Medical Design Briefs

www.medicaldesignbriefs.
com
Welcome to
your Digital Edition of
Medical Design Briefs
December 2016
December 2016
Preparing for Industry 4.0

Silicone Adhesives for Medical Devices
Validating Instructions for Reprocessed Devices
Vote for Readers Choice Product of the Year
INSIDE: 2017 Product

Buyers Guide page 26
From the Publishers of
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Intro
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Off-The-Shelf-Custom
SM
Its Not An Oxymoron.

Conventional thinking would suggest that getting
a medical-grade foot control that is customized to
your unique specifications requires investments in
NRE and/or tooling and months of development.
This need not be the case. Many OEM requirements

can effectively be addressed using our broad
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1. Exam Chair Control

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Intro
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Strengthen
December 2016
the Healers.
Device
Reprocess
Validating Instructions for Reprocessed
Devices

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Intro
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Intro
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December 2016

Validating Instructions for Reprocessed Devices

Intro
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High performance resistors are essential to meeting

the demanding requirements of the medical industry
RCX Series
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Intro
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work
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Intro
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December 2016
Published by Tech Briefs Media Group, an SAE International Company
COLUMN
SPECIAL SUPPLEMENT
4 From the Editor
26 2017 Product Buyers Guide
FEATURES
ON THE COVER
6 The Next Industrial Revolution and What It Could Mean for

Medical Device Manufacturing
14 Silicone Adhesives for Medical Device Assemblies
20 Validating IFUs for Reprocessed Medical Devices
TECH BRIEFS
72 Motion Capture Technology Brings a New Age of Mobility to
Veteran Amputees
73 The Helping Hand Project: Changing Lives One Hand at a Time
74 Promising Biomaterial to Build Better Bones with 3D
Printing
76 Toward Visible-Light-Based Imaging for Medical Devices
78 DARPA Helps Paralyzed Man Feel Again Using a BrainControlled Robotic Arm
One area of medical manufacturing that will

gain tremendous advantages the next industrial revolution is the customization of
patient-specific devices, including prosthetics. The need for high-quality, high-mix products lends itself perfectly to the Industry 4.0
model. Based on cyber-physical systems
(CPS) that integrate computational networks
with the surrounding physical world and its
process, this change to the manufacturing
architecture brings with it much higher levels of intelligence and plant automation.
Physical objects passing through production processes will incorporate their
own embedded software and computing power to interact with more intelligent machines, cyber-physical production systems (CPPS), on the plant floor.
For more information on the future of medical device manufacturing, please
read the article on page 6.
(Image courtesy of Critical Manufacturing)
DEPARTMENTS
36 Vote for the Annual Readers Choice Awards
70 R&D Roundup
80 New Products & Services
82 Advertisers Index
Intro
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Intro
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From the Editor

MDUFA IV: Shorter Review
Times, More Consistency, and
More Oversight
The reauthorization of the Medical
Device
User
Fee
Amendments
(MDUFA) brings more pressure for
FDA to shorten its review times back to
historical norms and to provide more
consistency in the review process. And
after the success of an independent
review authorized in MDUFA III in
2012, MDUFA IV has authorized two
independent reviews of the agency over
the next five years. Total funding for the
five-year agreement is $999.5 million.
Under the new agreement, the average total time to decision for 510(k)s
will drop to 108 days by the fifth year
of the program (FY 2022). That
brings it back to historical norms from
about a decade ago, says AdvaMeds
Janet Trunzo, senior executive vice
president for technology and regulatory affairs. For PMAs, the average total
time goal will be reduced to 290 days,
a 25% decrease from the current
benchmark.
A new goal for the presubmission
process is for FDA to provide feedback
at least five days before a scheduled

presubmission meeting. In the past,
feedback has been received as late as
the night before the meeting.
A number of changes in MDUFA IV
came from the independent assessment
authorized under MDUFA III conducted
by management consulting firm Booz
Allen Hamilton. One significant recommendation calls for FDA to implement a
quality management system (QMS)
approach to the device review process. A
QMS unit will conduct audits to identify
areas for improvement.
The role of an outside observer for
improving the review process cannot be
underestimated, said Trunzo, which is
why she says the MDUFA IV agreement
funds two additional outside assessments of the review process.
The new agreement also includes
process reforms related to the deficiency letters FDA often sends to product sponsors during the review
process. All deficiency letters will now
include a reference to the basis for the
deficiency determination, citing specific language from a regulation, guidance document, or standard. All defi-
ciency letters will also undergo supervisory review.

Trunzo says this reform is designed to
build more consistency and predictability into the review process. One of the
areas that was identified in the independent assessment under MDUFA III
is that the additional information
requests needed greater consistency.
And the one way to do it is to provide a
citation as to the basis for the additional information that is being requested.
Also included in the agreement is
funding for a three-year project to
assess whether real-world evidence can
be used effectively to support premarket review activities.
The end result is a win for patients
who will have more timely access to
technology. It will be a win for FDA to
fulfill its mission, to not only protect
the public health, but promote medical
advancements. Finally, its a win for
innovation as there will be greater efficiency and predictability in the agencys
review processes, says Trunzo.
Sherrie Trigg
Editor and Director of Medical Content
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Medical Design Briefs, December 2016
Intro
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THE NEXT INDUSTRIAL REVOLUTION

AND WHAT IT COULD MEAN FOR
MEDICAL DEVICE MANUFACTURING
he next industrial revolution is on its

way. It is bringing innovative technologies that are available and proven
and placing them in the modern manufacturing plants. The cloud, the Internet
of Things, mobile computing technology, embedded computing, advanced
analytical software, and 3D printing all
have a part to play in the future of manufacturing. Known as Industry 4.0, this
revolution will change the way we manufacture devices by enabling much
greater levels of distributed intelligence
for greater production autonomy, flexibility, and economy.
What then could this mean for manufacturers of medical devices? When
looking at the medical industry, there
are many more intricacies involved in
ensuring and enforcing compliance
with its many regulations. These regulations are an essential part of patient
safety and, although they may make
the adoption of Industry 4.0 a bit slower in maturing and stabilizing, this revolution will be embraced. Like previous industrial revolutions, Industry 4.0
fundamentally offers manufacturers so
many benefits, it simply cannot be
ignored.
One area of medical manufacturing
that will gain tremendous advantages
from Industry 4.0 is the customization of
patient-specific devices. The need for
6
high-quality, high-mix products lends

itself perfectly to the Industry 4.0 model.
Based on cyber-physical systems (CPS)
that integrate computational networks
with the surrounding physical world and
its process, this change to the manufacturing architecture brings with it much
higher levels of intelligence and plant
automation. Physical objects passing
through production processes will incorporate their own embedded software
and computing power to interact with
more intelligent machines, cyberphysical production systems (CPPS), on
the plant floor.
Products (the service consumers: CPS)
and software-enhanced equipment (the
service providers: CPPS) will exchange
intelligent information to enable selfmanagement and optimization of the
production line. Products will know what
process steps they need and machines
will know their own state, capacity, and
configuration options. This decentralized model of manufacturing means that
production decisions can be made without the need for operator intervention.
It offers robustness, autonomy, selforganization, self-maintenance, selfrepair, and predictability. In such a way,
the automatic production of completely
customized products to exact patient
needs becomes not only practical but
highly efficient and economical.
Handling Big Data and Meeting

Regulations
Of course this decentralized control of
manufacturing execution creates a huge
amount of data that needs to be analyzed
and acted upon. Technologies including
the Industrial Internet of Things (IIoT),
big data analytics, and the cloud all help
for this to be handled and used efficiently, but the shop floor context is still needed to make sense of the information collected. While some data can be stored
locally in the CPS, information relevant
to higher systems can be sent to big data
structures and, with the correct vertical
integration, to enhanced manufacturing
execution systems (MES). Correct handling and filtering of this information
will lead to supply chain optimization
and better control of quality because
actions to correct or improve can be triggered much more rapidly.
To work efficiently, the smart shopfloor also requires service-oriented ways
of alerting the rest of the information
system to the information available.
However, that is not likely to all come
from the CPS and CPPS directly. In
Industry 4.0, the MES solution must be
truly modular and interoperable so that
all functions or services can be consumed by CPS smart materials, CPPS
smart equipment, or any other shopfloor entity.
Intro
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The decentralization of the control
systems inherent to Industry 4.0 brings
with it many opportunities, but also specific challenges to the medical industry.
Having materials, products, and
machines that make autonomous decisions challenges the traditional
approach to imposing corporate quality
guidelines. An MES that can aggregate
the vast quantities of data and put them
into context will add a level of factory
control that is vital to compliance with
the requirements of medical regulatory
bodies. Careful vertical integration of
the MES is needed to ensure equipment
is properly maintained and calibrated,
to check that processing recipes are correctly applied, and to confirm that
processes are operating within acceptable control tolerances.
Although vertical integration within
the Industry 4.0 model for the medical
industry probably needs to be deeper
and more carefully engineered than
for any other industry, there is also a
significant advantage of this approach.
Having the IIoT means that all necessary records for compliance can be
stored; covering every piece of infor-
The use of tablets to connect to machines eliminates the need for multiple logins or different interfaces. Relevant information to carry out necessary works can load onto workers tablet interface as
they approach a machine and their whereabouts will also be part of the plant information.
mation needed to meet FDA and other

regulatory body requirements. This
includes unique device identifiers
(UDI), electronic signatures, and certification of any operators that manually
interact with the process. Exceptions

and full electronic device history
records (eDHR) can be stored in the
device itself as it is built in real time.
This means that the full, readable his-
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We play nice with CO

OC and COP
P.
Medical Adhessive 1072-M from Dymax. 2"&/#&15.#%5.0'.%#'5"*+5-&/1.05"&'.05&,&"#'5#*5*"5',&./--5.#%5
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Intro
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Using tablets or smartphones with appropriate security and control, many

areas where personnel need to connect with the plant can be made more
efficient.
tory of the product is readily available at any time for review

by customers, auditors, or any other interested party.
Inspire... Create... Deliver...
Increased Mobility Adds Efficiency

Having elements throughout the manufacturing plant
that are autonomous with distributed computing and communication capability, it no longer makes sense to have
fixed workstations for operators to interact with the plant.
The advance of mobile computing technology provides an
ideal opportunity to drive further efficiency into how a
plant operates. Using tablets or smartphones with appropriate security and control, many areas where personnel need
to connect with the plant can be made more efficient. For
example, if maintenance technicians can use tablets to connect to machines as they need to, they do not need to battle
with multiple logins or different interfaces. Relevant information to carry out necessary works can load onto their
interface as they approach a machine and their whereabouts will also be part of the plant information. Combined
with the CPPS advising its status and needs, the efficiency of
both planned and unplanned maintenance can see substantial increases.
Of course, having information about products, equipment
and personnel throughout the plant floor also opens up the
possibility of using virtual reality to further help plant efficiency and productivity. The complete status of the shop floor can
be visualized in real time in 3D maps, making it easy to identify
inefficiencies or problem areas and implement corrective
actions. Augmented reality scenarios also become a possibility
to help operators and technicians with their work and to
reduce the risk of human error.
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As pioneers and innovators in the silicone injection molding
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10
Traceability throughout the Supply Chain

As individual products passing through the production
process have bidirectional communication capability, they
can be connected to systems from anywhere and tracked
throughout production even outside of the plant floor
into the wider supply chain. This end-to-end track-and-trace
capability makes the supply chain itself highly integrated,
transparent, more reliable, and agile.
Intro
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Intro
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The Efficiency of Autonomy
With products and machines making
decisions about the most expedient
route to a finished product, Industry
4.0 significantly changes the manufacturing outlook. Alongside the ease
with which each individual product
can be customized without the need
for a person to cradle it through a different production process, the whole
concept of the smart factory opens up
other possibilities for efficiency drives.
If people are not needed on the shop
floor, there is the potential for reducing energy overheads with cold and/or
dark factories.
The use of CPPS and a smart supply
chain make inventory management
leaner as well. There are also billions of
potential savings in scrap or wasted
materials as the whole production
process is optimized. Using the powerful
software available for advanced data
analysis and the huge streams of realtime data from the shop floor, production scenarios may also be predicted
rather than just reacted to, which further maximizes productivity and
improves business decision making.
Summary
Alongside realizing truly efficient
production of patient-specific devices
and other high-mix production batches, the Industry 4.0 model will give a
level of efficiency that will significantly
accelerate general manufacturing
processes. This increase in productivity will reduce production costs and
enable faster time to market.
Intelligent operation and data analysis
will give complete visibility of an operation; enabling smarter strategic decisions and further enhancement to
processes.
Industry 4.0 will not happen
overnight. There will be a transition
and, particularly in medical applications, time will be required to prove
quality systems. As autonomous smart
materials, products, and production
systems (CPS and CPPS) become a
marketplace on the plant floor, a traditional centralized UI-focused MES will
not be effective not even for compliance, optimization, and monitoring.
To enable the transition to Industry
4.0, MES for the future must address
the challenges of a logical decentral-
ization to support highly automated

CPS with operations dispersed across
different systems. They need to provide appropriate connectivity, mobile
computing capability, use of the IIoT
and cloud, and advanced analytical
services. Careful vertical integration
is especially important to ensure
compliance with medical industry
regulations.
For the medical device industry, the
idea of decentralized, autonomous production capability is not just a want but
a need to track the future of medical science. As medical device products
become smarter as part of CPS, they
have communication with monitoring
systems and remote physicians. These
are evolving into part of an Internet of
Services (IoS), which is opening up new
possibilities for providers. Healthcare
will eventually be connected via CPS
into an IoS and the requirements for
medical device manufacturing must
support it.
This article was written by Francisco
Almada Lobo, CEO, Critical Manufacturing,
Moreira da Maia, Portugal. For more information, visit http://info.hotims.com/61068-160.
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Intro
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When Anna was diagnosed

with a ventricular septal
defect, a septal occluder
made with Fort Wayne Metals
Nitinol wire closed the hole
between the chambers of her
heart, enabling it to pump
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Silicone Adhesives for

Medical Device Assemblies
M
edical device assemblies present

unique challenges beyond those
associated with manufacturing and
assembly of products for consumer and
industrial applications. While sharing
the need for ensuring reliable, robust
seals or bonds with these industrial
applications, medical applications are
subject to stringent requirements for
biocompatibility and must withstand
harsh treatment during sterilization
using high temperatures, radiation, or
chemicals.
Specialized silicone adhesives combine characteristics for meeting more
conventional assembly challenges while
also meeting the unique requirements
of medical device assembly. By drawing
on a variety of one- and two-part silicone
medical adhesives, manufacturers of
medical products can address the
diverse requirements of medical applications without compromising the
strength and integrity of the various
bonds, seals, and coatings essential for
safe and reliable medical products.
Silicone Advantages
Silicones are elastomeric systems that
offer a unique combination of flexibility
and strength that makes them attractive
for ensuring successful bonding in
diverse applications and industries.
Silicone adhesives, sealants, coatings,
and potting compounds can withstand
shock, vibration, impact, and aggressive
thermal cycling, while maintaining elasticity, stress resistance, and long-term
high-temperature resistance. Along with
their thermal stability, silicone adhesives
are available in optically clear formulations and a wide range of hardnesses
while ensuring high bond strength even
between dissimilar substrates.
At the same time, the biocompatible
characteristics of silicone adhesives have
earned them a leading role in medical
applications. Whether used for adhesive
purposes, as sealants, coatings, or as potting/encapsulation compounds, all
medical-grade silicones need to be non14
Fast-curing single-component silicone adhesives such as MasterSil 912Med are ideal for bonding
many plastic and rubber substrates.
toxic and show compatibility with blood

and body fluids. Additionally, they must
be biologically inert and must satisfy ISO
10993-5/USP Class VI specifications for
biocompatibility, nonirritating, and nonsensitizing behavior. At the same time,
medical silicones are able to withstand
the impact of different types of sterilization methods including gamma radiation, ethylene oxide (EtO) sterilization,
and various other chemical sterilizing
agents. Medical-grade silicones are
designed to meet these requirements.
Applications for Medical Adhesives
With their unique characteristics, silicone adhesives offer cost-effective solutions for the assembly of reusable and disposable medical devices. Indeed, they
find a long history of use in medical products. Easy to apply, silicones bond well to
a wide variety of substrates, speed produc-
tivity, and cure at room and elevated temperatures. Consequently, these materials
continue to find ready application in
meeting diverse requirements for bonding, sealing, potting, or coating in a wide
range of medical and surgical devices,
instruments, and peripheral products.
While nonimplantable medical devices
are the prime market for the use of silicone
adhesives, the growing variety of medicalgrade silicone formulations provides an
effective solution to an expanding range of
medical applications. These applications
fall into three basic categories:
Disposable medical devices
Reusable medical devices
External medical equipment and systems
Disposable Medical Devices
Disposable medical devices have always
been a prime area for the exceptional
bonding characteristics of medical-grade
Intro
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i-CLAMPS
(I D C)
One-Way Series
Two-Way Series
T-Series
s IDC (Insulation Displacement Connectors) s Easy to use s Quick and reliable connections s Tamper Proof
s Designed to withstand shock and vibration s Housing made from durable Polycarbonate s Tin plated High Performance
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Intro
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Silicone Adhesives
silicones. Although these products are
used only once, they must nevertheless
first go through some type of sterilization
or disinfecting process before they are
packaged for one-time use. In turn, the
silicone adhesive material must be able to
stand up to this process. Because of their
unique characteristics, medical-grade silicones find extensive use in disposable
medical devices, including catheters,
infusion pumps, IV kits, blood exchangers, and syringes and cannulae.
Reusable Medical Devices
Reusable devices and instruments are
typically used on multiple patients.
Reusable instruments include the following:
Most surgical instruments, including surgical forceps and all types of cutting
instruments
Stethoscopes and endoscopes (which
may be partially reusable/partially disposable)
Robotic surgical instruments
Laparoscopic instrumentation and related surgical accessory instrumentation
External medical equipment and systems
All of these are subjected to multiple
sterilization processes, depending upon
the type of instrument. This sterilization
process can combine a wide range of
methods including heat/steam autoclave, EtO, vaporization, plasma, gamma

radiation, and electron beam. Silicones
typically stand up to these sterilization
methods without degradation. Only
repeated autoclaving environments can
cause a loss in flexibility or lead to them
turning brittle.
Although the working area of most
external medical systems does not penetrate the human body, they all come into
close contact with the patient.
Consequently, all of these systems must
be sterile, and all bonding components
used anywhere in or on the systems must
be both biocompatible and resistant to
continual antimicrobial cleaning, disinfecting, and partial device sterilization.
External medical equipment examples
include MRI machines, PET and CT
scanners, ultrasound machines, electrocardiograph devices, tonometers, x-ray
machines, otoscopes, spirometers, and
drug-delivery systems.
Matching Unique Requirements
All medical-grade silicone adhesives
and sealants provide biocompatibility
verified by meeting the testing
requirements for USP Class VI and ISO
cytotoxicity specifications. While these
attributes are extremely important,
equally important are the materials
Low-viscosity, optically clear silicone compounds such as MasterSil 151Med offer good flow properties, high flexibility, and excellent adhesion to silicone elastomers.
16
benefits and performance properties

themselves. Silicones are well known
for their ability to form strong bonds
with a wide variety of substrate materials including glass, plastics, metals, and
rubbers, among other substrates. It is
also important to note that only silicone adhesives can bond to silicone
substrates.
The availability of silicone adhesives
in one- or two-part formulations offers a
range of fast cure schedules to match
the unique requirements of each application. Both one- and two-part silicone
systems provide high reliability and withstand difficult conditions encountered
in use. Both cure at ambient or elevated
temperatures, and select formulations
provide fast tack-free times and withstand liquid sterilants, gamma radiation,
and EtO very well. Both are also available in a wide service temperature
range. Some of the formulations are
even optically clear.
These two types of silicone materials
add to the flexibility of choice when
matching the material to the application. Each offers benefits and special
properties as described below.
One-Part Medical Silicones
No-mix one-part medical silicones
offer a unique combination of flexibility
and
high-temperature
resistance.
Whenever medical device bonding is
required, one-part silicones excel. These
one-part silicones bond exceptionally
well to a wide variety of substrates including metals, composites, ceramics, and
glass, as well as many rubbers and plastics.
In fact, certain medical silicone adhesives
bond particularly well to metals.
One-part silicones cure at room temperature via moisture in the air.
Typical of one-part silicones, the curing rate is based on the humidity level:
The higher the humidity, the faster the
cure, and thinner sections cure more
quickly than thicker ones. In many
cases, it is essential to use a fast-curing
system that offers a tack-free time ranging from 10 to 20 minutes, depending
upon the application. For applications
requiring a more extended tack-free
time, a faster curing medical-grade silicone system with a tack-free time of 15
30 minutes has been developed.
These adhesives can resist the most
aggressive types of thermal cycling and
can endure mechanical and thermal
shock. Furthermore, silicones offer a
very broad service temperature range.
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Medical equipment must meet special

requirements. These requirements place
special signicance on fusing and ltering
when selecting components used in medical
equipment. Patient-connected medical equipment
can be subjected to low-leakage current
requirements. The use of a low-leakage lter in
the 5A range at 250VAC is desirable. In addition,
fusing of both line and neutral connections may
be required (i.e. double fusing).
Interpower offers 2, 3, 4, and 5-function
hospital-grade power entry modules. Functions
may include a power inlet or access outlet,
lter, switch, circuit protection, and/or voltage
selector. There are screw-mount and snap-in
options available.
From 1 piece to 1,000 pieces or more, Interpower
has no minimum order requirements and offers
a 1-week U.S. manufacturing lead-time on
non-stock Interpower products. All Interpower
manufactured products are 100% tested.
No minimum order requirements
1-week U.S. manufacturing lead-time on
non-stock Interpower products
Same day shipments on in-stock products
Free technical support
Order Online! www.interpower.com
ORDER A FREE CATALOG TODAY! E-mail catalog@interpower.com or call toll-free.
Business Hours: 7 a.m.6 p.m. Central Time
INTERPOWER | P.O. Box 115 | 100 Interpower Ave | Oskaloosa, IA 52577 |

