYROLITE Med 2, ASTM type 1
tensile bars molded from the material
0 No attack
were annealed for 4 hours at 64 °C. The
test bars were preconditioned for at least
1 Slight attack >40h, at 23 ± 2 °C, 50 ± 5% relative humid-
Mild Crazing ity prior to strain exposure (ASTM-D
618). Note: ESCR Upon Exposure to (70
2 Moderate attack percent) IPA/Water (ASTM D543-14)
and Mechanical Property Changes
3 Severe attack
(ASTM D638, Section 12).
The tensile bars were mounted on
Severe Crazing control strain jigs at 0.5, 1.0, and 1.5 per-
4 Broke on strain jig cent respectively (see Figure3). A wet
patch saturated in 70 percent IPA was
applied every 30 minutes for 5 hours.
Fig. 4 – Compatibility assessment to include visual evaluation across the test specimens and pro- Tensile testing per ASTM D638 was per-
posed ranking system. formed on all specimens (5 replicates)
Medical Design Briefs, June 2021 www.medicaldesignbriefs.com 11

Acrylic Copolymers
designed to apply a predetermined

Disinfectants Modulus Strength Elongation at Yield Elongation at Break Crazing
amount of strain onto the specimens. A
Control (unexposed saturated cotton patch (such as sterile
at 1.5% strain) gauze) was draped over them such that
Formaldehyde test specimen is in direct contact with
the disinfectant reagent being tested.
Peracetic acid (PA)
The length of exposure was 24 hours at
Hydrogen room temperature. Three sets of meas-
peroxide (HP) urement data were taken; a set of speci-
HP/PA/Acetic acid mens (five replicates) under no strain
and no reagent applied, strain and no
Bleach
reagent, and strain and each disinfec-
Glutaraldehyde tant reagent.
Ortho-phthaldehyde Table 3 shows the impact of disinfec-
tant exposure on CYROLITE Med 2 at
Diethylene glycol
butyl (DEGB) ether 1.5 percent strain for 24 hours. The data
shows excellent chemical resistance to 6
Table 2. ESCR for CYROLITE® Med 2 after 1.5 percent strain and exposure to 10 different disinfec- of 10 disinfectants tested, with tensile
tants for 24 h showing the tensile property retention (percent). Note: For formaldehyde and per-
acetic acid, CYROLITE® Med 2 retained 90 percent property retention at 1 percent strain. Property property retention 95 percent, and no
retention: >90% (green), 80–90% (yellow), <80% (red). visual signs of crazing or stress cracking.
For the remaining four agents, the bars
Oncology Drugs Modulus Strength Crazing show 75 percent tensile property reten-
tion. The elongation at yield and break
Cisplatin (1.0 mg/ml), Water No
had 90 percent retention for all 10 dis-
Carboplatin (10.0 mg/ml), 10 mg Mannitol, Water No infectants tested, indicating that the duc-
Mitomycin (0.5 mg/ml), 1 mg Mannitol, Water No tility of the polymer is maintained after
chemical exposure and induced stress.
Gemcitabine (Gemzar) (38.0 mg/ml), Mannitol, Water No
Oxaliplatin (2.0 mg/ml), 5% Dextrose, Water No Exposure to Chemotherapy Drugs

in Carrier Solvents
5-Fluorouracyl (50.0 mg/ml), Water, pH 9.2 No ASTM type 1 tensile bars were
Epirubicin (Ellence) (2.0 mg/ml), Water, pH 3.0 No annealed at material-specific VICAT soft-
ening temperature for ~4 hours. These
Propofol (10.0 mg/ml), Soybean Oil, Glycerin, Egg
No were mounted on jigs designed to
Phospholipids
induce a 1 percent strain and held for 24
Cyclosphosphamide (20.00 mg/ml), 0.9% Benzyl hours. Five test bars were tested per
No
Alcohol, Water chemotherapy drug in their carrier sol-
Ifosfamide (50.0 mg/ml), Additives, Water No vent for 13 different drugs by wet patch
method.
Doxorubicin Hydrochloride (2.0 mg/ml), Water, pH 3.0 No
Figure 8 shows the impact of chemo-
Paclitaxel (Taxol) (6.0 mg/ml), Castor Oil, Alcohol No therapy drugs in their carrier solvents
Table 3. Tensile property retention for CYROLITE®
Med 2 after 1.0 percent strain and exposure to for CYROLITE Med 2. CYROLITE Med
10 oncology drugs for 24 hours. Property retention: >90% (green), 80–90% (yellow), <80% (red). 2 shows excellent tensile property reten-
tion, 95 percent after exposure to
and the percent change in tensile prop- Table 2). Certainly, the high perform- chemotherapy drugs while strained at 1
erties of each material reported for each ance is a direct function of the composi- percent for 24 hours. It is imperative to
reagent reported. Tensile property re- tion and the careful formulation of com- understand the impact of the carrier sol-
tention was measured using an exten- ponents that present a compatibilized vents these drugs are administered in;
someter at 10 percent based on 50 mm blend. It is essential to understand that they can potentially pose a more aggres-
gage length at a cross head speed of 2 the preconditioning enables sufficient sive interaction with the polymer materi-
in./min. Tensile strength and modulus segmental motion during annealing to al than the therapeutic drug component
were reported to three significant fig- potentially eliminate any residual mold- and lead to brittle catastrophic failures.
ures with standard deviation reported to ing stresses and offer a homogenous
two significant figures. Elongation at part with representative properties, Conclusion
yield (percent) and elongation at break hence yielding a ductile, toughened, Ideally, the industry would benefit
(percent) were reported to two signifi- and IPA-resistant material. from both objective and standardized
cant figures (ASTM D6436). metrics to provide an overview of differ-
Interestingly, the material shows ten- Exposure to Disinfectants ent product offerings with their respec-
sile property retention 95 percent, This test was conducted using Wet tive pros and cons and performance
specifically tensile strength, modulus, Patch Method (ASTM D543 - 14). Stan- thresholds. However, the feasible impli-
and elongation at yield, after exposure dard type 1 ASTM tensile testing speci- cation of these standardized metrics
to IPA for 5 hours at all strain levels (see mens were mounted to strain jigs would require industry-wide harmoniza-

tion, collaborative partnership, and a
defined framework for assessing the
material offerings industry-wide.
This article has presented the key
considerations for evaluating ESCR,
thereby mitigating the aforementioned
inconsistencies in testing and highlight-
ing the need to meet customer needs.
Unifying the testing methods in line
with the proposed key considerations
would present the medical device man-
ufacturer with an objective selection
process. Moreover, the standardized
approach would synergize the therapeu-
tic measures in healthcare with the pro-
tection offered through advanced mate-
rial solutions from evolving harmful
disease-causing pathogens.
References
1. Bajaj, P., Wright, K. D., Bernhard, K., Heyl,
D., Biagini, M., Sneeringer, A., Zadrozny,
M., CYROLITE® Impact modified acrylic
copolymers Part I – Understanding
chemical resistance, Medical Design Briefs,
May 2021.
2. Bajaj, P., Wright, K. D., Bernhard, K., Heyl
D., “Chemical and Environmental Stress-
Crack Resistance of PMMA-Based Com -
pounds in the Medical Environment,”
Kunststoffe International, 2019: 3, 12–14.
www.kunststoffe-international.com/
8390588.
3. Nowatzki, P. J., “Chemical Resistance
testing of Polycarbonates and blends with
Hospital Disinfectants and Cleaners,”
Antec 2020.
4. Chemical compatibility with hospital
disinfectants and oncology drugs,
Eastman.
5. Chemical Resistance Performance Testing
for Healthcare Materials, SABIC ASTM
D618 – 13 Standard Practice for Con-
ditioning Plastics for Testing. 7KHUHLVQRURRPIRUHUURUZKHQ
6. Röhm CRYOLITE, https://www.cyrolite.
com/en. ZRUNLQJZLWKKXPDQOLYHV
7. ASTM D638 – 14 Standard Test Method
for Tensile Properties of Plastics. &NFSTPOµTáVJEDPOUSPMQOFVNBUJDTQPSUGPMJP
8. ASTM D543 – 14 Standard Practices for
Evaluating the Resistance of Plastics to BEESFTTFTUIFVOJRVFOFFETPGBOBMZUJDBMJOTUSVNFOU
Chemical Reagents. NFEJDBMEFWJDFNBOVGBDUVSFST0VSUFBNPGFYQFSUT
9. ASTM D6436 – 14 Standard Guide for
Reporting Properties for Plastics and XPSLXJUIZPVUPQSPWJEFBDPNQMFUFDVTUPNJ[FE
Thermoplastic Elastomers. TPMVUJPO CBTFEPOZPVSUJNFUPNBSLFUSFRVJSFNFOUT
This article was written by Pooja Bajaj, Learn more at: (PHUVRQFRPPHGLFDO
PhD, Product Development Manager – BU Email: Medical@Emerson.com
Molding Compounds, Medical; Kierra D.
Wright, PhD, Product Development Manager
– BU Molding Compounds, Medical; Kay
Bernhard, Director of Global Technical
Competency Center – Medical; Dirk Heyl,
Technical Marketing Manager – Medical;
Maurice Biagini, Global Business Director –
Medical; Andrew Sneeringer, Technical
Marketing Specialist – Medical; and Michael The Emerson logo is a trademark and a service mark of Emerson Electric Co. © 2021 Emerson Electric Co.
Zadrozny, Strategic Account Manager –
Medical, Roehm America LLC, Parsippany,
NJ. For more information, visit http://
info.hotims.com/79414-340.
Medical Design Briefs, June 2021 Free Info at http://info.hotims.com/79414-793 13

NEXT GEN
POC Diagnostics:
Electronic Measurement
Technology Driven
by Global Demand
for COVID-19 Testing
he in-vitro diagnostic (IVD)
T
mens taken from the human body” com- mobile antibodies and is captured using
home point-of-care (POC) pared with in-vivo products, which per- fixed antibodies to produce a color line
product landscape will look form the same but within the human that LEDs and photodiodes will detect.
very different over the coming body as defined by the FDA. According Glucose test strips require a very small
years as new products to detect to FDA, “POC testing means that results drop of blood at the tip of the strip where
the COVID-19 virus are launched. It is are delivered to patients in the patient the chemical enzymes are stored.
driven in part by FDA’s Emergency Use care settings, like hospitals, urgent care An electrical connection is made from
Authorization (EUA), which fast-tracks centers, and emergency rooms, instead the meter to the test zone on the strip to
the traditional 510(k) process so that of samples being sent to a laboratory.” allow a voltage stimulus and measure-
COVID testing can be as ubiquitous as ment, whereas a system using nitrocellu-
measuring your temperature. Optical vs. Electrochemical Test lose strips only requires a simple me-
And $157 million has already been dis- Techniques chanical interface like a light pipe to
tributed by the Biomedical Advanced IVD POC products available today like focus the LED signal on the strip and
Research Development Agency (BARDA) glucose meters or pregnancy test kits will capture the reflected signal on the pho-
to support the development of more than soon share “shelf space” with start-ups todiode. This article focuses on the
40 COVID-19 diagnostic products. Some offering novel sensors and meters using more widely used POC electrochemical
of those products are targeted for POC nasal swabs, saliva, urine, sweat, and measurement technique. Future articles
use cases versus laboratory testing. Many blood. These new IVD products will use will address optical techniques.
new companies entering the market are the latest in sensor technologies, ultra
planning a diagnostic roadmap of capa- low power analog, precision mixed- EC Measurement Background
bilities beyond their entry point of signal, and digital processing, and they In every household, two-terminal bat-
COVID-19 testing. will be highly portable, including using teries are the most common example of
biocompatible enclosures for wearable a dc power supply. They are used for
IVD and POC Defined applications. They will also harness the flashlights, mobile phones, clocks, etc. A
“In vitro diagnostic products are those enormous computing power of smart- well-known EC application is the elec-
reagents, instruments, and systems phones and the cloud. trolysis of compounds. A common in-
intended for use in the diagnosis of dis- The two basic measurement techniques dustrial example is the chlor-alkali
ease or other conditions, including a for IVD POC home testing are optical and process where the salt (NaCl) and water
bestv/Shutterstock.com
determination of the state of health, in electrochemical (EC). Pregnancy test kits, (H2O) in saltwater are split into chlorine
order to cure, mitigate, treat, or prevent for example, detect human chorionic (Cl2), hydrogen (H2), and sodium hy-
disease or its sequelae. Such products gonadotropin (hCG) in urine. Urine is droxide (NaOH).
are intended for use in the collection, placed on the end of the nitrocellulose The disadvantage of two-terminal EC
preparation, and examination of speci- strip and flows; hCG binds with dyed applications is that it is not possible to

investigate a single electrode and
thus a single event (see Figure 1).
The current flows through the
anode (electrode where oxidation
happens) and the cathode (electrode
where reduction takes place). So, both
these electrodes influence the measured
current and the current-limiting process
cannot be determined. This is especially
an issue in analytical chemistry. Another
issue is concentration polarization. This
is the effect of an electrode changing its
environment and thus its potential dur-
ing an electrochemical reaction. For
most electroanalytical methods, a poten-
+
Vout
-
Rf
a) b) c)
WE WE
WE CE
E E I
I
RE CE
RE CE
Vbias +
Fig 1 – Current and potential in a two-electrode system (a) and in a three-electrode system (b), and the
schematic of a potentiostat control circuit (c).

Next-Gen POC Diagnostics
Fig. 2 – Desktop potentiostat (left) from the 1990s and handheld potentiostat (right) from 2020. (Left photo courtesy of University of Rostock – Institute
for Electronic Appliances and Circuits)
tiostat is required (see Figure 2). A po- working electrode, but since the circuit trode (CE), also known as auxiliary elec-
tentiostat uses three electrodes and a needs to be closed and current needs to trode, the counter-reaction to the work-
feedback loop to control the potential flow, a reaction that is inverse to the ing electrode’s reactions takes place.
and measure the current flowing at just reaction at the working electrode must The current is flowing between the
one of these electrodes, the working occur; that is, if an oxidation occurs at working and the counter electrode. The
electrode. The potential will be meas- the working electrode, a reduction must potential is controlled between the
ured to a fixed reference point and thus take place at the reference electrode. If working electrode and reference elec-
a lot of information about the event hap- a current flows at a constant potential, trode. The potential between the count-
pening at the working electrode can be an electrochemical reaction must hap- er electrode and reference electrode is
gathered. pen according to Faraday’s law. adjusted in such a way that the current
Why not just two electrodes? One rea- The change of the solution surround- flowing through the working electrode
son is that the potential of the working ing the reference electrode, due to a at a certain potential between working
electrode cannot be measures against a flowing current, leads to a change of the and reference electrode is satisfied.
fixed point when there are only two elec- potential that is supposed to be the fixed This technology allows the use of
trodes. Imagine a two-electrode system reference point. But the current flow many different electrochemical tech-
that consists of the already mentioned cannot be limited through the reference niques like cyclic voltammetry, square
working electrode, and the electrode, electrode (RE), because all limitations wave voltammetry, open circuit potential
whose potential should be the fixed ref- should be caused by the desired process measurements, etc. (see Table 1). The
erence point, is the reference electrode. to investigate; that is, the process at the precise potential control and current
In this case, a certain potential is working electrode (WE). measurement allow the detection of
applied between these electrodes and an The solution for this problem is a many substances. This has led to many
electrochemical reaction happens at the third electrode. At this counter elec- lab-based quantitative measurements. It
is not always possible to wait for a labora-
Technique Working principle Advantages Application areas tory or to ship samples. On-site POC
Cyclic Linear potential ramps, Shape often Fundamental research, measurements, especially during the
Voltammetry current recorded characteristic, fast, characterization pandemic, have become very important.
quantitative signal Electroanalysis, the detection of sub-
Square Wave Potential pulses superimposed Sensitive, overcomes Quantitative
stances by electrochemistry, offers many
Voltammetry on a linear ramp, current diffusion limitation, measurements options to quantitatively determine dif-
difference between right quantitative signal ferent substances and species, but for
before the pulse and the end many years potentiostats were lab bound
of the pulse (see Figure 3). Now the newest genera-
Open Circuit Zero current, potential is Noninvasive, Corrosion research, tion of compact potentiostats offered by
Potentiometry measured quantitative signal ion-selective electrodes PalmSens, for example, with expertise in
instrument design, including hardware,
Electrochemical AC potential applied, Very interface- Coatings, corrosion, firmware, and software offer potentio-
Impedance impedance and phase shift sensitive, label-free battery research, stat systems with high precision, porta-
Spectroscopy from AC current calculated detection label-free biosensors
bility, programmability, and low cost.
Table 1. Different electrochemical techniques enable precise potential control and current measure- The compact and ready-to-use poten-
ment for the detection of many substances. tiostats like the Sensit Smart, are capable

Next-Gen POC Diagnostics
of common electrochemical techniques

and advanced techniques like electro-
chemical impedance spectroscopy (EIS).
While having the size of a common glu-
cose meter, these devices offer more
functionalities and are more versatile.
EIS is a very interface-sensitive tech-
nique, which allows among other appli-
cations label-free detection of biomole-
cules for example DNA.1 It is no surprise
that in 2021 these compact potentiostats
were also used for different SARS-CoV-2
detection systems.2–5 While the academ-
ic world reacted swiftly and developed
many new detection methods for SARS-
CoV-2, the translation of the proof of
principles into a commercial product is
a challenging task. Developing a dedicat-
ed device including electronics design,
firmware, and software requires a team
Fig. 3 – The electrochemistry chip ADuCM355 by Analog Devices is part of the EmStat Pico poten- of specialized staff and time.
tiostat module, which was used to build the handheld, Bluetooth-operated potentiostat Sensit BT. Commercial solutions that support
this translation are available as well. The
development can be accelerated by
using potentiostat modules. Instead of
designing your own potentiostats and
firmware, potentiostat modules provide
the electrochemical methods of the
measurement system. Another option is
to use modular potentiostats, which can
be changed into an individual product
with just a few customizations. The sim-
plest version of such a solution is just
exchanging the logo on the device.
More advanced solutions allow modifica-
Fig. 4 – Potentiostat module on a development board (left), modular potentiostat (middle, right). tion of the electrode connection, as well
Another reason for long development times is software development. Potentiostat modules often as offering battery and Bluetooth op-
have specialized firmware and software development kits (SDK) which allow writing simple user inter-
faces in a short amount of time, because the communication with potentiostat itself is simplified. tions and customized keypads. Such
The software developer is in full control without learning the details on a circuitry level. turnkey electronic design services allow
having prototypes of a reader within a
few months (see Figure 4).

IVD System Architecture
Let’s take a closer look at what’s in the
box of a typical EC system and the trade-
offs needed when creating a require-
ments document for a new meter
! " design. System power management is
typically a good starting point in any new
design (see Figure 5). The number of

tests a meter will need to perform, along
with the timing, voltages, and currents
of those tests and communication
(wired/wireless/display/sound) will de-

fine the capacity requirements for the

battery.
Many home glucose meters on the
market today use 3 V CR2032 batteries, as
they are small and provide sufficient
power of 250 mAHr to support up to a
year of daily testing with each test lasting
Fig. 5 – Block diagram of an IVD system. less than 5 seconds. For example, if the

system electronics consume 10 mA over 5 boost circuits and LDOs to ensure clean 2. H. Zhao et al, “Ultrasensitive supersandwich-
seconds (0.00138Hr), then each test stable supply voltages to the measure- type electrochemical sensor for SARS-
CoV-2 from the infected COVID-19
draws 0.0138 mAHr, which supports 250 ment front end. patients using a smartphone,” Sensors and
mAHr/0.0138 mAHr = 18,000 tests be- Actuators B: Chemical,” 2021: 327:15,
fore replacing the battery. However, if the Conclusion January 2021, https://doi.org/10.1016/
j.snb.2020. 128899.
electrochemical test takes tens of seconds POC devices to diagnose viruses, joint 3. J. Li and and P. Lillehoj, “Microfluidic
or even minutes and the electrochemical infections, or nutrient deficiencies, for Magneto Immunosensor for Rapid, High
reaction requires higher currents, then example, are here to stay. They will Sensitivity Measurements of SARS-CoV-2
Nucleocapsid Protein in Serum,” ACS
much higher capacity batteries must be become smaller, cheaper, produced in Sensors, 2021: 6, 3, 1270–1278, https://
employed, which increases the enclosure high volume, and more versatile. As doi.org/10.1021/acssensors.0c02561.
volume, weight, and cost. Rechargeable competition increases, proven measure- 4. Md. Azahar Ali et al., “Sensing of COVID-
19 Antibodies in Seconds via Aerosol Jet
batteries are an option, but time-sensitive ment technologies and system design Printed Three Dimensional Electrodes,”
testing to address immediate treatment expertise will be a competitive advantage medRxiv, September 2020, https://doi.org/
decisions for home use typically avoids and speed time to market. PalmSens, for 10.1101/2020.09.13.20193722.
5. S. Traynor, “Dynamic Bio Barcode Assay
rechargeable batteries. example, delivers tested market-ready Enables Electrochemical Detection of a
In such cases, stand-alone potentiostat potentiostats or calibrated potentiostat Cancer Biomarker in Undiluted Human
modules like the EmStat Pico are ideal modules to integrate into hardware, Plasma: A Sample In Answer Out Ap-
proach,” Angewandte Chemie, 2020: 132, 50,
for the analog front-end function. On- while Tri-Star Design offers turnkey cer- December 7, 2020, https://doi.org/
chip sequencers and deep ADC FIFOs tified product design and development 10.1002/ange.202009664.
allow the analog front end to operate services with expertise in high precision,
while the processor is shut down, thus low-power wireless systems. Both compa- This article was written by Paul Errico
saving power. High-speed analog-to- nies are official partners of Analog (perrico@tristardes.com), Healthcare Senior
digital conversion enables duty cycling Devices. Account Manager, TriStar Design, Hopkinton,
of the front-end measurement system to MA, and Ardy van den Berg (info@palmsens.
References
reduce power consumption. In addition 1. M. Gebala and W. Schuhmann, “Under- com), Business Developer, PalmSens, Houten,
to the battery capacity, it is important to standing properties of electrified The Netherlands. For more information on
consider the voltage requirements for interfaces as a prerequisite for label-free TriStar Design, visit http://info.hotims.com/
DNA hybridization detection,” Physical
each block. High-precision, wide dynam- Chemistry Chemical Physics, 2012: Issue 43, 79414-341. For more information on PalmSens,
ic range analog circuits may require https://doi.org/10.1039/C2CP42382K. visit http://info.hotims.com/79414-370.

