Anda di halaman 1dari 76

Welcome to your October 2016 Digital Edition of

Medical Design Briefs and


Medical Manufacturing and Fabrication
Medical Design Briefs
www.medicaldesignbriefs.com

Medical Manufacturing and Fabrication


October 2016

October 2016

Enabling Medical Devices with IoT


Wearable Sensors Meet Changing
Needs of Healthcare

Medical Manufacturing &


Fabrication

Tube-Cutting Technology for the Future


Advances in Abrasive Waterjet
Micromachining
Five-Axis Grinding: A High-Speed Option
for Medical
The Evolution of Laser Texturing
SPECIAL SECTION:
Technology Leaders in Contract
Manufacturing/Outsourcing

Supplement to Medical Design Briefs

From the Publishers of

Click Here

Click Here

How to Navigate the Magazine:


At the bottom of each page, you will see a navigation bar with the following buttons:

Arrows: Click on the right or left facing arrow to turn the page forward or backward.

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


Cov Cover: Click on this icon to quickly turn to the front cover.
ToC Table of Contents: Click on this icon to quickly turn to the table of contents.

Zoom In: Click on this magnifying glass icon to zoom in on the page.

Zoom Out: Click on this magnifying glass icon to zoom out on the page.

Find: Click on this icon to search the document.

You can also use the standard Acrobat Reader tools to navigate through each magazine.

Intro

Cov

ToC

Are your cusstomers ask


a ing forr a
wirele
ess foot sw
witch?
We can help
h lp.

Wir
ireeless foot swittche
c es and reecceeivveers arre avva
aila
able in a wide va
arietty
of function
nal co
onfigurra
ations and pa
ackka
agings.
For over 10 years, STEUTE has pioneered the
t development of wireless technology expressly fo
or mediical
applicationss, with thousands of installed foot
o switches controlling radio
ology equipment, ophthalmicc surgical
systems, surrgical microscopes, patient tab
bles and laser-based devices.
STEUTE Wireless Foot Switches:
Feature robust, reliable fo
ourth-generaation 2.4 GHz frequency-hopp
ping technology
Complyy with all FDA wireless guidelin
nes and FCC requirements
Can be aesthetically and ergonomicaally optimized to meet your un
nique application needs
Contact uss for a no-cost, no-obligatio
on design consultation, or to discuss receiving a comp
plimentary
wireless, foot
o switch evaluation kit.

(203) 244-6302

www.steutemeditech.com

info
o@steutemeditech.com

Free Info at http://info.hotims.com/49748-817

Intro

Cov

ToC

www.medicaldesignbriefs.com

October 2016

Enabling Medical Devices with IoT


Wearable Sensors Meet Changing
Needs of Healthcare

Medical Manufacturing &


Fabrication

SPECIAL SECTION:
Technology Leaders in Contract
Manufacturing/Outsourcing

From the Publishers of

Intro

Cov

ToC

Free Info at http://info.hotims.com/61066-837

Intro

Cov

ToC

www.medicaldesignbriefs.com

October 2016

Enabling Medical Devices with IoT


Wearable Sensors Meet Changing
Needs of Healthcare

Medical Manufacturing &


Fabrication

SPECIAL SECTION:
Technology Leaders in Contract
Manufacturing/Outsourcing

From the Publishers of

Intro

Cov

ToC

work
experts
with
the

3;5,),46="803),46)
,1+64)0,5=16/=760;3(;60,461:=10*;0;3)
1::446)=16/=1::446=10*;0;3)
*;10*,:1043=;0)=
2;5,1:,;/=03;) =31,/) =16/=,;3)
,41)431:;=03;) =136) =16/=;),6)

;30,51::,60;+310;/=5121,:,0,;).=;;2=;82;30,);.=;51/;)=
4 =;82;3,;65;.=;),+6= 43='16 15031,:,0.=70=1::='1&;)=
<;:;9=;8=;/,51:="=43=),6+:;=)435;=)4:0,46.=0)016/,6+=
234/50=/;(;:42';60=16/='16 1503,6+=13;=#*10=/3,(;)=)=16/=
#*10=#;=/;:,(;3= 43=4.=
$,0*=43=0;1'=4 =;6+,6;;3) ='10;3,1:=16/=24:';3=;82;30) =
16/=)&,::;/=0;5*6,5,16) =#;=13;=3;1/= 43=#*10;(;3=43=234;50=
/;'16/).=$;3;=0*10=21306;3=0*10=516=*;13=#*10=4=13;=)1,6+ =
6/;3)016/=43=6;;/) =16/=133,(;=10=1=5)04',;/=)4:0,46.=
;0)=+;0=04=#43&=46=43=234;50.

BA@?>=<;:;9=;8=7654324310;/.=-::=3,+*0)=3;);3(;/.=<;:;9=;8=,)=1=3;+,)0;3;/=031/;'13&=16/=
%$43&=#,0*=0*;="82;30)!=,)=1=031/;'13&=4 =<;:;9=;8=7654324310;/=,6=0*;=..=16/43=40*;3=
54603,;).=0*;3=3;+,)0;3;/=031/;'13&)=13;=2342;30=4 =0*;,3=3;)2;50,(;=4#6;3).

*46;=?.@@..@?=43=?.@.>.>@A?
"'1,:=4;',6 40;:;9=;8.54'
$;=###.0;:;9=;8';/,51:4;'.54'
45,1:=;/,1=15;44& = ,6&;/76 =16/= 44+:;
.

Free Info at http://info.hotims.com/61066-838

Intro

Cov

ToC

Free Info at http://info.hotims.com/61066-839

Intro

Cov

ToC

October 2016

Published by Tech Briefs Media Group, an SAE International Company

COLUMN

SPECIAL SECTION

4 From the Editor

Technology Leaders in Contract Manufacturing/Outsourcing


18 Emerging Technologies: Challenge or Opportunity for the
Medical Device Industry?

FEATURES
6 How the IoT Is Enabling the Next Generation of Medical
Devices
12 Wearable Medical Sensors Provide New Solutions to
Changing Needs

23 Medical Device Outsourcing: Intellectual Property


Considerations

ON THE COVER

TECH BRIEFS
38 Implanted Devices Can Talk Through Wi-Fi
39 Tiny Solar Cells Deliver Big Power
40 Biodegradable Polymer Is Stronger and Longer Lasting
41 Gaming Camera Aids MS Treatment
42 Dust-Sized Sensors Could Create Electroceuticals

DEPARTMENTS

A number of healthcare trends including connecting medical devices to the Internet of


Things, using 3D printing, and producing wearable electronics have created strong incentives for designing devices that are built using
the latest information technology functionality.
These trends are being driven by everything
from tech-savvy patients to shifting care settings
and require new expertise in areas such as
complex molding, electronic circuits, low-power
wireless technology, materials, and more. To
learn more about how to address these trends,
please read the article on page 18.
(Image courtesy of Nypro Healthcare)

36 R&D Roundup
44 New Products & Services
48 Advertisers Index

Two heads are better than one.


Your idea. Our design. Both working together from the start to make
great things possible. Thats what happens when Nason partners
with customers in the medical equipment industry to create
cutting-edge, fully custom switches and cylinders and thats
why were proud to be a small part of something big.

nasonptc.com/app_stories

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-840

Intro

Cov

ToC

MULTIPHYSICS FOR EVERYONE


The evolution of computational
tools for numerical simulation of
physics-based systems has reached
a major milestone.

COMSOL MULTIPHYSICS

APPLICATION BUILDER

Custom applications are now being


developed by simulation specialists
using the Application Builder in
COMSOL Multiphysics.

APPLICATION

With a local installation of


COMSOL Server, applications
can be deployed within an entire
organization and accessed worldwide.
Make your organization truly benet
from the power of analysis.

comsol.com/application-builder

Copyright 2016 COMSOL. COMSOL, the COMSOL logo, COMSOL Multiphysics, Capture the Concept, COMSOL Desktop, COMSOL Server, LiveLink, and Simulation for Everyone are either
registered trademarks or trademarks of COMSOL AB. All other trademarks are the property of their respective owners, and COMSOL AB and its subsidiaries and products are not aliated with,
endorsed by, sponsored by, or supported by those trademark owners. For a list of such trademark owners, see www.comsol.com/trademarks.

Free Info at http://info.hotims.com/61066-841

Intro

Cov

ToC

From the Editor


Muddy Waters May Be in
Hot Water over Flawed
St. Jude Report
In late August, short-selling investment
firm Muddy Waters issued an alarming
report claiming that St. Jude Medicals
pacemakers, ICDs, and CRTs should be
recalled or remediated for what it determined were cybersecurity vulnerabilities.
In the report, the firm said, We have
seen demonstrations of two types of cyber
attacks against STJ implantable cardiac

devices: a crash attack that causes


Cardiac Devices to malfunction including by apparently pacing at a potentially
dangerous rate; and, a battery drain attack
that could be particularly harmful to
device dependent users. In its report
Muddy Waters further asserted that despite
having no background in cybersecurity, it
had been able to replicate in-house key
exploits that help to enable these attacks.
Within days of Muddy Waters report,
independent researchers at the University

IS THE ANSWER
TO MY DESIGN
CHALLENGE ALWAYS
A PART NUMBER?
Ask Smalley. We dont want you
to settle for ordinary wave springs
or retaining rings. Our engineers
deliver technical collaboration and
customization far beyond whats
in a typical parts catalogdoing
whatever it takes to meet your
unique performance requirements.
Stamped Ring
Constant Section Ring
Spirolox Ring
Smalley retaining rings
eliminate the protruding
ears that interfere with
assemblies, while providing
a 360-degree retaining
surface. And their unique
design means no special
tools are required.

Visit smalley.com
for your no-charge
test samples.

THE ENGINEERS CHOICE

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-842

of Michigan attempted to replicate the


findings, but were unable to do so and
said that the report has major flaws of its
own. The team is composed of several
leading
medical
device
security
researchers and a cardiologist from
the U-M Health Systems Frankel
Cardiovascular Center. In reproducing
the experiments that led to the allegations, the U-M researchers said that they
came to strikingly different conclusions.
The U-M team said that the error messages the report cites as evidence of a successful crash attack into a homemonitored implantable cardiac defibrillator are the same set of errors that display
if the device isnt properly plugged in.
If such a major allegation can be
checked and then discredited so
easily, it is easy to question the motivation
behind publishing such a report.
The report is inconclusive because the
evidence does not support their conclusions, said Kevin Fu, U-M associate professor of computer science and engineering and director of the Archimedes
Center for Medical Device Security. Fu is
also co-founder of medical device security
startup Virta Labs.
Fu goes on to say that to the armchair
engineer [the error] may look startling,
but to a clinician it just means you didnt
plug it in. In laymans terms, its like
claiming that hackers took over your computer, but then later discovering that you
simply forgot to plug in your keyboard.
As expected, St. Jude swiftly fired back at
Muddy Waters with a lawsuit for false
statements, false advertising, conspiracy,
and the related manipulation of the public markets in connection with St. Jude
Medicals implantable cardiac management devices, citing the findings of the
U-M researchers in their complaint.
St. Judes stock fell sharply when the
report was issued. Its lawsuit alleges that
Muddy Waters intentionally disseminated false and misleading information in
order to lower the value of St. Jude
Medicals stock and to wrongfully profit
from a drop in share value through a
short-selling scheme.
For the sake of the many patients who
rely on these critical medical devices,
lets hope for a quick resolution to this
very sad turn of events and a lesson
learned for anyone else who may be
tempted to make such claims without
the expertise to back them up.
Sherrie Trigg
Editor

Intro

Cov

ToC

Free Info at http://info.hotims.com/61066-843

Intro

Cov

ToC

How the IoT Is Enabling the Next


Generation of Medical Devices

he Internet of Things (IoT) has penetrated all sectors of the technological sphere at an accelerating pace.
According to Gartner, by the end of
2016, 6.4 billion IoT connected devices
will be used worldwide, and by 2020, this
number will soar to 20.8 billion. This
predicted increase is indicative of the
importance IoT will have on innovation
within the healthcare industry; specifically, medical devices.
There are numerous benefits surrounding the utilization of IoT in medical devices: enabling preventative care,
home care, critical care response, and
others. As medical device manufacturers, healthcare practitioners, and enthusiasts continue to embrace the benefits
of technology in healthcare, it may be of
interest, especially for medical device
manufacturers, to explore the intersection of medical technology and IoT.
For medical device manufacturers to
successfully enter and establish themselves in the new connected healthcare
industry, it is imperative that they look
beyond traditional forms of technological
innovation. IoT for example, would be an
avenue for consideration. Medical device
manufacturers are uniquely positioned to
be successful in this market, as they have
a profound understanding of the regulatory process, critical applications, and
patient risk. If they correctly integrate
IoT in their next-generation devices within the regulatory environment, they will
have a true market advantage.
IoT connected devices will enable a
new generation of medical devices
capable of transmitting data on an
ongoing basis. Not only are there more
dollars within the medical sector, but
the industry can experience real-time
response. With this innovation, feedback loops can be generated to engage
healthcare professionals in a timely
manner. Additionally, IoT will enable
the medical community to perform
deep data and data analytics, and ultimately produce cost-effectiveness within all these sectors.

IoT connected devices can deter illnesses and manage chronic disease, among other benefits.

IoT and Preventative Care


IoT connected devices will revolutionize the way healthcare is provided, especially in the area of preventative healthcare. According to the Centers for
Disease Control (CDC), seven out of ten
U.S. deaths are caused by chronic disease. Roughly half of the country's population is diagnosed with a chronic illness
such as heart disease, cancer, diabetes,
AIDS, or other ailments classified by the
medical community as preventable. The
increase in the number of individuals
diagnosed with chronic illness is not necessarily because people are not interested in taking the steps to live a healthier
life. The issue here is that people are not
getting the feedback they need when
they are proactive in making changes to
their lifestyle. They have limited feedback on how the implemented changes
are directly impacting their short- and
long-term health goals. This sets up the
individual for relapse and patient noncompliance, which costs $289 billion
annually, according to the CDC.
With IoT connected devices, homebased monitoring tools will become connected, enabling the patient to have
access to the data and make better

health decisions. Unfortunately, the


healthcare system follows a reactive
model, where action is only taken when
illnesses occur. This often leads to
chronic problems and critical-care treatment. IoT devices have the potential to
facilitate a directional shift from a reactive healthcare system to a more preventative healthcare system, which can help
people live healthier lives and deter illnesses while driving down costs.
For example, a glucometer becoming
an IoT connected device would greatly
improve its usability. Today, when a diabetic uses their glucometer, the device
simply stores a few readings that are not
meant to be analyzed by the user. Most
diabetics will not use a glucometer to
understand their blood sugar level patterns. They adjust their sugar intake
according to their blood-glucose level at
the moment, but until they visit their
doctor, the majority of diabetics are not
informed of their progress.
Freestyle, a medical device company
that introduced a glucose monitoring
system that logs insulin doses and glucose readings together, surveyed approximately 1,000 Type 1 and Type 2 diabetics
and found that 36 percent do not log

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

We play nice with COC and COP.


Medical Adhesive 1072-M from Dymax. 'VIEXIH[MXLMRWMKLXWJVSQPIEHMRKVIWMRI\TIVXWXS[SVOWTIGMGEPP][MXL
'3'ERH'34WYFWXVEXIWERHLIPTTVIZIRXTVSHYGXJEMPYVI;LIR]SYGLSSWI1]SYEPWSKIX
%REHLIWMZIXLEXMWIEW]XSETTP]ERHGYVIWUYMGOP][MXLMRWIGSRHWYRHIV0)(ERH9:PEQTW
 'SQTPMERGI[MXL-73G]XSXS\MGMX]FMSGSQTEXMFMPMX]XIWXMRK
 %TEVXRIVWLMT[MXLEGSQTER]XLEXGERLIPT]SYFIGSQIQSVIGSWXIJJIGXMZI
 8LIGSQFMREXMSRSJWYTTSVXXIGLRSPSK]ERHXLIHMWTIRWMRKERHGYVMRKIUYMTQIRX]SYRIIHXSKEMRE
competitive advantage

Only from Dymax. The company that


_;rvou1olr-mr;u=oul0;;u

OUR TECHNOLOGY. YOUR ADVANTAGE.

Get help on your next project today dymax.com/1072


Free Info at http://info.hotims.com/61066-844

Intro

Cov

ToC

Next Generation of Medical Devices


their results because of various reasons.
Some people believe it is inconvenient
and time-consuming, and most patients
feel that keeping a log is not useful as
many do not know what to do with the
data. Through IoT, data can be automatically obtained, transmitted, and analyzed by software. This information is
stored and can be used to create a trend
analysis so an individual can see how
their decisions are impacting their blood
glucose on a daily, weekly, or monthly
basis without logging this information.
By cutting down the time between the
patients daily use of the glucometer and
their visits to the doctor for proper pattern analysis, it incentivizes diabetics to
act faster and smarter when it comes to
their health. Also, positive feedback and
reinforcement will encourage individuals to make healthier choices. This would
work similarly with other medical devices
such as blood pressure monitors, cardiac
monitors, etc. Heart monitoring devices
could help patients receive early treatment before their condition becomes
critical, enabling health professionals to
detect abnormalities and arrhythmias,
and automatically send the data, creating
a more efficient diagnosis process.

ages, and a variety of different metrics in


order to make well-informed decisions.
However, with the constant transmission and compilation of data, there is a
high chance of hoarding data that is not
necessarily useful. The key challenge is
to determine what data is relevant, how
long to store it, and what data can be
deleted. Otherwise, efficiency is compromised as an infinite pile of data is analyzed when only a small portion is useful.
This is a very real challenge that will have
to be addressed in order to preserve the
efficacy of IoT connected devices.
IoT devices can also improve data analytics through their accuracy, speed, and
plethora of transferable information. In
population health improvement, healthcare leaders such as health administrators, insurers, consultants, and/or academics collect the data for a particular
population that they analyze to determine what the averages are and how they
can improve the averages of that patient
population. The key point is that data
IoT Enabled Deep Data and Data
must be aggregated. With IoT devices,
Analytics
data will be forwarded automatically,
Better preventative care and remote
making it more accessible and acceleratmonitoring is only the tip of the iceberg
ing analysis and results. Providers will
when it comes to the benefits of IoT
increasingly look to analytics to provide
integration within medical devices.
predictive and prescriptive capabilities.
Deep data and data analytics also proIoT and Remote Home Care
Data analytics would be achieved by
vide an opportunity for IoT to positively
Battling chronic diseases and managdevices and software. Medtronic develimpact the medical device industry. At
the moment, extracting data from a
ing them at home is challenging, taking
oped a wearable medical device that can
medical device is a daunting process. It
a toll on both the patient and caregiver.
send glucose level alerts up to 30 minutes
When patients are ill but not sick enough
either has to be integrated into the elecahead. In this example, the pump delivto be admitted to the hospital, the need
tronic health record, or be networkers tiny drops of insulin in accordance to
for a caregiver is crucial. However, the
enabled, as it cannot push data to health
the bodys needs, and can be temporarily
job of the caregiver is very involved and
providers. If IoT devices are designed to
altered around daily activities. It incorpocostly. In fact, according to AARP, more
constantly push data, it can be stored
rates a continuous glucose monitoring
than 34 million unpaid caregivers proand analyzed to look at anomalies, aversystem where the user can get readings
vide care to someone over the age
every five minutes, straight to the
of 18 who is ill or has a disability.
pump. Throughout the day, gluThe Institute of Medicine (IOM)
cose levels can be automatically
found that unpaid caregivers protracked, including the effects of
vide an estimated 90 percent of
food or exercise, to provide a more
long-term care, while the Family
complete picture. The testing of
Caregiver Alliance (FCA) reported
glucose levels and insulin distributhat the majority of caregivers (83
tion can be done simultaneously
percent) were related to the
with the constant communication
patient. In 2007, an average of
of data throughout the device. IoT
$5,531 is paid out of caregivers
can be a key contributor once it is
pockets to care for someone age 50
integrated. This information can
or older. Further, the caregivers
be transmitted to the diabetics
responsibilities can be demanding.
doctor for remote monitoring and
A NAC report said they found it
eliminate the need for constant
difficult to find time for themcheckups. Medical device compaselves, manage emotional and bioflux is an ambulatory monitor that detects heart arrhyth- nies will see a better approach to
mias, helping physicians diagnose cardiovascular disease or
physical stress, and balance work coronary heart disease. It performs remote mobile cardiac serving consumer markets by
telemetry (MCT) diagnostic monitoring for up to 30 consecuand family responsibilities.
aggregating and interpreting the
Having IoT connected devices tive days, and transmits ECG data via a built-in cellular radio in often massive amounts of data
real time so cardiac-triggered events can be monitored
would be beneficial in reducing remotely as they occur.
acquired via IoT devices.
emotional and financial strain on caregivers, and provide better healthcare to
the patient. These devices can be used to
provide at-home patient care without
the need for another person to be present 24/7. According to AARP, 37 percent of caregivers had to reduce their
work hours or quit their job due to the
responsibility of caring for someone age
50 and older.
A support system of IoT connected
devices can be used to facilitate self-care
and lead to better patient compliance. For
example, cameras and sensors can be used
to track patient movements and behaviors
in the home. Monitors can collect and
transmit a variety of data to healthcare
providers, eliminating the need to visit or
call a clinic. These technologies can also
provide reminders to people at home to
take medications, measure their blood
pressure, perform physical therapy, or
schedule follow-up appointments.

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

ww w . th elee c o. c om

See us at
COMPAMED
Hall 8a, Stand K09

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
and experience to deliver the precise, reliable performance you require.
Whatever problem you face, make the solution easy.
Contact The Lee Company today.