Toll-Free Phone: (800) 662-2290 | Toll-Free Fax: (800) 645-5360 | info@interpower.com
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Silicone Adhesives
PTFE
Solenoid-Operated
As a one-part material, these adhesives can be manually dispensed from

their application container and can
also be adapted to semi-automated or
fully automated silicone-dispensing systems, if required. Their unique combination of fast curing, thermal stability,
and wide range of viscosities make
these materials ideally suited to a variety of bonding applications such as
bonding cannulae to hubs in virtually
all types and configurations of syringeneedle assembly applications.
Isolation
& Pinch
Valvess
Two-Part Medical Silicones

Two-part silicones are among the
most versatile polymer compounds
used in medical devices, particularly in
the area of electronics. They adhere
well to a variety of substrate materials
and operate over a wide range of temperatures. Furthermore, they provide
excellent protection from chemicals,
moisture, and mechanical shock and
vibration. These characteristics make
two-part adhesives the first choice for
use in a variety of functions in medical
electronics, including bonding, sealing, potting, encapsulating, and coating electronic parts. Indeed, two-part
silicone systems are commonly the
choice for the assembly of medical,
electrical, electronic, optical, and
other devices.
Manufacturers can find two-part medical silicone adhesives that offer an
exceptionally low viscosity, providing a
particularly effective material for potting and encapsulation. As a result,
these materials routinely find use in
medical packaging applications including board coating, all types of potting,
lid and housing seals, LED assembly,
and different types of component
attachment and sealing.
Manufacturers can also find two-part
medical silicone adhesives designed to
meet unique assembly requirements for
bonding complex structures or even
forming bonds at interfaces with little
or no access to air.
Widely used in medical devices, such
two-part systems offer high flexibility
and excellent temperature resistance
typically required for those applications. They meet USP Class VI testing
and ISO 10993-5 for cytotoxicity and
offer robust performance characteristics. Their exceptionally long working
life aids exacting assembly operations,
and they readily cure at room temperature or at elevated temperatures for
Ideal for use with

ith sensitive or
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they interact with medical grade
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Intro
faster cure times. Once cured, these

two-part systems provide stress relief
for the bonded assembly with their
ability to withstand severe thermal
cycling, vibration, and shock.
Primed for Certification
Adhesive manufacturers offer a
range of specialty epoxies, primers for
polyolefins, UV curable adhesives, and
silicones that have been fully tested to
meet USP Class VI requirements for
the medical device industry. In fact,
many of Master Bond's special-grade
products have passed this rigorous
test. Nevertheless, Class VI compliance
only aids product certification; it does
not automatically mean the adhesive
system can be used a priori in a medical device.
Meticulous care and attention must
be paid to all FDA regulations regarding medical devices and their constituents. In the case of Master Bond
special-grade products, their Class VI
certification can be considered a strong
indication that its adhesive systems
should not cause any problems when
the device is submitted to the FDA for
approval. Choosing the appropriate
adhesive, sealing, coating, or potting
compound that is certified for the USP
Class VI testing or cytotoxicity thus provides a good starting point for medical
device manufacturers.
Conclusion
Medical product assemblies are subject to stringent requirements for biocompatibility of adhesives needed to
seal, bond, pot, or encapsulate components. At the same time, medical products can present a broad array of
requirements for flexibility, strength,
thermal stability, and more, which are
encountered in any consumer or
industrial product.
For manufacturers, the challenge
lies in finding an adhesive system able
to address assembly requirements
while meeting the unique challenges
associated with medical products and
the medical environment in general.
Medical-grade silicone adhesive systems such as those from Master Bond
provide manufacturers with a broad
selection of choices needed to match
the unique requirements of each individual medical product.
Venkat Nandivada is manager of technical
support at Master Bond. For more information, visit http://info.hotims.com/61068-161.
Cov
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From
m Con
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To Finis
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Validating IFUs for

Reprocessed Medical Devices
I
ncidents of nosocomial or healthcare

acquired infections (HAIs) and bacteria that have become resistant to antibiotics (superbugs) are a concern for
U.S. FDA. These ongoing incidents have
heightened FDAs attention to manufacturers of reprocessed medical devices.
Manufacturers need to design devices
that can be reprocessed effectively after
patient contact, validate that the devices
can be reprocessed in the healthcare
facility, and publish clear reprocessing
procedures and instructions for use
(IFU) that are easy for healthcare personnel to understand and follow.
changes to users, user tasks, user interface, or use environments from those of
the predicate devices.
The ability to clean a medical device
should not be an afterthought for manufacturers; they need to consider ease of
cleaning in the initial device design and
engineering discussions. FDA recommends incorporating features that effectively facilitate reprocessing (e.g., flush
ports) when designing a medical device
that will be cleaned in a healthcare environment. When cleaning is taken into
account in the early design phase of
device development, it can positively
impact the ability for healthcare personnel to effectively clean the device, which
will improve patient safety.
FDA Guidance
FDA issued two key guidance documents that address critical recommendations for manufacturers: Reprocessing Medical
Devices in Health Care Settings:
Validation
Methods
and
Labeling and Class II Special
Controls Guidance Document:
Instrumentation for Clinical
Multiplex Test Systems.1,2
These valuable resources outline
important cleaning considerations for manufacturers of
reusable medical devices.
One key draft guidance document that specifically addresses
critical human factors is List of
Highest Priority Devices for
Human Factors Review.3 This
draft guidance is intended to
assist medical device manufacturers in following appropriate
human factors guidelines and
usability engineering processes
to maximize the likelihood that
new medical devices will be safe
after cleaning. Complex devices
that have clear potential for serious harm resulting from user
error need to be validated for
human factors. Human factors
data should be included in premarket submissions for these
complex devices unless the submission does not involve any Devices soiled with clinical contaminates.
20
Six Criteria for Reprocessing

Instructions
FDA outlines the following six criteria
for manufacturers to follow when developing reprocessing instructions:
1. Labeling should reflect the intended
use of the device. Medical device
manufacturers must provide reprocessing instructions that are consistent throughout each product line.
Validation testing needs to reflect the
design and intended use of the device
by simulating the contaminants, procedure, and wait period between the
medical procedure and reprocessing
the device.
2. Reprocessing instructions for reusable
devices should advise users to thoroughly clean the device. All
cleaning instructions must
include the text description,
explanation, and diagrams of
proper disassembly, use of protective covers and sheaths,
and any applicable flushing
instructions.
3. Reprocessing
instructions
should indicate the appropriate microbicidal process for
the device. Reprocessing
instructions must include disinfection or sterilization
processes (depending on the
Spaulding classification) of
the device and the compatibility of the device with the
microbicidal process.
4. Reprocessing instructions
should be technically feasible and include only devices
and accessories that are
legally marketed. All products, equipment, and accessories used to reprocess
devices should be defined
with part numbers and have
appropriate FDA clearance.
Any parameters and processes validated and specified in
the IFUs must be easily performed in any health care
facility.
Intro
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Interpower manufactures North American

and international hospital-grade power cords
and cord sets. While some countries have
standards in regards to overall medical
equipment, a few countries/regions have
standards or recommendations in regards
to specic medical-related components
(e.g. plugs and cords). Hospital-grade power
cords and cord sets as well as plugs and
sockets are subject to special requirements
or recommendations in Australia, Denmark,
Japan, and North America. Contact Customer
Service at Interpower with questions.
North American and international
hospital-grade cords are available in a
variety of lengths and colors. Plus, we
have value-added options, such as custom
packaging and custom labeling.
From 1 piece to 1,000 pieces or more,
Interpower offers no minimum order
requirements and just a 1-week U.S.
manufacturing lead-time on non-stock
Interpower products. All Interpower
manufactured cords are 100% tested.
1-week U.S. manufacturing

lead-time on non-stock
Interpower products
No minimum order
requirements
Same day shipments available

for in-stock products
Over 4 million parts in stock
Free technical support
Order Online! www.interpower.com
ORDER A FREE CATALOG TODAY! E-mail catalog@interpower.com or call toll-free.
Business Hours: 7 a.m.6 p.m. Central Time
INTERPOWER | P.O. Box 115 | 100 Interpower Ave | Oskaloosa, IA 52577 |

Toll-Free Phone: (800) 662-2290 | Toll-Free Fax: (800) 645-5360 | info@interpower.com
Intro
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Validating IFUs
5. Reprocessing instructions should be
comprehensive. Every step of the
reprocessing instructions should be
thoroughly defined and explained.
This includes any special accessories
needed to complete each cleaning
step (including cleaning agents), disassembly, rinsing steps (including
water quality), and reassembly.
6. Reprocessing instructions should be
understandable. All reprocessing
steps must be specified in sequential
order from initial processing through
terminal processing. These instructions should be text descriptions and
should include charts, diagrams, and
videos when available.
Conducting In-Use or Human
Factors Testing
Manufacturers must assess the ability
of healthcare personnel to follow the
IFUs. FDA recommends in-use testing or
human factors testing to verify that the
medical devices can be adequately
cleaned after patient contact in a healthcare setting. First, the contaminants
present in the healthcare facility should
be understood. Next, the devices determined to have the greatest cleaning
challenges should be subjected to the
worst-case soil scenario (in some scenarios, this would be contamination by
patient use).
Once the devices and contaminants
have been determined, the manufacturer can conduct classroom training for
the healthcare personnel. The purpose
of the classroom exercise is to educate
the trainees to appropriately clean the
devices during in-use testing. IFUs and
other training materials must be ready
and available for the classroom training.
During this exercise, the manufacturer
can solicit feedback from the trainees
about the ease of use of the IFUs. This
exercise is significant because it shows
the manufacturer exactly how the IFUs
are being used in the healthcare setting.
Depending on the feedback, the manufacturers may need to adjust the IFUs if
there are any usability issues.
The technicians who are selected for
training should work in central processing and should not have prior experience with the devices that are being
assessed. An expert from the manufacturer needs to be present for the in-use
testing to answer questions that arise
during cleaning. A qualified moderator
facilitates the initial discussion, leads the
classroom training, administers a survey,
Cleaning medical devices.
Automated washing of medical devices.
22
Intro
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w w w.th eleec o. c om
Go ahead, push us to your limits.
We love a good challenge.

If you need a uid handling component for whatever reason, no matter
how extreme, talk to The Lee Company. Weve been solving complex
uid control problems in all kinds of industries for more than 60 years.
Our extensive family of precision uid control products offers unsurpassed
reliability in just about every conguration you could imagine, including:
Were not just talking about off-the-shelf solutions, either. A Lee

engineer will be happy to discuss your application, and develop a
custom design if needed. From managing nanoliter droplets to
creating fully integrated uidic systems, were unsurpassed in breadth
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Whatever problem you face, make the solution easy.
Contact The Lee Company today.
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Custom Engineered Designs

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Intro
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Validating IFUs
and solicits feedback after the conclusion of the in-use testing.
There are three recommended methods to perform the in-use testing of a
device that has been cleaned in a healthcare setting to comply with FDA guidance:
1. The medical device manufacturer will
observe a technician cleaning the medical device. After the cleaning process,
the device will be sent to a third-party
testing laboratory. The laboratory will
extract the device using validated
extraction methods and test the extractions for residuals specific to the device
type and surgical procedure. Organism
recovery may also be tested, and organisms identified, to ensure that no highconcern organisms remain viable.
2. The medical device manufacturer will
observe a technician cleaning the medical device as in the first method.
However, employees from the thirdparty laboratory will extract the device
at the healthcare facility after it has
been cleaned using validated extraction methods. These extractions will be

sent to the third partys laboratory and
tested for residuals specific to the
device type and surgical procedure.
Organism recovery may also be tested,
and organisms identified, to ensure no
high-concern organisms remain viable.
3. The third method is specific to scope inuse testing. As in the other two methods, the medical device manufacturer
will observe a technician cleaning and
disinfecting the scope. Trained personnel will extract the scope using an endoscope culturing kit, and samples will be
sent to a third-party laboratory for testing. Protein and total organic carbon
(TOC) residuals may be tested as well as
organism recovery to ensure that no
high-concern organisms remain viable.
Conclusion
Human factors related to healthcare
reprocessing of medical devices is a valuable component of product development for all medical devices. If reprocessing steps are performed incorrectly, or
not at all, it could result in serious harm
to the next patient. In-use, or human factors testing, is a powerful method to
ensure that users can appropriately follow and perform all of the reprocessing
steps. This is an integral part of preparing the device for regulatory submission.
Proper reprocessing of medical devices
will decrease hospital acquired infections
and increase patient safety.
References
1. Food and Drug Administration. 2015.
Guidance for Industry and FDA Staff
Processing/Reprocessing Medical Devices
in Health Care Settings: Validation
Methods and Labeling. U.S. Department
of Health and Human Ser vices,
Washington, DC.
Class II Special Controls Guidance
Document: Medical Washers and
Medical Washer-Disinfectors; Guidance
for the Medical Device Industry and
FDA Review Staff. FDA. Infection
Control Devices Branch. Division of
Dental, Infection Control and General
Hospital Devices. Office of Device
Evaluation. Center for Devices and
Radiological Health.
Draft Guidance for Industry and FDA Staff
List of Highest Priority Devices for
Human Factors Review. U.S. Department
of Health and Human Ser vices,
Washington, DC.
@ MachinedSprings.com
This article was written by Emily Mitzel,

M.S., consulting manager/senior scientist
at Nelson Laboratories, Salt Lake City, UT.
For more information, visit http://info.
hotims.com/61068-163.
For more information on Machined Springs, including custom

applications, go to MachinedSprings.com or call (877) 435-4225
2016 Helical Products Company | www.heli-cal.com
24
Intro
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CREATING TOMORROWS SOLUTIONS
WITH SO MANY APPLICATIONS,

OUR SILICONES ARE JUST
WHAT THE DOCTOR ORDERED.
ELASTOSIL
Flexible and easyto-clean wire/cable
surfaces.
SILPURAN
High purity silicone
elastomers for devices
in and outside the
operating room, such as
insulin pumps, enteral
feeding, catheters
and tubing.
ELASTOSIL
Surgical tray liners for
instrument stability
and low-slip surface.
ELASTOSIL
Soft feel and
ergonomic design
for surgical handles.
SEMICOSIL
Reliable, conformable
coatings for electronic
component protection.
WACKERs SILPURAN, ELASTOSIL and SEMICOSIL silicones are ideally suited for medical care
devices, improving the performance of hoses, catheters, membranes, valves, handles for surgical
instruments and more. Silicones are heavily relied upon every day and help to improve health care in
many ways. No wonder they are the commonly prescribed solutions in the industry.
Wacker Chemical Corporation, 3301 Sutton Road, Adrian, MI 49221, USA
TEL: +1 888 922 5374, FAX: +1 517 264 4068, www.wacker.com/healthcare, info.usa@wacker.com
Intro
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Special Advertiser Supported Section
Medical Design Briefs 2017 Product Buyers Guide

Connectors/Interconnects/
Switches ........................................26
Electronic Components..................26
Filter & IV Components..................28
Fluid Handling/Pumps & Valves......28
Manufacturing Equipment .............30
Materials/Plastics/
Adhesives ......................................30
Mechanical Components/
Hardware.......................................32
Motion Control/Motors ..................32
Connectors/
Interconnects/
Switches
Optics/Optical Components ...........33

Packaging/Enclosures ...................34
Power Supplies & Batteries ...........34
Sensors/Detectors/
Data Acquisition ............................34
Software........................................35
Sterilization Equipment .................35
Test/Inspection/Metrology ............36
Tubing & Extrusion.........................36
Ametek Engineered Medical

Components
www.ametekemc.com
Amphenol Industrial Products
Group
www.amphenol-industrial.com
Anomet Products
Phone: 508-842-3069
Fax: 508-842-0847
info@anometproducts.com
www.anometproducts.com
Electronic
Components
ODU USA
www.odu-usa.com
ACCES I/O Products, Inc.

www.accesio.com
Okay Industries
www.okayind.com
Accu-Glass Products, Inc.

http://accuglassproducts.com
Omnetics Connector Corp.

www.omnetics.com
Adhesives Research
www.adhesivesresearch.com
Alpha Wire
www.alphawire.com
Keystone Electronics Corp.

Phone: 800-221-5510
Fax: 718-956-9040
kec@keyelco.com
sales@keyelco.com
www.keyelco.com
Advanced Interconnections
Corp.
www.advanced.com
NKK Switches
www.nkkswitches.com
LEMO USA, Inc.

Phone: 800-444-5366
Fax: 707-206-3774
jcarlson@lemo.com
www.lemo.com
Linemaster Switch Corporation
www.linemaster.com
LinkTech Couplings
www.linktechcouplings.com
Photofabrication
Engineering, Inc. PEI
Phone: 508-478-2025
Fax: 508-478-3582
pei@photofabrication.com
www.photofabrication.com
Proto Labs
Phone: 877-479-3680
Fax: 763-479-2679
customerservice@protolabs.com
www.protolabs.com
Carlisle Interconnect
Technologies
www.CarlisleIT.com
Qosina Corporation
Phone: 631-242-3000
Fax: 631-242-3230
deanna@qosina.com
www.qosina.com
Cornell Dubilier Electronics

www.cde.com
EI Microcircuits, Inc.
www.eimicro.com
EAO Corporation
www.eao.com
Lyons Tool and Die Co.

Phone: 203-238-2689
Fax: 203-237-8769
will.lyons@lyons.com
www.lyons.com
Coilcraft CPS
www.coilcraft.com
Schurter, Inc.
Phone: 707-636-6000
info@schurterinc.com
www.schurter.com
Colder Products Company

www.cpcworldwide.com
EPCOS Inc.,
a TDK Group Company
Phone: 732-906-4300
salesUSA@epcos.com
www.epcos.com
Silcotech North America

www.silcotech.ca
Cotronics Corp.
www.cotronics.com
Micro Systems Technologies

Management AG
Phone: +41 44 804 63 00
info@mst.com
www.mst.com
DG Interconnect
http://dginterconnect.com
Direct Sound Corporation
http://connectdsc.com
Fischer Connectors
www.fischerconnectors.com
Mill-Max Manufacturing Corp.

www.mill-max.com
Heilind Electronics
www.heilind.com
Molex Incorporated
http://innovate.molex.com/
medical_LP
High Speed Interconnects

www.highspeedint.com
Bal Seal Engineering, Inc.

Phone: 949-460-2100
Fax: 949-460-2100
sales@balseal.com
www.balseal.com
Clippard Instrument
Laboratory, Inc.
Phone: 513-521-4261
Fax: 513-521-4464
chris.agricola@clippard.com
www.clippard.com
Quail Electronics, Inc.

www.quail.com
Autosplice, Inc.
www.autosplice.com
Analog Devices Inc.

www.analog.com
Steute Meditech, Inc.

Phone: 203-244-6302
Fax: 203-894-8065
info@steuteusa.com
First Sensor, Inc.

Phone: 818-706-3400
Fax: 818-889-7053
contact.us@first-sensor.com
www.first-sensor.com
Nicomatic
www.nicomatic.com
26
Intro
Cov
ToC
Intro
Cov
ToC
2017 Product Buyers Guide

Electronic Components
continued
Heatron, Inc.
Phone: 913-651-4420
Fax: 913-651-5352
sales@heatron.com
www.heatron.com
maxon precision motors, Inc.