Algorithms, Wearables Help Ultra-Sensitive, Small Optomechanical
Monitor Parkinson’s Ultrasound Sensor
Scientists have developed algo- An optomechanical ultrasound sensor on
rithms that, combined with wear- a silicon photonic chip provides unprece-
able sensors, could help clinicians dented sensitivity due to an innovative
to monitor the progression of optomechanical waveguide. Because of this
Algorithms and wearable sen- Parkinson’s disease and assess the high-sensitivity waveguide, the 20-μm sen-
sors help clinicians to monitor The optomechanical
the progression of Parkinson’s effects of medications commonly ultrasound sensor sor has a detection limit two orders of mag-
disease. (Credit: EPFL) used by people with this neurode- on a silicon photonic nitudes better than piezoelectric elements
chip provides unprece-
generative disorder. dented sensitivity. of identical size. The low detection limit of
Doctors caring for people with Parkinson’s disease need to (Credit: imec) the sensor enables new clinical and biomed-
be able to assess the severity of the symptoms and alter the ical applications of ultrasonic and photoa-
doses of medications that reduce such symptoms. To do so, cli- coustic imaging such as deep-tissue mammography and the study
nicians rely on a handful of tests, such as those that measure of vascularization or innervation of potential tumorous tissue.
gait speed — or how fast people walk. The sensor is based on a highly sensitive split-rib optomechan-
Researchers recruited 27 people with Parkinson’s disease and ical waveguide fabricated using new CMOS-compatible process-
provided each of them with a foot-worn sensor that recorded how ing. A low detection limit can improve the trade-off between
fast they walked. During the clinical assessment, the researchers imaging resolution and depth for ultrasound applications and is
asked patients to do two types of walking tests: in one, people had crucial for photoacoustic imaging, where pressures are up to
to walk for 20 meters in a straight line; in another test, they were three orders of magnitude lower than in conventional ultra-
asked to walk in circles for five times. The walking tests were done sound imaging techniques. Furthermore, it may enable low-pres-
when patients were on a medication that reduces motor problems, sure applications like through-skull functional brain imaging,
and then they repeated when individuals were off the medica- which suffers from the strong ultrasound attenuation of bone.
tion. Based on data collected from the sensors, the team calcu- A fine-pitched (30 μm) matrix of these tiny sensors can be
lated the average and the fastest gait speed for each individual. easily integrated on-chip with photonic multiplexers. This
The findings suggest that monitoring gait speed during daily opens the possibility of new applications such as miniaturized
activities with wearable technology could help doctors optimize catheters because the sensor matrices require only few optical
medication dosages depending on motor symptoms of individ- fibers to be connected instead of one electrical connection per
ual patients. The sensors and the dedicated algorithms allow cli- element in the case of piezoelectric sensors.
nicians to monitor patients remotely, which could help to protect For more information, visit www.medicaldesignbriefs.com/
vulnerable people in situations such as the coronavirus pandemic. roundup/0621/sensor.
For more information, visit www.medicaldesignbriefs.com/
roundup/0621/wearables. Reduced Heat Leakage Improves
Wearable Heat Harvester
Kirigami-Style Fabrication Researchers report significant en-
Enables 3D Nanostructures hancements in preventing heat leakage
A new technique that mimics the in the flexible body heat harvester. The
ancient Japanese art of kirigami may A flexible heat harvesting harvesters use heat energy from the
offer an easier way to fabricate com- device shows better effi- human body to power wearable tech-
Strategically placed cuts to ciency at retaining heat
structural films can create plex 3D nanostructures for use in to power the device. nologies such as smart watches that
3D nanostructures when applications, including healthcare. (Credit: Mehmet Ozturk) measure heart rate, blood oxygen, glu-
force is applied to the films.
(Credit: Jennifer M. McCann/ The researchers used kirigami at cose, and other health parameters and
Penn State MRI) the nanoscale to create complex 3D never need to have their batteries recharged. The technology
nanostructures. These 3D structures relies on the same principles governing rigid thermoelectric har-
are difficult to fabricate because current nanofabrication process- vesters that convert heat to electrical energy.
es are based on the technology used to fabricate microelectron- Improvements to the device in 2020 included a high thermal
ics which only use planar, or flat, films. Without kirigami tech- conductivity silicone elastomer — essentially a type of rubber —
niques, complex three-dimensional structures would be much that encapsulated the EGaIn interconnects. The newest itera-
more complicated to fabricate or simply impossible to make. tion of the device adds aerogel flakes to the silicone elastomer to
By introducing minimum changes to the dimensions of the reduce the elastomer’s thermal conductivity. Experimental
cuts in the film, the researchers drastically changed the 3D results showed that this innovation reduced the heat leakage
shape of the pop-up architectures and demonstrated through the elastomer by half.
nanoscale devices that can tilt or change their curvature just by One the patented technology’s strengths is that it employs the
changing the width of the cuts a few nanometers. same semiconductor elements that are used in rigid devices per-
Future research will focus on applying these kirigami tech- fected after decades of research. The approach also provides a
niques to materials that are one atom thick, and thin actuators low-cost opportunity for existing rigid thermoelectric module
made of piezoelectrics. manufacturers to enter the flexible thermoelectric market.
For more information, visit www.medicaldesignbriefs.com/ For more information, visit www.medicaldesignbriefs.com/
roundup/0621/kirigami. roundup/0621/harvester.

3D Printed Implants Bioactive Implant Coatings
with Antibiotics Resistant to Most Bacterial
Researchers have fabricat- Strains
ed antibiotic-containing 3D Multilayer antibacterial coatings
scaffold implants at high offer a prolonged effect and a univer-
temperatures. These scaf- sal spectrum of action. The coating is
Covering the antibiotics with lamellar
inorganic protectors protects the anti- folds not only support bone Multilayer antibacterial based on modified titanium oxide
bacterial agents. (Credit: KeAi) regeneration but manage coatings offer a pro- and several antiseptic components.
longed effect and a uni-
the bone infections that can versal spectrum of The coatings can be used in modern
arise as a result of injury or surgery. Incorporating antibiotics action. (Credit: MISIS) implantology as a protective layer for
into these scaffolds is not straightforward because the 3D print- the prevention of concomitant com-
ing process consists of melting the material at high tempera- plications — inflammation or implant rejection.
tures and antibiotics are heat sensitive. The multilayer coating synthesizes the protective properties of
Scientists found that covering the antibiotics with lamellar nanoparticles, biopolymers, anticoagulants, and antibiotics. The
inorganic protectors, prior to mixing them with the polymer antibiotic and silver nanoparticles provide an antibacterial effect,
and placing them in the 3D scaffolds, not only protected the while heparin prevents bacterial cells from sticking to the tissue
antibacterial agents but also enabled a more controlled release. surface, which reduces the amount of antibacterial agent required.
This extended the period the antimicrobials were active and The chemical composition of the resulting coating layers was
helped keep local antibiotic concentrations under potentially carefully studied by the developers using infrared and x-ray
toxic levels. At the same time, the cells in contact with these scaf- photoelectron spectroscopy. Scientists have found out that the
folds maintained their viability and could perform normal cell incorporation of therapeutic components occurs throughout
functions, including bone formation — the goal of the implant. the whole plasma-applied polymer layer.
Until now, the direct incorporation of antibiotics and other According to the developers, the coatings can be used as an
bioactive molecules within 3D printed scaffolds has been limit- antibacterial implant modifier, allowing it to accelerate implan-
ed to the few polymers that can be processed at low tempera- tation by reducing the risks of associated inflammation and
tures. This novel approach shows that the library of polymers stimulating the growth of osteoblastic cells. Researchers are cur-
can be expanded to include many more. rently planning to move to the preclinical development stage.
For more information, visit www.medicaldesignbriefs.com/ For more information, visit www.medicaldesignbriefs.com/
roundup/0621/implants. roundup/0621/coatings.
ROBOTIC END - EFFECTORS
Measure all six components of force

and torque in a compact, rugged sensor.
r
r.
Interface Structure
high-strength alloy provides IP60, High-Speed Electronics
IP65, and IP68 environmental interfaces for Ethernet, PROFINET,
protection as needed EtherNet/IP, Analog, USB, CAN
EtherCAT, Wireless, and more
Sensing
Sensin
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Cohesive Circuit Protection for Wearable Electronics
The cellulose nanofiber
coating counters bending Electronic circuit Without coating /1 min
130 °C
damage and retains - + Short-
circuit
electrode function under
water.
Osaka University
Osaka, Japan 100.0 °C 5 mm
No 10 °C
Most electronic devices aren’t water- Water Short-
circuit
proof, much to your irritation if a sprin- With CNF coating /1 h
130 °C
kler suddenly sprays you while you’re talk-
CNF coating
ing outside on your cellphone. Some elec-
tronics can be made at least water-resistant
by, for example, using special glues to fuse
outer components together. Flexible elec-
tronics are another story. Their sealant
materials must be able to bend, yet with 23.9 °C 5 mm
Conductive Line Substrate
current technology it’s inevitable that 10 °C
(copper)
eventually such a sealant will crack or sep-
arate from the device — and there goes
your water-resistant coating. Fig. 1 – Water is detrimental to electronic devices because it easily causes short circuits and acci-
dents, such as overheating/ignition. By coating electronic circuits with cellulose nanofibers (CNFs),
Researchers are determined to come it is possible to prevent water-induced short circuits in a completely different approach compared
up with a solution. Cellulose nanofibers with conventional waterproofing coatings.
are a proposed polymer coating for flex-
ible electronics. These fibers are made Conventional waterproof coating CNF Coating
from renewable resources and are envi-
ronmentally friendly. However, they usu-
ally absorb water — commonly thought + +
to be a fatal limitation for imparting - -
water resistance. + +
In a study recently published in ACS Damaged Damaged
and and
Applied Nanomaterials, researchers from submerged submerged
Osaka University developed self-healing - 2 mm - 2 mm
cellulose nanofibers that slightly dis-

Short-circuit in a short time No Short-circuit even after 24 h
perse in water and act to protect a cop-
per electrode, enabling the electrode to
Fig. 2 – Water inevitably penetrates waterproof coatings if they are damaged, and water can easily
function for an extended period. The cause malfunctions due to dendrite growth. Cellulose nanofibers (CNFs) migrate toward the anode
researchers’ flexible circuit protection and gel, thus inhibiting short circuits even if the CNF coating film is damaged.
mechanism retains electrode function
underwater and can undergo hundreds “Our results aren’t attributable to sim- where device failure is unacceptable —
of bending cycles. ple ion-exchange or nanofiber length,” for example, medical devices used in
“In our initial work, an unprotected explains Masaya Nogi, senior author. emergency disaster response.”
copper electrode failed after 5 minutes “The nanofibers aggregate in water into In preliminary work, even an ultrathin
of dripping water onto it,” says Takaaki a protective layer made cohesive by polymer coating thickness of only 1.5
Kasuga, lead author. “Remarkably, a cel- locally acidic conditions and polymer μm, and some other polymers, per-
lulose nanofiber coating prevented fail- cross-linking.” formed similarly to the originally tested
ure over at least a day of the same water A more rigorous test of the polymer setup. They’ll become a staple of wear-
challenge.” coating was its performance after 300 able electronics, and perhaps even med-
Why is this? Remember that cellulose cycles of bending underwater over the ical devices, in the coming years.
fibers don’t repel water. Instead, this course of an hour. A conventional poly- The article, “Cellulose nanofiber coat-
polymer coating migrates in the elec- mer coating usually failed, but the cellu- ings on Cu electrodes for cohesive pro-
trode in such a way to prevent formation lose nanofibers continued to power LEDs. tection against water-induced short-cir-
of conductive metal filaments that cause “You’ll be able to stretch, bend, and cuit failures,” was published in ACS
short-circuits. The electrodes even main- fold electronics with our coating, and Applied Nanomaterials at DOI: https://
tained their function after the cellulose they’ll still retain their water resistance,” doi.org/10.1021/acsanm.1c00267.
coating was scratched to simulate bend- says Kasuga. “This is critical for use in For more information, visit https://resou.
ing damage. applications under extreme conditions osaka-u.ac.jp.

Our team members believe in
your mission to improve lives.
We manufacture your products

standards so your devices are
ready for critical procedures when

resources allows you to focus on


Tiny Wireless Implant Detects Oxygen Deep Within
the Body
The implant provides real-
time measurements of
tissue oxygen levels.
UC Berkeley
Berkeley, CA
Engineers at the University of California,

Berkeley, have created a tiny wireless
implant that can provide real-time meas-
urements of tissue oxygen levels deep
underneath the skin. The device, which is
smaller than the average ladybug and pow-
ered by ultrasound waves, could help doc-
tors monitor the health of transplanted
organs or tissue and provide an early warn- This wireless implant, developed by engineers at the University of California, Berkeley, can measure the
ing of potential transplant failure. oxygenation of living tissue deep below the surface of the skin. (Credit: UC Berkeley/Soner Sonmezoglu)
The technology, created in collabora-
tion with physicians at the University of
California, San Francisco, also paves the μLED
way for the creation of a variety of minia- O2-sensing film
turized sensors that could track other key
biochemical markers in the body, such as
Piezo-crystal IC
pH or carbon dioxide. These sensors
could one day provide doctors with mini-
mally invasive methods for monitoring
the biochemistry inside functioning or-
gans and tissues.
“It’s very difficult to measure things
deep inside the body,” says Michel
Maharbiz, a professor of electrical engi-
neering and computer sciences at UC
Berkeley and a Chan Zuckerberg Biohub
Investigator. “The device demonstrates Optical filter
how, using ultrasound technology cou-
pled with very clever integrated circuit
design, you can create sophisticated
implants that go very deep into tissue to A schematic of the oxygen-detecting implant, which measures 4.5 mm long by 3 mm wide. The
μLED, O2-sensing film, and optical filter make up the oxygen sensor, and are controlled by an inte-
take data from organs.” grated circuit (IC). The piezo-crystal converts an electronic signal from the IC into ultrasonic waves
Maharbiz is the senior author of a new that can be transmitted safely through living tissue. (Credit: UC Berkeley/Soner Sonmezoglu)
paper describing the device, which appears
in the journal Nature Biotechnology. deep tissue oxygenation, they require UC Berkeley electrical engineering and
Oxygen is a key component to cells’ long scanning times, and so are unable computer sciences assistant professor
ability to harness energy from the food to provide data in real-time. Rikky Muller. Stimdust can detect and
that we eat, and nearly all tissues in the Since 2013, Maharbiz has been design- stimulate electrical nerve firings in the
body require a steady supply in order to ing miniaturized implants that use ultra- body. Soner Sonmezoglu, a postdoctoral
survive. Most methods for measuring tis- sonic waves to wirelessly communicate with researcher in engineering at UC Berkeley,
sue oxygenation can only provide infor- the outside world. Ultrasonic waves, which led the effort to expand the implant’s
mation about what is happening near are a form of sound too high in frequency capabilities to include oxygen sensing.
the surface of the body. That is because to be detected by the human ear, can travel Incorporating the oxygen sensor
these methods rely on electromagnetic harmlessly through the body at much involved integrating both an LED light
waves, such as infrared light, which can longer distances than electromagnetic source and an optical detector into the
only penetrate a few centimeters into waves and are already the basis of ultra- tiny device, as well as designing a more
skin or organ tissue. While there are sound imaging technology in medicine. complicated set of electronic controls to
types of magnetic resonance imaging One example of such a device is operate and read out the sensor. The
that can provide information about Stimdust, designed in collaboration with team tested the device by monitoring the

oxygen levels inside the muscles of live Development, became involved in the optical platform in the sensor could be
sheep. Sonmezoglu points out that this work because of its potential for moni- readily adapted to measure other bio-
type of oxygen sensor differs from the toring fetal development and caring for chemistry in the body.
pulse oximeters that are used to meas- premature babies. “By just changing this platform that
ure oxygen saturation in the blood. “In premature infants, for example, we we built for the oxygen sensor, you can
While pulse oximeters measure the frequently need to give supplemental modify the device to measure, for exam-
proportion of hemoglobin in the blood oxygen but don’t have a reliable tissue ple, pH, reactive oxygen species, glu-
that is oxygenated, the new device is readout of oxygen concentration,” cose, or carbon dioxide,” Sonmezoglu
able to directly measure the amount of Maltepe says. “Further miniaturized ver- says. “Also, if we could modify the pack-
oxygen in tissue. sions of this device could help us better aging to make it smaller, you could
“One potential application of this de- manage oxygen exposure in our preterm imagine being able to inject into the
vice is to monitor organ transplants, be- infants in the intensive care nursery set- body with a needle, or through laparo-
cause in the months after organ trans- ting and help minimize some of the neg- scopic surgery, making the implantation
plantation, vascular complications can ative consequences of excessive oxygen even easier.”
occur, and these complications may lead exposure, such as retinopathy of prema- This work was supported by the Chan
to graft dysfunction,” Sonmezoglu says. turity or chronic lung disease.” Zuckerberg Biohub and by the National
“It could be used to measure tumor The technology could be further Institutes of Health’s Eunice Kennedy
hypoxia, as well, which can help doctors improved, Sonmezoglu says, by housing Shriver National Institute of Child Health
guide cancer radiation therapy.” the sensor so that it could survive long and Human Development through grants
Study co-authors Jeffrey Fineman and term in the body. Further miniaturizing R44HD094414 and R01HD07245.
Emin Maltepe, who both are pediatri- the device would also simplify the im- This article was written by Kara Manke,
cians at UCSF and members of the plantation process, which currently re- UC Berkeley. For more information, visit
Initiative for Pediatric Drug and Device quires surgery. In addition, he says, the https://news.berkeley.edu.
Tiny Implantable Tool for Light-Sheet Imaging of Brain

Activity
The tool shows promise
for imaging brain activity
in 3D with high speed
and contrast.
SPIE
Bellingham, WA
Tools that allow neuroscientists to

record and quantify functional activity
within the living brain are in great
demand. Traditionally, researchers have
used techniques such as functional mag-
netic resonance imaging, but this method
cannot record neural activity with high
Optical microscope image of the implantable shanks (141 μm pitch) of a light sheet neural probe.
spatial resolution or in moving subjects. Light is emitted by nanophotonic gratings on the shanks to form light sheets. (Credit: Sacher et al.,
In recent years, a technology called opto- doi 10.1117/1.NPh.8.2.025003)
genetics has shown considerable success in
recording neural activity from animals in activity in 3D with high speed and contrast brain imaging with nontransparent
real time with single neuron resolution. (overcoming multiple limitations of other organisms (like a mouse) is difficult
Optogenetic tools use light to control imaging technologies). In this technique, because of the size of the necessary
neurons and record signals in tissues a thin sheet of laser light (light-sheet) is apparatus. To make experiments with
that are genetically modified to express directed through a brain tissue region of nontransparent animals and, in the
light-sensitive and fluorescent proteins. interest, and fluorescent activity reporters future, freely moving animals feasible,
However, existing technologies for imag- within the brain tissues respond by emit- researchers will first need to miniaturize
ing light signals from the brain have ting fluorescence signals that microscopes many of the components.
drawbacks in their size, imaging speed, or can detect. A key component for the miniaturiza-
contrast that limit their applications in Scanning a light sheet in the tissue tion is the light-sheet generator itself,
experimental neuroscience. enables high-speed, high-contrast, volu- which needs to be inserted into the brain
A technology called light-sheet fluorescence metric imaging of the brain activity. and thus must be as small as possible to
imaging shows promise for imaging brain Currently, using light-sheet fluorescence avoid displacing too much brain tissue. In

a b
Connected to micromanipulator
Image
488 nm sensor
laser beam Scanning system
Imaging system
Chip Tube lens
Carrier
er Bandpass filter
Obj. Chip Fib ndle
b u Electrically
tunable lens
MEMS mirror
f = 35 mm f = 150 mm
Objective
Aga
Fiber ros
Fiber bundle facet (core addressing) e
bundle Fiber bundle Fluorescence
GRIN lens
Probe
Probe chip
Mouse brain
Optical addressing method and proposal for deep-brain photonic-probe-enabled light-sheet fluorescence microscopy (LSFM). Schematic of the optical
addressing method (not to scale) (a). The scanning system addresses on-chip edge couplers via spatial addressing of the cores of an image fiber bundle.
Bottom inset: micrographs of the distal facet of a fiber bundle connected to the scanning system with different cores addressed. Top inset: annotated
photograph of a packaged light-sheet neural probe inserted into an agarose block. Illustration of the proposed use of the light-sheet neural probe with
a GRIN lens endoscope for deep brain LSFM (not to scale) (b). (Credit: Sacher et al., doi 10.1117/1.NPh.8.2.025003)
a new study reported in Neurophotonics, an propagation distances of 300 micrometers limited the use of light-sheet fluorescence
international team of researchers from the in free space. When tested in brain tissues imaging in experimental neuroscience.
California Institute of Technology (USA), from mice that were genetically engi- We predict that this technology will lead to
University of Toronto (Canada), Uni- neered to express fluorescent proteins in new variants of light-sheet microscopy for
versity Health Network (Canada), the Max their brains, the probes permitted the deep brain imaging and behavior experi-
Planck Institute of Microstructure Physics researchers to image areas as large as 240 ments with freely moving animals.”
(Germany), and Advanced Micro Foundry × 490 μm. Moreover, the level of image Such variants would be a boon to neuro-
(Singapore) developed a miniature light- contrast was superior to that with an alter- scientists seeking to understand the work-
sheet generator, or a photonic neural native imaging method called epifluores- ings of the brain.
probe, that can be implanted into a living cence microscopy. The open access research article, W.D.
animal’s brain. Describing the significance of his team’s Sacher et al., “Implantable photonic
The researchers used nanophotonic work, the study’s lead author, Wesley neural probes for light-sheet fluores-
technology to create ultrathin silicon- Sacher, says, “This new implantable pho- cence brain imaging,” was published in
based photonic neural probes that emit tonic neural probe technology for gener- Neurophotonics 8(2), 025003, doi 10.
multiple addressable thin sheets of light ating light sheets within the brain circum- 1117/1.NPh.8.2.025003.
with thicknesses <16 micrometers over vents many of the constraints that have For more information, visit https://spie.org.
E-health Patches Monitor Pulse and Blood Pressure

The wireless patches
power themselves with
Organic
harvested energy. Rectifier
Power generation Circuit Energy
Osaka University device using Strorage Organic
Osaka, Japan ferroelectric polymer Capacitor Piezoelectric
Sensors
Scientists at Osaka University, in coop-

eration with Joanneum Research (Weiz,
Austria), have introduced wireless health
monitoring patches that use embedded Substrate thickness : 1μm Total thickess
piezoelectric nanogenerators to power < 2.5 μm
themselves with harvested biomechanical
energy. This work may lead to new
autonomous health sensors as well as bat-
tery-less wearable electronic devices. Fig. 1 – Sheet-type piezoelectric system with self-generation and storage functions.

S O LU T I O N S FO R M E D I CA L
1 cm
The sheet-type piezoelectric system. Accurate biomonitoring is possible

without being noticed; the ultrathin and soft sheet system realizes attach-
ment of the device to the skin. (Credit: Osaka University)
As wearable technology and smart sensors become increas-

ingly popular, the problem of providing power to all of these
devices become more relevant. While the energy requirements
of each component may be modest, the need for wires or even
batteries become burdensome and inconvenient. That is why
new energy harvesting methods are needed. Also, the ability
for integrated health monitors to use ambient motion to both
NSK MBSA Motorized
power and activate sensors will help accelerate their adoption Ball Screw Actuator
for Compact, Precision
in doctor’s offices. Linear Motion
Now, an international team of researchers from Japan and
Austria has invented new ultraflexible patches with a ferroelec-
tric polymer that can not only sense a patient’s pulse and blood
pressure, but also power themselves from normal movements.
The key was starting with a substrate just 1 μm thick. Using a
strong electric field, ferroelectric crystalline domains in a
copolymer were aligned so that the sample had a large electric
Compact,
Comp
Compac
act,
t high-accuracy
hig
gh-
h accu
cura
racy
cy
dipole moment. Based on the piezoelectric effect, which is very
efficient in converting natural motion into small electric volt- posi
pos ti
tion
onin
ing
g th
positioning thro
roug
ugh
h se
through seam
amle
less
sss
seamless
ages, the device responds rapidly to strain or pressure changes. mechatronic
mech
mechat
atro
roni
nicc integration.
inte
integr
grat
atio
i n.
n
These voltages can be transduced either into signals for the
medical sensors or to directly harvest the energy (see Figure 1).
“Our e-health patches may be employed as part of screening Forr life
Fo life-critical
fe-cri
r tical medical, imagi
imaging
ging
ng
for lifestyle-related diseases such as heart disorders, signs of and laboratory
and la applications, NSK
stress, and sleep apnea,” says Andreas Petritz, first author on inte
integr
g ates a high-resolution
integrates
the paper.
The authors estimate that multilayer patches can harvest up to mo with our precision-
motor
200 mJ per day from biomechanical motions if placed on joints, machined
m chined ball screw
ma sccrew to
o create
e
like knees or elbows. This is enough to monitor cardiovascular Ball Screw
the MBSA Motorized Ball S rew
Sc
parameters several times a day. And the patches are so thin that
they are barely perceptible thus making a necessary evil for many Th
he result: smooth,
Actuator. The sm
moo
oth,
patients — daily health monitoring — less unpleasant. near-silent, extremely reliable
“We expect that our findings will assist in the development of and ultra-accurate motion,
other sheet-type sensor systems that can perform precise biomon-
itoring when affixed to the skin surface,” says Tsuyoshi Sekitani, improving efficiency and
senior author. Additional modules allow other features, such as throughput while lowering costs.
wireless communication with a smartphone or computer.
The article, “Imperceptible energy harvesting device and bio-
Enabling Automation in
medical sensor based on ultraflexible ferroelectric transducers
and organic diodes,” was published in Nature Communications at Motion & Control. WWW.NSKAUTOMATION.COM
DOI: https://doi.org/10.1038/s41467-021-22663-6.
For more information, visit https://resou.osaka-u.ac.jp.