Miniature Solenoid Valves


Fixed and Variable Volume Pumps

Innovation in Miniature

Atomizing and Dispense Nozzles


Micro Dispensing Valves

SCAN THIS CODE

Integrated Fluidic Manifolds

The Lee Company 2 Pettipaug Road | Westbrook, CT 06498-0424

Custom Engineered Designs


Westbrook

Tel: 860-399-6281 | 800-533-7584 | www.theleeco.com

London

Paris

Frankfurt

Milan

Stockholm

Free Info at http://info.hotims.com/61066-845

Intro

Cov

ToC

Next Generation of Medical Devices


IoT and Critical Care Response
Traditionally, critical care response
is most effective within a hospital
where nurses are alerted via medical
devices to help patients in distress.
However, once a patient leaves the hospital, this type of immediate feedback
is no longer available. IoT devices will
allow data to be transmitted to a
remote location monitored by healthcare professionals who can expertly
analyze the data. Taking it further,
machine intelligence and algorithms
can be utilized to autodetect anomalies, enabling data to be transmitted
to the appropriate individual for a
response. Knowledge of the patients
background and medical history
would be readily available, and the
critical care response can be tailored
to the patients needs.
One of the key issues of critical care
response is the lack of information
received by the critical response team
in the event of an emergency. When
911 is dialed, an EMT arrives and
attempts to care for the patient with
no prior knowledge of the person.
Most of the information they receive is

what they are able to gain from family


members or the individual. There is
no data on medication used by the
patient or the presence of chronic illness. If an IoT system is implemented,
the device can send an alert and
inform the EMT about the patient
(e.g. chronic illnesses, allergies, medications, and/or medical complications) so they can respond faster and
more accurately. This will also drive
costs down, because it will enable the
patient to be cared for faster while also
minimizing complications.
A reduction in complications can
result in early hospital release and a
decrease in hospital fees. For example,
eCall is a vehicle emergency call system
that recognizes when a car has been in
a collision, and with IoT, eCall can
actually calculate the severity and communicate the location of the accident
and direction of travel. This information is automatically sent to the appropriate emergency services. Once IoT is
involved, individual health records can
be communicated through this system,
leading to a faster, better, and a more
prepared response.

Cadence is dedicated to making mission critical products.


That is why our Product Realization Center TM is 100% dedicated to
providing finished medical devices. From concept through commercialization,
let Cadence be your partner of choice to make your new products a reality.
Finished Device
Contract Manufacturing
Finished Device
Assembly

Complete Supply
Chain Management

Certified Cleanroom
Manufacturing
Final Packaging
& Labeling

Sterilization
Management

Rapid
Prototyping

cadenceinc.com/finisheddevices
sales@cadenceinc.com
800.252.3371

How IoT Will Disrupt Healthcare


With the advent of IoT connectivity,
the opportunities for medical device
manufacturers are endless. The automatic transmission of medically relevant data through IoT connected
devices will revolutionize the healthcare industry and the way data is analyzed. Doctors and physicians will be
able to assist their patients faster and
more accurately with the instant sharing of data.
With IoT enabled devices, there can
finally be a shift from a reactive healthcare system to a preventative one,
where illnesses will not only be better
treated, but will also be avoidable.
Elderly patients will be able to stay
home alone with their IoT connected
monitors, and both physicians and
patients will have complete access to
medical information. Additionally,
critical response personnel will be
able to handle emergency situations
more effectively, resulting in a faster,
better, and more affordable healthcare industry.
This article was written by Waqaas AlSiddiq, CEO and Founder of biotricity Inc.,
Redwood City, CA. For more information,
visit http://info.hotims.com/61066-160.
Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-846

10

Enabling Cost-Effectiveness with IoT


Cost-effectiveness can be achieved in
a variety of ways with IoT connected
medical devices. By shifting from a
reactive healthcare industry to a preventative one, medical fees can
decrease substantially. According to a
2015 U.S. Census Bureau Statistic
Brain Research Institute report,
patient care took over 64 percent of
the healthcare industry, generating
annual revenue of $1.068 trillion.
Cutting down the cost is not only a
benefit from IoT connected devices,
but is mandatory.
There are two aspects of cost-savings
for IoT. The first is due to the reduction in complications due to faster
treatment because EMTs have better
knowledge of the patient. The second
aspect is due to the patient being
released from the hospital faster
because data is transmitted in real
time, which enables patients to use a
less-expensive facility for long-term
care. While improving the healthcare
industry with a better system to save
lives, cost-effectiveness is an all-encompassing end result for the integration
of IoT within medical devices.

Intro

Cov

ToC

Did you know that any standard


Lumenera product can be adapted to
meet your exact application needs?

CUSTOM & OEM


IMAGING SOLUTIONS

FOR YOUR UNIQUE APPLICATION REQUIREMENTS


NTS

WHY PARTNER WITH LUMENERA TO CREATE AN IMAGING


SOLUTION FOR YOUR LIFE SCIENCES APPLICATION?
- Locked custom hardware and firmware for FDA approval and custom use case
- Long product life cycles (10 + years)
- FCC class B Certification, critical for meeting your EMI requirements for FDA approvals
- Same API for all of Lumenera cameras, which makes it easier to integrate multiple cameras
- Scientific Grade (-SCI) for tighter tolerance and superior image quality
- Custom labelling with customer specific part numbers
- Locking industrial micro USB and Hirose GPI/O connector for power and control of
peripherals and synchronization of lighting
- Board level or enclosed cameras
- A 30-day evaluation unit
- Industry leading 4-year warranty
- Extensive OS support (32 and 64-bit versions of Windows and Linux)
- Pre- and post-sales engineering support for systems integration

From small, low-cost tweaks and modifications, to complete


made-to-spec solutions, partner with Lumenera to create
an imaging solution thats right for you.

www.lumenera.com
Free Info at http://info.hotims.com/61066-847

Intro

Cov

ToC

Wearable Medical Sensors Provide


New Solutions to Changing Needs
T

he healthcare world today is one that


is rapidly changing and ever-evolving.
Several dynamics are driving these
changes, including an aging population,
the increasing prevalence of chronic diseases, and pressure on healthcare
providers to deliver high-quality medical
care at the lowest cost possible. Factors
like these are putting pressure on an
already strained healthcare system, fueling the need for medical solutions that
are aimed at enhancing efficiencies,
reducing costs, and helping improve
patient care, the patient experience, and
patient satisfaction.
For medical device manufacturers,
this means healthcare providers are
looking for new, more advanced solutions in every patient setting from
hospital to home that will help them
do their jobs better, and leave their
patients feeling satisfied and pleased
with their care.
For example, when looking at the
medical information technology market, recent advancements in electronic
medical records and barcode medication scanning are trending, bringing
added convenience to healthcare
providers when charting patient information, delivering medication, and
more. Technologies like these are not
only improving the accuracy of care
such as having instant access to a
patients most recent medication
dosage but also leave patients feeling better informed about their care
and, thus, more satisfied with the care
they are receiving.
Similarly, the use of wearable medical
sensors in at-home healthcare applications is another recent trend that has
been taking off. According to Grand
View Research, the global market for
wearable medical devices is expected to
reach $27.8 billion by 2022. That may
seem like a hefty prediction, but consider this: the median age of the U.S. population increased from 35.3 in 2000 to
37.2 in 2010, according to the 2010 U.S.

Census Bureau brief. The baby boomer


segment continues to age, life expectancies are increasing, and health awareness is increasing. Chronic diseases are
soon expected to become the worlds
leading cause of death and disability,
accounting for nearly 75 percent of
deaths by 2020, according to a United
Nations Division for Social Policy and
Development, Department of Economic
and Social Affairs report. Remote
patient monitoring is projected to exhibit growth of more than 25 percent in the
next seven years. All of these factors create additional demand for wearable
medical devices.
With projected growth and opportunity in the wearable medical sensor device
manufacturing business, manufacturers,
device designers, and converters are
aiming to create wearable sensor solutions that will deliver superior performance and added convenience, as well as
enhanced patient comfort, to better
meet the many needs of healthcare
providers today.

Research predicts the global market for wearable medical devices is expected to reach
$27.8 billion by 2022, creating an abundance
of opportunity for manufacturers, design engineers, and converters.

12

Wearable Medical Sensors: A Brief


Overview
Wearable medical sensors are worn by
a patient and come in many forms. They
are designed to monitor and wirelessly
transmit physiologic information from a
patient to a patients physician. The
physician can receive the information
provided by the wearable medical sensor
via their computer, smartphone, or other
connected device.
With features that make them easy for
patients to use, wearable medical sensors
operate in a manner similar to many
devices that track fitness levels. For example, they allow long-term, continuous
monitoring of physiologic information
such as heart rate, blood pressure, blood
oxygen saturation, insulin levels, respiration, and more. Additionally, they can also
provide an accurate assessment of a
patients health status.
Wearable medical sensors are most
commonly used for at-home applications,
although they are also used in various settings where medical monitoring or testing
is required. The unique advantages
offered by at-home wearable medical sensor technology are appealing to healthcare providers and patients for numerous
reasons. For example, sensors designed
for use at home can collect and transmit
data to physicians that would otherwise be
cost-prohibitive when conducted in a clinical setting.
In addition to reducing costs for both
providers and patients, innovations in
medical devices that can be worn at home
can enhance the efficiency of patient
health information collection for healthcare providers, and promote usability
among patients since wearable devices
minimally impact a patients daily life and
free them from frequent physician visits.
And, while there are various types of wearable medical devices out there from
watches to shoe insoles those that directly adhere to a patients skin continue to
emerge as one of the more popular choices for healthcare providers and patients.

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Interpower manufactures North American and international hospital-grade power cords and cord sets. The United States, Canada,
Australia, Denmark, and Japan are the countries that have hospital or medical requirements for their plugs and cords. For other
countries there are no special performance or construction requirements for medical applications. From 1 piece to 1,000 pieces or
more, we offer no minimum order requirements and just a 1-week U.S. manufacturing lead-time on non-stock Interpower products.
Interpower manufactured cords are 100% tested.
We offer a variety of lengths with an extensive range of clear, black, and gray North American plugs. Value-added options such as
custom packaging and custom labeling are available upon request.

Made in Iowa
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

NEW UNIQUE DEVICE IDENTIFICATION SYSTEM


Due to increasing concerns about product recalls, counterfeit devices, and patient safety, the FDA
has started the process of developing a Unique Device Identication System in regards to most
medical devices. This system is a unique numeric or alphanumeric code which includes a list of
product identiers. Currently identication methods are fragmented and its sometimes difcult
to trace the original product back to the manufacturer. While medical cords are not classied as
a medical device by the FDA, at Interpower we can provide serial numbers on medical cords per
your specic requirements.

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
Free Info at http://info.hotims.com/61066-848

Intro

Cov

ToC

New Solutions to Changing Needs


Multilayer, Direct-to-Skin
sion levels, to high- or extraPSA Solutions
strength adhesion levels. The
High-quality, skin-friendly
right
adhesive
systems
pressure-sensitive adhesives
should provide customers
(PSAs) have been used in
with the flexibility to choose
medical device-to-skin applithe adhesive strength, quick
cations for decades, and
tack, peel strength from skin,
PSA suppliers have been
shear strength, and removworking diligently to create
ability necessary to meet
medical-grade
adhesives
their customized needs.
specifically for these appliTo create the right syscations. In fact, skin-related
tem, one must carefully
applications have shaped
consider the proper combithe way medical-grade adhenation of substrate and
sives are designed creatadhesive to create the
ing functionally diverse
desired moisture vapor
adhesives based on factors
transition rate (MVTR). If
such as patient age, gender,
the medical sensor needs to
Extremely easy to use, wearable medical sensors monitor and wirelessly transethnicity, physical environ- mit physiologic information from patients to physicians via computers, smart- offer high levels of breathament, length of wear, and phones, and other devices.
bility, the adhesive must be
more. With at-home wearhighly breathable.
able medical sensor applications that
most basic terms, its multilayered and
With recent advancements in adheadhere directly to a patients skin, varifully customizable. It maintains three of
sives technology, some of the most
ables such as physical movement, sweatthe most important priorities for the
ideal adhesives for wearable medical
ing, showering, or changes in body heat,
growing wearable sensor trend: performsensor applications are those that are
for example, are important factors to
ance, convenience, and patient comfort.
solvent- and latex-free, and made with
consider when selecting an adhesive.
Medical-grade adhesives for wearable
100 percent solids technology. This
So, what does a successful wearable
medical sensors often come in varying levadhesive technology is known to promedical sensor PSA look like? In the
els of adhesion from low or soft adhevide excellent long-term adhesion up

ROBOTIC END - EFFECTORS

Measure all six components of


force and torque in a compact,
rugged sensor.
Interface Structurehigh-strength
alloy provides IP60, IP65, and IP68
environmental protection as needed
Low-noise Electronicsinterfaces for
Ethernet, PCI, USB, EtherNet/IP, PROFINET,
CAN, EtherCAT, Wireless, and more
Sensing Beams and Flexuresdesigned
for high stiffness and overload protection

The F/T Sensor outperforms traditional load cells, instantly providing


all loading data in every axis. Engineered for high overload protection
and low noise, its the ultimate force/torque sensor. Only from ATI.

www.ati-ia.com/ets
919.772.0115

14

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-849

Intro

Cov

ToC

to 14 days, as well as ultraclean removability without irritation; therefore,


patients dont have to sacrifice comfort
for performance.
And, unlike relatively expensive solventcoated acrylic adhesives, 100 percent
solids-coated acrylic adhesives can be
produced much more cost-effectively
since the manufacturing process for
these adhesives does not require energyconsuming drying ovens or challenging cleanup. Additionally, 100 percent
solids adhesives are inert, nonoutgassing, nonfluorescing, nonmigratory, and usable in applications requiring very precise deposition control
also making them a confident, costeffective solution for wearable medical
sensors. It is also extremely flexible
and can be coated on a wide variety of
materials, including foams, films, or
fabrics, as single-coated products or
double-coated products.
There are several considerations manufacturers, design engineers, and converters should make when pairing the
adhesive with an ideal product material.
Each material has its own unique characteristics and some are more ideal than
others for certain applications. Some of
the most common product constructions
for wearable device sensors include
transparent films or film tapes, foam
tapes, and nonwoven tapes. Below are a
few important highlights about each of
these substrates.
Transparent films or film tapes
Transparent films or film tapes provide
a durable, see-through finish for wearable device sensors requiring trans-

parency. Depending on the film construction, films can offer important


performance characteristics such as
conformability, breathability, good oxygen and moisture vapor exchange,
waterproof and fluid-barrier properties, and impermeability to bacteria
and viruses. Common film materials
include polyurethane, polyethylene,
and polyester, and include paper casting sheets and liners, which are well
suited to accommodate different converting methods. Films are known as a
versatile material and can be coated
with varying adhesive coat-weights
depending on the level of adhesion
and moisture vapor transmission rates
necessary for the application.
Foam tapes Foam tapes are ideal for
wearable sensor applications that necessitate sustained skin contact. They are
designed to hold tubes and wires in
place more comfortably, in addition to
providing enhanced stability for sensors. Foam tapes are also known for
their excellent adhesion and clean
removability.
Nonwoven tapes Key performance
attributes of non-woven tapes include
breathability, good oxygen and moisture vapor rate exchange, elasticity,
and conformability. Nonwoven tapes
are designed to enhance both performance and patient comfort. They
are often constructed of materials such
as spun-laced polyester or elastic fabric, for example, and are typically recommended for electromedical and
bandage-type applications, making
them ideal for wearable device sensors.

We are there,
when reliability
is of top priority.
Our innovative sensor solutions
make medical devices even
safer and more efficient.

For years, PSA suppliers have been working to develop custom, multilayered, medical-grade adhesives for wearable medical sensor applications that are designed to deliver improved performance
as well as added convenience and patient comfort.

Medical Design Briefs, October 2016

www.first-sensor.com

www.medicaldesignbriefs.com

Intro

Cov

ToC

New Solutions to Changing Needs


Selecting the Right PSA
When evaluating a PSA for a wearable
sensor application, manufacturers, design
engineers, and converters should not only
consider the composition of the PSA and
how the layers of the PSA best match the
specific wearable sensor application, but
should also consider the supplier providing the PSA.
Customization is key. With medicalgrade adhesives, customization should be
one of the most important qualifications

for device manufacturers, designers, and


converters when choosing a PSA supplier.
Medical-grade adhesives are not typically
an off-the-shelf product, and an ideal PSA
supplier will have product customization at
the top of the companys list of offerings.
To meet the demanding needs of
medical-grade adhesive products, a supplier should offer significant flexibility
when it comes to custom-matching adhesives to foams, films, fabrics, and more. A
progressive supplier can contribute to

Introducing the UV10 line of


USP Class VI approved adhesives

Which is the right one for you?


BOTH SYSTEMS FEATURE:
Optical clarity Refractive index 1.557
Fast curing Cures in 20-30 seconds under UV light

UV10Med

UV10TKMed

FLOWABLE

GAP FILLER
Viscosity
200 to 500 cps

HIGH STRENGTH BONDS

Viscosity
35,000 to
45,000 cps

TEMPERATURE RESISTANCE
Serviceable
from
-60F to +450F

Tensile
strength
>5,000 psi

Suitable for
thin coatings

Withstands
repeated
sterilization

Hackensack, NJ 07601 USA +1.201.343.898 main@masterbond.com

www.masterbond.com

Abundant Opportunity on the Horizon


The dynamics driving change in the
world of healthcare today, coupled with
the explosive projected growth of the
wearable medical sensor market and the
increasing popularity of direct-to-skin
wearable sensor products, present endless opportunity for device manufacturers, design engineers, and converters in
the wearable medical sensor business.
With customized, multilayered PSAs
and a trusted PSA supplier partner at
their side these key medical device
players can deliver healthcare providers
and their patients high-performing wearable medical sensors that are certain to
deliver sought-after product benefits
such as convenience and comfort.
This article was written by Janet Page,
Marketing Manager at Mactac Performance
Adhesives, Stow, OH. For more information,
visit http://info.hotims.com/61066-163.
Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-851

16

long-term success with product customization. The best adhesives suppliers


are those who are not limited to stock
products, but who partner to develop custom solutions appropriate for their customers applications.
Manufacturing processes are critical.
Some of the most important traits to look
for when it comes to direct-to-skin medical adhesives are securement to the
skin, MVTR and fluid-barrier abilities,
clean and smooth removability, and skin
compatibility, among others. Other
important qualities include latex-free
and hypoallergenic properties.
To achieve these varying medicalgrade adhesive properties, adhesive
manufacturers will pay close attention
to the quality of each individual component used, both before mixing the
components and again after mixing. A
good supplier will also conduct quality
inspections before delivering the
mixed components to the coater,
throughout the coating process, and
once again during the manufacturing
slitting stage.
To ensure complete control over the
entire manufacturing process, an ideal
adhesives manufacturer will have inhouse mixing and reactive extrusion
and compounding capabilities. They
will also follow strict process guidelines,
such as current Good Manufacturing
Practice (cGMP) guidelines, and ensure
their direct-skin-contact PSAs meet outlined International Organization for
Standardization (ISO) and Food and
Drug Administration (FDA) guidelines.

Intro

Cov

ToC

The Gold Standard


When it comes to critical applications, ultra-high reliability
is the only option.Learn more about our
precision, high-quality gold solder materials at:

VERY made in America


since 1934

indium.com/solders/gold
Free Info at http://info.hotims.com/61066-852

Intro

Cov

ToC

TECHNOLOGY LEADERS Contract Manufacturing/Outsourcing

Emerging Technologies: Challenge or


Opportunity for the Medical Device Industry?

isiongain predicts the global


medical devices market will
reach $398 billion in 2017.1 To
win share in this growing market, device companies need to stay out in
front of manufacturing advancements so
they can quickly integrate information
technology (IT) functionality, accelerate
time to market, and control costs.
A number of healthcare trends are
increasing the importance of incorporating sensors, controllers, wireless connectivity, firmware, and remote monitoring into new devices. The transition of
care delivery from acute settings to the
community, patients interest in tracking
their own health, an aging population
with chronic conditions that must be
managed, the rise of accountable care,
and greater focus on prevention to drive
down costs all have created strong incentives for designing devices built on the
latest IT and getting them to market
faster than the competition.
To capitalize on this opportunity,
device companies need access to manufacturing resources either in house or
contracted that can produce technologically complex products with speed,
precision, compliance, and consistently
high quality. Advanced capabilities that
can facilitate the next generation of
tech-enabled medical devices include:
Connecting devices to the Internet of
Things (IoT)
Using additive manufacturing (3D
printing)
Producing wearable electronics such as
smart clothing, skin-adhered sensors
As a practical matter, many device
companies which are often small
startups lack the knowledge, expertise, and infrastructure to successfully
integrate IT components into their
products, or to apply computer-driven
manufacturing techniques. Instead, they
often turn to manufacturing service
providers with specialized capabilities.
For instance, because technology
transfer from the consumer sector
(think fitness trackers and smartphonebased monitoring) is so common in

The Internet of Things is a network of objects, usually connected wirelessly.

medical devices, the industry can benefit


by partnering with manufacturers that
have expertise in consumer electronics,
including wearables.
A partner with the latest plastics
manufacturing equipment, such as 3D
printing technology, can help meet
demand for faster throughput and
lower costs. Finally, a manufacturing
services provider that keeps abreast of
the emerging IoT arena can help companies equip devices with Internet connectivity and sophisticated sensors that
perform cost-effective, remote maintenance and support, as well as patient
monitoring, data collection, and communication with clinicians or other
IoT-connected devices.
Trends Behind IT-Enabled Medical
Devices
IT can help the device industry design
products that target a wide array of
healthcare trends.
Globally, the rise of the middle class in
nations such as China and India means
more opportunity for affordable yet
technologically advanced devices.
Patients are increasingly tech savvy and
expect medical technology to offer the
same functionality and features as
their consumer electronics.
Care delivery settings are shifting from

18

the hospital to the home or extended


care facility to save money and lighten
the burden on providers. Managing
patients or helping them selfmanage in these settings is driving
greater needs for remote diagnostic
devices, monitoring via the IoT and
wearables that can capture and transmit information on events and day-today health status.
The healthcare reimbursement model
is evolving from payment for performance to payment for outcomes. To
increase the likelihood of positive
results while keeping costs under control, providers need devices that can
help them remotely manage, or even
diagnose, their patients.
With an aging population subject to
chronic conditions such as diabetes
and hypertension, providers need efficient ways to oversee patients without
constant, burdensome office visits.
This oversight includes ensuring
patients compliance with various therapies by tracking when a medication is
taken, how often, and at what dosage.
The goal of connected health for populations depends on a network of linked
devices and other objects collecting,
sending, and receiving data about people, environments, and processes without human interaction or input.