Phone: 508-677-0520
Fax: 508-677-0530
info@maxonmotorusa.com
www.maxonmotorusa.com
Helwig Carbon Products, Inc.

www.helwigcarbon.com
MEGA Electronics, Inc.

www.megaelectronics.com
Proto Labs
Phone: 877-479-3680
Fax: 763-479-2679
www.protolabs.com
RBC Medical Innovations
www.rbccorp.com
IS Med Specialties
www.ismedspec.com
Metrigraphics LLC
www.metrigraphicsllc.com
Nordson MEDICAL
www.nordsonmedical.com
Micro Crystal AG
www.microcrystal.com
Hotwatt Inc.
Phone: 978-777-0070
Fax: 978-774-2409
sales@hotwatt.com
www.hotwatt.com
International Manufacturing
Services, Inc. (IMS)
Phone: 401-683-9700 x311
jdavoll@ims-resistors.com
Schurter, Inc.
Phone: 707-636-6000
info@schurterinc.com
www.schurter.com

Management AG
Phone: +41 44 804 63 00
info@mst.com
www.mst.com
Microchip Technology, Inc.
www.microchip.com
Mill-Max Mfg. Corp.
www.mill-max.com
Watlow Electric Mfg. Company

www.watlow.com
New England Wire Technologies

www.newenglandwire.com
ON Semiconductor
www.onsemi.com
Littelfuse, Inc.
www.littelfuse.com
Phoenix Contact
www.phoenixcontact.com/usa_
home.htm
Weiss-Aug
www.weiss-aug.com
Air Logic
www.air-logic.com
Ark-Plas
www.ark-plas.com
ASCO Valve, Inc.

www.ascovalve.com
Ci Medical Technologies
www.classicind.com
Photofabrication
Engineering, Inc. (PEI)
Phone: 508-478-2025
Fax: 508-478-3582
Qosina Corporation
Phone: 631-242-3000
Fax: 631-242-3230
deanna@qosina.com
www.qosina.com
Fluid Handling/
Pumps & Valves
Filter & IV
Components
AW-Lake Company
www.aw-lake.com
Elcam Medical
www.elcam-medical.com
Evonik Industries
www.cyrolite.com

Phone: 949-460-2100
Fax: 949-460-2100
sales@balseal.com
www.balseal.com
Industrial Specialties Mfg.

www.industrialspec.com
Premier Magnetics
www.premiermag.com

Phone: 203-238-2689
Fax: 203-237-8769
www.lyons.com
Poly-Pipets, Inc.
www.polypipets.com
Porex Corporation
www.porex.com
Voltage Multipliers Inc.

www.voltagemultipliers.com
Mouser Electronics
www.mouser.com

Phone: 800-221-5510
Fax: 718-956-9040
kec@keyelco.com
sales@keyelco.com
www.keyelco.com
STMicroelectronics
www.st.com
TTI, Inc.
www.ttiinc.com
Minnesota Wire
www.mnwire.com
Jensen Tools + Supply

www.jensentools.com
Southco
www.southco.com
Thermacore, Inc.
www.thermacore.com
Interpower
Phone: 800-662-2290
Fax: 800-6455360
info@interpower.com
www.interpower.com
Pexco LLC
Phone: 404-564-8560
Fax: 404-564-8579
marketing@pexco.com
www.pexco.com/medical
Teseq Inc./AMETEK
www.teseq.com/en/index.php
Minmax Power Inc.

www.minmaxpower.com
International Polymer
Engineering
Phone: 877-410-3265
Fax: 480-929-9799
krockhold@ipeweb.com
www.ipeweb.com
Bimba Manufacturing
www.bimba.com
28
Intro
Cov
ToC
Intro
Cov
ToC

Fluid Handling/Pumps & Values
continued
Schtte
www.schutteusa.com
B. Braun OEM Division

www.bbraunoem.com
Excelitas Technologies
Phone: 905-821-2600
omnicure@excelitas.com
www.excelitas.com/omnicure
Qosina Corporation
Phone: 631-242-3000
Fax: 631-242-3230
deanna@qosina.com
www.qosina.com
Cadence, Inc.
Phone: 800-252-3371
Fax: 540-248-4400
sales@cadenceinc.com
www.cadenceinc.com
Clippard Instrument
Laboratory, Inc.
Phone: 513-521-4261
Fax: 513-521-4464
www.clippard.com
Diener Precision Pumps
www.dienerprecisionpumps.com
Fabco-Air, Inc.
www.fabco-air.com
Materials/Plastics/
Adhesives
Thomas Division
www.gd-thomas.com
TriContinent by Gardner Denver
www.tricontinent.com
Watson-Marlow Pumps Group
www.watson-marlow.com
Hammill Medical
Phone: 419-476-0789
Fax: 419-476-7568
spearson@hammillmedical.com
www.hammillmedical.com
Interface Catheter Solutions
www.interfaceusa.com
Manufacturing
Equipment
IPG Photonics Corp.

www.ipgphotonics.com/
microsystems
Aberdeen Technologies, Inc.

www.aberdeentech.com
Kahle Automation
www.kahleautomation.com
AeroGo, Inc.
www.aerogo.com
Fluid Metering Inc.
Phone: 516-922-6050
Fax: 516-223-3388
pumps@fmipump.com
www.fmipump.com
TRUMPF Inc.
www.us.trumpf.com
GF Machining Solutions
www.gfms.com
Senior Operations LLC

www.metalbellows.com
IVEK Corporation
www.ivek.com
Arthur G. Russell Co, The
Phone: 860-583-4109
Fax: 860-583-1686
agr@arthurgrussell.com
www.arthurgrussell.com
Magnetic Component
Engineering
www.mceproducts.com
Aspect Automation
www.aspectautomation.com
Nordson EFD
www.nordsonefd.com
Parker Precision Fluidics
Division
www.parker.com/precisionfluidics
Pexco LLC
Phone: 404-564-8560
Fax: 404-564-8579
marketing@pexco.com
AZCO Corp.
Phone: 973-439-1428
Fax: 973-439-9411
cs@azcocorp.com
www.azcocorp.com
Bally Ribbon Mills

www.ballyribbon.com
Biomedical Structures,
a division of ETE Medical
www.bmsri.com
Boston Centerless
www.bostoncenterless.com
Marubeni Citizen-Cincom Inc.

Phone: 201-818-0100
Fax: 201-818-1877
dbrooks@mctz.com
www.marucit.com
NPI/Medical
www.npi-med.com
Curtiss-Wright Surface
Technologies
www.paryleneinc.com
DA/Pro Rubber, Inc.
www.daprorubber.com
DELO Industrial Adhesives
www.delo.de
PhotoMachining, Inc.
www.photomachining.com
DuPont Performance Materials

www.plastics.dupont.com
Rofin-Baasel, Inc.
www.rofin.com
Dukane
www.dukane.com/us
Eastman Chemical Company

www.eastman.com
Intro
Cov
ToC
Carwild Corporation
www.carwild.net
CS Hyde Company
www.cshyde.com
Oxford Lasers, Inc.

www.oxfordlasers.com
DENSO Robotics
www.densorobotics.com
Boyd Coatings Research

Company, Inc.
www.boydcoatings.com
Micro Waterjet LLC

www.microwaterjet.com
Online Controls, Inc.

www.onlinecontrols.com
Delta ModTech
www.deltamodtech.com
30
Axis Prototypes Inc.

www.axisproto.com

Phone: 203-238-2689
Fax: 203-237-8769
www.lyons.com
American Kuhne
www.americankuhne.com
KNF Neuberger, Inc.

www.knfusa.com
Anomet Products
Phone: 508-842-3069
Fax: 508-842-0847
info@anometproducts.com
ATL (Ad Tape & Label)

www.atlco.com
Amada Miyachi America

www.amadamiyachi.com
Iwaki America
www.iwakicustompumps.com
Able Electropolishing Co., Inc.

www.ableelectropolishing.com
Applied Silicone Corporation

www.appliedsilicone.com
KMC Systems
www.kmcsystems.com
Altron Inc.
www.altronmfg.com
Halkey-Roberts Corporation
www.halkeyroberts.com
SPI Lasers LLC

www.spilasers.com
Thermonics Corp.
www.thermonics-chillers.com/
Genistar Inc.
www.genistar.com
Rotork Fairchild
www.fairchildproducts.com
Sono-Tek Corporation
www.sono-tek.com

Materials/Plastics/Adhesives
continued
General Plastics Manufacturing

Co.
www.generalplastics.com
Phone: 905-821-2600
NuSil Technology
www.nusil.com
gSource, LLC
www.gsource.com
Offray Specialty Narrow Fabrics

www.osnf.com
Hunter Products Inc.

www.hunterproducts.com
Fabrico Medical
www.fabrico.com
Hydromer, Inc.
www.hydromer.com
Flambeau Medical Markets

Group
www.flambeaumedical.com
Johnson Matthey
www.matthey.com
Pexco LLC
Phone: 404-564-8560
Fax: 404-564-8579
marketing@pexco.com
Lumen Dynamics Group

www.ldgi.com
Fort Wayne Metals

www.fwmetals.com
Ray Products
www.rayplastics.com/
RTP Company
www.rtpcompany.com
SABIC
www.sabic.com
PolyOne
www.polyone.com
MACtac North America

www.mactac.com/medical
Secant Medical
www.secantmedical.com
Master Bond Inc.

www.masterbond.com
Foster Corporation
Phone: 860-928-4102
Fax: 860-928-4226
info@fostercomp.com
www.fostercomp.com
Proto Labs
Phone: 877-479-3680
Fax: 763-479-2679
www.protolabs.com
Matrix Plastic Products

www.matrixtooling.com
Metallix Refining Inc.
www.metallix.com
PTI Engineered Plastics

Phone: 586-263-5100
Fax: 586-263-6680
kaiser@teampti.com
www.teampti.com
Pulse Technologies, Inc.
http://pulsetechnologies.com
Lubrizol Corporation
www.lubrizol.com
Formacoat
www.formacoat.com
NFI Corp.
www.nficorp.com
Seitz LLC
www.seitzllc.com
31
Intro
Cov
ToC

Materials/Plastics/Adhesives
SMC Ltd.
Phone: 715-247-3500
Fax: 715-247-3500
inquiry@smcltd.com
www.smcltd.com
continued
Springfield Spring &

Stamping
www.springfieldspring.com
Apple Rubber Products Inc.

www.applerubber.com
igus, Inc.
www.igus.com
AST Bearings
www.astbearings.com
John Evans Sons, Inc.

www.springcompany.com
Smalley Steel Ring Company

www.smalley.com
Autosplice, Inc.
www.autosplice.com
Solvay Specialty Polymers

www.solvay.com
Phone: 949-460-2100
Fax: 949-460-2100
sales@balseal.com
www.balseal.com
Specialty Coating Systems

www.scscoatings.com
Super Brush LLC
www.superbrush.com
Tech-Etch, Inc.
www.tech-etch.com
BellowsTech, LLC
www.bellowstech.com
Teknicote
www.teknicote.com
Boca Bearing Company

www.bocabearings.com
Teknor Apex Company

www.teknorapex.com
Braxton Manufacturing
Company, Inc.
www.braxtonmfg.com
Ulbrich Stainless Steels &

Special Metals, Inc.
Phone: 800-243-1676
Fax: 203-239-7479
information@ulbrich.com
www.ulbrich.com
Stock Drive Products/Sterling

Instrument
www.sdp-si.com
Lee Spring
www.leespring.com
Sussex Wire, Inc.

www.sussexwire.com

Phone: 203-238-2689
Fax: 203-237-8769
www.lyons.com
Trelleborg
www.trelleborg.com
TLX Technologies, LLC
www.tlxtech.com
Marshall Manufacturing
Company
www.marshallmfg.com
Tolomatic
www.tolomatic.com
PennEngineering
www.pemnet.com
UTITEC, Inc.
www.utitec.com
Motion Control/
Motors
Carr Lane Mfg. Co.

www.carrlane.com
Connecticut Spring & Stamping
www.ctspring.com
Wacker Chemical Corp.

Phone: 888-922-5374
info.usa@wacker.com
www.wacker.com/healthcare

Phone: 203-244-6302
Fax: 203-894-8065
info@steuteusa.com
Stratasys Direct Manufacturing

www.stratasysdirect.com
Cadence, Inc.
Phone: 800-252-3371
Fax: 540-248-4400
www.cadenceinc.com
VitalDyne, Inc.
www.vitaldyne.com

Phone: 800-221-5510
Fax: 718-956-9040
kec@keyelco.com
sales@keyelco.com
www.keyelco.com
Criterion Tool/Criterion
Instrument
www.criteriontool.com
Donatelle
wwwdonatellemedical.com
Photofabrication
Phone: 508-478-2025
Fax: 508-478-3582
Pleora Technologies Inc.
www.pleora.com
Aerotech, Inc.
www.aerotech.com
AMETEK Precision Motion
Control
www.ametekdfs.com
Applimotion Inc.
www.applimotion.com
Whyco Chromium Finishing

www.whyco.com
BEI Kimco Magnetics

www.beikimco.com
EBTEC, an EDAC
Technologies Company
Phone: 413-786-0393
Fax: 413-789-2851
ahumphries@
edactechnologies.com
www.ebteccorpcom
Zeus
Phone: 803-268-9500
Fax: 803-533-5694
support@zeusinc.com
www.zeusinc.com
Mechanical
Components/Hardware
Ace Wire Spring & Form Co., Inc.
www.acewirespring.com
AMETEK Hunter Spring
www.hunterspringsandreels.com
Proto Labs
Phone: 877-479-3680
Fax: 763-479-2679
www.protolabs.com
Schneeberger, Inc.
www.schneeberger.com
Senior Aerospace Metal
Bellows
www.metalbellows.com
Economy Spring
Phone: 860-621-7358
Fax: 860-621-7882
info@mw-ind.com
www.mw-ind.com/brands/
economyspring
32
Intro
Cov
ToC
Bimba Mfg. Company

www.bimba.com
Clippard Instrument
Laboratory, Inc.
Phone: 513-521-4261
Fax: 513-521-4464
www.clippard.com

Motion Control/Motors
continued
Custom Machine and Tool Co., Inc.

www.cmtco.com
MICROMO
www.micromo.com
GAM Enterprises
www.gamweb.com
Micronor Inc.
www.micronor.com
Haydon Kerk Motion Solutions, Inc.

www.haydonkerk.com
Moog Components Group

www.moog.com/components
Diverse Optics Inc.

www.diverseoptics.com
Moticont
www.moticont.com
Phone: 401-683-9700 x311
Optimal Engineering Systems,

Inc.
www.oesincorp.com
PI (Physik Instrumente)
www.pi-medical.net
Optics/
Optical Components
Fiberoptic Components, LLC

www.lightguides.com
Berliner Glas KGaA Herbert

Kubatz GmbH & Co.
www.berlinerglas.com
Portescap
www.portescap.com
Coherent Inc.
www.coherent.com
Servometer
www.servometer.com
First Sensor, Inc.

Phone: 818-706-3400
Fax: 818-889-7053
Criterion Instrument
www.criteriontool.com
Siemens Industry, Inc.

www.usa.siemens.com/cnc
Phone: 905-821-2600
Fiber Optic Center, Inc.
www.focenter.com
BEA Lasers
http://bealasers.com
Pittman Motors
www.pittman-motors.com

Phone: 508-677-0520
Fax: 508-677-0530
Edmund Optics
www.edmundoptics.com
Archer OpTx
www.archeroptx.com
PIK Power, Inc.

www.pikpower.com
Ludl Electronic Products Ltd.

www.ludl.com
eagleyard Photonics GmbH

www.eagleyard.com
Velmex, Inc.
Phone: 585-657-6151
Fax: 585-657-6153
info@velmex.com
www.velmex.com
Crystal IS
www.cisuvc.com
A Clear Difference
in What We Coat For You
Focused on Coating
Proven contract manufacturing expertise with
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Focused on You
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Focused on Performance
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IRUDQ\PHGLFDOGHYLFHFRDWLQJFKDOOHQJH
Focused on Value
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Formacoat LLC partners with customers who choose to focus on their core
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K\GURSKLOLFDQGK\GURSKRELFFRDWLQJRSHUDWLRQV:HEXLOGDGLUHFWSHUVRQDOL]HG
UHODWLRQVKLSZLWKHDFKFOLHQWGUDZLQJXSRQRXUH[SHUWLVHDQGDUUD\RIGLHUHQW
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Making the Tools of

Medicine Run Smoother
Get Focused on an Eye for Expertise!

&DOORU(PDLO)RUPDFRDW7RGD\QIR#IRUPDFRDWFRP
33
Intro
Cov
ToC

Optics/Optical Components
continued
Grayhill Inc.
www.grayhill.com
IMPERX, Inc.
www.imperx.com
InfraTec GmbH Infrarotsensorik
und Messtechnik
www.infratec-infrared.com
Phone: 401-683-9700 x311
Kugler of America, Ltd.
www.kuglerofamerica.com
Schott North America, Inc.

Lighting and Imaging
Phone: 508-765-9744
Fax: 508-765-1299
lightingimaging@us.schott.com
www.us.schott.com/
lightingimaging
Quality Tech Services Inc. (QTS)

www.qtspackage.com
Protek Power North America

www.protekpowerna.com
Technipaq, Inc.
www.technipaq.com
RRC Power Solutions

www.rrc-ps.com
Tek Pak Inc.

www.tekpak.com
TDI Power
www.tdipower.com
Thoro Packaging
www.thoropkg.com
TDK-Lambda Americas, Inc.

www.us.tdk-lambda.com/lp
Power Supplies &

Batteries
Westech Optical Corporation
Phone: 585-377-2490
jcarlino@westechoptical.com
www.westechoptical.com
Laser-compact/Laser-export
www.laser-export.com
Sensors/Detectors/
Data Acquisition
Astrodyne TDI
www.astrodynetdi.com
Autosplice, Inc.
www.autosplice.com
ATI Industrial Automation

Phone: 919-772-0115
Fax: 919-772-8259
info@ati-ia.com
www.ati-ia.com
Autec Power Systems

www.autec.com
Laservision USA
www.lasersafety.com
Zeus
Phone: 803-268-9500
Fax: 803-533-5694
support@zeusinc.com
www.zeusinc.com
Lighthouse Imaging
www.lighthouseoptics.com
Metrigraphics
www.metrigraphicsllc.com
Cell-Con, Inc.
Phone: 800-771-7139
sales@cell-con.com
www.cell-con.com
Zygo Corporation
www.zygo.com
Micro Laser Systems, Inc.

www.microlaser.com
Packaging/Enclosures
Microlap Technologies, Inc.

www.microlap.com
Accu Seal Corporation

www.accu-seal.com
Modulight, Inc.
www.modulight.com
Caplugs
www.caplugs.com
OFS
www.ofsoptics.com
Custom Case Group

http://customcasegroup.com
Optikos Corporation
www.optikos.com
Photofabrication
Phone: 508-478-2025
Fax: 508-478-3582
Princetel, Inc.
www.princetel.com
Protek Power North America
www.protekpowerna.com
Reynard Corporation
www.reynardcorp.com
Seiwa Optical America, Inc.
www.seiwaamerica.com
EMCO High Voltage Corporation

www.emcohighvoltage.com
Phone: 401-683-9700 x311
Interpower Corporation
www.interpower.com

Phone: 203-238-2689
Fax: 203-237-8769
www.lyons.com
Photofabrication
Phone: 508-478-2025
Fax: 508-478-3582
BitFlow, Inc.
www.bitflow.com
CMOSIS GmbH
www.cmosis.com
GlobTek, Inc.
www.globtek.com
Mirrorcle Technologies Inc.

www.mirrorcletech.com
OSI Laser Diode Inc

www.laserdiode.com
AWAIBA
www.awaiba.com
Phone: 905-821-2600
Exergen Corporation
www.exergen.com
Fastec Imaging
www.fastecimaging.com
Fiberoptic Components LLC
www.lightguides.com

Management AG
Phone: +41 44 804 63 00
info@mst.com
www.mst.com
First Sensor, Inc.

Phone: 818-706-3400
Fax: 818-889-7053
Minmax Power
www.minmaxpower.com
Framos Technologies
www.framos.com
Murata Power Solutions

www.murata-ps.com
Gems Sensors & Controls

www.gemssensors.com
Pixus Technologies
www.pixustechnologies.com
PIK Power, Inc.

www.pikpower.com
Hamamatsu Corporation
www.hamamatsu.com
Premold Corp
www.premoldcorp.com
Power Partners, Inc.

www.powerpartners-inc.com
Heraeus Sensor Technology USA

www.hst-us.com
34
Intro
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ToC

Sensors/Detectors/Data Acquisition
Honeywell Sensing and Control
http://sensing.honeywell.com
continued
Software
ARM
www.arm.com
Phone: 401-683-9700 x311
ANSYS SpaceClaim
www.spaceclaim.com
COMSOL, Inc.
Phone: 781-273-3322
Fax: 781-273-6603
info@comsol.com
www.comsol.com
Introtek International
www.introtek.com
Laser Components USA, Inc.
www.laser-components.com
Luna Optoelectronics
http://lunainc.com/optoelectronics
Critical Manufacturing
www.criticalmanufacturing.com
Dassault Systmes SolidWorks
Corp.
www.solidworks.com

Phone: 508-677-0520
Fax: 508-677-0530
Grand Avenue Software

www.grandavenue.com
IQMS
www.iqms.com
Maplesoft
www.maplesoft.com
Measurement Specialties
www.meas-spec.com
MediSens Conference
www.medisens-conference.com
Omnify
www.omnifysoft.com
CARTRIDGE
HEATERS
Photon Engineering LLC

www.photonengr.com
Photonis
www.photonisusa.com
Remcom
www.remcom.com
Photron, Inc.
www.photron.com
Sparta Systems
www.spartasystems.com
Pressure Profile Systems

www.pressureprofile.com
Sterling Medical Devices

http://sterlingmedicaldevices.com
Princeton Lightwave
www.princetonlightwave.com
Wind River
www.windriver.com
Servoflo Corporation
www.servoflo.com
Sensirion
www.sensirion.com
Maximum
surface
temperatures
up to 1400F.
Sterilization
Equipment
Tekscan, Inc.
www.tekscan.com
Basic designs
are readily
adaptable to a
wide variety of
applications,
special
requirements,
sizes, and
ratings.
Clean Air Products

www.cleanairproducts.com
Toshiba Imaging Systems

Division
www.toshibacameras.com
Vancive Medical Technologies
http://vancive.averydennison.com
Watlow
www.watlow.com
MicroCare
www.microcare.com
Nordion
www.nordion.com
Noxilizer, Inc.
www.noxilizer.com
Xenics
www.xenics.com
Designed for
maximum:
Watt density,
temperature,
heat transfer,
and heater life.
HotWatt Inc.
128 Maple St.
Danvers, MA
01923-2096
Tel:978-777-0070;
Fax:978-774-2409
email:
sales@hotwatt.com
www.hotwatt.com
Nutek Corporation
www.nutekcorp.com
Zurich Instruments AG
www.zhinst.com
Intro
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35
VOTE FOR

Sterilization Equipment
continued
Sterigenics International LLC

www.sterigenics.com
Nelson Laboratories, Inc.

www.nelsonlabs.com
STERIS Corporation
www.steris.com
Nikon Metrology
www.nikonmetrology.com
Steri-Tek
www.steri-tek.com
Ocean Optics
www.oceanoptics.com
Synergy Health
www.synergyhealthplc.com
Pfeiffer Vacuum
www.pfeiffer-vacuum.com
Xenon Corporation
www.xenoncorp.com
Primara Test- und ZertifizierGmbH

www.primara.net
Test/Inspection/
Metrology
Q-PLUS Labs
www.qpluslabs.com
Advanced Inspection Services

(AIS)
www.advancedinspect.com
Averna
www.averna.com
Shimadzu Scientific
Instruments
www.ssi.shimadzu.com
Strainoptics, Inc.
www.strainoptics.com
Tektronix
www.tek.com
Werth, Inc.
www.werthinc.com
WuXi AppTec
www.wuxiapptec.com
Cadence, Inc.
Phone: 800-252-3371
Fax: 540-248-4400
www.cadenceinc.com
Tubing & Extrusion
CertifiGroup
www.certifigroup.com
Advanced Tube Solutions, LLC

www.advancedtube.com
Cincinnati Sub-Zero
www.cszindustrial.com
Each month, the editors of Medical Design Briefs choose a

Product of the Month that has exceptional technical merit and
practical value for MDBs design engineering readers.
Now that these have been selected, were asking readers to
help choose the Readers Choice Product of the Year Awards.
AVX Corporation
Accu-P MP Series Thin Film Chip
Capacitors
Cincinnati Test Systems

www.cincinnati-test.com
Compliance West USA
www.compwest.com
American Kuhne, a brand of

Graham Engineering
Corporation
Phone: 717-848-3755
Fax: 717-846-1931
sales@americankuhne.com
www.americankuhne.com
Creaform
www.creaform3D.com
CSZ Testing
www.csztesting.com
Epix, Inc.
www.epixinc.com
Gradient Lens Corporation
www.gradientlens.com
InterTest
www.intertest.com
Cadence, Inc.
Phone: 800-252-3371
Fax: 540-248-4400
www.cadenceinc.com
InterTest, Inc. Cameras

www.intertest.com
Laboratory Testing Inc.
www.labtesting.com
Lenox Instrument Company, Inc.
www.lenoxinst.com
Command Medical Products, Inc.

www.commandmedical.com
Lumetrics
www.lumetrics.com
Duke Empirical
www.dukeempirical.com
Mahr Federal, Inc.

www.mahr.com
Eldon James Corp

www.eldonjames.com
Mark-10 Corp
www.mark-10.com
Fluortek
www.fluortek.com
Microtest Laboratories, Inc.

www.microtestlabs.com
Mititoyo America Corporation
www.mitutoyo.com
MSI-Viking Gage
www.msi-viking.com
Guill Tool & Extrusion Co., Inc.

www.guill.com
Pressure Profile Systems, Inc.