Surgical Sutures Inspired by Human Tendons
Next-generation sutures These next-generation sutures contain and the INRS Énergie Matériaux Télé-
can deliver drugs, prevent a slippery, yet tough gel envelope, imitat- communications Research Centre.
ing the structure of soft connective tissues.
infections, and monitor In putting the TGS sutures to the test, the ■ Inspired by the Tendon
wounds. researchers found that the nearly friction- To tackle the problem, the team devel-
McGill University less gel surface mitigated the damage typ- oped a new technology that mimics the
Montreal, QC, Canada ically caused by traditional sutures. mechanics of tendons. “Our design is
Conventional sutures have been around inspired by the human body, the endo-
for centuries and are used to hold wounds tenon sheath, which is both tough and
Sutures are used to close wounds and together until the healing process is com- strong due to its double-network structure.
speed up the natural healing process, plete. But they are far from ideal for tissue It binds collagen fibers together while its
but they can also complicate matters by repair. The rough fibers can slice and dam- elastin network strengthens it,” says lead
causing damage to soft tissues with age already fragile tissues, leading to dis- author Zhenwei Ma, a PhD student under
their stiff fibers. To remedy the prob- comfort and post-surgery complications. the supervision of Assistant Professor
lem, researchers from Montreal have Part of the problem lies in the mismatch Jianyu Li at McGill University.
developed innovative tough gel between our soft tissues and the rigid The endotenon sheath not only forms a
sheathed (TGS) sutures inspired by the sutures that rub against contacting tissue, slippery surface to reduce friction with sur-
human tendon. say the researchers from McGill University rounding tissues in joints, but it also deliv-
ers necessary materials for tissue repair in
a tendon injury. In the same way, TGS
sutures can be engineered to provide per-
sonalized medicine based on a patient’s
needs, say the researchers.
■ Personalized Wound Treatment

“This technology provides a versatile
tool for advanced wound management.
We believe it could be used to deliver
drugs, prevent infections, or even monitor
wounds with near-infrared imaging,” says
Li of the Department of Mechanical
Engineering.
“The ability to monitor wounds locally
and adjust the treatment strategy for bet-
ter healing is an exciting direction to
explore,” says Li, who is also a Canada
Research Chair in Biomaterials and
Musculoskeletal Health.
Tough gel sheathed (TGS) sutures. (Credit: Zhenwei Ma, McGill University) For more information, visit www.mcgill.ca.
Exosome-Coated Stent Heals Vascular Injury, Repairs

Damaged Tissue
The stent delivers vessels from narrowing and deliver regen- The result is restenosis: a re-narrowing
regenerative stem cell- erative stem cell-derived therapy to of the blood vessel previously opened
blood-starved, or ischemic, tissue. by angioplasty.
derived therapy to blood- Angioplasty — a procedure that “The inflammatory response that
starved tissue. opens blocked arteries — often involves stents cause can decrease their benefit,”
North Carolina State University placing a metal stent to reinforce arteri- says Ke Cheng, corresponding author of
Raleigh, NC al walls and prevent them from collaps- the research. “Ideally, if we could stop
ing once the blockage is removed. smooth muscle cells from over-reacting
However, the stent’s placement usually and proliferating, but recruit endothelial
Researchers from North Carolina State causes some injury to the blood vessel cells to cover the stent, it would mitigate the
University have developed an exosome- wall, which stimulates smooth muscle inflammatory response and prevent reste-
coated stent with a “smart-release” trigger cells to proliferate and migrate to the nosis.” Cheng is the Randall B. Terry Jr.
that could both prevent reopened blood site in an attempt to repair the injury. Distinguished Professor in Regenerative

Ultra-Miniature - High Reliability
!

UNSURPASSED
UNSURPASSED QUALITY
QUALITY
THE
THE MEDICAL
MEDICAL INDUSTRY
INDUSTRY
COUNTS
COUNTS ON
ON
Exosomes (magenta) released from a stent in the blood vessel. (Credit: Cheng Lab)
Medicine at NC State and a professor in The research team performed in vitro

the NC State/UNC-Chapel Hill Joint testing to ensure biocompatibility and
Department of Biomedical Engineering. test the release mechanism. They found
There are drug-eluting stents cur- that in the presence of ROS, the exo-
rently in use coated with drugs that dis- somes released up to 60 percent of their
courage cell proliferation, but these secretions within 48 hours post-injury.
anti-proliferative drugs also delay stent In a rat model of ischemic injury, the
coverage by endothelial cells — which researchers compared their exosome-
are the cells healthcare providers want eluting stent (EES) to both a bare metal
to coat the stent. stent (BMS) and a drug-eluting stent
To solve this problem, Cheng and his (DES). They found that in comparison to
team developed a stent coating com- the BMS, their stent performed better in
posed of exosomes derived from mes- both decreasing stenosis and promoting
enchymal stem cells. Exosomes are tiny endothelial coverage. While the DES per-
nano-sized sacs secreted by most cell formed similarly to the EES in preventing
types. The idea behind the coating was restenosis, the EES was less injurious to
two-fold: first, since the exosomes are the vessel wall and had better endothelial
composed of materials not much differ- coverage overall. In addition, the exo-
ent from cell membranes, they camou- somes released from EES promoted mus-
flage the stent to trick smooth muscle cle regeneration in rats with hind limb
cells and the body’s immune system. ischemia. The researchers plan to test the
Second, the exosomes promote cover- stent in a large animal model with an eye
age of the stent by endothelial cells and, toward eventual clinical trials.
Medical Grade Crystals,
in the case of injury, travel downstream “This bioactive stent promotes vascu-
to the site to promote tissue repair. lar healing and ischemic repair, and a Oscillators and Sensors
To prevent premature depletion of patient wouldn’t need additional proce-

the therapy, the stent releases exosomes dures for regenerative therapy after the
when it encounters reactive oxygen stent is in place,” Cheng says. “The stent
species (ROS) — which are more preva- is the perfect carrier for exosomes, and
lent during an inflammatory response. the exosomes make the stent safer and

“Think of it as a smart release function more potent in tissue repair.”
for the exosomes,” Cheng says. “Ischemic The research appears in Nature
reperfusion injuries, which occur when Biomedical Engineering and was supported ISO 9001
blood flow is diminished and then by the National Institutes of Health and AS9100
reestablished, create a lot of ROS. Let’s the American Heart Association. NC State
say the heart is damaged by ischemia. postdoctoral research scholars Shiqi Hu STATEK CORPORATION
The enhanced ROS will trigger the and Zhenhua Li are co-first authors. 512 N. Main St., Orange, CA 92868
release of the exosomes on the stent, and This article was written by Tracey Peake, Tel. 714-639-7810 Fax 714-997-1256
regenerative therapy will travel through NC State. For more information, visit https://
the blood vessel to the site of the injury.” news.ncsu.edu. www . STATEK . com
Medical Design Briefs, June 2021 www.medicaldesignbriefs.com Free Info at http://info.hotims.com/79414-801

AM: Quickly Adapting in Tandem with Medical Innovation
ecently, we’ve seen a lot of talk around the topic of the
R healthcare industry still being in the midst of stabilizing
inventory and recovering from the post-pandemic peak. When
resources were being drained rapidly due to the increased
demand onset by the COVID-19 pandemic — hospitals, doc-
tor’s offices, and other healthcare providers were forced to
develop solutions quickly to maintain adequate safety meas-
ures for their staff and patients alike.
This last year is just one proof point of how additive manu-
facturing (AM) is shaping the narrative around health. While
AM brings speed and efficiency along with the option of an
alternative supply chain, it also brings the ability to create a
bespoke approach to patient care.
■ Why Adaptability Is Crucial

Additive manufacturing, otherwise frequently referred to as Custom orthotics created with additive manufacturing by Forecast 3D for
3D printing, was instrumental in assisting businesses to quickly FitMyFoot.
pivot their manufacturing services to personal protective
equipment (PPE) at scale during the peak of this unprecedent- Throughout the past couple of decades, engineers and sci-
ed period of time. The ability to respond quickly and adapt to entists have also been researching the possibility of using organ
the current landscape makes AM an ideal solution to produce cells and tissues in additive manufacturing. With this research,
parts that are in short supply, either due to a surge in demand the industry is working towards the ability to 3D print new
or as a result of supply chain disruption. When patient mor- organs for transplants.
phologies or supply deviate from the understood norm, the The applications of this technology would lead to the avail-
adaptability of 3D printing is crucial. ability of custom-made organs, derived from patient’s own cells
The manufacturing time for a 3D printed product can be as and tissues. These manufacturing breakthroughs would in turn
soon as a couple of hours, and depending on the application, lead to a significant decrease in the rejection rate of organ
this method could be quite faster than other methods of pro- transplants.3 This research shows the potential future possibil-
duction. When it comes to developing prototypes for new med- ities of 3D printing in the healthcare field.
ical devices, 3D printing can not only be much faster, it can
also be cost-effective to manufacture products. ■ Custom Applications of AM
With AM, supply can be determined based on the day’s cur- The AM process has immense value when it comes to creat-
rent demand or by printing “as needed” — leading to ing patient-specific solutions. Each 3D printed item can be
increased efficiency, by reducing the amount of wasted prod- developed to precise specifications for patients who require a
uct. There are also greater technical capabilities with 3D print- custom-fitted device. These medical devices range anywhere in
ing being able to produce lightweight, lattice-type structures, complexity from anatomically correct models for complex sur-
compared to injection molding manufacturing.1 geries to custom-made arch-supporting shoe inserts.
One type of custom solution that has been developed using
■ Materials Usage In AM 3D printing are life-sized anatomical prototypes — not to be
AM’s unique ability to utilize various polymer and metal confused with 3D printing of actual organs. These 3D models
materials is significant in medical device manufacturing. With are used as tools for complicated surgeries and educational
the varying properties of each filament, engineers can develop opportunities for medical students.
customized options for their end users. For example, materials Utilizing these resources as diagrams, doctors can gain a bet-
like nylon and titanium are ideal for use in healthcare produc- ter visual understanding while preparing for patient treat-
tion due to their biocompatibility.2 ments. This can be especially useful in surgeries that are not
routinely performed — or even when comparing the physiolo-
gy of an adult to a child for determining surgical procedures.2
An example of a custom AM hybrid-solution product would
be FitMyFoot’s arch support insoles. Doctors and engineers
identified the arch as being the most valuable component of
shoe support inserts; so they set forth in identifying a way to
custom build a product specific to the recipient.
Their solution was a combination of a stock injection-mold-
ed piece for the bottom layer, with the 3D printed arch support
being manufactured for the top layer. This unique approach
digitally maps each foot, using over 200 points to create a 3D
Anatomically accurate jaw created by Forecast 3D. printable file unique to each individual foot.4

NEW
Nasopharyngeal swabs created by Forecast 3D.
■ Other Capabilities of AM
Alternatively, sometimes the need for mass production out-
weighs customization. During a disruption brought on by nat-
ural disasters, pandemics, or even foreign conflicts, AM has the
ability to quickly produce products for consumer use without
supply chain disruption. Rapid prototyping processes were ini-
tially created to enable a component to be produced in a mat-
ter of hours, which would be much faster than other manufac-
turing processes that took multiple days.2 A great example of
this type of manufacturing being put into action was when AM
specialists all over the world were able to help quickly meet the
urgent needs of healthcare professionals and medical device
providers during the COVID-19 pandemic.
Early last year, Forecast 3D participated in a consortium with
healthcare partners to leverage rapid prototyping to develop
and distribute nasopharyngeal swabs on a large scale in as few
as eight weeks. At this moment, the company is able to mass-
produce up to 100,000 swabs per day with Multi Jet Fusion, Design engineers have
using a fleet of industrial-grade HP Jet Fusion 3D printing sys- strict requirements
tems.5 This mass production of swabs helped better prepare for medical device
healthcare workers in their ability to test for respiratory viruses. manufacturing
AM has a broad spectrum of applications. Not only do the
technological advancements over the last couple of decades
provide the ability to adapt quickly in high-pressure situations, EP3HTMed was
but 3D printing also empowers the healthcare field to continue formulated as a no-mix,
pushing the envelope of innovation when it comes to patient- Cures quickly easy to use system
centered care. in 5-10 minutes
at 300°F
References
1. Gayette, M. “Top Ten Advantages of Additive Manufacturing.” PTC, 13
Dec. 2019, www.ptc.com/en/blogs/cad/10-additive-manufacturing-
advantages.
2. “Intro to Additive Manufacturing: Materials and Performance,” Serviceable from
www.forecast3d.com/resource-center/materials-and-performance. Resists repeated
-60°F to +400°F
3. Yasinski, E. “On the Road to 3-D Printed Organs.” The Scientist cycles of steam
Magazine®, 26 Feb. 2020, www.the-scientist.com/news-opinion/on- sterilization
the-road-to-3-d-printed-organs-67187.
4. Hayford, R. “Customized Production With 3D Printing.” FORECAST
3D, 10 Dec. 2020, www.forecast3d.com/customized-production- Withstands
with-3d-printing. chemical
5. Lang, A. “Behind the Scenes of FORECAST 3D’s 1 Millionth Nasal Improves sterilants, EtO
Swab Production.” GKN Powder Metallurgy, 24 June 2020, manufacturing and radiation
news.pminnovationblog.com/blog/behind-the-scenes-of-forecast- efficiency
3ds-1-millionth-nasal-swab-production.
This article was written by Ted Rowan, Strategic Business

Development at Forecast 3D, Carlsbad, CA. For more information, visit Hackensack, NJ 07601 USA +1.201.343.8983 ∙ main masterbond.com
http://info.hotims.com/79414-344. www.masterbond.com

GlobAl
INNOVATIONS
Gold Nanoparticles Enable Long-Term Implantable Sensor ‘Tattoo’

Johannes Gutenberg University, Mainz, Germany
T
he idea of implantable sensors that manently. As they can be easily coated
continuously transmit information with various different receptors, they are
on vital values and concentrations an ideal platform for implantable sen-
of substances or drugs in the body has sors,” explains Dr. Katharina Kaefer, first
fascinated physicians and scientists for a author of the study.
long time. Such sensors enable the con- The novel concept is generalizable
stant monitoring of disease progression and has the potential to extend the
and therapeutic success. However, until lifetime of implantable sensors. In the
now, implantable sensors have not been future, gold nanoparticle-based im -
suitable to remain in the body perma- plantable sensors could be used to
nently but had to be replaced after a few observe concentrations of different
days or weeks. On the one hand, there is biomarkers or drugs in the body simul-
the problem of implant rejection be- taneously. Such sensors could find
cause the body recognizes the sensor as application in drug development, med-
a foreign object. On the other hand, the ical research, or personalized medicine
sensor’s color, which indicates concen- to aid in the management of chronic
Gold nanoparticles embedded in a porous
tration changes, has been unstable so far hydrogel can be implanted under the skin and diseases.
and would fade over time. Scientists at used as medical sensors. The sensor is like an
Johannes Gutenberg University Mainz invisible tattoo, revealing concentration changes ■ Interdisciplinary Teamwork Brought
of substances in the blood by color change.
(JGU) have developed a novel type of (Credit: Nanobiotechnology Group, JGU Depart- Success
implantable sensor that can be operated ment of Chemistry) Sönnichsen had the idea of using gold
in the body for several months. The sen- nanoparticles as implanted sensors in
sor is based on color-stable gold nano- ble tattoo, not much bigger than a 2004 when he started his research in bio-
particles that are modified with recep- penny and thinner than one millime- physical chemistry as a junior professor
tors for specific molecules. Embedded ter,” says Sönnichsen, head of the in Mainz. However, the project was not
into an artificial polymeric tissue, the Nanobiotechnology Group at JGU. realized until 10 years later in coopera-
nanogold is implanted under the skin Since the gold nanoparticles are in- tion with Dr. Thies Schroeder and Dr.
where it reports changes in drug con- frared, they are not visible to the eye. Katharina Kaefer, both scientists at JGU.
centrations by changing its color. However, a special kind of measurement Schroeder was experienced in biological
device can detect their color noninva- research and laboratory animal science
■ Implant Reports Information as sively through the skin. and had already completed several years
an ‘Invisible Tattoo’ In their study published in Nano of research work in the United States.
Prof. Carsten Sönnichsen’s research Letters, the JGU researchers implanted Kaefer was looking for an exciting topic
group at JGU has been using gold nano- their gold nanoparticle sensors under for her doctorate and was particularly
particles as sensors to detect tiny amounts the skin of hairless rats. Color changes interested in the complex and interdisci-
of proteins in microscopic flow cells for in these sensors were monitored follow- plinary nature of the project. Initial
many years. Gold nanoparticles act as ing the administration of various doses results led to a stipend awarded to
small antennas for light: They strongly of an antibiotic. The drug molecules are Kaefer by the Max Planck Graduate
absorb and scatter it and, therefore, transported to the sensor via the blood- Center (MPGC) as well as financial sup-
appear colorful. They react to alterations stream. By binding to specific receptors port from Stiftung Rheinland-Pfalz für
in their surroundings by changing color. on the surface of the gold nanoparticles, Innovation.
Sönnichsen’s team has exploited this con- they induce color change that is depend- “Such a project requires many people
cept for implanted medical sensing. ent on drug concentration. Thanks to with different scientific backgrounds.
To prevent the tiny particles from the color-stable gold nanoparticles and Step by step we were able to convince
swimming away or being degraded by the tissue-integrating hydrogel, the sen- more and more people of our idea,” says
immune cells, they are embedded in a sor was found to remain mechanically Sönnichsen. “Ultimately, it was inter-
porous hydrogel with a tissue-like con- and optically stable over several months. disciplinary teamwork that resulted in
sistency. Once implanted under the the successful development of the first
skin, small blood vessels and cells grow ■ Long-Lasting Implantable Sensors functional implanted sensor with gold
into the pores. The sensor is integrated “We are used to colored objects bleach- nanoparticles.”
in the tissue and is not rejected as a for- ing over time. Gold nanoparticles, howev- For more information, visit https://www.
eign body. “Our sensor is like an invisi- er, do not bleach but keep their color per- uni-mainz.de.

Coping with
the Pandemic:
Transitioning from
Aerospace to Medical
page 36
Resource Directory
page 40
Cover image supplied by Web Industries
2021 RESOURCE GUIDE

www.medicaldesignbriefs.com
Coping with
the Pandemic:
Transitioning from
Aerospace to Medical
W
hen the COVID-19 pan- scaled up to produce vast quan-
demic grounded much of tities of lateral flow immunoas-
the U.S. aerospace business say (LFI) antigen tests and per-
in 2020, Web Industries, a sonal protective equipment
Massachusetts-based contract manu- (PPE) in a matter of months. Its story
facturer, was forced to improvise. offers pointers for other companies
The business shifted its attention considering a similar transition.
and resources from aerospace, the
company’s largest profit center, to its Adapting to Changing Market Forces
medical sector, which had experi- The story begins with the pandem-
enced a surge of demand. ic’s bringing air travel to a halt and
The transition proved a daunting devastating the aircraft manufac-
challenge. It meant transforming vir- turing industry. As a result, the
tually every aspect of the company’s company suffered a slump in its
operations, from infrastructure to aerospace unit, which fashions
technology, logistics to staffing — all materials for parts in aircraft
while establishing strict guidelines to interiors, engines, wings, fuse-
prevent infection and keep employ- lages, and other structural ele-
ees safe. Web reinvented itself and ments. The slump triggered
Once completed, the kits are fed horizontally

into a flow wrapper and securely packaged in
foil pouches, with each pouch identified by
product information labels. A camera system
[not pictured] scans each printed label and
verifies that the information is
correct and meets
FDA requirements.
(Credit: Web
Industries)
36 www.medicaldesignbriefs.com 2021 Resource Guide

Web’s turn to the medical sector. Despite orizations (EUA) from the U.S. Food and antigen test device production and reas-
the challenges, the company had a solid Drug Administration (FDA), Web and its signed engineers and technical staff from
foundation on which to build. It was one partners were able to move forward much the aerospace division to Holliston. The
of the few U.S.-based contract manufac- quicker. The company faced a tight dead- relocated employees brought with them
turers with a network of domestic facto- line — 12 weeks — to complete the first experience in converting flexible materi-
ries capable of processing the type of stage of test development. als and working in a regulated industry to
flexible materials used in diagnostic manufacture the critical components for
tests. Plus, its medical business featured antigen test devices. At the same time, the
an LFI competency, established in 2014. company began a massive recruiting
Web consulted first with potential sup-
“It is not the effort to hire hundreds of new employees
ply partners and identified a new oppor- to fill manufacturing positions.
tunity in the medical field: producing
strongest of the The ramp-up in test production
rapid LFI antigen test devices. Antigen occurred in two phases. Phase one
tests are one of the two main diagnostic
species that entailed building capacity, mostly manu-
tools used to detect COVID-19 infections, al, to scale to 1 million devices per week.
along with molecular RT-PCR tests. Speed
survives, nor the Phase two involved full automation of all
and ease of use are LFI antigen test hall- processes and high-volume production
marks. The antigens recognize proteins
most intelligent. It is to exceed 2 million test devices per
on the virus’s surface by sampling a nasal week. Web, with its supply partners and
or throat swab. They can be administered
the one that is most strong support from its OEM partner,
and read close to the point of care. built a solid supply chain and procured
Results appear within 15–30 minutes. In
adaptable to change.” the necessary automation to support this
contrast, RT-PCR tests require specialized volume’s production of antigen test
— Charles Darwin
laboratory processing and can take a few devices. The production process also
hours up to an entire week for results. adhered to exceptional quality stan-
As with vaccines, diagnostic tests usually dards and took place in an FDA-
take years to design, develop, and Phase One: Proof of Concept regulated environment.
earn approval. But under Web invested millions in its Holliston, The COVID-19 antigen test kit contains
Emergency Use Auth- MA, LFI facility to accommodate rapid a plastic cartridge housing an LFI test
Web Industries converted from manual operations to completely automated production. The equipment
is now integrated seamlessly on the factory floor. Automated production steps include reagent deposi-
tion, lamination, test strip cutting and placement, and packaging. (Credit: Web Industries)
2021 Resource Guide www.medicaldesignbriefs.com 37

