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Welcome to
your Digital Edition of
Medical Design Briefs
February 2016
➭
Intro
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From the Publishers of
www.medicaldesignbriefs.com February 2016
Regional Focus: California Medtech
Choosing the Right Power Supply
Force Sensors for Device Design
Regional Focus: California Medtech
Choosing the Right Power Supply
Force Sensors for Device Design
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AIntro
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From the Publishers of
www.medicaldesignbriefs.com February 2016
Regional Focus: California Medtech
Choosing the Right Power Supply
Force Sensors for Device Design
Regional Focus: California Medtech
Choosing the Right Power Supply
Force Sensors for Device Design
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AIntro
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AIntro
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AIntro
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AIntro
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4 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-795
February 2016
Published by Tech Briefs Media Group, an SAE International Company
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■ COLUMN
6 From the Editor
■ FEATURES
10 California’s Medtech Pipeline: World Class Resources,
Entrepreneurial Spirit, and a Great Climate for Innovation
18 Precision Manufacturing of Medical Devices Using Ultra-
Short Pulse Lasers
25 Thin Film Force Sensors: Changing the Medical Device
Design Game
30 9 Tough Questions to Ask About Your Dispense Valves
34 Selecting Power Supplies for Medical Equipment Designs
56 Controlling Backlash in Mammography Systems
■ TECH BRIEFS
40 LED Probes to Map the Brain
41 Making Electronics More Flexible with Self-Healing Gel
42 3D-Printed Airways Continue to Save Lives
44 Portable Acoustic Holography Systems for Therapeutic
Ultrasound Sources
45 Keeping Prosthetic Legs from Tripping
46 Gaming Technology Takes Aim at X-Rays
■ DEPARTMENTS
37 Global Innovations
38 R&D Roundup
48 New Products & Services
55 Advertisers Index
■ ON THE COVER
Researchers at the University of Michigan Department
of Electrical Engineering and Computer Science have
built and tested in mice neural probes that hold what
are believed to be the smallest implantable LEDs ever
made. The probes can control and record the activity
of many individual neurons, measuring how changes in
the activity of a single neuron can affect its neighbors.
To learn more about their groundbreaking technology,
please read the article on page 40.
(Credit: University of Michigan)
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AIntro
Ch-Ch-Ch-Changes According to the late,
great David Bowie, “the
stars look very different
today”. After two years
of collecting the 2.3%
Medical Device Excise Tax, the tax has
now been suspended for all of 2016 and
2017 when President Obama signed the
Consolidated Appropriations Act of
2016. The tax was expected to raise
almost $30 billion over 10 years from
manufacturers in order to help pay for
“Obamacare”. This should help the US
medical device market over the next
few years, claimed research and con-
sulting firm GlobalData.
While representatives from both parties
in Congress, especially in states with large
amounts of medical device companies,
like Minnesota, Indiana, and California,
wanted to repeal the tax in principle ever
since it went into effect in January 2013,
they were unable to find an offset for the
amount the tax was supposed to generate.
It’s still unknown how the projected
$30 billion over 10 years to be raised by
this tax will be replaced.
These savings are supposed to shore up
R&D and staffing resources that medtech
companies battling the tax claimed were
being impinged upon. According to
watchdog group MapLight, a nonparti-
san research group that tracks money's
influence on politics, the medical device
industry spent 5 years and more than
$110 million lobbying Congress and fed-
eral agencies to repeal the medical device
tax. In addition, the group says, that top
manufacturers and their trade group also
donated $19.5 million to House mem-
bers since Oct. 1, 2012.
So, now let’s see how much of these
savings gets spent on recruiting talent
and R&D efforts. Companies like
Masimo have pledged to increase
investment in infrastructure and R&D
in response to the tax moratorium.
Others, like NuVasive, plan to
build new manufacturing facilities.
NuVasive’s new facility in Ohio is
expected to add 300 full-time positions.
And, Sterigenics International commit-
ted more than $80 million in capital
investments in the past year including
expansion to increase capacity by 30
percent in one plant and tripling steril-
ization capacity at another.
However, in the past couple of weeks,
companies have been announcing layoffs
in large numbers. On January 19, Johnson
& Johnson announced that it will cut 4 to
6 percent of its medical devices workforce,
about 3,000 jobs, over the next two years as
part of restructuring. On January 8,
Abbott Laboratories announced it was
closing a California vascular device manu-
facturing facility and laying off 144
employees. And, C.R. Bard plans to close
three plants in Minnesota by the end of
2016, meaning layoffs for 185 employees.
