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Welcome to
your Digital Edition of
Medical Design Briefs
May 2011
Intro
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www.medicaldesignbriefs.com April 2011 www.medicaldesignbriefs.com May 2011
From the Publishers of
Challenges in Design Development:
Why Design Controls Make Sense
Whats So Hard About Medical Device
Software Compliance?
Envisioning the Future of Robots in Surgery,
Drug Delivery, and Beyond
MD&M East 2011 Product Preview
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Intro
www.medicaldesignbriefs.com April 2011 www.medicaldesignbriefs.com May 2011
From the Publishers of
Whats So Hard About Medical Device
Envisioning the Future of Robots in Surgery,
Drug Delivery, and Beyond
MD&M East 2011 Product Preview
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Intro
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Intro
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Intro
2 Medical Design Briefs, May 2011 Free Info at http://info.hotims.com/34454-793
May 2011
FEATURES
4 Challenges in Design Development: Why Design Controls
Make Sense
12 Envisioning the Future of Robots in Surgery, Drug Delivery,
and Beyond
15 Whats So Hard About Medical Device Software
Compliance?
17 Mission Accomplished
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Intro
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Intro
4 www.medicaldesignbriefs.com Medical Design Briefs, May 2011
T
he time and investment needed to
bring an idea for a new medical pro -
duct successfully to commercial realiza-
tion can be daunting. In developing
new drugs, the costs and timing
required to conduct multiple stages of
clinical studies, even under the best of
circumstances, can be a non-starter if
the projected long-term revenue and
profit potential are not sufficient to jus-
tify the cost and risk associated with
development. Similarly, the develop-
ment of software-driven instrumenta-
tion products is complex in the extent
of interactions among components and
the number of areas where a seemingly
small problem with one mechanical
component, or a mistake in one line of
software coding, can lead to catastroph-
ic product system failure. Even the
development of simple single-use
medical devices can involve years of
development and millions of dollars in
capital investment.
Its no wonder that with product
development scenarios frequently
involving such large investments in time
and resources, product development
teams can be under intense pressure to
avoid manifestations of Murphys Law:
If anything can go wrong, it will. What
is not always fully appreciated is that reg-
ulations put in place by the United
States Food & Drug Administration
(FDA) with regard to medical product
development are helpful to ensure con-
sistency and thoroughness in the devel-
opment process. In 1990, the Safe
Medical Device Act (SMDA, Public Law
No. 101-629) was approved as an amend-
ment to the federal Food, Drug, and
Cosmetic Act. The SMDA included a set
of regulations called Design Controls to
better regulate the design process for
Medical Devices (21CFR, Part 820.30).
These regulations are legally applicable
only to certain classes of medical device
and diagnostic products, yet the princi-
ples behind Design Controls are logical
and can be applied to any type of med-
ical product development.
Early phase development that in -
cludes exploratory R&D, development
of concept models, and early feasibility
testing is not governed by Design
Controls. Design Controls begin after an
initial product concept has been deter-
mined and Design Inputs are formally
documented, prior to formal Design
Verification and Validation testing.
Product Requirements/
Design Inputs
Frequently, the requirements of the
customer are not well understood. It is
not enough to say the product being
designed must be able to jump there
must be an understanding of how high
the product must be able to jump from
the customer perspective (known as the
Voice of the Customer). Then, the
engineer or scientist must translate that
voice of the customer into specifications
with quantifiable design boundaries
that enable measurement of develop-
ment progress, and ultimately be able to
assess the degree to which the product
will consistently meet the requirement.
In the example above, one might deter-
mine the initial design input to be:
Under x and y conditions, the product
must be able to jump vertically 2.30.2
meters with at least 95% confidence.
Design Controls require that a set of
Design Inputs be established early in the
product development process. Design
Inputs are a set of technical specifications
with quantifiable design boundaries that
represent a translation of the customer
requirements into measurable engineer-
ing terms. As a design evolves and test
methods and acceptance criteria are bet-
ter determined, the Design Inputs docu-
ment is supposed to be updated and treat-
ed as a formal revision-controlled docu-
ment. Frequently, Design Inputs are
incomplete, unclear, or not measurable.
Without adequate Design Inputs, the risk
of completing qualification all the way
through clinical studies only to find prob-
lems during expensive clinical studies is
increased. The product might even work
sufficiently to get approved, only to find
surprises following commercialization.
Risk Analysis
During the early stages of develop-
ment, risk analysis that identifies and
evaluates the risk associated with various
potential product failure modes should
be conducted. Failure Mode Effects
Analyses can help determine potential
sources of failure and potential patient
hazards due to Customer Use/Misuse
(UFMEA), Design (DFMEA) or Process
(PFMEA). For complex product systems,
Fault Tree Analysis can be an effective
alternative for risk analysis.
Risk analyses are done prior to final
qualification testing since verification
Customer / Product
Requirements
Design Inputs
Design
Design Output
Design Verification
Design Validation
Design Transfer/
Launch
Post - Market
Surveillance
Risk Analyses

Fig.1 Flow of Design Control
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Intro
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Intro
and validation testing frequently are
part of risk mitigation. Design For Six
Sigma (DFSS) is frequently applied to
critical design elements to ensure a sta-
tistically adequate safety margin in reli-
ably meeting requirements.
Comprehensive risk analysis can be
effective in avoiding those dreaded
manifestations of Murphys Law. Early
identification of potential risks allows
the project team an opportunity to
adjust the design or process, or to miti-
gate the likelihood of occurrence or
potential severity of the hazard. This
reduces the possibility of a last-minute
major program setback.
Unfortunately, risk analyses are not
always comprehensive and risks are not
always fully mitigated. This can ultimate-
ly lead to recalls of commercialized
products, or expensive product re-engi-
neering programs. Management may
then ask, How could this happen? or
Why did we not anticipate this failure in
advance? Risk analysis done merely as a
paperwork exercise to meet a company
SOP may not capture the real issues
known as Garbage In, Garbage Out.
Risk analysis needs to tap appropriate
expertise regarding medical use, prod-
uct design, and manufacturing. Even
with the most rigorous of efforts to
develop risk analysis, there are legiti-
mate unknowns regarding frequency of
occurrence of certain failures when esti-
mated early during product develop-
ment. This is why risk analysis docu-
ments must be updated periodically as
frequency of occurrence or severity of
the hazard become better understood or
new failure modes are discovered.
Risk Management is central to imple-
mentation of and compliance with
Design Controls. Expectations and best
practices in the utilization of Risk
Management have evolved significantly
over the past 10 years. Since many med-
ical products were developed prior to
adoption of expanded risk management
methodologies, supporting technical files
sometimes lack comprehensive risk analy-
sis. Hence, many companies have remedi-
ation programs in place to address the
need for supporting risk analysis.
Design & Development Planning
FDA Design Controls require that the
development process occur in a
thought ful, planned manner. Each
manufacturer shall establish and main-
tain plans that describe or reference the
design and development activities and
define responsibility for implementa-
tion. [(21 CFR820.30(b)]
Poor project planning can result in a
process that is ad hoc and lacking in con-
fidence as to when milestones may be
achieved. Good planning that results in
realistic schedules can reduce pressure on
the project team, and thus mitigate a his-
torical contributing factor to design
defects that can cause patient injury. By
mandating the creation and maintenance
of Design & Development Plans, FDA is
forcing industry to do what it should be
doing anyway. A comprehensive Design &
Development Plan may include the fol-
lowing interdisciplinary areas:
i. Prototype Development Plan
ii. Quality Plan
iii. Manufacturing Plan
iv. Risk Management Plan
v. Regulatory Plan
vi. Verification and Validation
Planning, including Clinical
Studies where applicable
vii. Launch Plan
Realistic schedules need to allow for
development as an iterative process, par-
ticularly when trial and error is required
through prototyping to fine-tune critical
tolerances, or in the case of software
6 Medical Design Briefs, May 2011
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development where time to eliminate
bugs in the system is normally needed.
Additionally, the common use of Stage
Gates and Design Reviews during devel-
opment implies the possibility of a feed-
back loop in the development process.
Design Verification and Validation
Design Verification refers to systemati-
cally testing to ensure that all the Design
Inputs are met by the proposed design
(see Fig. 1). Verification testing needs to
be sufficient to address any required mit-
igations identified by Risk Analysis.
Correspondingly, Design Validation
through clinical studies or simulated
product use testing is performed to
check that the user needs have been met.
Design Validation is critical because
Design Inputs are not always complete or
accurately translated from the customer.
Frequently, project files contain gaps,
where not all Design Inputs were verified
or customer use conditions validated.
Another common problem is that verifi-
cation and validation testing is not statis-
tically adequate. Lastly, verification and
validation test planning needs to ensure
that the product remains functional and
reliable after the intended shelf life.
Design Reviews
Design Reviews are essential check-
points conducted periodically to ensure
that design process deliverables are
being sufficiently performed. Design
review meetings are intended to ensure
the following:
1. Design Inputs are comprehensive
and measurable
2. Verification and validation testing is
thorough (all Design Inputs veri-
fied and all user needs validated)
and statistically sufficient
3. Risks have been identified and suffi-
ciently mitigated
4. Design Development Plans are
updated, sufficient, and realistic
5. Prior to manufacturing ramp-up
(Design Transfer), specifications
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Design Inputs Approved with
Planned Verification Methods
Test Report Written
Conduct Next Set of Verification
Tests or Proceed to Validation
Testing
Verification Test Protocol Approved
to Evaluate a Design Output for
Conformance to Design Input(s)
Prepare for Formal Design Review
When all Deliverable Elements
Appear Satisfactory to Move to the
Next Phase of Development
Informal Design Review
Design Work Commences
Formal Design Review
Go to Next Phase of Development
Informal Design Review
Multiple Redesign/Test
Loops May be Required
Before all Design Inputs
and Product
Requirements are Met