Parker Hannifin Precision
Ultra-thin, Single-Element
Fluidics Division
Miniature Force Sensors
Miniature Proportional Valve VSO
LowPro
OPS Solutions
Blended Reality Tool for
Manufacturing
Aerotech, Inc.
Hexapod for Positioning Accuracy
Stratasys Ltd.
J750 3D Printer
Natvar, a Tekni-Plex company

4- and 5-Layer Coextruded
Tubing
Icon Labs
Floodgate Defender Industrial
Firewall
Panacol-Elosol
UV Plastic Adhesive
Zeus Industrial Products

LCP Monofilament
Power Partners
AC/DC Power Supply
Find out more about the 12 nominated products and

cast your vote by visiting:
www.medicaldesignbriefs.com/poy
Only one vote per person will be counted. All votes must
HTP-Meds
www.htpmeds.com
36
be submitted by January 23, 2017.

Intro
Nordson EFD
P-Jet and P-Dot Non-Contact
Dispensing Systems
Cov
ToC

Tubing & Extrusion
continued
International Polymer
Engineering
Phone: 877-410-3265
Fax: 480-929-9799
krockhold@ipeweb.com
www.ipeweb.com
Qosina Corporation
Phone: 631-242-3000
Fax: 631-242-3230
deanna@qosina.com
www.qosina.com
Power Supplies and

Cords to 60601-1
Raumedic AG
www.raumedic.com
Johnson Matthey
www.jmmedical.com
Kent Elastomer Products, Inc.
www.kentelastomer.com
When power is critical to your equipment

as well as your patients, you can rely on
MEGA Electronics to deliver.
Silcotech North America Inc.

Phone: 905-857-9998
Fax: 416-301-9739
Iboettger@silcotech.com
www.silcotech.ca
Medefab
Phone: 603-532-5656
m.trombley@medefab.com
www.medefab.com
Power supplies and cords to UL60601-1 and

international approvals. Power supplies meet
Energy Level VI, 4th edition and 2x MOPP.
Upon your next requirement, please keep
MEGA in mind.
Sunlite Plastics, Inc.

www.sunliteplastics.com
MEGA Electronics Inc.

4B Jules Lane
New Brunswick, NJ 08901
tel. 732.249.2656 fax. 732.249.7442
www.megaelectronics.com
medicalsales@megaelectronics.com
Medical Extrusion
Technologies, Inc.
www.medicalextrusion.com
MicroLumen, Inc.
www.microlumen.com
Superior Tube
Phone: 610-489-5200
Fax: 610-489-5252
sales.superiortube@ametek.com
www.superiortube.com
Microspec Corporation
www.microspecorporation.com
Modified Polymer Components
www.modifiedpolymer.com
MRPC
www.mrpcorp.com
TE Connectivity
www.te.com
AIR HEATERS
Teel Plastics
www.teel.com
The Air Process

heater will
provide hot air
and gas up to
1000F (540C)
with infinite
control by
varying the
voltage and air
velocity
supplied.
NewAge Industries, Inc.

Phone: 215-526-2300
Fax: 215-526-2190
sales@newageindustries.com
www.newageindustries.com
New England Catheter
www.necatheter.com
Teleflex Medical OEM

Phone: 847-596-3100
Fax: 847-596-3101
oeminfo@teleflex.com
www.teleflexmedicaloem.com
Vention Medical
www.ventionmedical.com
Can be
manufactured
with male or
female NPT
threaded
fittings, hose
adaptors,
flanges, or
custom fittings
to your
specifications.
Vesta Inc.
www.vestainc.com
Pexco LLC
Phone: 404-564-8560
Fax: 404-564-8579
marketing@pexco.com
W.L. Gore & Associates, Inc.

www.gore.com
Polygon Company
www.polygoncomposites.com
Zeus
Phone: 803-268-9500
Fax: 803-533-5694
support@zeusinc.com
www.zeusinc.com
Precision Extrusion, Inc.

www.precisionextrusion.com
Putnam Plastics
www.putnamplastics.com
HotWatt Inc.
128 Maple St.
Danvers, MA
01923-2096
Tel:978-777-0070
Fax:978-774-2409
email:
sales@hotwatt.com
www.hotwatt.com
Intro
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37
Advertisement
Marubeni Citizen-Cincom Inc.

40 Boroline Rd. #6
Allendale, NJ 07401
Phone: 201-818-0100
Fax: 201-818-1877
E-mail: sales@mctz.com
www.marucit.com
Target Markets
Company Description
Marubeni Citizen-Cincom (MCC), best known for their highly
precise, highly versatile Swiss-type turning centers, has added
the Laser L2000 to their product line to better serve the medical parts manufacturing industry.
Since 1984, MCC has successfully made CITIZEN Cincom
machines the most widely accepted Swiss-type turning centers
in North America, with over 10,000 machines sold. The addition
of MIYANO fixed head turning centers to the Citizen family provides more solutions for 2 mm to 64 mm bar applications.
MCC is headquartered in Allendale, NJ, with additional
sales/service offices in California, Illinois, and Massachusetts
(which also houses their technical center). These offices support a network of full-service distributors throughout North
and South America.
Preferred by Medical Parts Manufacturers

Many well-known medical parts manufacturers trust Citizen
lathes for the production of quality medical components,
including orthopedic bone screws, dental implants, medical
instruments, and more. In addition, the Cincom and Miyano
products are also popular in the manufacture of complex and
precision parts for aerospace, electronics, business machines,
automobile components, fiber optics, tools, jewelry, and more.
The capabilities are endless.
Services/Products Offered
The Cincom line of automatic CNC lathes are engineered for
exceptional cutting performance. They feature Citizens unique
Cincom software, which allows for superimposed, synchronized
control of all axes simultaneously. Citizen technology has also
been implemented in some of the Miyano multi-function turning centers. In addition, accessories configured specifically for
use with Cincom enhances the ability to make precision parts
quickly and efficiently.
Laser System L2000
Wire Ejection Systems
High-Pressure Coolant Systems and Mist Control units
Whirling Units and Cutting Heads
Robot Loading and Unloading
Fast set-up, quick changeover, and easy-to-use technology
backed up by their legendary, full-service distributor network
offer a sound investment and solid value.
www.marucit.com
38
Intro
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Laser System L2000

THE Complete Manufacturing System
Laser Cutting and Conventional

Machining on a Single Machine
Near Endless Geometric

Shape Possibilities
Minimal Burrs
Faster Than EDM
Machining
Available for
Machine Accuracies
.00001"
ADVANTAGES OF THE LASER SYSTEM L2000

Specifications and Benefits
Optical Head Specifications
IPG Photonics leading provider

of Fiber Lasers in the world
Laser is 100% supported in the USA
Air cooled
400 watt output power
10 Micron delivery fiber
Internal Pulse Generator with
endless parameter possibilities
CCD Integrated Camera for optical

viewing and alignment
Fine X,Y Beam adjustment for
beam alignment to nozzle
Internal coaxial light built in for easy alignment
75-100 mm Focal Lengths available
Head assembly is completely liquid tight
Head is 100% made and supported in USA
Kerf widths down to 20 microns
&
www.marucit.com
Allendale, NJ
(201) 818-0100
Elk Grove Village, IL

(847) 364-9060
Fountain Valley, CA
(714) 434-6224
Agawam, MA
(413) 786-6655
Intro
Cov
ToC
Advertisement
Our Technology. Your Advantage.

Dymax Corporation
318 Industrial Lane
Torrington, CT 06790
Phone: 860-482-1010
Fax: 860-496-0608
E-mail: info@dymax.com
www.dymax.com
Company Description
Target Markets
Dymax Corporation is
a leading manufacturer
of advanced light-curable
adhesives, coatings, dispensing systems, and
light-curing equipment.
Dymax products are optimized to work together
to provide design engineers with complete system solutions to dramatically improve manufacturing efficiency
and lower costs.
The corporate headquarters are in Torrington, Connecticut,
USA, with additional locations in Germany, China, Hong Kong,
Korea, and Singapore.
ISO 9001 and 14001 Certified
Privately Held
275+ Employees Worldwide
30+ Patents
Worldwide Network of Sales Partners
Dymax targets Design and R&D Engineers at disposable medical device OEMs that manufacture:
Syringes
Catheters
Respiratory Masks
Infusion Sets
Hearing Aids
Optics
Surgical Instruments
Diagnostic Equipment
Medical Device Sub-Assemblies
Dymax MD Medical Device Adhesives are USP Class VI and

ISO 10993 certified, RoHS compliant, and 100% solvent free.
They are specifically designed to form high-strength bonds to
the plastic, glass, and metal substrates commonly found in disposable medical devices.
Fast, on-demand cures increase throughput and reduce
waste
Formulations available for bonding through UV-blocking or
practically opaque substrates
Blue and Ultra-Red fluorescing adhesives permit in-line
visual inspection for uninterrupted processing
Products/Services Offered
At Dymax we combine our product offering with our expert
knowledge of light-cure technology. Where others only supply
products, we are committed to developing a true collaborative
partnership, bringing our total process knowledge to our customers specific application challenges.
Because we understand the process as a whole, and not just
individual aspects of it, we can offer our customers a solution
where chemistry, material, and equipment work seamlessly
together with maximum efficiency. Our application engineering
teams assist with product and process design, testing, evaluation, and pre-production trials through the life of the assembly
process. Thats an advantage you just cant get anywhere else.
www.dymax.com
40
Intro
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Advertisement
Fort Wayne Metals

9609 Ardmore Ave.
Fort Wayne, IN 46809
Phone: 260-747-4154
Fax: 260-747-0398
E-mail: info@fwmetals.com
www.fwmetals.com
Company Description
Target Markets
Fort Wayne Metals is a leading manufacturer of medical

grade materials. We are FDA registered and ISO 9001, AS 9100C
and ISO 13485 certified.
Fort Wayne Metals offers access to an unparalleled breadth
of materials, including round wire, flat wire in a variety of
shapes, rod, strands, cables, DFT metal-on-metal composites,
HHS Tube, and SLT Wire.
We routinely work with stainless steel (304V, 304LV, 316LVM)
and a wide range of super alloys (35N LT, MP35N, L605,
CCM/FWM 1537, Elgiloy/FWM 1058), commercially pure
titanium and titanium alloys, Nitinol, and a range of high performance alloys.
Our most recent developments are 4TiTUDE Titanium,
which combines the benefits of Grade 4 Titanium with the
strength of alloyed Titanium; and Silk Nitinol, the smoothest
oxide-free Nitinol available.
We work with wire diameters from 0.0005" (0.0127 mm) to
0.55" (14 mm).
Cardiac rhythm management

Endoscopy
Dental implants
Orthodontic
Orthopaedics
Neurostimulation
Vascular therapy
Our portfolio of services includes extrusion coating, laser
ablation, a variety of cleaning processes, as well as custom
assembly based on customer designs.
We also offer laboratory services in our state-of-the-art testing facility, utilizing the most advanced instrumentation for
material characterization and development. The Materials
Testing Laboratory has been awarded ISO/IEC 17025 accreditation in both chemical and mechanical testing fields by the
American Association for Laboratory Accreditation (A2LA). Our
independent lab offers a wide range of services including metallurgy, interstitial gas analysis, differential scanning calorimetry, corrosion testing, and mechanical and fatigue testing.
www.fwmetals.com
Intro
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Advertisement
International Manufacturing Services, Inc.

50 Schoolhouse Ln.
Portsmouth, RI 02871
Phone: 401-683-9700
Fax: 401-683-5571
Email: ims@ims-resistors.com
Target Markets
Medical, Space, Military, RF and Microwave, Power, LED,
Satellite
Company Description
IMS is a privately held ISO 9001:2008 certified premier
provider of thick and thin film passive resistive products. For
over 40 years IMS has been transforming customer requirements into concrete solutions. Our headquarters located in
Portsmouth, Rhode Island combines our corporate offices,
manufacturing, and design and testing, which enables fast turnaround times and quick delivery of high-quality products. Our
staff is highly trained and experienced to work with you on all
stages of your project.
IMS specializes in the production and sales of chip resistors,

attenuators, and related thick film products and services to
thousands of manufacturers throughout all of the electronics
industries. IMS' strength is the ability to be flexible and respond
to customer needs and offer high quality products with the
fastest delivery and best service in the industry. IMS has one of
the broadest non-magnetic resistive surface mount technology
product offerings in the industry. Non-magnetic parts are especially important to the medical equipment and MRI coil industries. In 2010, IMS introduced non-magnetic Ultra Leach
Resistant (ULR) metallization for its alumina substrate products
and soon thereafter for its aluminum nitride products as well.
ULR material has 150% greater leach resistance than nickel
barrier. In the futureIMS will be here to meet the challenges
coming from advanced technologies and sophisticated new
products. We are continually investing in technology for new
product design and manufacturing.
Non-Magnetic Resistors
Thin and Thick Film Chip Resistors
ThermaBridge
Chip Terminations
Resistive Power Splitters
42
Intro
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Advertisement

31-07 20th Road
Astoria, New York 11105
Phone: 800-221-5510
Fax: 718-956-9040
E-mail: sales@keyelco.com
www.keyelco.com
Company Description
For more than 65 years,
has been manufacturing
precision electronic interconnect components and
hardware, supplying quality products worldwide at
competitive prices. Whether you are developing
(Portable) Ultra-Sound
Devices; Defibrillators;
Implantable Pace Makers; or Mobile, Electro-surgical
Instruments, Keystone products are engineered specifically for
use by OEM Designers and Engineers who create and develop
state-of-the-art medical devices, electronic products, instruments, and systems.
All Keystone facilities are fully integrated with 3D/CAD product modeling and CAD/CAM precision tool and die operations.
Keystone is an ISO 9001:2008 certified company and complies
with RoHS and REACH directives.
It is our policy to
continuously improve
our products to better
satisfy the needs of
our customers and to
deliver quality products, every time and
on time. All products
are available through
our global distribution network.
Target Markets
Medical, Automotive, Defense, Aerospace, Solar, Electronics,
Appliance, and Consumer Products.
Keystone manufactures precision electronic interconnect
components and hardware, supplying quality products worldwide at competitive prices. Applications and Engineering specialists utilize progressive dies, four-slide, wire forming, in-die
tapping and high-speed blanking along with automated machining to produce tight tolerance standard and custom products
such as:
Battery Clips, Contacts & Holders
Fuse Clips & Holders
Terminals & Test Points
Spacers & Standoffs
Panel Hardware
Pins, Plugs, Jacks & Sockets
PC Board Hardware
Multi-Purpose Hardware
Secondary operations include Tapping, Drilling, Assembly,
and Finishing. Application engineering services are available
for product modifications or special design requirements.
Request catalog M65.
www.keyelco.com
Intro
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43
Advertisement
Lyons
185 Research Parkway
Meriden, CT 06450
Phone: 800-422-9363
E-mail: sales@lyons.com
www.lyons.com; www.MedicalDeviceSolutions.com
Company Description
Lyons provides manufacturing solutions to the Medical
Device Industry. As an FDA registered and ISO 9001:2008 and
ISO 13485:2003 certified company, we are committed to providing quality products and services. From product development to
production, look to Lyons for your medical device solutions.
Precision Metal Stamping

Specializing in complex, difficult parts. Our tooling design
and engineering groups will work with you to develop the most
cost-effective components for your applications. Our capabilities include material thicknesses ranging from less than .001"
up to .125" in various material types. We provide heat treating,
plating, passivation, welding, machining, and assembly.
Target Markets
Medical Devices and Surgical Instruments/Implants
Complex CNC Machining and Wire EDM
Spindle speeds on our CNCs of 50,000 RPMs allow for
smooth finishes on your smallest features. Providing parts
made from stainless steel, titanium, aluminum, plastics, and
much more. Our Wire EDMs are capable of producing complex
features on prototype and production quantities.
Rapid Prototyping
Specializing in rapid prototyping of precision metal stampings, assemblies, machined components, medical devices, surgical knives, and scissors.
Cleanroom Packaging and Assembly
Utilize our private cleanrooms for your production requirements. Whether its a new product launch or an existing program, you can rely on Lyons to provide you with the service and
attention that others have come to expect.
www.lyons.com; www.MedicalDeviceSolutions.com
44
Intro
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Advertisement
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
Company Description
MicroLumen has been a leading manufacturer of high performance medical products since 1987. Our shaft and tubing
systems are used in a wide range of minimally invasive, critical
OEM applications such as cardiovascular catheters, stent delivery systems, urological retrieval devices, and drug delivery.
Primary materials include Polyimide, PTFE, Nylon, Pebax,
Tecoflex (polyurethane), and various polymers specifically
designed to provide exceptional mechanical, thermal, and
chemical properties. Our proprietary process delivers significantly tighter tolerances than conventionally extruded products.
MicroLumen offers innovative solutions and aids engineers
in the design of very specialized medical devices. Our diversified product line and secondary operations include: custom
laser machining, etching, composite constructions, assembly,
and braid/coil reinforced shafts that solve specific tasks.
Contact our engineering team for possibilities.
High Performance Medical Tubing. MicroLumen manufactures custom tubing for critical applications & minimally invasive medical devices. Polyimide is a thermoset plastic and has
excellent mechanical, thermal, and chemical properties. Typical
applications include cardiovascular & urological catheters,
stent deployment, and drug delivery systems.
ID ranges = 0.10mm to 2.11mm with various wall profiles.
Ultra-thin PTFE liners are available for reduced surface friction
and can be delivered on a mandrel. Braid and coil reinforced
designs are available for added flexibility, torque, and column
strength. Pebax & Tecoflex jackets are available, as well as flexible tips, marker bands, value added sub-assembly, and custom
laser machining. ISO 9001:2000 certified & USP Class VI.
www.microlumen.com
Target Markets
Cardiovascular, Neurovascular, Urology, Peripheral Vascular,
Electrophysiology
Intro
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45
Advertisement
PTI Engineered Plastics

50900 Corporate Drive
Macomb, MI 48044
Phone: 586-263-5100
Fax: 586-263-6680
E-mail: ckaiser@teampti.com
www.teampti.com
Design
PTI can take you from mind to manufacturing, starting with
their industrial design and development studio. PTI Design can
optimize your design, or take your idea through their five-phase
process to assure your product has the competitive edge in the
market. PTI uses 3D CAD software and Moldflow simulation
tools to test and validate your product prior to manufacturing.
Company Description
PTI Engineered Plastics specializes in low-volume custom
injection molding. Their state-of-the-art 155,000 square foot
facility in Macomb, Michigan, provides full design services, engineering, tooling, production, as well as cleanroom manufacturing and validation services.
PTI is FDA, UL, and ITAR registered and ISO 13485:2003, ISO
9001:2008, ISO 16949:2009 certified.
Tooling
On PTI's Tool Room
floor, youll find a fully
integrated tooling network, (18) high-speed
vertical machining centers, three of which
are Makino with spindle speeds of 20,000
RPMs complimented
by a Makino Horizontal
Machine. All machines
utilize thermal shrink
Collet tooling for precision and accuracy.
Their EDM department
includes (4) high-speed graphite robotic load machining centers with spindle speeds up to 54,000 RPM. They offer plunge
EDM machining as well as wire EDM capabilities. PTI uses an
array of materials from aluminum, mild steel, hardened steel
and stainless. Injection mold types include unit mold insert, free
standing, shuttle loading, hot runner, single cavity, and multiple
cavities.
Manufacturing
PTI's manufacturing floor currently has (44) injection molding machines ranging from 12 to 750 tons of clamping force
with .33 to 98 oz. shot capacity. Manufacturing capabilities
include low and high volume production, insert/overmolding,
high-temperature molding, contract manufacturing, assembly,
and packaging.
Cleanroom Manufacturing
Services within ISO Class 8 Cleanroom include injection
molding, assembly, secondary operations, and packaging.
Validation
PTI is fully versed and staffed in the IQ/OQ/PQ validation
protocol.
Target Markets
www.teampti.com
Medical Devices, OEM
46
Intro
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Advertisement
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ROFIN-BAASEL, Inc.
68 Barnum Road
Devens, MA 01434-3508
Phone: 978-635-9100
Fax: 978-635-9199
E-mail: info@rofin-baasel.com
www.ROFIN.com
Company Description
ROFIN, One Laser Solution Supplier for

all your Medical Device Manufacturing
Needs.
Founded in 1975, ROFIN is the leading
developer and manufacturer of lasers
and laser-based technologies for industrial material processing. From laser
sources for integration to purpose-built
solutions, marking systems from ROFIN
provide biologically-benign, fast and efficient ID, text and graphics marking on a
wide variety of materialstitanium
implants, glass or polymer medical
devices, or surgical stainless steel instruments to ensure traceability.
And we offer award-winning service, training and qualityworldwide.
In addition to laser marking solutions, ROFIN provides highprecision cutting systems to process stents with tube diameters
of less than 200m and ultra-precise cutting of hollow-point
needles. And ROFIN lasers weld spots and seams even in the
micron range with no post processing needed; essential for biocompatible materials including shape memory alloys.
Precise Material Processing for the Highest Demands