Recently, GE Healthcare, which moved
to the UK in 2003, has announced that it
will be moving back to the US early in
2016 to new headquarters in Chicago, IL.
But Ireland’s finance minister in October
said the country would halve its corporate
tax rate to 6.25 percent for innovative
companies—ones with earnings tied to
patents, copyrights, or other R&D created
in Ireland. After Medtronic bought
Covidien and moved its headquarters to
Dublin, who else will follow?
Beth G. Sisk, Editor
6 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-797
From the Editor
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TEST YOUR MEDICAL PRODUCTS FOR EXPORT
The Interpower® International Power Source is an AC power source used to verify your product design and for product testing. The unit can be used on a bench top or is rack mountable.
Interpower has four models available which have an input of 100–240VAC/50–60Hz. The first two models are supplied with a NEMA 5-20 plug and have an output of 2200VA maximum with a Low Range variable of 10–138VAC at 16Arms maximum and High Range variable of 10–276VAC at 8Arms maximum, 47–450Hz. The second two models are supplied with a NEMA 5-15 plug and have an output of 1725VA maximum with a Low Range variable of 10–138VAC at 12.5Arms maximum and High Range variable of 10–276VAC at 6.25Arms maximum, 47–450Hz. For each output option we offer a model with a RS232 and USB port and a model with no communication ports.
The Interpower International Power Source can also be ordered for international use with a country-specific input power plug.
Interpower offers a 1-week U.S. manufacturing lead-time and same day shipments on in-stock products. From 1 to 1,000 pieces or more, we have no minimum order requirements.
• Remote control operation ideal for automated test applications using optional IPS Interface Software
• Software available for use with models equipped with RS232/ USB interfaces which are easily integrated into ATE systems
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• Interpower carries a variety of North American and international power cords and cord sets
• Rental units are also available
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Medical Design Briefs, February 2016 www.medicaldesignbriefs.com 9
Advertorial
When designing, building, and maintaining hospital-grade products for medical applications, it’simportant to know if there are any standards or country-specific recommendations that need tobe followed. The safety of both healthcare professionals and their patients may depend on theproper and reliable functioning of such products and their components, right down to the cordsand plugs that help to power up the devices and connect their accessories and peripherals.
To find out more about how power cords and plugs are designed and manufactured to meet the stan-dards that apply to medical-grade products, Medical Design Briefs recently spoke with Ron Barnett,product development manager with the Interpower Group of Companies, Oskaloosa, IA. Interpower isa major international supplier of power system components for a variety of industries—including health-care facilities and medical devices. Interpower manufactures cord sets and power cords in the UnitedStates for the North American and international markets, and also has an office in the United Kingdom.
I N S I D E S T O RY
MDB: When it comes to power systemcomponents designed for equipmentto be used in hospitals or other med-ical facilities, aren’t the design andperformance standards the same allaround the world?
Ron Barnett: No, they’re not. Mostcountries have overall standards that apply to medical equip-ment, but a few countries or regions also have standards or rec-ommendations that apply to specific medical-related compo-nents, such as plugs and cords. Hospital-grade power cords andcord sets, as well as plugs and sockets, and some power entrymodules are subject to special requirements or recommenda-tions in Australia, Denmark, Japan, and New Zealand, as well asthroughout North America.
MDB: When it comes to dealing with power systems, specif-ically, is there a reason why there are so many regionalorganizations and related standards?
Barnett: Designing for compliance with international productsafety requirements begins with an understanding of where thestandards originate and who certifies that a product meets aspecific standard.
The development of a unified market in the European Union(EU) has resulted in the elimination of most national devia-tions from European standards. However, not everything isuniform throughout the EU. There are five different Class Igrounded plugs in common use in Europe. Switzerland andItaly both have 10A and 16A variations of their plug.Denmark’s standard provides for variations for use with med-ical and sensitive computer equipment. Nevertheless, theoverall trend has been toward uniform electrical standards inEurope, and even the acceptance of test results betweennational agencies in some cases.
MDB: How different do power cords need to be? What char-acteristics do they have?
Barnett: Of course plug and socket configurations vary through-out the world, and there are even more variations when it comesto medically specific types. These variations are all reflected inregional standards. The standards may also establish require-
ments for cord sets, including conductor sizes, jacketing, length,and even color. In some instances, standards permit local facili-ties to specify such components according to their own localpreferences and practices. An example would be the “clear”North American hospital-grade plug which is not mandatory butpreferred by some engineers and medical facilities.
MDB: When they are intended for use with specific devices,are power system components such as plugs, sockets, andcord sets usually custom designed, or can they be boughtessentially “off the shelf”?