Fig.2 The Iterative Nature of Product Development and Design Reviews.
FDA Design Controls
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Intro
are finalized and manufacturing
processes are properly validated.
6. Regulatory clearances are received
prior to clinical or commercial
human use.
Design reviews provide objective inde-
pendent review and management over-
sight that ensures that day-to-day pres-
sures to deliver the product design quick-
ly do not lead to shortcuts that could jeop-
ardize product quality. Formal Design
Reviews must be documented and identi-
fied issues must be tracked and resolved.
Informal Design Reviews include activities
such as review and approval of test reports
or approval of engineering drawings.
Informal reviews do not require inde-
pendent reviews, issues tracking, etc. as
required for Formal Design Reviews.
Design & Development Plans should rec-
ognize that Design Reviews may require
certain development activities to be iterat-
ed (see Fig. 2).
The Importance of Design
History Files
Maintaining a record of the design
process is required as part of Design
Controls, but it is also good business
practice. Product lifecycles do not end
with initial launch of the product.
Product or process changes typically
are required at different points over
the lifetime of the product. Many
changes require a new look at risk
analyses to identify new risks or
changes in frequency of occurrence.
Additionally, new tests or portions of
previous verification or validation test-
ing may need to be repeated.
Accordingly, key revision-controlled
documents such as Design Inputs, Risk
Analyses, and Design Outputs are updat-
ed as necessary over the lifetime of the
product. The ready availability of these
core documents as part of a Design
History File (DHF) means that when
product changes are needed, a reposito-
ry of design information is available and
needs only to be reviewed or modified.
Recreating such analysis and documen-
tation to enable a minor product or
process change can slow down a compa-
nys change control process.
Additionally, having ready access to
comprehensive hazards and risk analysis
allows more efficient and credible deter-
mination of required actions when
investigating product issues encoun-
tered by customers. If an FDA investiga-
tor responding to reports of patient
harm associated with a product discov-
ers that there is not even a process in
place by which the risk of harm could
have been anticipated, red flags arise
that there could be many other poten-
tially harmful situations that also were
not predicted. If the development and
post-market surveillance processes are
sound, product recalls or emergency
field corrective actions may still be nec-
essary, but the company will be less like-
ly to face regulatory actions due to non-
compliance concerns.
Conclusion
In summary, design development
requires significant analysis and docu-
mentation to ensure that requirements
are understood, risks are addressed, and
that, ultimately, the product launched
will be safe and effective. The small
investment in additional front-end docu-
mentation can avoid embarrassing and
costly program delays, save time and
money in the long run, and reduce the
risk of harm to patients.
This article was written by Larry Servi,
Director of Product and Process Development
for Regulatory Compliance Associates, Inc.
in Kenosha, WI. Contact Larry at
[email protected] or visit http://info.
hotims.com/34454-162.
FDA Design Controls
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I
n October of 2010, the first all-robotic
surgery reportedly took place at
Montreal General Hospital in Montreal,
Canada. Intuitive Surgicals da Vinci sur-
gical robot worked in conjunction with
the McSleepy anesthesia robot to per-
form a prostatectomy.
Robotic surgery may be most closely
associated with prostatectomies, but
researchers across the world are working
to develop an impressive range of med-
ical applications for robots. The medical
robots of the future will serve various
functions, from highly visible roles (such
as a robotic scrub nurse), down to invisi-
ble ones (like delivering drugs directly
to infected tumors in the body).
Unfortunately, prototypes may be slow
to progress from the research stage into
commercial development. In order to
ensure that concepts are able to trans-
late into clinically feasible products,
robotics engineers might consider learn-
ing more about medicine, according to
Dr. Nobuhiko Hata, PhD., associate pro-
fessor and director of the Surgical
Navigation and Robotics Laboratory at
Brigham and Womens Hospital and
Harvard Medical School.
Professional training specifically tai-
lored to medical robotics, but with
enough exposure to the reality of medi-
cine, is highly needed, said Dr. Hata.
He cites nanotechnology, material sci-
ence, chemistry, tissue engineering, and
artificial organs as some of the areas he
would like to study more in depth as he
proceeds with his work.
While robots wont displace human
surgeons anytime soon, they are gain-
ing recognition as potentially viable
aids in the operating room and other
medical applications. What follows is a
sample of concepts in development
that demonstrate the bright future of
robots in medicine.
Miniature Robot Fly
Researchers at the Technion Israel
Institute of Technology have developed
a prototype of a miniature robotic fly
sized at about a millimeter in diameter
and 14 millimeters long. It fits on the tip
of a finger and is made out of biocom-
patible silicone and metal. In the future,
researchers hope it will be able to enter
the body to diagnose diseases and
potentially deliver drugs directly to
infected tumors.
The robot is based on micro-electro-
mechanical systems (MEMS) technology
and its micro legs are steered either by
an external magnetic force or through
an on-board actuation system. a magnet
that is moved over the body from the
outside. Researchers plan to add a tiny
camera to the robot so it can potentially
be used in brachytherapy, short-distance
radiation therapy, which is commonly
used to treat head, neck, and prostate
cancer. Another next step is to scale the
robot down to a tenth of its current
diameter about 100 microns.
Cardiac Therapy
The HeartLander, a miniature mobile
robot that delivers minimally invasive
therapy to the surface of the beating
heart, is under development at the
Robotics Institute at Carnegie Mellon
University. The crawling robot features
two body sections that are each 5 mm
tall, 8 mm wide, and 10 mm long.
Locomotion is made possible by a wire
transmission that runs through the teth-
er to offboard motors. A graphical inter-
face shows the exact location of the
robot on the heart; real-time location is
measured using a miniature magnetic
tracking sensor (microBIRD, Ascension
Technology) located on the front body
of the crawling robot.
The robot can be driven using a joy-
stick, or it can automatically walk to a
specific target location on the heart. It is
inserted into the body through a skin
incision directly below the sternum, pro-
viding direct access to the heart without
requiring deflation of the left lung. The
surgeon then makes another incision in
the pericardium (the sac that encloses
the heart) and places the robot directly
on the surface of the heart.
The HeartLander uses suction to
adhere to the epicardial (outer) surface
of the heart, a technique used by FDA-
approved medical devices that stabilize
the heart. The vacuum pressure is moni-
tored and controlled by the computer.
Kinect Lends a Hand to
Robotic Surgery
Since surgeons need to review med-
ical images and records during sur-
gery, a robotic scrub nurse may some-
A prototype of a miniature robotic fly, about
0.04" in diameter, is designed to enter the body
to diagnose diseases and potentially deliver
drugs directly to infected tumors. (Technion
Israel Institute of Technology)
The HeartLander, developed at the Robotics
Institute at Carnegie Mellon University, is a
crawling robot that delivers minimally invasive
therapy to the surface of the beating heart.
Envisioning the Future of Robots in
Surgery, Drug Delivery, and Beyond
Cov ToC
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Intro
day increase operating room efficiency
by recognizing hand gestures and call-
ing up the specific images that the sur-
geon needs to view while operating.
Vision-based hand gesture recognition
technology could help reduce not only
the length of surgeries but also the
potential for infection, according to
Juan Pablo Wachs, an assistant profes-
sor of industrial engineering at
Purdue University.
The system under development at
Purdue uses a camera and specialized
algorithms to recognize hand gestures as
commands that instruct a computer or
robot. Further research is needed to
enable computers to understand the
context in which gestures are made, so
that they can discriminate between in -
tended and unintended gestures.
A prototype robotic scrub nurse is cur-
rently working with faculty in the univer-
sitys School of Veterinary Medicine.
Meanwhile, researchers hope to refine
the algorithms to isolate the hands and
apply anthropometry predicting
the position of the hands based on
knowledge of where the surgeons head
is. The tracking is achieved through a
camera mounted over the screen used
for visualization of images. The system
uses a type of camera developed by
Microsoft, called Kinect, that senses
three-dimensional space. Even tually, the
researchers plan to integrate voice
recognition, but will continue to focus
primarily on gesture recognition
research.
Incorporating a better sense of touch
into robotic-assisted surgery systems is
another application for Microsoft
Kinect. Electrical engineering grad stu-
dents at the University of Washington
recently adapted this technology for use
with surgical robots by writing code that
directs the Kinect to map and react to
environments in three dimensions. The
system then sends spatial information
about these environments back to the
user. Such technology could provide sur-
geons with useful feedback about how
far to move the tool; for example, the
system could be programmed to define
off-limits areas such as vital organs.
Robots: Friends in
Hostile Situations
A recent Georgia Institute of Tech -
nology study found that patients gener-
ally responded more positively to a
Medical Design Briefs, May 2011 13
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Purdue industrial engineering graduate student
Mithun Jacob uses a prototype robotic scrub
nurse with graduate student Yu-Ting Li.
Researchers are developing a system that rec-
ognizes hand gestures to control the robot or
tell a computer to display medical images of the
patient during an operation. (Purdue University
photo/Mark Simons)
Cov ToC
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Intro
www.medicaldesignbriefs.com Medical Design Briefs, May 2011
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robotic nurses touch when they
believed the robot intended to clean
their arm, as opposed to when they
believed the robot intended to comfort
them. While robots may not ever be able
to compete with humans when it comes
to displays of compassion, it is this same
lack of humanity that makes them so
useful in other situations, particularly in
the line of fire.
Robots can be especially valuable in
hostile or high-risk environments that
present a danger for humans, such as
search and rescue operations or on the
battlefield. Since medics become vulnera-
ble to danger whenever they are called
upon to assess an injured soldier in the
battlefield, scientists at PERL Research
(Huntsville, AL) (www.perlresearch.com)
were awarded a contract from the U.S.
Army Medical Research and Materiel
Commands Telemedicine and Advanced
Technology Research Center to develop a
system to provide real-time, continuous
estimation of a patients health status: the
Dynamic Injury Severity Estimation
System (DISE).
Our assessment technology is based
on thermographic sensing, explained
PERL Research senior scientist Paul
Cox. With our sensor suite, we are able
to remotely perform Glasgow Coma
Scale (GCS) and establish triage cate-
gories. The robotic triage system is an
integrated system of intelligent software
and sensors that optimally integrates a
medic's remote assessment with an artifi-
cial intelligence decision algorithm to
determine the status of the injured sol-
dier remotely.
The thermographic camera measures
the persons heart rate, respiration rate,
and skin temperature. Also included are
a spinal injury sensor and handheld
triage computer that can determine
injury severity based on the persons vital
signs. The system integrates the medics
assessment (based on remote video
monitoring and audio interaction)
along with automated processing of the
sensor data to determine the condition
of the injured soldier.
For initial capabilities (remote triage
and GCS), the system could be used in
the field in less than two years. For more
detailed patient assessment capabilities,
such as the detection of internal hemor-
rhaging, more research is needed. PERL
has completed initial testing with subjects
using a lower body negative pressure
chamber to simulate blood loss that can
occur when a limb is severed or severely
damaged. Early results indicate a correla-
tion between the parameters extracted
from the thermographic camera and
stroke volume data (the amount of blood
being pumped with each heartbeat).
Stroke volume is an indicator of hem-
orrhaging but is not practical to meas-
ure in the field using current devices. As
more research takes place, someday this
robotic technology will be able to aid in
the early detection of internal hemor-
rhaging in soldiers on the battlefield.
PERL Research is working with the U.S. Army to develop the Dynamic Injury Severity Estimation
System (DISE), an integrated system of intelligent software and sensors on a robot. (PERL Research)
The Future of Medical Robots
Cov ToC
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Intro
Medical Design Briefs, May 2011 www.medicaldesignbriefs.com
From One
Engineer
To Another
Find out:
indium.us/C201
scan code with
mobile device
t answers
t blogs
t tech papers
t one-on-one
t support
t live chat
What is the
best way
to solder to
Nitinol?
Eric Bastow
Senior Technical Support Engineer
[email protected]
2011 Indium Corporation
ASIA t CHINA t EUROPE t USA
indium.com
T
he IEC 62304 standard for medical
device software is causing system
engineers worldwide to step back and
examine their software development
methods with considerable scrutiny.
Although at one time, software develop-
ment and testing was an integral part of
overall system design and production,
the IEC 62304 standard focuses on soft-
ware as a separate lifecycle process that
requires strong support for risk manage-
ment and safety assessment. This does
not mean, however, that complying with
IEC 62304 should necessarily slow down
the medical device software develop-
ment process. By applying best practices
guidance and process automation, med-
ical device companies can reap the ben-
efits of getting through regulatory
approvals faster, lowering costs, and
delivering safer devices.
The Bright Side of the
IEC 62304 Standard
The IEC 62304 standard may even
present manufacturers with an oppor-
tunity to hone their competitive edge.
As with smartphones, automobiles, and
other embedded devices, software com-
ponent is an increasingly critical com-
ponent in todays medical devices, and
it is driving much of the innovation that
distinguishes one companys products
from anothers. Envisioning and deliv-
ering differentiation through software
is helping savvy medical device compa-
nies penetrate new markets and out-
shine the competition.
For some businesses, IEC 62304 com-
pliance may serve to jump-start greater
competitive strengths based on software.
For companies with mature software
capability already in place, compliance
will be a trivial matter. Whether their cur-
rent software development and delivery
capabilities are based on traditional, iter-
ative, or agile practices, the IEC 62304
standard allows organizations to retain
their existing processes. However, some
may need to add capabilities to instanti-
ate a more robust software delivery
process one that not only affords good
quality and risk management, but also
prioritizes established software develop-
ment best practices. This includes soft-
ware configuration management, with
traceability of requirements and artifacts
among the various processes in place.
All of these processes are vital for
dependable software development and
delivery and thats equally true for
software engineers in IT as well as any
number of embedded device markets.
But coordinating people, processes, and
tools is never easy.
The primary difficulty has to do with
the nature of software itself. While the
best thing about software is that it is
soft (i.e., relatively easy to change), this
is also its riskiest attribute. Unlike
bridge construction, most software
does not deal with natural phenomena
where laws of physics or materials pro-
vide a widely understandable frame-
work. Instead, most software is con-
strained only by human imagination;
the quality of software is judged not by
precise mathematics and physical toler-
ances, but by the degree to which it sat-
isfies a users expectations, which is
highly subjective.
For these reasons, agile and iterative
delivery methods enforce frequent
stakeholder review of the working soft-
ware under development, which helps
guide software projects toward more sat-
isfactory outcomes. But software practi-
tioners following the more pure agile
methods such as Scrum or XP may
find that the new emphasis on require-
ments in IEC 62304 demands a more
formal, less agile-feeling lifecycle. Pure
Whats So Hard
About Medical Device
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Intro
agile methods will need to be scaled up
with additional guidance from configu-
ration and requirements management
practices, at the minimum. Modeling
your architecture is another great way to
scale up the process to the requirements
expected of IEC 62304.
The good news is that this standard
doesnt require any one specific software
development and delivery process. A
company can choose to use its tradition-
al waterfall methods if preferred; it
can use the Unified Process (UP) or one
of its flavors, such as IBMs Rational
Unified Process (RUP), or tailor its agile
development practices to conform to
IEC 62304 requirements.
A Worldwide Standard
With IEC 62304, the marketplace has
changed for medical device manufactur-
ers. A number of years ago, the U.S.
Food and Drug Administration (FDA)
was the gold standard for medical device
scrutiny and assurance. Once businesses
received FDA approval for their devices,
that usually meant the rest of the world
approved as well. However, over the
course of time, the EU and Asia-Pacific
countries developed their own stricter
standards, and manufacturers could no
longer count on FDA approval as a
green light for multinational distribu-
tion of products.
Today, medical devices must pass
through all countries regulatory agen-
cies individually. Add to that consumer
demands for ever-higher software per-
formance, as noted earlier, and device
approval has become an increasingly
complex proposition.
Yet again, theres a silver lining here:
Because the standard has been adopted
worldwide, a company may find an eas-
ier route to market for new devices,
since most countries have established
this as the standard for their software
development regulatory needs. While
approval in all countries is still
required, at least the countries are ask-
ing companies to meet the same stan-
dard, which offers companies a frame-
work for meeting software require-
ments in all countries without having to
satisfy individual regulations.
Next Steps for Medical
Device Manufacturers
IEC 62304 compliance does not need
to slow down medical device software
development. However, companies
should perform a gap analysis to see
how closely their own process maps to
the specifications of IEC 62304. They
may eventually hire a third party to help
comply with the new standard, but it is
advisable to do the gap analysis first, just
to take an inventory of the process and
its typical artifacts. Sometimes compa-
nies may find that their documented
process isnt the one they actually follow
in practice.
Manufacturers should get started by
examining their process on paper. Of
course, having a consistent process
across groups is helpful for management
to understand what is happening. But is
this process truly the one being fol-
lowed? Companies should be honest
with themselves to determine if their
departures from the stated process
occur across all products, or only some.
Try to determine where software tools
are most helpful where the integra-
tions are strong and consistent across
the entire organization and identify
the areas for improvement as well.
If a manufacturer determines it isnt
meeting its paper process, it could simply
be that the process is good in theory but
difficult in practice. Compare both to
what the IEC 62304 standard requires.
Does it follow all the phases the standard
says are needed? Is there traceability
between the phases as required? Most of
the time manufacturers can step through
this comparison the first time by them-
selves. If necessary, they can then bring
in a third party to review the whole
process and obtain recommendations
for closing any gaps discovered. A third
party may recommend changes in the
process (even simplifications) as well as
specific tools that: (a) offer strong collab-
oration across the software development
lifecycle, and (b) are specifically geared
to support software and systems delivery.
Of course, it is up to each individual
organization to decide what works best,
and changes should be carefully consid-
ered both in light of the IEC 62304 spec-
ification as well as the product delivery
culture and history of success. The best
tool solutions will be those that allow
incremental adoption of new capabili-
ties, allowing companies to avoid whole-
sale process changes and massive new
infrastructure investments.
This article was written by Martin Bakal,
Electronics Industry Leader for IBM
Rational, Westford, MA. For more informa-
tion, visit http://info.hotims.com/34454-
161.
AM
A Division of Quality
Vision International
Medical Device Software Compliance
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Intro
Medical Design Briefs, May 2011 www.medicaldesignbriefs.com 17
NASA-developed technologies have found new uses in a variety of medical-related applications.
Here we highlight some of those spinoff innovations that had their roots in NASA.
A
rgonide Corporation, a company focused on the
research, production, and marketing of specialty nano-
materials, was seeking to develop applications for its
NanoCeram
fibers. Only 2 nanometers in diameter, these