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Have great design ideas you cant


manufacture at the right cost?
Swiss-Turn U-Cut
Laser-Cut Slot
Laser-Cut Spiral
.0015" Wide

Swiss-Turn
ID Chamfer

Swiss-Turn
U-Cut

Laser-Cut
Windows

For Tubes .050" to .625" OD

NOW YOU CAN.


Accu-LaserSwiss redenes manufacturing capabilities,
TM

speed, precision and cost-savings for ultra-complex metal tubes.

Accu-LaserSwiss gives you manufacturing capabilities never before available. This new technology fully
integrates a six-axis precision automatic lathe with a fully enabled laser cutting module. It cuts costs,
dramatically reduces cycle time and lets you create features that would be impossible on a conventional
Swissturn like slots as narrow as .0015" and small holes with no tool wear. As co-developer of this
innovative laser machining process, Okay is the only manufacturer offering it today. Give us a call or drop
us an email and see how you can start doing more for less tomorrow.

Okay Headquarters | 200 Ellis Street | New Britain, CT 06051


Tel (860) 225-8700 | sales@okayind.com | okayind.com

Manufacturing. Rely. Ability.


Swiss-Type Turning Laser Cut Tubes CNC Machining Automated Assembly Laser Welding & Marking Precision Metal Stamping
Accu-Blade Scissors & Blades Production Proven Prototyping Award-Winning Product Development
Other locations: Medical Products Manufacturing: Berlin, CT USA Medical Precision Components Manufacturing: Alajuela, Costa Rica
Free Info at http://info.hotims.com/61066-853

Intro

Cov

ToC

TECHNOLOGY LEADERS Contract Manufacturing/Outsourcing

Connecting to the Internet of Things


The IoT is a network of physical
objects (things), including everyday
items, equipment, and devices, that are
connected to the Internet, usually wirelessly. Through the use of built-in sensors, these objects collect and transmit
data, share information with each
other, or control and manage a device
or process.
The IoT is well suited to healthcare
applications because it facilitates oversight and self-monitoring, streamlines
data collection, and promotes communications between patients and providers.
According to an IDC report, the IoT
market for remote health monitoring
will grow to over $12.4 billion in 2018.2
Many medical device manufacturers
have started to prepare for implementation of this new business model, where
the device is only one part of the solution. However, they often lack expertise
in complex electronics that can enable
and support remote connectivity, data
collection, and data analysis for their particular device and use case.
The IoT presents many technical challenges for medical device developers.
Transmitting, securely managing, and
analyzing the vast amounts of data collected by sensors in IoT-enabled devices
will involve many different technologies.
Confidentiality of patient data makes
this process even more complicated,
requiring expertise in secure transmission over the network, and secure storage in the cloud or another repository.
Manufacturing capabilities needed
for IoT-enabled medical devices such as

glucose monitors, inhalers, infusion


pumps, insulin pens, and cardiac monitors include:
Device integration
Connectivity using emerging standards
such as ZigBee, a cost- and energyefficient wireless network standard, as
well as more mature systems like radiofrequency identification (RFID) and
low-power Bluetooth connections
Sensors
Energy solutions that can optimize or
extend device life
Printed electronics
Using Additive Manufacturing
Additive manufacturing, also known as
3D printing, is a process that creates a
three-dimensional object by building successive layers of raw material such as plastic or metal. Objects are produced from a
digital 3D file, such as a computeraided design (CAD) drawing or a computed tomography (CT) image. The
flexibility of 3D printing allows designers to make changes easily without the
need to set up additional equipment or
tools. It also enables manufacturers to
create devices precisely matched to a
patients anatomy.
Devices from shoe insoles to eyeglasses, and from hearing aids to prosthetics,
can be customized for optimal fit and
function. Examples include a 3D printed vertebra to replace a patients cancerous vertebra, and a 3D printed ventilated hand cast to replace heavy, occlusive
plaster or fiberglass casts.
Medical devices produced by 3D
printing include orthopedic and cranial

With 3D printing, devices can be made that exactly


match a patients anatomy.

The IoT is well suited to healthcare because it facilites data collection and communication.

20

implants, surgical instruments, dental


restorations such as crowns, and external prosthetics. As of December 2015,
the U.S. Food and Drug Administration
(FDA) had cleared more than 85 3D
printed medical devices.3
As a replacement for traditional plastics and composites processing, particularly injection molding, additive manufacturing offers major benefits, including avoiding the high cost and extensive
time required for designing and building mold tools. Although traditional
injection molding operations are actually faster than 3D printing, molding
requires lead times of several weeks for
tooling. The competitive sweet spot for
3D printing is manufacturing up to
100,000 items a year.
Additive manufacturing also allows
faster prototyping and simplifies aesthetic
and physical customization (fitting devices
to the patient). Additional advantages of
this technology are cost-effectiveness and
flexibility when creating devices used in
clinical studies, where quantities are small
and design changes are often required
after evaluation.
In some cases, 3D printing allows
device companies to produce structures
or forms that are simply not possible
using injection molding due to technical
constraints such as an inability to demold
parts with complex geometries and intricate interior structures.
Using 3D printing technology for
high-volume production requires general manufacturing competence, understanding of material properties and performance, and access to digital factory
facilities that offer systems for transferring and managing input data, processing, and yields.

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-854

Intro

Cov

ToC

SWIS
SS CONTRA
ACT
M
AIS
NSU
TURI
NG
G
SW
SFCAOCNTRA
AICT

CTURI
ING
G
FRO
OM
MASNTUOFCAK
TUBING
FRO
MASIT
TUBING
IN
NO
ST
NOLC
EK
SS
STEEL

IN
N STAINLESS STEEL

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

TECHNOLOGY LEADERS Contract Manufacturing/Outsourcing

Mastering Multiple Technologies


to Create Wearables
IDTechEx analysts estimate that
the wearable technology market
will be worth over $30 billion in
2016, growing to over $100 billion
by 2023.4 Wearable medical
devices range from fitness and
wellness monitors to clothing with
integrated sensors that can track
vital signs and detect issues with
various body functions.
Because wearable medical
devices involve so many different
types of advanced technology and Although they may appear simple, wearable devices contain
processes, it is very difficult for sophisticated technologies.
companies to prototype and prodelays, require heavy capital outlays, and
duce them without assistance from a
present serious risks.
manufacturing partner. For instance, a
One solution is to partner with a
fitness band looks simple on the surface,
provider that offers knowledge and techbut contains sophisticated miniaturized
nical expertise in the design and manutechnology. Such bands are challenging
facturing of electronics particularly
to manufacture because they require
facilities capable of automated, high-volconsumer electronics as well as medical devices. These providers not only
ume production, and a deep understandhave extensive, advanced manufacturing
ing of flexible materials, such as thermocapabilities and global supply chains, but
plastic elastomers, and how to integrate
can also advise device companies on difelectronics into the polymer.
Manufacturers must possess experiferent material, technology, and process
options that can control costs and accelerence, infrastructure, and technical capaate time to market. Further, these compabilities in these areas:
nies offer extensive regulatory expertise
Complex molding
to help ensure approval of novel devices.
Electronic circuits, including flexible
circuits
References
Miniaturization
1 The global medical devices market will
Batteries
reach $398.0bn in 2017 predicts new
Low-power wireless connectivity
Visiongain report. News release.
https://www.visiongain.com/Press_Release/
Sensors, including conductive biosen498/%E2%80%98The-global-medicalsors, gyroscopes, magnetometers and
devices-market-will-reach-398-0bn-inbarometers; optical sensors; wearable
2017%E2%80%99-predicts-new-visiongainreport
electrodes; chemical sensors; flexible
2 Growth of IoT means business worth
stretch, pressure, and impact sensors;
billions of dollars for verticals: IDC.
temperature sensors; and microphones
http://theinternetofallthings.com/growthiot-means-business-worth-billions-dollars 3D printing
verticals-idc-2014-05-13/. Posted May 13,
Materials and textiles
2014.
Benefits of Partnership
Many device companies and consumer product companies that wish to
enter the connected health market lack
expertise in complex electronics that
will enable and support remote connectivity, data collection, and data analysis.
They may also face the hurdle of building manufacturing infrastructure for
their specific device and finding experts
in technologies such as additive manufacturing. This approach can cause

This article was written by Ralph


Hugeneck, Senior Director of Technology at
Nypro Healthcare, a Jabil Company, St.
Petersburg, FL. For more information, visit
http://info.hotims.com/61066-161.

www.medicaldesignbriefs.com

Free Info at http://info.hotims.com/61066-855

Intro

3 3D Printing of Medical Devices. U.S.


Food and Drug Administration.
http://www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/3DPrint
ingofMedicalDevices/default.htm.
Updated May 12, 2016.
4 Wearable
Technology
2016-2026.
http://www.idtechex.com/research/reports/
wearable-technology-2016-2026-000483.asp

Cov

ToC

Medical Design Briefs, October 2016

TECHNOLOGY LEADERS Contract Manufacturing/Outsourcing

Medical Device Outsourcing: Intellectual


Property Considerations

utsourcing can save costs and


provide other commercial benefits. With outsourcing efforts
related to medical devices, it is
important to understand some aspects
of U.S. intellectual property (IP) law.
This is especially true for inventive medical devices, where there is value not just
in the device itself but in the ideas
behind the device. When outsourcing
creative work, the IP issues are of utmost
importance. But even when outsourcing
seemingly noncreative work, such as
manufacturing, these issues should still
be addressed. This article touches on
three such issues: sharing, inventorship,
and ownership of IP. While discussed in
the context of medical device outsourcing, these issues are also important to
technological outsourcing in general.
With medical device technology, outsourcing comes in many forms. Doctors
often task medical device makers with
improving medical devices and procedures. To commercialize a device, these
and other inventive entities may work
with engineers, designers, manufacturers, R&D labs, universities, incubators,
or shops-for-hire. In all cases, the first
step in outsourcing is
approaching a potential
outsourcee, where proprietary information may be
shared.

Sharing IP: Identify Preoutsourcing IP


If you are outsourcing
innovative work, where the
outsourcee will make an
inventive
contribution,
each party typically brings
know-how to the table.
When outsourcing noninnovative work, you want
proof of the IP you owned
going into the arrangement, to ensure that you
protect it from potentially
unscrupulous outsourcees.
It is therefore important to
identify the relevant pre-

outsourcing IP owned on either side.


The pre-outsourcing IP can be identified in the agreement or contract covering the outsourcing arrangement. Such
agreements come in many forms, such
as manufacturing agreements, consulting agreements, license agreements, or
joint development agreements. These
agreements define each partys role in
the outsourced project and should identify what each party separately owned
beforehand.
The way in which the pre-outsourcing
IP is identified depends on the nature of
the IP. Existing devices or devices currently
under separate development can be identified with engineering drawings. Software
can be identified with functional descriptions, flowcharts, or code. Manufacturing,
testing, or other broad capabilities may be
described in writing, tables, charts, etc.
The pre-outsourcing IP may also be
identified with lists of patents and
patent applications. A utility patent
application will clearly identify the subject matter possessed, with enabling
written description and informative
drawings. The pre-outsourcing filing
date of the application will also facilitate

proving prior possession of the IP.


Some IP is best not disclosed to the
public (for example, in a patent application) but is better kept as a trade secret.
Accordingly, entering into an initial
nondisclosure agreement (NDA) before
negotiation of the outsourcing agreement is common. An NDA is a written,
contractual agreement to keep confidential the information to be shared.
Confidentially sharing pre-existing
know-how before agreeing to the binding outsourcing agreement will identify
any deal-breaking limitations or duplications of technical capabilities. The NDA
should also reference, or be included in,
the outsourcing agreement.
Inventorship: Identify Contributions of
Each Party
In addition to identifying the preoutsourcing IP, it is important to understand how each party contributes to the IP
developed during the outsourcing.
Patentable inventions may be developed
by one party alone or jointly by multiple
parties. Identification of all inventors
no more, no less is necessary for
enforcement of any resulting patent and

For inventive medical devices, there is often value in the ideas behind the device.

Medical Design Briefs, October 2016

www.medicaldesignbriefs.com

Intro

Cov

ToC

23

TECHNOLOGY LEADERS Contract Manufacturing/Outsourcing

affects who owns the rights to these


patentable inventions.
To be an inventor of a patentable
invention, conception is the cornerstone. An inventor is not one who merely reduces the idea to practice, such as a
technician or manufacturer performing
their typical roles. The inventor instead
must contribute a definite and permanent idea of the complete and operative
invention, such that an ordinary engineer could practice the invention.
Joint inventorship results when the
ideas of multiple people are combined
to produce an invention. In any patent
application filed pursuant to the outsourcing, the scope of the rights in the
invention is described in the numbered
listing of claims at the end of the
patent document. To qualify as a joint
inventor, a person merely needs to have
made an inventive contribution to just
one of these claims.
Joint inventorship may also occur
where an outsourcee performs seemingly noninventive functions, such as manufacturing, assembly, testing, or consulting. For instance, if the idea as originally
conceived is difficult to make, a manufacturer who changes the design for simpler fabrication may be an inventor.
However, to be a joint inventor, a persons contribution must help distinguish
the invention from the existing state of
the art. It must be more than contributing existing ideas or obvious modifications. The analysis is often contextual.
For instance, conceiving of screws to fasten parts together is not typically an
inventive contribution. But in the context of regenerative scaffolds secured to
tissue or bone, the use of a particular
screw design may need to be considered
for inventorship purposes.
Ownership: Understand Who Owns the IP
For patentable inventions, inventors
are owners in the United States until
they transfer their ownership to another
party. Inventors are usually under a contractual obligation to assign ownership
of the IP they develop to their employers, typically under an employment
agreement. With outsourcing, the
assignment may be across the table to
another party. Be clear as to whether
such assignment is direct to that party or
assigned indirectly via the inventors

employer. For instance, startups may use


employees at incubators or similar
organizations for assistance with design
or engineering. If the startup is to own
the IP, typically the incubator employees
will assign the rights to the incubator,
who will then assign it to the startup.
What if those employees execute
assignments directly to both the incubator and the startup? When outsourcing, look out for such conflicting
agreements. Also, be aware that inventions can be assigned before they are
conceived. For example, employment,
consulting, or other such agreements
can include language where inventors
both agree to assign and presently do
assign inventions made during their
employment and/or their participation in the outsourcing effort. This
type of agreement makes it possible to
make present assignments of future
inventions. With outsourcing, such
agreements can be used to proactively
address allocation of ownership, but
they can also present unforeseen issues
where one party or the other does not
appreciate the scope of the language in
an IP assignment clause.
For example, suppose a medical
device designer partners with a manufacturer to improve a vascular graft design
for less-expensive fabrication. Typically, a
joint development agreement would outline who owns what. Ownership of
expected improvements may be straightforward, but who will own unexpected
spin-offs? For example, what if the manufacturer is inspired by the graft invention to invent a new stent? Or if the manufacturer invents a new tool to make the
graft? Ownership of such related inventions will depend on the language of the
assignments and the collaboration agreement. Broadly drafted provisions, including present assignments, should thus be
incorporated, if capturing ownership in
such situations is desired.
Where employees from both the outsourcer and the outsourcee make inventive contributions, the default in the
United States is joint ownership by the
parties to a patent claiming both contributions. While joint ownership may be
desirable in certain limited situations,
some important and often undesirable
consequences of joint ownership on
patent rights should be understood. Joint

24

owners of a patent may make, use, sell, or


license the patented invention without
the consent of, and without accounting
to, the other owners. Therefore, a joint
owner may unilaterally grant to a licensee
the right to make and sell the invention,
and the licensees payments need not be
shared with the other joint owners.
Joint ownership can also adversely
affect enforcement of patent rights.
Under U.S. law, all joint owners of a
patent must agree to sue for infringement. Further, an accused infringer
may protect himself from a lawsuit by
getting a license from a co-owner. This
may occur where a previously unidentified inventor, who did not assign
away his ownership rights, grants a
license to the accused infringer.
Additionally, all joint owners must act
together as a composite entity in
patent matters before the U.S. Patent
and Trademark Office. Any friction
among the group may create delay and
increase the costs for such matters.
Conclusion
Outsourcing can be great for medical
device development. To fully realize the
benefits, it is critical to consider these
three IP issues: sharing information,
inventorship, and ownership. First, identify and agree to the pre-outsourcing IP
possessed by each party. If possible, file a
patent application before making any disclosure. Regardless, agree to keep any disclosed know-how confidential. Second,
proper identification of inventors in outsourcing efforts can be difficult but is
necessary for enforcement of the patent.
Inventors must have conceived of an
inventive contribution to at least one of
the patent claims. Third, the default owners of inventions are the inventors, and
ownership is transferred using written
assignments. To capture ownership of
unanticipated IP, use broadly drafted provisions in nonconflicting assignments
and joint development agreements. If
joint ownership is being considered,
understand that joint owners can unilaterally use and profit from the patent, and
that joint ownership can complicate
enforcement of patent rights.
This article was written by Tom Cowan,
Associate at Knobbe Martens, San Diego,
CA. For more information, visit
http://info.hotims.com/61066-167.

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Advertisement

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

Free Info at http://info.hotims.com/61066-856

Medical Design Briefs, October 2016

www.medicaldesignbriefs.com

Intro

Cov

ToC

25

Advertisement

Fluortek
12 McFadden Rd.
Easton PA, 18045
Phone: 610-559-9000
Fax: 610-559-1919
E-mail: orders@fluortek.com
www.Fluortek.com

quality system, Fluortek can deliver nonsterile partially finished


or fully custom-assembled devices to your exact specifications.
Material Capabilities Include:
PTFE
Melt Fluoropolymers
Polyolefins
Thermoplastic Elastomers
Thermoplastic
Polyurethanes
Polyamides
PEEK

Company Description
Since 1980, Fluortek has
been serving the needs of
the worlds leading medical device manufacturers,
specializing in the creation
of extrusions engineered
to custom requirements
and unique applications.
From R&D runs to full contract production quantities, Fluortek meets the
exacting needs of todays
leading medical device
manufacturers while taking you from concept to
production faster and
more cost-effectively than
ever before.

Extrusion Capabilities
Include:
Multi-Lumen & Profile
Tubing
Bump/Taper Tubing
Heatshrink (PTFE, FEP, PE)
Radiopaque Splittable Sheaths
Thin Wall PTFE Liners
Braid and Coil Reinforced Tubing
Custom Material Compounding
Value Added Capabilities Include:
Thermoforming Operations
Mechanical Operations
General Assembly
Fluoropolymer Etching
Annealing
Printing

Target Markets
Our ultimate goal is to create solutions that drive your
companys growth.

Medical Devices, OEM

Products/Services Offered
Every extrusion that
leaves the Fluortek manufacturing facility is a custom
product, designed to the
exact needs of our customer. Combine that with
the industrys most accessibleand most responsive
customer service staff, and
its clear why Fluortek is
chosen every day by medical device manufacturers
around the world. We offer
one of the broadest ranges
of material options, extrusion solutions, and valueadded services in the industry. Backed by extensive engineering experience and a medically focused ISO 13485 certified

www.Fluortek.com

Free Info at http://info.hotims.com/61066-857

26

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Advertisement

Nelson Laboratories, LLC


6280 S. Redwood Rd.
Salt Lake City, UT 84123
Phone: 801-290-7500
Fax: 801-290-7998
E-mail: sales@nelsonlabs.com
www.nelsonlabs.com

Company Description

Services/Products Offered

Nelson Laboratories is a leading provider of microbiology


testing and consulting services for medtech companies. We go
beyond exceptional quality and rigorous testing standards to
provide solutions that improve patient outcomes and minimize
client risk. We call it The Science of Success. It means giving
clients direct access to industry experts who can help find solutions to complex problems, providing precise test results that
ensure product safety and efficacy, and delivering value
through superior testing solutions and service. We know that
every test matters. It's what drives us to set the very highest of
standards. Learn more at www.nelsonlabs.com.

Getting ready to launch a medical device? Nelson


Laboratories will help you ensure your product meets federal
requirements and validate your product claims. Working with
Nelson Labs gives you access to in-depth testing expertise,
innovative testing techniques, and world-class facilities and
equipment all designed to you help you get your products to
market faster and minimize risk. Learn about the wide range of
tests we offer for biocompatibility, cleaning validations, facility
validation, reusable device studies, raw materials screening,
sterilization and packaging validations, cleanroom and isolator
facilities, and routine quality control tests.

Target Markets
Orthopedics
Cardiovascular
Endoscopy
Wound Management

Hospital Consumables
Tissue
Pharmaceuticals

www.nelsonlabs.com

Free Info at http://info.hotims.com/61066-858

Medical Design Briefs, October 2016

www.medicaldesignbriefs.com

Intro

Cov

ToC

27

Advertisement

TELEFLEX MEDICAL OEM


1425 Tri-State Parkway, Suite 120
Gurnee, IL 60031
Phone: 800-474-0178 or 508-964-6021
E-mail: oeminfo@teleflex.com
www.teleflexmedicaloem.com or www.teleflexmedicaloem.cn

Target Markets
TELEFLEX MEDICAL OEM is ready to help you succeed. We
welcome product development and manufacturing projects
from medical equipment manufacturers, both large and small.

Company Description:

Products/Services Offered

Extensive, integrated capabilities. Decades of experience.