Barnett: Many power system components can be bought offthe shelf, and Interpower carries an inventory of more than fourmillion such parts in stock. However, designers are now realiz-ing that a US manufacturer such as Interpower can manufac-ture a custom hospital-grade cord set and have it shipped with-in a week. Consequently, many designers are now asking forcomponents with custom lengths, custom packaging, and cus-tom labeling.
MDB: Have you observed any new or especially challengingtrends among the requirements that device designers haveimposed on power systems and connectors in recent years?
Barnett: Yes. FDA’s new requirements for unique device identi-fiers (UDIs), issued in September 2013, have created new chal-lenges for device manufacturers. The agency’s reasons forthese new rules include concerns about product recalls, coun-terfeit devices, and patient safety.
Although FDA does not classify medical cords as medicaldevices, Interpower is able to offer medical cords with serialnumbers in accord with customer requirements.
MDB: Where should engineers go for more information?
Barnett: Designers can check with CSA, UL, or any of the test-ing agencies in the countries they are exporting to. A wealth ofinformation is also available on the Interpower website atwww.interpower.com.
To find out more about the Interpower Group of Companies,visit the full-length version of this interview, available online atwww.medicaldesignbriefs.com/InsideStory0216.
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10 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
While the headquarters of the
world’s largest medical device and
diagnostics corporations have historical-
ly been located, well, elsewhere,
California has long occupied a role of
central importance for the advancement
of medical technologies.
In fact, it would be hard to imagine
what today’s medtech sector might be
like without the influence of California’s
early medtech entrepreneurs. The R&D
processes created by those product devel-
opers—sometimes without significant
corporate funding or the resources of
government or university labs—have
given the medical device industry a num-
ber of distinctive characteristics when
compared to other life sciences sectors.
Today, California’s entrepreneurial
culture continues to be an important
foundation of medtech innovation. But
the growth and increasing sophistica-
tion of the sector over the past four
decades have elevated the need
for many other resources.
Connected AcademiaCalifornia’s academic resources
have proven up to the challenge,
with 11 of the top 100 universities on
the Shanghai index located in the
state. Top players include the
University of California campuses at
Berkeley, Davis, Irvine, Los Angeles,
San Diego, San Francisco, Santa
Barbara, and Santa Cruz, plus the
well-known private powerhouses at
the California Institute of
Technology, Stanford University,
and the University of Southern
California. Several of these universi-
ties have programs focused directly
on medical technology innovation and
entrepreneurship.
For instance, UC Irvine’s Samueli
School of Engineering houses the
Edwards Lifesciences Center for
Advanced Cardiovascular Technology,
an academic-based research and train-
ing center aimed at fostering an interdis-
ciplinary approach toward the under-
standing of cardiovascular disease.
At Stanford, the schools of medicine
and engineering came together to create
the Stanford Biodesign program, whose
mission is to train students, fellows, and
faculty in the Biodesign process, a sys-
tematic approach to needs-finding and
the invention and implementation of
new biomedical technologies. Key com-
ponents of the program include classes
in medtech innovation, mentoring of
students and faculty in the technology
transfer process, and career services for
students interested in medtech careers.
USC boasts the Alfred E. Mann Institute
for Biomedical Engineering, a nonprofit
organization intended to bridge the gap
between biomedical invention and the
creation of commercially successful med-
ical products that improve and save lives.
The institute was established by well-
known serial medtech entrepreneur Al
Mann, who selected USC because of its
rich pool of biomedical talent.
Equally important, life sciences activ-
ities in California’s universities are rela-
tively well funded. In fiscal year 2015,
according to the 2016 report of the
California Life Sciences Association
(CLSA), San Diego, the National
Institutes of Health (NIH) awarded
California scientists more than 7,300
research grants totaling $3.26 billion—
the most of any state in the nation. In
addition to the usual university sus-
pects, top NIH grant recipients in
California during FY 2015 included the
Scripps Research Institute in La
Jolla, a nonprofit research institu-
tion whose philosophy emphasizes
the creation of basic knowledge in
the biosciences for its application in
medicine. (See Table 1)
“California is blessed with a rare
combination of very favorable factors
that help drive innovation,” says Josh
Makower, MD, MBA, a consulting
professor of medicine at Stanford
University Medical School and
cofounder of the university’s
Biodesign program. “There’s an
amazing pool of senior, experienced
entrepreneurs, inventors, and inno-
vators who are capable of mentoring
others; a constant flow of talent from
nearby companies and universities;
Institution Total NIH Grants FY 2015 ($ millions)
UC San Francisco 539
Stanford University 402
UC San Diego 366
UCLA 359
UC Davis 188
USC 171
Scripps Research Institute 166
UC Berkeley 114
UC Irvine 101
California Institute ofTechnology
54
Table 1 – Top California organizations receiving NIH fundingfor FY 2015 (through September 28, 2015). Source:National Institutes of Health.