Coping with the Pandemic
Automated reel-to-reel machines precisely align and laminate treated materials. (Credit: Web Industries)
strip; a collection swab; positive and nega- was ensuring the safety of all employees. needed to maintain the right test pro-
tive control swabs; and a tube filled with Preventing COVID-19 infections among duction humidity. The company also
reagent fluid that also works as dropper. on site-based employees was critical. obtained additional offsite warehousing
During use, the sample swab is inserted Workers’ health was paramount. From to store test materials and components
into the tube and mixed with the reagent the pandemic’s start, a team of 14 Web and installed a new enterprise resource
solution. Fluid from the tube is then dis- Industries’ employees met every day, planning (ERP) software suite, which
pensed into a designated well on the test seven days a week, via Zoom to develop consolidated many business functions
device. The fluid flows across the device’s an infection-prevention strategy. Relying including production, distribution, fi-
treated sample pad, prompting a chemi- on guidance from the Centers for nance, and supply chain. The ERP sys-
cal response to the specimen. Trained cli- Disease Control and Prevention, the tem keeps close track of data needed to
nicians then insert the test into a portable team identified and implemented best meet FDA record-keeping requirements.
test-reading device to obtain the results. practices at all company locations. Web acquired capabilities that facilitat-
The initial development phase was Social distancing and masking were ed conversion from manual operations
mainly a batch process involving separate mandated, and temperature checks were to completely automated production.
manual operations. During this phase, required whenever an employee or visitor These included pick-and-place machines,
the lateral flow strips were cut using off- entered a Web facility. The team also devel- machine vision cameras, and check-
line cutting machines. Multiple layers of oped procedures for necessary actions in weigher systems. The equipment is now
material were aligned and laminated case of an infection, including rules on linked together and integrated seamlessly
together. Assembly technicians then man- quarantining workers and cleaning affect- on the factory floor. The company auto-
ually inserted the laminated strips into ed areas. The group continues to meet reg- mated each production step, including
the test cassettes. It was a labor-intensive ularly to review prevention practices. reagent deposition, lamination, test strip
process, but over the next few weeks Web cutting and placement, and packaging.
steadily increased its test kit output, and Phase Two: Full Automation In simplified form, the production
within just 12 weeks, Web produced After the initial market push, Web process works as follows: After large
12,000 devices, meeting its OEM’s time to scaled to full production. This entailed batches of reagent and conjugate are
market. This was confirmation to Web not just incremental changes, but a total made according to the test recipe, they
and its OEM partner that the project was transformation of operations and process- are deposited onto test strip materials
viable and could be successfully scaled to es. It meant producing millions of antigen via precision spraying or coating. Auto-
high-volume production. tests per week, rather than thousands. mated reel-to-reel machines precisely
To accommodate full automation, align and laminate the treated materials.
Taking Precautions Web repurposed and added thousands Cutting machines, formerly offline, were
A challenge to scaling from an initial of square feet at its Holliston facility. brought online and integrated with pick-
volume of 12,000 to a million per week This included more space for dry rooms and-place machines. These lightly grasp

and accurately insert the lateral flow current employees had to be trained in that can be purchased over the counter
strips into the test cassettes. Accurate the requisite skills. Holliston’s workforce and administered at home.
placement is necessary for the test to grew at an exponential rate. In less than The future might bring more chal-
function properly. Camera systems auto- a year it increased tenfold, from about 50 lenges for the company. After the
matically verify the correct positioning to over 500 employees. COVID-19 virus runs its course, new
of the strip. applications for diagnostic testing are
Once completed, the kits are fed hor- More Changes sure to arise. Some experts have stated
izontally into a flow wrapper and secure- Making Medical Gowns. Elsewhere, that the pandemic moved forward the
ly packaged in foil pouches, with each Web facilities geared up to supply PPE. acceptance of diagnostic testing by 10
pouch identified by product informa- The Ft. Wayne, IN, plant was configured to years. The acceptance of LFI antigen test
tion labels. Another camera system scans meet the demand for nonwoven materials has opened doors for more infectious
each printed label and verifies that the for protective gear for healthcare profes- and non-infectious disease tests. Ad-
information is correct and meets FDA sionals. When gown-demand eventually ditionally, demand for PPE will likely
requirements. The automation made outstripped available capacity, the compa- recede, and PPE manufacturing and
possible high-volume production. By ny employed its machinery and expertise engineering resources will be adapted to
early 2021, the company reached a key for aircraft engine and satellite compo- yet unknown applications.
milestone: several million antigen tests nents at facilities in Vermont, Georgia, and Likewise, when the aerospace industry
per week produced, packaged, and Texas to craft medical gowns. rebounds from the downturn, the com-
shipped to its OEM partner. New Testing Era. To date, Web’s OEM pany is prepared to support the uptick in
In addition to technology issues, the has shipped rapid LFI antigen tests for demand from the commercial aerospace
production ramp-up also resulted in per- COVID-19 to dozens of U.S. nursing market. Maintaining its core competency
sonnel-related challenges. Web’s HR homes, schools, government agencies, during this downturn is critical to ensure
department assisted employees in trans- and other settings for administration to that Web meets its customers’ needs.
ferring to Holliston from other Web facil- thousands of people. The tests inform This article was written by Kevin Young, Vice
ities. HR also scoured the country for individuals of their infection status with- President of Corporate Development & Medical,
new employees with specialized skills. It in 15 minutes. The success of rapid tests Web Industries, Marlborough, MA. He can be
was difficult, for example, to find work- and other innovations spurred by the reached at kyoung@webindustries.com. For more
ers with experience operating automated pandemic will likely usher in new gener- information, visit http://info.hotims.com/
pick-and-place machines. Often, new or ations of tests for various diseases, tests 79414-342.
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Medical Design Briefs 2021 Resource Directory
Avery Dennison Medical Nanolayr
3D Printing/Prototyping ..................40 Manufacturing Equipment ................46
www.medical.averydennison.com www.nanolayr.com
Adhesives/Coatings ..........................40 Materials/Plastics/Metals ................47
Assembly ..........................................41 Mechanical Components/Hardware......47
Molding ............................................48 Biocoat, Inc. NuSil Technology, LLC
Cleanroom ........................................41
Motion Control/Motors ....................48 https://biocoat.com www.avantorsciences.com/
Connectors/Interconnects/Switches....41
Consulting/FDA Compliance..............42 Optics/Optical Components ..............49 pages/en/nusil
Contract Manufacturing....................42 Packaging ........................................49 Chroma Color
Disposables ......................................43 Power Supplies & Batteries ..............50 www.chromacolors.com Panacol
Product Research/ www.panacol.com
Electronic Components ....................43 Design/Development ........................50
Electronics Manufacturing................44 CHT USA
Sensors/Detectors/Data Acquisition......51 www.cht-silicones.com
Filters & IV Components ..................45 Software............................................51 Para-Coat Technologies
Fluid Handling/Pumps & Valves ........45 Sterilization ......................................51 www.pctconformalcoating.com
In Vitro Diagnostics ..........................45 Test Services ....................................52 Coatings2Go
Laser Cutting/Marking......................45 Test/Inspection/Metrology ..............52 www.coatings2go.com Permabond Engineering
Machining/Stamping ........................46 Tubing & Extrusion............................52 Adhesives
www.permabond.com
3D Printing/ PlastiComp, Inc.

www.plasticomp.com
Prototyping Cotronics Corp.
PBC Linear
718-788-5533 Polymer Science
3D Systems 815-389-5600 www.polymerscience.com
sales@cotronicscorp.com
www.3dsystems.com sales@pbclinear.com
www.cotronics.com
www.pbclinear.com PPG
Axis Prototypes Inc. medicaldesignbriefs.com/rd121/ www.ppgindustrialcoatings.com
www.axisproto.com pbclinear Dymax
https://dymax.com
B9 Creations Precision Coating
Proto Labs
www.b9c.com www.protolabs.com Endura Coatings www.precisioncoating.com
www.enduracoatings.com
Boston Micro Fabrication – BMF PVA TePla
www.bmf3d.com Epoxies Etc. www.pvatepla.com/en
www.epoxies.com
Röhm
Epoxy Technology www.roehm.com
Renishaw
www.epotek.com
847-286-9953
Scapa Healthcare
usa@renishaw.com EpoxySet Inc. www.scapahealthcare.com
Diverse Optics Inc. www.renishaw.com www.epxoxysetinc.com
909-727-1550 medicaldesignbriefs.com/rd121/ Solar Atmospheres
info@diverseoptics.com renishaw Fluoramics, Inc. https://solaratm.com
https://diverseoptics.com/ www.fluoramics.com
medicaldesignbriefs.com/rd121/ Schmit Prototypes
www.schmitprototypes.com
diverseoptics Formacoat
Stratasys Direct Manufacturing www.formacoat.com
GPI Prototype & Manufacturing www.stratasysdirect.com
Services General Magnaplate
http://gpiprototype.com Specialty Coating Systems
Turner Medtech www.magnaplate.com
www.turnermedtech.com 317-244-1200
H.B. Fuller Company SCSsales@scscoatings.com
www.hbfuller.com/medical www.scscoatings.com
medicaldesignbriefs.com/rd121/
Adhesives/Coatings Hydromer, Inc scscoatings
MW Life Sciences http://hydromer.com
800-225-6975 3M Surmodics
sales@mwlifesciences.com www.3m.com Innovative Surface www.surmodics.com
www.mwlifesciences.com/ Technologies, Inc.
medicaldesignbriefs.com/rd121/ AccuCoat, Inc. Teknicote
mwlifesciences www.accucoatinc.com Jaro Corp. www.teknicote.com
www.jarocorp.com
Aculon
www.aculon.com Mactac
Adhesives Research www.mactac.com
www.adhesivesresearch.com
NSK Americas Teleflex Medical OEM
734-913-7500 800-295-8505
strackh@nsk-corp.com oeminfo@teleflex.com
nskautomation.com www.teleflexmedicaloem.com
Master Bond medicaldesignbriefs.com/rd121/
nsk Argon Medical Devices 201-343-8983 teleflexmedicaloem
800-927-4669 www.masterbond.com
cps.customerservice@ The Electrolizing Corp. of Ohio
argonmedical.com www.ecofohio.com
https://bit.ly/ArgonMedicalCPS

2021 Resource Directory
Adhesives/Coatings continued
VaporTech Air Logic

https://vaportech.com https://air-logic.com
Whyco Finishing Technology Altech Corp.

Kahle Automation Cadence, Inc.
www.whyco.com www.altechcorp.com
973-993-1850 800-252-3371
YES (Yield Engineering Kahle@KahleAutomation.com sales@cadenceinc.com Ametek Engineered Medical
Systems, Inc.) www.KahleAutomation.com www.cadenceinc.com Components
www.yieldengineering.com medicaldesignbriefs.com/rd121/ www.ametekemc.com
kahleautomation Chemtronics
www.chemtronics.com Amphenol Industrial Products
Group
Clean Air Products www.amphenol-industrial.com
Assembly www.cleanairproducts.com
C&K
MICRO HEMCO Corporation www.ckswitches.com
732-302-0800 www.hemcocorp.com
sales@micro-co.com Carlisle Interconnect
www.micro-co.com Technologies
www.CarlisleIT.com
Asahi Intecc USA, Inc.
760-473-4265 Micro Systems Technologies
www.mst.com Caton Connector Corp.
davidz@asahi-intecc-us.com www.caton.com
International Polymer
https://components.asahi-intecc. Engineering (IPE)
com/us/home CPC
877-410-3265
medicaldesignbriefs.com/rd121/ www.cpcworldwide.com
asahiintecc customerservice@ipeweb.com
www.ipeweb.com
EAO Corporation
Orchid Orthopedic Solutions www.eao.com
517-694-2300
sales@orchid-ortho.com Eldon James Corporation
www.orchid-ortho.com www.eldonjames.com
B.Braun Medical Inc. medicaldesignbriefs.com/rd121/
OEM Division orchid-ortho MICRO ERNI USA
484-240-8301 732-302-0800 www.erni.com/en/home
info@bbraun.com sales@micro-co.com
us.bbraunoem.com www.micro-co.com
bbraunoem
THE ARTHUR G. RUSSELL CO.
Bosch Rexroth 860-583-4109 Fischer Connectors, Inc.
www.boschrexroth-us.com david.aquilino@arthurgrussell. 678-393-5435
com PBC Linear Maria.carter@fischerconnectors.
www.arthurgrussell.com 815-389-5600 com
sales@pbclinear.com www.fischerconnectors.com
www.pbclinear.com medicaldesignbriefs.com/rd121/
medicaldesignbriefs.com/rd121/ fischerconnectors
Cadence, Inc. pbclinear
800-252-3371 Heilind Electronics
sales@cadenceinc.com Trelleborg Healthcare & www.heilind.com
www.cadenceinc.com Medical
224-223-2129 High Speed Interconnects
amy.swab@trelleborg.com www.highspeedint.com
www.trelleborg.com/healthcare Trelleborg Healthcare &
Medical Hirose Electric
Viant Medical 224-223-2129 www.hirose.com/us
Carl Stahl Sava Industries https://viantmedical.com amy.swab@trelleborg.com
973-750-9911 www.trelleborg.com/healthcare
info@savacable.com
savacable.com
savacable Cleanroom Interpower
Connectors/ 641-673-5000
Fabrico Medical AdvanceTEC Interconnects/ rbright@interpower.com
www.fabrico.com/medical www.advancetecllc.com www.interpower.com
Switches medicaldesignbriefs.com/rd121/
Haumiller Engineering BMP Medical interpower
www.haumiller.com www.biomedicalpolymers.com Advanced Interconnections Corp.
www.advanced.com Kensington Electronics
Herrmann Ultrasonics, Inc. www.keiconn.com
www.herrmannultrasonics.com

Connectors/Interconnects/Switches continued
Confluent Medical
Consulting/FDA Contract https://confluentmedical.com
Compliance Manufacturing
Donatelle
Keystone Electronics Corp.
www.donatellemedical.com
800-221-5510 Anthrotech, Inc. A&M Biomedical
kec@keyelco.com www.anthrotech.net www.ambiomedical.com
DRAVON MEDICAL INC.
www.keyelco.com www.dravon.com
medicaldesignbriefs.com/rd121/ CMIC Able Electropolishing
keystone www.en.cmicgroup.com www.ableelectropolishing.com
Flambeau Medical
www.flambeaumedical.com
Lemo USA, Inc. Admedes GmbH
www.lemo.com www.admedes.com
Flex
www.flex.com
Mill-Max Manufacturing Corp.
www.mill-max.com DDL, Inc. Forefront
952-941-9226 www.forefrontmedical.com
Minnesota Wire ddlinforequests@ddltesting.com
www.mnwire.com www.ddltesting.com Argon Medical Devices
medicaldesignbriefs.com/rd121/ 800-927-4669
Nicomatic ddl cps.customerservice@
www.nicomatic.com argonmedical.com
Emergo by UL https://bit.ly/ArgonMedicalCPS Halkey-Roberts Corporation
NorComp www.emergobyul.com
www.norcomp.net 727-471-4200
Sales@HalkeyRoberts.com
EMMA International Consulting www.halkeyroberts.com
NKK Switches Group, Inc.
www.nkkswitches.com www.emmainternational.com medicaldesignbriefs.com/rd121/
halkeyroberts
Asahi Intecc USA, Inc.
ODU USA Freudenberg Medical 760-473-4265 Hammill Medical
www.odu-usa.com www.freudenbergmedical.com davidz@asahi-intecc-us.com www.hammillmedical.com
https://components.asahi-intecc.
Icon plc com/us/home Industrias Plasticas Medicas
www.iconplc.com medicaldesignbriefs.com/rd121/ https://ipm.mx/en
asahiintecc
Innovatum
OFS www.innovatum.com Autocam Medical
888-342-3743 www.autocam-medical.com
www.ofsoptics.com Maetrics
medicaldesignbriefs.com/rd121/ www.maetrics.com Bihlermed
ofs International Polymer
www.bihlermed.com Engineering (IPE)
McCormick
Omnetics Connector LifeScience Consultants, LLC 877-410-3265
Biomerics customerservice@ipeweb.com
Corporation www.mccormicklifescience.com
https://biomerics.com www.ipeweb.com
www.omnetics.com
Phoenix Contact Jabil

www.phoenixcontact.com/usa_ www.jabil.com
home.htm
mdi Consultants, Inc. Cadence, Inc.
Reed Switch Developments Corp. 516-482-9001
www.reedswitchdevelopments. 800-252-3371
com info@mdiconsultants.com sales@cadenceinc.com
https://mdiconsultants.com/ JunoPacific
www.cadenceinc.com 763-703-5000
SAB North America sales@junopacific.com
www.sabcable.com Noblitt & Rueland Carclo Technical Plastics
www.fdaconsulting.com https://junopacific.com
www.carclo-ctp.com medicaldesignbriefs.com/rd121/
Parexel junopacific
www.parexel.com
QMS Consulting, Inc.

SCHURTER www.qms-consultancy.com/
707-636-3000 Carl Stahl Sava Industries
info.sinc@schurter.com QPharma 973-750-9911 Keystone Electronics Corp.
www.schurter.com www.qpharmacorp.com info@savacable.com 800-221-5510
medicaldesignbriefs.com/rd121/ savacable.com kec@keyelco.com
schurter Regulatory Compliance medicaldesignbriefs.com/rd121/ www.keyelco.com
Associates Inc. savacable
Smiths Interconnect www.rcainc.com keystone
www.smithsinterconnect.com Command Medical Products, Inc.
RJR Consulting, Inc. www.commandmedical.com
www.rjrconsulting.com

Contract Manufacturing continued
KMC Systems Stellartech Research Corp.

www.kmcsystems.com www.stellartec.com
Leistritz Tapecon Inc.

Orchid Orthopedic Solutions Diverse Optics Inc.
leistritzcorp.com www.tapecon.com
517-694-2300 909-727-1550
LINEMASTER SWITCH CORP. sales@orchid-ortho.com Teamvantage info@diverseoptics.com
www.linemaster.com www.orchid-ortho.com www.teamvantage.com https://diverseoptics.com
medicaldesignbriefs.com/rd121/ medicaldesignbriefs.com/rd121/
Mack Molding Co. orchid-ortho Tegra Medical diverseoptics
www.mack.com www.tegramedical.com
PDC, LLC – Precision Die Elcam Medical
Cutting www.elcam-medical.com
Marshall Manufacturing www.pdcintl.com
Company
www.marshallmfg.com Phillips-Medisize Corp.
www.phillipsmedisize.com
McLean Medical & Scientific Inc./ Teleflex Medical OEM
Surgical Technologies Inc. Plitek
www.plitek.com 800-295-8505
www.surgicaltechnolgies.com MICRO
oeminfo@teleflex.com
732-302-0800
MDI www.teleflexmedicaloem.com
sales@micro-co.com
www.moldeddevices.com medicaldesignbriefs.com/rd121/
teleflexmedicaloem www.micro-co.com
Medical Murray
www.medicalmurray.com Tessy Plastics
Promex
www.tessy.com
408-496-0222
info@promex-ind.com Timbercon
https://promex-ind.com www.timbercon.com MW Life Sciences
800-225-6975
Proven Process Medical Devices
https://provenprocess.com TouchMark sales@mwlifesciences.com
MICRO www.padprint.com www.mwlifesciences.com
732-302-0800 Providien medicaldesignbriefs.com/rd121/
sales@micro-co.com www.providienmedical.com mwlifesciences
www.micro-co.com
Pulse Technologies, Inc. NextPhase Medical Devices
Minnetronix www.pulsetechnologies.com https://nextphasemed.com
www.minnetronix.com Trelleborg Healthcare &
Q Medical Devices
https://qco.net/qmd Medical Poly-Pipets, Inc.
Model Solution USA 224-223-2129 www.polypipets.com
www.model-solution.com amy.swab@trelleborg.com
www.trelleborg.com/healthcare Super Brush LLC
www.superbrush.com
Triangle
Qosina www.trianglemfg.com
631-242-3000
MW Life Sciences UFP MedTech
800-225-6975
info@qosina.com
www.ufpmedtech.com Electronic
www.qosina.com
sales@mwlifesciences.com Components
www.mwlifesciences.com RBC Medical Innovations West Pharma
medicaldesignbriefs.com/rd121/ www.rbccorp.com www.westpharma.com ACCES I/O Products, Inc.
mwlifesciences www.accesio.com
RepExact, LLC
New Concept Technology, Inc. www.repexact.com Accu-Glass Products, Inc.
www.newconcepttech.com http://accuglassproducts.com
Saint-Gobain Life Sciences Disposables
Nolato Medical Components Alpha Wire
www.medical.saint-gobain.com
www.nolato.com www.alphawire.com
SMC Ltd.
www.smcltd.com American Standard Circuits, Inc.
www.asc-i.com
Argon Medical Devices Amperite Co., a division of
800-927-4669 Olympic Controls Corp.
OFS cps.customerservice@ www.amperite.com
888-342-3743 argonmedical.com
www.ofsoptics.com Spectrum Plastics Group https://bit.ly/ArgonMedicalCPS Analog Devices Inc.
medicaldesignbriefs.com/rd121/ 404-564-8560 www.analog.com
ofs marketing@spectrumplastics.
com AVX Corporation
www.spectrumplastics.com www.avx.com
Boyd Corp.
www.boydcorp.com

Electronic Components continued
Coilcraft CPS KOA Speer Electronics Inc. Princetel, Inc. Voltage Multipliers Inc.
www.coilcraft.com www.koaspeer.com www.princetel.com www.voltagemultipliers.com
Congatec Kontron Renesas Electronics Corp. Watlow

www.congatec.com www.kontron.com www.renesas.com www.watlow.com
Cornell Dubilier Electronics Laird Rolec Wavelength Electronics, Inc.

www.cde.com www.lairdtech.com www.rolec-usa.com/en www.teamwavelength.com
Crystal IS Rowebots Zippertubing

www.cisuvc.com www.rowebots.com www.zippertubing.com
Data Modul Inc.

www.data-modul.com Micro Crystal AG
sales@microcrystal.com
Diamond Systems
www.microcrystal.com Electronics
www.diamondsystems.com SCHURTER Manufacturing
Microchip Technology, Inc. 707-636-3000
ENM Company
www.enmco.com www.microchip.com info.sinc@schurter.com A2e Technologies
www.schurter.com www.a2etechnologies.com
First Sensor, Inc. Microtips Technology medicaldesignbriefs.com/rd121/
www.first-sensor.com www.microtipsusa.com schurter Cirtronics Corporation
www.cirtronics.com
Gowanda Components Group Minco Products, Inc. Sensirion
www.gowandacomponents www.minco.com www.sensirion.com Creation Technologies
group.com www.creationtech.com
Mouser Electronics Servoflo Corporation
Heatron, Inc. www.mouser.com www.servoflo.com EI Microcircuits, Inc.
www.heatron.com www.eimicro.com
Skyworks Solutions, Inc.
Hightec MC AG www.skyworksinc.com IEC Electronics
www.hightec.ch www.iec-electronics.com
InfraTec NSK Americas

www.infratec-infrared.com 734-913-7500
strackh@nsk-corp.com
nskautomation.com Statek Corporation
medicaldesignbriefs.com/rd121/ 714-639-7810 Innovative Sensor
nsk sales@statek.com Technology – IST AG
www.statek.com 702-894-9891
Innovative Sensor ivelina.peneva@ist-ag.com
Technology - IST AG STMicroelectronics www.ist-ag.com/en-us
702-894-9891 www.st.com medicaldesignbriefs.com/rd121/
ivelina.peneva@ist-ag.com ist-ag
www.ist-ag.com/en-us Sunnex
OFS www.SunnexLights.com
medicaldesignbriefs.com/rd121/ International Manufacturing
888-342-3743 Services
ist-ag
www.ofsoptics.com TDK Electronics Inc. www.ims-resistors.com
medicaldesignbriefs.com/rd121/ www.tdk-electronics.tdk.com
ofs JADAK, a Novanta Company
TE Connectivity www.jadaktech.com
ON Semiconductor www.te.com
www.onsemi.com
Interpower Tech-Etch, Inc.
641-673-5000 www.tech-etch.com
rbright@interpower.com
www.interpower.com Technologic Systems
www.embeddedARM.com Keystone Electronics Corp.
medicaldesignbriefs.com/rd121/ 800-221-5510
interpower Orthogone Tekscan kec@keyelco.com
514-316-1917 www.tekscan.com www.keyelco.com
Johanson Technology sbriere@orthogone.com
www.johansontechnology.com medicaldesignbriefs.com/rd121/
www.orthogone.com Teledyne Lumenera keystone
www.lumenera.com
Peerless Electronics, Inc. Kimball Electronics
www.peerlesselectronics.com TTI, Inc. www.kimballelectronics.com
www.ttiinc.com
Pressure Profile Systems Molex Incorporated
Keystone Electronics Corp. www.pressureprofile.com UTE Microwave, Inc. www.molex.com
800-221-5510 http://utemicrowave.com
kec@keyelco.com NEO Tech
VersaLogic www.neotech.com
www.keyelco.com www.versalogic.com
keystone

Electronics Manufacturing continued
Fluid Handling/ Laser Cutting/

Pumps & Valves Marking
Orthogone Innovative Sensor
514-316-1917 AW-Lake Company Technology – IST AG
sbriere@orthogone.com www.aw-lake.com 702-894-9891
www.orthogone.com ivelina.peneva@ist-ag.com
Backer Hotwatt Inc. www.ist-ag.com/en-us
PalPilot www.hotwatt.com medicaldesignbriefs.com/rd121/ AMADA WELD TECH INC.
www.palpilot.com ist-ag 626-303-5676
Bimba Manufacturing Barbara.Kuntz@
PCBCart www.bimba.com IVEK Corporation AmadaWeldTech.com
www.pcbcart.com www.ivek.com www.amadaweldtech.com
Precision Assembly Iwaki America amadaweldtech
Technologies, Inc. iwakiamerica.com
www.pat-inc.com
Clippard
PVA
www.pva.net 877-245-6247
sales@clippard.com
QoSTronics www.clippard.com Cadence, Inc.
medicaldesignbriefs.com/rd121/ Kahle Automation
www.qostronics.com 800-252-3371
clippard 973-993-1850
sales@cadenceinc.com
Kahle@KahleAutomation.com
TRICOR Systems Inc. www.cadenceinc.com
www.tricor-systems.com Cole-Parmer www.KahleAutomation.com
www.cole-parmer.com medicaldesignbriefs.com/rd121/ FOBA
Universal Electronics kahleautomation
www.fobalaser.com
www.ueinc.com Diener Precision Pumps
www.dienerprecisionpumps.com KNF Neuberger, Inc.
Laser Impressions
www.knfusa.com
www.laserimpressions.com
KOGANEI International
America, Inc. MECCO
Filters & www.koganeiusa.com www.mecco.com
IV Components Dynaflo, Inc.
Parker Precision Fluidics MeKo Laser Material
877-244-4330 Processing
Ark-Plas www.parker.com/ppf
www.ark-plas.com sales@dynaflopumps.com www.MeKo.de
www.dynaflopumps.com
Gore Micron Laser Technology
www.gore.com www.micronlaser.com
Injectech, LLC MKS Spectra-Physics

The Lee Company www.spectra-physics.com
www.injectech.net
860-399-6281
Emerson ASCO
russog@theleeco.com Pulse Systems
800-927-2726
www.theleeco.com www.pulsesystems.com
www.Emerson.com/ASCO
theleeco Resonetics
Fabco-Air, Inc.
International Polymer www.fabco-air.com www.resonetics.com
Engineering (IPE)
877-410-3265 Fairchild
customerservice@ipeweb.com www.fairchildproducts.com
In Vitro Diagnostics
www.ipeweb.com
Fluid Metering Inc.
www.fmipump.com BSI Spectralytics
www.bsigroup.com 320-275-2118
sales@spectralytics.com
Corgenix
www.spectralytics.com
www.corgenix.com
Kahle Automation medicaldesignbriefs.com/rd121/
973-993-1850 spectralytics
Halkey-Roberts Corporation Creative Diagnostics
Kahle@KahleAutomation.com www.creative-diagnostics.com
727-471-4200
www.KahleAutomation.com Sales@HalkeyRoberts.com
medicaldesignbriefs.com/rd121/ www.halkeyroberts.com NanoComposix
kahleautomation www.nanocomposix.com
halkeyroberts
Porex Corporation TUV Rheinland Spectrum Plastics Group
www.porex.com of North America, Inc. 404-564-8560
Industrial Specialties Mfg.
www.industrialspec.com www.tuv.com/usa/en/ marketing@spectrumplastics.
Röchling Group com
www.roechling.com/us www.spectrumplastics.com

Laser Cutting/Marking continued
Kemac Technology, Inc. BitFlow, Inc.

www.kemactech.com www.bitflow.com
Kenmode Coherent
Trotec Laser rms Company
www.kenmode.com www.coherent.com
866-226-8505 763-786-1520
trish.steding@troteclaser.com Lyons sales@machine.com DENSO Robotics
troteclaser.com www.lyons.com https://rmsmachining.com www.densorobotics.com
troteclaser M&K Engineering, Inc. rmscompany EMUGE-FRANKEN
www.mkeng.com www.emuge.com
VitalDyne Medical, Inc.
www.vitaldyne.com Glebar
www.glebar.com
rms Surgical Greenerd Press & Machine Co.