Deep expertise. A dedication to design for manufacturability.
That is why you should work with the experts at TELEFLEX
MEDICAL OEM. We are that partner that can hear what you are
saying, understand your needs, and arrive at innovative, customized solutions.
The TELEFLEX MEDICAL OEM team has what it takes to
inspire innovation, follow through on every detail, and, ultimately, get your product into the market. We are the go to
people for OEMs worldwide who want to partner with a proven
leader in custom-engineered:
Extrusions
Diagnostic and interventional catheters
Balloons and balloon catheters
Sheath/dilator sets (introducers)
Specialized sutures, braids, and fibers
Bioabsorbable sutures, yarns, and resins

If innovation in medical devices is on your agenda, you


should be partnering with TELEFLEX MEDICAL OEM. Great
work is what drives us and what we deliver for our customers.
We are a world-class 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 get your great ideas off the drawing board and
into production. Our vertically integrated, 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 private labeling
Sterilization

www.teleflexmedicaloem.com

Free Info at http://info.hotims.com/61066-859

28

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

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

Products/Services Offered

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, 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 heat shrinks, PEEKshrink,


FluoroPEELZ peelable fusing sleeves, thin-walled Sub-LiteWall, Aeos ePTFE, Absorv bioabsorbables, Bioweb electrospun composites, drawn fiber, and multi-lumen tubing. Zeus
also offers a full array of Optimized Tubing Solutions, 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 componentry samples with swift delivery. Zeus also offers the expertise of our traveling Technical
Z-teams comprised of polymer scientists, engineers, and
technicians who are available to consult on pressing on-site
projects.

Target Markets
Peripheral Vascular, Cardiovascular, Neurovascular, Structural
Heart, Cardiac Rhythm Management/Electrophysiology, GI
Endoscopy

www.zeusinc.com

Free Info at http://info.hotims.com/61066-860

Medical Design Briefs, October 2016

www.medicaldesignbriefs.com

Intro

Cov

ToC

29

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
www.anometproducts.com

Products/Services Offered
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

www.anometproducts.com

Free Info at http://info.hotims.com/61066-861

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


30

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-862

Intro

Cov

ToC

Advertisement

Nordson MEDICAL, Avalon Catheter Solutions


2610 E. Homestead Place
Rancho Dominguez, CA 90220
Phone: 310-761-8660
Fax: 310-761-8665
E-mail: info@avalonlabs.com
www.nordsonmedical.com

Company Description
Nordson MEDICAL, Avalon Catheter Solutions utilizes liquid polymers to produce reinforced tubing for medical
devices. Polymer solution casting can achieve both flexibility and pushability along a catheter shaft by utilizing polymer layers to encapsulate multiple components and reinforcements such as braids, coils, and hypotubes. This technology lends itself to varying wall thicknesses and diameters
along the length of the device in a single piece construction
while maintaining tight tolerances.

Target Markets
Catheters, Cannula, Shafts, and Assemblies

Products/Services Offered
Our technology provides a multitude of medical device design
options while streamlining manufacturing processes for improving manufacturability and reliability.
Shapes
Single and multi-lumen
Complex geometric designs
Embedded Reinforcement/Features
Coiling and braiding (flat, round wire)
Hypotubes
Malleable and laser cut wires
Radiopaque/imaging targets
(marker bands, tantalum dots)
Medical-grade stainless steel or
nitinol
Tubing/Shaft Features
Kink resistant
Column strength
Varying durometer or wall thickness along the length
Lubricious inner and/or outer surface
Hubs, Luers, Caps, and Connectors
Custom or standard colors
Hub bonding

www.nordsonmedical.com

Free Info at http://info.hotims.com/61066-863

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-864

Intro

Cov

ToC

31

Advertisement

Target Markets
Single and Disposable Finished Medical Devices
SMC Ltd.
330 SMC Drive
Somerset, WI 54025
Phone: 715-247-3500
Fax: 715-247-4462
E-mail: inquiry@smcltd.com
www.smcltd.com

Products/Services Offered

Company Description
SMC Ltd. offers finished device manufacturing services for
the medical and pharmaceutical industry.
With 12 facilities in
North America, Costa
Rica, and India, SMC
provides services including, optimized supply chain, world-class device manufacturing, highest quality standards, and expertise in finished devices. Facilities offer ISO
13485, quality systems, white room, and class 7 and 8 clean
rooms.

Passion for technology has driven SMC Ltd. to be a leading


manufacturing partner to the top medical device OEMs. With
operations spanning the United States, Costa Rica, and India,
SMC is positioned to assist with you on your next finished medical device.
Our strength in IQ/OQ/PQ, network of established and qualified suppliers, and experience in custom component manufacturing allow us to manage your program from concept through
distribution.
With services spanning product design, engineering, prototyping, custom component manufacturing, assembly, testing, packaging, and strategic supply chain management,
together we customize solutions to meet the specific needs
of your product.

www.smcltd.com

Free Info at http://info.hotims.com/61066-865

CONTRACT
MANUFACTURING
ELECTRONIC INTEGRATION
Whether you require up-front services such as electronic integration design or full manufacturing
GETEFMPMXMIW2(LEWXLIFERH[MHXLXSFVMRK]SYVRMWLIHHIZMGIXSVIEPM^EXMSR;MXLKPSFEPPSGEXMSRW[I
EVITSWMXMSRIHXSWIVZI]SYVRIIHWJVSQEVIKMSREPPIZIP8SWIILS[[IGERTEVXRIV[MXL]SYSR]SYVRI\X
medical device visit: [[[WQGPXHGSQ

715.247.3500 inquiry@smcltd.com

32

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-866

Intro

Cov

ToC

Advertisement

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

Products/Services Offered

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

Free Info at http://info.hotims.com/61066-867

Medical Design Briefs, October 2016

33

Free Info at http://info.hotims.com/61066-868

Intro

Cov

ToC

Advertisement

Target Markets
Medical and Life Sciences
Cadence, Inc.
9 Technology Drive
Staunton, VA 24401
Phone: 800-252-3371
Fax: 540-248-4400
E-mail: sales@cadenceinc.com
www.cadenceinc.com

Products/Services Offered

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
ex p e r t i s e,
making new
products a
reality.

Cadence is a fullservice contract manufacturer offering assembly, packaging, and


sterilization services
in our Product Realization Center, as
well as in our nearshore operations in
the Dominican Republic. 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. We are vertically integrated with
extensive in-house metals and plastics manufacturing expertise
including machining, metal stamping, grinding, tubing fabrication, laser welding, plastic injection molding, and much more.

www.cadenceinc.com

Free Info at http://info.hotims.com/61066-869

Webinars
Available On Demand!

Getting Started with Medical Device


Security: Top Ten Steps to Take Today
In this Webinar, we will explore some of the goals and challenges of medical device security today. After reviewing some
foundational concepts, we will discuss the Top Ten Steps that a medical device manufacturing company can take today to start
enhancing the security of its medical devices. Practical, actionable information will be clearly presented and explained.

Speaker

This 30-minute Webinar includes:


Live Q&A session
Application Demo
Access to archived event on demand

Chana OLeary
Sr. Application Security Consultant
OpenSky Corp.

Please visit www.techbriefs.com/webinar328

34

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Advertisement

MASCOT
P.O. Box 177
N-1601, Fredrikstad, Norway
Phone: +47 69 36 43 00
E-mail: sales@mascot.com
www.mascot.no

Company Description:
The custom design, development, and manufacturing of
power supplies and chargers to customers specifications,
including small modifications of existing models to entirely
new units, enclosed or open frame.
Contact us for a quote experience the Mascot way of
doing business!

Target Markets
Medical
Industrial
Safety & Security

Products/Services Offered:
Power Supplies
AC/DC desktop/wall mount, DC/DC converters, DC/AC Inverters
Battery chargers
Li-Ion, NiMH, and lead acid batteries
Founded in 1938, Mascot was one of the radio manufacturing pioneers in Norway. Today, Mascot is a leading manufacturer of power supplies and battery chargers for several markets. We offer same-day shipment from stock of standard
products or custom units designed in cooperation with our
experienced development team.

www.mascot.no

Free Info at http://info.hotims.com/61066-896

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-897

Intro

Cov

ToC

35

Superconducting Coil Improves


MRI Performance
Led by scientist Jared Wosik,
researchers from the University of
Houston, Houston, TX, have built a
high-temperature superconducting
coil that allows magnetic resonance
imaging (MRI) scanners to produce
A University of Houston
higher-resolution images.
research team developed
a high-temperature superCompared with conventional coils,
conducting coil that allows
images are acquired in a shorter
MRI scanners to produce
amount of time. Test results demonhigher-resolution images.
strated that the technology reveals
brain structures that are not easily visualized with the traditional MRI components.
The cryo-coil boosts signal-to-noise ratio (SNR) a measure
of the strength of signals carrying useful information by a factor of two to three, compared with standard coils. High SNR characteristics lead to better imaging resolution.
Results from preliminary testing of the 7 Tesla MRI Cryoprobe were presented at the International Symposium of
Magnetic Resonance in Medicine annual meeting in May. The
researchers demonstrated a 34-m isotropic resolution.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/25306.
Researchers Develop Gold
Standard for Artificial Joints
Physicists from Rice University,
Houston, TX, have discovered a
stronger material for artificial knee
and hip joints. A 3:1 mixture of titanium and gold created a tightly packed,
cubic crystalline structure that
Rice University physicists
imparts greater hardness.
"Its four times harder than pure discovered a titanium-gold
alloy for use in artificial
titanium, which is what is currently joints that is four times
being used in most dental implants harder than most steels.
and replacement joints, said lead sci- This is the crystal structure of beta titanium-3entist Emilia Morosan.
gold. (Credit: E. Morosan,
Morosan initially studied titanium- Rice University)
gold, a 1:1 ratio compound and magnetic material. After being unable to grind the compound into
powder for x-ray purposes, the researcher experimented with
other combinations of the two elements.
One of the created compounds was a mixture of three parts
titanium and one part gold that had been prepared at high
temperature.
Because titanium and gold by themselves are among the
most biocompatible metals and are often used in medical
implants, the Rice University team believe titanium-3-gold
provides a valuable option for artificial joints.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/25307.
36

Sensor Monitors Blood Alcohol Levels


Engineers at the University of California, San Diego, CA,
have developed a flexible wearable sensor that accurately measures an individuals blood alcohol
level from sweat and transmits the
data wirelessly to a laptop or smartphone. The device could be used
by doctors for continuous, noninvasive, and real-time monitoring
of blood alcohol content.
Engineers at the University of
A group led by nanoengineering
California San Diego have
professor
Joseph Wang fabricated a
developed a flexible wearable
sensor that can accurately
tattoo, equipped with screen-printmeasure a persons blood
ed electrodes and a small hydrogel
alcohol level from sweat and
patch containing pilocarpine, a
transmit the data wirelessly
drug that passes through the skin
to a laptop or smartphone.
and induces sweat.
After the temporary tattoo releases the pilocarpine, the
resulting sweat comes into contact with an electrode coated
with alcohol oxidase. The enzyme selectively reacts with alcohol to generate hydrogen peroxide, which is electrochemically
detected. The information is then sent to the electronic circuit
board as electrical signals, and the data is communicated wirelessly via Bluetooth to a mobile device.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/25308.
Soft Materials Feature
Broad Range of Motion
Researchers at the Harvard John
A. Paulson School of Engineering
and Applied Sciences (SEAS),
Cambridge, MA, have developed a
dielectric elastomer with a broad
range of motion. The soft material
requires relatively low actuation
An artificial muscle built from a
voltage and no rigid components.
sandwich of soft, stretchable
In building a dielectric elas- elastomers and carbon nanotomer, the team combined two tube electrodes. This type of
actuator could be used in wearknown materials that worked well able devices, soft grippers,
individually an elastomer that laparoscopic surgical tools,
eliminated the need for rigid robots, and more. (Credit: Peter
Allen, Harvard SEAS)
components and an electrode of
carbon nanotubes developed in Harvards lab.
The modified materials begin as liquids and can be cured
rapidly under UV light to produce paper-thin sheets. Because
the sheets are sticky, the materials adhere well to each other,
and to the electrodes. The nanotubes neither increase the stiffness of the elastomer nor decrease the energy density.
The actuator could be used in a variety of applications,
including wearable devices, laparoscopic surgical tools, and
artificial muscles.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/25309.

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Transient Battery Self-Destructs When Dropped


in Water
A self-destructing, lithium-ion
battery from Iowa State University,
Ames, IA, delivers 2.5 V and dissolves or dissipates in 30 minutes
when dropped in water.
Unlike conventional electronics
that are designed to last for extensive periods of time, a key and
unique attribute of transient elecIowa State scientists have
tronics is to operate over a typically
developed a working batshort and well-defined period, and
tery that dissolves and disperses in water. The batundergo fast and, ideally, complete
tery is tiny; its about 1
self-deconstruction and vanish
mm thick, 5 mm long, and
when transiency is triggered, the
6 mm wide. (Credit: Ashley
Christopherson)
scientists wrote in their paper.
The transient battery is made up
of eight layers, including an anode, a cathode, and the electrolyte separator all wrapped up in two layers of a polyvinyl
alcohol-based polymer. The battery itself is small about 1
mm thick, 5 mm long, and 6 mm wide.
When the battery is dropped into water, the polymer casing
swells, breaks apart the electrodes, and dissolves away. The battery contains nanoparticles that disperse (and not degrade) as
the batterys casing breaks the electrodes apart.
The Iowa State technology could save patients from the pain
of removing a medical device.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/25310.

Medical Design Briefs,October 2016

Vibrating Footwear Supports Visually Impaired


A new space boot from the Massachusetts Institute of
Technology, Cambridge, MA, and the Charles Stark Draper
Laboratory, Cambridge, MA, has built-in sensors and tiny haptic motors. Vibrations from the motors guide the wearer
around obstacles.
By communicating spatial information to users, the technology could support the design of navigation systems for the
visually impaired.
After a pilot attempt that incorporated six haptic motors around
a subjects feet, graduate student
Alison Gibson is now developing
a boot with motors at only three
locations: the toe, the heel, and Researchers are developing a
the front of the foot away from new boot with built-in sensors
the middle location where stimuli and tiny haptic motors, whose
vibrations can guide the weardo not consistently register.
er around or over obstacles.
Stimuli will jump from low to Vibrations will jump from low to
high intensity when the wearer is high intensity when the wearer
is at risk of colliding with an
at risk of colliding with an obsta- obstacle. (Credit: Jose-Luis
cle. The high-intensity stimuli will Olivares, MIT)
also be pulsed to help distinguish
the sensation from the low-intensity warnings.
In principle, the motor at the side of the foot could help
guide the user around obstacles. The first trial of the boot,
however, will concentrate entirely on the problem of stepping
over obstacles of different heights.
For more information, visit www.medicaldesignbriefs.com/
component/content/article/1104-mdb/features/25311.

37

Free Info at http://info.hotims.com/61066-870

Intro

Cov

ToC

Implanted Devices Can Talk Through Wi-Fi


Implanted and wearable
electronics reflect signals
for ultra-low-power
communication.
University of Washington,
Seattle, WA
University of Washington (UW) engineers have introduced a new way of communicating that allows devices such as
brain implants, contact lenses, and smaller wearable electronics to talk to everyday
devices like smartphones and watches.
This new interscatter communication
works by converting Bluetooth signals
into Wi-Fi transmissions over the air.
Using only reflections, an interscatter
device such as a smart contact lens converts Bluetooth signals from a smartwatch,
for example, into Wi-Fi transmissions that
can be picked up by a smartphone.
Wireless connectivity for implanted
devices can transform how we manage
chronic diseases, said Vikram Iyer, a
UW electrical engineering doctoral student. For example, a contact lens could
monitor a diabetics blood sugar level in
tears and send notifications to the
phone when the blood sugar level goes
down.
Due to their size and location within
the body, the smart contact lenses are
too constrained by power demands to
send data using conventional wireless
transmissions. That means that so far
they have been unable to send data over
Wi-Fi to smartphones and other mobile
devices. Those same requirements also
limit emerging technologies such as
brain implants that treat Parkinsons disease, stimulate organs, and may one day
even reanimate limbs.
The team of UW electrical engineers
and computer scientists has demonstrated for the first time that these types of
power-limited devices can talk to other
devices using standard Wi-Fi communication. Their system requires no specialized equipment, relying solely on common mobile devices to generate Wi-Fi
signals using 10,000 times less energy
than conventional methods. Instead of
generating Wi-Fi signals on your own,
our technology creates Wi-Fi by using
Bluetooth transmissions from nearby
mobile devices such as smartwatches,
said Vamsi Talla, a recent UW doctoral
graduate in electrical engineering who is

Interscatter communication generates low-power Wi-Fi transmissions using everyday mobile


devices. In one example, Bluetooth signals from a smartwatch (left) transmit data from a neural
device that can be implanted in a patients brain (right) to a smartphone via Wi-FI. (Credit: Mark
Stone, University of Washington)

now a research associate in the


Department of Computer Science and
Engineering.
How It Works
The teams process relies on a communication technique called backscatter,
which allows devices to exchange information simply by reflecting existing signals. Because the new technique enables
intertechnology communication, the
team calls it interscattering. Interscatter
communication uses the Bluetooth, WiFi, or ZigBee radios embedded in common mobile devices like smartphones,
watches, laptops, tablets, and headsets to
serve as both sources and receivers for
these reflected signals.
The team demonstrated one example
in which a smartwatch transmitted a
Bluetooth signal to a smart contact lens
outfitted with an antenna. To create a
blank slate on which new information
can be written, the UW team developed
an innovative way to transform the
Bluetooth transmission into a singletone signal that can be further manipulated and transformed. By backscattering that single-tone signal, the contact
lens can encode data such as health

38

information it may be collecting into


a standard Wi-Fi packet.
Bluetooth devices randomize data
transmissions using a process called
scrambling, said Shyam Gollakota, assistant professor of computer science and
engineering. We figured out a way to
reverse engineer this scrambling process
to send out a single-tone signal from
Bluetooth-enabled devices such as
smartphones and watches using a software app.
The challenge, however, is that the
backscattering process creates an
unwanted mirror image copy of the signal, which consumes more bandwidth
and interferes with networks on the mirror copy Wi-Fi channel. But the UW
team developed a technique called singlesideband backscatter to eliminate the
unintended byproduct. That means
that we can use just as much bandwidth
as a Wi-Fi network and you can still have
other Wi-Fi networks operate without
interference, said electrical engineering doctoral student Bryce Kellogg.
The researchers who work in UWs
Networks and Mobile Systems Lab and
Sensor Systems Lab built three proofof-concept demonstrations for previous-

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

ly infeasible applications, including a


smart contact lens and an implantable
neural recording device that can communicate directly with smartphones and
watches.
Preserving battery life is very important in implanted medical devices, since

replacing the battery in a pacemaker or


brain stimulator requires surgery and
puts patients at potential risk from complications, said Joshua Smith, associate
professor of electrical engineering and
of computer science and engineering.
Interscatter can enable Wi-Fi for these

implanted devices while consuming only


tens of microwatts of power.
An informational video is available at www.
youtube.com/watch?v=MoeFYCGbthk&
feature=youtu.be.
For more information, visit www.washington.
edu/news/.

Tiny Solar Cells Deliver Big Power


The microscale cells
capture current from
charges moving side-to-side.
University of WisconsinMadison, Madison, WI
Engineers at the University of
Wisconsin-Madison have created microscale solar cells that could power a multitude of personal devices, including
wearable medical sensors, smartwatches,
and autofocusing contact lenses. While
large, rooftop photovoltaic arrays generate electricity from charges moving vertically, these small cells capture current

from charges moving side-to-side, or laterally. The researchers claim that their
cells generate significantly more energy
than other lateral solar energy systems.
Lateral solar cells hold promise for
compact devices because arranging electrodes horizontally allows engineers to
sidestep a traditional solar cell fabrication
process the arduous task of perfectly
aligning multiple layers of the cells material atop one another. From a fabrication point of view, it is always going to be
easier to make side-by-side structures,
says Hongrui Jiang, a UW-Madison professor of electrical and computer engineering. Top-down structures need to be
made in multiple steps and then aligned,

which is very challenging at small scales.


Lateral solar cells also offer engineers
greater flexibility in materials selection.
Top-down photovoltaic cells are made
up of two electrodes surrounding a semiconducting material, like slices of bread
around the filling in a sandwich. When
light hits the top slice, charge travels
through the filling to the bottom layer
and creates electric current.
In the top-down arrangement, one
layer needs to do two jobs; it must let in
light and transmit charge. Therefore, the
material for one electrode in a typical
solar cell must be not only highly transparent, but also electrically conductive. Not
many substances perform both tasks well.