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Medical Design Briefs, February 2016 www.medicaldesignbriefs.com 11
and a culture of innovation stemming
from years of successful local companies
such as Fairchild, Intel, Apple, Oracle,
Guidant, Devices for Vascular
Intervention, Perclose, Facebook,
Twitter, Ardian, Acclarent, and so on.”
Makower is his own best example. A
serial entrepreneur in his own right, he is
founder and CEO of ExploraMed
Development LLC, Mountain View, one
of many West Coast medtech incubators.
(See Table 2) In addition, he is a venture
partner with New Enterprise Associates,
Menlo Park, where he supports the firm’s
investing activity in the medical device
arena. And he is coauthor of a compendi-
um created to support teaching efforts in
Stanford’s Biodesign program.
“In California, we have access to a
wealth of innovation and knowledge
generated from local tech companies,
universities, and health systems,” agrees
Joe Randolph, president and CEO of the
Innovation Institute, a medtech incuba-
tor based in Newport Beach. “Medical
device manufacturers are at our finger-
tips in Camarillo, Irvine, Menlo Park,
Mountain View, Pleasanton, Redwood
City, San Diego, San Francisco, San Jose,
Santa Rosa, and even Silicon Valley.
Even the likes of Google and Apple have
stepped into the medical device space
with new apps and wearables.”
California’s universities are making
the most of their advantages, turning
out a steady stream of life sciences grad-
uates who are prepped and ready to take
on employment in some sector of the
state’s life sciences industry. According
to the CLSA, the state’s universities
awarded nearly 1,300 life sciences doc-
torates in 2013, feeding an industry that
employed more than 281,000 people in
2014. Of those employees, the largest
proportion was found in the medical
devices, instruments, and diagnostics
sector, which rose to employ more than
74,000 in 2014.
“What makes California unique is its
high level of academia, venture capital,
workforce, infrastructure, space—and
of course California’s entrepreneurial
and risk-taking spirit—that together
create a prime location for startups and
entrepreneurs looking to make their
footprint in the booming medtech
space,” says Sara Radcliffe, CLSA presi-
dent and CEO. “With nearly 75,000
employees up and down the state, med-
ical technologies make up by far the
largest sector of California’s life sci-
ences industry.”
Access to CapitalAs important as California’s academic
institutions are in the process of becom-
ing, the state’s medtech sector was a pro-
ductive engine of innovation long
before universities ever got into the act.
“Everywhere in the world, port cities
have historically been the hubs of inno-
vation, because that’s where trade and
cultures came together to forge new
thinking and new ideas,” says Randolph.
Because of its diverse population and
key role in international commerce,
California has similar attributes that dis-
tinguish it from most other states.
“Today, California is a travel destina-
tion for tourists because of its weather
and entertainment attractions,” he says.
Table 2 – A selection of medtech accelerators and incubators in California.
Organization Location URL
Bio, Tech, and Beyond San Diego http://biotechnbeyond.com
Emergence Life Science Incubator Berkeley http://www.emergence-llc.com/home.htmlEvoNexus San Diego www.evonexus.orgExploraMed Development LLC Mountain View www.exploramed.com
Fogarty Institute for Innovation Mountain View www.fogartyinstitute.org
The Foundry Menlo Park www.thefoundry.com
Frost Data Capital San Juan Capistrano www.frostdatacapital.com
Inceptus Medical Aliso Viejo www.inceptusmedical.com
Incuvate Irvine www.bio-md.com
JLabs @ QB3 San Francisco http://jlabs.jnjinnovation.com/locations/jlabs-qb3
JLabs San Diego San Diego http://jlabs.jnjinnovation.com/locations/san-diego
JLabs South San Francisco South San Francisco http://jlabs.jnjinnovation.com/locations/jlabs-ssf
MedForce LLC Davis www.medforce.biz
OCTANe LaunchPad Aliso Viejo http://launchpad.octaneoc.org
Rock Health San Francisco http://rockhealth.com
Rosenman Institute, QB3 San Francisco http://qb3.org/rosenman
StartUp Health Academy Oakland www.chcf.org/projects/2012/startup-health-academy
StartX Med Palo Alto http://startx.com/
Wireless Health Hub San Diego http://wirelesshealthhub.org
West Health Incubator San Diego www.westhealth.org
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12 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
“But it’s a destination for new medtech
companies because of its universities,
tech companies, commerce, and access
to venture capital.”