nano aluminum oxide fibers possessed unusual bio-adhesive
properties. When formulated into a
filter material, the electropositive
fibers attracted and retained elec-
tronegative particles such as bacteria
and viruses in water-based solutions.
This technology caught the interest
of NASA as a possible solution for
improved water filtration in space
cabins.
NASAs Johnson Space Center
awarded Argonide (Sanford, FL) a
Phase I Small Business In novation
Research (SBIR) contract to deter-
mine the feasibility of using the
companys filter for purifying recy-
cled space cabin water. Since viruses
and bacteria can be carried aboard
space cabins by space crews, the abil-
ity to detect and remove these harm-
ful substances is a concern for NASA. The Space Agency also
desired an improved filter to polish the effluent from con-
densed and waste water, producing potable drinking water.
During its Phase I partnership with NASA, Argonide devel-
oped a laboratory-size filter capable of removing greater than
99.9999 percent of bacteria and viruses from water at flow rates
more than 200 times faster than virus-rated membranes that
remove particles by sieving. Since the new filters pore size is
rather large compared to other membranes, it is also less suscep-
tible to clogging by small particles. In September 2002, Argonide
began a Phase II SBIR project with Johnson to develop a full-size
cartridge capable of serving a full space crew. This effort, which
is still ongoing, enabled the company to demonstrate that its fil-
ter media is an efficient absorbent for DNA and RNA.
How it Works
Argonide supplies NanoCeram as laboratory-size filter discs
and in the form of a syringe filter. The filters unique character
can be demonstrated by its ability to remove particulate dyes
such as Metanyl yellow. Although Metanyl yellows particle size
is only 2 nanometers approximately the size of a DNA mole-
cule the NanoCeram syringe filter is capable of retaining it
as the fluid is passed through the syringe without much back
pressure. Another distinctive advantage is the filters ability to
remove greater than 99.96 percent of endotoxins. As a contam-
inant formed from the residue of destroyed bacteria, endotox-
ins can cause toxic shock and present a major concern in phar-
maceutical products.
Named one of the top 100 most technologically significant
new products of 2002 by R&D Mag azine, Argonides Nano -
Ceram syringe filters and laboratory filter discs provide the
biotechnology and life science industries with fast, accurate,
and cost-effective tools for separating proteins and other
macromolecules. NanoCerams key
applications include sterilizing
pharmaceuticals and medical
serums; filtering DNA, RNA, and
endotoxins; and immobilizing bac-
teria and mammalian cells in
biosynthesis. The filters are capable
of sterilizing water from all microbi-
ological pathogens, including bio-
logical warfare weapons. Since the
filters absorption is based on the
ionic charge of the macromole-
cules, the potential exists for sepa-
rating proteins and other particu-
lates on the basis of their charge dif-
ferences. The separation of specific
proteins signifies a major new
thrust in biotechnology.
Argonides innovation may also
be applied to tissue engineering, as the NanoCeram fibers have
also been found to simulate new bone growth. When the mate-
rial is grafted into damaged bone, the fibers attract and retain
bone cells, permitting new growth at higher rates than hydrox-
yapatite, a natural bone mineral. Since the fibers mimic the nat-
ural fibrous hydroxyapatites shape and adhesion, the result is a
healthy new bone with physical properties almost identical to
the patients original bone. This application may help patients
suffering from forms of osteosarcoma, osteoporosis, and scleros-
teosis, a disorder in which progressive bone overgrowth leads to
facial deformities.
Since the principal application of the NanoCeram filters is
based on their ability to remove viruses from water, the filter
cartridge Argonide is developing through its Phase II SBIR
contract has many potential applications in water purifica-
tion. For example, although municipal water is monitored for
bacterial contamination on a routine basis, viruses are not
monitored and there are no regulations for their removal.
This is primarily due to the difficulty in monitoring for spe-
cific virus contamination. A low-cost filter cartridge such as
Argonides could be used for sampling viruses, allowing for a
more routine analysis of municipal water treatment plant
sources and effluents.
This potential application presents significant benefits, since
viral hepatitis A and Norwalk virus epidemics have been water-
borne on numerous occasions. Recent studies have shown that
viruses can percolate far further underground than bacteria
and can contaminate ground water supplies as a result.
Freeing Water From Viruses and Bacteria
The NanoCeram
syringe filters and laboratory filter

discs are fast, accurate, and cost-effective tools for sep-
arating proteins, viruses, and other macromolecules.
Cov ToC
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Intro
S P O N S O R E D B Y P R I Z E S P O N S O R S
E L E C T R O N I C S
C AT E G O R Y
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Calling all design engineers. Its up to you.
Share your new product ideas with the world,
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Cov ToC
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Intro
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business and industry leaders who can help bring your idea to market.
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Cov ToC
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Intro
The threat of terrorists contaminating water supplies is also
increasing the need for a water filtration system with
NanoCerams capabilities. Argonide has received a contract to
develop a concentrator that would collect biological agent
viruses from water for the purpose of detection by real-time
sensors. In another program, Argonide has demonstrated effi-
cient collection of viruses containing aerosols, for the purpose
of identifying aerosolized pathogens.
For consumers, Argonide is also developing a polishing filter
that would be used in portable water purification devices for
campers, backpackers, and military personnel. Present devices,
while capable of filtering bacteria from water, are unable to fil-
ter viruses. Adding a NanoCeram polishing filter to the efflu-
ent of an existing filtration device could remove more than
99.99 percent of viruses. Another application is a point-of-use
filter for residences with either municipal or pumped well
water. On a global level, Argonide is working on low-cost grav-
ity filters that might be used to purify surface or well water in
third world countries.
More Information
For more information about NanoCeram
filters, visit http://info.