ROFIN specializes in:
Innovative ID, text, and graphics marking solutions for medical
device manufacturing. Biocompatible and durable, laser marking by modifying the material color, annealing on metal, carbonization or foaming in polymers all provide corrosion-free
marking without creating burrs or debris or inserting any filler
material.
Lasers for welding of finest wires, micro probes, colored or
transparent thermoplastics, and other medical devices requiring high-strength joints suited for high temperature sterilization with non-porous, sterile surfaces, essential for biocompatible materials.
Laser Fine Cutting systems process stents with tube diameters of less than 200 microns with cut widths smaller than 20
microns. Laser cutting of hollow needle points and side openings on finest tubes.
Solutions for Laser structuring, such as precise and selective
material ablation of guide wires to achieve marks for cardiosurgery.
Target Markets
Lasers for cutting, welding, marking, or surface treatment
have become indispensable tools for a variety of todays manufacturing industries:
Medical Device Technology
Glass Industry
Machine Tool Industry
Tool and Mold Making
Automotive
Jewelry Design
Semiconductor
Photovoltaic industry
LED Market
Packaging Industry
Electronic Industry
Plastic Processing
www.ROFIN.com
48
Intro
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ToC
Advertisement

901 Ethan Allen Highway, Suite 102
Ridgefield, CT 06877
Phone: 203-244-6302
Fax: 203-894-8065
E-mail: info@steuteusa.com
www.steuteusa.com
Target Markets
Manufacturers of diagnostic medical systems, therapeutic
medical devices, and image retrieval equipment. Applications
include radiological equipment, ophthalmic surgery systems,
ultrasonic systems, laser-based dental and dermatology equipment, surgical microscopes, navigation systems, examination
chairs and tables, electrosurgical generators, orthopedic surgery equipment, endoscopic surgical systems, and MRI equipment.
Company Description
STEUTE designs and manufactures fully-compliant, medicalgrade foot controls for OEMs of medical devices. Units include
off-the-shelf-custom and fully-customized cabled and customized wireless (RF) designs. Each is developed for:
Optimal functionality
User comfort and ease-of-use
Aesthetics that compliment your system
Full medical compliance (CE, IEC, UL, CSA, FCC)
Wireless designs feature:
Safe, noise immune performance.
Encrypted bi-directional communication protocol.
Low Power consumption.
Optional sleep-mode with < 200ms wake-up time.
Worldwide acceptance.
The design and production of ergonomically-optimized foot
operated controls using their diverse assortment of actuator
platforms/consoles, field-proven actuators (pedals, pushbuttons, rocker switches, joy sticks, slide switches, joy pads), strain
reliefs, cables, connectors, and customer-specific graphics.
Most are designed with no engineering development or tooling
expense to the OEM. Wireless designs feature data interfaces
customized to the OEM's system electronics (e.g. formatted for
easy interconnection to the host electronics, e.g. dry contacts,
RS232 serial presentation, USB formats, I2C, or other desired
protocol).
www.steuteusa.com
Intro
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49
Advertisement
Teleflex Medical OEM

1425 Tri-State Parkway, Suite 120
Gurnee, IL 60031
Phone: 800-474-0178 or 508-964-6021
Email: oeminfo@teleflex.com
www.teleflexmedicaloem.com or www.teleflexmedicaloem.cn
Company Description
Vertically integrated capabilities. Deep expertise. Decades of
experience. You should Work With The Experts at Teleflex
Medical OEM. We are that product development and manufacturing partner that can hear what you are saying, understand
your needs, and arrive at innovative, highly customized solutions. That is why we are the go to people for OEMs worldwide
who want to partner with a global leader in custom-engineered:
Extrusions
Diagnostic and interventional catheters
Balloons and balloon catheters
Sheath/dilator sets
Specialized sutures, braids, and fibers
Bioabsorbable sutures, yarns, and resins
If innovation in medical devices is on your agenda, TELEFLEX

MEDICAL OEM should be on your team. We are a well-qualified
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. Together, we will develop
tailor-made solutions for existing challenges and emerging
medical innovations. Our extensive, in-house capabilities
include:
Product concept development
Engineering
Design for manufacturability
Regulatory affairs
Material selection and formulation
Prototyping, testing, and validation
Custom tooling
Production process development
Manufacturing
Finishing operations
Assembly
Packaging and labeling
Lets get to work on your next project.
Target Markets
Teleflex Medical OEM is ready to help you succeed. Through
our global network of state-of-the-art facilities, we partner with
customer across the
world. We welcome
product development
and manufacturing
projects from medical equipment manufacturers, both large
and small. Lets get
to work on your next
project.
www.teleflexmedicaloem.com or
www.teleflexmedicaloem.cns
50
Intro
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Advertisement
Zeus
3737 Industrial Blvd.
Orangeburg, SC 29118
Phone: 803-268-9500
Fax: 803-533-5694
E-mail: support@zeusinc.com
www.zeusinc.com
Company Description
For 50 years, Zeus has delivered precision polymer solutions
for the medical device industry. We specialize in precision extrusions of PTFE, FEP, PEEK, PFA, ETFE, PVDF, LCP, bioabsorbable
polymers, and other engineered plastics. Headquartered in
Orangeburg, SC, Zeus operates multiple facilities in North
America and internationally guaranteeing a stable source of
supply anywhere in the world. Our resources include a worldclass team of polymer scientists and engineers that assist customers in elevating their concept from prototype to full-scale
commercialization.
Our product line includes extruded tubing, heat shrinks,

PEEKshrink, FluoroPEELZ peelable fusing sleeves, thinwalled Sub-Lite-Wall, Aeos ePTFE porous products,
Absorvbioabsorbable tubing, Bioweb electrospun composites, drawn fiber, and multi-lumen tubing. Zeus also offers a full
array of secondary/value-add products including flaring, flanging, pad printing, etching, and more. In 2015, Zeus launched the
Virtual Sample Locker (VSL), a simple-to-use complimentary
online service providing customers with constant access to
catheter component samples with swift delivery. Continuing
our history of innovation, we quickly followed VSL with the
unveiling of our LCP (liquid crystal polymer) monofilament fiber
for the creation of MRI-compatible catheters. More recently we
have made available our Aeos expanded PTFE (ePTFE) suture
monofilament in bulk and unbranded quantities to create your
own suture lines. Zeus also offers the expertise of our traveling
Technical Z-teams polymer scientists, engineers, and technicians who are available to consult on urgent on-site projects.
Target Markets
Peripheral vascular, Cardiovascular, Neurovascular, Structural
heart, Cardiac rhythm Management/Electrophysiology, GI
endoscopy, aerospace, energy, automotive and fiber optics
www.zeusinc.com
Intro
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51
Advertisement
The Lee Company

2 Pettipaug Road, P.O. Box 424
Westbrook, CT 06498
Phone: 860-399-6281
Fax: 860-399-2270
E-mail: inquiry@theleeco.com
www.theleeco.com
Company Description
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 instrumentation, analytical/clinical chemistry, and medical disposable applications. 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 800 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 companys
distribution network spans the entire globe.
Lees unique capabilities in miniaturization and engineering

expertise (one of every seven employees is a graduate engineer) keep the company at the forefront of fluid flow technology, and enable it to work effectively with customers to solve difficult fluid control problems.
Products include high quality 2- and 3-way miniature solenoid valves, latching solenoid valves, high speed microdispense valves, nozzles, press-in check valves, calibrated flow
restrictors, fixed and variable volume pumps, custom manifold
systems, and other inert fluid handling components.
Target Markets
In vitro diagnostics, scientific instrumentation, drug discovery, and medical equipment such as oxygen delivery, patient
monitoring, dialysis, and compression therapy
www.theleeco.com
52
Intro
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Advertisement
Wacker Chemical Corporation

3301 Sutton Road
Adrian, MI 49221
Phone: 1-888-922-5374
Fax: 517-264-4068
E-mail: info.usa@wacker.com
Company Description
Target Markets
WACKER is one of the worlds leading and most researchintensive chemical companies, with total sales of 5.3 billion
(2015). Products range from silicones, binders, and polymer
additives for diverse industrial sectors to bioengineered pharmaceutical actives and hyperpure silicon for semiconductor
and solar applications. Spanning the globe with five business
divisions, we offer highly specialized products and comprehensive service via 25 production sites, 22 technical competence
centers, 50 sales offices, and 15 WACKER ACADEMY training
centers in Europe, North, and Central America, as well as in Asia
and China. WACKER is represented in North America by Wacker
Chemical Corporation, Adrian, MI.
As a technology leader focusing on sustainability, WACKERs

extensive range of specialized products has application in many
of the worlds key industries:
Health Care (Medical Devices, Orthopedics, Prosthesis, Wound
Care)
Consumer Care
Automotive & Transport
Energy, Electrical Systems & Electronics
Composites
Renewable Energies
Textiles, Leather & Fabrics
Adhesives & Sealants
Chemical Industries
Life Science
Construction
Food
Coatings & Paints
Elastomers & Plastics
For the health care industry, it is essential the materials
employed meet the highest quality requirements. Pure silicones
meet these demands. Their extraordinary properties make
them ideal for highly sensitive health care applications. These
consumer properties include biocompatibility and skin friendly,
durable and long lasting, highly resistant to weathering and
radiation, media resistant and highly elastic, and are easy to
clean and are very low moisture absorbent. Manufacturing benefits include excellent mechanical properties and gas permeability, easy processing properties, room temperature or fast
curing grades available and excellent stability at temperatures
from -50C to 200C.
SILPURAN HTV, LSR, and RTV silicone rubber grades are
manufactured in strict accordance with ISO 9001 quality standards and tested for biocompatibility compliance to ISO 10993
and USP-Class VI standards. SILPURAN silicone rubber grades
are your assurance our materials are manufactured to the highest quality and purity standards possible.
Intro
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53
Advertisement
throughout the world. As a leader in clad composite wire for the

medical device industry, our team of highly skilled experienced
material engineers has been on the leading edge of many of the
following areas during this time.
Cardiac Rhythm Management
(Pacing and Defibrillation)
Neurostimulation
Vascular Therapy (Stents,
Catheters, Guidewires)
Biosensors and Monitors
Marker Band Alternatives
Anomet Products
830 Boston Turnpike
Shrewsbury, MA 01545
Phone: 508-842-3069
Fax: 508-842-0847
E-mail: info@anometproducts.com
Company Description
Anomet Products manufactures clad
metal wire combining high-strength, highlyconductive, biocompatible, and radio-opaque
alloys into one material system. Typical
wire combinations include 316LVM, Gold and
Gold alloys, MP35N, Nitinol, Tantalum,
Titanium, Platinum and Platinum-Iridium
alloys, Palladium, Silver, and others. Precious
metal-clad wire is a cost-effective alternative to solid PM wire.
Anomet's clad-metal wire can include precious metal cores

or claddings such as platinum for biocompatibility, gold for contact resistance, tantalum for radiopacity under fluoroscopy, and
silver for conductivity. Each alloy can be clad to core materials
such as copper (Cu) or copper alloys, niobium (Nb), molybdenum (Mo), MP35N and Ni-Co-Cr-Mo alloys, Nitinol (NiTi) and
Nickel-Titanium alloys, Platinum (Pt) alloys or Platinum-Iridium
(Pt-Ir), silver (Ag), stainless steel (302, 304V, 316LVM), tantalum
(Ta) or tantalum-tungsten (Ta-W) alloys, and titanium (Ti) or
titanium alloys. Draw on Anomets 40 years of clad-wire experience to engineer the perfect solution.
MP35N is a registered trademark of SPS Technologies, Inc.
Target Markets
For over 30 years, Anomet Products has been designing and
manufacturing clad metal wire used in medical devices
for Medical Devices
Composite Metal Wire

High Strength High Conductivity
Biocompatible Radiopaque Resilient
Flexible Kink Resistant Cost Effective
Alternative to Solid Precious Metal W ire
Combine two or more

metals or alloys into
a clad metal wire
system
that acts as one.
info@anometproducts.com (508) 842-3069 www.anometproducts.com

54
Intro
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Advertisement
Arthur G. Russell Company

750 Clark Avenue
Bristol, CT 06010
Phone: 860-583-4109
Fax: 860-583-0686
E-mail: david.aquilino@arthurgrussell.com
Company Description
The Arthur G. Russell Company, Inc. designs and develops
innovative automatic assembly systems for the medical device
industry that require the highest level of quality for products
such as syringes, blood collection tubes, IV catheters, dosage
dispensers, and other products that must satisfy stringent FDA
requirements.
Target Markets
Knowing that quality and dependability are as important on

the assembly line as in the final productthat's why we work with
you from the start. In addition to custom designing a system that
will exceed your expectations and be flexible enough to grow with
you as your product demands change, we can provide proof-ofprinciple, which helps develop key processes for automation.
AGR offers the best approach for the application. Complete
systems include adhesive application and curing, ultrasonic and
spin welding, high-speed inspection, labeling, and filling, all
while providing the integration required for a turn-key system.
Providing more than just assembly equipment, we provide
you with the edge you need to stay competitive in your market.
Medical Devices, Pharmaceutical, High-Volume Consumer

Products, High-Volume Disposable Goods, Packaging
55
Intro
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Advertisement
Branson Ultrasonics
41 Eagle Road
Danbury, CT 06810
Phone: 203-796-0400
E-mail: info@bransonultrasonics.com
www.BransonUltrasonics.com
Company Description
Emerson leads the medical global assembly technology
market with the industry leading portfolio of Branson
Ultrasonic plastic joining, laser welding, ultrasonic metal
welding, and precision cleaning equipment. Branson products
are supported by a network of more than 1800 employees in
70 sales and support offices worldwide that provide the highest
levels of sales, service and support virtually anywhere.
Whatever your assembly needs, Branson products and support
make it possible..
Veriow
Technologies
case study
available upon
request
Target Markets
Unmatched expertise
in materials joining and
precision cleaning
Medical Devices, OEM, Automotive, Business & Consumer

Electronics, Home Appliances, Robotics, Packaging,
Nonwovens
Branson is recognized worldwide for offering

the broadest range of advanced solutions
for materials joining and precision cleaning for
the medical industry. Branson offers:
Emerson offers Bransons process neutral approach to

provide the best product technology solution for todays
medical market. Our in-depth medical industry experience
provides a competitive advantage to our customers in all
aspects of product development and regulatory compliance,
by delivering the most robust manufacturing solutions available
today. Employing a process neutral approach to application
development insures customers receive the best solution to
address product specifications, regulatory, and budgetary
needs.
Branson 2000Xc Ultrasonic Welding System delivers consistent,
precise, high quality welds, fast cycle times. The 2000Xc
assists with FDA 21 CFR, part 11 regulation compliance.
Branson 3g/3i Laser Welding Systems features patented
STTlr laser weld technology capable of meeting medical
device manufacturers
challenge for a clearon-clear, particular
free, pre cise weld
joint, with superior
aesthetic quality,
confirming Bransons
position as a global
technology leader.
A wide array of plastics joining, metal

welding, and cleaning technologies
Quality products and consistent performance
medical manufacturers require
2000Xc ultrasonic welders with secure
process controls and detailed weld data to
assist with medical FDA 21 CFR part 11
regulations compliance
Ultrasonic precision cleaning, from benchtop
baths to large industrial & automated systems
Worldwide resources for true global
support & service
bransonultrasonics.com 203-796-0400
See Us At MD&M WEST 2017, Booth #2439
www.BransonUltrasonics.com
Branson Ultrasonics Corporation 2016.

The Emerson logo is a trademark and service mark of Emerson Electric Co.
56
Intro
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Target Markets
Medical and Life Sciences
Cadence, Inc.
9 Technology Dr.
Staunton, VA 24401
Phone: 540-248-2200
Fax: 540-248-4400
E-mail: sales@cadenceinc.com
www.cadenceinc.com
Company Description
Cadence offers complete services that range from initial design
through manufacturing and full supply chain management of medical devices and life science products. We also have extensive plastics and metals expertise, making new products a reality.
Cadence is a full service contract manufacturing partner

offering assembly, packaging, and sterilization services in our
Product Realization Center located in Pittsburgh, PA. From
concept through commercialization, Cadence can assist with
product design, design
for manufacturing, prototyping, complete supply chain management,
and production of your
finished medical device
and life science products. We are vertically
integrated with extensive in-house metals
and plastics manufacturing expertise including machining, metal stamping, sharpening grinding, tubing fabrication, laser welding and cutting,
plastic injection molding, insert molding, and much more.
www.cadenceinc.com
Cadence is dedicated to making mission critical products.

That is why our Product Realization CenterTM is 100% dedicated to providing
finished medical devices.
Finished Device
Contract Manufacturing
Certified Cleanroom
Manufacturing
Sterilization
Management
Complete Supply
Chain Management
cadenceinc.com/finisheddevices
cadenceinc.com/finisheddevices
800.252.3371
57
Intro
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Advertisement
Cotronics Corporation
131 47th Street, Brooklyn, NY 11232
Phone: 718-788-5533
Fax: 718-788-5538
E-mail: sales@cotronics.com
www.cotronics.com
Company Description
For more than 40 years, Cotronics highly skilled staff of researchers, engineers,
chemists, technicians, and sales assistants
HIGH TEMPERATURE
MATERIALS FOR
ELECTRICAL l STRUCTURAL l INDUSTRIAL l MEDICAL

APPLICATIONS TO 4000F
Flexible Conductive Silver Based Epoxy
have provided the aerospace, automotive,

nuclear, semi-conductor, instrumentation,
appliances, and chemical processing industries a reliable source of superior quality,
high temperature products specially formulated to meet the demanding specifications todays technology requires.
Cotronics provides the utmost in excellence and quality control in their new, computerized manufacturing facility. Call 718788-5533 for Cotronics: application engineers for specific technical information,
adhesive suggestions, and custom solutions; Cotronics customer service department for price quotes and placing orders
for high temperature stock materials.
Duralco 125 thermally conductive electrical epoxy bonds to most

metals, ceramics and plastics to form a stress-free adhesive bond.
Continuous service up to 450F.
High Temperature
Low Expansion Adhesive
Resbond 905 Quartz is formulated for
bondng low expansion and thermal shock
resistant ceramics. Ideal for electronic
and metallurgical applications to 2500F.
Thermally Conductive Adhesives

Duralco 132 thermally conductive
adhesives combine Cotronics unique, high
temperature resins with highly conductive
fillers to form thermally conductive, adhesive
bonds with continuous service up to 500F.
High Expansion Adhesive

Thermeez 7030 bonds and protects
to 1800F. Apply to ceramics, ceramic
cloths, door and tadpole gaskets and
metals. Excellent adhesion to steel,
stainless, aluminum, lead and ceramics.
High temperature materials and adhesives for electrical and industrial
applications for use to 4000F.
We offer high temperature solutions to
satisfy the most difficult electrical, structural, and industrial applications with the
following proven Cotronics brand name
products: Duralco (High Temperature
Epoxies), Resbond (High Temperature
Ceramic Adhesives), Rescor (Machinable
and Castable Ceramics, Thermeez
(Insulation Products), Durabond (Maintenance and Repair Products), and High
Purity Materials.
High Purity, Alumina Adhesive

Protects Critical Electronic Components
Resbond 989 offers continuous protection to 3000F. Apply
directly to metals, glass, ceramics, graphite and silicon carbide.
Provides high bond strength and excellent electrical, moisture,
chemical and solvent resistance for bonding and sealing.
You have challenging applications we have solutions!

High Temperature Products Since 1971
COTRONICS
CORP.
131 47th Street, Brooklyn, NY 11232 Web: www.cotronics.com
Call: 718.788.5533 Fax: 718.788.5538 Email: sales@cotronics.com
www.cotronics.com
TECH SUPPORT I CUSTOM FORMULATIONS I QUANTITY PRICING
58
Intro
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Advertisement
a busin
ness unit of
EDA
AC
T
TECHNOLOGIES
EBTEC, an EDAC Technologies Company

120 Shoemaker Lane
Agawam, MA 01001
Phone: 413-786-0393
Fax: 413-789-2851
E-mail: ahumphries@edactechnologies.com
www.ebteccorp.com
We already
conquered
outer space.
Company Description
EBTEC has been serving the Medical, Aerospace, Automotive,
Power Generation, Semi-Conductor, and Industrial marketplaces
for over 55 Years with Electron Beam Welding, Laser Welding,
Cutting & Drilling, Abrasive Water Jet, and Fabrication.
EBTEC maintains AS9100/ISO9000 certification and NADCAP certifications for welding, non-conventional machining,
and airflow.
Now were
redening
inner space.
Target Markets
Medical
Aerospace
Power Generation
Semiconductor
Industrial
When there is no room for error, EBTECs highenergy beam processes deliver precision.
Our wide range of high-energy beam processes

are ideal for precision medical products, whose
detailed manufacturing requirements often
preclude welding or machining by conventional
methods. From laser and electron beam fusion
to laser cutting, drilling and beyond, all of our
processes are backed by EBTECs sophisticated
engineering and design capabilities.
High energy beam sciences are core to the offerings at

EBTEC Corporation. These offerings include Electron Beam
Welding (EBW), Laser Cutting (LBC), Laser Drilling (LBD),
Laser Welding (LBW), Abrasive Waterjet Cutting, and some
EDM services. EBTEC utilizes advanced technologies and
processes, providing cost-effective services to some of the
largest companies in the Medical, Aerospace, Power
Generation, Industrial, and Defense industries. EBTEC is set up
for development applications as well as high
volume and offers competitive solutions, at the
right price, and the right
delivery to meet your
processing needs
From concept through completion discover

how we can utilize technology and imagination
to turn your design challenges into reality.
www.ebteccorp.com
tel 413.786.0393
www.ebteccorp.com
Intro
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Advertisement
Economy Spring
29 DePaolo Dr., Southington, CT 06489
Phone: 860-621-7358
Fax: 860-621-7882
E-mail: info@mw-ind.com
www.mw-ind.com/brands/economy-spring
Company Description
Economy Spring is a leading manufacturer of precision and custom wire
forms, metal stampings, coil springs,
tubular components, and product

assemblies, optimized for the medical
and pharmaceutical markets. We provide prototype services with our inhouse tool engineering and preliminary
pilot production that helps support initial device development programs
across the entire value stream.
Engineered Drug Delivery
Target Markets
Solutions .....
Medical Contract Manufacturing R&D

OEM Drug Delivery R&D and
Manufacturing
Medical Device Manufacturing
FDA Registered
ISO 9001
ISO 13485 Compliant
Services / Products Offered

The Economy Spring engineering
team is always available to work as an
extension of their customers engineering team, ready to provide optimized
designs, project management, and production assistance that will help facilitate bringing to market new and innovative products on time and within budget.
Wire Forms
Metal Stampings,
Coil Springs
Product Assemblies
Surgical Staples,
Hypodermic Needles
Laparoscopic Device Hardware
Drug Delivery System Components
Catheter Guide Wire
Surgical Sharps
......for more than 40 years!