Unquestionably, access to large pools of
venture capital controlled by local groups
of investors willing to underwrite early-
stage R&D was a major factor in the rise
and success of California’s medtech inno-
vation sector—and it remains an impor-
tant underpinning for the sector today.
Nationwide and across all industries,
California companies are often the desti-
nation of choice for venture capital
investments. According to interim pro-
jections for 2015, California was expect-
ed to pull in roughly 60 percent ($37.4
billion) of all venture capital invested in
US enterprises during the year.
Massachusetts, with the next-highest
total of venture investments, was expect-
ed to receive billions of dollars less.
California’s lead over other states is
even greater when it comes to the life
sciences. Interim projections estimated
that roughly $4.79 billion in life sciences
venture capital would be invested in
California companies during 2015—
more than double the investments
expected for the second-ranked state—
again, Massachusetts. (See Table 3)
And the story is just the same when
investments in medical technologies are
considered. For 2015, California was
projected to receive $14 million of the
$40 million in venture capital invested
nationally in seed-stage medical device
companies. And even higher propor-
tions were projected for venture-backed
funding across early-, expansion-, and
later-stage medical device companies.
In return for such strong support of
California’s culture of medtech innova-
tion, venture capitalists have traditional-
ly been rewarded with double-digit
returns on their investment in time-
frames that made the pharma sector
look glacially slow.
But that was then.
While venture capitalists nationwide
still favor investment in medical technol-
ogy start-ups, they are less likely than in
the past to get involved with seed- or
early-stage companies, preferring to wait
until new products have been derisked
through bench and clinical testing—and
sometimes even regulatory clearance,
according to the National Venture
Capital Association, Medical Innovation
and Competitiveness Coalition. In part,
such investor hesitancy has arisen
because of widespread concerns about
the health of the medtech ecosystem,
including both the competence and
pace of regulatory systems in the US and
abroad, as well as the mechanisms that
lead to coverage, payment, and adop-
tion by healthcare payors and providers.
As the source of many such start-ups,
California’s medtech community has
experienced a greater fall-off in seed-
and early-stage VC investment than
many other regions.
Fortunately, California is also rich in
angel investors, who have begun to play
vital roles in supporting seed- and early-
stage medtech ventures during the past
decade. (See Table 4)
CB Insights reports that from 2009 to
2014, the nation’s top 20 angel investors
did just over half of their deals with com-
panies based in California’s Silicon
Valley. Moreover, 9 of the nation’s top 20
angel groups are based in California,
including 5 of the 10 angel groups
ranked as having the strongest net-
works—important both for strategic
expertise in a field such as health tech-
nology and for raising additional capital.
Such a heavy concentration of angel
capital plays well for California’s medtech
sector. From 2011 through the middle of
2014, the nation’s top 20 angel groups
invested heavily in Internet- and health-
care-focused deals, with healthcare captur-
ing 21 percent of the groups’ investments.
“California has a strong medtech
ecosystem, with a well-educated work-
force, innovation-oriented academic cen-
ters, and strong venture funding,” says
Jan B. Pietzsch, PhD, consulting associate
professor of management and engineer-
ing in Stanford’s Biodesign program and
CEO of Wing Tech Inc., a consultancy
that helps companies evaluate the clinical
and business potential of medical tech-
nologies. “In addition, California is home
to innovation in other tech sectors that
exert a positive influence on medtech.”
“California is rich in talent, research
funding, and venture capital investment,
and is the birthplace of biotechnology and
CBI Rank(2010–H115)
Venture Investor City URL
1 Alta Partners San Francisco www.altapartners.com
4New EnterpriseAssociates (NEA)
Menlo Park www.nea.com
4 Versant Ventures Menlo Park www.versantventures.com
7Kleiner PerkinsCaufield and Byers
Menlo Park www.kpcb.com
9 InterWest Partners Menlo Park www.interwest.com
9 Sofinnova Ventures Menlo Park www.sofinnova.com
12 Delphi Ventures San Mateo http://delphiventures.com
14 Clarus Ventures South San Francisco www.clarusventures.com
15 5AM Ventures Menlo Park http://5amventures.com
15 Bay City Capital San Francisco www.baycitycapital.com
15 Three Arch Partners San Mateo www.threearchpartners.com
Table 3 – Among the top venture capital investors in US-based exited healthcare companies from
2010 through the first half of 2015 are 11 VC firms based in California. Source CB Insights.