hotims.com/34454-160.
20 Medical Design Briefs, May 2011
Some folks might think a diametral pitch is a roundabout way of selling
something, but we know better at Forest City Gear.
Our gearheads live with the math and physics of gears on their minds, every
day. Plus, they bring an unmatched knowledge of materials and CNC machine
tool functionalities to the difficult task of making the world's very best gears, to
exacting customer specifications, time after time after time. In our world, you
see, consistency is not the hobgoblin of little minds, with all apologies to Mr.
Emerson (the essayist, not the electric motor magnate). Doing something right
"most" of the time simply isn't good enough at Forest City Gear, as it isn't for
our customers.
They demand we make it right, every time, as our products help their products
perform better. As a result, their reputation rides, in part, on ours. This is a very
special trust and we do our best to preserve it, all the while trying to improve the
products we deliver. We do this by maintaining a machine shop that's the envy
of the gear world, from the first drawing to every step in the machining process
to the final inspection in our state-of-the-industry QC department and finally, to
the careful product handling and packaging.
For a sample of how good a gear company can be, when they maintain such
"top of mind awareness" for customers, check out www.forestcitygear.com.
We'll be thinking about you.
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R
esearch with tiny artificial muscles
may yield a full-page active Braille sys-
tem that can refresh automatically and
come to life right beneath your fingertips.
Yosi-Bar Cohen, a senior researcher at
NASAs Jet Propulsion Laboratory in
Pasadena, CA, was inspired during a
business trip to Washington, D.C., where
a convention for people with visual
impairments was taking place.
Bar-Cohen came up with an idea to
create a living Braille, a digital, refresh-
able Braille device using electroactive
polymers, also known as artificial mus-
cles. He wrote up a technology report
and included information in a related
book that he published. His writings
inspired other scientists and engineers to
create active displays using this technolo-
gy, and prototypes are now under devel-
opment around the world.
I hope that sometime in the future we
will have Braille on an iPhone. It will be
portable and able to project a picture of a
neighborhood popping up in front of you
in the form of raised dots, said Bar-
Cohen. A digital Braille operated by arti-
ficial muscles could provide for rapid
information exchange, such as e-mail,
text messaging, and access to the Web and
other electronic databases or archives.
According to the World Health
Organization, about 314 million people
are visually impaired worldwide; 45 mil-
lion of them are blind.
Bar-Cohen was contacted by the
Center for Braille Innovation of the
Boston-based National Braille Press to
reach out to the Electroactive Polymer
community and take advantage of his
role in this field. The National Braille
Press is a non-profit Braille printing and
publishing house that promotes the lit-
eracy of blind children through Braille.
Braille Displays Get
New Life With
Artificial Muscles
Cov ToC
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Intro
How it Works
Unlike hardcopy Braille, a refreshable display requires the
raising and lowering of a large number of densely packed
dots that allow a person to quickly read them. Currently, com-
mercial active Braille devices are limited to a single line of
characters. A full page of Braille typically has 25 lines of up to
40 characters per line. Characters are represented by six or
eight dots per cell, arranged in two columns. Production of a
page of refreshable Braille using electroactive polymers
requires individually activating and controlling thousands of
raiseable dots.
Some of the leading-edge work in Braille technology was devel-
oped at SRI (Menlo Park, CA). The Braille display developed at
SRI is based on activating a type of polymer consisting of a thin
sheet of acrylic that deforms in response to voltage applied across
the film. The individual Braille dots are defined by a pattern on
this film, and each dot is independently activated to produce the
dot combinations for Braille letters and numbers.
In currently available active refreshable Braille displays, each
dot is a pin driven by a small motor or electromagnetic coil. In
contrast, in the SRI display the actuators are defined regions
on a single sheet of film. Thus, while each dot is raised or low-
ered by its own applied voltage, there are no motors, bulky
actuators, or similar components. Since the system has far
fewer discrete components for a Braille dot array, it would be
potentially much lower in cost.
Where it Stands
National Braille Press (Boston, MA) recently established a
Center for Braille Innovation. Theyre looking for the Holy
Braille, a full-page electronic Braille display, at a low cost.
We feel that the exciting field of electroactive polymer tech-
nology has matured to the point where it can provide real solu-
tions for Braille displays, said Noel H. Runyan, National Braille
Press, Center for Braille Innovation.
In the spring of 2010, Bar-Cohen included a special session on
tactile displays at an SPIE conference. SPIE is the international
society for optics and photonics. He hopes these baby steps may
someday lead to a full-page Braille system that will allow people
to feel and see the universe beneath their fingers.
More Information
For more information about ongoing research in Braille innovation,
visit www.nbp.org.
(603) 516-1229
The NanoCeram
technology enables filter sterilization of medical serums

and biological fluids.
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Intro
Biosensing Technology Offers Advanced Diagnostic
Capabilities
An electronic biosensing platform, combining nanoelectronics and three-dimensional
electronic system integration, could replace the conventional microplate.
Georgia Institute of Technology, Atlanta, GA
Electronic biosensing tech -
nology could someday dis-
place the multi-welled micro -
plate, long a standard tool in
biomedical research and
diagnostic laboratories. Es -
sentially arrays of tiny test
tubes, microplates have been
used for decades to simulta-
neously test multiple samples
for their responses to chemi-
cals, living organisms, or
antibodies. Fluor escence or
color changes in labels asso-
ciated with compounds on
the plates can signal the
presence of particular pro-
teins or gene sequences.
Researchers hope to re -
place these microplates with
modern microelectronics
technology, including disposable arrays
containing thousands of electronic sen-
sors connected to powerful signal pro-
cessing circuitry. If successful, this new
electronic biosensing platform could
make real-time disease diagnosis possible
potentially in a physicians office by
helping select individualized therapeutic
ap proaches.
The device could facilitate personal-
ized medicine by detecting the gene
mutations that are indicative of cancer
and determining treatment. Fund a -
mental to the new biosensing system is
the ability to electronically detect
markers that differentiate between
healthy and diseased cells. These
markers could be differences in pro-
teins, mutations in DNA, or even spe-
cific levels of ions that exist at differ-
ent amounts in cancer cells.
Researchers are finding more and
more differences like these that could
be exploited to create fast and inex-
pensive electronic detection tech-
niques that dont rely on conventional
labels.
The general-purpose sensing platform
is being developed using nanoelectron-
ics and three-dimensional electronic sys-
tem integration to modernize and add
new applications to the old microplate
application.
The three-dimensional sensor arrays
are fabricated using conventional low-
cost, top-down microelectronics technol-
ogy. Though existing sample preparation
and loading systems may have to be mod-
ified, the new biosensor arrays should be
compatible with existing workflows in
research and diagnostic labs.
A key advantage of the platform is
that sensing will be done using low-cost,
disposable components, while informa-
tion processing will be done by reusable
conventional integrated circuits con-
nected temporarily to the array. Ultra-
high density spring-like mechanically
compliant connectors and advanced
through-silicon vias will make the
electrical connections while allowing
technicians to replace the biosensor
arrays without damaging the underly-
ing circuitry.
Separating the sensing and process-
ing portions allows fabrication to be
optimized for each type of device.
Without the separation, the types of
materials and processes that can be
used to fabricate the sensors are severe-
ly limited.
The sensitivity of the tiny electronic
sensors can often be greater than current
systems, potentially allowing diseases to
be detected earlier. Because the sample
wells will be substantially smaller than
those of current micro plates
allowing a smaller form
factor they could permit
more testing to be done with
a given sample volume.
The technology could
also facilitate use of ligand-
based sensing that recog-
nizes specific genetic se -
quences in DNA or messen-
ger RNA.
So far, the researchers have
demonstrated a biosensing
system with silicon nano wire
sensors in a 16-well device
built on a one-centimeter by
one-centimeter chip. The
nanowires, just 50 70
nanometers, differentiated
between ovarian cancer cells
and healthy ovarian epithelial
cells at a variety of cell densities.
Silicon nanowire sensor technology
can be used to simultaneously detect
large numbers of different cells and bio-
materials without labels. Beyond that
versatile technology, the biosensing plat-
form could accommodate a broad range
of other sensors, including technologies
that may not exist yet. Ultimately, hun-
dreds of thousands of different sensors
could be included on each chip, enough
to rapidly detect markers for a broad
range of diseases.
Genetic mutations can lead to a large
number of different disease states that
can affect a patients response to disease
or medication, but current labeled sens-
ing methods are limited in their ability
to detect large numbers of different
markers simultaneously.
Mapping single nucleotide polymor-
phisms (SNPs), variations that account
for approximately 90 percent of human
genetic variation, could be used to deter-
mine a patients propensity for a disease,
or their likelihood of benefitting from a
particular intervention. The new
biosensing technology could enable
caregivers to produce and analyze SNP
maps at the point-of-care.
This technology was done by the Georgia
Institute of Technology, Atlanta, Georgia. For
more information, visit http://www.gatech.edu.
The new electronic microplate is shown in front of the technology it aims to
replace, the conventional microplate. (Georgia Tech)
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Intro
Although the concept of nanotech-
nology (controlling matter on an atomic
scale) dates back to 1959, it is only now
becoming more commercially realized.
It has the potential to challenge the way
all products are extruded in almost
every type of medical tubular or related
industrial product applications.
NanoFlow die technology builds
upon earlier engineered benefits, in -
cluding thin walls and high-strength tub-
ing in a variety of materials required for
high-speed and high-volume applica-
tions, as well as an ultra-low-volume
design that minimizes the polymer resi-
dence time in the chamber for certain
types of medical tubes.
Guills NanoFlow die extrusion tech-
nology is specially designed to create an
environmentally friendlier or greener
end product in medical applications, an
increasing concern for manufacturers
that face strict governmental regulations.
Access to the right tubing that is engi-
neered to meet or exceed the medical
industry/OEMs demands is always a pri-
mary objective. Nanotechnology dies
serve as a key instrument in the toolbox
of solutions that can improve upon the
limitations of todays tubing.
Advanced nanotechnology, when used
in extrusion tubing as opposed to the
conventional format, offers significant
savings through the use of less material
and/or less expensive material, as well as
a reduction in different materials need-
ed for production. In working to over-
come the limitations of a number of lay-
ers to use in tubular or hollow products,
far more layers can now be extruded,
giving manufacturers the ability to cre-
ate an extremely wide range of advanced
medical tubes to fulfill the growing list
of specialty products.
When manufacturing any type of tub-
ing, every tooling application aims to
lower production costs while optimizing
the extrusion process, and increase pro-
ductivity while reducing the overall cycle
time with better quality and precision.
These essential production bench-
marks are extremely important for man-
ufacturers in todays competitive market-
place. For medical tubing like high-pres-
sure catheters, angioplasty devices, stent
delivery catheters, and medical balloons
(implanted tubing or other inserted in
the body for extended time periods),
the material properties mechanical,
physical, chemical, electrical, and ther-
mal are especially critical to their
proper functioning. These types of med-
ical devices in particular, along with
many others, illustrate the increasingly
diversified arena of medical tubing
products.
Whether for high-end diagnostic or
therapeutic catheters, in most of these
essential medical tubing applications,
the unwritten industry rule is generally
to make smaller tubes with thinner walls.
RoHS Compliant ~ ISO 9001 Certified
(718) 956-8900 e-mail: [email protected] FAX (718) 956-9040
(800) 221-5510 Website: keyelco.com
Available from our global distributor network