Meier Tool & Engineering 763-576-6497 www.greenerd.com
Machining/ sales@rmssurgical.com
763-427-6275
Stamping sales@meiertool.com https://rmssurgical.com Haas Multigrind LLC
https://meiertool.com medicaldesignbriefs.com/rd121/ www.multigrind.com/en
Alpha Grainger Manufacturing, Inc. medicaldesignbriefs.com/rd121/ rmssurgical
www.agmi.com meiertool JULABO USA
Sandvik Coromant www.julabo.us
Autosplice, Inc. www.sandvik.coromant.com
www.autosplice.com
Sorenson Precision
Batten & Allen www.sorensonprecision.com
www.batten-allen.com MICRO
Swiss Automation Kahle Automation
732-302-0800
www.swissautomation.com 973-993-1850
sales@micro-co.com
www.micro-co.com Kahle@KahleAutomation.com
Twin City EDM & Mfg, Inc. www.KahleAutomation.com
www.twincityedm.com medicaldesignbriefs.com/rd121/
Microcision
Cadence, Inc. www.microcision.com kahleautomation
800-252-3371 Vaupell
Vaupell.com Kinematic Automation
sales@cadenceinc.com
www.cadenceinc.com www.kinematic.com
Xact Wire EDM
www.xactedm.com Kurt Manufacturing Company
www.kurtworkholding.com
MW Life Sciences
800-225-6975
sales@mwlifesciences.com
Carl Stahl Sava Industries www.mwlifesciences.com/ Manufacturing
973-750-9911 medicaldesignbriefs.com/rd121/
info@savacable.com mwlifesciences
Equipment
Marposs
savacable.com
Norman Noble, Inc. 248-370-0404
savacable www.nnoble.com marposs@us.marposs.com
www.marposs.com
CMT OKAY Industries medicaldesignbriefs.com/rd121/
www.cmtco.com www.okayind.com 3DT LLC marposs
262-253-6700
Criterion Tool & Die Orbel Corporation sales@3DTLLC.com Mikrotron
www.criteriontool.com www.orbel.com www.mikrotron.de
www.3DTLLC.com
CSS 3dt Norton | Saint-Gobain
www.ctspring.com Abrasives
www.nortonabrasives.com/en-
us
Disposable Instrument
Company Inc.
Orchid Orthopedic Solutions OK Sealer – Division of OK
www.disposableinstrument.com
517-694-2300 International
sales@orchid-ortho.com AMADA WELD TECH INC. www.oksealer.com
GMI Corp.
www.orchid-ortho.com 626-303-5676
www.teamgmi.net Barbara.Kuntz@
medicaldesignbriefs.com/rd121/ On Line Controls, Inc.
orchid-ortho AmadaWeldTech.com www.onlinecontrols.com
Hobson & Motzer
www.amadaweldtech.com
www.hobsonmotzer.com
Penn United Technologies Inc. medicaldesignbriefs.com/rd121/ Palomar Technologies, Inc.
www.pennunited.com amadaweldtech www.palomartechnologies.com
K.S. of West Virginia
www.kswv.us

Manufacturing Equipment continued
Covestro Memry
www.covestro.com www.memry.com
Metal Cutting Corporation

PBC Linear Asahi Intecc USA, Inc.
https://metalcutting.com
815-389-5600 760-473-4265
sales@pbclinear.com Momentive davidz@asahi-intecc-us.com
www.pbclinear.com www.momentive.com https://components.asahi-intecc.
CS Hyde Company
medicaldesignbriefs.com/rd121/ com/us/home
pbclinear 800-461-4161
Poly-Med Inc. medicaldesignbriefs.com/rd121/
resources@cshyde.com asahiintecc
www.cshyde.com www.poly-med.com
medicaldesignbriefs.com/rd121/ Bal Seal Engineering, Inc.
cshyde RTP Company
www.rtpcompany.com www.balseal.com
Curbell Plastics, Inc.
Renishaw
www.curbellplastics.com
847-286-9953
usa@renishaw.com
www.renishaw.com
medicaldesignbriefs.com/rd121/ Teleflex Medical OEM Carl Stahl Sava Industries
renishaw 800-295-8505 973-750-9911
oeminfo@teleflex.com info@savacable.com
Simco-Ion Industrial Diverse Optics Inc.
www.teleflexmedicaloem.com savacable.com
www.simco-ion.com 909-727-1550
info@diverseoptics.com savacable
Thermal Care https://diverseoptics.com teleflexmedicaloem
www.thermalcare.com medicaldesignbriefs.com/rd121/ DESIGNATRONICS INC.
diverseoptics www.designatronics.com
Trumpf
www.trumpf.com Dow Electri-Flex Company
www.dow.com/en-us www.electriflex.com
Z-Laser Trotec Laser
www.z-laser.com Dunmore 866-226-8505
www.dunmore.com trish.steding@troteclaser.com
troteclaser.com
DuPont medicaldesignbriefs.com/rd121/
www.dupont.com troteclaser
Materials/Plastics/ Indo MIM Inc.
Metals Eastman 609-651-8238
www.eastman.com infous@indo-mim.com
Achilles USA www.indo-mim.com
www.achillesusa.com Edge International medicaldesignbriefs.com/rd121/
www.edgeintl.com indo-mim
Ulbrich Stainless Steels &
Anomet Products Special Metals, Inc. John Evans Sons, Inc.
www.anometproducts.com Elkem 800-243-1676
www.elkem.com/silicones www.springcompany.com
info@ulbrich.com
www.ulbrich.com
EMS-GRIVORY medicaldesignbriefs.com/rd121/
www.emsgrivory.com ulbrich
Asahi Intecc USA, Inc. Fort Wayne Metals Wacker Chemical Corporation
www.fwmetals.com Keystone Electronics Corp.
760-473-4265 www.wacker.com
800-221-5510
davidz@asahi-intecc-us.com kec@keyelco.com
Foster Corporation
https://components.asahi-intecc. www.fostercomp.com www.keyelco.com
com/us/home medicaldesignbriefs.com/rd121/
medicaldesignbriefs.com/rd121/ keystone
asahiintecc
Indium Corporation Mechanical
www.indium.com
Components/ Lampin
Bally Ribbon Mills
www.ballyribbon.com Hardware www.lampin.com
Medicoil
Banner Medical Innovations Acme Monaco Corporation
www.medicoil.com
www.banner-medical.com www.acmemonaco.com
Engineering (IPE) Microlap Technologies, Inc.
Advanced Cooling Technologies
877-410-3265 www.microlap.com
https://go.1-act.com/medical-
customerservice@ipeweb.com thermal-management
www.ipeweb.com NBK America LLC
AG Industries, Filtration Group www.nbk1560.com/en-US
Boston Centerless
Lubrizol LifeSciences www.agindustries.com
781-994-5000
www.lubrizol.com/lifesciences
dperilli@bostoncenterless.com
www.bostoncenterless.com

Mechanical Components/Hardware continued
Beaumont Premold Corp.

www.beaumontinc.com www.premoldcorp.com Motion Control/
ProMed
Motors
Crescent Industries
NSK Americas
www.crescentind.com https://promedmolding.com
734-913-7500 ABM Drives
strackh@nsk-corp.com www.abm-drives.com
Currier Plastics, Inc PSI Molded Plastics
nskautomation.com www.currierplastics.com www.psimp.com
medicaldesignbriefs.com/rd121/ Aerotech, Inc.
nsk www.aerotech.com/medical
PTI Engineered Plastics
www.teampti.com
QMD Allied Motion
https://qco.net/qmd www.alliedmotion.com
RenyMed
Da/Pro Rubber, Inc. www.renymed.com
Southco BEI Kimco
www.southco.com 918-258-9386 www.beikimco.com
sales@daprorubber.com Seaway Plastics Engineering
www.daprorubber.com seawayplastics.com
Steinmeyer
www.steinmeyer.com Seitz LLC
www.seitzllc.com
Steute Meditech, Inc
www.SteuteMeditech.com Senior Metal Bellows Carl Stahl Sava Industries
www.metalbellows.com 973-750-9911
Diverse Optics Inc. info@savacable.com
909-727-1550 Silcotech North America Inc. savacable.com
info@diverseoptics.com www.silcotech.com medicaldesignbriefs.com/rd121/
Molding https://diverseoptics.com savacable
medicaldesignbriefs.com/rd121/ SIMTEC Silicone Parts
Aberdeen Technologies, Inc. diverseoptics www.simtec-silicone.com Custom Machine and Tool Co.,
www.aberdeentech.com Inc.
Diversified Plastics, Inc. www.cmtco.com
www.divplast.com
Del-Tron Precision, Inc.
Empire Precision Plastics deltron.com
www.empireprecision.com Spectrum Plastics Group
Accumold ebm-papst, Inc.
404-564-8560
515-964-5741 Husky www.ebmpapst.us
marketing@spectrumplastics.
micromolding@accu-mold.com www.husky.ca com
Energid
www.accu-mold.com www.spectrumplastics.com
ICO Mold www.energid.com
accumold https://icomold.com
Thomas Division
FAULHABER MICROMO LLC
www.gd-thomas.com
Advanced Molding Matrix Plastic Products www.faulhaber.com
Technologies www.matrixplastic.com
www.advancedmt.com GAM Enterprises
www.gamweb.com
Albright
http://albright1.com HANNING ELEKTRO-WERKE
Trelleborg Healthcare GmbH & Co. KG
& Medical www.hanning-hew.com
Medbio LLC 224-223-2129
616-245-0214 amy.swab@trelleborg.com Haydon Kerk Pittman
info@medbioinc.com www.trelleborg.com/healthcare www.haydonkerkpittman.com
www.medbioinc.com
Argon Medical Devices TriContinent by Gardner Denver IKO International Inc. –
800-927-4669 MTD Micro Molding www.tricontinent.com Parsippany, NJ
cps.customerservice@ www.mtdmicromolding.com www.ikont.com
argonmedical.com Watson-Marlow Pumps Group
https://bit.ly/ArgonMedicalCPS Nypromold www.watson-marlow.com Kollmorgen
www.nypromold.com www.kollmorgen.com
Westfall Technik
Pelham Plastics www.westfalltechnik.com LM76
www.pelhamplastics.com www.lm76.com
Wright Engineered Plastics
Photonis www.wepmolding.com Ludl Electronic Products Ltd.
B.Braun Medical Inc. www.photonisusa.com
OEM Division www.ludl.com
484-240-8301 Xometry
Plastic Design International, www.xometry.com maxon
info@bbraun.com Inc.
us.bbraunoem.com www.maxongroup.us
www.plasticdesign.com
bbraunoem Molon Motor & Coil Corporation
www.molon.com

Motion Control/Motors continued
Moog Components Group Telco Intercontinental Corp. Fiber Optic Center, Inc.
www.moog.com www.telcointercon.com www.focenter.com Packaging
Moticont Thomson Industries Fiberoptic Components, LLC Accu Seal Corporation
www.moticont.com www.thomsonlinear.com www.lightguides.com www.accu-seal.com
Nexen Group, Inc. Tolomatic Hamamatsu Corporation Amcor

www.nexengroup.com www.tolomatic.com www.hamamatsu.com www.amcor.com
Nippon Pulse America, Inc. IMPERX, Inc. Atlas Vac Machine. LLC
www.nipponpulse.com www.imperx.com www.atlasvac.com
Kugler of America, Ltd.

Velmex Inc www.kuglerofamerica.com
585-657-6151
kreissig@velmex.com Laser Components USA, Inc.
NSK Americas www.velmex.com www.laser-components.com B.Braun Medical Inc.
734-913-7500 OEM Division
strackh@nsk-corp.com Lighthouse Imaging 484-240-8301
nskautomation.com www.lighthouseoptics.com info@bbraun.com
medicaldesignbriefs.com/rd121/ us.bbraunoem.com
nsk Optics/ Marktech Optoelectronics medicaldesignbriefs.com/rd121/
www.marktechopto.com bbraunoem
Optimal Engineering Systems,
Optical Components
Inc. Micro Laser Systems, Inc. Brentwood Medical
www.oesincorp.com Access Optics www.microlaser.com https://medical.brentwood
www.accessoptics.com industries.com/packaging
Parker Hannifin – Mirrorcle Technologies Inc.
Electromechanical & Drives Div. Archer OpTx www.mirrorcletech.com Caplugs
http://parker.com/emdusa www.archeroptx.com www.caplugs.com
Modulight, Inc.
PI Avo Photonics www.modulight.com Custom Case Group
www.pi-usa.us www.avophotonics.com http://customcasegroup.com
Portescap BEA Lasers

www.portescap.com http://bealasers.com
Power-Packer Berliner Glas OFS

www.powerpackerus.com www.berlinerglas.com 888-342-3743 DDL, Inc.
www.ofsoptics.com 952-941-9226
QuickSilver Controls, Inc. Cambridge Technology, a medicaldesignbriefs.com/rd121/
Novanta Company ddlinforequests@ddltesting.com
www.QuickSilverControls.com ofs
www.cambridgetechnology.com www.ddltesting.com
Reliant Systems, Inc. Optikos Corporation ddl
www.reliantsystemsinc.com Canon Medical Systems www.optikos.com
https://us.medical.canon
DuraTech Industries
Opto Diode Corp., a Division of www.duratech.com
ITW
www.optodiode.com Gel-Pak
www.gelpak.com
Renishaw OSI Optoelectronics
847-286-9953 Diverse Optics Inc. www.osioptoelectronics.com J-Pac Medical
usa@renishaw.com 909-727-1550 www.j-pacmedical.com
www.renishaw.com info@diverseoptics.com Photron, Inc.
medicaldesignbriefs.com/rd121/ https://diverseoptics.com www.photron.com Millstone Medical
renishaw medicaldesignbriefs.com/rd121/ www.millstonemedical.com
diverseoptics Precision Glass & Optics
Schneeberger, Inc. www.pgo.com OKW Enclosures, Inc.
www.schneeberger.com Eagleyard Photonics GmbH www.okwenclosures.com
www.eagleyard.com Reynard Corporation
Sepac www.reynardcorp.com
https://sepac.com Edmund Optics
www.edmundoptics.com RPMC Lasers, Inc.
Southern Gear www.rpmclasers.com
www.southerngear.net Enable Inc.
Xenon Corporation PBC Linear
www.enableimaging.com
www.xenoncorp.com 815-389-5600
Stock Drive Products/Sterling sales@pbclinear.com
Instrument Epix, Inc.
www.sdp-si.com www.epixinc.com Zygo Corporation www.pbclinear.com
www.zygo.com medicaldesignbriefs.com/rd121/
pbclinear

Packaging continued
Pixus Technologies COSEL USA Inc.

www.pixustechnologies.com www.coselusa.com
Placon Emerson-SolaHD
www.placon.com Argon Medical Devices MW Life Sciences
www.emerson.com/
en-us/automation/solahd 800-927-4669 800-225-6975
Prent Corporation cps.customerservice@ sales@mwlifesciences.com
www.prent.com GlobTek, Inc. argonmedical.com www.mwlifesciences.com
www.globtek.com https://bit.ly/ArgonMedicalCPS medicaldesignbriefs.com/rd121/
mwlifesciences
Inspired Energy LLC Baren-Boym
www.inspiredenergy.com www.baren-boym.com Nortech Medical Solutions
www.nortechsys.com
BB7, Inc.
QTS Medical Device
Outsourcing www.bb7.com Northeast Biomedical
www.northeastbiomed.com
952-942-8321
Boston UX
info@qtspackage.com www.bostonux.com Novo Engineering
https://qtspackage.com/ Interpower www.novoengineering.com
medicaldesignbriefs.com/rd121/ 641-673-5000 Cambridge Consultants
qts rbright@interpower.com www.cambridgeconsultants.com
www.interpower.com
QuickPouch CCS Cooper Consulting Service,
www.quickpouch.com interpower LLC
www.cooperconsultingservice.com
NSK Americas
Littelfuse, Inc. 734-913-7500
www.littelfuse.com Celestica
www.celestica.com strackh@nsk-corp.com
nskautomation.com
MEGA Electronics, Inc.
Spectrum Plastics Group Charles River medicaldesignbriefs.com/rd121/
www.megaelectronics.com nsk
404-564-8560 www.criver.com
marketing@spectrumplastics. Mike Doherty Designs, LLC
com Cooper Consulting Service Omnica
https://mikedohertydesigns.com/
www.cooperconsultingservice.com www.omnica.com
www.spectrumplastics.com/
Minmax Power Inc.
Technipaq, Inc. www.minmax.com.tw/en Cyient
www.technipaq.com www.cyient.com
Murata Power Solutions
Tek Pak Inc. Daedalus
www.murata-ps.com
www.tekpak.com https://daed.com Orchid Orthopedic Solutions
Polytron Devices 517-694-2300
TEQ D&K Engineering sales@orchid-ortho.com
www.polytrondevices.com www.dkengineering.com
www.teqnow.com www.orchid-ortho.com
Thoro Packaging Quail Electronics, Inc. medicaldesignbriefs.com/rd121/
Delve orchid-ortho
www.thoropkg.com www.quail.com www.delve.com
RRC Power Solutions Design Catapult
www.rrc-ps.com www.designcatapult.com
Power Supplies & Triad Magnetics DW Product Development, Inc.
Batteries www.triadmagnetics.com www.dwcanada.com Orthogone
514-316-1917
Absopulse Electronics Ltd. XP Power Eclipse Product Development sbriere@orthogone.com
www.absopulse.com www.xppower.com www.eclipsepd.com www.orthogone.com
Astrodyne TDI Forma Medical Device Design Sagentia

www.astrodynetdi.com www.formamedical www.sagentia.com
devicedesign.com
Autec Power Systems Product Research/ StarFish Medical
www.autec.com HDA Technology https://starfishmedical.com
Design/Development www.hdatechnology.com
Bel Power Solutions & Protection Start Medical Product
https://belfuse.com/ 42 Technology HS Design Development
power-solutions www.42technology.com www.hs-design.com www.startllc.com
Accurate Medical Systems, Inc. Idneo Sterling Medical Devices

www.accuratemedicalsystems.com www.idneo.com www.sterlingmedicaldevices.com
Applied Design Technologies Inc. Insight PD Sunrise Labs

www.applieddesigntechnologies. www.insightpd.com www.sunriselabs.com
Cell-Con, Inc. com
800-771-7139 Ion Design Syprosoft Engineering
sales@cell-con.com www.iondesign.com www.syprosoft.com
www.cell-con.com

Product Research/Design/Development continued
TecMed Incorporated Gems Sensors & Controls

www.tecmed.com www.gemssensors.com Software
HBM, Inc. ANSYS Orthogone
www.hbm.com www.ansys.com
514-316-1917
Heraeus Sensor Technology USA sbriere@orthogone.com
Arena Solutions
www.hst-us.com www.arenasolutions.com www.orthogone.com
Teleflex Medical OEM
800-295-8505 Photon Engineering LLC
oeminfo@teleflex.com Honeywell Safety and ARM
Productivity Solutions www.photonengr.com
www.teleflexmedicaloem.com www.arm.com
https://sps.honeywell.com/us/en
medicaldesignbriefs.com/rd121/ Precision Systems, Inc.
teleflexmedicaloem Barr Group
www.psi-software.com
www.barrgroup.com
UEGroup Promenade Software Inc.
www.uegroup.com Check Point www.promenadesoftware.com
www.checkpoint.com
Worrell Innovative Sensor Propel
www.worrell.com Technology - IST AG COMSOL www.propelplm.com
702-894-9891 www.comsol.com
Ximedica ivelina.peneva@ist-ag.com Siemens Embedded, a segment
www.ximedica.com www.ist-ag.com/en-us Critical Manufacturing of Siemens Digital Industries
medicaldesignbriefs.com/rd121/ www.criticalmanufacturing.com Software
ist-ag www.siemens.com/embedded
Cytellix
Introtek International https://cytellix.com Sparta Systems
Sensors/Detectors/ www.introtek.com www.spartasystems.com
Dassault Systèmes SolidWorks
Data Acquisition Micronor Inc. Corp. SpiderOak
www.micronor.com www.solidworks.com www.spideroak.com
AMS AG
https://ams.com ETQ Stat-Ease, Inc.
www.etq.com www.statease.com
Geisel Software, Inc. Tietronix Medical

OFS www.geisel-software.com https://medical.tietronix.com
888-342-3743
ATI Industrial Automation Grand Avenue Software Wibu-Systems USA
www.ofsoptics.com
919-772-0115 www.grandavenue.com www.wibuusa.com
info@ati-ia.com ofs
www.ati-ia.com Green Hills Software Wind River
OmniVision Technologies, Inc. www.ghs.com www.windriver.com
CAS Dataloggers www.ovt.com
www.dataloggerinc.com ICS Zontec Inc.
www.ics.com www.zontec-spc.com
City Technology
www.citytech.com IQMS
www.iqms.com
DunAn Sensing Orthogone
www.dunansensing.com
514-316-1917
LDRA Sterilization
www.ldra.com
sbriere@orthogone.com
Evergreen Telemetry Anderson Sterilizers
www.evergreentelemetry.com www.orthogone.com Macadamian www.anpro.com
www.macadamian.com
Excelitas Technologies Corp.
www.excelitas.com Maplesoft
www.maplesoft.com
Framos Technologies
www.framos.com Renishaw Master Control B.Braun Medical Inc.
847-286-9953 www.mastercontrol.com OEM Division
usa@renishaw.com 484-240-8301
www.renishaw.com OnScale info@bbraun.com
medicaldesignbriefs.com/rd121/ www.onscale.com us.bbraunoem.com
renishaw medicaldesignbriefs.com/rd121/
FUTEK Advanced Sensor OnShape bbraunoem
Technology RJG www.onshape.com
949-465-0900 www.rjginc.com E-BEAM Services, Inc.
futek@futek.com OPEN MIND Technologies www.ebeamservices.com
www.futek.com Sensor Scientific Inc. www.openmind-tech.com/
sensorsci.com en-us.html MicroCare
www.microcare.com

Sterilization continued
Nordion, a Sotera Health Co. Dynatec Laboratories WestPak Instron

www.nordion.com www.dynatec-labs.com www.westpak.com www.instron.com
Noxilizer, Inc. EAG Laboratories WuXi AppTec Lenox Instrument Company,

www.noxilizer.com www.eag.com https://medicaldevice.wuxi- Inc.
apptec.com www.lenoxinst.com
Sterigenics Element
https://sterigenics.com www.element.com X2 Metrology Mahr Inc.
www.x2metrology.com www.mahr.com
Sterilucent, Inc.
www.sterilucent.com Zaxis
www.zaxisinc.com
Eurofins Medical Device