California’s Medtech Pipeline
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AIntro
a leader in exciting new fields such as dig-
ital health, genomics, and precision medi-
cine,” agrees CLSA’s Radcliffe. “When all
factors are combined, it becomes clear
why California is a sought after location for
talent, entrepreneurs, and investors alike
to establish their home.”
New Waves of InnovationAccording to CLSA, California is
home to 2,848 life sciences companies.
While 1,186 of those companies are in
the biotechnology or pharmaceutical
sectors, the remaining 1,662 companies
form a strong majority with a focus on
medical devices and equipment.
Whether fresh out of the box or long
established, California’s medtech com-
panies are often at the cutting edge of
new developments in healthcare.
“An exciting trend that is beginning
to attract the attention of investors is the
application of electromodulation,” says
Ahmed Enany, president and CEO of
the Southern California Biomedical
Council, Los Angeles. “This approach
uses implants to deliver electrical cur-
rent at specific frequencies near or
around certain nerves—the vagus nerve,
for example—to target and solve such
medical problems as inflammation and
hypertension, which have previously
been treated with drugs. If the approach
works, it would enable clinicians to treat
patients without risking the side effects
associated with drugs.”
Enany cites several examples of
California companies that have begun to
explore electromodulation therapies.
NeuroSigma Inc., Los Angeles, is devel-
oping trigeminal nerve stimulation
(TNS) for a variety of disorders, includ-
ing epilepsy, depression, attention deficit
hyperactivity disorder, post-traumatic
stress disorder, Lennox-Gastaut syn-
drome, and traumatic brain injury. The
company’s TNS therapy can be delivered
via its noninvasive Monarch external
trigeminal nerve stimulation system. The
company is also developing a minimally
invasive subcutaneous TNS system.
SetPoint Medical in Valencia is devel-
oping an implant and conducting
research to demonstrate that its technol-
ogy can be used effectively to treat debil-
itating inflammatory diseases, such as
Crohn’s disease and rheumatoid arthri-
tis. SetPoint’s microregulator is
designed to supplement the body’s natu-
ral inflammatory reflex by providing
built-in therapy at a lower cost and
improved safety compared with drugs or
biologic solutions. “If they are success-
ful,” notes Enany, “this would be first
time that anybody developed a device to
treat inflammation, thereby avoiding the
side effects of the drugs currently used
to treat inflammation.
“This is a field that is even starting to
attract the attention of big pharma com-
panies,” says Enany. “GlaxoSmithKline
got turned on by electromodulation,
and ended up creating a fund specifical-
ly to invest in the field.”
A similar approach is used by
Bioness, also in Valencia, which mar-
kets implantable and non-implantable
devices designed to help patients beat
paralysis and restore full or partial
movement to people who have suffered
from accidents, stroke, multiple sclero-
sis, or other degenerative disorders of
the central nervous system. The compa-
ny’s L300 Foot Drop system is for
patients living with foot drop, while its
L300 Plus system is for foot drop plus
thigh weakness. The company’s H200
Hand Rehabilitation system is used for
hand paralysis therapy.
Electrostimulation also led to Los
Angeles County’s latest FDA premarket
approval, which was granted in 2013 to
Second Sight, located in Sylmar. The
company’s Argus II retinal prosthesis sys-
tem provides electrical stimulation of
the retina to elicit visual perception in
blind individuals with severe to pro-
found retinitis pigmentosa. The implant
is an epiretinal prosthesis surgically
implanted in and on the eye that
14 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
Angel Group Location URL
Angels' Forum Palo Alto www.angelsforum.com
ArcView InvestorNetwork
San Franciscohttp://arcviewgroup.com/investornetwork
Astia Angels San Francisco (and New York) http://astia.org
Band of Angels Menlo Park www.bandangels.com
Golden SeedsSan Francisco (and Boston,New York)
www.goldenseeds.com
HealthTech Capital Los Altos Hills www.healthtechcapital.com
Keiretsu Forum, OrangeCounty
Costa Mesawww.keiretsuforum.com/global-chapters/orange-county
Life Science Angels Sunnyvale www.lifescienceangels.com
North Bay Angels Healdsburg www.northbayangels.com
Pasadena Angels Pasadena www.pasadenaangels.com
Sacramento Angels Sacramento www.sacangels.com
Shasta Angel Group forEntrepreneurs (SAGE)
Redding www.shastaangels.com
Sand Hill Angels LLC Sunnyvale www.sandhillangels.com
Stanislaus-Merced Angels Modestohttps://gust.com/organizations/stanislaus-merced-angels
Tech Coast Angels
Los Angeles, Orange,Riverside, San Bernardino,San Diego, and SantaBarbara counties
www.techcoastangels.com
TiE Angels, Silicon Valley Santa Clarahttp://sv.tie.org/initiative/tie-angels
Table 4 – California angel groups with a focus on medical technologies. Source: Angel CapitalAssociation, group websites.