Low profile SMT and THM versions
Available for one or two cells
Holds battery securely in place
Polarity clearly marked for orientation
Battery installation and removal does
not require tools
UL94V-0 heat resistant nylon housing
well suited for reflow soldering
Accommodates cells with or without
built-in PCB protection circuits
Die Extrusion Technology for Medical Tubing Applications
Patent-pending process would allow 1000-plus layers from a single extruder.
Guill Tool & Engineering Co., West Warwick, RI
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Intro
Todays medical OEM needs to be
equipped with the latest technologically
effective and non-invasive tubular prod-
ucts in order to inspire the provider and
build patient confidence.
In the never-ending quest for im -
provement in medical tubing, the Nano -
Flow die (patent pending) is poised to
create 1,000-plus layers from a single
extruder, as opposed to roughly fewer
than a dozen layers prior to the Nano -
Flows development. The Nano Flows
layer thickness is in the micrometer
(1 millionth of a meter) to nanometer
(1 billionth of a meter) range.
The end product of NanoFlow tubing
features multiple layers that are not dis-
tinguishable to the naked eye alone, very
similar to a multilayer bottle produced by
blow molding techniques. Unlike a multi-
layer bottle, however, when looking at the
NanoFlow tubing, one cannot distinguish
the number of layers. Perhaps a better
analogy is a layered piece of plywood,
where almost all of the layers are indistin-
guishable to the viewer even when look-
ing at it from the side.
Barrier properties, such as when sensi-
tive materials require protection from the
air, can be better engineered by designing
the thinnest layers, which will force mate-
rials to crystallize. Gas (O
2
, H
2
O, EtOH)
barrier-type properties will also be made
possible with the proprietary NanoFlow
tubular die technology. Optical and
mechanical properties will be enhanced
as well. Better mechanical properties will
create increased impact and fracture
toughness. An increase in ductility can
mean an increase in tear strength. Strong,
brittle materials prone to crack propaga-
tion can be combined with soft ductile lay-
ers to limit the crack propagation.
Nanotechnology promises a whole
host of benefits, but what remains essen-
tial to most manufacturers is the signifi-
cant savings theyll incur through the
use of less material and/or less expen-
sive material, not including the reduc-
tion in different materials needed for
extrusion.
With state-of-the-art 3D CAD, CFD,
and FEA (Finite Element Analysis) to
assist engineers in the nanotechnology
process, customization of the die will be
key in accommodating critical character-
istics included in every final product cre-
ated from extrusion tubing.
This technology was done by Guill Tool &
Engineering Co., West Warwick, RI. For more
information, visit http://info.hotims.com/
34454-164.
Guills NanoFlow Technology die is specially designed to create a greener end product in medical
applications.
Blood Pressure Monitoring Tool
A computer control mouse device includes a sphygmomanometer and software
package to take recordings and store them as digital data.
CalHealth, Irvine, CA
The MDMouse system incorporates a
pre-existing medical device into a con-
ventional computer control mouse. The
tool is designed to measure blood pres-
sure outside of the medical environment,
and to provide that information for use
by individuals, clinical evaluation compa-
nies (CROs), healthcare providers, and
healthcare payers.
The system consists of a computer
control mouse device that includes a
blood pressure monitor and an applica-
tion software package that resides on a
PC where the blood pressure readings
are displayed. The software application
for the MDMouse system displays the
blood pressure readings to the user and
provides a means of maintaining
records and allowing the user to access
past readings at any time. In addition,
the software allows the user to direct
his/her records to a third party, such as
a physician or insurance company, or in
the event of use for clinical studies, the
data can go directly to the study spon-
sor. Other features of the system include
the ability to set alarms to remind the
user to take his or her blood pressure or
medications, or set up doctors appoint-
ments.
The MDMouse system is easy to use
and readily available to the patient. In
todays world, patients are in front of
their computers regularly; this device
makes it convenient for them to take
blood pressure readings without leaving
their chairs. Additionally, there is signifi-
cantly greater accuracy in machine-to-
machine communication, as used by the
MDMouse system, as opposed to relying
on patients to write down their readings
and then consolidate them on a monthly
basis. The blood pressure readings go
directly from the MDMouse system sen-
sor to the computer for recording on the
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Intro
hard drive there is no human interac-
tion required and none allowed. This
information can be easily inserted into an
Electronic Health Record (EHR) system.
Once EHR systems are fully implemented
in the U.S., it will be imperative that all
the blood pressure monitors do what the
MDMouse system already accomplishes:
automatically move the data collected
remotely into those EHR systems.
Inside a standard-sized computer
mouse is a blood pressure finger cuff
that is placed over the index finger to
allow blood pressure measurement.
Additional components include a
pneumatic pump to inflate and deflate
the cuff and a pressure sensor to iden-
tify the pulse during cuff deflation,
thus allowing for measurement of
blood pressure by a standard method
(the oscillometric method). These
components, and the electrical power
source and processing capabilities of
the computer to which the MDMouse
hardware is attached, comprise a high-
ly accurate sphygmomanometer. The
PC, using the installed MDMouse soft-
ware, along with the MDMouse device,
will perform the calculations necessary
to turn the digital data obtained by the
sensor into useful information for dis-
play on the PC.
The hardware consists of the following
elements: a commercially available opti-
cal mouse and an electronic sphygmo-
manometer. The electronic sphygmo-
manometer consists of a pressure cuff
assembly that has the following compo-
nents: inflatable air bag, a solenoid, an
extender arm, a motorized air pump, a
pressure sensor, and a release valve.
The solenoid and the extender arm are
used to extend the cuff assembly out of
the mouse housing so it can be used for
taking blood pressure. The air pump pro-
vides the pressurized air to selectively
expand the air bag so that it grasps the
users finger when it is inserted into the
finger cuff. The pressure sensor senses
the pressure at the interface between the
air bag and the finger surface. The
release valve is used to release air from
the air bag at a rate that is related to how
the pressure sensor oscillometrically sens-
es the systolic and diastolic blood pres-
sure at the finger.
The blood pressure monitoring com-
ponents that are situated in the mouse
housing receive commands from the
application software such as start moni-
Medical Design Briefs, May 2011 25 Free Info at http://info.hotims.com/34454-810
The MDMouse system (shown with door closed and door open) consists of a computer control
mouse device that includes a blood pressure monitor and an application software package that
resides on a PC where the blood pressure readings are displayed.
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Intro
Laser Sintering for Customized Medical Applications
Additive, layer-by-layer manufacturing process allows for the manufacture of complex
geometries in plastic and metal implants and orthoses.
EOS GmbH Electro Optical Systems, Krailling, Germany
toring to begin each testing session and
that software also receives back the read-
ings taken by the sensors in the mouse.
That data communication is done
through an MCA and USB to the UART
bridge using the PCs USB port.
The actual taking of an individuals
blood pressure using the MDMouse
device proceeds as follows: The pres-
sure of the cuff against the finger
inserted into the cuff opening is initial-
ly increased until arterial vessel pulsa-
tion is beyond cutoff (total occlusion or
shutdown of the artery). The cuff pres-
sure is then slowly decreased until the
first detection of arterial vessel pulsa-
tion occurs (the first pumping of the
heart also commonly known as
Korotkoff Phase I). The corresponding
cuff pressure at this point will be sub-
stantially equal to systolic blood pres-
sure, which is the pressure when the
heart is pumping.
As cuff pressure continues to
decrease, arterial vessel pulsations will
eventually become undetectable
through the cuff because of the lack
of adequate cuff pressure to sense
those pulsations (commonly known as
Korotkoff Phase V). The pressure of
the cuff at this point will be substan-
tially equal to diastolic blood pressure
the pressure when the heart is at
rest. The frequency of pulsations
sensed between the systolic and dias-
tolic pressures is measured and is sub-
stantially equal to the heartbeat rate
or pulse rate of the individual. These
two cuff pressures and the pulsation
frequency are measured and cap-
tured by the MDMouse application
software.
The application software installed
on the users PC then utilizes the digi-
tal data to create a display of the indi-
viduals blood pressure readings and
pulse rate. The software also provides
additional functions including record-
ing the data and graphically plotting
data over a number of parameters such
as three-day averages. Communication
of the data is also handled by the appli-
cation software, including sending
emails to medical personnel or archiv-
ing data.
This device goes beyond the standard
use of the oscillometric process using a
PC rather than a micro-chip, as is the
case with other blood pressure moni-
tors. Because the end result of blood
pressure monitoring using the oscillo-
metric process is a collection of data
points, the more data that can be gener-
ated, the better the result. By using the
PCs significantly greater compute
power, the MDMouse can generate
many thousands of data points instead
of the many hundreds that the typical
BP monitor works with.
CalHealth anticipates having its first
MDMouse product available for pur-
chase by May or June of 2011.
This technology was done by CalHealth,
Irvine, CA. For more information, visit
http://info.hotims.com/34454-195.
Engineers have long been aware
of the potential of laser sintering to
create innovative and beneficial
medical products. Because it is an
additive (layer-by-layer) manufactur-
ing pro cess, laser sintering can build
parts free of the traditional con-
straints imposed by machining or
molding.
Recent medical applications of laser
sintering are now demonstrating the
technologys unique capabilities for
mass customization and the manufac-
ture of designs with complex geome-
tries in both plastics and metals.
Plastic Drill Guides for Knee
Surgery
Conventional knee replacement
surgery involves reusable measure-
ment and drilling guides that are
available in predetermined sizes. The
inevitable variation in the shape of
each patients knee means that one
of these sizes may be the best fit, but
none of them is a perfect fit. A better
option is to make each guide patient-
specific.
Fig. 1 - Drill guides used for implant surgery can be customized to each individuals geometry, increasing
the precision of the surgical process and the implant fit. (Courtesy of Materialise)
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Intro
One medical device supplier is currently laser sintering a
customizable, disposable drill guide from a biocompatible
polyamide thermoplastic (based on PA 12). Starting with a
3D MRI or CT-scan image of the knee, a surgical drill guide
(used to pinpoint drilling location) can be designed, and
then laser sintered, to reflect a patients joint geometry to a
tolerance of within a few millimeters (see Fig. 1). Using such
guides results in smaller incisions, better-fitting implants,
and faster patient recovery. Manufacturing a custom guide
for individual patients would be far more expensive if not
prohibitively so than using traditional manufacturing
methods.
Titanium Dental Implants
Dental implants have long been made from titanium
because of its strength-to-weight ratio, corrosion resistance,
biocompatibility, and affinity for binding with human bone.
Creating dental implants with direct metal laser-sintering
(DMLS) produces significant improvements in their design
and function.
One suppliers patented line of titanium
dental implants includes a uniquely complex
surface geometry that promotes bone growth.
The dental implant surface is characterized by
2-200 micron cavities created during laser sin-
tering (see Fig. 2). These porous surface char-
acteristics cannot be readily obtained through
traditional metal-finishing methods. Both the
pores and the isoelasticity of the dental
implant surface (a Youngs modulus nearly
identical to that of bone) promote osseointe-
gration and accelerated bone healing follow-
ing surgery (see Fig. 3). The dental implants
are manufactured using Ti64, a pre-alloyed
Ti6AIV4 alloy powder that is much like its con-
ventional counterpart.
Other Applications
The same manufacturing characteristics
that make laser sintering an excellent choice
for these examples have led to other medical
applications: replacement plastic hip drill guides; lightweight,
durable ortheses; and cobalt-chrome dental bridges and cop-
ings, among others. Medical designers are also exploring other
in vivo applications, such as a new high-performance steriliz-
able PEEK thermoplastic for customized implants, and a
cobalt-chrome knee implant now at the prototype stage.
This technology was done by EOS GmbH Electro Optical
Systems, Krailling, Germany. For more information, visit
http://info.hotims.com/34454-163.
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Fig. 2 - A sintered titanium dental implant illustrates the patented surface structure that pro-
motes bone growth. The inset shows a close-up of the 2-200 micron-sized pores and cavities.
(Courtesy of Leader Italia)
Fig. 3 - A scanning electron microscope (SEM) image shows new bone
growth inside the cavities and pores of a sintered titanium surface after
eight weeks. (Courtesy of Leader Italia)
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Intro
Single, Stationary Lens Able to Create Microscopic 3D
Images
Freeform lens could someday provide a proof of concept for manufacturers of
microelectronics and medical devices.
Ohio State University, Columbus, OH
A lens that enables microscopic
objects to be seen from nine different
angles at once to create a 3D image has
been developed. Other 3D microscopes
use multiple lenses or cameras that
move around an object; the new lens is
the first single, stationary lens to create
microscopic 3D images by itself.
The lens may serve as a proof of con-
cept for manufacturers of microelec-
tronics and medical devices, who cur-
rently use very complex machinery to
view the tiny components that they
assemble.
Though the engineers milled their
prototype thermoplastic lens on a
precision cutting machine, the same
lens could be manufactured less
expensively through traditional mold-
ing techniques.
The prototype lens, which is about the
size of a fingernail, looks at first glance
like a gem cut for a ring, with a flat top
surrounded by eight facets. But while
gemstones are cut for symmetry, this
lens is not symmetric. The sizes and
angles of the facets vary in minute ways
that are hard to see with the naked eye.
The lens is a freeform lens, a type of
freeform optics. No matter what direc-
tion one looks at the lens, one sees a dif-
ferent shape. Freeform optics have been
in use for more than a decade. But
researchers were able to write a computer
program to design a freeform lens capa-
ble of imaging microscopic objects. They
used a commercially available milling
tool with a diamond blade to cut the
shape from a piece of the common ther-
moplastic material polymethyl methacry-
late, a transparent plastic that is some-
times called acrylic glass. The machine
Cubic-Millimeter Energy-Autonomous Wireless
Intraocular Pressure Monitor
Once implanted in the eye, this complete millimeter-scale computing system tracks
the progress of glaucoma.
University of Michigan, Ann Arbor, MI
A prototype implantable eye pressure
monitor for glaucoma patients is
believed to contain the first complete
millimeter-scale computing system. The
pressure monitor is designed to be
implanted in the eye to conveniently
and continuously track the progress of
glaucoma, a potentially blinding disease.
It is expected to be commercially avail-
able in several years.
In a package that is just over 1 cubic
millimeter, the system fits an ultra-low-
power microprocessor, a pressure sensor,
memory, a thin-film battery, a solar cell,
and a wireless radio with an antenna that
can transmit data to an external reader
device that would be held near the eye.
The processor in the eye pressure
monitor is the third generation of the
Phoenix chip, which uses a unique
power gating architecture and an
extreme sleep mode to achieve ultra-low
power consumption. The newest system
wakes every 15 minutes to take measure-
ments and consumes an average of 5.3
nanowatts. To keep the battery charged,
it requires exposure to 10 hours of
indoor light each day or 1.5 hours of
sunlight. It can store up to a
weeks worth of information.
Adding a compact radio that
needs no tuning to find the
right frequency could be a key
enabler to organizing millime-
ter-scale systems into wireless
sensor networks. These net-
works could one day track pollu-
tion, monitor structural integri-
ty, perform surveillance, or
make virtually any object smart
and trackable. Researchers are
developing a consolidated radio
with an on-chip antenna that
does not need the bulky exter-
nal crystal that engineers rely on
today when two isolated devices need to
talk to each other. The crystal reference
keeps time and selects a radio frequency
band. Integrating the antenna and elimi-
nating this crystal significantly shrinks the
radio system.
The new antenna will be engineered to
keep time on its own and serve as its own
reference. By integrating the antenna
through an advanced CMOS process, they
can precisely control its shape and size
and therefore how it oscillates in response
to electrical signals. The researchers are
now working on lowering the radios
power consumption so that it is compati-
ble with millimeter-scale batteries.
This technology was done by University of
Michigan, Ann Arbor, MI. The university is pur-
suing patent protection for the intellectual proper-
ty, and is seeking commercialization partners to
help bring the technology to market. For more
information, visit http://www.engin.umich.edu.
Designed for use in an implantable eye-pressure monitor,
University of Michigan researchers developed what is
believed to be the first complete millimeter-scale computing
system. (Credit: Gyouho Kim)
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Intro
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shaved bits of plastic from the lens in increments of 10 nanome-
ters, or 10 billionths of a meter a distance about 5,000 times
smaller than the diameter of a human hair.
The final lens resembled a rhinestone, with a faceted top
and a wide, flat bottom. They installed the lens on a micro-
scope with a camera looking down through the faceted side,
and centered tiny objects beneath the flat side.
The lens allows scientists to see the real shape of micro-sam-
ples rather than just a two-dimensional projection. Each facet
captured an image of the objects from a different angle, which
can be combined on a computer into a 3D image. The engi-
neers successfully recorded 3D images of the tip of a ballpoint
pen which has a diameter of about 1 millimeter and a
mini drill bit with a diameter of 0.2 millimeters.
In the future, this technology could be useful for manufac-
turers, including the medical testing industry, which is working
to shrink devices that analyze fluid samples. Cutting tiny reser-
voirs and channels in plastic requires a clear view, and the
depths must be carved with precision. Computer-controlled
ma chines, rather than humans, do the carving. The new lens
could be placed in front of equipment that is already in use. It
could also simplify the design of future machine vision equip-
ment, since multiple lenses or moving cameras would no
longer be necessary.
Other devices could use the tiny lens, and the researchers
have since produced a grid-shaped array of lenses made to fit
an optical sensor. Another dome-shaped lens is actually made
of more than 1,000 tiny lenses, similar in appearance to an
insects eye.
This technology was done by Ohio State University, Columbus, OH.
For more information, visit http://www.osu.edu.
A lens invented at Ohio State University enables microscopes to capture
3D images of tiny objects. (Photo by Kevin Fitzsimons, courtesy of Ohio
State University)
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High-Precision Dispenser
Nordson EFD (Westlake, OH) has
introduced the Ultimus V high-
precision dispenser designed to keep
the amount of adhesive or other fluid
vused in medical device assembly
processes consistent as it gets thicker
or thinner, or as the volume of fluid
in the syringe decreases. For fluids that change viscosity, the
Ultimus V stores and automatically adjusts dispensing settings to
keep the amount of fluid applied constant. To compensate for
changing fluid levels when using thinner fluids, the Optimeter auto-
matically adjusts air flow to maintain uniform deposit size.
For Free Info Visit http://info.hotims.com/34454-175
PEEK Thermoplastic
Minnesota Rubber and Plastics
(Minneapolis, MN) offers PEEK (poly-
etheretherketone), a high-performance
thermoplastic that offers long operating life
with chemical resistance and retention of
mechanical properties up to 570 F (300
C). PEEK components are useful for appli-
cations in medical appliances, medical pumps, IV systems, feeding
devices, and implantable and non-implantable medical devices. They
are also useful where fluid isolation is required by the seal design.
Reaction Injection Molding Process
Premold Corp. (Oconomowoc, WI)
offers the PREMOLD PROCESS, an
approach that includes design consultation,
detailed engineering, and comprehensive
manufacturing solutions for medical equip-
ment manufacturers. Design consultation
offers guidance on how to make part
designs more efficient for the Reaction
Injection Molding (RIM) process and
ensures that assemblies meet precise design
specifications. Detailed engineering
addresses potential production problems and offers advice on low-
ering part and tooling costs without loss of quality. Comprehensive
manufacturing solutions are also offered as a part of the process.
Miniature Diaphragm Pump
The Precision Fluidics Division of Parker Hannifin
(Hollis, NH) has introduced the T5 pump series, fea-
turing a miniature 13 mm wide and 14 gram package.
The diaphragm pump provides a low inductance
solution for a variety of applications. It
flows efficiently at 100250 cc/minute,
suitable for gas sampling applications in the
field or in the hospital. The LI (Low Inductance) version offers a
0.05 mH safety rating and includes an ironless core motor.
N
ew Products
Product Focus: MD&M East Exhibitor Preview
See these and other new products at MD&M East, June 7-9, New York, NY (www.mdmeast.com)
LED-Curable Catheter Adhesive
DYMAX Corporation (Torrington, CT) has
introduced the 210-CTH MD
medical device
adhesive, a tack-free, LED-curable adhesive for-
mulated for on-demand cure with the DYMAX
BlueWave
LED Prime UVA spot-curing lamp.