Testing Marposs
717-656-2300 248-370-0404
STERIS Applied Sterilization Medical-Device@Eurofins.com Test/Inspection/ marposs@us.marposs.com
Technologies https://www.eurofins.com/ www.marposs.com
877-783-7479 medical-device
Metrology medicaldesignbriefs.com/rd121/
ast_info@steris.com marposs
https://www.steris-ast.com/ Exact Metrology
medicaldesignbriefs.com/rd121/ www.exactmetrology.com MB Dynamics, Inc.
steris-ast www.mbdynamics.com
Gilero
Steri-Tek www.gilero.com 3DT LLC MSI-Viking Gage
www.steri-tek.com 262-253-6700 www.msi-viking.com
Hexagon Manufacturing sales@3DTLLC.com
Tovatech Ultrasonic Intelligence www.3DTLLC.com NI
www.tovatech.com www.hexagonmi.com medicaldesignbriefs.com/rd121/ www.ni.com/en-us.html
3dt
Highpower Validation Testing & Nikon Metrology
Lab Services 4D Technology Corporation www.nikonmetrology.com
www.highpowervtls.com www.4dtechnology.com
Test Services Pfeiffer Vacuum
Laboratory Testing Inc. Actco Metrology Services www.pfeiffer-vacuum.com
Advanced Inspection Services www.labtesting.com www.actcometrology.com
www.advancedinspect.com
MDT – Medical Device Testing Bristol Instruments, Inc.
Akron Rubber Development Services www.bristol-inst.com
Laboratory, Inc. www.devicetesting.com
www.ardl.com Chroma Systems Solutions, Inc. Renishaw
Microtest Laboratories, Inc. www.chromausa.com 847-286-9953
Anderson Materials Evaluation, Inc. https://microtestlabsinc.com
www.andersonmaterials.com usa@renishaw.com
Cincinnati Test Systems www.renishaw.com
NAMSA www.cincinnati-test.com
Avomeen medicaldesignbriefs.com/rd121/
www.namsa.com renishaw
www.avomeen.com
Creaform
www.creaform3D.com Servo Innovations LLC
Boston Analytical
www.bostonanalytical.com www.servoinnovations.com
ED&D
CertifiGroup www.productsafet.com The L.S. Starrett Co.
https://certifigroup.com Nelson Laboratories, LLC www.starrett.com
801-290-7524 Excel Technologies
Compliance West USA www.exceltechnologies.com Werth, Inc.
sales@nelsonlabs.com
www.compwest.com www.nelsonlabs.com www.werthinc.com
Consumer Product Testing Co. nelsonlabs
www.cptclabs.com
Q-Plus Labs
CSZ, a Weiss Technik company Tubing & Extrusion
www.cszindustrial.com www.qpluslabs.com
Innovative Sensor
Stress Engineering Services Technology - IST AG
www.stress.com 702-894-9891
ivelina.peneva@ist-ag.com
Toxicon www.ist-ag.com/en-us
www.toxikon.com medicaldesignbriefs.com/rd121/
DDL, Inc. ist-ag Asahi Intecc USA, Inc.
952-941-9226 760-473-4265
UL LLC
ddlinforequests@ddltesting.com in-phase technologies davidz@asahi-intecc-us.com
www.ul.com/healthcare-and-
www.ddltesting.com life-sciences www.in-phasetech.com https://components.asahi-intecc.
medicaldesignbriefs.com/rd121/ com/us/home
ddl ViVitro Labs Inc. medicaldesignbriefs.com/rd121/
www.vivitrolabs.com asahiintecc

Tubing & Extrusion continued
Axis Medical Extrusion

www.axismedicalextrusion.com STAY IN MOTION.
S O LU T I O N S FO R M E D I CA L
Microspec Corporation
603-924-4300
info@microspecorporation.com
www.microspecorporation.com
STAY IN CONTROL.
B.Braun Medical Inc.
OEM Division
MRPC
484-240-8301 www.mrpcorp.com
info@bbraun.com
us.bbraunoem.com New England Tubing
medicaldesignbriefs.com/rd121/ Technologies
bbraunoem www.newenglandtubing.com
Duke Extrusion
www.dukeextrusion.com
Exalt Custom Tubing

www.exaltcustomtubing.com
NewAge Industries, Inc.
GenX Medical 215-526-2300
www.genxmeds.com info@newageindustries.com
www.newageindustries.com
Guill Tool & Engineering Co., Inc.
www.guill.com
Polygon Company
www.polygoncomposites.com
Putnam Plastics
www.putnamplastics.com
Engineering (IPE)
877-410-3265
customerservice@ipeweb.com
www.ipeweb.com Spectrum Plastics Group
404-564-8560
Junkosha
www.junkosha.com/en marketing@spectrumplastics.
com
www.spectrumplastics.com
NSK NH-NS Series
Linear Guides with
Superior Tube K1 Lubrication Units
www.superiortube.com
Kahle Automation Teel Plastics High positioning accuracy
973-993-1850 www.teel.com
Kahle@KahleAutomation.com and high
d hi h lload
d capacities
i i for
f
www.KahleAutomation.com medical equipment
kahleautomation
Combining maximum precision
800-295-8505 with extremely high load
oeminfo@teleflex.com ratings, the NH-NS series linear
www.teleflexmedicaloem.com
Medical Extrusion medicaldesignbriefs.com/rd121/ guides are the ideal solution
Technologies, Inc. teleflexmedicaloem
800-618-4346 for high-speed, long-life linear
info@medicalextrusion.com positioning for medical imaging
www.medicalextrusion.com
medicaldesignbriefs.com/rd121/ equipment. Available with K1
medicalextrusion lubrication units for smooth,
Trelleborg Healthcare & reliable performance and longer
Medical
224-223-2129 maintenance-free service life.
amy.swab@trelleborg.com
www.trelleborg.com/healthcare
Microlumen, Inc. Enabling Automation in
813-886-1200 Xponent Global
sales@microlumen.com www.xponentglobal.com Motion & Control. WWW.NSKAUTOMATION.COM
www.microlumen.com
medicaldesignbriefs.com/rd121/ Zeus
microlumen www.zeusinc.com

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B. Braun Medical Inc.

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Phone: 484-240-8301
Fax: 610-691-1785
E-mail: info@bbraun.com
us.bbraunoem.com
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Carl Stahl Sava Industries

4 North Corporate Drive Target Markets
Riverdale, NJ 07457
Phone: 973-750-9911 Surgical Robotics, Endoscopy, Laparoscopy, Exoskeletons,
Fax: 973-835-0877 and other medical device markets.
E-mail: bruce.staubitz@savacable.com
savacable.com
Company Description Carl Stahl Sava Industries has built mechanical, medical
cable assemblies used in surgical robots, heart surgery, as well
Using tungsten, stainless steel, and other materials, Carl as a variety of implantable, endoscopic and laparoscopic appli-
Stahl Sava Industries has prioritized three things for 50 years cations. Sava’s medical cable is used in robotic surgery appli-
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The Chemours Company

1007 Market Street
Wilmington, DE 19899
Contact: www.chemours.com/en/contact
www.chemours.com
Company Description Products/Services Offered
Chemours is a different kind of chemistry company, driven by Chemours features a broad portfolio of advanced high-per-
our purpose to create a more colorful, capable, and cleaner formance materials that solve the world’s most challenging
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Target Markets
• 5G • Industrial
• Automotive • Medical
• Electronics • Packaging
• Energy • Semiconductor
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Cretex Medical
311 Lowell Ave Products/Services Offered
Elk River, MN 55330
Phone: 763-441-2121 Our companies, rms Company, rms Surgical, Meier Tool &
E-mail: info@cretexmedical.com Engineering, JunoPacific, Spectralytics and QTS provide a
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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 combina-
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E-mail: medical-device@eurofins.com Medical Device Testing works with medical device companies to
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Company Description
With extensive knowledge of commercialization processes,
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FUTEK Advanced Sensor Technology, Inc.

10 Thomas
Irvine, CA 92618
Phone: 949-465-0900
E-mail: futek@futek.com
www.futek.com
We Make Innovation Possible FUTEK is helping progress the emerging technologies by pro-
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Interpower® delivery. Request shipments as needed during this 1-year peri-

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Medical
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Design…Easy…Fast. At Interpower we want to make it easy for Products/Services Offered

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55 South Denton Avenue
New Hyde Park, NY 11040
Phone: 800-221-5510
Fax: 516-328-1080
E-mail: sales@keyelco.com
www.keyelco.com
Company Description
For more than 75 years,

has been manufacturing
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quality products worldwide.
W h e t h e r yo u a re 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 modeling
and CAD/CAM to produce precision tools and production parts.
Keystone is an ISO 9001:2015 certified company and complies with
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rectives. It is our policy
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ducts are available
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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
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be manufactured to meet your special needs. Keystone’s Design
Keystone has a diverse manufacturing base of equipment and Engineering specialists and our responsive customer
including progressive dies, four-slide, wire forming, in-die tapping service team are all vital in-house resources which constitute
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standard products you will find in Product Design Guide M70 and
Keystone’s Dynamic Catalog on-line.
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MicroLumen, Inc.
One MicroLumen Way
Oldsmar, FL 34677 USA
Phone: 813-886-1200
Fax: 813-886-3262
E-mail: sales@microlumen.com
www.microlumen.com
MicroLumen has been a leading manufacturer of high per- High Performance Medical Tubing. MicroLumen manufac-
formance medical products since 1987. Our shaft and tubing tures custom tubing for critical applications & minimally inva-
systems are used in a wide range of minimally invasive, critical sive medical devices. Polyimide is a thermoset plastic and has
OEM applications such as cardiovascular catheters, stent deliv- excellent mechanical, thermal, and chemical properties. Typical
ery systems, urological retrieval devices, and drug delivery. applications include cardiovascular and urological catheters,
Primary materials include Polyimide, PTFE, Nylon, Pebax®, stent deployment, and drug-delivery systems.
Tecoflex® (polyurethane), and various polymers specifically ID ranges = 0.10 mm to 2.11 mm with various wall profiles.
designed to provide exceptional mechanical, thermal, and chem- Ultra-thin PTFE liners are available for reduced surface friction
ical properties. Our proprietary process delivers significantly and can be delivered on a mandrel. Braid and coil reinforced
tighter tolerances than conventionally extruded products. designs are available for added flexibility, torque, and column
MicroLumen offers innovative solutions and aids engineers strength. Pebax & Tecoflex jackets are available, as well as flex-
in the design of very specialized medical devices. Our diversi- ible tips, marker bands, value added sub-assembly, and custom
fied product line and secondary operations include: custom laser machining. ISO 13485:2016 certified & USP Class VI.
laser machining, etching, composite constructions, assembly,
and braid/coil reinforced shafts that solve specific tasks.
Contact our engineering team for possibilities. www.microlumen.com
Target Markets
Cardiovascular, Neurovascular, Urology, Peripheral Vascular,

Electrophysiology

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New England Wire Technologies New England Wire Technologies has manufactured technolog-
130 North Main Street ically advanced wire and cable for 120 years. Our 400,000 square
Lisbon, NH 03585 foot, state-of-the-art facility, houses manufacturing, R&D, quality/
Phone: 603-838-6624 testing, tooling/machine fabrication and office space. As an
Fax: 603-838-7090 ISO9001 registered company, we specialize in technical cable
E-mail: sales@newenglandwire.com solutions, short lead times, and unparalleled customer service.
www.newenglandwire.com Founded in 1898, New England Wire is advancing innovation
in several industries including medical device and electronics,
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New England Tubing Technologies, incorporated in 2001,
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Working directly with clients in the medical electronics and
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ter and multi-lumen tubing, hybrid tubing configurations, as
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ers of thermoplastic to fluoropolymer, and braiding.
Our team of design engineers work personally with each cus-
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custom OEM components from their specifications or to meet
unique performance characteristic requirements.
We help our customers dream beyond today’s technology
and achieve the impossible!
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Orchid Orthopedic Solutions

1365 N. Cedar Street Services/Products Offered
Mason, MI 48842
Phone: 517-694-2300 Orchid is a global company offering a broad array of services
Fax: 517-694-2340 and capabilities for orthopedic and medical device develop-
E-mail: sales@orchid-ortho.com ment and manufacturing:
www.orchid-ortho.com • Product design, development and prototyping
• Forging and investment casting
• Advanced machining technologies (metal and plastic)
• Complex instrument assemblies
Company Description
• Bone in-growth coatings and surface treatments
• Sterile packaging
Orchid is a worldwide leader of orthopedic medical device
• Quality & Regulatory services
outsourcing, providing contract design and manufacturing
services. We are a strategic sourcing partner that can handle an
entire project or provide services at a single point in the
process. We have the broadest portfolio in the industry, ranging
from design and development through finished goods manufac-
turing and packaging, and we improve our customers’ supply
chains through our supply chain solutions. By providing reliable
results, developing new technologies and being the best total
supply chain value in the industry, Orchid is your strategic
sourcing partner for orthopedic device solutions worldwide.
Target Markets
• Hip reconstruction • Trauma

• Knee reconstruction • Extremities
• Spine • Sports Medicine
www.orchid-ortho.com

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PBC Linear
6402 E. Rockton Road
Roscoe, IL 61073
Phone: 800-962-8979
E-mail: sales@pbclinear.com
www.pbclinear.com
Company Description
The story of PBC Linear begins with an innovative and

patented solution in bearing design, the Frelon®-lined plain
bearing. That successful bearing design, which remains integral
to their signature Simplicity® bearing, is part of an expanding
family of linear motion products manufactured at their head-
quarters in Roscoe, Illinois USA. In addition to their extensive
product line, PBC Linear employs dedicated engineers that
work together with industry professionals to produce proto-
types, pilots, and small production runs, helping to bring cus-
tomer ideas to market.
Target Markets
PBC Linear supplies components and linear motion systems

to a variety of applications in the medical industry, including
devices, diagnostics, and lab automation.
PBC Linear is a leader in the engineering, manufacturing,

and assembly of a wide range of linear motion products, along
with custom engineering services. Their signature Simplicity®
line of plain bearings includes pillow blocks, flange mounts, pre-
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assemblies. Building off that strong foundation, they have fur-
ther pushed their sophisticated family of products to include
lead screws and motor lead screw assemblies, actuators, and
cartesian robotics.
www.pbclinear.com

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3750 Annapolis Lane North Products/Services Offered
Plymouth, MN 55447
Phone: 800-474-0178 or 508-964-6021 If innovation in medical devices is on your agenda, TELEFLEX
Email: oeminfo@teleflex.com MEDICAL OEM should be on your team. We are a well-qualified
www.teleflexmedicaloem.com team of engineers, material and polymer experts, and skilled
technicians that will seem like a natural extension of your own
R&D department and operations staff. Our extensive capabili-
ties include:
Company Description
• Product concept development
• Engineering
Vertically integrated capabilities. Deep expertise. Decades
• Design for manufacturability
of experience. “Work With The Experts™” at Teleflex Medical
• Material selection and formulation
OEM. We are the product development and manufacturing
• Prototyping, testing, and validation
partner that can hear what you are saying, understand your
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• Production process development
custom-engineered:
• Manufacturing
• Extrusion/Micro-diameter tubing
• Finishing operations
• Diagnostic and interventional catheters
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• Balloons and balloon catheters
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EPIC Medtec® Centers: Device Development Reimagined
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• Get your device to market faster
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Let’s get to work on your next project.
• Reduce technical risks
• Work with us on site or remotely
You have a great idea for a medical device. You know what
Target Markets this device needs to do. But your R&D resources are involved
with other projects; or you may need insight or unbiased opin-
Teleflex Medical OEM is a leader in medical device develop-
ion of a device’s design for manufacturability. Working together
ment and manufacturing. We partner with companies across
at one of our three EPIC Medtec® Centers, we can identify chal-
the world, both large and small, to get their projects off the
lenges and find innovative solutions.
drawing board and into the market.
www.teleflexmedicaloem.com

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The Lee Company

2 Pettipaug Road, P.O. Box 424 Products/Services Offered
Westbrook, CT 06498
Phone: 860-399-6281 Lee’s unique capabilities in miniaturization and engineering
Fax: 860-399-2270 expertise keep the company at the forefront of fluid flow tech-
E-mail: inquiry@theleeco.com nology, and enable it to work effectively with customers to
www.theleeco.com solve difficult fluid control problems.
Products include high quality miniature solenoid valves (con-
ventional and chemically inert models), high speed micro-
dispense valves, atomizing and dispense nozzles, fixed and vari-
Company Description
able volume pumps, integrated fluidic manifolds, inert tubing
and fluid control components, and custom engineered designs.
Since its founding in 1948, The Lee Company has pioneered
the development of miniature fluid control components for
automated fluid handling in medical and scientific instrumenta-
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
advanced technology into smaller packages.
The Lee Company employs more than 1000 people at its
Technical Centers in Westbrook and Essex, Connecticut, where
all engineering and manufacturing is performed. Lee Company
sales offices, staffed by degreed sales engineers, are located
throughout the United States and Europe, and the company’s
distribution network spans the entire globe.
Target Markets
In vitro diagnostics, scientific instrumentation, drug discov-

ery, and medical equipment such as oxygen delivery, patient
monitoring, dialysis, and compression therapy www.theleeco.com

T R EL L EB O R G H E A LT H C A R E & M ED I C A L
WHO WE ARE
At Trelleborg Healthcare & Medical, we help medical device
companies negotiate the development process from concept to
commercialization. By forming lasting partnerships with customers,
we help to design, develop, manufacture and bring to market
innovative engineered solutions for demanding medical device,
biotech and pharmaceutical applications.
Customers rely on Trelleborg to accelerate time to market through

the use of advanced engineering processes, prototyping and
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ensure a reliable, high-quality supply.
VITAL STATISTICS MAJOR MARKETS

Trelleborg Healthcare & Medical is a part of Trelleborg Sealing Trelleborg Healthcare & Medical has a global footprint,
Solutions, which is a business area of Trelleborg Group. servicing a range of medical device, biotech and
• Employees: 6,899 pharmaceutical sectors, including:
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EPDM, FKM, PTFE DQGPolyurethane
St. Louis Park, MN 55416
Tel: +1 763-972-9206
E-mail: tssusa@trelleborg.com
WWW.TRELLEBORG.COM/HEALTHCARE

T RELLEBORG HE A LTH CA RE & MEDICA L
Partner with Trelleborg Healthcare & Medical to develop, manufacture and bring to market
innovative engineered solutions for demanding medical devices.
With 30 plus years of experience in medical device manufacturing, Trelleborg delivers:
• Broad material and manufacturing capabilities

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Target Markets
• Medical Device
• Micro Optics
Accumold • Micro Electronics
1711 SE Oralabor Rd. • Other Emerging Technologies
Ankeny, IA 50021
Phone: 515-964-5741
E-mail: micromolding@accu-mold.com Products/Services Offered
www.accu-mold.com
Accumold® is a high-tech manu-
facturer of precision micro, small
Company Description and lead frame injection molded
plastic components. Utilizing pro-
Accumold® has been an cesses developed from Accumold’s
expert in micro molding Micro-Mold® technology, the com-
for more than three dec- pany designs, builds and produces
ades. Our 130,000 sq ft unique molds and parts efficiently
facility is home to our infor a wide variety of applications.
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tion teams. The company tures, to parts that are less than 1 mm in size. These complex
currently operates 155+ parts often include tight tolerances measuring only a few
molding machines in sev- microns. Processes include: insert molding, clean room mold-
eral Class-7 and 8 clean ing, 2-shot molding, and custom automated manufacturing
room spaces. Accumold is cells. Common materials include: PEEK, Ultem, LCP, and most
ISO 13485, 9001 and 14001 engineered thermoplastics.
certified.
www.accu-mold.com
70 Free Info at http://info.hotims.com/79414-823 2021 Resource Guide

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Target Markets
• Medical
• Automotive
AMADA WELD TECH INC. • Aerospace
1820 South Myrtle Ave. • Battery
Monrovia, CA 91016 • Electronic Components
Phone: 626-303-5676
E-mail: info@amadaweldtech.com
www.amadaweldtech.com Products/Services Offered
Based in Southern California,

Company Description AMADA WELD TECH is a leading
manufacturer of equipment and
The challenges of systems for resistance welding,
today’s medical device laser welding, laser marking, laser
manufacturing appli- cutting, laser micromachining, her-
cations are pushing metic sealing, and hot bar bonding.
the need for more so- Since 1948, AMADA WELD
phisticated manufac- TECH AMERICA has worked to achieve one goal: to solve our
turing technologies, customer’s manufacturing challenges. Knowing there is no one
and AMADA WELD solution that fits all, we strive to provide our customers with
TECH is leading the innovative and reliable manufacturing technology solutions so
way with our compre- that we may be their single source provider.
hensive range of resistance and laser welding, laser marking, The company also offers free feasibility studies, training, and
and laser cutting and micromachining equipment and systems. applications development support.
An ISO:9001-2015 certified company.
Laser Solutions for Medical

Device Manufacturing
Enhance Your Productivity
The challenges of today’s medical device manufacturing
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for more sophisticated manufacturing technologies and AMADA
WELD TECH, in consult with medical device industry expert Precision Medical Tube Cutting
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• Equipment & systems for cutting, marking, micromachining

and welding
• Fiber, UV, picosecond and femtosecond laser sources
• Cut fine features in tubes and stent – no post-processing!
• Black laser marking for UDI
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Speak directly with our advanced engineering experts
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Arthur G. Russell Company

750 Clark Avenue
Bristol, CT 06010
Phone: 860-583-4109
Fax: 860-583-0686
E-mail: david.aquilino@arthurgrussell.com
www.arthurgrussell.com
Company Description
Knowing that quality and dependability are as important on the
The Arthur G. Russell Company, Inc. designs and develops assembly line as in the final product that's why we work with
innovative automatic assembly systems for the medical device you from the start. In addition to custom designing a system that
industry that require the highest level of quality for products will exceed your expectations and be flexible enough to grow with
such as syringes, blood collection tubes, IV catheters, dosage you as your product demands change, we can provide “proof-of-
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Target Markets while providing the integration required for a turnkey system.
Providing more than just assembly equipment, we provide
Medical Devices, Pharmaceutical, High-Volume Consumer you with the edge you need to stay competitive in your market.
Products, High-Volume Disposable Goods, Packaging
www.arthurgrussell.com

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Target Markets
Component, subassembly, or full assembly of catheters,

delivery systems, access systems in cardiovascular, peripheral,
Asahi Intecc USA, Inc. neuro, abdominal, endoscopic, orthopedic, ENT specialties.
22 Executive Park, Suite 110 Non-medical inquiries welcome.
Irvine, CA 92614
Phone: 949-756-8252
Fax: 949-756-8165
E-mail: davidz@asahi-intecc-us.com Products/Services Offered
www.asahi-inteccusa.com
• Cable Tube OD 0.008 ~ 0.1539"
• Flat Wire Torque Coils and
Company Description Flexible Shafts to 6mm
• PTFE SPC MANDRELS from
Asahi Intecc Co., 0.45mm to 2.30mm. PTFE wall
Ltd. ISO 9001/13485- thickness (one side can range
certified manufactur- from 0.008mm to 0.012mm)
er of stainless, tung- • OEM/ODM Guidewire: Guidewire, Diagnostic catheter, PTCA
sten, nitinol compo- guiding catheter, PTCA balloon catheter, etc
nents, ACTONE cable • Stainless Steel Cables and Assemblies: 0.002” to 3mm ~ 4mm.
tube, TORQUE HYPO- • Miniature Coil: round wire OD from .0039", flat wire OD from .0055"
TUBES, drivecables, • Torque Transmission Wire: 1x3, 1x7, 1x19 OD from .012" to 0.078"
torque coils, round or • Torque Transmission Coil: OD from 0.012" to 0.1563", 2-3 layers
flat wire coils, single rotational fidelity/motor, NURD
or multi lumen or • Variable Durometer Tubes
variable flexibility polymer extrusions in PU, PEBAX, PFA, PTFE
or coatings inside/outside hollow stainless shafts or braids.
www.asahi-inteccusa.com
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.
PTFE Liner Thinnest wall 0.0003”
Excellent lubricity and
chemical resistance
Reinforced with SS304, ISO 13485 • 9001

Tungsten, 66PA, PEEK and more
for torque and kink resistance
Braid-reinforced
Shaft Cables Cable
Coils
Variable Tubes
Durometer Tube
Provides a linear smooth
transition between a delicately
soft tip to a hard proximal end
Coatings + Metal Machining & Tubing &
Components Assembly Braiding
ASAHI INTECC USA, Inc. | 22 Executive Park, Suite 110 | Irvine, CA 92614 | phone: (949) 756-8252 ext. 302 | www.asahi-inteccusa.com

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Target Markets
Medical and Life Science
Cadence, Inc.
9 Technology Drive Products/Services Offered
Staunton, VA 24401
Phone: 540-248-2200 From concept through commercialization, Cadence can assist
Fax: 540-248-4400 our customers every step of the way product design, design for
E-mail: sales@cadenceinc.com manufacturing, rapid
www.cadenceinc.com prototyping, complete
supply chain manage-
ment, and production
Company Description of your finished med-
ical device and life sci-
Cadence, Inc. is a full-service contract manufacturing partner ence products. We
for medical device and diagnostics companies worldwide. Our offer cleanroom man-
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ise that includes machining, metal stamping, sharpening/grinding,
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injection molding, insert molding, and much more!
www.cadenceinc.com
A correct cadence
for drug delivery devices.
Finished devices
Point-of-care testing
Sharps expertise - needles
Precision inserters for devices
Microstamping & multislide technologies
800-252-3371 | cadenceinc.rocks

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Cotronics Corporation Duralco™ (High Temperature Epoxies), You have challenging applications…
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Company Description
For almost 50 years, Cotronics’ highly

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High Temperature Products Since 1971 131 47th Street
COTRONICS
Brooklyn, NY 11232
www.cotronics.com
sales@cotronics.com
Tel: 718.788.5533
CORP. Fax: 718.788.5538
QUALITY PRODUCTS I CUSTOM FORMULATIONS I ISO 9001:2015 CERTIFIED

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Target Markets
• Medical
• Aerospace
Da/Pro Rubber, Inc. • Computer/Industrial
601 N Poplar Ave. • Oil & Gas
Broken Arrow, OK 74012
Phone: 918-258-9386
E-mail: sales@daprorubber.com Products/Services Offered
www.daprorubber.com
Da/Pro offers rub-
ber compression
Company Description molding, liquid in -
jection molding, trans-
Since 1960, fer molding, over-
Da/Pro Rubber, molding/insert mold-
Inc. has been a ing, custom com-
family-owned pounding, sub-assem-
leading manufac- bly, e n g i n e e r i n g
turer of precision design assistance,
molded rubber, and conductive rub-
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products. Our injection molding, commodity plastic injection molding, over-
rubber and plas- molding/insert molding, sub-assembly, hot stamping, and engi-
tic manufactur- neering design assistance.
ing facilities in Oklahoma, California, Massachusetts, Singapore,
and Malaysia. Da/Pro offers liquid injection molding (LIM), com-
pression molding, injection molding, transfer molding services, www.daprorubber.com
and is equipped with a class 10,000 clean room.