Smart electronic solutions


from design to nished
medical devices
Cicor is a leading international high-tech
industrial group active in advanced microelectronics,
substrates and electronic solutions.
The group offers complete outsourcing services
and a broad range of innovative technologies,
electronics and a wide range of production options
from PCB assembly, system assembly, box-building,
toolmaking and plastic injection moulding.
With 10 production sites and more than
20 representative ofces worldwide, the group
supplies high-quality custom-made solutions
to its clients worldwide.
Electronic Solutions
T +41 71 913 73 73
info-europe@cicor.com

America
Cicor Americas Inc.
T +1 617 576 2005
info-americas@cicor.com

Asia
Cicor Asia Pte Ltd.
T +65 6546 16 60
info-asia@cicor.com

cicor.com

Headquarter
T +41 71 913 73 00
info@cicor.com

Free Info at http://info.hotims.com/61066-871

Europe
Advanced Microelectronics
& Substrates
T +41 32 843 05 00
info-europe@cicor.com

Intro

Cov

ToC

Hongrui Jiang inspects the alignment of a light source to illuminate lateral solar cells. The solar cells
developed by Jiangs group harvest almost three times more electricity from incoming light as compared with existing technologies. (Credit: Stephanie Precourt)

How It Works
Instead of building its solar cell sandwich one layer at a time, Jiangs group
created a densely packed, side-by-side
array of miniature electrodes on top of
transparent glass. The resulting structure akin to an entire loaf of breads

worth of solar-cell sandwiches standing


up sideways on a clear plate separates
light-harvesting and charge-conducting
functions between the two components.
Generally, synthesizing such sideways
sandwiches isnt simple. Approaches that
rely on complicated internal nanowires

or expensive materials called perovskites


fall short on multiple measures of solar
cell quality.
Existing top-of-the-line lateral solar
cells convert 1.8 percent of incoming
light into useful electricity. Jiangs group
nearly tripled that measure, achieving
up to 5.2 percent efficiency. In other
structures, a lot of volume goes wasted
because there are no electrodes, or the
electrodes are mismatched, says Jiang.
The technology we developed allows us
to make very compact lateral structures
that take advantage of the full volume.
Packing so many electrodes into such a
small volume boosted the devices fill factors, a metric related to the maximum
attainable power, voltage, and current. The
structures realized fill factors up to 0.6,
which the researchers claim is more than
twice the demonstrated maximum for
other lateral, new-generation solar cells.
Jiang and colleagues are working to
make their solar cells even smaller and
more efficient by exploring materials
that further optimize transparency and
conductivity. Ultimately, they plan to
develop a small-scale, flexible solar cell
that could provide power to an electrically tunable contact lens.
For more information, visit http://
news.wisc.edu.

Biodegradable Polymer Is Stronger and Longer Lasting


Treating PLA with heat
and pressure makes it
more useful in medical
applications.
Brown University,
Providence, RI
Polylactic acid, or PLA, is a biodegradable polymer commonly used to make a
variety of products, from disposable cups
to medical implants to drug-delivery systems. A team of Brown University

researchers has shown that by treating


PLA at various temperatures and pressures, they can induce a new polymer
phase in the material that could possibly
decrease the rate at which it degrades.
Its an exciting finding from the standpoint of basic science, in that weve found
a new polymer phase and have identified
a method for inducing it, said Edith
Mathiowitz, a professor of medical science
and engineering at Brown. In terms of
applications, the polymer we worked with
in this study has many uses, and we believe

Treating polylactic acid, a commonly used polymer material, with heat and pressure creates crystals
and causes polymer strands to become more organized. Those changes could make the material
more useful in medical applications. (Credit: Mathiowitz Lab, Brown University)

40

the properties we have discovered now


will allow us to make it better.
PLA is a semicrystalline material,
meaning that parts of the materials
molecular structure are ordered into
crystals. The rest is disordered, or amorphous, like glass. Work by previous
researchers had shown that treating PLA
with heat could increase the materials
crystalline makeup, which could help to
increase its strength. Researchers in
Mathiowitzs lab, led by doctoral candidate and U.S. Navy veteran Christopher
Baker, wanted to see whether adding
pressure to the treatment process would
further influence the materials structure.
Baker treated PLA samples under a
variety of different temperature and
pressure conditions for varying amounts
of time. Pressures ranged from 2,000 to
20,000 psi. Temperatures used for treatments were above, below, and nearly
equal to the glass transition temperature
for PLA the temperature at which the

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

amorphous parts of the material transition from solid to rubbery.


Baker showed that the treatments
increased the amount of crystalline area
in the material, but there was another
more surprising finding. At higher temperatures and pressures, the amorphous
parts of the material became birefringent, meaning that they bend light differently depending upon how the light
is polarized. That is an indicator of a
substantial structural change in the
amorphous portions of the material.
Generally speaking, birefringence is a
property found in crystalline materials,
and seeing it in the amorphous regions of
PLA was a surprise to the researchers.
Baker then used several methods to further characterize how the amorphous
regions had changed. Using a technique
called x-ray diffraction, he showed that
polymer strands in some of the amorphous sections had become dramatically
more ordered. The polymer strands are
normally a tangled mess, Baker said.
But we found when we processed the
material that the amorphous region
became less entangled and much more
oriented in a particular direction.
Further thermal analysis showed that
the more ordered sections had a higher
glass transition temperature. In general,
amorphous materials with higher glass
transition temperatures degrade at significantly slower rates.
According to the researchers, the new
amorphous phase combined with the
overall increase in crystallinity in the
treated samples could have significant
implications for the materials mechanical properties. The higher crystallinity
could make it stronger, while the more
ordered amorphous sections could
make it last longer. That slower rate of
degradation could be particularly useful
in medical applications, an area in
which Mathiowitzs lab specializes.
For example, PLA is used as a coating for
implantable drug-delivery systems. If the
rate at which PLA degrades can be controlled, the rate at which it delivers a drug
can be altered. There is also interest in
using PLA for plates and screws used to stabilize broken bones. The advantage to PLA
implants is that they degrade over time, so
a patient would not need a second surgery
to remove them. PLA may degrade too
quickly for some of these applications, but
if this new polymer phase slows degradation, it may become a better option.
For more information, visit http://
news.brown.edu.

Gaming Camera Aids MS Treatment


A 3D depth-sensing
camera can measure
walking difficulties.
McGill University, Montreal,
Quebec, Canada
A device commonly found in living
rooms around the world could be an
inexpensive and effective means of eval-

uating the walking difficulties of multiple sclerosis (MS) patients. The


Microsoft Kinect is a 3D depth-sensing
camera used in interactive video activities such as tennis and dancing. It can be
hooked up to an Xbox gaming console
or a Windows computer.
A team of McGill University researchers collaborated with the Montreal
Neurological Institute and Hospital to

@ MachinedSprings.com

2016 Helical Products Company | www.heli-cal.com

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-872

Intro

Cov

ToC

41

A team of researchers led by McGill University postdoctoral fellow Farnood Gholami tested whether
the Kinect could detect the differences in gait of MS patients compared with healthy individuals.
(Credit: Shawn Hayward)

test whether the Kinect could detect the


differences in gait of MS patients compared with healthy individuals. In current clinical practice, the walking movement of MS patients is usually assessed by
their doctors, and subjective evaluations
may distort results because two different
clinicians may give the same patient different evaluations. Using a camera that
detects movement and computer algorithms that quantify the patients walking
patterns can reduce the potential for
human error.
The researchers were led by postdoctoral fellow Farnood Gholami and supervised by Jozsef Kvecses from the
Department of Mechanical Engineering
and Centre for Intelligent Machines.

Gholami captured the movement of 10


MS patients and 10 members of an ageand-sex-matched control group using
the Kinect device. The MS patients had
previously been assessed for gait abnormalities using the traditional clinician
method.
How It Works
Using the data, the team then developed computer algorithms that quantified gait characteristics of MS patients
and healthy people. The investigators
found that gait characteristics measured
with the Kinect camera and analyzed
with the developed algorithms were
reproducible, and were different
between MS patients and the healthy

individuals. Moreover, the gait characteristics of MS patients obtained by the


algorithm were correlated with clinical
measures of gait. The algorithms could
mathematically define the characteristics of gait in MS patients at different
severity levels, accurately determining
the level of gait abnormality.
Gholami says he became interested
in using motion-capture technology for
clinical purposes as a PhD student, but
the equipment he was using at the time
was very expensive, difficult to use, and
nonportable, making widespread clinical use prohibitive. The Kinect device
gave him an inexpensive tool that
appears accurate enough to do the job.
This tool may help the clinician provide a better diagnosis of gait pathology,
and may be used to observe if a prescribed medication has been effective on
the gait of the patient or not, he says.
Our developed framework can likely be
used for other diseases causing gait
abnormalities as well, for instance
Parkinsons disease.
Daria Trojan, a physiatrist in the
Department of Neurology and Neurosurgery working at the Montreal Neurological Institute and Hospital, says the
tool could be useful to assess treatment
effects of certain interventions, such as
rehabilitation or medication, and to document MS disease progression as reflected by gait deterioration. It may also be
useful as a measure in clinical trials. The
next step is to conduct a study with a larger group of MS patients, including evaluation in a gait laboratory, using a newer
version of the Kinect device that promises
to improve accuracy.
For more information, visit www.mcgill.ca/
neuro/Kinect-MS-Device-Gait.

Dust-Sized Sensors Could Create Electroceuticals


Wireless, implantable
sensors could have wide
use in body monitoring.
University of California,
Berkeley, CA
University of California, Berkeley
engineers have built the first dustsized, wireless sensors that can be
implanted in the body, bringing closer
the day when a Fitbit-like device could

monitor internal nerves, muscles, or


organs in real time. These batteryless
sensors, called neural dust, can also be
used to stimulate nerves and muscles,
opening the door to electroceuticals
to treat disorders such as epilepsy, stimulate the immune system, or tamp
down inflammation.
The neural dust, which the team
implanted in the muscles and peripheral
nerves of rats, is unique in that ultrasound is used both to power and to read
out the measurements. Ultrasound tech-

42

nology is already well developed for hospital use, and ultrasound vibrations can
penetrate nearly anywhere in the body,
unlike radio waves, the researchers say.
I think the long-term prospects for
neural dust are not only within nerves
and the brain, but much broader, said
Michel Maharbiz, an associate professor
of electrical engineering and computer
sciences. Having access to in-body
telemetry has never been possible because there has been no way to put something super tiny super deep. But now I

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Ultra-Miniature - High Reliability


Quartz Crystals, Oscillators
and Sensors

UNSURPASSED QUALITY
THE MEDICAL INDUSTRY
COUNTS ON

The sensor mote contains a piezoelectric crystal (silver cube) and a simple electronic circuit that
responds to the voltage across two electrodes to alter the backscatter from ultrasound pulses produced by a transducer outside the body. The voltage across the electrodes can be determined by
analyzing the ultrasound backscatter. (Credit: Ryan Neely, UC Berkeley)

can take a speck of nothing and park it


next to a nerve or organ, GI tract, or a
muscle, and read out the data.
How It Works
The sensors, which the researchers
have already shrunk to a 1-mm cube
(about the size of a large grain of sand),
contain a piezoelectric crystal that converts ultrasound vibrations from outside
the body into electricity to power a tiny,
onboard transistor that is in contact with
a nerve or muscle fiber. A voltage spike
in the fiber alters the circuit and the
vibration of the crystal, which changes
the echo detected by the ultrasound
receiver, typically the same device that
generates the vibrations. The slight
change, called backscatter, allows them
to determine the voltage.
In their experiment, the UC Berkeley
team powered up the passive sensors
every 100 microseconds with six 540nanosecond ultrasound pulses, which
gave them a continual, real-time readout. They coated the first-generation
motes, which were 3 mm long, 1 mm
high, and 4 5 mm thick, with surgicalgrade epoxy. However, they are currently building motes from biocompatible
thin films that would potentially last in
the body without degradation for a
decade or more.
While the experiments so far have
involved the peripheral nervous system
and muscles, the neural dust motes
could work equally well in the central
nervous system and brain to control

prosthetics, the researchers say. Todays


implantable electrodes degrade within 1
to 2 years, and all connect to wires that
pass through holes in the skull. Wireless
sensors could be sealed in, preventing
infection and unwanted movement of
the electrodes.
Researchers had previously estimated
that they could eventually shrink the
sensors down to a cube 50 m on a side,
about half the width of a human hair. At
that size, the motes could be used in the
brain and central nervous system,
replacing wire electrodes.
The team is working now to miniaturize the device further, find more biocompatible materials, and improve the
surface transceiver that sends and
receives the ultrasounds, ideally using
beam-steering technology to focus the
sounds waves on individual motes.
Theyre also working to expand the
motes ability to detect nonelectrical signals, such as oxygen or hormone levels.
The vision is to implant these neural
dust motes anywhere in the body, and
have a patch over the implanted site
send ultrasonic waves to wake up and
receive necessary information from the
motes for the desired therapy you
want, said Dongjin Seo, a graduate student in electrical engineering and computer sciences. Eventually you would
use multiple implants and one patch
that would ping each implant individually, or all simultaneously.
For more information, visit http://
news.berkeley.edu/category/research/.

Medical Design Briefs, October 2016

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Grade Crystals,


Oscillators and Sensors
High stability and precision
Used in implantable devices
Excellent long term aging
Low power consumption
ISO 9001:2008
AS9100C

STATEK CORPORATION

512 N. Main St., Orange, CA 92868


Tel. 714-639-7810
Fax 714-997-1256

www . STATEK . com


Free Info at http://info.hotims.com/61066-873

Photonics Alignment Platform

PRODUCT OF THE MONTH


UV Plastic Adhesive
Panacol-Elosol GmbH, Steinbach, Germany, offers a UV
adhesive for bonding plastics that is available in three different
viscosities. The appropriate viscosity can be chosen depending
on the application. Vitralit
7311 is low viscosity and works
well for tight bond gaps, Vitralit
7311 T is a mid-range viscosity
version, and Vitralit 7311 Gel
features high-viscosity, non-flowing properties.
All three variations of Vitralit 7311 adhere to most plastics,
such as PC, PVC, and PMMA, as well as to metal and glass. The
adhesive is transparent and non-yellowing and is resistant to
alcohols and humidity. Once cured, the adhesive will be viscoplastic. For use in medical applications, Vitralit 7311 is currently being tested according to USP Class VI and DIN ISO
10993-4/-5 standards.
The adhesive cures in seconds with ultraviolet or visible light.
High-intensity LEDs at 405 nm wavelength are recommended
for the best curing results. This wavelength also allows the
bonding of UV-blocked materials like polycarbonate.
For Free Info Visit http://info.hotims.com/61066-170

Aerotech, Pittsburgh, PA, introduced


the FiberMaxHP second-generation
photonics alignment platform. The
noncontact, direct-drive technology is
capable of 2-nm linear and 0.05-rad
rotary minimum incremental motion
with speeds to 400 mm/s. FiberMaxHP
is available with three to six axes of
direct-drive alignment, and with one to three axes of manual angular alignment with 2 of motion. These manual adjustment axes
mount directly to the direct-drive platform. Aerotechs controllers
work with a variety of smart cameras and machine vision systems.
Standard scanning routines include fast align, hill climb, spiral, and
raster searches in up to six axes of motion. Virtual pivot-point kinematics enable rotation to occur at any user-defined point in space
rather than the physical rotation point of products axes.
For Free Info Visit http://info.hotims.com/61066-171

Stainless Steel Cylinder


Bimba Manufacturing, University Park, IL,
added a compact, stainless steel cylinder to its
Flat-I product line. The stainless steel Flat-I cylinders were designed for applications in which frequent, corrosive wash downs are required to prevent the propagation of bacteria. They come in
eight bore sizes, including 9/16, 3/4, 1-1/16,
1-1/2, 2, 2-1/2, 3, and 4 in. The cylinders have an
IP69K rating 6 for being dust-tight and 9 for protection against
liquids. A hard chrome-plated, stainless steel piston rod helps
extend rod seal life, and minimal mounting holes reduce catch
points.
For Free Info Visit http://info.hotims.com/61066-172

Silicone System
The Silcast 8446 silicone system from EpoxySet, Lincoln, RI, is
designed for bonding to metal surfaces. It protects sensitive electronics
from environmental conditions, thermal
cycling stresses, and vibrational shock. It
can be silk screened to create automotive
gaskets, or used as a potting/encapsulation compound for component protection of delicate parts. In addition, its
rugged enough to use directly for casting
production pieces. The system has a 10:1 mix ratio that has a 16-hour
work time, but can cure in 10 minutes @150 C.

Medical Motion
Limb Orthotics
Surgical Chairs
Medical Carts
Diagnostic
Equipment
Surgical Lighting

Reell improves
mobility and
positioning

For Free Info Visit http://info.hotims.com/61066-173

Vision Sensors

Patented ReellTorq
Technology
reell.com

Innovative Torque Solutions

Our promise Better motion for a better life

For Free Info Visit http://info.hotims.com/61066-174

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-874

44

Festo Corp., Hauppauge, NY, introduced


the SBSI series of low-cost vision sensors for
code reading and quality inspection. The
series offers rugged IP67 housing, built-in
lighting, and EtherNet/IP capability. SBSI sensors can be ordered as components, parts of a subsystem ready for
assembly, or incorporated into a plug-and-play module. The SBSI-B
reads 1D and 2D codes in addition to Direct Part Marking (DPM)
codes. These code readers can be used to identify, track, and trace products for production flow, logistics, and serialization. The SBSI-B reads
up to 10 codes per image. The SBSI-Q for quality inspection can be
used to ensure all relevant parts are mounted and/or accounted for.

Intro

Cov

ToC

Color Concentrates
Foster, Putnam, CT, offers a new line of
color concentrates using FDA 21CFR 73 subpart D pigments for medical device applications. MediBatch color concentrates will be
available in quantities as low as a single
pound. Single pound quantities available
from stock can pigment up to 25 lb of natural
polymer. The color concentrates are formulated with a polymer carrier
that is compatible with a range of base resins, including nylons and
polyurethanes. Twelve standard concentrates, including green, red, yellow, blue, violet, black and white, are available from stock in 1-, 5-, and
10-lb quantities. Custom colored concentrates are also available.
For Free Info Visit http://info.hotims.com/61066-175

High-Volume Manufacturing
J-Pac Medical, Somersworth, NH,
announced that it will provide highvolume, automated manufacturing
capabilities specifically designed for its
on-chip reagent blister technology. The
companys production capabilities
include precision reagent filling for single- and multiple-well formats with
in-line quality control, self-diagnostics with automated detection of nonconforming materials, and multiple sealing profiles unique to each customer application. J-Pac developed two reagent delivery technologies in
single or multi-well formats for common lab-on-chip formats burst and
frangible seal blisters. Frangible and burst seal technology store and
enable the controlled release of testing reagents, eliminating the need for
complex fluid handling.
Free Info at http://info.hotims.com/61066-875

For Free Info Visit http://info.hotims.com/61066-177

Fiber Optic Microswitch


Micronor, Camarillo, CA, introduced the MR386 ZapFREE
Microswitch a fiber-optic microswitch for MRI, medical, and industrial applications. It is interchangeable
with the industry-standard V15-series electrical
microswitch. The Micronor MR386 nonelectrical, passive sensor provides EMI and RFI
immunity, isolation from high voltage and lightning and inherent safety in explosive atmospheres. It can operate
interference-free over distances up to 1500 m. Industrial and MRI safe
models are offered. The industrial model features an extended temperature range of 40 to +80 C. The nonmetallic MRI safe model was purposely designed for use inside the bore and is magnetically invisible to the
imaging process. With a temperature range of 5 to +60 C, this model targets medical, hospital, laboratory, and instrumentation applications.

mdi Consultants, Inc.


Internationally Recognized Consulting Company to the MEDICAL
DEVICE/IVD/PHARMACEUTICAL INDUSTRIES
mdi Consultants Inc. has the expertise and can provide you
exceptional professional aid in the following areas:
 FDA compliance Regulatory strategy development, clinical
trial development/ management, cGMP compliance, ISO, CE
Mark, On-site audits, validation (process, software and
sterilization)
 510(k)/PMA/ANDA/NDA/DMF/IDE Planning - Preparation
and Submission, device listing and registration
 Customized Quality Systems for FDA QSR/cGMP/ISO
Compliance
 FDA Troubleshooting, Response to 483 and Warning letters
 UDI & GUDID Compliance
 Official Correspondent and United States Agent for Foreign
Companies
 FDAAWARE FDA database for all your FDA inspectional
insights

For Free Info Visit http://info.hotims.com/61066-178

Temperature Data Logger


Omega Engineering, Stamford, CT, offers
the OM-CP-CRYO-TEMP temperature data logger that records temperatures as low as 86 C
(122 F). It can be used in applications such as
monitoring blood plasma, vaccines, and pharmaceutical products. The standalone device
does not require any additional probes. The
enclosure is designed with a handle for easy attachment, and is IP65
splash resistant. It uses a USB docking station to communicate with a
personal computer or laptop, and provides date- and time-stamped
temperature readings. Users can view the data in graphical or tabular
form. High and low alarm limits and warning limits can be programmed through the software.

Main Office:
55 Northern Blvd., Great Neck, NY 11021
(Tel.) 516-482 9001 (Fax) 516-482-0186
Email: info@mdiconsultants.com
Website: www.mdiconsultants.com

For Free Info Visit http://info.hotims.com/61066-179

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-876

Intro

Cov

ToC

45

Universal Code Reader

DC Miniature Motor

Pepperl+Fuchs, Twinsburg, OH, announced


the MAC335 universal code reader. The stationary barcode imager reads the most common 1D
and 2D code symbologies without having to
change settings. With 1.3-megapixel resolution,
it can read small and large codes at distances
ranging from 20 to 300 mm at a rate of 3 readings per second. The
MAC335 also features the companys standard operator interface,
Vision-Configurator, which lets users set parameters and displays
images from the reader. The 24-VDC device offers IP65 protection,
and is rated for use in temperatures ranging from 0 to 50 C.

Portescap, West Chester, PA added a


16-mm-diameter frame size to its DCP
range of Athlonix brush DC mini
motors. The 12-V 16DCP motor is 26 mm
long, and features a coreless design with
a self-supporting coil and magnetic circuit. The motor is available in two variations (precious metal commutation and graphite commutation) that
both have an Alnico magnet inside. Maximum continuous torque
reaches 2.63 mNm. An REE (Restriction of Electro Erosion) coil
option is available.

For Free Info Visit http://info.hotims.com/61066-180

For Free Info Visit http://info.hotims.com/61066-182

Round Actuators

Sensor Packaging

PI, Auburn, MA, introduced a new line of round multilayer actuators in its proprietary PICMA ceramic series, and expanded its current line of rings and round chips with larger dimensions. The P-088
circular series PICMA piezo actuators, chips, and tubular stacks have
an operating voltage of 20 to 100 V, and
resonant frequency up to 68 kHz. UHV-compatible versions with solderable contacts are
available. The expanded PD0xx series of
miniature annular PZT chips now have
outer diameters from 5 to 16 mm and inner
diameters of 2.5 to 8 mm. The largest diameter, 16 mm, delivers 6000 N (1300 lb) of blocking force in circular
form and 4400 N in annular shape. Travel range of 2 m is achieved at
100 V.