The adhesive is designed for rapid bonding of a
wide variety of plastics typically used in the man-
ufacture of catheters. Bondable substrates
include PC, PU, ABS, and PVC. 210-CTH is moisture-resistant, cures
tack-free with light in less than 0.4 seconds, and is suitable for Y-con-
nector assembly, connector-to-tube bonding, and balloon bonding.
It is compatible with gamma, EtO, and e-beam sterilization.
Prototyping Tool Set
Qosina (Edgewood, NY) has introduced a
needle hub sample kit as a prototyping tool
set for designers and engineers. The combi-
nation of hub connector, bushing, and cap
allows for the creation of a fluid delivery or
withdrawal system. The kit contains 24 poly-
carbonate hubs in round, rectangular, octagonal, and anatomic body
styles. Each hub comes in 14 G, 15 G, 16 G, and Universal size. Pre-
drilled caps to match different body types are color-coded for each
size. Spin lock collars can be added to the four hubs featuring a male
luer slip connector for conversion to a rotating male luer lock.
Silicone Sealing Solutions
Apple Rubber Products (Lancaster,
NY) offers medical silicone seals that
feature resistance to UV light, ozone,
and weather; hydrophobic properties;
temperature range of -94 F to 400 F;
dimensional stability in adverse condi-
tions; and resistance to long-term compression set. The company
also offers medical-grade elastomers that pass USP Class VI testing,
such as Viton fluoroelastomer (FKM) and EPDM rubber for med-
ical applications. The elastomers feature improved chemical resis-
tors, heat resistance (400 F), and low permeability to gases.
Antimicrobial Technology
BASF (Florham Park, NJ) offers
Hygentic
technology, a series of
silver antimicrobials with different
properties regarding silver release
rate and mechanism. They can be
used alone or in combination to tai-
lor the release of active silver to
meet application requirements. Hygentic allows continuous, con-
trolled release of active silver ions over extended time intervals. It
can be processed in a wide range of materials for medical devices
and is tolerant to high temperature processing.
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Wide variety of lens assemblies in stock for
high-res diagnostic cameras. Over 60 years
of design and manufacturing experience.
2011 Universe Kogaku (America) Inc.
UKAoptics.com
516- 624-2444
[email protected]
S| h0 19 4 9
CUSTOM
MEDICAL
IMAGING
LENSES
FROM PROTOTYPE TO PRODUCTI ON
1000s of Lens Sizes in Stock.
Most Lenses Ship Same Day.
Ultra-Miniature Converters
EMCO High Voltage Corp oration (Sutter
Creek, CA) has introduced the A Series of
ultra-miniature, DC to HV DC converters
that occupy less than one-tenth of a cubic
inch of volume, and an extremely low profile
of 0.250 inches (6.35 mm). Controllable out-
put voltages range from 100 volts to 6000 volts. These component-
sized converters are suitable for applications requiring minimal
size and weight. Turn-on voltage is less than 0.7 volts, allowing for
wide output voltage operating range. Use of a resonant, quasi-
sinewave oscillator and fully shielded transformer result in clean,
reliable high voltage conversion with low ripple, EMI/RFI and
input ripple current, making it suitable for noise-sensitive equip-
ment. A separate high impedance control pin is standard, ideal
for external error amplifier control in closed loop systems or sim-
ple on/off control. Output power is 1 watt standard, with 1.5 watts
available as an option. No external components or minimum load
are required. Isolation is 500V bias on the output return. Input
to output leakage current is very low at less than 100 nA and cou-
pling capacitance is <250 pF.
Video Intubation System
The AVID Airway System is an interchange-
able component-based video laryngoscopy sys-
tem, designed and manufactured by Instrument
Technology (Westfield, MA) to handle intuba-
tion applications. The system includes an articu-
lation lever, an LCD screen on a pivoting mount
for viewing from different angles, power supply
for the camera, screen, and light source, and a
video output socket that allows connection to an
external monitor for viewing by other doctors
and students (in training scenarios).
Dry Lubricant Coating
The Duraglide family of dry film lubricants
from MicroCare Medical (New Britain, CT) is cus-
tom-blended for single-use medical devices and
mechanical assemblies destined for the operating
room that function outside of the body, such as
catheters, cutting tools, staplers, hypotubes, and
other surface to surface complex assemblies.
Featuring microdispersion PTFE technology,
Duraglide deposits a thin, smooth, fast-drying lubricant film over
a surface, which reduces the force required to actuate, or execute,
the device by 25 to 30 percent. The lubricants also offer nonflam-
mable handling, storage, and use, materials compatibility, and
environmental properties meeting EPA regulations.
Biomedical Textiles
Biomedical textiles from Secant
Medical (Perkasie, PA) offer design flex-
ibility and choice with unique combina-
tions of fabric geometries and versatile
fiber architectures to enable less inva-
sive delivery techniques in new thera-
peutic applications. The company will also offer a symposium ses-
sion at MD&M East on June 8, titled Working with Modern
Materials: Advances in Materials for Demanding Biomedical
Applications.
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AAC provides products dedicated to the elimination of vibration, energy
absorption and protection of components and devices from shock and
possible destruction.
Silicone Gel Pads, Sheets and Silicone Gel Isolators are highly effective
in isolating vibration in low frequency applications with loads ranging from
0.11 to 165 pounds per mount. They are ozone, UV and chemical resistant
and operate at -40F to +392F.
DURABLE
Master Bond EP42HT-2 Epoxy Adhesive
For Disposable and Reusable Medical Devices
USP Class VI Certified Resists repeated autoclaving,
ETO, radiation and cold chemical sterilization cycles
Room temperature and/or heat curing Easy to mix
and apply High bond strength Superior durability
Outstanding dimensional stability Withstands up to
435F Available in two colors Convenient packaging
Prompt Technical Assistance
www.masterbond.com [email protected]
154 Hobart St., Hackensack, NJ 07601
TEL: 201-343-8983 FAX: 201-343-2132
N
ew Products
Laser Sintering System
EOS GmbH (Krailling, Germany)
has released the EOSINT M280, the
updated version of the EOSINT
M270, for additive layer manufactur-
ing of metal components. The system
produces metal parts on the basis of
3D CAD data in only a few hours, with
no need for tools. The Direct Metal
Laser-Sinter (DMLS) process builds
the parts up layer by layer by melting fine metal powder with a
laser beam, which enables the creation of complex geometries
including free-form surfaces, deep grooves, and 3D cooling chan-
nels. The system is equipped with a solid state laser of either 200
or 400 watt. The Laser Power Monitoring (LPM) makes it possible
to control this during the building process. It operates in both
protective nitrogen and argon atmospheres and is able to process
a range of materials, from light metals to stainless and tooling
steel, to super alloys.
Peristaltic Pumps
Watson-Marlow Pumps Group (Wilmington,
MA) offers the 400/RX1 pump for medical
design and manufacturing. It is suitable for
catheter washing and cooling applications
requiring pressures to 100 psi or flow rates up to
80 mL/min. It features ergonomic and error-
free tube loading and unloading. a clear guard
for full view of pump operation, and a guard-open safety switch.
The pump is available to medical device OEMs as a complete
plug-and-play cased pump or as a panel mount unit.
Thin-Film Optical Coatings
Abrisa Technologies (Santa Paula, CA)
delivers customized precision optical glass
assemblies and thin-film optical coatings for
medical devices and analytical instruments.
Glass is cleanable, dimensionally stable, and
inert to most chemicals with the exception of
hydrofluoric acid. The glass substrates can be
polished, machined, drilled, patterned, coated with thin film materi-
als, and bonded into assemblies. Fabricated glass parts are available
from 6 mm to over 1,000 mm in diameter, with tolerance of 0.025%.
Glass substrate thicknesses range from 0.1 mm to over 25 mm. Hole
drilling starts at 0.7 mm, with typical diameters starting at 2 mm.
Illuminated Pushbutton Switch
The RP8300 Series illuminated round push-
button switch from E-Switch (Minneapolis, MN)
is encased in a metal die cast housing and fea-
tures a threaded panel mount. It is sealed to
IP65 standards and offers a long life expectancy,
with 500,000 operating life cycles at full load. Contact rating is 125
mA at 125 VAC, and 100 mA at 50 VDC. Contact resistance is 50
milliohms (initial max) and insulation resistance is 1,000
Megaohms min. at 500 VDC. Operating temperature ranges from
-30 C to 85 C.
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Ultra-Miniature Rotary Position Sensor
Piher International (Libertyville, IL)
offers the non-contacting MTS 360 SMD
rotary position sensor, suitable for optical
imaging stabilization and precision bio-
medical devices. The MTS combines a
through-shaft design with 360 absolute
position feedback in an ultra miniature size. It offers reliability up
to 25 million cycles. Featuring a size of only 6 mm 17 mm 18 mm,
engineers can integrate the sensor directly on a PCB without pack-
aging issues. The standard model features a 4 mm double D-flat
shaft and an (8) pad SMD footprint compatible with most reflow
soldering systems. The MTS offers linearity as low as 0.5% and is
rated for use at -40 C to 150 C. The sensor can operate up to 300
RPM and can be programmed with full scale output with angles
shorter than 360 degrees. Output is selectable between Analog,
PWM 12 bits, or Serial Protocol (SPI) at 14 bits, and includes a sec-
ond output channel to provide a programmable switch signal.
CAD/CAM/CNC Solutions
Siemens (Chicago, IL) offers CNC
solutions featuring the Sinumerik
840D sl CNC, the Sinamics
S120
drive system, and high-performance
motors that enable machine tool users
to create CAD/CAM data with NX
CAM, as well as a system platform for
high-speed cutting for medical part manufacturing. CNC solutions
offer flexibility for exact measurement and calibration of multi-axes
kinematics and coupled motion of the tool orientation for manu-
facturing of implants, bone screws, and hip prostheses. All impor-
tant tool-related data is saved and can be recalled later in a single
step. Jerk limitation, pre-control, and the perfected look ahead
function support the operator during tool- and mold-making.
Over 20 Years of Robotic End-Effector Innovation
www.ati-ia.com/ns
Standard Features: Six Axes of Force/Torque Sensing
(Fx Fy Fz Tx Ty Tz) High Overload Protection Interfaces
for Ethernet, PCI, USB, EtherNet/IP, CAN, and more Sizes
from 17 mm - 250 mm diameter Custom sensors available
Applications: Product Testing Biomedical Research
Finger Force Research Rehabilitation Research Robotics
Six-Axis
Force/Torque
Sensors
When power is critical to your equipment as
well as your patients, you can rely on MEGA
Electronics to deliver. Produced in ISO9000
facilities, our line of hospital grade powercords,
related components and DC to DC converters
all conform to the highest standards.
Upon your next requirement, please keep
MEGA in mind.
Hospital Grade
Powercords and
DC to DC Converters
MEGA Electronics Inc.
4B Jules Lane
New Brunswick.New Jersey. 08901
tel. 732.249.2656 fax. 732.249.7442
www.megaelectronics.com
[email protected]
Ergonomic Connectors
LEMO USA (Rohnert Park, CA) has
introduced the REDEL
XP Connector
Series, designed using a plastic material
that is resistant to sterilization. The latch-
ing system is embedded in the shell for
increased impact resistance with a high
contact density for medical applications, ranging from catheters to
surgical instruments. It is available with four different keyways to
prevent inadvertent cross connects or misconnects. The outer
shell standard color is gray with an option of white or black.
Backnuts and receptacle front nuts are available in seven colors for
application identification. Contact configurations range from 4 to
22 contacts and can be crimp or solder type. The new design fea-
tures an ergonomic grip for surgeons and medical staff.
Medical Elastomer
Teknor Apex Company (Pawtucket, RI) has
released the Medalist MD458, a high-purity for-
mulation that has passed ISO 10993-5 cytotoxi-
city testing, is RoHS compliant, and provides a
Shore A hardness of 70. It features a flammabil-
ity classification of HB (UL-94) and a maximum
continuous operating temperature rating of
105 C (UL-1581). The compound is suitable for a range of appli-
cations, including hospital and healthcare environments requir-
ing flexibility, durability, and chemical resistance.
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Intro
N
ew Products
Visible Optical Filter for Spot Curing
IRphotonics (Hamden, CT) offers the Visible Optical
Filter for the iCure
AS200 Thermal Spot Curing System to