California’s Medtech Pipeline
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AIntro
includes an antenna, an electronics case,
and an electrode array. The external
equipment includes glasses, a video pro-
cessing unit, and a cable. “The device
receives a signal from the glasses that the
person wears,” explains Enany. “The sig-
nal is transmitted to a computer, which
in turn sends the signal to the implant.
The implant translates the signal into
electrical impulses that the brain can
translate into shapes.
“This is a very exciting technology,”
says Enany. “It opens the door for more
advanced devices in order to make blind-
ness a thing of the past, which is the
ultimate objective of Second Sight.”
While advancing technologies
may be the bread-and-butter of
California’s medtech sector,
responding to the megatrends influ-
encing healthcare is also essential
for companies that expect to be seen
as leaders in their fields.
“We’re seeing a great deal of inter-
est in consumer-oriented devices,
including medical applications creat-
ed to run on smartphones and other
consumer electronic devices,” says
Pietzsch. “Companies are also
expressing heavy interest in personalized
medicine, including the use of genetic
markers for diagnostic purposes.”
For Makower, some of the products of
such new approaches constitute an entire-
ly new field that he terms ‘healthtech’.
“Healthtech is the combination of tradi-
tional device technologies transformed
into a form factor that allows customers or
patients to use the technology themselves
safely, potentially disintermediating the
traditional medical-industrial pathway,
reducing costs, and improving the quality
of their experience,” he explains.
“It’s been widely recognized that
healthcare is becoming much more con-
sumer-driven, with many patients going
online first to learn about their condi-
tion even before they see their first physi-
cian,” Makower adds. “It follows that if
solutions to their needs could be made
available directly through ecommerce or
retail channels, those consumers would
be highly likely to purchase and use
those technologies, as they do other con-
sumer products, before they seek more
expensive alternatives.”
Makower offers the example of a new
hearing technology by Eargo in
Mountain View as an example of just
such a device. “Eargo has created a
truly invisible hearing technology
that is fully rechargeable (i.e., no
batteries required), does not
require fitting or molding, and can
be purchased directly from the com-
pany at a fraction of the cost of tra-
ditional hearing aids.”
Similarly enabled by advanced elec-
tronics is a smart contact lens devel-
oped by Google, Inc., now part of
Alphabet, that can tell diabetes
patients about their blood glucose
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16 www.medicaldesignbriefs.com Medical Design Briefs, February 2016 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
levels. “This is an example of a break-
through innovation that is also disruptive,
because it eliminates the constant finger
pricking,” observes Randolph. “They use
a wireless chip and miniaturized glucose
sensor embedded between two layers of
soft contact lenses to continuously meas-
ure glucose in tears.”
On the basis of such advanced tech-
nologies, Alphabet has launched a new
company called Verily Life Sciences that
is focusing on innovations that affect mil-
lions, such as cardiovascular disease, can-
cer, and mental health. Following Verily’s
launch, Johnson & Johnson announced
a collaboration with Verily to create an
independent surgical solutions company,
Verb Surgical Inc. in Mountain View that
will develop robotic surgery platforms
integrating advanced technologies.
Randolph agrees that consumer
engagement is an important element of
devices now under development. “We
are seeing a proliferation of medical
devices that help the consumer become
more accountable for their own care,
including tracking fitness, mental
health, and overall health,” he says.
“And we’re also seeing a trend toward
adopting consumer engagement prod-
ucts from other industries, including
retail, where they engage digital con-
sumers at every touchpoint in the cus-
tomer experience.”
Generating Excitement The depth and breadth of
California’s life sciences sectors often
encourages synergies that might be dif-
ficult to explore in other region of the
country. “We’re seeing compelling
advances in the fields of digital health,
genomics and next-generation sequenc-
ing, and precision medicine,” says
Radcliffe. “In the case of digital health,
this is also an example of a convergence
across two sectors where California has
long led the way—computing and wire-
less telecommunications technologies,
and the life sciences.
“Similarly, fulfilling the promise of
genomics and precision medicine will also
require ‘big data’ technologies and tools,
also positioning the state at the forefront,”
she adds. “We’re excited by the innova-
tions we are seeing in all these fields.”
Enany agrees that digital health is a
trend that shows signs of continuing
long into the future. “We have a lot of
companies developing digital health
solutions, including software, applica-
tions, wearables, and other types of
devices that incorporate digital tech-
nologies in order to solve health prob-
lems,” he says. “Also important are
transdermal or implantable devices
that can continuously transmit patient
information to caregivers.