Medical Device OEMs rely on Economy Spring for:
Engineering design expertise
Cleanroom controlled environments
Quality inspection
Rapid
Prototyping
Services
www.mw-ind.com/brands/
economy-spring
Southington, CT 06489
info@mw-ind.com
60
Tel: 860.621.7358
Intro
Cov
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Advertisement
Cure
with
Condence
2260 Argentia Rd.
Mississauga, ON, Canada L5N 6H7
Phone: 905 821-2600
E-mail: omnicure@excelitas.com
NEW
Company Description
Excelitas Technologies innovative OmniCure UV curing
solutions provide leading manufacturers worldwide with the
most advanced, streamlined, and reliable UV
curing technology. Leveraging over 30 years
of industry expertise,
OmniCure delivers fast
and consistent UV curing results, ensuring our customers capitalize on highest
product quality and production efficiency savings.
OmniCure LX500 UV LED

Spot Curing Solution
Target Markets
Medical Device Assembly
Electronics/Optoelectronics Manufacturing
Fiber Optics and Coatings
Industrial Manufacturing
Digital Printing
t Outstanding optical stability for

consistent curing results
t Integrated calibration utility to
ensure superior process control
t Precise programming and realtime data logging with maximum

exibility
OmniCure offers UV Lamp and LED curing solutions for

small-to-wide area curing of adhesives, coatings, and inks.
OmniCure S and LX Series UV spot-curing systems are used
for precision adhesive curing of medical devices, i.e., catheters,
cannulas, endoscopes, as well as electronics. New, ultra-compact OmniCure LX500 LED
curing system uniquely
designed with proprietary
Intelli-Lamp technology,
monitors LED head temperature, lifetime data, and automatically maintains optical
stability 5% for maximum
process assurance.
OmniCure AC Series UV LED area-curing systems
designed with advanced front-end optics, provide high-peak
irradiance, and exceptional uniformity at different working
distances for outstanding productivity and reduced costs.
t Compact design to simplify

integration with your assembly line
Visit us at:
MD&M West
Booth 2233 February 7-9, 2017
Anaheim, CA
www.excelitas.com/OmniCure
www.excelitas.com
2260 Argentia Road
Mississauga, Ontario, L5N 6H7 CANADA
Intro
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61
Advertisement
Heatrons ISO 9001 and FDA-registered manufacturing facilities produce millions of heating elements, thick film circuits,
and LED assemblies per year right here in the USA. Using our
design or yours, entrusting manufacturing and assembly to
Heatron simplifies your supply chain.
Heatron, Inc.
3000 Wilson Ave.
Leavenworth, KS 66048
Phone: 913-651-4420
Fax: 913-651-5332
E-mail: sales@heatron.com
www.Heatron.com
Company Description
Medical device designers looking for cost-effective and highperforming heating solutions for their products prefer Heatron.
Our innovative heating solutions are custom-designed for each
application, and optimized for performance, production, cost,
and regulatory compliance.
Frequent applications include handheld devices, laboratory
equipment, fluid warming, dialysis, patient
warming, DNA sequencing, diagnostics, and
sleep apnea devices
developed by the worlds
most innovative medical
device companies.
Heatrons core products include flexible heating elements,

cartridge heaters, thick film heaters and circuits, and LED
boards and modules. These products can be custom-designed
or manufactured to your specifications.
Etched foil heaters in silicone rubber, polyimide, polyester or mica
Wire wound heaters
Optically clear heaters
Cartridge heaters, including
deep drawn, electropolish
and non-stick options
Thick film heaters on metal
or ceramic
Thick film electronics
LED boards and modules
Value-added services like turnkey assembly, circuit design, testing
and failure analysis, and supply chain services help you get your product to market quickly, and scale smoothly as your production grows.
www.heatron.com
62
Intro
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Advertisement
LEMO USA, Inc.

635 Park Court
Rohnert Park, CA 94928
Phone: 800-444-5366
Fax: 707-206-3774
E-mail: Info-US@LEMO.com
www.LEMO.com
Company Description
LEMO is a global leader in the design and manufacture
of high quality precision custom connection and cable
assembly solutions. LEMO provides connector and cable
solutions that can be found in many challenging medical
applications from catheters to surgical instruments. For
more information about LEMOs Medical Solutions, go to:
www.lemo.com/en/application/medical-connector.
Target Markets
Minimally Invasive Surgery
Non-Invasive Surgery
Single-Patient Disposable
Surgical Navigation / Robots
Wearable Electronic Products
Dental Equipment
And more.
LEMO Begins with Quality,
Reliability, and Innovation
LEMO, with headquarters in
Switzerland and LEMO subsidiaries around the world, is a
global leader providing high
quality precision custom circular
connectors, wire, and cable
assembly solutions. LEMO has
been designing and manufacturing connectors since 1946.
The REDEL brand (plastic) of
LEMO connectors are a well established product series in the
medical market. As with all LEMO products, including their
popular Unipole Multipole (metal) connector series, the
REDEL connector series has been designed to ensure quality
performance in the most demanding life sustaining medical
applications from catheters to surgical instruments. LEMO is
ISO 13485:2003 Certified for medical cable assemblies.
www.LEMO.com
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63
Advertisement
maxon precision motors, inc.

101 Waldron Road
Fall River, MA 02720
Phone: 508-677-0520
Company Description
maxon drives set the world in motion.
maxon motor combines electric motors,
gears and DC motor controls into high-
precision, intelligent drive systems that

can be custom-made to fit the specific
needs of customer applications. maxon
motor helps provide innovative solutions at competitive prices for numerous applications in various markets.
Target Markets
Industrial automation, medical technology, security technology, instrumentation, communications, aerospace and
defense, and consumer applications,
among others.
Fast track your project.

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Offering solutions that fit your customized needs. maxon motor develops
and builds precision drive systems. Our DC
motors with ironless windings are among
the best in the world. They are used wherever requirements are demanding and
engineers cannot afford compromise:
maxon motors drive NASA's Mars rovers.
They can also be found in insulin pumps,
surgical power tools, humanoid robots,
and in precision industrial applications. We
not only provide motors, gearheads,
encoders, and controllers, but also offer
our know-how and many years of experience. Since 1961, maxon's engineers have
been true partners in the quest to create
the right solution for each customer.
Prototypes, custom systems, or large
series: Whatever your requirements may
be, we are happy to be of assistance.
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64
Intro
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Advertisement
Target Markets
Medical Device Industry
Active Implants
Imaging & Diagnostics
Drug Delivery
Sensors
Micro Systems Technologies Management AG

Neuhofstrasse 4
CH-6340 Baar
Switzerland
Phone: +41 44 804 63 00
Fax: +41 44 804 63 01
E-mail: info@mst.com
www.mst.com
Hearing Aids
Industrial
Aerospace & Defense
Telecommunication
HF/Microwave
Company Description
The Micro Systems
Technologies (MST)
Group comprises four
technology companies
with more than 1,000
employeeslocated in
Germany, the United
States, and Switzerland.
The globally active
group provides innovative products and services for medical devices, especially active implants, and other hightech industries that demand exceptional performance and reliability.
The Micro Systems Technologies Group offers:

highly complex HDI, high-frequency and high-reliability PCBs
in flex, rigid-flex, and rigid technology
high-performance batteries, battery packs, and hermetic
feedthroughs for active implants
manufacturing of multilayer ceramic substrates based on
LTCC (Low Temperature Co-fired Ceramic) and thick film
advanced assembly in the field of SMT and chip & wire, as well
as semiconductor packaging processes including production
of stacked die BGAs using transfer molding
design and manufacturing of electronic modules for class III
devices including SMD board assembly services
During manufacturing, MST companies guarantee complete
traceability of materials and processes.
www.mst.com
Micro Systems Technologies engineering for life
Innovative solutions for medical devices

from concept to series production
> Medical microelectronics (design service,
substrate manufacturing, semiconductor
packaging, board assembly, test services)
www.mst.com
Micro Systems Technologies, Neuhofstrasse 4, CH-6340 Baar, Switzerland,
Phone +41 (44) 804 63 00, Fax +41 (44) 804 63 01, info@mst.com, www.mst.com
MST Group. Active around the globe, the Micro Systems Technologies (MST) Group
consists of four technology companies with more than 1100 employees in three
countries: DYCONEX AG, Switzerland, LITRONIK Batterietechnologie GmbH, Germany,
Micro Systems Engineering GmbH, Germany, Micro Systems Engineering, Inc., USA
> Batteries and battery packs for active implants

> Hermetic feedthroughs for medtech implants
65
Intro
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Advertisement
Target Markets
Medical plastics, cardiovascular, peripheral vascular,
microvascular, urology, neurology, electrophysiology, orthopedic, dental, drug delivery, sports medicine, cosmetic surgery,
nerve reconstruction, cranial maxillofacial surgery, bioresorbable, and general fluid and gas administration.
Pexco LLC
2500 Northwinds Parkway #472
Alpharetta, GA 30009
Phone: 404-564-8560
Fax: 404-564-8579
E-mail: Marketing@pexco.com
Company Description
Pexco manufactures for medical OEMs specialty plastics, medical injection molding,
medical tubing, machined plastics, and
assemblies. Our five
North American ISO
13485 certified operations provide both
high volume and small
batch production to
customers across the
globe.
Single and multilumen tubing;

high pressure, wire-reinforced,
coiled and braided tubing; mandrel
core extrusion for wire-reinforced
production; thin walled tubing; IV
Cannula/Catheter tubing; paratubing, solvent and UV bonded; balloon
tubing for 05mm to 50mm balloons;
co-extrusion and multilayered
extrusion; and striped tubing
across most all major medical plastic material categories.
Injection molding, insert-molding, over-molding, micro molding; implantable PEEK, screws, anchors, and fasteners; metal
replacement; bioresorbable PLLA, PLA, PLD, PLG, PLDL, PG.
Up Yoour Game
with Pexco Medical
Precision Extrusion,
Extrusion Fab
and Assembly
Microextruded parts of the
tightest tolerances
Thinner walls
Superior integrity
High performance plastics
and all major medical
polymers
40
04.564.8560
Pexc
co.com/medical
66
Intro
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Advertisement
Photofabrication Engineering, Inc. (PEI)

500 Fortune Blvd.
Milford, MA 01757
Phone: 508-478-2025
Fax: 508-478-3582
E-Mail: pei@photofabrication.com
Company Description
PEI has been a world-class manufacturer of precision and
decorative photochemically machined products for over 40
years. Located an hour west of Boston in beautiful Milford, MA,
PEIs 40,000 square foot, ISO 9001/AS9102 facility continues to
add new capabilities and adapt to the ever-changing requirements of our customers.
Target Markets
Photo-Chemical Machining (PCM) is a process utilized for the

precision removal of selective areas of metal through chemical
action. This process is recognized by the Society of
Manufacturing Engineers and offers the user a method for the
creation of highly precise, burr-free metal parts. This process
also allows for very quick cycle times and with extremely
affordable tooling
costs. A fabulous
way to develop new
designs and maintain design consistency in volume production.
Additional valueadded services offered include plating,
heat treating, assembly, forming, coatings, polishing, silk
screening and many
more. Please inquire
for other services.
Medical implants, Medical tools, Medical blades, Maxofacial

Cranial Mesh, Battery anodes/cathodes, Energy storage as well
as Aerospace & Defense
67
Intro
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Advertisement
SCHURTER Inc.
447 Aviation Boulevard
Santa Rosa, CA, 95403
Phone: 800-848 2600; 707-636 3000
Fax: 707-636 3033
E-mail: info@schurterinc.com
www.schurterinc.com
MSM LA CS
Company Description
SCHURTER has been a trusted component supplier to the medical industry
since 1933. Manufacturers have come to
Robust metal switch

with ceramic actuator
rely on SCHURTERs circuit protection,

AC connectors, and switches to safely
downsize and optimize equipment performance. Power entry modules offer
integrated or discrete low leakage filters, with V-Lock medical and standard
cord sets.
Target Markets
Medical Equipment used for diagnosis, analysis, dental applications, radiology, rehabilitation, and/or patient monitoring.
SCHURTER offers components and
solutions that meet the most stringent
safety and EMC design requirements
according to IEC 60601-1 and IEC 606011-11 for Protection Class I and II equipment. Products and services meet the
highest demands for quality because
systems such as ISO 9001, ISO 14001,
OHSAS 18001, the Six Sigma method,
and the Business Excellence Model
ensure the highest operating standards.
SCHURTER aligns its innovations with
trends in medical technology, and supports manufacturers of medical equipment around the world in their product
developments for the advancement of
patient care in hospitals, doctors
offices, labs, as well as at home.
Robust stainless steel latching action switch with backlit ceramic

actuator resists scratches, abrasions and chemicals.
http://
medical-technology.schurter.com
- Maximum rated current: 16 A @ 250 VAC

- LED supply voltage: 24 VDC
- Mounting diameter: 19 or 22 mm
- Ingress protection: IP64 from front contact area
- Impact resistance: IK07
- Temperature range: -20 C to +85 C
- Approvals: ENEC, UL, CSA, and CQC
- Standards: IEC 61058-1 and UL 1054
msm-la-cs.schurter. com
68
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Advertisement
Target Markets
industrial, medical, commercial appliance, packaging, instrumentation, aviation, transportation and military
Hotwatt
Inc.
128 Maple St.
Danvers, MA 01923
Phone: 978-777-0070
Fax: 978-774-2409
E-mail: sales@hotwatt.com
www.hotwatt.com
Company Description
Electric Heaters for
Medical Equipment
Hotwatt, made in
USA, is a quality supplier to Medical OEM's
and has maintained
leadership manufacturing of resistance heating elements for over
65 years. Applications include but are not limited to Fluid heating, Sterilization, Incubation, Humidifiers, Pharmaceuticals, Lab
equipment, and Portable Heated Trays.
Hotwatt has manufactured

specialized electric heating
elements for over 65 years, all
made in the USA. Products
include cartridge, air process,
immersion, strip and finned
strip, tubular and finned tubular, band, compressor crankcase, foil, flexible rope and ceramic
heaters. We are a quality supplier to OEM's in the in industrial,
medical, commercial appliance, packaging, instrumentation,
aviation, transportation and military fields. Our most popular
product is our cartridge heaters. We make low to medium and
high watt density cartridge heaters. Cartridge heaters provide
localized heat to restricted work areas requiring close thermal
control. Dies, platens, and a variety of other types of processing
equipment are efficiently heated. Closely controlled work temperatures up to 1400 F (760 C) are obtained by a combination
of heater location and proper wattage output.
www.hotwatt.com
Target Markets
Medical Device, Aerospace, Electronics, Military, Automotive
Specialty Coating Systems (SCS)
7645 Woodland Drive
Indianapolis, IN 46278
Phone: 317-244-1200
Fax: 317-240-2739
E-mail: scssales@scscoatings.com
www.scscoatings.com
Company Description
With more than
45 years of coating and application
experience, SCS
provides industryleading Pary lene
conformal coating services and
technologies to the
medical device, electronics, aerospace, military, and automotive
industries. SCS meets the needs of our customers through 21 coating facilities throughout the Americas, Europe, and Asia. For more
information, visit SCScoatings.com.
Biocompatible and biostable, SCS

Parylene conformal coatings provide
excellent moisture, chemical, and
dielectric barrier properties to a wide
range of devices and components,
including stents, pacemakers, needles,
catheters, neurostimulation devices,
electrosurgical tools, circuit boards,
sensors, MEMS, LEDs, and more. Applied
in a vapor deposition process, Parylene
coatings are ultra-thin (usually measured in
microns), lightweight, and offer unmatched penetration into
tubes and crevices, providing complete protection of the
component. The companys microRESIST Antimicrobial
Parylene Technology combines the protective benefits of
ultra-thin Parylene with antimicrobial properties to effectively eliminate harmful microorganisms on coated medical
devices and components.
www.SCScoatings.com
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69
Advanced Imaging Reveals Fetal Brain Activity

A new approach from the University of Washington, Seattle,
WA, images functional activity in the brains of individual fetuses. The study, led by professor Colin Studholme, Ph.D.,
addresses a common problem of functional MRI: if the subject
moves during the scanning, the images appear distorted.
By correcting for motion, the team created a four-dimensional
reconstruction of brain activity in moving subjects. The 4D
method enables studies of
fetuses, small children,
and other subjects who do
not stay still for long.
The imaging developFunctional MRI of a fetal brain, showing
ment
focused on the
activated regions (red) of the default mode
network. (Credit: S. Seshamani, et al)
default mode network a
collection of regions that
are active when the brain is at rest. Fetal brains are often in default
mode, but little is known about how the network develops.
Brain activity was detected based on blood flow to the brain's
active regions. The team collected multiple MRI measurements, each providing slightly different perspectives.
The new strategy enables investigations into both normal
brain development and the effects of a mothers diet or environment on the functional growth of the fetal brain.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/25593.
Artificial Blood Vessels for Patients with Heart Defects
Biomedical engineers from the
University of Minnesota, Minneapolis,
MN, created artificial blood vessels. If
confirmed in humans, the grafts could
prevent repeated surgeries for children with congenital heart defects.
Department
of
Biomedical After being implanted in a
Engineering Professor Robert patient, the off-the-shelf
material can grow in the
Tranquillo and his colleagues gener- body. (Credit: University of
ated vessel-like tubes from a post- Minnesota)
natal donors skin cells, and then
removed the cells to minimize the chance of rejection.
To develop the graft material, researchers combined sheep
skin cells in a gelatin-like material called fibrin. After forming
a tube, the team used a bioreactor to rhythmically pump in the
nutrients necessary for cell growth. The pumping bioreactor
provided both nutrients and exercise to strengthen and stiffen the tube. The researchers then employed special detergents
to wash away all of the sheep cells, leaving behind a cell-free
matrix that thwarts an immune reaction when implanted.
When the vessel graft replaced a part of the pulmonary artery
in three lambs at five weeks of age, the implanted grafts were soon
populated by the animals own cells, causing the vessel to bend its
shape and grow together with the recipient until adulthood.
70
4D Imaging Captures Patients' Risk of Stroke

Atrial fibrillation, the most common form of cardiac arrhythmia,
affects 33.5 million people worldwide.
The slow, sluggish blood flow caused
by atrial fibrillation can lead to blood
clots, which then travel to the brain
and initiate stroke. The risk of block4D flow CMR can measage or hemorrhage of a blood vessel,
ure in-vivo 3D blood flow
however, is difficult to predict.
dynamics in the heart
Michael Markl, a professor of bioand
atria.
(Credit:
Northwestern University)
medical engineering at Northwestern
University, Evanston, IL, has developed a new imaging technique that can help to predict who is
most at risk for stroke. The breakthrough could lead to better
treatment for patients with atrial fibrillation.
Called atrial 4D flow CMR, Markls cardiac magnetic resonance (CMR) imaging test detects the bloods velocity through
the heart and body. Without the use of contrast agents, the
non-invasive program images blood flow dynamically, and in
multiple spatial dimensions.
It allows you to measure flow, diffusion of molecules, and
tissue elasticity. You can interrogate the human body in a very
detailed manner, said Markl.
The software also integrates into current MRI equipment
without the need of special hardware and scanners or equipment upgrades.
Contact Lens Senses Glucose
A contact lens technology from
the University of Houston, Houston,
TX, samples glucose levels in a wearers tears. The tiny device, built from
multiple layers of gold nanowires
stacked on top of a gold film,
employs a technique called surfaceenhanced Raman scattering to
The above illustration
detect small samples.
shows the schematic proTo determine molecular proper- cedure for the fabrication
ties, surface-enhanced Raman scat- of a surface-enhanced
tering uses information about how Raman scattering contact
lens via transfer printing.
light interacts with a material. The (Credit: University of
University of Houston device, pro- Houston)
duced using solvent-assisted nanotransfer printing methods, enhances the sensing properties of
the technique by creating hot spots, or narrow gaps within the
nanostructure. The openings intensify the Raman signal.
Although traditional nanofabrication techniques rely on a
hard substrate usually glass or a silicon wafer the
researchers wanted a flexible nanostructure more suited to wearable electronics. The layered nanoarray was produced on a hard
substrate but lifted off and printed onto a soft contact lens.
Intro
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mdi Consultants, Inc.