Remtec, Bristol, RI, has merged its metalized ceramic packaging


capabilities with the glass-to-metal packaging capabilities of its parent
company, LTI. Additional engineering capabilities include a variety of assembly operations, such as standard SMT soldering, gold
tin soldering, and CuSil brazing. Typical
attachment components are lead-frames,
pins, bushings, contacts, connectors, and
lugs, as well as Kovar and ceramic ring
frames for hermetic assembly. With the combined capabilities of both companies, Remtec can offer sensor designers a number of interrelated metallization technologies, including
thick and thin films, PCTF metallization, and AgENIG (Electroless
Ni-Immersion Au over thick film Ag).

For Free Info Visit http://info.hotims.com/61066-181

For Free Info Visit http://info.hotims.com/61066-183

Confocal Microscope
Zeiss, Oberkochen, Germany, introduced
the Smartproof 5 widefield confocal microscope. The microscope system provides 3D
reconstructions and roughness measurements for a range of surfaces. Users can
install and run Smartproof 5 without additional antivibration equipment. The optics,
electronics, and camera are all embedded in
the microscope. The software provides the
user with workflow routines, and teachable
inspection jobs and the graphical user interface guide the user through recurring tasks.
In addition to geometrical measurements,
the system can perform roughness analyses in
2D (profile) and 3D (area), both based on
ISO standards.

Designed to keep working through


wash downs, immersion in water
and in dusty environments, the
Vert-X 13 is only 13 mm in
diameter. That makes it easy to t
almost any application.
Key specs include:
t-JOFBSJUZ
t3FTPMVUJPOPSCJUT
t4FBMFEUP*1
t0VUQVUPQUJPOTWPMUBHF 
18. 41* 44*BOE*ODSFNFOUBM

For Free Info Visit


http://info.hotims.com/61066-189

For complete Vert-X 13 information visit


www.novotechik.com/v13
iV1-]VU/iii\xn{nx{{U >\vJiVV
Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/61066-877

46

Intro

Cov

ToC

Metal Cables

Photo Etching

Carl Stahl Sava Industries, Riverdale, NJ, announced availability of its


new Integrated Ball Technique (IBT) that creates an integrated ball
at the end of its precision metal cables. The technique creates a ball
position on biocompatible, implantable cables used in a variety of surgical implants. IBT is available in multiple cable diameters and several
biocompatible materials. The integrated ball prevents the cable from
passing a through-hole, and provides
an anchor point to hold the cable in
place. The spherical geometry of the
ball also allows it to rotate freely within its mating pocket to provide
mechanical flexibility.

Tech-Etch, Plymouth, MA, provides photo


chemical etching of tungsten. Tungsten, which
is extremely dense, is used in medical applications such as grids that collimate and attenuate
stray x-rays in CT scanners, and ID tags used in
implanted medical devices. Tech-Etch also produces component parts made from several
other specialty metals, including titanium, niobium, elgiloy, MP35N, and
nitinol. Parts range in thickness from 0.0005 in. and up. Designs can be
proved in preproduction quantities without having to commit to tooling.
Laminating, plating, heat treating, and assembly are available in house.

For Free Info Visit http://info.hotims.com/61066-184

For Free Info Visit http://info.hotims.com/61066-186

UV/Vis Spectrophotometer

Steute Meditech, Ridgefield, CT, introduced wireless,


medical-grade, handheld controls designed with its
proprietary 2.4-GHz frequency-hopping protocol.
The bidirectional, 32 RF-channel protocol
changes transmission frequency 200 times per
second. The controls feature sleep-mode, a
wake-up time of less than 200 ms, and real-time
battery-charge status monitoring. A USB stick receiver is available with the system. The controls are powered by replaceable
AAA alkaline cells, and offer Ingress protection up to IP X8. Mechanical
life expectancy is greater than one million operations.

Laboratory-Equipment, Fullerton,
CA, is offering PerkinElmers LAMBDA
465 UV/Vis spectrophotometer. It has a
visible, near-IR, near-UV spectrum
range of 190 to 1100 nm. Data can be
acquired in 20 milliseconds, with a 1-nm
resolution. The benchtop analyzer has an optics system with both tungsten and deuterium light sources. Plug-and-play, autocalibrating, modular accessories snap into place and can be configured in combination to
support specific applications. LAMBDA 465 features Microsoft-based 21
CFR part 11-compliant software. Loaded samples are aligned by the software, and the instrument automatically creates test reports and saves data
in an encrypted database.

For Free Info Visit http://info.hotims.com/61066-185

For Free Info Visit http://info.hotims.com/61066-187

Wireless Handheld Controls

MULTIPHYSICS
MODELING AND
SIMULATION
SOFTWARE

CLEAN ROOM
MOLDING,
ASSEMBLY, AND
PACKAGING

CYANOACRYLATE FOR
MEDICAL
APPLICATIONS

COMSOL Multiphysics is an
integrated software environment
for creating physics-based models and simulation apps. Add-on products allow the
simulation of electrical, mechanical, fluid flow, and
chemical applications. Interfacing tools enable its
integration with major technical computing and CAD
tools. Simulation experts rely on COMSOL Server
product to deploy apps to their colleagues and customers worldwide. www.comsol.com/products

Master Bond MB297Med


is a high-strength, rapidcuring, one-component
ethyl cyanoacrylate adhesive that meets USP Class VI
specifications for medical use. Its ultrafast bonding
takes place at room temperature with no mixing
required. MB297Med offers cost-effective solutions
to production and repair applications as well as versatility, high strength, and fatigue resistance.
http://www.masterbond.com/tds/mb297med

COMSOL, Inc.

Master Bond

Free Info at http://info.hotims.com/60166-878

Free Info at http://info.hotims.com/60166-879

DURABLE,
FLEXIBLE
TUBING GET
A SAMPLE
Superthane polyurethane
tubing handles liquids
and gases and is naturally flexible no leachable
plasticizers. Available in both ether and ester formulations, its made from nontoxic ingredients that conform to FDA standards. The ether formulation offers
protection against moisture, fungi, and ultraviolet
rays and is NSF-61 listed for use with potable water.
No DEHP or phthalates. Made in USA.
http://www.newageindustries.com/sample-mdb8

NewAge Industries, Inc.

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.
Free Info at http://info.hotims.com/60166-880

TRUMICRO
2020:
ULTRAFAST
AND COMPACT
DESIGN

POROUS
CERAMIC
VACUUM
CHUCK
PhotoMachining offers a porous ceramic
vacuum chuck for use
with thin films and other flat samples. Pore sizes
under 25 microns assure uniform suction and holding
power for even the smallest parts. PhotoMachining
also provides contract laser-manufacturing services,
and designs and builds custom laser-based manufacturing equipment. PhotoMachining, Inc., 4 Industrial Dr.,
Unit 40, Pelham, NH 03076; Tel: 603-882-9944; Fax:
603-886-8844; rschaeffer@photomachining.com;
www.photomachining.com

The TruMicro Series 2000 is a compact picosecond


fiber laser. With 20 ps pulse duration, excellent
beam quality, and up to 10 W average power, it is
ideal for cost-efficient precision materials processing. Proven industrial applications include foil cutting, thin film removal, and corrosion-free marking.
www.medicaldesignbriefs.com/trumpf201610

TRUMPF Inc

PhotoMachining, Inc.

Free Info at http://info.hotims.com/60166-881

Free Info at http://info.hotims.com/60166-882

Medical Design Briefs, October 2016

Free Info at http://info.hotims.com/60166-883

www.medicaldesignbriefs.com

Intro

Cov

ToC

47

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

Anomet Products ..........................................861, 862 ........................30


Arthur G. Russell Company .....................................890 .........................7a
ATI Industrial Automation ........................................849 ........................14
Branson Ultrasonics Corp. .....................................892 .......................14a
Cadence, Inc. ...............................................846, 869 ..................10, 34
Cicor Management AG ...........................................871 ........................39
COMSOL, Inc. ..............................................841, 878 ....................3, 47
Dymax Corporation ........................................844, 856 ....................7, 25
Fiberoptic Components, LLC ...................................891 .......................11a
First Sensor AG.....................................................850 ........................15

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
Audience Development Coordinator............................................Stacey Nelson
Subscription Changes/Cancellations ...............................mdb@kmpsgroup.com

Fluortek................................................................857 ........................26
Helical Products Co., Inc. ......................................872 ........................41
igus, Inc. .............................................................887 .........................1a
Indium Corporation ................................................852 ........................17
Interpower Corporation...........................................848 ........................13
KMC Systems, Inc. ...............................................886...................COV IIa
Lumenera Corporation............................................847 ........................11
Marubeni Citizen-Cincom Inc. ..................................889 .........................5a
MASCOT ......................................................896, 897 ........................35
Master Bond Inc. .........................................851, 879 ..................16, 47
mdi Consultants, Inc. ............................................876 ........................45
Medbio, Inc. ........................................................880 ........................47
MicroLumen Inc. ..................................................837 ............COV TIP-ON
Nason ..................................................................840 ..........................2
Nelson Laboratories, Inc. ...............................854, 858 ..................21, 27
NewAge Industries Inc. ........................................881 ........................47
Nordson MEDICAL, Avalon Catheter Solutions .....863, 864 .........................31
Novotechnik ..........................................................877 ........................46
Okay Industries ......................................................853 ........................19
PhotoMachining, Inc. .............................................882 ........................47
Proto Labs, Inc. ...........................................843, 888.....................5, 3a
Reell Precision Manufacturing, Inc. .........................874 ........................44
Sensirion AG .........................................................875 ........................45
Smalley ................................................................842 ..........................4
SMC Ltd. ....................................................865, 866 ........................32
Specialty Coating Systems, Inc. ......................867, 868 ........................33
Statek Corporation.................................................873 ........................43
Steute Meditech, Inc. ............................................885 ...................COV IV
Teleflex Medical OEM......................................838, 859 ..............COV II, 28
The Lee Company ..................................................845 ..........................9
TRUMPF Inc. ...............................................839, 883 ....................1, 47
Ulbrich Stainless Steels & Special Metals, Inc. ..........870 ........................37
Unimed S.A. .........................................................855 ........................22
Zeus, Inc. ....................................................860, 884..............29, COV III

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)
individual tech briefs that are supplied by NASA. Editorial, sales, production, and circulation
offices are located at 261 Fifth Avenue, Suite 1901, New York, NY 10016. Subscriptions for
non-qualified subscribers in the U.S. and Puerto Rico, $75.00 for 1 year. Single copies $8.50
each. Foreign Subscriptions 1 year U.S. funds $195.00. Single copies $21.75 each. Digital
copies: $24.00. Remit by check, draft, postal, express orders or VISA, MasterCard or
American Express. Other remittances at senders risk. Address all communications for subscriptions or circulation to Medical Design Briefs, 261 Fifth Avenue, Suite 1901, New York, NY
10016. Periodicals postage paid at New York, NY and additional mailing offices.
POSTMASTER: Send address changes and cancellations to Medical Design Briefs,
P.O. Box 47857, Plymouth, MN 55447.
October 2016, Volume 6, Number 10.

48

TECH BRIEFS MEDIA GROUP, AN SAE INTERNATIONAL COMPANY


261 Fifth Avenue, Suite 1901, New York, NY 10016
(212) 490-3999 FAX (646) 829-0800
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
Accounting/Human Resources Manager ......................................Sylvia Bonilla
Office Manager.....................................................................Alfredo Vasquez
Receptionist ..............................................................Elizabeth Brache-Torres
MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES
MA, NH, ME, VT, RI, Eastern Canada.............................................Ed Marecki
.........................................................................................Tatiana Marshall
(401) 351-0274
CT .......................................................................................Stan Greenfield
(203) 938-2418
MI, IN, WI..............................................................................Chris Kennedy
(847) 498-4520 ext. 3008
NJ, PA, DE...............................................................................John Murray
(973) 409-4685
Southeast, TX ...........................................................................Ray Tompkins
(281) 313-1004
NY, OH..................................................................................Ryan Beckman
(973) 409-4687
MN, ND, SD, IL, KY, MO, KS, IA, NE, Central Canada .......................Bob Casey
(847) 223-5225
Northwest, N. Calif., Western Canada.........................................Craig Pitcher
(408) 778-0300
CO, UT, MT, WY, ID, NM .............................................................Tim Powers
(973) 409-4762
S. Calif., AZ, NV ............................................................................Tom Boris
(949) 715-7779
Europe Central & Eastern.......................................................Joseph Heeg
49-621-841-5702
Sven Anacker
49-202-27169-11
Europe Western ......................................................................Chris Shaw
44-1270-522130
Integrated Media Specialists.....................................................Patrick Harvey
(973) 409-4686
Angelo Danza
(973) 874-0271
Scott Williams
(973) 545-2464
Rick Rosenberg
(973) 545-2565
Todd Holtz
(973) 545-2566
Reprints ................................................................................Rhonda Brown
(866) 879-9144, ext. 194

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Design Briefs, October 2016

Every hero needs a cape.

Protecting technicians, surgeons, and patients.


Go radiation-free with LCP (Liquid Crystal Polymer) monolament.
When you need an MRI-compatible braiding option, Zeus LCP is the
safe alternative to metal. You be the hero, let us be the cape.

Visit radiation-free.com to learn more.

AMERICAS: +1 803.268.9500 | EUROPE: +353 (0)74 9109700 | ASIA/PACIFIC: +86 13922204986

support@zeusinc.com | www.zeusinc.com
Free Info at http://info.hotims.com/61066-884

Intro

Cov

ToC

Are your cusstomers ask


a ing forr a
wirele
ess foot sw
witch?
We can help
h lp.

Wir
ireeless foot swittche
c es and reecceeivveers arre avva
aila
able in a wide va
arietty
of function
nal co
onfigurra
ations and pa
ackka
agings.
For over 10 years, STEUTE has pioneered the
t development of wireless technology expressly fo
or mediical
applicationss, with thousands of installed foot
o switches controlling radio
ology equipment, ophthalmicc surgical
systems, surrgical microscopes, patient tab
bles and laser-based devices.
STEUTE Wireless Foot Switches:
Feature robust, reliable fo
ourth-generaation 2.4 GHz frequency-hopp
ping technology
Complyy with all FDA wireless guidelin
nes and FCC requirements
Can be aesthetically and ergonomicaally optimized to meet your un
nique application needs
Contact uss for a no-cost, no-obligatio
on design consultation, or to discuss receiving a comp
plimentary
wireless, foot
o switch evaluation kit.

(203) 244-6302

www.steutemeditech.com

Intro

Cov

ToC

info
o@steutemeditech.com

October 2016

Tube-Cutting Technology for the Future


Advances in Abrasive Waterjet
Micromachining
Five-Axis Grinding: A High-Speed Option
for Medical
The Evolution of Laser Texturing

Supplement to Medical Design Briefs

Intro

Cov

ToC

Free Info at http://info.hotims.com/61066-886

Intro

Cov

ToC

Replace your
metal bearings

6a

reduce costs by
y 40%

9a

12a

FEATURES
2a

New Tube-Cutting Technology Meets Next-Generation


Production Needs

6a Accelerating Abrasives with the Greatest Precision to Produce


Intricate Medical Components
9a Grinding Machines Offer Unique Capabilities for the Medical
Industry

Reduce cost and increase


technology with iglide

12a Laser Texturing Continues to Evolve in Medical Applications

TECH BRIEFS

100% self-lubricating,
maintenance-free, and
available in a range of 40+
materials for all applications.
Product selection tools,
reliable lifetime calculation,
CAD downloads, and more
available online. Thousands of
dimensions in stock and ready
to ship as early as same-day.

15a NIST Illuminates Transfer of Nanoscale Motion Through


Microscale Machine
16a Electrochemical Etching Improves 3D Printing of Metals

DEPARTMENTS
17a New Products & Services

ON THE COVER
In the world of stents and hypo tube cutting, the
amount of post-processing can be significant. New
laser types and system design improvements are
leading to an increase in throughput due to
greater equipment uptime and reduced cutting
cycle times. Femtosecond lasers, for example,
eliminate the need to post-process parts, a costly
part of manufacturing. To read more about how
this technology addresses the key metrics of
uptime, running costs, yield, and production
throughput, read the article on page 2a.

sales@igus.com
1.800.521.2747

(Credit: Amada Miyachi America)

Medical Manufacturing & Fabrication, October 2016

Intro

Free Info at http://info.hotims.com/61066-887

Cov

ToC

1a

Meets Next-Generation Production Needs

tents and hypodermic tubes


(hypotubes) are used in countless
applications, and the demand is
growing rapidly in response to the continued demand for stent applications
and growth of minimally invasive surgery. The sheer number and diversity of
devices is rapidly increasing, and with it,
the demand for more laser-cut stents,
flexible tubing, cannulas and micro cannulas, needles, biopsy devices, and other
minimally invasive tools. Figure 1 shows
examples that represent common features of modern stents.
While legacy stent and tube-cutting
systems have performed well during
recent decades, new cutting technologies coming onto the market offer
faster and better cuts, with higher production rates.

Replacing Legacy Cutting Systems


The pulsed neodymium-doped yttrium aluminum garnet (Nd:YAG) lasers
used in the past decade have definitely
been great workhorses. They have performed well, and have been excellent
profit centers for many companies.
Unfortunately, the original integrated
pulsed Nd:YAG lasers that remain in
operation are now obsolete and difficult
to service. While many of these systems
have been upgraded to fiber lasers, they
still have stage sets that are well past
their sell-by date, running on slow and
aging controllers with legacy software.
Simply put, lasers, stages, controllers,
software, water systems, and automated
tube loader technology have all moved
on to enable faster and better cuts with
higher production rates and less downtime. Heres how:
Lasers The pulsed Nd:YAG lasers
formerly used have been superseded by
fiber lasers with better beam quality that
does not change with pulse energy and
average power. These lasers also provide
pulse frequencies up to and beyond 5
kilohertz (kHz) to maximize acceleration and speed for a range of part thick-

Fig. 1 Laser-cut stents.

nesses and features. Whats more, they


produce pulse durations down to tens of
microseconds for fine feature cutting.
From an operational standpoint, the
fiber lasers have a number of advantages. They are air-cooled, run off singlephase, 240-V electrical power, and have
diodes with lifetimes greater than 70,000
hours, which equates to minimal operational costs. Figure 2 shows an example
of a tube produced by one of the new
laser tube-cutters on the market, and a
close-up of laser tube cutting.
Controllers and Stages New stage
controllers provide many additional features. For example, they can handle
larger part programs, they feature higher resolution of the tooling trajectory,
and they use the EtherCAT Ethernet
fieldbus, one of the fastest industrial
Ethernet technologies.
With faster processors, up-to-date
operating systems, and operatororientated interfaces, the control software ceases to be something to be battled with, and becomes an element that

2a

www.medicaldesignbriefs.com

Intro

Cov

ToC

can be streamlined for operational efficiency. The stages have also been
improved with higher acceleration
times, which can equate to large cycle
time savings for complex, small-featured
parts. Large monitor screens also allow
more information to be displayed on a
single screen without the need to toggle
back and forth between screens.
Water Systems In many legacy system designs, the water system was a
weak point, requiring constant attention and maintenance to keep the
machine running. Such issues as small
water tank sizes, short-lifetime pumps,
and lack of internal flow monitoring
all added up to an unreliable system.
This was compounded by equipment
that was difficult to access, even when
simply changing water filters. Fast forward to newer systems, which have a
10-gallon tank size, 4-level debris filtering, intelligent programmable flow
valves, multiple solenoid switches to
prevent large water leaks, and drawermounted hardware that enables filter

Medical Manufacturing & Fabrication, October 2016

Free Info at http://info.hotims.com/61066-888

Intro

Cov

ToC

changing in seconds. The user interface provides the operator all necessary information, along with precutting safeguards and go/no-go limits
to ensure that all is well.
System Design A final advantage of
the latest fiber laser-cutting systems is
that the machine can be designed
without the previous constraints posed
by fixed-beam delivery and a granite

support structure. Using newer fiber


laser technology enables the laser to
be mounted in the machine base with
the flexible fiber routed to the focus
head. The use of a composite base that
has better vibration damping than
granite also allows for a cantilever arm
support, providing a very open
machine from an operator accessibility
perspective.

New on the Scene: Femtosecond


Disk Lasers
Femtosecond (fs) lasers offer a new
cutting regime that sets them apart even
from the newer microsecond pulsing
fiber lasers. Femtosecond light pulses
are ultra-short pulses (USPs). One fs =
1015 seconds and, as a calibration
point, a 300-fs pulse equates to a physical
length of pulse of only 90 m.
Whereas fiber lasers cut by a melt and
eject process using a high-pressure coaxial gas, femtosecond lasers sublimate the
material from solid to vapor. This material removal process produces cuts of the
highest quality, with no burrs and with
high dimensional accuracy.
Since the lasers pulse duration is
around 400 fs, the pulse has a shorter
duration than the conduction time of
metals, so the material can be cut with
no thermal input to the remaining material. This so-called cold processing
enables cutting of very fine features and
eliminates any potential for micro cracking that can be an issue for nitinol.
In the world of stents and hypo tube
cutting, the amount of post-processing
can be significant, especially for materials
such as nitinol. Femtosecond lasers
remove the need to post-process the parts
for burr removal, and eliminate this costly manufacturing element. Although the
cutting speed of a femtosecond laser is
sometimes slower than that of fiber lasers,
eliminating the post-process step can justify the return on investment (ROI).

Increased Throughput and


Reduced Cycle Time

Fig. 2 (Top) A tube produced by one of the new laser tube-cutters on the market, and a close-up of
laser tube cutting (bottom).