enable heating of heat-sensitive plastics used in disposable
medical devices. The optical filter eliminates all visible wave-
lengths except for a mild red pointer glow to provide
infrared energy above 800 nm. When coupled with the pre-
cision and power of the iCure, it accelerates the curing of
two-part glues without affecting heat-sensitive thermoplas-
tics. The iCure provides highly focused light energy through
a proprietary mid IR fiber optic light guide that leverages the
broad spectrum of energy available from 300-3600 nm. UV-
sensitive substrates are also protected through the used of an
optical UV cut-off optical filter that allows only the wave-
lengths greater than 400 nm to be transmitted through the
iCure light guide and filters out any wavelengths in the harm-
ful UV region.
Ultrasound Imaging Chipset
The MD1715 and TC8020 ultrasound
driver chipset from Supertex
(Sunnyvale, CA) generates a five level
waveform for high-resolution imaging in
medical ultrasound applications. The
MD1715 is a two-channel logic con-
troller circuit with 12 low impedance,
high speed, MOSFET gate drivers. It has
two sets of control logic inputs, each set
containing three pairs of MOSFET gate drivers designed to tightly match
the drive requirements of the TC8020. The TC8020 is the output stage of
the pulser, with six pairs of N- and P-channel MOSFETs. It is designed to
have high input impedance and provides typical peak currents of 3.5
amps at 200V and fast switching speed. The MD1715 is available in a 40-
lead QFN package (MD1715K6-G) and the TC8020 is available in a 56-lead
QFN package (TC8020K6-G).
Compliance Software Tool Suite
LDRA (Wirral, UK) has launched a tool suite
that offers support for the IEC 61508 and IEC
61508:2010 standards, functional safety standards
for electrical/electronic/programmable elec-
tronic (E/E/PE) systems, from requirements
through design, code, analysis, and certification.
IEC 61508 translates Safety Integrity Levels (SIL)
into software-specific objectives where the rigor of
testing hinges on whether the system involves low
or high/continuous demand situations. The tool
suite automatically checks compliance to the IEC 61508 standard through all stages of the
software development lifecycle. It extends compliance down to the processor level with auto-
mated documentation that offers proof of compliance throughout all stages of development.
UV Curable Silicone Rubber
Momentive Performance Materials
(Columbus, OH) has introduced the
Addisil UV 60 EX elastomer for medical
applications where lower temperatures
during manufacturing and typical silicone
rubber physical properties are both
mandatory. The elastomer has minimal
shrinkage and reduced air entrapment
when compared to heat cured materials. It
can be used with existing silicone extru-
sion equipment and common UV light
curing systems.
For Free Info Visit
http://info.hotims.com/34454-186
Horizontal SMT Spring Pin
Mill-Max (Oyster Bay, NY) offers a
low-profile, horizontal, surface
mount spring pin designed for
edge board interface applications:
board-to-board or device-to-board. The
0967 mounts parallel to the PC board so that the
plunger travel is horizontal to the board surface. The
above board height of .100" (2.54 mm) provides a low profile
for tight packaging requirements. It is rated at 2A continuous, 3A
peak and offers durability of 1 million cycles. Typically mounted on
the edge of a PC board, it can be mated with a board running perpen-
dicular to it, or parallel PC boards can be daisy-chained together by
using the Mill-Max 7937 horizontal SMT target pin and 0967 on
opposing boards.
Compact Power Supplies
Protek Power (Hudson, MA)
has introduced the PM202 and
PU202 Series AC/DC power sup-
plies, which offer 200 watts of per-
formance for a variety of applica-
tions ranging from patient vicinity
medical devices to laboratory
equipment. The power supplies
accept a 90-264VAC universal input. Single output models have
voltages ranging from 12VDC to 48VDC. The compact and low
profile, 3" 5" 1.5" footprint makes the series suitable for designs
with critical space constraints. Units provide 150W of power in
convection cooled environments and 200W with forced
air cooling.
Virus Detecting Software
Hagiwara Sys-Com (Irvine, CA) has launched the Vaccine
USB, a portable virus detection tool for Windows OS-based
industrial systems. The software requires no installation and
virus definitions can be downloaded to the Vaccine USB
from any internet-accessible computer so that users can per-
form the virus scan with the latest definition file even in net-
work-isolated environments. It is suitable for usage in indus-
trial settings including medical systems and test & measure-
ment devices.
Rapid Prototyping
Jabil (St. Petersburg, FL) has opened a Class 100K
clean room for rapid prototyping of disposable med-
ical devices. The new facility provides capabilities for
ultrasonic welding, ultraviolet curing, solvent bond-
ing, overmolding, laminar air flow, and bag and blis-
ter packaging and testing. The room was designed to
offer the same assembly capabilities and processes
used in manufacturing plants.
For Free Info Visit
http://info.hotims.com/34454-189
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Intro
Free catalogs and literature for Medical Design Briefs readers. To order, enter the corresponding number
on the Online Reader Service Page at www.medicaldesignbriefs.com/rs, or visit the appropriate URL.
LITERATURE & WEB SITE
SPOTLI GHT
Free Info at http://info.hotims.com/34454-830 Free Info at http://info.hotims.com/34454-828
PHOTO ETCHING
THIN TITANIUM
COMPONENTS
Inert and biocompatible Titan -
ium is used in medical implanta-
tion applications including max-
illofacial and craniofacial recon-
struction plates, anode and cath-
ode battery current collectors and
telemetry antennas in implanted devices. Other
etched materials special to the medical devices
include nitinol, niobium, Elgiloy, tungsten and poly-
imide. Download Engineering Thin Medical Parts
brochure. www.tech-etch.com/photoetch
Tech-Etch
MEDICAL GRADE
REINFORCED
SILICONE TUBING
Designed to endure temper-
ature extremes, flexible
Silbrade
Medical tubing
handles temperature varia-
tions from 80F to 350F (62C to 177C).
Applications include biological fluid transfer, blood
plasma lines, adhesive and viscous materials transfer,
pharmaceuticals, sterile filling, and more. Made in
USA. www.newageindustries.com/mdb/
NewAge
Industries Inc.
ZERO BACKLASH
UNIVERSAL JOINTS
GTC Falcon MINIJOINTS
fea ture Zero Backlash for
instrumentation and control
systems where the accurate
transmission of information
is essential. MINIJOINTS are stainless steel through-
out with sealed-in lubrication. Made in 3 types:
Single, Double, and Telescoping. Inch and Metric
sizes. Immediate shipment from stock. High
Vacuum, special sizes readily available. GTC Falcon,
Inc.; Tel: 888-309-0646; Fax: 508-746-6494; e-mail:
[email protected]; www.gtcfalcon.com
GTC Falcon Inc.
QUALITY
COMPLIANCE
SOFTWARE - YOUR
CLOUD OR OURS
Grand Avenue Software deliv-
ers validated quality compli-
ance software solutions over the Internet or Intranet
for companies serving the life sciences industries.
Solution areas include Document Control, Design
Control, CAPA, Nonconforming Materials, Audits,
Complaint Handling, Training, and Equipment
Management. The result: dramatically improved effi-
ciency and compliance. Visit www.grandavenue.com;
Tel: 651.204.1743; [email protected]
Grand Avenue Software
Medical Design Briefs, May 2011 www.medicaldesignbriefs.com 35
MEDICAL CLAD
METAL WIRE
Anomet Products man-
ufactures clad metal
medical wire combin-
ing high-strength, high-
ly-conductive, biocom-
patible, and radiopaque
alloys into one material system with a complete
metallurgical bond between layers. Typical wire com-
binations include 316LVM, Gold, MP35N, Nitinol,
Palladium, Platinum, Silver, Tantalum, Titanium and
others. Customized composite wire solutions to meet
your unique wire challenges. Anomet Products;
www.anometproducts.com/medicalwire.html
Anomet Products
USED
LABORATORY
EQUIPMENT
PhotoMachining, Inc. is a
contract laser manufac-
turer and custom systems
builder. We specialize in
laser micromachining
using lasers from the far IR through the UV. In addi-
tion, we sell used, refurbished, and like new labora-
tory equipment including lasers, optics, optical hard-
ware, electronics, microscopes, etc. Contact
[email protected], or phone 603-882-
9944. www.photomachining.com
PhotoMachining, Inc.
POWER & TEMPERATURE
CONTROL
MANAGEMENT
SYSTEMS
This publication illustrates our
experience as a UL 508A Cert -
ified Panel Shop in designing and
building custom electrical control panels. It also
presents a user-friendly guide to selecting a tempera-
ture control based on the performance required.
Tempco is an ISO 9001 Certified Quality Company
manufacturing Electric Heaters, Temperature Sen -
sors, Temp erature Controls and Process Heating
Systems. Tempco Electric Heater Corporation; Tel:
800-323-6859; www.tempco.com; [email protected].
Tempco Electric Heater Corporation
FREE MAGAZINE
ON MULTIPHYSICS
SIMULATION IN
INDUSTRY
Are you interested in what your
peers in engineering and sci-
ence have achieved through the
use of multiphysics simulation
in their work? The most recent issue of COMSOL
News gives you 60 pages worth of case studies that
illustrate recent achievements in industry - all made
possible by COMSOLs modeling tools. Check out a
complimentary copy of the magazine today at
www.comsol.com/ntblit.
COMSOL
Discover the
Latest Advances
in LEDs and
Solid-State
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New from the
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magazine features design tutorials,
tech reports, application notes and
product news on energy-efficient LEDs.
View free of charge at:
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Intro
Published by ............................................................Tech Briefs Media Group
Publisher ....................................................................Joseph T. Pramberger
Editorial Director ........................................................................Linda L. Bell
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Editor, PTB and Embedded Technology ...................................Bruce A. Bennett
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Nick Lukianoff
Editor, Green Design & Manufacturing ........................................Kendra Smith
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Designer .........................................................................Bernadette Torres
Marketing Director...............................................................Debora Rothwell
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Circulation/Audience Development Coordinator ......................Brandie Denlinger
TECH BRIEFS MEDIA GROUP
1466 Broadway, Suite 910, New York, NY 10036
(212) 490-3999 FAX (212) 986-7864
Chief Executive Officer ..................................................Domenic A. Mucchetti
Executive Vice-President .........................................................Luke Schnirring
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Craig Pitcher
at (408) 778-0300
CO, UT, MT, WY, ID, NM ...........................................................Cynthia Louis
at (970) 223-3911
S. Calif., AZ, NV ............................................................................Tom Boris
at (949) 715-7779
New Business Managers .........................................................Patrick Harvey
at (973) 409-4686
Angelo Danza
at (973) 874-0271
Tim Powers
at (973) 409-4762
Michael Barboza
at (973) 545-2565
Reprints .....................................................................................Jill Kaletha
at (866) 879-9144, x168
ADVERTISERS INDEX
Ace Controls, Inc. ......................................798 ......................8
Advanced Antivibration Components..............818 ....................32
Air-Logic ...................................................810 ....................25
Alconox, Incorporated .................................802 ....................13
Anomet Products.......................................823 ....................35
ATI Industrial Automation.............................820 ....................33
Avnet Electronics........................................799 ......................9
Boyd Coatings Research Co., Inc..................815 ....................31
COMSOL, Inc. ....................................794, 824 ................3, 35
Create The Future Design Contest................806................18-19
Edmund Optics...........................................803 ....................14
ElectroCraft, Inc.........................................808 ....................21
Forest City Gear.........................................807 ....................20
Grand Avenue Software, Inc.........................825 ....................35
GTC Falcon Inc...........................................826 ....................35
Indium Corporation.....................................804 ....................15
John Evans Sons, Inc. ................................793 ......................2
Keystone Electronics Corp. ..........................809 ....................23
KNF Neuberger, Inc. ...................................811 ....................27
Linemaster Switch Corporation ....................821................COV III
Master Bond Inc. .......................................817 ....................32
mdi Consultants, Inc. ..................................796 ......................6
MEGA Electronics, Inc.................................819 ....................33
NewAge Industries, Inc. ..............................827 ....................35
PhotoMachining Inc. ...................................828 ....................35
Proto Labs, Inc. .........................................797 ......................7
RAM Optical Instrumentation .......................805 ....................16
Secant Medical, LLC...................................800 ....................10
SENSORS Tech Forum ................................801 ....................11
Silcotech North America, Inc. ......................813 ....................29
Sterling Smartware Solutions.......................795 ......................5
Steute Meditech, Inc. .................................822...............COV IV
Tech-Etch, Inc. ...........................................829 ....................35
Tempco Electric Heater Corp. ......................830 ....................35
Toshiba Imaging Systems Div........................792 ......................1
Universe Kogaku America, Inc......................816 ....................31
VISIONx, Inc...............................................791 ................COV II
Voltage Multipliers, Inc. ...............................814 ....................29
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.
Reader Service
Company Number Page
Medical Design Briefs, ISSN# 2158-561X, copyright 2011 in U.S., is published monthly
(except February, August & December) by Tech Briefs Media Group, 1466 Broadway,
Ste. 910, New York, NY 10036-7309. The copyright information does not include the
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May 2011, Volume 1, Number 4.
BPA Worldwide Membership Applied for February 2011
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A
Intro