The sensor's accurate monitoring of the glucose level in
human tears provides an alternative approach to blood testing
and invasive glucose monitoring.
Researchers Develop 'Strength Test' for Platelets
By squeezing two protein dots
together, biomedical engineers
from Emory University, Atlanta, GA,
and the Georgia Institute of
Technology, Atlanta, GA, have created a microfluidic testing ground for
platelet strength. The health assessThe microfluidic device
diagnoses bleeding disorment supports the diagnosis of
ders. By squeezing two problood clotting disorders.
tein dots, platelet strength
A blood clot contracts shortly after
is revealed. (Credit: Emory
University/Georgia Tech)
being formed, promoting wound
closure and restoration of normal
blood flow. The process, however, is often deficient in a variety
of blood clotting disorders.
The scientists inferred the strength of a patient's platelets by
measuring the movement of protein dots, taking a picture, and
then analyzing the image on a computer.
The dots are made of fibrinogen, a sticky protein and precursor
for fibrin, which forms a mesh of insoluble strands in a blood clot.
The researchers also used chemical tools to dissect platelet
contraction. The team demonstrated that inhibitors of
Rho/ROCK enzymes prevent platelet contraction, but
inhibitors of a related pathway, MLCK (myosin light chain
kinase), did not. According to the scientists, individual platelet
contraction could become a test for development or refinement of blood thinning drugs.
Mobile Device Detects Irregular Heartbeat
VTT Technical Research Centre of Finland, Espoo, Finland,
has developed a mobile app and thumb-sized device that detects
arrhythmia. The technology, suitable for pre- and post-surgery
monitoring of heart patients, registers an individual's electrocardiogram (ECG) signal whenever symptoms occur.
The "Beat2Phone" accurately measures the user's heart rate and heart
rate variability to identify not only an
irregular beat, but also overburdening Beat2Phone helps to
atrial fibrillation,
and prolonged stress. The Android- detect
other types of arrhythmia,
compatible wearable device also and cardiac conduction
includes position and activity sensors. disorders. (Credit: VTT)
There is no need for patients to
visit a hospital, because the data is sent automatically from a
mobile phone to medical staff via a cloud service," said Timo
Varpula, Principal Scientist at VTT.
The mobile tool has been tested by heart patients at Turku
University Central Hospital, as well as by athletes with heart
conditions. In the tests, the Beat2Phone helped to detect atrial
fibrillation, arrhythmia, and a cardiac conduction disorder.
The affected patients were admitted for further tests once the
individuals had shown their electrocardiograms to a physician.
Internationally Recognized Consulting Company to the MEDICAL

DEVICE/IVD/PHARMACEUTICAL INDUSTRIES
mdi Consultants Inc. has the expertise and can provide you
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Website: www.mdiconsultants.com
Upcoming...
Webinars
Securing Medical
Devices in a Hostile
World: Challenges
and Ideas for Manufacturers
Wednesday, December 7, 2016 at 2:00 pm U.S. EST
All around the world medical devices are being deployed in
increasingly unsecured environments. This Webinar will provide a
brief discussion of the top cybersecurity issues that medical
devices face today and will also explore the most effective way
to assess the state of the devices security, including a
discussion on appropriate mitigations that can be used.
Speaker:
Chana OLeary
Sr. Application Security Consultant,
OpenSky Corp.
This 30-minute Webinar includes:

Live Q&A session
Application Demo
Access to archived event on demand
Please visit www.techbriefs.com/webinar398
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Motion Capture Technology Brings a New Age of

Mobility to Veteran Amputees
Precision measurements
of motion capture
technology are leading to
the development of
improved prostheses.
Cleveland VA (Veterans
Affairs) Medical Center,
Cleveland, OH/University of
Colorado, Boulder, CO
For veterans who have lost a limb, a
prosthesis is a lifeline. An artificial
device not only provides mobility and
enables routine activity, it can be life giving emotionally as well as physically.
Designing and manufacturing the
most efficient and comfortable prostheses requires the collection of very accurate measurements and movement data.
Two facilities located in different parts
of the country are using Vicon motion
capture technology to conduct groundbreaking research that is making a dramatic difference in the lives of
amputees, many of them veterans.
Better, Faster, Stronger
At the Cleveland VA (Veterans Affairs)
Medical Center, Elizabeth Hardin, Ph.D.
and Matt Fleming, prosthesis fabricator
and former Marine, make up a seasoned
team thats pushing the boundaries of
life science research to help design and
create better-performing prostheses.
Motion capture technology is used
extensively in the medical centers
Motion Study Lab and Advanced
Prosthetics and V-Gait Lab, and is vital to
their research with Dan Simon, professor of electrical engineering at
Cleveland State University.
The two labs at the center have a total
of 26 Vicon cameras in use, serving 12
research projects in addition to clinical
outreach. While each lab collects
motion and force data, one focuses
more on the activities of daily living
including sitting, standing, and walking
over ground using a 10-m walkway
while the other uses a force-measuring
treadmill to collect data in a virtual environment, related to walking, jogging,
and running at various speeds.
According to Hardin, the setup in both
labs has fantastic resolution, capturing
50, 14-mm markers over 10 m of motion
72
A patient with bilateral prostheses uses live feedback from the Vicon system in the virtual environment to work on pelvic control and foot alignment with his VA physical therapist in the Advanced
Prosthetics Lab of the Cleveland VA Medical Center. (Credit: Vicon)
Elizabeth Hardin (left) applies reflective markers to a patient with bilateral prostheses in the virtual
reality system of the Advanced Prosthetics Lab while Amputee Coordinator, Joe Bonscer (right)
checks the safety harness. (Credit: Vicon)
with no marker dropout. But perhaps

most important to the team is precision.
Accuracy and valid measurements are
critical to their research and to the data
that drives the engineering and creation
that is ushering a new age of prosthetic
development.
For Fleming, an amputee, his experi-
ence and intimate knowledge of the

challenges faced by amputees is invaluable to his fabrication work. I apply my
day-to-day life experience to my work,
he says. I know what I need my own
prosthesis to do; it needs to serve a lot of
complex functions, so that drives my
work here at the lab.
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Improving on Biology?
VA research scientist and Assistant
Professor Alena Grabowski is also doing
groundbreaking work in her Applied
Biomechanics Lab at the University of
Colorado, Boulder. Here, a 10-camera
Vicon motion capture system operates in
a full 3D environment.
Two treadmills, both 3D force and
speed measuring units, measure the
forces exerted by the leg for different
states of motion: walking, running, and
sprinting up to nearly 30 miles per hour
in the case of elite athletes.
Precision measurements are critical as
the mechanics of the body change
according to the gait. Further, analyzing
how the movements of a prosthetic leg
differ from a biological one is a fundamental part of the process. The Vicon
system helps isolate each segment of the
leg, which is essential to understanding
how the body moves. The team is also
working to develop quantitative algorithms to assess how prostheses function
dynamically.
Everybody wants a better functioning
body, says Grabowski. Its critical that
we look at how the body moves and analyze each different segment.
Motion capture technology is helping
the lab excel within advanced bionics.
Grabowski and her team are studying a
powered ankle/foot prosthesis, a rela-
tively new device on the market. Theyre

working to better understand the product and assess its function, testing, for
example, its effectiveness in challenging
situations such as on slopes as opposed
to how it functions on flat ground. Its all
about the nuances and the goal is always
how can we make it more effective?
Grabowski can imagine the day when
technology helps the industry move to a
new stage of prosthetic and assistive
device performance. People want highfunctioning devices, says Grabowski. To
that end, shes aiming high. My hope is
that we move to a point where we can
create something thats better than a biological leg. We have some great creative
minds that can rethink and redesign
whats possible.
We are there,
when reliability
is of top priority.
Our innovative sensor solutions
make medical devices even
safer and more efficient.
The Road Ahead

Each lab is doing work that has farreaching impact, improving the quality of
life and independence of amputees. The
capture of precise motion data is critical
to this research. As cameras get smaller
and more powerful and set-ups easier to
install, more and more facilities around
the world are advancing the development
of prostheses. This accessibility and the
results like those above will ensure that
daily life for veterans and all those who
have lost limbs will only improve.
For more information, visit www.vicon.com.
The Helping Hand Project: Changing

Lives One Hand at a Time
Engineering students
create prosthetic hands
for children with 3D
printing.
University of North Carolina,
Chapel Hill, NC
Swing a baseball bat, eat with a fork and
knife, steer a bike with both handles
without two hands, a child cant do any of
these ordinary activities that most children
take for granted. But now The Helping
Hand Project (The HHP), a nonprofit
organization based in Chapel Hill, NC, is
using the latest advancements in 3D printing technology to make sure fewer children have to live life with such limitations.
The HHP is nonprofit organization
that was started by students at the
University of North Carolina at Chapel

Hill, and specializes in providing 3Dprinted prosthetic hands free of
charge for children in need so that
they have every opportunity to live their
lives to the fullest potential.
In the United States, each year, at least
1,500 children are born with upper-limb
differences. This loss of function may be
restored with prosthetic devices, but the
costs are high, and children may quickly
outgrow the devices. In addition, many
children who have physical disabilities
and need prosthetic hands can use standard designs, but some require custom
designs that fit their unique anatomies.
Because of this, many families are
unable to provide children with devices
to reestablish full functionality.
In the fall of 2014, biomedical engineering students at UNC-Chapel Hill
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Many children who have physical disabilities and need prosthetic hands require custom designs that
fit their unique anatomies. (Credit: The Helping Hand Project)
The low-cost 3D-printed prosthetic hands restore loss of function for children. (Credit: The Helping
Hand Project)
recognized this need and began working

on prosthetic hands as a project under
the universitys Biomedical Engineering
Club. The clubs very first helping
hand was built for a young boy named
Holden Mora, who was born with symbrachydactyly, a condition in which the
hand stops growing early in amniotic
development. Using 3D printed parts,

the team created a hand for Holden for
less than $40 worth of materials.
Since then, The HHP has printed hands
for 20 children and continues to serve
them by maintaining contact with these
children so they may receive new devices
as they grow. And through in-person meet-
ings and online groups offered to the children and their families, The HHP provides support that goes far beyond simply
providing a prosthetic device.
Students dedicated hours of their time
developing these hands, using the
resources available to them in the biomedical engineering labs, along with a
mix of open-source and custom designs.
And in 2015, when the demand for its
3D-printed hands outstripped the supply
the nonprofits older 3D printers could
deliver, The HHP partnered with Lenovo
to help provide the performance and
speed the nonprofit needed to keep its
waiting list as short as possible.
Now, HHP engineers design and print
devices using Solidworks applications on
the Lenovo ThinkStation P500. And
they count on Lenovos lead
ThinkStation engineer to quickly print
the 3D print device at Lenovos own
facility based on the CAD files and the
childs hand specs received from The
HHP. Having Lenovos engineers
onboard to help cuts the printing time
substantially, allowing children to
receive their hands in just 1824 hours.
With the help of corporate support
and volunteers, the project that was
once just a part of UNC-Chapel Hills
Biomedical Engineering Club is now a
nonprofit organization. Going beyond
UNC campus, The HHP has also seized
the opportunity to expand and inspire
young students in its community
through traveling workshops. The HHP
is partnering with BetaBox, a company
that provides mobile prototyping labs, to
bring workshops to local schools and
teach the students how HHP hands are
developed. Students even have the
opportunity to work together and assemble a hand, providing them with an
exciting introduction to STEM and an
opportunity to witness firsthand how
their work can benefit a child in need.
For more information, visit www.
helpinghandproject.org/home.html.
Promising Biomaterial to Build Better Bones with 3D Printing

A 3D printable ink
produces a synthetic bone
implant that rapidly
induces bone regeneration.
Northwestern University,
Evanston, IL
74
A Northwestern University research

team has developed a 3D printable ink that
produces a synthetic bone implant that
rapidly induces bone regeneration and
growth. This hyperelastic bone material,
the shape of which can be easily customized, one day could be especially useful
for the treatment of bone defects in chil-
dren. The findings were published in the

journal Science Translational Medicine.
Bone implantation surgery is never an
easy process, but it is particularly painful
and complicated for children. With both
adults and children, bone is often harvested from elsewhere in the body to replace
the missing bone, which can lead to other
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A hyperelastic bone in the shape of a section of the human spine, 3D printed using an ink developed
at Northwestern University. (Credit: Northwestern University)
complications and pain. Metallic implants

are sometimes used, but this is not a permanent fix for growing children.
Adults have more options when it
comes to implants, said Ramille Shah,
Ph.D., who led the research. Pediatric
patients do not. If you give them a permanent implant, you have to do more
surgeries in the future as they grow.
They might face years of difficulty.
Shah and her team aim to change the
nature of bone implants, and they particularly want to help pediatric patients.
Shah is an assistant professor of surgery
in the Division of Organ Transplantation
at Feinberg and of Materials Science and
Engineering at the McCormick School
of Engineering.
Adam Jakus, Ph.D., a postdoctoral fellow in Shahs laboratory, is the first
author of the paper, which evaluated the
material with human stem cells and within animal models.
Shahs 3D printed biomaterial is a mix
of hydroxyapatite (a calcium mineral
found naturally in human bone) and a
biocompatible, biodegradable polymer
that is used in many medical applications,
including sutures. Shahs hyperelastic
bone material shows great promise in
in vivo animal models; this success lies in
the printed structures unique properties.
The material is majority hydroxyapatite,
yet it is hyperelastic, robust, and porous at
the nano, micro, and macro levels.
Porosity is huge when it comes to tissue
regeneration, because you want cells and
blood vessels to infiltrate the scaffold,
Shah said. Our 3D structure has different
levels of porosity that is advantageous for
its physical and biological properties.
While hydroxyapatite has been proven to
induce bone regeneration, it is also notoriously tricky to work with. Clinical products
that use hydroxyapatite or other calcium
phosphate ceramics are hard and brittle. To
A close-up view of a hyperelastic bone scaffold. (Credit: Northwestern University)
compensate for that, previous researchers

created structures composed mostly of polymers, but this shields the activity of the bioceramic. Shahs bone biomaterial, however,
is 90 percent by weight hydroxyapatite and
just 10 percent by weight polymer, and it
still maintains its elasticity because of the
way its structure is designed and printed.
The high concentration of hydroxyapatite
creates an environment that induces rapid
bone regeneration.
Cells can sense the hydroxyapatite
and respond to its bioactivity, Shah said.
When you put stem cells on our scaffolds, they turn into bone cells and start
to up-regulate their expression of bonespecific genes. This is in the absence of
any other osteo-inducing substances. Its
just the interaction between the cells
and the material itself.
Thats not to say that other substances
couldnt be combined into the ink.
Because the 3D printing process is performed at room temperature, Shahs
team was able to incorporate other elements, such as antibiotics, into the ink.
We can incorporate antibiotics to
reduce the possibility of infection after surgery, Shah said. We also can combine the
ink with different types of growth factors, if
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needed, to further enhance regeneration.

Its really a multifunctional material.
One of the biggest advantages, however, is that the end product can be customized to the patient. In traditional
bone transplant surgeries, the bone
after its taken from another part of the
body has to be shaped and molded to
exactly fit the area where it is needed.
Using Shahs synthetic material, physicians would be able to scan the patients
body and 3D print a personalized product. Alternatively, due to its mechanical

properties, the biomaterial also can be
easily trimmed and cut to size and shape
during a procedure. Not only is this
faster, but also less painful compared to
using autograft material.
Shah imagines that hospitals may one
day have 3D printers, where customized
implants can be printed while the
patient waits.
The turnaround time for an implant

thats specialized for a customer could
be within 24 hours, Shah said. That
could change the world of craniofacial
and orthopedic surgery, and, I hope, will
improve patient outcomes.
A video demonstrating the process
is available at www.youtube.com/
watch?v=5-VdPeoVCAI.
For more information, visit news.
feinberg.northwestern.edu.
Toward Visible-Light-Based Imaging for Medical Devices

System accounts for the
deflection of light particles
passing through animal
tissue.
Massachusetts Institute of
Technology, Cambridge, MA
MIT researchers have developed a
technique for recovering visual information from light that has scattered because
of interactions with the environment
such as passing through human tissue.
The technique could lead to medicalimaging systems that use visible light,
which carries much more information
than x-rays or ultrasound waves.
In experiments, the researchers fired a
laser beam through a mask a thick
sheet of plastic with slits cut through it in
a certain configuration, such as the letter
A and then through a 1.5-cm tissue
phantom, a slab of material designed to
mimic the optical properties of human
tissue for purposes of calibrating imaging systems. Light scattered by the tissue
phantom was then collected by a high-
speed camera, which could measure the

lights time of arrival. From that information, the researchers algorithms were
able to reconstruct an accurate image of
the pattern cut into the mask.
The reason our eyes are sensitive
only in this narrow part of the spectrum
is because this is where light and matter
interact most, says Guy Satat, a graduate
student at the MIT Media Lab and first
author on the new paper. This is why xray is able to go inside the body, because
there is very little interaction. Thats why
it cant distinguish between different
In experiments, the researchers fired a laser beam through a mask a thick sheet of plastic with slits cut through it in a certain configuration, such
as the letter A and then through a 1.5-cm tissue phantom, a slab of material designed to mimic the optical properties of human tissue for purposes
of calibrating imaging systems. Light scattered by the tissue phantom was then collected by a high-speed camera, which could measure the lights time
of arrival. (Credit: Camera Culture Group/MIT)
76
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An illustration shows the researchers experimental setup. The data captured by the camera can be
thought of as a movie a two-dimensional image that changes over time.
(Credit: Camera Culture Group/MIT
types of tissue, or see bleeding, or see

oxygenated or deoxygenated blood.
Satats coauthors on the new paper,
published in Scientific Reports, are three
other members of the Media Labs
Camera Culture group: Ramesh Raskar,
the groups leader, Satats thesis advisor,
and an associate professor of media arts
and sciences; Barmak Heshmat, a research
scientist; and Dan Raviv, a postdoc.
How it Works
Like many of the Camera Culture
groups projects, the new system relies on
a pulsed laser that emits ultrashort bursts
of light, and a high-speed camera that can
distinguish the arrival times of different
groups of photons, or light particles.
When a light burst reaches a scattering
medium, such as a tissue phantom, some
photons pass through unmolested; some
are only slightly deflected from a straight
path; and some bounce around inside the
medium for a comparatively long time.
The first photons to arrive at the sensor
have thus undergone the least scattering;
the last to arrive have undergone the most.
Where previous techniques have
attempted to reconstruct images using
only those first, unscattered photons,
the MIT researchers technique uses the
entire optical signal. Hence its name: allphotons imaging.
The data captured by the camera can be
thought of as a movie a two-dimensional
image that changes over time. To get a
sense of how all-photons imaging works,
suppose that light arrives at the camera
from only one point in the visual field. The
first photons to reach the camera pass

through the scattering medium unimpeded: They show up as just a single illuminated pixel in the first frame of the movie.
The next photons to arrive have
undergone slightly more scattering, so
in the second frame of the video, they
show up as a small circle centered on the
single pixel from the first frame. With
each successive frame, the circle
expands in diameter, until the final
frame just shows a general, hazy light.
The problem, of course, is that in practice the camera is registering light from
many points in the visual field, whose
expanding circles overlap. The job of the
researchers algorithm is to sort out
which photons illuminating which pixels
of the image originated where.
The first step is to determine how the
overall intensity of the image changes in
time. This provides an estimate of how
much scattering the light has undergone: If the intensity spikes quickly and
tails off quickly, the light hasnt been
scattered much. If the intensity increases
slowly and tails off slowly, it has.
On the basis of that estimate, the algorithm considers each pixel of each successive frame and calculates the probability that it corresponds to any given point
in the visual field. Then it goes back to
the first frame of video and, using the
probabilistic model it has just constructed, predicts what the next frame of video
will look like. With each successive
frame, it compares its prediction to the
actual camera measurement and adjusts
its model accordingly. Finally, using the
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final version of the model, it deduces the

pattern of light most likely to have produced the sequence of measurements
the camera made.
One limitation of the current version
of the system is that the light emitter and
the camera are on opposite sides of the
scattering medium. That limits its applicability for medical imaging, although
Satat believes that it should be possible to
use fluorescent particles known as fluorophores, which can be injected into the
bloodstream and are already used in
medical imaging, as a light source.
People have been using what is
known as time gating, the idea that photons not only have intensity but also
time-of-arrival information and that if
you gate for a particular time of arrival
you get photons with certain specific
path lengths and therefore [come] from
a certain specific depth in the object,

says Ashok Veeraraghavan, an assistant
professor of electrical and computer
engineering at Rice University. This
paper is taking that concept one level
further and saying that even the photons
that arrive at slightly different times contribute some spatial information.
Looking through scattering media is
a problem thats of large consequence,
he adds. But he cautions that the new
paper does not entirely solve it. Theres
maybe one barrier thats been crossed,
but there are maybe three more barriers
that need to be crossed before this
becomes practical, he says.
A video is available demonstrating the
imaging method at www.youtube.com/
watch?v=Qa47Y7jbW1I.
For more information, visit http://
news.mit.edu.
DARPA Helps Paralyzed Man Feel