4a

www.medicaldesignbriefs.com

Intro

Cov

ToC

The new laser types and system design


improvements are leading to an increase
in throughput, which is happening
organically based on greater equipment
uptime and reduced cutting cycle times.
The reduction in cycle time is based on
the complexity of the cut pattern and
the number of discrete cuts on the part.
The reduction in cycle time for a stent
or cutting a flexible tube is estimated at
around 30 percent.
The key metrics of uptime, running
costs, yield, and production throughput will be somewhat case-specific, but
on average, ROI for purchasing new
cutting equipment is expected to be
within 34 years.
This article was written by Geoff
Shannon, PhD, Manager of Advanced
Technology at Amada Miyachi America,
Monrovia, CA. For more information, visit
http://info.hotims.com/61066-200.

Medical Manufacturing & Fabrication, October 2016

Supported by MCCs legendary, full service, distributor network.

Experience the difference.

Cincom Sliding Headstock Type Automatic CNC Lathe

2-YEAR Machine and


Control Limited Warranty

www.marucit.com

Machine specifications

&GGJDJFOU 'BTU)JHIMZ1SPEVDUJWF

Maximum machining diameter (D)


Maximum machining length (L)
Main spindle speed
Back spindle speed
Live tools

0GGFSJOHBXJEFSBOHFPGUPPMJOHBOE
BDDFTTPSJFTGPSNBDIJOJOHDPNQMFYQBSUT

16 mm (.63")

200 mm (7.87")/1 chucking


15,000 rpm
10,000 rpm
7 standard

The World Leader in CNC Swiss Turning

Allendale, NJ
(201) 818-0100

Elk Grove Village, IL


(847) 364-9060

Fountain Valley, CA
(714) 434-6224

Agawam, MA
(413) 786-6655

Free Info at http://info.hotims.com/61066-889

Intro

Cov

ToC

Fig. 1 Cranial mesh plate.

Accelerating Abrasives
with the Greatest Precision to
Produce Intricate Medical Components

he latest medical developments


typically involve smaller, more precise structures. These can be
implants, assemblies, or components
and motors in robotic equipment. With
the demand for smaller parts, the
requirements for producing these parts
have become more challenging.
We often think of medical components as implantable structures such as
bone supports, or cranial and ocular
mesh plates (see Figures 1 and 2).
Feature tolerance and location are both
important to the proper function of
these structures.
The prosthetic limb of the future is
one that can be controlled by the
patients nervous system. These limbs
are functionally proper, and replicate
the movements and capabilities of the
limbs that they are replacing (see
Figure 3). From the shoulder mechanism to the knuckle on each finger,
these manipulating assemblies are
designed to operate so that the slightest movement or amount of pressure
desired is properly applied to
the device.
There are also R&D and laboratory
devices and components, such as the
assay array shown in Figure 4 cut from
Hiperco-50 used in optical microscopes.
The critical geometry and spacing from
anode to cathode in the array must be
accurate and consistent.

One of the most recent surgical developments is the introduction of robotassisted surgery. These human-tocomputer-controlled machines are capable of performing procedures with
much more precision and less trauma
than previous open surgery techniques.
It is essential that these robots are
designed and built to extremely high tolerance specifications, from the drive
motors and measuring system, to the
mechanical gearing and manipulators
that come in contact with the patient.
In addition to the increased demand
for high-tolerance specifications and
reduction in component size, new materials are being developed. Therefore, a
method of manufacturing for new materials must also be developed. New superalloys, as well as metals and elastomers
with memory and shape-changing characteristics, are becoming more common
as developments advance in biocompatible materials. Many of these materials
are heat-sensitive; they are programmed at a specific temperature to
function properly. Inducing heat by
means of thermal material removal,
such as wire electrical discharge machining (EDM) or laser cutting, will negatively impact such materials, and in some
cases, these manufacturing processes are
not even a compatible option.
Some characteristics related to thermal cutting can include both a recast

6a

www.medicaldesignbriefs.com

Intro

Cov

ToC

layer and an annealed layer below the


recast surface. These characteristics
often have to be eliminated by postprocessing such as heat treating.
For thin films and foils, the parts often
curl up during the thermal cutting
process, resulting in deformed parts that
are deemed unacceptable. Very often,
thin materials are machined by means of
photochemical etching. Multiple features are created simultaneously, and
accuracy is sufficient for many applications. However, accumulative tolerance
can be an issue if part-to-part consistency
is critical. In addition, thicker materials
may need to sacrifice dimensional tolerance because this process relies on a
time-based chemical reaction.
High-precision small components and
implants have traditionally been cut
using wire EDM; however, there are
undesirable characteristics due to the
thermal process of EDM cutting. For
materials that are nonconductive, wire
EDM cutting is incompatible.

Abrasive Waterjet Micromachining


Advances in abrasive waterjet micromachining have been developed andcontinue to be developed in order to
refine the process of machining by
means of abrasive particle acceleration
through a high-velocity water stream.
Today, cut features as narrow as 200 m
to an accuracy of 10 m are being

Medical Manufacturing & Fabrication, October 2016

Free Info at http://info.hotims.com/61066-890

Intro

Cov

ToC

Accelerating Abrasives

Fig. 2 Ocular mesh plate.

achieved globally with the use of micromanufacturing with abrasive waterjet


technology.
Aside from abrasive waterjet micromachining being designated as a cold
machining process, there is a significant processing speed difference when
compared with wire EDM machining.
Because wire EDM cutting has an
advantage where thicker material is
concerned, there is an opportunity to
stack thinner materials in a fixture in
order to process multiple layers of
material in a single cut. In some cases,
this serves as a speed advantage over
abrasive waterjet micromachining. For
example, if cutting a single part by wire
EDM takes five hours, the same material can be stacked 50 layers thick, reducing the per-piece time to six minutes
per part. This only serves as an advantage if the heat-affected zones referred
to earlier are not vital to the part being
produced. Additionally, thin foils can
be problematic for wire EDM cutting in
a stacked configuration due to the
potential of the thermal process essentially welding the layers of thin foil
together along the cut edge.
With any manufacturing process,
there will be limitations. For abrasive
waterjet micromachining, material
thickness is the primary concern when
striving to achieve precision results.
For most materials, a substrate thickness greater than 1.5 mm will result in
draft angles that will likely exceed 10
m. In addition, the process of waterjet micromachining is currently twoaxis, and is only conducive to cutting
parts from flat material, or material
that can be constrained in flat form.
Pure waterjet cutting is sometimes
an option with softer materials, such as
silicone and soft durometer elas-

Fig. 3 Functional prosthetic arm. (Courtesy of the Johns Hopkins University Applied Physics
Laboratory)

tomers. Pure water cutting typically


slices material as a blade would, without actually realizing a kerf line. Pure
water cutting is often used when the
material being machined has an open
cell configuration, and is susceptible
to holding unwanted particles such as
abrasive media. The water stream
diameter for pure water cutting can be
as small as 80 m.
However, materials such as silicone
rubber react to pure water cutting
much like they would react to blade
cutting. The material, depending on
thickness and durometer, may displace
while cutting, affecting the geometric
profile of the device or part being created. In addition, pure water cutting
may realize characteristics in the material such as striations and/or draft
angle. The solution to these challenges is, when applicable, to use a
small abrasive waterjet cutting system
and closely regulate and monitor the
amount of abrasive being accelerated
through the material. This allows the
abrasive to perform the majority of the
cutting action without displacing
material, thus removing material at
the kerf and creating a much finer cut
edge surface.
Considering the various advantages
that abrasive waterjet micromachining

8a

www.medicaldesignbriefs.com

Intro

Cov

ToC

Fig. 4 Free-floating magnetic probes.

has over traditional manufacturing


methods, this process is not a solution
for all cases. Due to the ease of programming and setup, it is ideal for
developmental and short-run production applications. When it comes to
high-volume part manufacturing
usually in the thousands of pieces per
delivery this process is not necessarily going to be the fastest or most effective, unless the material is so unique
that it cannot be punched or stamped.
This article was written by Steve Parette,
Managing Director at Micro Waterjet LLC,
Huntersville, NC. For more information, visit
http://info.hotims.com/61066-201.

Medical Manufacturing & Fabrication, October 2016

GRINDING MACHINES OFFER


UNIQUE CAPABILITIES
FOR THE MEDICAL INDUSTRY

he recent emergence of specially


designed
five-axis
grinding
machines can now meet the highest expectations of accuracy and machine
dynamics within the special demands of
the medical industry, particularly the
orthopedic segment. A short setup time
and high flexibility in equipment and
software changeover are among these
new machines many advantages for end
users. To achieve this performance level,
many companies have relied on their
experience in building various machine
tools, which include grinding machines
and multispindle lathes.
A key feature on these new grinding
centers is direct drive technology in all
five axes. The axes x, y, and z are driven
by linear motors as well. By eliminating

ball screws or gears from the drive system and components, these machines
have the capability to perform extremely
accurate and highly dynamic movements at the same time. The onboard
drive technology not only offers high
dynamics, but is a backlash-free drive system that can accelerate fast and is not
prone to unwanted wear or otherwise
harming the drives. The advanced CNC
technology complements the drives and
programming options, and the drive
and control concept allows an effective
velocity at the part surface of over 500
inches per minute.
Orthopedic implants such as
femoral knees, tibial trays, and hipstems plus instruments such as hiprasps, medical-cutters, drills, step

Knee joints being ground on a CNC five-axis grinding center.

Medical Manufacturing & Fabrication, October 2016

Intro

drills, and reamers gain large benefits from this technology. High-speed
machining is helping to reduce production costs and offers a wider variety
of options and a different approach to
cutting technique and tool life.
But there is another aspect of
machine utilization in orthopedic production work thats highly important:
how can you program all these diverse,
one-off, or low-volume parts on just one
machining platform?

Machine Programming
Each class of workpieces would typically need a special software solution to
address its characteristics and start from
a simple drawing supported by parameter input pages, DXF contour import
functionality, or very complexgeometry 3D CAD models.
Standard geometry features
combined with very demanding freeform surfaces such as
femoral knee implants make
the programming challenge
seem quite extreme.
Builders have developed
software packages in-house
that combine off-line programming and simulation capabilities of the entire workpiece
from the blank to the finished
product. The software incorporates machine and accessory
environments and collision
checks, then simulates production before the machining job
gets started. This programming platform ensures stable
production with predictable
work output on one hand, and
on the other hand, it is an
absolute time saver for the production engineering department to get the CNC code prepared and ready for the
machine without losing precious production time. The
program information gets

www.medicaldesignbriefs.com

Cov

ToC

9a

GRINDING MACHINES
stored in a file thats been sent to the
machine, and gets called up at the
machine control panel to start the job.
Only a few simple mouse clicks are
necessary to create such a program, combining part handling, part probing, tool
measurement, wheel dressing, grinding,
milling, abrasive belting, and polishing
operations, with no special skills needed
to understand and program the code.
The software concept is designed as a
typical one-page screen. All software features can be placed individually on the
screen and easily changed to a different
arrangement. Each arrangement can
then be stored under a separate profile
name, and switching over from one program to another involves only a mouse
click to have all software features onscreen, where they match the programmers expectations.
For long, thin-geometry drills or
reamers such as those often used in
orthopedic surgeries, it is necessary to
support the part while machining exactly at the grinding point. To accomplish
this task, the machine can be equipped
with a dual auxiliary slide system carrying a tailstock to hold the part on center, and a steady rest slide to absorb the
grinding forces and hold the part where
needed. These slides can be independently programmed, positioned, activated, or deactivated while machining is in
progress.
On parts such as femoral knee
implants, dealing with free-form surfaces is mandatory. Achieving a constant
but highly effective velocity at the part
surface, without losing the accuracy by
grinding hundreds of parallel lines, is a
unique challenge. Software typically
offers an interface to CAD-CAM systems
that provide the post-processing routine
for such high-volume data and complex
geometry tool path information.

The CNC controls all axes of motion and the rotating arbor that carries various tools for machining
operations.

Machining Options to Reduce Cost


For operations where milling is an
expedient substitution for conventional
grinding, the machine can switch the
drive parameter setting to perform an
optimum cutting path for this type of
machining. Also, live radius compensation can be applied to milling applications in full five axes of motion to control
and offset part dimensions, or to compensate for diverse cutter dimensions.
But grinding and milling operations are
not the end of the machining sequence
option list. In some cases, abrasive belting and polishing can make sense, too.

Robotic loading and unloading are programmed for operator-free material handling.

These additional operations are now possible within the machining envelope, as
the tool magazine on these new grinding
centers can be extended from 5 up to 12
or 24 magazine places to store specially
designed belting assemblies and polishing arbors. This magazine and spindle
concept is designed to carry the tool and
its coolant manifold in the same place,
but optimized for each application. An

10a

www.medicaldesignbriefs.com

Intro

Cov

ToC

integrated polishing spray nozzle can


provide the polishing compound into
the finishing process.
Not only do the development of the
machine, software, and elaborate clamping systems belong to this new spectrum
of machine capabilities, but so does the
machining of complex or costly materials
such as cobalt-chrome, titanium, stainless steel, and even ceramics, to find the

Medical Manufacturing & Fabrication, October 2016

Hip stems (left) and knee joints are typical orthopedic products made in a more efficient manner, even when one-offs, on new grinding machining centers
with full-cycle simulation software onboard.

right technological solution for the orthopedic application.


Cast blank femoral knee implants, for example, have shown
after the grinding process a part splay effect in which the inner
contour has opened. The grinder must be able to reduce and
eliminate the part splay effect through technology that uses the
right tools, coolant supply, and programming method.
For freeform surfaces, a CAD-CAM system needs to be in
place to provide the complex tool path information. For
instruments such as surgical bone rasps, the software must
offer its own built-in CAD-CAM interface. Only a blank CAD
model and a drawing should be needed to get started. With
a model import function, all kinds of toothing systems can
then be programmed, simulated, and measured within the
same programming platform, from straight, angled, helical,
and fan-style toothing to chip breakers. The software packages now being offered in the market provide pre-defined
input parameter masks to create programs within a few minutes. The special needs for grinding and milling operations
are optimized in lean programming packages for any programmer to use, even without extensive experience in
grinding on such tasks.
Reducing production costs is an ongoing challenge for all
orthopedic market players. Big and small companies alike are
facing this fact in the medical field, and as a result, it is the challenge for machine builders as well. Automation, therefore,
becomes more significant to provide a constant and predictable
workflow. For low-, mid-, or high-volume part batches, or a higher
diversity on the part spectrum, automation solutions need to
address this challenge. Depending on part or batch size, a chain
loader that has from 50 to 160 part stations can be equipped onto
a machine. For extended needs, part volumes, more diverse
mixes of different parts, or other applications such as part measurement, finishing options, and part storage, a robotic cell is a
very open system that can be attached to the grinding machine
and programmed to interact seamlessly, with all the necessary big
data capture via the CNC and the proper bus communication.
For all machining applications, part clamping is a final, critical necessity. For clamping round and cylindrical instruments,
automated collets or hydraulic chucks are available. To clamp
and hold workpieces such as femoral knees, tibial trays, hipstems, or hip-rasps, builders offer a wide range of fully automated or manual clamping solutions.

Process engineering and consulting from the early stages of a


project until the installation of the equipment accompanied by
training programs for machine operators, programmers, and
maintenance staff alike are other important hallmarks of
todays medical grinding machine builders value proposition.
This article was written by Thomas Simmich, Sales and
Technical Consultant, Medical and CAD/CAM Grinding
Machines, for Schtte LLC, Jackson, MI. For more information,
visit http://info.hotims.com/61066-202.

Custom Fiber Optics for OEMs

Customers worldwide have come to


Fiberoptic Components for their most
challenging product cable designs. Our
high quality borosilicate, silica and plastic
fiber cables can be customized and
configured to support medical laser and
illumination applications.

Let us assist you in development of


your next generation design.
Lightguides.com
978.422.0422
ISO 13485 & 9001

Medical Manufacturing & Fabrication, October 2016

Intro

Free Info at http://info.hotims.com/61066-891

Cov

ToC

11a

Fig. 1 - With laser texturing, medical manufacturers can create medical tools that pick up less
fluid and debris, mark implants for tracking, and
add textures that aid in implant acceptance.

Laser Texturing Continues to

Evolve in Medical Applications

materials, including ceramics, gems


(e.g., sapphire), various polymers, and
glass, for medical applications.
Femto lasers are able to cut moreintricate patterns than previous laser
technologies because the laser beams
are smaller and thus can create smaller
details in parts. Such intricate cutting
capabilities enable laser texturing to be
used for even the smallest medical
applications.
With femto lasers, it is also possible
to generate very fine microstructures
that can be measured in nanometers.
These microstructures create colors
through a naturally occurring phenomenon within the finished piece that
are visible when held to a light source
(see Figure 3).
In addition to the development of
femto lasers, the other significant technological breakthrough in laser texturing is the development of five-axis duallaser systems. A dual-laser system is one
that can automatically change its laser
source from one type to another within
seconds. This allows manufacturers to
machine a wider variety of materials on a
single machine than with single-laser systems. Such increased versatility means
that manufacturers can perform more
work from one laser texturing machine
than was previously possible.
With single laser systems, operators
can manipulate the lasers strength by

12a

www.medicaldesignbriefs.com

n the medical device industry, surface


texture has become an important
aspect of product design. It not only
provides the means to refine the physical appearance of an item, but also
increases an items surface grip qualities.
And through surface texturing, manufacturers can create medical tools that
pick up less fluid and debris, mark
implants for tracking, and add textures
that aid in implant acceptance. So it is of
no surprise that these medical manufacturers are increasingly seeking ways to
improve the level of control exerted in
surface texturing. Laser texturing is
often the technology of choice and is
now applied to many medical parts.
In addition to helping manufacturers
create better implants and medical
tools, laser texturing can also can be
used in the production of molds and
dies for medical components. These
applications have benefitted from recent
developments in laser texturing, including the introduction of femto lasers and
dual laser systems (see Figure 1).
Femto lasers are the latest laser technology available on the market. These
cold lasers create perfectly sharp corners
and edges because they generate completely burr-free surfaces (see Figure 2).
Burrs are even undetectable when the
cutting surface is viewed under a microscope at 200x magnification. This new
class of laser opens up a variety of new

Intro

Cov

ToC

changing the laser power settings, which


gives a certain degree of control, but the
ability to change to a different type of
laser entirely enables greater control
over the laser texturing process. Fast
changes between laser sources are especially important for those medical manufacturers that experience frequent
shifts in part demands and designs.
Those shops depend on flexible equipment to quickly respond to the needs of
their customers.
As the use of laser texturing continues
to grow, advances such as five-axis
machine movement have further
improved it. With five-axis capability,
manufacturers increase their productivity because this machining process dramatically reduces the need to manually
manipulate workpieces during the part
production cycle. Laser texturing technology also undercuts round shapes,
meaning that the underside of a sphere
can be machined without turning the
part over. The reduction in necessary
setups also eliminates stacked errors
from finished parts.
A current limitation to laser texturing
is the size of the laser field, which is only
as wide as the lens of the laser. Once texturing is complete within that field, the
machine must readjust to place an
untexturized surface under the lens.
However, new technology in automated
laser positioning is on the horizon that

Medical Manufacturing & Fabrication, October 2016

will eliminate this barrier. Advances in


the technology will enable lasers to follow along a machining surface without
having to stop and reposition.
Automatic adjustments could make the
laser texturing process up to 2030 percent faster than it is currently.
Automation further enhances the productivity of laser texturing. Process
automation makes laser texturing a
more viable machining process for highproduction environments because the
automation increases the production
capacity of the machine. Additionally,
modular work holding systems easily
integrate laser texturing with other
processes that a manufacturer may
already use. Production parts can mount
on pallets with a reference system that
transfers across multiple machining
processes and eliminates the need to rereference parts between steps, which
drastically reduces setup times.
Traditionally, one of two technologies
has been employed to provide mold tex-

turing. Moldmakers with five-axis machining capabilities often use them to create
textures in addition to general machining. This can be an acceptable alternative
if the shop has excess five-axis machine
capacity or only a relatively small percentage of jobs that require texturing.
Otherwise, the opportunity costs quickly
accumulate, as the equipment could be
more productively utilized with roughing
and finishing operations than with timeconsuming texturing. Additionally, texturing in this manner requires very small,
specialized tools, which increases the cost
of the process.
In those situations, moldmakers may
turn to chemical etching. Compared
with five-axis machining, this method
offers substantial time and cost savings.
Unfortunately, it also requires sacrifices
in the areas of consistency and quality
due to the impossibility of precisely controlling the texture produced. Chemical
etching also carries with it environmental issues that must be addressed.

Fig. 2 - Manufacturing technology OEMs such as GF Machining Solutions continue to advance laser texturing machines with the incorporation of femto cold lasers and five-axis dual-laser systems.