0ustom 0eslgns
0LM Irusted
lP68 - Lasy to 0lean Models
LINEMASTER
MEDICAL
F0A 5l0(k) 0learance

Proven Medical Grade Foot Controls
POB 238
29 Plaine Hill Rd.
Woodstock, CT 06281 USA
Tel. 860-974-1000 Fax 860-974-0691
or 800-974-3668 (Toll Free Fax)
TM

ME MED ED

DI DICAAL CCCA CA

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Intro
Setting the Standard for Medical-Grade Foot Controls
(203) 244-6300 w w w . s t e u t e u s a . c o m [email protected]
Steute Wireless 2.4-MED
Like Bluetooth
,
But Better
Over the
years, many of our
medical device OEMs have
asked us to get rid of the wire.
In response, Steute has pioneered the use of
wireless technology for their medical-grade foot controls.
Our knowledge of Bluetooth
, ZigBee
, WLAN, Infrared and other

technologies has enabled us to understand the advantages and
limitations of each.
Based on this understanding, we have developed our new 2.4-MED
wireless protocol expressly for medical devices. This bidirectional, 2.4GHz,
frequency-hopping system offers:
Safe, noise-immune performance Low-power consumption (25mA)
Programmable sleep mode Fast wake-up time (<200ms)
Real-time battery charge monitoring International compliance
Our design engineers would be pleased to review your application,
and offer a solution that complements your medical device. For
more information, or a copy of our white-paper, Selecting a
Wireless Technology , please call or visit our website.
Channel
5
Channel
27
Channel
18
Channel
32
>
STEUTE2.4-MED Protocol
(32 channels hopping at 200 hops per second)
Encrypted data frame sent on 4
consecutive channels
Dental System Control Surgical Microscope Control Examination Chair Control Biopsy Sampling System
Cov ToC
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Intro

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Cov ToC

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