Again Using a Brain-Controlled
Robotic Arm
Neural interface opens
new possibilities in
prosthetics.
DARPA, Arlington, VA
medical devices
medical
devices
needles
and
probes
needles and probes
Unimed SA
Lausanne,
Unimed SASwitzerland
phone
+41 21
624 21 51
Lausanne,
Switzerland
fax
+41
21
624
phone +41 21 62453
2132
51
www.unimed.ch
fax
+41 21 624 53 32
e-mail: info@unimed.ch
www.unimed.ch
e-mail: info@unimed.ch
A DARPA-funded research team has

demonstrated for the first time in a
human a technology that allows an individual to experience the sensation of
touch directly in the brain through a
neural interface system connected to a
robotic arm. By enabling two-way communication between brain and machine
outgoing signals for movement and
inbound signals for sensation the
technology could ultimately support
new ways for people to engage with each
other and with the world.
The work was supported by DARPAs
Revolutionizing Prosthetics program, and
performed by the University of Pittsburgh
and the University of Pittsburgh Medical
Center. The results were detailed in a
study published online in the journal
Science Translational Medicine, and the technology was among a number of advanced
demonstrations presented to President
Barack Obama at a White House innovation event in Pittsburgh in October.
DARPA has previously demonstrated
direct neural control of a robotic arm,
and now weve completed the circuit,

sending information from a robotic arm
back to the brain, said Justin Sanchez,
director of DARPAs Biological Technologies Office and the program manager for Revolutionizing Prosthetics. This
new capability fundamentally changes
the relationship between humans and
machines.
The volunteer for the study, Nathan
Copeland, has lived with quadriplegia
from the upper chest down since a 2004
car accident that broke his neck and
injured his spinal cord. Nearly 10 years
following his accident, after agreeing to
participate in clinical trials, Nathan
underwent surgery to have four microelectrode arrays each about half the
size of a shirt button placed in his
brain, two in the motor cortex and two
in the sensory cortex regions that correspond to feeling in his fingers and palm.
The researchers ran wires from those
arrays to a robotic arm developed by the
Applied Physics Laboratory (APL) at
Johns Hopkins University. The APL arm
contains sophisticated torque sensors
that can detect when pressure is being
applied to any of its fingers, and can
convert those physical sensations into
electrical signals that the wires carry
back to the arrays in Nathans brain to
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Using a neural interface system connected to a robotic arm, Nathan Copeland, who has lived with
quadriplegia from the upper chest down since a 2004 car accident, was able to report with nearly
100 percent accuracy which finger was being touched. (Credit: DARPA)
amputees. The Agencys Hand Proprioception and Touch Interfaces (HAPTIX) program is pursuing an alternative
approach, using the peripheral nervous
system to communicate motor commands and sensory feedback between
the brain and a prosthetic limb. The
program plans to initiate take-home trials of a complete, FDA-approved HAPTIX prosthesis system by 2019.
A video of the demonstration of the
brain-controlled robotic arm is available at
www.youtube.com/watch?v=A4BR4Iqfy7w.
For more information, visit www.darpa.mil.
ARM Compiler for Safety

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provide precise patterns of stimulation

to his sensory neurons.
In the very first set of tests, in which
researchers gently touched each of the
robotic fingers while Nathan was blindfolded, he was able to report with nearly
100 percent accuracy which finger was
being touched. The feeling, he reported,
was as if his own hand were being touched.
At one point, instead of pressing one
finger, the team decided to press two
without telling him, said Sanchez. He
responded in jest asking whether somebody was trying to play a trick on him.
That is when we knew that the feelings
he was perceiving through the robotic
hand were near-natural.
These latest results build on a series of
DARPA achievements in directly interfacing the brain with a robotic arm.
Earlier studies with volunteers Tim
Hemmes and Jan Scheuermann demonstrated motor control of the APL arm
using a brain-machine interface. Based
on DARPAs success with those early tests,
we asked, Can we do the experiment in
reverse and do for sensation what we did
for the motor system? Sanchez said.
DARPA previewed its success with
touch restoration in 2015 at Wait, What?
A Future Technology Forum, an event
that brought together thought leaders
and expert scientists and engineers to
generate new ideas and accelerate the
development of novel capabilities. Full,
peer-reviewed details of the research are
described for the first time in the Science
Translational Medicine article.
The interface system is one of two
dozen technological breakthroughs that
were on display at The White House
Frontiers Conference, where Nathan
and the lead researchers from Pitt talked
about the technology, what it could
mean for people living with spinal cord
injury, and what new possibilities it
could open for society.
Part of the Presidents Brain Initiative,
DARPAs Revolutionizing Prosthetics program is funding research to refine stimulation patterns and incorporate new types
of sensations beyond pressure to achieve
the goals of delivering near-natural motor
control and sensation to users of prosthetics. Improvements in these and related
neurotechnologies could someday lead to
near-seamless combinations of the cognitive functions of the human brain and the
computing processes of machines.
Revolutionizing Prosthetics is not
DARPAs only program to pursue the
restoration of a sense of touch to
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79
Low-Pressure, Compact Sensor
PRODUCT OF THE MONTH

AC/DC Power Supply
Power Partners, Hudson, MA, has released
a new AC/DC power supply from its medical open frame/u-channel product line. The
BF-rated-output PPWAM360 series is designed to
deliver 360 W in a high power density 4 6 in. footprint
with 90264 V AC input and five single output models (12,
24, 28, 48, and 54 V DC). The series is Class I rated and has approvals
to UL/EN 60601-1, 3rd edition, for medical as well as UL/EN 609501, 2nd amendment ITE approvals. The series is also approved to the
latest EN 60601-1-2, 4th edition, EMC medical standard.
Units are 90 percent efficient at 230 V AC input. They have <100
A @ 264 V AC earth leakage current, 2X MOPP primary to secondary isolation, short circuit/overload/overvoltage protection, and nominimum load requirements. The power supplies have an operating
temperature range of 0 to 70 C (100 percent power to 50 C, derating to 50 percent power at 70 C), and mean time between failure of
>250,000 hours per Bellcore TR-332 at full load and 25 C ambient.
For Free Info Visit http://info.hotims.com/61068-166
2016 Product of the Year

Finalist
All Sensors, Morgan Hill, CA, has

announced a new low-pressure sensor. The
BLC series offers design engineers excellent performance over pressure ranges of
1 inH2O through 30 inH2O and 15 psia.
The basic sensor is based on the companys
CoBeam2 technology. The devices provide a high output signal at a low operating voltage maintaining comparable output levels to traditional equivalent basic sensing elements.
This lower supply voltage enables improved warm-up shift while the
CoBeam2 technology itself reduces package stress susceptibility, resulting in improved overall long-term stability.
Computer-on-Module
A computer-on-module (COM) is available
from Kontron, Augsberg, Germany. The COMebBD7 module is a Xeon processor D-1500-based
COMe that delivers server-class performance in
the COM Express basic standard form factor
(125 95mm) and is designed according to the
new Type 7 standard. The module is equipped
with Approtect, the companys standard hardwarebased embedded security product. Type 7 is a complementary specification to the existing Type 6 pin out.
Twin-Cylinder Air Compressors
MEMS Sensor
Gardner Denver Thomas, Sheboygan,

WI, offers new twin-cylinder pump air compressors designed for pressure and vacuum
and high flow. The compact design of the
2380 series makes it suitable for a range of
applications including medical and dental.
The air compressors provide 100 psi (6.9
bar) maximum pressure with open flow of
2.3 cfm (65 l/min). The fan-cooled 2380 series has a
one-piece monolithic head. Weighing 12 lb, the unit is 9.31 in. (236.5
mm) long 5.14 in. (130.6 mm) wide 6.73 in. (171 mm) high. The
twin-cylinder design provides long-life reliability with low vibration and
quiet operation.
Silicon Microstructures, Milpitas,

CA, a subsidiary of Elmos, has
launched the SM5221 and SM6221
fully digital, low-pressure microelectromechanical systems (MEMS)
sensor series as part of the AccuStable SM5000 and SM6000 families.
Covering pressure ranges from 0.3 to 2.0 psi (21 to 140 cmH2O), the
sensors have a better than 1 percent initial accuracy and less than 1 percent total output shift over life (1 percent shift over 1000 hours HTOL).
The SMX221 series offer gauge, differential, and asymmetric calibration, 14-bit digital I2C output, and 1 percent total accuracy.
Interconnect Sample Kit
EpoxySet, Lincoln, RI, offers the EC-1006M-4, flexible epoxy for

electronic pottings. The formula is UL-94V0 approved and is said to
have excellent electrical insulating properties and dielectric
strength. It can be cured at room temperature or with mild heat. Its lowviscosity system allows for encapsulations of even the most intricate circuits
and components because it cures with
very low stress. It can be temperature
cycled from 55 to 120 C and has
excellent resistance to mechanical and
vibrational shock. The thermally conductive epoxy provides high
heat dissipation, making it ideal for addressing electronic protection requirements or for potting and encapsulations that require
thermal stability.
AVX, Fountain Inn, SC, has

released a sample kit that showcases a
broad range of connectors ideal for
use in medical and IoT applications
in which small size and high-reliability
performance are critical. Available as
both a physical sample and as an interactive online simulation, the sample kit consists of a PCB loaded with 15 examples of board-to-board,
wire-to-board, battery, and pogo pin connectors, including several of
the STRIPT UL-approved, insulator-less single contacts. The physical
version of the sample kit features a white lid designed to simulate a
replaceable or disposable module and offers two active demonstrations.
The virtual kit allows users to navigate the board with their cursor and
provides brief descriptions of each connector category, summary information about each series, and links to each product page. The kit
includes board-to-board connectors, battery connectors, and wire-toboard poke-home connectors.
Flexible Epoxy
80
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PRODUCT SPOTLIGHT
Liquid Crystal Display

Kyocera, Plymouth,
MI, has introduced a
robust 5.7 in. liquid
crystal display (LCD)
with an ultrathin profile
specifically designed for
portable
industrial
devices using the VGA standard. The lightweight LCD module is ideal for handheld
devices used in demanding applications,
including medical diagnostics. The TFT-LCD
features 640 480 resolution, slim bezel, and
an ultrathin profile with outline dimensions of
127.2 100.4 6 mm and an active display area
of 115.2 86.4 mm.
COMSOL Multiphysics is an integrated software environment for creating physics-based models and simulation apps. Add-on products allow the simulation of electrical, mechanical, acoustic, fluid flow, thermal, and
chemical applications. Interfacing tools enable its integration with all major technical computing and CAD
tools. Simulation experts rely on COMSOL Server
product to deploy apps to their colleagues and customers worldwide. https://www.comsol.com/products
Momentive
Performance
Materials,
Waterford, NY, has launched a new selfbonding material to
address
increasing
demands for hard-soft
designs. The family of
Silopren LSR 27x9
liquid silicone rubbers
helps to achieve bonding between silicone and thermoplastics,
reduces assembly steps, and meets various
complex design requirements. The new
primerless LSR technology enables the combination of two materials via a two-shot overmolding process for a hard-soft design as well
as cost-efficient manufacturing of high partquantities in one integrated molding process.
For Free Info Visit
http://info.hotims.com/61068-174
Automated Dispensing
A fully automated precision dispensing system is available from Graco Advanced Fluid
Dispense (AFD), North Canton, OH. The
Graco UniXact provides a single source for
motion, fluid dispense, and
process monitoring for thermal interface management
(TIM) applications. The system helps electronic manufacturing OEMs shift from
thermal pads to dispensable
material, which is widely used for thermal management of smaller electronic devices. The platform is ideal for mass production of electronic
components with smaller form factors, miniaturized systems, and increased circuit density. It
is designed to handle highly viscous and highly
abrasive TIM materials. It features the 1 gal
Dynamite Pump and Graco rod-positive displacement valves, which eliminate the drawbacks associated with time-pressure valves.
New Fluid Metering, Inc. offers

a catalog of precision dispensers
and metering pumps for laboratory, industrial, process and
OEM applications. FMI products
features unique piston-type positive displacement
units with no valves, low-dead volume, 1% accuracy, a
ceramic/fluorocarbon fluid path, and a range from
500 nanoliters per dispense up to 4,600 ml/min continuous metering. Many new products are included
in this catalog, which can be viewed and downloaded
from the FMI website. www.fmipump.com
Fluid Metering, Inc.
COMSOL, Inc.
ELECTRICALLY
CONDUCTIVE
ADHESIVE
For Free Info Visit

Liquid Silicone Elastomers
NEW DISPENSERS &

METERING PUMP
CATALOG
MULTIPHYSICS
MODELING,
SIMULATION,
APP DESIGN AND
DEPLOYMENT
SOFTWARE
Master Bond EP3HTSMed

is a one-component,
silver-filled, electrically
conductive epoxy system featuring high shear
strength and excellent temperature resistance along
with a fast cure schedule. It fully meets USP Class VI
requirements and has exceptional conductivity.
EP3HTSMed produces durable, high-strength bonds
that resist severe thermal cycling and many chemicals. http://www.masterbond.com/tds/ep3htsmed
CLEAN ROOM
MOLDING,
ASSEMBLY, AND
PACKAGING
Medbio is an ISO 13485:2003 certified full-service
contract manufacturer, specializing in precision
injection molding, assembly, packaging, design support, and project management. All manufacturing is
done in our certified ISO Class 7 and 8 clean rooms.
From components to full assemblies, Medbio has the
experience to solve your most difficult manufacturing challenges. www.medbioinc.com
Medbio, Inc.
Master Bond
PHTHALATE-FREE,
ANTIMICROBIAL
TUBING
LASER MICROMACHINING
Clearflo Ag-47 tubing contains antimicrobial technology to guard against bacteria

such as E. coli, listeria, salmonella, and MRSA. The ingredient is throughout the tubing, not only on the interior
as with other products, for bacteria protection on all
tubing surfaces. Especially effective with the infrequent
use of fluids in warm conditions. No latex or animalderived components; NSF-51 listed. Free sample.
http://www.newageindustries.com/sample-mdb5
PhotoMachining, Inc.,
performs precision laser
micromachining on a variety of different materials
including plastics, metals,
glass, ceramics, etc. Our
eleven different types of
lasers allow us wide flexibility to address many applications. We also design
and manufacture custom laser machine tools.
Contact sales@photomachining.com, or phone
603-882-9944. www.photomachining.com
NewAge Industries, Inc.
PhotoMachining, Inc.
TRUMPF
TRULASER
STATION 5005
Become an INSIDER
Start your free subscription
to Tech Briefs INSIDER
e-mail newsletter to keep
pace with the latest technology advances and licensing opportunities in aerospace, electronics, photonics, manufacturing, and
other key fields.
For laser welding of small

to medium sized components,
the
compact
TruLaser Station 5005
with integrated exhaust
system offers efficiency,
accuracy, and flexibility. It can be equipped with a variety of focusing/scanner optics, and is ideal for processing many materials, including stainless steel and
plastics. www.medicaldesignbriefs.com/trumpf201612
TRUMPF Inc.
www.techbriefs.com/insider
For Free Info Visit

Intro
Cov
ToC
81
ADVERTISERS INDEX
For free product literature, enter advertisers reader
service numbers at www.techbriefs.com/rs, or visit the
Web site beneath their ad in this issue.
Company
Reader Service
Number
Page
Air-Logic ...............................................................806 ........................31

Anomet Products ..........................................826, 827 ........................54
ARM Ltd. ............................................................863 ........................79
Arthur G. Russell Company .............................828, 829 ........................55
ATI Industrial Automation ........................................789 ..........................4
Branson Ultrasonics.......................................830, 831 ........................56
Cadence, Inc. ...............................................832, 833 ........................57
Clippard Instrument Laboratory................................801 ........................18
COMSOL, Inc. ..............................................788, 864 ....................3, 81
Cotronics Corporation ....................................834, 835 ........................58
DA/Pro Rubber Inc. .............................................787 ..........................2
Dymax Corporation ........................................793, 814 ....................9, 40
EBTEC an EDAC Technologies Company ............836, 837 ........................59
Economy Spring.............................................838, 839 ........................60
Edmund Optics ......................................................860 ........................75
Excelitas Technologies ....................................840, 841 ........................61
First Sensor AG.....................................................859 ........................73
Fluid Metering, Inc. ...............................................865 ........................81
Formacoat ............................................................807 ........................33
Fort Wayne Metals ........................................798, 815 ..................13, 41
Heatron, Inc. ...............................................842, 843 ........................62
Helical Products Co., Inc. ......................................804 ........................24
Hotwatt Inc. ........................................809, 811, 856 ............35, 37, 69
International Manufacturing Services, Inc. ........785, 816 ..............COV II, 42
International Polymer Engineering.............................794 ........................10
Interpower Corporation...................................800, 803 ..................17, 21
Keystone Electronics Corp. ............................799, 817 ..................15, 43
LEMO USA, Inc. ...........................................844, 845 ........................63
Lyons Tool & Die Co. .....................................805, 818 ..................27, 44
Marubeni Citizen-Cincom Inc. ..........................812, 813 ..................38, 39
Master Bond Inc. .........................................808, 866 ..................35, 81
maxon precision motors, Inc . .........................846, 847 ........................64
mdi Consultants.....................................................858 ........................71
Medbio, Inc. ........................................................867 ........................81
MEDEFAB .............................................................802 ........................19
MEGA Electronics, Inc. ..........................................810 ........................37
Micro Systems Tech. Mgmt. AG ......................848, 849 ........................65
MicroLumen Inc. ..................................................819 ........................45
NewAge Industies.................................................868 ........................81
Pexco, LLC ...................................................850, 851 ........................66
Photofabrication Engineering, Inc . ...................852, 853 ........................67
PhotoMachining, Inc. .............................................869 ........................81
Proto Labs, Inc. ...................................................790 ..........................5
PTI Engineered Plastics, Inc. ..........................791, 820 ....................7, 46
Qosina Corp. ................................................796, 821 ..................11, 47
ROFIN-BAASEL, Inc. ......................................822, 870..............48, COV III
SCHURTER, Inc. ...........................................854, 855 ........................68
Silcotech North America.........................................795 ........................10
SMC Ltd. .............................................................797 ........................12
Specialty Coating Systems, Inc. ...............................857 ........................69
Statek Corporation.................................................861 ........................77
Steute Meditech, Inc. ....................................823, 871 .............49, COV IV
Swiss Automation ..................................................792 ..........................8
Teleflex Medical OEM......................................786, 824 ....................1, 50
The Lee Company ..........................................703, 872 ..................23, 52
TRUMPF Inc. ...............................................875, 876 ..................29, 81
Unimed S.A. ........................................................862 ........................78
Wacker Chemical Corp. .................................873, 874 ..................25, 53
Zeus, Inc. .......................................................784, 825....COV IA-COV IB, 51
Medical Design Briefs, ISSN# 2158-561X, USPS 4865, copyright 2016 in U.S., is published
monthly by Tech Briefs Media Group, an SAE International Company, 261 Fifth Avenue, Ste.
1901, New York, NY 10016. The copyright information does not include the (U.S. rights to)
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10016. Periodicals postage paid at New York, NY and additional mailing offices.
POSTMASTER: Send address changes and cancellations to Medical Design Briefs,
P.O. Box 47857, Plymouth, MN 55447.
December 2016, Volume 6, Number 12.
82
Publisher ....................................................................Joseph T. Pramberger

Associate Publisher ....................................................................Helene Beck
(908) 300-2538
Sales Director........................................................................Desiree Stygar
(908) 300-2539
Editorial Director ........................................................................Linda L. Bell
Editor & Director of Medical Content ..........................................Sherrie Trigg
Managing Editor, Tech Briefs TV .................................................Kendra Smith
Production Manager .............................................................Adam Santiago
Assistant Production Manager.................................................Kevin Coltrinari
Creative Director ......................................................................Lois Erlacher
Senior Designer ...................................................................Ayinde Frederick
Marketing Director ...............................................................Debora Rothwell
Marketing Communications Manager ...........................................Monica Bond
Digital Marketing Coordinator .................................................Kaitlyn Sommer
Audience Development/Circulation Director .........................Marilyn Samuelsen
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Subscription Changes/Cancellations ...............................mdb@kmpsgroup.com
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Chief Executive Officer ..................................................Domenic A. Mucchetti
Executive Vice-President .........................................................Luke Schnirring
Technology Director ................................................................Oliver Rockwell
Systems Administrator ..............................................................Vlad Gladoun
Web Developer........................................................................Karina Carter
Digital Media Manager ............................................................................Peter Bonavita
Digital Media Assistant Manager ............................................................Anel Guerrero
Digital Media Assistants ...............Peter Weiland, Howard Ng, Md Jaliluzzaman
Digital Media Audience Coordinator.............................................Jamil Barrett
Credit/Collection ......................................................................Felecia Lahey
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MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES

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MI, IN, WI..............................................................................Chris Kennedy
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NJ, PA, DE...............................................................................John Murray
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(847) 223-5225
Northwest, N. Calif., Western Canada.........................................Craig Pitcher
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CO, UT, MT, WY, ID, NM .............................................................Tim Powers
(973) 409-4762
S. Calif., AZ, NV ............................................................................Tom Boris
(949) 715-7779
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Reprints ................................................................................Rhonda Brown
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Intro
Cov
ToC
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Intro
Cov
ToC
Off-The-Shelf-Custom
SM
Its Not An Oxymoron.

Conventional thinking would suggest that getting
a medical-grade foot control that is customized to
your unique specifications requires investments in
NRE and/or tooling and months of development.
This need not be the case. Many OEM requirements

can effectively be addressed using our broad
array of field-proven foot control elements
e.g. platforms, actuator styles, selectable actuating
forces, graphic options (colors, icons, logos), cable
styles, strain reliefs, handles/foot rests, and floor
contact pads.
Our design team has combined these and other
elements to satisfy medical device OEM needs
worldwide. (A few solutions are shown above.) Each
design is optimized for functionality, user comfort,
ease-of-use, and aesthetic appearance. And each
is certified to meet all relevant medical Standards
Directives and Regulatory requirements.
(203) 244-6302
Cov
ToC
1. Exam Chair Control

2. HF Generator Control
3. CT Scanner Control
4. Bone Saw Control

5. Eye Surgery
System Control
Write or call for a no-obligation proposal. Well

gladly share some ideas for a customized foot
control that complements your medical device
design without cost or obligation.
Intro
info@steutemeditech.com

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Preparing for Industry 4.0

INSIDE: 2017 Product

From the Publishers of

How to Navigate the Magazine:

Intro Introduction: Click on this icon to quickly turn to this page.

Find: Click on this icon to search the document.

Its Not An Oxymoron.

This need not be the case. Many OEM requirements

1. Exam Chair Control

4. Bone Saw Control

Write or call for a no-obligation proposal. Well

Preparing for Industry 4.0

INSIDE: 2017 Product

Partnering with thinkers, explorers,

Visit zeusmedical.com to learn more.

From the Publishers of

A Braid for a New Age.

AMERICAS: +1 803.268.9500 | EUROPE: +353 (0)74 9109700

Preparing for Industry 4.0

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High performance resistors are essential to meeting

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Free Info at http://info.hotims.com/61068-785

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Published by Tech Briefs Media Group, an SAE International Company

4 From the Editor

26 2017 Product Buyers Guide

6 The Next Industrial Revolution and What It Could Mean for

One area of medical manufacturing that will

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MULTIPHYSICS FOR EVERYONE

Custom applications are now being

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From the Editor

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he next industrial revolution is on its

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