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Target Markets
Medical Device, Pharmaceutical and Consumer Goods
DDL, Inc.
10200 Valley View Rd., Suite 101 Products/Services Offered
Eden Prairie, MN 55344
Phone: 952-941-9226 Package Testing
Fax: 952-941-9318 DDL’s package testing serv-
E-mail: ddlinfo@ddltesting.com ices evaluate the strength and
www.ddltesting.com integrity of packaging systems
before and after simulating
the anticipated distribution
Company Description and storage conditions that
the systems may undergo.
DDL Inc. is an ISO/
IEC 17025 accredited Medical Device Testing
testing lab that pro- DDL specializes in testing medical devices such as luer fit-
vides package, med- tings, syringes, needles, catheters, guidewires, surgical sutures,
ical, drug device, and cannulae, and tracheal tubes.
closed container in-
tegrity testing services. Container Closure Integrity Testing
The company’s team Package integrity verification requires careful examination of
of engineers and tech- package leakage given the specific product and its life cycle. DDL’s
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Diverse Optics Inc

We see your 10339 Dorset Street
Rancho Cucamonga, CA 91730
FUTURE
Phone: 909-593-9330
E-mail: info@diverseoptics.com
https://diverseoptics.com
differently. Company Description
Diverse Optics is the leader in diamond turning and preci-

sion injection molding of custom polymer optics. For over 25
years, we’ve manufactured the most challenging compo-
nents and assemblies for leading defense, medical, and com-
mercial applications. Whether it’s prototypes or production
molded optics, we’ll show you how polymer optics are
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Target Markets
Medical, Defense, Commercial
We know that your optics

are as unique as you are. For
over 25 years, Diverse
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us show you how polymer optics are perfected.
(909) 559-1300
DIVERSEOPTICS.COM https://diverseoptics.com

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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 Products/Services Offered
E-mail: sales@halkeyroberts.com
www.halkeyroberts.com Halkey-Roberts is a global leader in the design and manufac-
ture of valves for medical device companies whose products
require precise delivery of fluids and gases. We supply global
Company Description medical device companies with off the shelf and custom solu-
tions for their fluid and gas delivery applications. Since 1941, we
Halkey-Roberts manu- have been offering innovative solutions like our new Male Luer
factures plastic compo- Valves. Our vertically integrated facility in St. Petersburg,
nents and subassemblies Florida, allows us to control the entire development and manu-
used in disposable medical facturing process of our products: from design, tooling, mold-
devices, including flow ing, high speed automation, regulatory support, and product
devices, medical valves, release. We offer extensive capabilities to customize our prod-
needle-free valves, cath- ucts to your specific application.
eter and tracheal tube
valves, tubing clamps, closures, and hand pumps.
Halkey-Roberts is ISO 9001 and ISO 13485 certified and man- www.halkeyroberts.com
ufactures to the standards of GMP.
Robertsite® Bag Access Valves (BAV)

Designed to be integrated by press fit or
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sales@halkeyroberts.com Visit our website to view our comprehensive line of needlefree swabable valves
727.471.4200
sales@halkeyroberts.com Visit our website to view our comprehensive line of needlefree swabable valves
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Target Markets
• Plastics • Aerospace
• Medical • Manufacturing
International Polymer Engineering (IPE) • Automotive • 3D Printing
2445 West Medtronic Way Aftermarket
Tempe, AZ 85281
Phone: 877-410-3265; 480-967-3265
Fax: 480-929-9799 Products/Services Offered
E-mail: customerservice@ipeweb.com
www.ipeweb.com IPE manufactures custom
profile extrusions made
from Fluroflex™ ePTFE and
Company Description a variety of melt thermo-
plastic materials. We use the
International Polymer Engineering (IPE) is ISO one of the latest techniques to reduce
only companies worldwide engineering complete custom costs and shorten manufac-
FluoroFlex™ ePTFE solutions. We also provide advanced turing lead times. We manu-
thermoplastic extrusions for your most demanding applica- facture a variety of components such as tubing, rods, sheets, 3D
tions. On top of printer filament, biopsy channel components, light guide cover
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extrusions, we offer tomize your products with laser markings and custom col-
design and devel- orations. When looking for a flexible, lubricious, chemically inert,
opment, material hydrophobic plastic for critical applications, few can meet or
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ing, flaring, clean-
room processing,
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Kahle designs and

builds machines for
Kahle Automation the assembly and
89 Headquarters Plaza N., 3rd floor inspection of all types
Morristown, NJ 07960 of medical devices
Phone: 973-993-1850 and drug delivery
E-mail: Kahle@KahleAutomation.com products. Kahle’s ser-
www.KahleAutomation.com vices include custom
equipment design,
system integration,
Company Description parts feeding, mate-
rial and package
Celebrating our 100th handling, and equipment validation, along with the documenta-
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worldwide supplier of turing applications.
automation and process Kahle’s staff is dedicated to designing solutions for only one
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Target Markets www.KahleAutomation.com
Medical Device and Life Science
Pointed in the
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Marposs
3300 Cross Creek Parkway
Company Description
Auburn Hills, MI 48326
Phone: 248-370-0404 Marposs, founded in 1964, is a world
Fax: 248-370-0991 leader in measurement, inspection and
E-mail: marposs@us.marposs.com test technologies focused on improving
www.marposs.com
quality and productivity while reducing

manufacturing costs. It offers in-
process gauging and control to post-
process measurement and inspection
on the shop floor for 100% inspection
of medical components.
SOLUTIONS FOR MEDICAL INDUSTRY
Target Markets
• Materials & Manufacturing

• Design & Testing
LEAK AND FLOW
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QULITY
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ure orthopedic joints, dental implants,
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cans, blood bags, catheters, needles,
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circuits and dialysis equipment. It is also
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Aeroel laser systems measure outside
diameters of tubes, rods and cables or
dimensions of profiles featuring rectan-
gular sections of transparent and opaque
Marposs, a worldwide leading supplier of materials, such as medical tubing.
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mdi Consultants, Inc. CE Mark consulting, ISO Comp - Registration, and Health Canada
55 Northern Boulevard, Suite 200 liance (ISO 9000:2000, ISO 14000, Com pliance.
Great Neck, NY 11021 ISO 13485:2016), Regulatory Con -
Phone: 516-482-9001 sulting, U.S. Agent Services, Auth -
Fax: 516-482-0186 orized Agent Services, Import Agent
E-Mail: info@mdiconsultants.com www.mdiconsultants.com
Services, Electronic Drug Listing and
www.mdiconsultants.com
Company Description
mdi Consultants is a leader in provid-

ing consulting services to the healthcare
industry worldwide. Our staff has over
200 years of industry, government,
and consulting experience, which we
use to assist medical device, pharma-
ceutical, biotechnology, and food compa-
nies achieve compliance with U.S.,
European, and Canadian regulations.
Dr. Anand Akerkar Alan Schwartz
Target Markets
Medical Device Companies, Pharma-

ceutical Companies, Biotechnology
Companies, Food Companies, Tobacco
Companies.
mdi Consultants offers a full range of

services focused on assisting compa-
nies across the globe achieve regulato-
ry and standard compliance with U.S.,
European, and Canadian agencies and
organizations. Our services include
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pliance, on-site audits, validation
(process, software, and sterilization)
and 510(k)/PMA/ANDA/NDA submis -
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ser vices, 483 & Warn ing Letter Re -
sponse services, MDSAP Assis tance,
Quality Sys tem Com pli ance services,

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Target Markets
Medical
Medbio, Inc.
5346 36th St., SE Products/Services Offered
Grand Rapids, MI 49506
Phone: 616-245-0214 The Medbio manage-
Fax: 616-245-0244 ment team averages over
E-mail: Info@medbioinc.com 25 years of experience in
www.medbioinc.com the medical device indus-
try. We have experience
with most medical-grade
Company Description thermoplastics, and im-
plantable-grade resins.
Located in Michigan, We currently mold prod-
Medbio is an ISO ucts for the major OEMs
13485:2016-certified in Orthopedics, Cardio-
contract manufacturer vascular, Ophthalmology, Neurological Surgery, General
offering innovative Surgery, Wound Care, Biotech (Diagnostics & cell growth), and
man ufacturing solu- Dental. From components to full assemblies, Medbio will tailor
tions for the medical our manufacturing services to meet your needs, taking your
device and biotech medical device from design to completion. We have the knowl-
industries. We special- edge, passion, and experience to solve your most difficult man-
ize in precision injec- ufacturing challenges.
tion molding, assembly, packaging, prototyping, and design
support. Building strategic partnerships and conducting busi-
ness with integrity, allows Medbio and our customers to achieve www.medbioinc.com
growth, success, and profitability.
Investing in the
Latest Technologies
Medbio is committed to the reduction of part
to part variation with the use of robots and
automation.
www.medbioinc.com

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tomers, polyurethane, nylon, Pebax, ABS, butyrate, PET, poly-

carbonate, polysulfone, PEEK, PES, FEP, ETFE, PVD, FEP, and
FEP heat shrink tubing, as well as multi-layer tubing. We pro-
duce close tolerance profiles in single and multi-lumen geome-
tries, in either engineering study lot sizes or for production
Medical Extrusion Technologies, Inc. volumes.
26608 Pierce Circle
Murrieta, CA 92562
Phone: 800-618-4346 Target Markets
Fax: 951-698-4346
E-mail: info@medicalextrusion.com Medical Device
Company Description
Medical Extrusion
Medical Extrusion Technologies, Inc. off-
Technologies, Inc. ers a full range of con-
manufactures cus- sultation services from
tom tubing extru- material selection to
sions from almost tooling development.
all thermoplastic • Consultation
resins. Our exper- • Design
tise is in smaller, • Development
multi-lumen config-
urations and single
lumens to 1.0". We
have process capa-
bilities for most thermoplastics including all polyethylenes,
polypropylenes, EVA, metallocenes, PVC, thermoplastic elas-
Precision matters.
Medical Extrusion Technologies-Texas, Inc.
(MET-Texas)
FEP Heat Shrink Tubing
The precision quality and consistency of the FEP heat

shrink you use matters. Just as important, working
with a partner well-versed in sophisticated medical
device industry standards. MET maintains precise, low
elongational growth and consistent recovery results for
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to your exact specifications. Precision also comes with
industry leading lead times, competitive pricing, and the
service levels you require. Need FEP? Contact MET.
Standard draw
1:3 1:6 Custom Sizes
MET Heat Shrink down ratios:
Cut to length Scored on 2 Easily Removable

Best in Performance sides (optional)
Best in Clarity at Expansion
Best in Finish at Recovery
Please contact us today for samples, quotes or questions:
Finish First with FEP from MET
MET@medicalextrusion.com
Facilities: California | Minnesota | Texas

TM
26608 Pierce Circle, Murrieta, CA 92562
www.MedicalExtrusion.com 800-618-4346 | PH: 951-698-4346 | FX: 951-698-4347

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MICRO highest quality products to customers in

140 Belmont Drive Company Description the medical device marketplace. A truly
Somerset, NJ 08873 global company, with three locations, we
Phone: 732-302-0800 Established in 1945, MICRO is a contract manufacture and distribute our products
E-mail: sales@micro-co.com manufacturer that draws on 75 years of to customers around the world.
www.micro-co.com manufacturing expertise to deliver the
Target Markets
• General
Surgery
• Orthopedics
• Cardiology
• Urology
• Women’s
Health
• Diabetes Management
Medical Device Manufacturing Products/Services Offered

From Concept To Market Full-service contract manufacturer of
We are vertically integrated to provide you with all the medical devices and subassemblies
including injection/insert molding, MIMs,
services and capabilities essential for complete medical and fabricated tube assemblies. We offer
device contract manufacturing. product development and design assis-
tance from prototyping and validation
to full-scale production.
Helping our Customers Save Lives. Our modern facility is cGMP-QSR
compliant and ISO-9001, ISO-13485, and
ISO-14001 certified. Staffed by highly
trained individuals, we maintain an ISO
Solutions: Class 8 environmentally controlled
cleanroom for surgical instrument
• Custom Tubing assembly.
• Clean Room Assembly We also produce a wide variety of
scissors, stapling and biopsy devices,
• MIM (Metal Injection Molding) as well as laparoscopic and arthroscop-
ic minimally invasive surgical instru-
• Precision Machining ments. MICRO is the world's largest
• Insert/Injection Molding manufacturer of titanium and stainless
steel ligation clips class-critical
• Precision Metal Stamping implant devices shipped directly to
inventory.
• Project management
Contact us today to discuss your next project: sales@micro-co.com
FDA Registered • ISO 13485 • ISO 9001 • ISO 14001 www.micro-co.com

MICRO 140 Belmont Drive, Somerset, NJ 08873 USA • Tel: 732 302 0800 • www.micro-co.com Free Info at http://info.hotims.com/79414-854

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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@microspecorporation.com
www.microspecorporation.com Most Thermoplastic Elastomers Extruded:
• Polyurethanes • Fluoropolymers: FEP, EFEP,
• Nylons and PFA
Company Description • High Heat Polymers: PEEK, • Bioabsorbable resins
Polysulfone and PEI • Custom formulations
For 30 years, medical
device companies the Extrusion Capabilities:
world over have turned • New Concepts • Micro-Extrusions
to Microspec for medical • Single-lumen Extrusions • Over-Extrusions
tubing that challenges • Multi-lumen Tubing • Fully-Encapsulated Stripes
the limits of extrusion • Bump Tubing • Coated Wire
technology. From con- • Co- and Tri-Extrusions • Profile Extrusions
cept to commercializa- • Multi-Durometer Extrusions • Balloon Tubing
tion, Microspec has built a global reputation for extruding some • Multi-layered Extrusions • Ribbon Extrusions
of the smallest, most complex, and tightest toleranced medical
parts in the industry.
Microspec’s mission is to supply innovative extrusion tech-
nology to the technologically advancing and changing medical www.microspecorporation.com
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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,
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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@microspecorporation.com
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Research & Development: Process Validation, Material

Assessment. Sterilization Validation: Radiation, Ethylene
Nelson Laboratories, LLC Oxide, Steam, VHP, STERRAD, Filtration. Packaging Validation
6280 South Redwood Rd. ISO 11607: Stability, Distribution, Container Closure, Physical,
Salt Lake City, UT 84123 Aging, Microbial. Biocompatibility ISO 10993: In Vitro and In
Phone: 801-290-7500 Vivo, Chemical Characterization, Toxicological Assessments.
Fax: 801-290-7998 Product Validation: Cleaning, Disinfection, Barrier Tests,
E-mail: sales@nelsonlabs.com Physical Tests, Environmental, Microbiologic. Lot Release (QC
www.nelsonlabs.com Tests): Bioburden, Sterility, Particulates, Bacterial Endotoxin,
EO Residuals, BI Sterility.
Company Description
Nelson Labs is a leading provider of global lab testing and

expert consulting services. We perform over 800 microbiologi-
cal and analytical laboratory tests for the medical device, and
pharmaceutical industries. Nelson Labs is regarded as a best-in-
class partner with a strong track record of collaborating with
customers to solve complex issues.
Target Markets
Cardiovascular, Orthopedics, Endoscopy, Wound Management,

Hospital Consumables, Personal Protective Equipment,
Pharmaceuticals. www.nelsonlabs.com

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Target Markets
Communications, medicine, industrial automation, sensing,

aerospace and defense
OFS
2000 Northeast Expressway
Norcross, GA 30071 Products/Services Offered
Phone: 770-798-5555
E-mail: ofs_medical@ofsoptics.com Many of today’s medical
www.ofsoptics.com applications use high-qual-
ity silica optical fiber.
Because a broad range
Company Description of optical fibers is avail-
able to serve this mar-
OFS is a world-leading designer, ket, users must careful-
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Qosina
2002 Orville Drive North Company Description
Ronkonkoma, NY 11779
Phone: 631-242-3000 Qosina is a leading global supplier of
Email: info@qosina.com more than 5,000 single-use components
www.qosina.com to the medical and bioprocess indus-
tries. We provide practical solutions to

meet the changing needs of today’s
engineer through innovation, technolo-
gy and continuous improvement.
Target Markets
11834 Medical device engineers, engineer-

T Connector ing management, product designers,
Barbed 80065 manufacturing engineers, contract
Duckbill Check Valve manufacturers/kitting personnel, and
FLL Inlet, MLL Outlet purchasing personnel in the medical
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80369 Bag Port
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80214
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Qosina helps medical device engi-
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20034 Purchase from Qosina to eliminate
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All trademarks and registered trademarks are the propertyy of their respective
respectiv owners.
owners
n
work to develop the part to your exact
Log on to qosina.com today specifications. We’re committed to pro-
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Qosina is a leading global supplier of thousands of OEM single-use components to the
ply with industry standards.
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2002-Q Orville Drive North, Ronkonkoma, NY 11779 USA qosina.com +1 (631) 242-3000 info@qosina.com www.qosina.com
Qosina Europe Srl: Via Ticino 6, 20095 - Cusano Milanino (MI) - Italy +39 02 66401337 info@qosinaeurope.com

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DG12
SCHURTER
447 Aviation Blvd
Santa Rosa, CA 95403
Phone: 707-636-3000
E-mail: info.sinc@schurter.com
www.schurter.com
Company Description
The SCHURTER Group is the world’s leading Swiss tech-

nology company providing components and complex solu-
tions that ensure safe power supply and simplified equip-
ment operation. The safe&easy brand claim not only refers to
the products, but
also the compa-
ny’s business phi-
losophy, which
strives for sus-
tainable success The most versatile Power
through innova-
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ty products and
service.
Power, performance, protection and packing
density have converged in SCHURTER's
Target Markets latest generation Power Entry Module.
SCHURTER products and solutions are developed espe-
cially for specific industry segments — medical, data and DG11 and DG12
communication, automotive, avionics and space, energy, and
the broader industrial market.
- IEC C14 Protection Class I or C18 II appliance inlet
rated 10 A to IEC and 15 A to UL / CSA at 250 VAC
- Trip free resettable circuit protection current range
Products/Services Offered 0.5 A - 15 A
- Ingress protection rating against dust and liquids IP67
SCHURTER is known globally as an innovator, manufactur- - Side or top and bottom flange mounting, or snap-in
er and distributor of fuses, connectors, circuit breakers,
mounting for 1-3 mm panel
switches, EMC products, and input systems. Touch screens
and touch panels, capacitive sensor keypads, membrane key-
- Recessed circuit breaker protects against
pads, and housing inadvertent actuation
systems are in - Compatible with V-Lock cord retention system to
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with its customers.
Within its busi- DG12 with line filter
ness unit Solutions,
SCHURTER com- - Filter ratings 1 A - 10 A
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- Standard X2 capacitors 220nF; optional X2 100nF
them at the cus-
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- Standard leakage current rating < 0.5mA or low
leakage medical < 5 A; optional <80 A
https://us.schurter.com/en/Landing-Page/
Industry/Medical-technology
schurter.com

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Specialty Coating Systems

7645 Woodland Drive Company Description
Indianapolis, IN 46278
Phone: 317-244-1200 With 50 years of experience, SCS is a
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Target Markets
• Cardiovascular • GI / Enteral Feeding

• Structural Heart • Pharmaceutical / BioPharma
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Fax: 404-564-8579 • MIS / Robotic Surgery • Industrial / Defense
E-mail: marketing@spectrumplastics.com • Fluid Management • Food & Beverage
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Target Markets
Drug dispensing, laboratory equipment, medical devices, materi-

al handling, analytical, chemical analysis, sampling, life
Clippard science/biotech, genetic research, gas chromatography, spectrom-
7390 Colerain Avenue etry, DNA synthesizing, blood analyzing, printing, diagnostic equip-
Cincinnati, OH 45239 ment, fermentation, packaging, water treatment and more.
Phone: 877-245-6247
E-mail: sales@clippard.com
www.clippard.com Products/Services Offered
Clippard Precision Control

Company Description products are used virtually
everywhere for control, inter-
Clippard is third-generation family-owned and operated. For face, sensing, logic, and actua-
more than 75 years, we’ve been proudly supporting our local com- tion functions. Some of the
munity and manufacturing right here in America. We are the pio- many products include elec-
neers of minia- tronic valves, isolation valves,
ture pneumat- pinch valves, flow controls,
ics; our history control valves, manifolds, pro-
and experience portional valves, 7/8/10/15 mm valves, cylinders, value-added
are unmatched assemblies and much more. With years of engineering and technical
in the industry. experience, Clippard continues to be a leader in manufacturing stan-
Our unique cul- dard and custom products, as well as custom assemblies for a broad
ture and strong spectrum of industries.
values truly sets
Clippard apart
from our com- www.clippard.com
petitors.
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: Americas 203-796-0400
Europe +49-6074-497-0 Emerson leads the
Asia +86-21-3781-0588 welding and assembly-
E-mail: Branson.Info@Emerson.com technology market for
www.Emerson.com/Branson medical device manufac-
turing by offering the
advanced technology of
Company Description Branson™ material joining
and precision cleaning
Emerson leads the solutions for healthcare,
medical global assem- life sciences and chemical laboratory applications. The breadth
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ceive the most ro- Through the support of global application engineers and our
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Orthopedic: Trauma plates, screws, spine Implants & external

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Orthodontic & Dental: Orthodontic brackets, components for
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Indo MIM Pvt Ltd
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E-mail: infous@indo-mim.com
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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@statek.com Product features:
www.statek.com • Ultra-miniature & low-profile • Helium impermeable
• Excellent long-term aging • High accuracy & stability
• Low power consumption • Fast start-up
Company Description • Full medical high-reliability • Full product traceability
testing & screening
In 1970, Statek Corporation was the first to use semiconductor
technology such as photolithography, chemical etching, and • CX16, SMT crystal, available form 32.0 kHz to 100 MHz, in
micromachining to manufacture quartz resonators in wafer 2.0mm × 1.2 mm footprint.
form. Today, Statek remains at the forefront of innovation in • CX18, SMT crystal, available from 30 MHz to 100 MHz, in a 1.6
the design, de- mm × 1.0 mm footprint.
velopment and • CXOU, SMT crystal oscillator, available from 32.768 kHz to 100
manufacturing kHz, in a 2.0 mm × 1.2 mm footprint
of highly reli- Statek’s products are used in all classes of FDA approved medical
able, ultra-mini- devices in both implantable and non-implantable applications.
ature quartz-
based frequen-
cy control prod-
www.statek.com
ucts.
Upcoming...
Webinars
Next-Generation Specialty Fluids for Industrial
Critical Cleaning: What You Need to Know
Wednesday, June 9, 2021 at 11:00 am U.S. EDT
As the world transitions to environmentally preferred solutions to achieve net zero carbon emissions, regulatory pressure is
starting to grow around the use of TCE (trichloroethylene) and nPB (n-propyl bromide) for vapor degreaser cleaning. In this 30-
minute Webinar, experts discuss today’s changing standards and provide suggestions for the most effective, affordable, and en-
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and environmental benefits of switching to a modern HFO-based cleaning fluid.
The Webinar also provides information on vapor degreasing equipment requirements, including necessary upgrades and modifi-
cations to existing equipment, and how to determine the most suitable, cost-effective cleaning fluids and methods.
Speakers:
David Ferguson Michael Fraser Emily Peck
Senior Technical Manager, Technical Service Chemist, Senior Chemist,
Precision Cleaners, Chemours MicroCare
MicroCare
Please visit www.techbriefs.com/webinar165