Medical Manufacturing & Fabrication, October 2016

Intro

As an alternative to chemical etching,


the laser texturing process entails using
a laser to sublimate material, or turn it
directly from solid to gas (see Figure 4).
Laser texturing centers can be equipped
with pulsed, fiber-optic lasers of varying
strengths and a variety of lenses with different focal lengths to maximize productivity. The process promises several key
advantages to mold making shops and
other part manufacturers requiring surface texturing.
Laser texturing offers far more precision and accuracy than can be achieved
via chemical etching. Regardless of how
much care is taken during etching, it is
impossible to eliminate variation that
results, even if it results in only slight differences between workpieces. Laser texturing machines produce textures
directly from digital files, allowing the
creation of any number of identical
components (see Figure 5). While variation is acceptable between components
in some applications, it becomes a much
more apparent issue for critical tighttolerance, high-precision medical components where differences could affect
part performance. Laser texturing
ensures accurate, high-quality, and completely repeatable surface finishes.
Unlike chemical etching, laser texturing has no environmental impact.
Because of the nature of the chemicals
used for etching, U.S. companies using
it must comply with a host of regulations
that substantially increase process costs.
Often as an alternative, these manufacturers will farm out their chemical etching work to suppliers in countries with
little or no environmental regulation.
Unfortunately, doing so substantially
increases lead times and restricts production flexibility when it comes to
responding to urgent customer needs.
In short, laser texturing is typically more
cost-effective and/or faster than chemi-

Fig. 3 - As laser beams get smaller, laser texturing systems can be used to create very tiny intricate surface patterns.

www.medicaldesignbriefs.com

Cov

ToC

13a

Laser Texturing

Fig. 4 The laser texturing process uses a laser


to sublimate material, turning it directly from
solid to gas.

cal etching, depending on whether


viewed in terms of domestic or international alternatives.
In addition to adherence to strict government regulations, chemical etching
is quite labor intensive, and each part
undergoing the process must be carefully prepared to ensure that the chemicals
only access the features to be textured.
Exposing other areas of the part to these

Fig. 5 - Laser texturing allows manufacturers to


produce part surface textures and patterns
directly from digital files.

chemicals can result in the entire piece


being scrapped. Additionally, the
process requires preparing chemical
baths into which the parts are submerged and cleaned and disposing of
the chemicals, all steps that involve a lot

Veriow Technologies case


study available upon request

Unmatched expertise for the medical industry

Branson is recognized worldwide for offering the broadest range of


advanced solutions for plastics joining, metal welding and precision
cleaning technologies.
bransonultrasonics.com 203-796-0400
Branson Ultrasonics Corporation 2016.
The Emerson logo is a trademark and service mark of
Emerson Electric Co.

Medical Manufacturing & Fabrication, October 2016

Free Info at http://info.hotims.com/61066-892

14a

Intro

Cov

ToC

of labor. In contrast, laser texturing consumes minimal labor. An operator sets


the part in the machine, loads the program, pushes the start button, and walks
away until the texturing is complete.
Although the actual process time
required for laser texturing substantially
exceeds that of chemical etching, laser
etching requires considerably less labor.
Laser texturing technology reproduces a
3D surface texturing within a few
microns of accuracy.
Laser texturing machines increase
productivity of the manufacturing
process because they can replace several
other machining steps. A five-axis laser
texturing system can machine a part on
all five sides without manual intervention of an operator, which saves up to 80
percent on setup time. A laser texturizer
can machine grooves and corners as well
as etch a workpiece, all in a single setup.
On the design side of manufacturing,
laser texturing provides for greater
legal protection of innovative and proprietary textures and patterns. The
inability of chemical etching to produce repeatable results renders the
process incapable of creating textures
that could be submitted for patent protection. Laser texturing overcomes this
obstacle, allowing manufacturers to create and legally protect surfaces that
result in a truly unique appearance and
feel in the final product.
Laser texturing can be used to protect
against counterfeit parts. Through the
part program, a user can create a unique
texture code on a nanoscale. Industry
experts predict that nanosized textures
will eventually be used in medical component traceability. In these instances, a manufacturer would create a unique pattern,
invisible to the naked eye, to mark parts to
uniquely identify those they produced.
With todays increasing demands for
product differentiation, laser texturing
machines provide medical manufacturers with a means to meet and exceed
their customers needs, whether its surfaces with intricate patterns and textures, precisely sharp corners, or resistance to debris. By incorporating previously unattainable levels of quality and
repeatability, a medical shop utilizing
laser texturing will quickly stand out in
the sea of competition.
This article was written by Gisbert
Ledvon, Director of Business Development,
GF Machining Solutions, Lincolnshire,
IL. For more information, visit
http://info.hotims.com/61066-203.

MANUFACTURING

NIST Illuminates Transfer of Nanoscale Motion Through


Microscale Machine
Research closes the gap between fabrication technology and motion metrology.
National Institute of Standards and Technology, Gaithersburg, MD

s U.S. industry develops smaller


mechanical systems, they face
bigger challenges microscopic
parts are more likely to stick together
and wear out when they make contact
with each other.
To help make microscopic mechanical (micromechanical) systems perform
reliably for advanced technologies,
researchers at the National Institute of
Standards and Technology (NIST) are
getting get back to basics, carefully measuring how parts move and interact.
For the first time, the NIST researchers
have measured the transfer of motion
through the contacting parts of a micromechanical system at nanometer and
microradian scales. Their test system consisted of a two-part linkage, with the
motion of one link driving the other. The
team not only resolved the motion with
record precision but also studied its performance and reliability.
Lessons learned from the study could
impact the fabrication and operation of
various micromechanical systems, including safety switches, robotic insects, and
manufacturing platforms. The motion of
micromechanical systems is sometimes
too small displacements of only a few
nanometers, or one billionth of a meter,
with correspondingly small rotations of a
few microradians for existing measurement methods to resolve. One microradian is the angle corresponding to the
length of an arc of about 10 meters along
the circumference of the earth.
There has been a gap between fabrication technology and motion metrology the processes exist to manufacture
complex mechanical systems with microscopic parts, but the performance and
reliability of these systems depends on
motion that has been difficult to measure. We are closing that gap, said
Samuel Stavis, a project leader at NIST.
Despite how simple this system
appears, no one had measured how it
moves at the length and angle scales that

we investigated, said researcher Craig


Copeland of NIST and the University of
Maryland. Before commercial manufacturers can optimize the design of more
complex systems such as microscopic
switches or motors, it is helpful to understand how relatively simple systems operate under various conditions.
The measurements, which the
researchers report in Microsystems &
Nanoengineering, rely on optical microscopy to track surface features on the
moving parts. The manufacturer can
build in the surface features during the
fabrication process so that the system is
ready for measurement right out of the
foundry. Or, the researchers can apply
fluorescent nanoparticles to the system
after fabrication for improved precision.
NIST researchers introduced this measurement method in a previous study and
have used related methods to track the
motion and interaction of other small
systems. Importantly, the ability to simultaneously track the motion of multiple
parts in a micromechanical system
allowed the researchers to study the
details of the interaction.

How it Works
In their experiment, the researchers
studied the transfer of motion through a
mechanical linkage, which is a system of
parts connected in order to control
forces and movement in machines. The
test system had two links that connected
and disconnected through a joint, which
is the point at which the links apply forces
to each other. The electrical heating and
thermal expansion of one link drove the
rotation of the other link around a pivot.
The researchers developed a model of
how the system should move under ideal
operating conditions and used that
model to understand their measurements of how the system moved under
practical operating conditions. The team
found that play in the joint between the
links, which is necessary to allow for fabri-

Medical Manufacturing & Fabrication, October 2016

Intro

(Top) A micromechanical linkage converts translation into rotation. The red box indicates the
region of the rotating part that has fluorescent
nanoparticles on it. (Bottom) A capture from a
video showing the fluorescent nanoparticles on
the rotating part of the linkage. Tracking the
nanoparticles enables tests of the performance
and reliability of the system. (Credit: NIST)

cation tolerances and prevent the parts


from jamming, had a central role in the
motion of the system. Specifically, the
amount of play was an important factor in
determining precisely how the links coupled and uncoupled, and how repeatable
this transfer of motion could be.
As long as the electrical input driving
the system was relatively free of noise, the
system worked surprisingly well, transferring the motion from one part to another very consistently for thousands of
operating cycles. It was perfectly repeatable within measurement uncertainty,
said Copeland, and reasonably consistent with our ideal model.
That is important, he notes, because
some researchers expect that the friction
between small parts would degrade the
performance and reliability of such a system. Many engineers have even abandoned the idea of making micromechanical systems out of moving parts that make
contact, switching to micromechanical
systems with parts that move by flexing to
avoid making contact with each other.
The results suggest that micromechanical systems that transfer motion
through contacting parts may have
underexplored applications, said Stavis.
However, the researchers found that
when they added a normal amount of

www.medicaldesignbriefs.com

Cov

ToC

15a

MANUFACTURING

electrical noise to the driving mechanism, the system became less reliable
and did not always succeed in transferring motion from one link to the other.
Further, exposure of the system to
atmospheric humidity for several weeks
caused the parts to stick together,
although the researchers could break
them loose and get them moving again.
These findings indicate that while
micromechanical systems have the

potential to transfer motion between


contacting parts with unexpectedly precise performance, the driving signal and
operating environment are critical to
the reliable output of motion. The team
now plans to improve their measurements and extend their work to more
complex systems with many moving
parts.
Micromechanical systems have many
potential commercial applications,

said Stavis. We think that innovative


measurements will help to realize that
potential.
This project was a collaboration
between researchers in NISTs Center for
Nanoscale Science and Technology
(CNST), NISTs Physical Measurement
Laboratory (PML), and the University of
Maryland as part of the NIST Innovations
in Measurement Science program.
For more information, visit www.nist.gov.

Electrochemical Etching Improves 3D printing of metals


New technique is a game-changer in 3D metal printing.
Arizona State University, Tempe, AZ

esearchers at Arizona State


University have made potentially
game-changing progress in the
emerging realms of 3D printing and
additive manufacturing an advance
that could have a dramatic impact on
how things are made from metals.
Owen Hildreth, an assistant professor
of mechanical and aerospace engineering in ASUs Ira A. Fulton Schools of
Engineering, has collaborated with several colleagues to develop a technique that
promises to make manufacturing of
metal components, devices, and structures less expensive, less technically complex, and less labor intensive. Significantly, the process overcomes what has
been a nagging difficulty for the 3D
printing of metal objects.
As an alternative to laborious machining processes, 3D printing has been a
major driver of additive manufacturing.
Conventional manufacturing is essentially a subtractive process. Manufacturers
start with a mass of material and remove
or subtract parts of the mass to produce a desired object.
Its like sculptors working with blocks
of marble, Hildreth explained. They
remove parts of the marble blocks until
they get the shape of whatever kind of
sculpture they wanted to create.
Additive manufacturing, particularly
with the use of 3D printing technology, is
the opposite, he said: You just add layers
of material until you get what you want.
You extrude products. The printer just
pushes things out in one piece. The
process works great with lightweight and
flexible plastics and polymers. But with
weighty metals, its much more of a challenge. Thats because when objects made
of plastics and similarly soft materials

Fig. 1 The arch was formed by first printing a


stainless steel arch supported in the center by
carbon steel. After printing, the carbon steel was
electrochemically removed in a mixture of nitric
acid with bubbling oxygen. Since carbon steel is
easily dissolved while stainless steel isnt, this
simple process leaves behind a free-standing
stainless steel arch that didnt require any of the
expensive machining operations that typically
plague 3D metals printing. (Credit: Owen Hildreth)

emerge from a 3D printer with extraneous material, the unneeded material can
usually be easily cut away to give the
object its intended form.

How it Works
The researchers employed a printing
method called directed energy deposition that enables the printing of an
object using two kinds of metal at the same
time in combination, and then electively
dissolving the sacrificial material with a
simple electrochemical etching technique.
To demonstrate their new approach,
they printed a stainless steel arch supported by carbon steel (see Figure 1).
The stainless steel is very chemically
resistant. The carbon steel is not very
chemically resistant, Hildreth said. The
printed metal structure was immersed in

16a

www.medicaldesignbriefs.com

Intro

Cov

ToC

a chemical bath of nitric oxide and


bubbling oxygen capable of dissolving
metals that are not chemically stable
in this case, the carbon steel supporting
the top of the arch.
We took advantage of the differences
in the chemical and electrochemical stability between the two metals, Hildreth
said. The carbon steel was etched away
without any machining. The stainless
steel wasnt affected. So what we have is
the worlds first 3D-printed metal arch
made with directed energy deposition.
What that makes possible is a big
reduction in the amount of post-processing required to remove support structures from 3D-printed metal components. Were fairly certain our method is
going to be applicable to a broad range
of metals used in manufacturing,
Hildreth said.
To achieve the advance, Hildreth
teamed up with Timothy Simpson, a professor of mechanical and nuclear engineering as well as industrial and manufacturing engineering at Pennsylvania
State University, and a leading expert in
both 3D printing of metals and additive
manufacturing. They were joined by
Pennsylvania State University engineering research associate Abdalla Nassar
and Kevin Chasse, a corrosion engineer
with the Naval Surface Warfare Center.
Together they authored the report
Dissolvable Metal Supports for 3D Direct
Metal Printing, published in a recent edition of the research journal 3-D Printing
and Additive Manufacturing. Hildreths
recent research in these areas has been
funded in large part through a Bisgrove
Scholars Program award he received in
2015 from Science Foundation Arizona.
For more information, visit www.asu.edu.

Medical Manufacturing & Fabrication, October 2016

Linear Motor and Ballscrew Positioning Stages

Laser Welding System

Aerotech, Pittsburgh, PA, offers its PRO series industrial linear


motor and ballscrew positioning stages in new sizes. Two new sizes
the PRO115LM and PRO190LM were added to the linear motor
series stage line. New features include a linear encoder option on
PROSLE ballscrew stages,
absolute encoder options on
both the linear motor and
ballscrew stages, and direct
mounting to English and metric optical tables.
For Free Info Visit http://info.hotims.com/61066-206

Dukane, St Charles, IL, has introduced a new


laser welding system that allows clear-to-clear plastic welding without the need for laser-absorbing
additives. The system incorporates a recently
developed 2-m laser with a greatly increased
absorption by clear polymers. The laser enables
highly controlled melting through the thickness
of optically clear parts. A new beam delivery system integrates both a programmable multi-axes servo gantry and a
scan head. LaserLinQTM software harmonizes the action of both components moving the beam, which ensures highly precise and controllable beam delivery when welding mid-size and large components.
For Free Info Visit http://info.hotims.com/61066-210

Direct Diode Laser Welder


Amada Miyachi America, Monrovia, CA,
launched a new 120-W direct diode laser
(DDL) welder for soldering and plastic welding. With low power consumption and high
efficiency, DDL lasers feature localized heating, which is ideal for small parts welding and
manufacturing applications with space limitations. The ML-5120A is equipped with a temperature control function, which requires a
separate dedicated unit to control laser output power. The welder
directly applies light emitted from laser diodes for thermal processing
without passing through a lasing medium.
For Free Info Visit http://info.hotims.com/61066-207

Clamping System for Milling


GF Machining Solutions, Lincolnshire, IL, offers
the System 3R Delphin Zero Point, a clamping system for use during heavy milling operations on a
variety of machine tools. With the Delphin system,
manufacturers can increase their overall productivity by streamlining setups and reducing machine
idle time. The system offers a clamping force of
60,000 N per chuck face, with an accuracy of 5 m
even in challenging conditions. It is available in pneumatic and
hydraulic operating systems for a variety of machine tools.
For Free Info Visit http://info.hotims.com/61066-211

3G Laser Welder

Extrusion Crosshead

Branson Ultrasonics, Danbury, CT,


offers a 3G laser welder with the company's Simultaneous Through-Transmission
Infrared (STTIr) laser welding technology. STTlr laser weld technology is
designed to produce a clear-on-clear,
particulate-free, hermetically sealed
weld and is ideal for welding delicate
parts or those embedded with electronics. STTIr shapes multiple stationary laser beams in a wave guide along the entire length of the weld
line. The wave guide that houses the laser ferrules can be configured on
multiple axes to accommodate highly complex 3D contours, allowing
designers to create parts for maximum functionality and ergonomic
appeal.
For Free Info Visit http://info.hotims.com/61066-208

Guill Tool, West Warwick, RI, offers a new rubber/silicone


extrusion crosshead with mechanically assisted gum
space (MAGS) adjustment. The 500 Series is designed
specifically for the flow characteristics and unique
processing challenges of elastomeric compounds. The MAGS adjustment method
allows the operator to make an adjustment
from a single point using a common socket wrench. A visual indicator
on the core tube allows the operator to see how far the gum space has
been moved, making adjustments much more accurate and repeatable.
The crosshead has a Center-Stage concentricity adjustment system that
reduces pressure on the tooling, allowing easier and more precise concentricity adjustments without loosening the face bolts.
For Free Info Visit http://info.hotims.com/61066-212

Laser Tracker Software


Micro Hardness Testers

Hexagon Manufacturing Intelligence,


North Kingstown, RI, launched its latest system software release and a new Ethernet Real
Time Feature Pack (RTFP) for the Leica
Absolute Tracker AT960 and AT930. The software offers 7DOF measurement capability for
applications such as laser tracker-based
machine control and robotic guidance. This technology adds a time dimension to the measurement data acquired by the laser tracker, made possible
by interfacing its LMF communications with the new industrial EtherCAT
protocol. It enables real-time machine control for milling, drilling, grinding,
polishing, and other processes in a large-scale manufacturing environment.
For Free Info Visit http://info.hotims.com/61066-213

Buehler, Lake Bluff, IL, has introduced the


Wilson VH1102 and VH1202 micro hardness
testers. The testers are designed to meet the
highest accuracy standards and can be used both
in quality control and research and development.
The instruments, which feature deadweight loads
from 10 g up to 2 kg, have nine different, automatically selectable loading stages. They are suitable for Knoop and Vickers micro hardness testing in accordance with ISO 6507, 9385, and 4546
or ASTM E384 and E92.
For Free Info Visit http://info.hotims.com/61066-209
Medical Manufacturing & Fabrication, October 2016

Intro

www.medicaldesignbriefs.com

Cov

ToC

17a

Laser Welder for Plastics

Automated Dispensing System

LPFK Laser & Electronics, Frth, Germany, has


introduced a new laser welding system for the production of microfluidic components. Lasers are ideally suited to medical technology applications
because they generate no dust or particles and can
process a wide range of materials without needing
any additives. The LPKF PowerWeld 2600 is
designed to support more efficient production and
simpler maintenance. The system can be equipped
with different laser sources, including fiber lasers,
which are ideal for extremely fine weld seams. The compact laser welding system features the round indexing table. The laser, control unit,
and cooling unit are integrated into the housing.
For Free Info Visit http://info.hotims.com/61066-214

Nordson EFD, East Providence, RI, has introduced a new four-axis


automated dispensing system. The R Series systems are configured for
precise fluid dispensing using EFD syringe barrel and valve systems.
The series includes proprietary TeachMotion software for simplified programming of 360 ID and OD dispensing. The
software enables repeatability and accuracy
in fluid placement and positioning. The systems 3D motion control provides easy programming of dots, lines, circles, arcs, compound arcs, and patterns on different planes.
The fourth axis allows for dispensing at any
angle along the 360 rotation plane.
For Free Info Visit http://info.hotims.com/61066-218

3D Inspection System

Application Development Lab

Mahr Federal, Providence, RI, has introduced the MarShaft SCOPE 600 plus 3D,
which uses a new measurement method for
special shaft applications. A combination of
optical and touch sensors allow for a functionally complete 3D inspection of the workpiece.
The companys MarShaft SCOPE plus system
uses a motorized tailstock and a calibration
for the linear axes. A matrix camera optically
measures characteristics such as diameters, lengths, radii, geometries,
location characteristics, cam angle, or cam lift in seconds. The additional 2D sensor detects features that are not optically measurable such
as concave cam shapes, axial run out on large shoulders, and reference elements in the axial direction such as blind holes.
For Free Info Visit http://info.hotims.com/61066-215

Resonetics, Nashua, NH, has added a


Lightspeed ADL Application Development Lab in its Dayton, OH, facility to
complement the existing lab in Boston.
This new 1,100 sq. ft operation is staffed
with 11 engineers and technicians and has
dedicated systems for laser ablation, cutting, and welding. The Dayton site will
focus on metal applications, while the
Boston lab will continue to emphasize polymer and glass applications.
The company has added five new laser systems to its labs, including two
femtosecond cutting systems, one zero kerf femtosecond system for
glass ablation, and one laser welding system.
For Free Info Visit http://info.hotims.com/61066-219

Fiber Punch Laser Processing


Combined Auto ID and Machine Vision Platform
Microscan, Renton, WA, offers the MicroHAWK, an enclosed imaging device for barcode reading and machine vision for clinical instruments. The device includes a fully integrated imaging engine and three industrialrated miniature imagers. These imaging
components can be embedded into systems
to automate processes such as alignment,
robotic guidance, and FDA UDI compliance validation within turnkey devices and
instruments. Smart cameras (MV-20, MV-30,
and MV-40) enable universal imaging of any code, text, or part feature
to accomplish any automation task based on visible data.
For Free Info Visit http://info.hotims.com/61066-216

Trumpf, Farmington, CT, offers


the TruMatic 6000 fiber punch laser
machine, which combines the advantages of high-speed solid-state laser
processing with high-quality punching and forming technology. This
newly introduced machine rapidly
laser cuts, punches, forms, and
engraves sheet metal up to 0.25 in. thick. The machine is designed for
scratch-free processing while an intuitive laser output control system
ensures superior quality when cutting delicate curves and tight radii. It
includes a TruDisk 3001 solid-state laser and provides 20 tn of punching force delivered at 1,000 strokes per minute
For Free Info Visit http://info.hotims.com/61066-220

Thermoforming Packaging Machine

CT Measurement Software

Multivac, Wolfertschwenden, Germany, has released the R 081 thermoforming packaging machine, an entry-level model for automatically
packing small or medium-sized batches. The compact system is ideal
for use in environments with limited space and is suitable for packaging sterile medical products in small
batch sizes or for test markets. With
a maximum output of 15 cycles per
minute, the R 081 is able to run rigid
and flexible films as well as Tyvek
and paper-based packaging materials with a total web thickness of up to 400 m. It can be equipped with
evacuation and gas flushing systems and can therefore also be used for
producing vacuum packs or packs with modified atmosphere and
reduced residual oxygen content.
For Free Info Visit http://info.hotims.com/61066-217

Werth, Old Saybrook,


CT, has introduced WinWerth measurement software, which takes two computed tomography (CT)
measurements with spectra tuned to a specific
material and computationally combines them into a single volume.
This volume can be used to check dimensions in any desired cross section using 2D contour image processing. A patented method for local
edge detection can also be used to derive a 3D point cloud for the
entire workpiece. By reducing the artifacts in the volume, dimensions
measured between the different materials have lower measurement
uncertainty.
For Free Info Visit http://info.hotims.com/61066-221

18a

www.medicaldesignbriefs.com

Intro

Cov

ToC

Medical Manufacturing & Fabrication, October 2016