PRODUCT OF THE MONTH 2021 Product of the Year
Finalist
■ Proportional Isolation Valve

Clippard Instrument Laboratory, Cincinnati, OH, has released a flow controller that uses an extremely fast-
reacting mems technology sensor upstream from a proportional valve, with the option of a DR-2 regulator for
accurate and precise pressure control in a small package. Unlike other mass flow controllers that require a 30-
minute warm-up time, large differential pressures, and limited flow ranges, the Cordis requires less than one
minute warm-up, and its pressure drop is ≤14 in. H2O. It features flow ranges as low as 0–30 sccm. Standard control options include 0.2–
10 VDC, 4.32–20 mA, and 3.3 VDC serial.
For Free Info Visit http://info.hotims.com/79414-345
Product Focus: Tubing
■ Silicone Elastomers ■ Heat-Shrink Tubing

Silicone healthcare solutions from Junkosha, Gloucestershire, UK, has launched
Dow Corning, Wilmington, DE, have cut-to-length and slit peelable heat shrink
been renamed to reflect the company’s tubing (PHST) for a wide range of catheter-
drive to develop innovative solutions for based procedures where flexibility is the key
patients. The Liveo™ brand reinforces DuPont’s commitment in requirement. Catheter delivery systems for
healthcare and replaces Dow Corning and Silastic trade names for the neurovascular treatments rely on increasingly complex shapes,
product line that includes pharma tubing and overmolded assemblies constructs, and polymers to deliver their intended treatment. This
for single-use systems in biopharma processing; transdermal and top- intricacy in catheter bonding and welding applications can only be
ical drug-delivery systems; medical adhesives for advanced wound consistently achieved through advanced technology innovations
care, ostomy care, and wearables; silicone elastomers for a wide range such as cut-to-length and slit PHST, which enables catheter manu-
of specialty medical devices, and more. facturers to use different lengths to not only reflow a catheter’s
For Free Info Visit http://info.hotims.com/79414-346 baseline materials, but also to attach complex shapes and construc-
tions. Key application areas include balloon mounting, catheter
■ Reinforced Polyimide Tubing lamination, forming, tacking, masking, bonding parallel tubes,
and polymer jacket compression.
Braid and coil-reinforced polyimide tubing
from Zeus, Orangeburg, SC, helps medical device
engineers optimize their catheter designs and fine-
tune key performance characteristics, paving the ■ Plastic and Rubber Tubing
way for improved procedural outcomes and NewAge Industries, Southampton, PA, has
increased patient safety. Reinforced polyimide tub- achieved B Corp™ certification from B Lab™, a
ing is available in full load and half load braid pat- nonprofit organization serving a global network
terns, as well as in coil configurations. It is available of companies using business as a force to benefit
with total wall thicknesses (inner layer plus reinforcement plus outer others. NewAge manufactures plastic and rub-
layer) as low as 0.002 in./0.051 mm and inside diameters (ID) down ber tubing in reinforced and unreinforced styles. The AdvantaPure
to 0.010 in./0.254 mm. Polyimide tubing provides excellent strength division of NewAge Industries is ISO 9001:2015 certified and special-
and abrasion resistance and maintains its properties at very small izes in high-purity tubing, hose, single-use process tubing manifolds,
dimensions. For applications where additional lubricity is needed, a AdvantaFlex® TPE tubing, BioClosure® container closure systems,
PI/PTFE composite provides a lower coefficient of friction. and other molded components.
For Free Info Visit http://info.hotims.com/79414-349 For Free Info Visit http://info.hotims.com/79414-347
■ Medical Connectors ■ Micro Peltier Modules

A new series of connectors with plastic CUI Devices, Lake Oswego, OR, has added
threaded rings is available from Binder, micro-Peltier modules to its Peltier module prod-
Camarillo, CA. The series 763 M12-A connec- uct line. Carrying compact package sizes with
tors have lightweight plastic threading rings that dimensions from 3.4 to 9.5 mm and profiles as
offer a cost-effective alternative to steel threading rings, while remaining low as 1.95 mm, these micro-Peltier modules offer reliable solid-state con-
just as robust and meeting IP67 and IP68 seal requirements. Vibration- struction, precise temperature control, and quiet operation for space-
resistant crimp contacts ensure secure signal and data transfer. Male and constrained designs where forced air cooling is not an option. The single-
female cable connectors are available with 3, 4, 5, 8, or 12 gold-plated con- stage thermoelectric coolers feature temperature deltas of 77 °C (Th =
tacts in a molded UV-resistant nylon (PA) housing. Series 763 ready-to- 50 °C), Qmax ratings from 0.2 to 4.7 W (Th = 50 °C), current ratings from
connect cable sets are available with 2- or 5-m cable lengths. 0.7 to 3.4 A, and voltage ratings from 0.5 to 3.9 V.

■ Motion Control Design Guide ■ 2D/3D Measurement System
Allied Motion Technologies, Amherst, NY, Exact Metrology, Brookfield, WI, offers a
has released a new guide to its custom motion high-speed integrated 2D and 3D measure-
control solutions for advanced medical equipment system. The InspecVision Planar is a 2D
ment applications. “Design Keys for Next inspection machine that allows manufactur-
Generation Medical Equipment” highlights sev- ers to verify product quality simply and quick-
eral motors, drives, and control systems, as well ly by performing 2D inspection, CAD compar-
as the advantages of each for specific applica- isons, and reverse engineering in seconds. Physical parts or even
tions. The company’s industry experience, co-design and develop- paper, acetate, or electronic image files can be reverse engineered
ment process, ISO 13485 certified production facilities, and global to create CAD files. Reverse engineering processes can also be car-
supply chain are also covered. Specific application challenges and ried out in 3D using optional 3D modules. For full 3D capability,
solutions featured include patient breathing equipment, cancer users simply add Opti-Scan 3D, while the SurfScan module extends
screening and oncology, medical hand tools and surgical robotics, Planar to 2.5D.
medical microscopes and imaging cameras, and more. For Free Info Visit http://info.hotims.com/79414-359
■ SMT Jumpers
■ Servo Positioner Keystone Electronics Corp., New
Destaco, Auburn Hills, MI, has added a Hyde Park, NY, has released a series of
servo positioner to its portfolio. The PGM40 true-zero-ohm high-current SMT jump-
servo positioner has been designed for use in ers designed to replace zero-ohm resis-
small, medium, and relatively high-speed tors. Quick and easy to set up, the jump-
positioning applications and can provide subpositioning on larger ers are suited as true-zero-ohm resistor replacements without the
servo-positioning setups. The servo positioner features a precision- need to change board designs or layouts. Four resistor chip sizes are
engineered parallel cam design, which enables it to combine high offered to simplify designs and footprint template compatibility:
indexing accuracy with rigid performance. It has low input inertia, 0402 chip size (Cat. # 5112), 0603 chip size (Cat. #5110), 0805 chip
allowing it to operate more precisely while reducing the starting size (Cat. #5106), and 1206 chip size (Cat. #5108). Manufactured
torque required and demanding less overall torque from the servomo- from copper with silver plating, the jumpers provide a low imped-
tor. The servo positioner has a high power-to-weight ratio and integrat- ance and circuit linkage with an identical footprint as a zero-ohm
ed motor-clamp system. resistor.
■ Counterbalance Support Hinge ■ Power Entry Module

Southco, Concordville, PA, has released a A power entry module from Schurter, Santa
counterbalance support hinge that reduces the Rosa, CA, provides a high level of functional
total cost of lifting and positioning heavy panels integration in minimal package dimensions.
and lids. The support hinge is designed to be The series DD11 power entry module is ideally
used in tandem with the CB counterbalance suited for equipment with low profile panels.
hinge in applications where the counterbalance Consisting of an IEC appliance inlet (C14),
hinge can support the full torque requirements which is compatible with cord retention, 1- or 2-pole fuse holder, and
of the panel or lid on its own. The support hinge enables ergonomic power ON/OFF switch, the module is available with side-mounting
lifting and position control when combined with a counterbalance flanges in addition to the existing model with top and bottom flanges.
hinge by using stored energy to balance the weight distribution of a lid Ideal for use in devices with limited space, it is suitable for applications
or panel. The hinges are fully adjustable, allowing the experience of in which high electrical and mechanical loads are present at the same
opening and closing the panel to be tailored to the unique require- time. Especially suited for medical applications, the series is designed
ments of the application. to comply with IEC 60601-2.
■ UV-Cured Glob Top ■ Vision System

EpoxySet, Woonsocket, RI, has intro- L.S. Starrett, Athol, MA, has enhanced
duced an epoxy chemistry designed as a its multi-sensor vision system with a 0.14
glob top encapsulant that can be cured rap- magnification lens. The AVR-FOV 0.14X
idly under 365 LED light. The Flashbond offers a field of view of 2.36 × 1.90 in.
UV-3610 system was specifically developed (60 × 48 mm). For greater efficiency and
for fully automated smart card assembly accuracy, more of the part can be viewed
lines but is also suitable for dam and fill and chip module encapsu- in every image on the system. Superimage technology, which allows
lations. It is very low shrinkage and produces a low ionic compound multiple images to be stitched together to form one larger image,
that is resistant to moisture, humidity, and other environmental con- together with touch probe technology, enables the system to accu-
ditions. With high-volume resistivity, it offers exceptional bond rately inspect a wide range of features on large or complex parts, as
strength to metal, ceramic, and glass. It has superior temperature well as on multiple small parts. It is equipped with the M3 software
cycling performance from –55° to 150 °C. The halogen-free system package from MetLogix, a traditional mouse, and a touchscreen
meets REACH and RoHS requirements. monitor.

PRODUCT SPOTLIGHT
PRECISION
ORIFICES & FILTERS
Bird Precision offers laser-drilled,
■ Custom Motion Controllers wire-lapped ruby and sapphire
orifices.
Nippon Pulse, Radford, VA, offers the creation of custom-designed • Huge variety of Orifices,
www.birdprecision.com
motion controller boards that utilize the company’s Pulse Commander sales@birdprecision.com Inserts, Connectors, and Fittings
• Unique micron orifices series
core for multi-axis applications. The boards can be designed to meet Control the Flow
sizes from .0004" thru .081"
unique specifications, helping streamline the design process to bring a new product to market faster • Highly repeatable flow from < .5sccm at 5psi • Extreme
or reduce the manufacture/testing time on an existing product. A custom motion control board is wear & chemical resistance • Engineering resources
ideal for application designs that need multiple axes of movement or that have many I/Os. The cus- & design guides. Please visit our award-winning website
for more information. Bird Precision, Waltham, MA;
tom design contains all components necessary to operate such as drives, controllers, safety, and I/O. Tel: 800-454-7369; Fax: 800-370-6308; e-mail: sales@
For Free Info Visit http://info.hotims.com/79414-356 birdprecision.com; www.birdprecision.com.
■ Nanocrystalline Filters Bird Precision

Kemet, Fort Lauderdale, FL, has launched a series of plastic box single- Free Info at http://info.hotims.com/79414-875
phase filters. The GTX series filter uses a unique material and design
designed to provide excellent EMI attenuation performance. The filter con- NANOSILICA
tains a nanocrystalline core, which offers higher permeability and lower loss- FILLED
es than ferrite material cores found in other EMI filters. This nanocrystalline core allows for a DUAL CURE
compact, lightweight, and high-density design, resulting in high attenuation and a small volumet- ADHESIVE
ric package compared to other EMI filters available.
Master Bond UV22DC80-
For Free Info Visit http://info.hotims.com/79414-353 1Med is a one-part adhe-
sive formulated to cure readily upon exposure to UV
■ Servo-Drive System light and crosslink in shadowed out areas with the
addition of heat. This abrasion resistant system fea-
Siemens, Plano, TX, has introduced a servo drive system in the safety tures superior dimensional stability and has very low
extra-low-voltage range for 24–48 V EC motors. The Simatic Micro-Drive sys- shrinkage upon cure. Optically clear UV22DC80-
1Med passes USP Class VI specifications for use in
tem with UL- and CE-marked components consists of the PDC (Profidrive
medical device assembly. http://www.masterbond.
Control) servo drive in conjunction with a range of motors and connecting com/tds/uv22dc80-1med
cables from product partners. The system offers units from 100 W to 1 kW and allows side-by-side rail
mounting. It is available in a standard and a fail-safe version. STO, SS1, SLT, SLS, and SSM safety- Master Bond
integrated functions are included with the Micro-Drive F variant.
For Free Info Visit http://info.hotims.com/79414-355 Free Info at http://info.hotims.com/79414-876
■ Push-Pull Connector SILICONE

LEMO, Rohnert Park, CA, offers a modular, ergonomic, rugged, and TUBING – FREE
reliable circular multipole connector for applications needing quick and SAMPLE
secure push-pull latching. The B-Series ranges from 00 to 5B size and fea- NSF-listed silicone tub-
tures the LEMO chocolate design pattern. The keying system allows for a ing handles tempera-
tures from –100°F to as
higher contact density while preventing mismating. Modular insert config- high as 500°F. Non-
urations include a wide range of high-density multi-pole or hybrid electrical contacts. Contact reactive to body tissues
types can be solder, crimp, PCB straight or PCB elbow, fiber, coaxial, thermocouple, pneumatic, and fluids. Odorless,
fluidic, or even high voltage. The connectors are UL listed. tasteless, and inert; no plasticizers. Stocked in perox-
ide or platinum cured. Made in USA with solar
For Free Info Visit http://info.hotims.com/79414-367 power. Request a sample. http://www.newageindus-
tries.com/ silicone_tubing.asp
■ Motion Controller
A new series of motion controllers from Faulhaber, Clearwater, FL, are NewAge® Industries Inc.
designed as slaves for control and positioning tasks of DC-micromotors, lin-
ear DC servomotors, or brushless DC-motors. The MC 3001 miniaturized
controllers offer 1.4 A in continuous operation and up to 5 A peak current.
With an overall height from 2.6 mm and a format from 16 × 27 mm, the motion controllers feature MEDTECH LEADERS
very high control dynamics. The controllers include the same functionality and uses the same inter-
faces (RS-232 and CANopen) and encoder interfaces as the company’s other MC V3.0 controllers. Free annual publication from
www.medicaldesignbriefs.com
Medical Design Briefs features

informative articles and pro-
files of leading companies
■ Solenoid Valve 2020
Technology Leaders
in nine areas of technology:
Electrical Connectors/Wires/
High-performance solenoid valves with a plastic body are now avail- Cables, Testing, Tubing/
able from Solenoid Solutions, Erie, PA. The Wattimizer series valves are Extrusion, Materials/Coatings/
ideal for air, gas, and corrosive media. For many applications, plastic Adhesives, Motors & Motion
Control/Robotics, Orthoped-
valve bodies offer significant value over metal-based bodies because they ics/Implants/Prosthetics,
are lightweight and corrosion resistant, and they offer a lower profile From the Publishers of
Electronics, Contract Manu-

and use convenient push-to-connect fittings. These plastic bodies are CUL recognized. The plastic facturing/Outsourcing, Gas/Fluid Handling/Pumps
valve body is approximately 1-in. diameter, comes with integral 1⁄4-in. OD tube push-to-connect port
fittings and has a maximum pressure rating of 125 psig at room temperature. www.medicaldesignbriefs.com/
For Free Info Visit http://info.hotims.com/79414-365 techleaders20
Medical Design Briefs, June 2021 www.medicaldesignbriefs.com Free Info at http://info.hotims.com/76506-xxx

99
ADVERTISERS INDEX
Advertiser Page Web
3DT LLC ......................................................33 .................................................3dtllc.com

Publisher ....................................................................Joseph T. Pramberger
Accumold ....................................................70 ...........................................accu-mold.com
Associate Publisher ....................................................................Helene Beck
AMADA WELD TECH INC. ............................71 ...................................amadaweldtech.com
(908) 300-2538
Asahi Intecc USA, Inc. ..................................73....................................asahi-inteccusa.com
Sales Director........................................................................Desiree Stygar
ATI Industrial Automation ..............................21...........................................www.ati-ia.com
(908) 300-2539
B. Braun Medical Inc. ..................................7, 54 .................................us.bbraunoem.com Editorial Director ........................................................................Linda L. Bell
Bird Precision ..............................................99 .......................................birdprecision.com Editor & Director of Medical Content ..........................................Sherrie Trigg
Branson........................................................94.................................emerson.com/branson Digital Editorial Manager .............................................................Billy Hurley
Cadence, Inc. ..............................................74 ..........................................cadenceinc.com Content Strategist, Audience Development ..................................Kendra Smith
Carl Stahl Sava Industries ..............................17, 55......................................savacable.com Production Manager .............................................................Adam Santiago
Clippard........................................................4, 94 ..........................................clippard.com Production Coordinator ........................................................James Rodriguez
Cotronics Corp. ............................................75 ............................................cotronics.com Creative Director ......................................................................Lois Erlacher
Create The Future Design Contest ..................Cover 3 ........createthefuturedesigncontest.com Graphic Designer .................................................................Annette Murphy
Cretex Medical..............................................23, 57................................cretexmedical.com Marketing Director................................................................Kaitlyn Sommer
Da/Pro Rubber Inc. ......................................76 ........................................daprorubber.com Senior Marketing Coordinator..........................................................Sam Mills
DDL, Inc. ....................................................77 ...........................................ddltesting.com Event Coordinator ....................................................................Briar Gibbons
Diverse Optics Inc. ......................................78.......................................diverseoptics.com Audience Development Director ......................................Christine Oldenbrook
Emerson ......................................................13 .................................emerson.com/medical Audience Development Coordinator............................................Stacey Nelson
Eurofins Medical Device Testing ......................2, 58 ..........................................eurofins.com Audience Development/Circulation Assistant.................................Erykah Davis
FUTEK Advanced Sensor Technology, Inc. ........1, 59 ..........................................go.futek.com Subscription Changes/Cancellations...................................MDB@OMEDA.com
Halkey-Roberts Corporation ............................79 ......................................halkeyroberts.com
(866) 354-1125
INDO-MIM ....................................................6, 95 ........................................indo-mim.com
International Polymer Engineering....................80................................................ipeweb.com SAE MEDIA GROUP
Interpower ....................................................60, Cover 4 .............................interpower.com
261 Fifth Avenue, Suite 1901, New York, NY 10016
(212) 490-3999
Kahle Automation ........................................81 ..................................kahleautomation.com
Executive Vice President .........................................................Luke Schnirring
Keystone Electronics Corp. ............................9, 61 ...........................................keyelco.com
Technology Director ................................................................Oliver Rockwell
Marposs ......................................................82 .............................................marposs.com
Director of Digital Products...........................................................Howard Ng
Master Bond Inc. ........................................33, 99 ..................................masterbond.com
Digital Media Associate.........................................................Md Jaliluzzaman
mdi Consultants, Inc. ....................................83 ....................................mdiconsultants.com
Digital Production Associate ...............................................Andrew Greenberg
Medbio, Inc. ................................................84 ...........................................medbioinc.com
Digital Production Associate .......................................................Symba Wong
Medical Extrusion Technologies ......................85..................................medicalextrusion.com
Digital Production Assistant ................................................Rowena Pagarigan
MICRO ........................................................86 .............................................micro-co.com
Budget & Forecasting ...............................................................Felecia Lahey
Micro Crystal AG ..........................................19........................................microcrystal.com
Accounting/Human Resources Manager ......................................Sylvia Bonilla
MicroLumen Inc. ..........................................Cover Tip-On, 62.....................microlumen.com A/R Clerk.................................................................................Crystal Ortiz
Microspec Corporation ..................................87 ............................microspecorporation.com Office Manager.....................................................................Alfredo Vasquez
MW Life Sciences ........................................Cover 2 .............................mwlifesciences.com Credit/Collection Manager .......................................................Stacie Pointek
Nelson Laboratories, LLC ..............................88...........................................nelsonlabs.com
New England Wire Technologies......................27, 63 .............................newenglandwire.com MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES
NewAge® Industries Inc. ..............................99.................................newageindustries.com
CT, WI, Europe .........................................................................Helene Beck
NSK America Inc. ..........................................29, 53...............................nskautomation.com
(908) 300-2538
OFS ............................................................89.............................................ofsoptics.com
IN, MI, Europe .......................................................................Desiree Stygar
Orchid Orthopedic Solutions ..........................64 ........................................orchid-ortho.com
(908) 300-2539
Orthogone ....................................................95 ...........................................orthogone.com
MA, NH, ME, VT, RI, Eastern Canada.............................................Ed Marecki
PBC Linear ..................................................25, 65 .......................................pbclinear.com (401) 351-0274
Pharmaceutical Microbiology NJ, PA, DE...............................................................................John Murray
West Coast Conference 2021 ........................39......................pharma-microbiology-usa.com (973) 409-4685
Qosina..........................................................90 ................................................qosina.com Southeast, TX ...........................................................................Ray Tompkins
SCHURTER ..................................................91..............................................schurter.com (281) 313-1004
Specialty Coating Systems, Inc ......................92.........................................scscoatings.com NY, OH..................................................................................Ryan Beckman
Spectrum Plastics Group ..............................93 .................................spectrumplastics.com (973) 409-4687
Statek Corporation ........................................31, 96...........................................statek.com MN, ND, SD, IL, KY, MO, KS, IA, NE, Central Canada .......................Bob Casey
(847) 223-5225
Teleflex Medical OEM ....................................3, 66 ..........................teleflexmedicaloem.com
Northwest, N. Calif., Western Canada ........................................Twyla Sulesky
The Arthur G. Russell Company ......................72 .....................................arthurgrussell.com
(408) 779-0005
The Chemours Company ................................56 ...........................................chemours.com
S. Calif., AZ, NM, Rocky Mountain States ......................................Tim Powers
The Lee Company ..........................................5, 67 .........................................theleeco.com (908) 892-2838
Trelleborg Healthcare & Medical......................68,69.......................trelleborg.com/healthcare Integrated Media Consultants ...................................................Patrick Harvey
(973) 409-4686
Scott Williams
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your Digital Edition of

Manufacturing for Medical Outsourcing: Transitioning

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Manufacturing for Medical Outsourcing: Transitioning

Manufacturing for Medical Outsourcing: Transitioning

FUTEK's miniaturized sensor technology LSB205

measurement and feedback allow the

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It’s where experience, quality

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1 Published by SAE Media Group

1 Pinch & Media Isolation Valves FEATURES

ON THE COVER

(Credit: Jackie Niam/Shutterstock)

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You’ve never seen

High Flow, Low Power, Low Leakage

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E ven as the world inches foward to

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CYROLITE® with balanced optical

8 www.medicaldesignbriefs.com Medical Design Briefs, June 2021

subjective when screening through strained environments and evaluating

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Tensile Stress (kpsi)

Table 1b. Tensile property retention for CYROLITE®

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designed to apply a predetermined

Oxaliplatin (2.0 mg/ml), 5% Dextrose, Water No Exposure to Chemotherapy Drugs

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of common electrochemical techniques

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20 www.medicaldesignbriefs.com Medical Design Briefs, June 2021

ROBOTIC END - EFFECTORS

Measure all six components of force

Engineered for high-performance and maximum stiffness,

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cellulose nanofibers that slightly dis-

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Engineers at the University of California,

24 www.medicaldesignbriefs.com Medical Design Briefs, June 2021

Tiny Implantable Tool for Light-Sheet Imaging of Brain

Tools that allow neuroscientists to

26 www.medicaldesignbriefs.com Medical Design Briefs, June 2021

E-health Patches Monitor Pulse and Blood Pressure

Scientists at Osaka University, in coop-