“And if you can add to these prod-
ucts the ability to manage big data and
develop analytics based on them,” says
Enany, “that can go a long way toward
anticipating medical problems, resolv-
ing them efficiently, and preventing
hospital readmissions.”
Right now, says Enany, digital health is
one of healthcare’s strongest areas of
investment. “Digital health is receiving
more investment money than traditional
medical device, biotechnology, or phar-
ma companies. It was expected that dig-
ital health investments in 2015 would
exceed $6 billion. From the standpoint
of new technologies, that’s an area
where people ought to be watching.”
But just as often as new medtech compa-
nies ride the crest of a growing healthcare
trend, they must also keep in touch with
needs expressed by patients and physi-
cians. The resulting technologies and
companies may not always have the appeal
of a new smartphone app, but their sheer
practicality and utility can provide a solid
foundation for a successful business.
Randolph agrees that the voice of users
plays an important role in medical device
development. “I am really impressed with
how clinicians step up when they observe
that existing products are not doing the
job to promote healing,” he says. “At our
Innovation Lab in Newport Beach, sever-
al of our California-grown technologies
include good examples of this traditional
route to product development.”
He cites in particular these two:
VisuFlow by St. Joseph Health System,
Irvine, a software product that helps clini-
cians visually manage step-by-step process-
es; and Sharpshell by St. Joseph Health
System, also in Irvine, a device for entrap-
ment and disposal of contaminated med-
ical sharps, which will help address the
staggering total of roughly 600,000
needlesticks and sharps-related injuries
reported in US hospitals annually.
In addition, says Randolph, “one phys-
ical therapist designed the Dart, a device
that creates angular resistance and acti-
vates isolated muscle groups to help heal
the ankle after injury, something that
was not available when he injured his
ankle in his earlier years as an Olympic
hopeful soccer player. And, an orthope-
dic surgeon found that he did not have
access to a device to properly elevate the
hand after surgery or injury, so he
designed a hand elevation support
device that allows for ambidextrous use
and is easily adjustable to fit most users.”
The Next Act Radcliffe notes that California’s
medtech sector has benefitted from
state government policies that recog-
nize and reward the value of life sci-
ences innovation. She cites the sup-
port that Governor Jerry Brown pro-
vided for recently enacted legislation
that exempts life sciences companies
from paying state sales tax when pur-
chasing equipment used for R&D
and manufacturing.
California’s approach to nurturing
such innovation is paying off. According
to CLSA, California’s life sciences sector
currently employs 281,000 people, has
1,235 therapies in the development
pipeline, and generates $130 billion in
revenue annually.
“But for the medtech sector to contin-
ue to grow and thrive here in California,
we need to make it easier for our entre-
preneurs to move new ideas forward,”
says Radcliffe. “This includes encourag-
ing sound government policies—partic-
ularly tax, intellectual property, regula-
tory, and coverage and payment poli-
cies—that recognize and reward the
value of life sciences innovation.”
This article was written by Steve Halasey,a contributing editor to Medical Design
Briefs. Additional information is availableonline at www.medicaldesignbriefs.com/CaliforniaMedtechMore.
California’s Medtech Pipeline
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AIntro
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AIntro
18 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
The rapid pace of innovation in the
medical device industry puts ever
increasing pressure on manufacturers to
achieve greater geometrical precision,
increase device lifetime and reliability,
and simultaneously reduce the cost of
making diverse portfolios of products. A
key step in manufacturing medical
implants, such as cardiovascular stents, is
laser micro machining, where the basic
device geometry is cut from an extruded
tube or other raw substrate. Today, most
device production is performed using
continuous wave (CW) lasers, which have
been commercially available for decades.
Nonetheless, manufacturers are switch-
ing to ultra-short pulse (USP) lasers for
new device production lines at a rapid
rate. In this article, we describe why this
is happening and what basics device and
process engineers should know to be suc-
cessful with USP laser machining.
USP Laser Micro MachiningFundamentals
Medical device manufacturers typical-
ly want to immediately answer two essen-
tial questions when evaluating a new
machining technology:
1. Will it achieve the necessary quality for
the device specification?
2. Is the process fast enough for the
required production run rate?
These questions are usually answered
through several iterations of laser appli-
cation demonstration by the medical
device manufacturer and laser supplier.
The closer the collaboration, the more
accurate the answers.
USP laser micro machining is selected
by manufacturers when they want to
avoid a heat affected zone (HAZ)—the
collateral damage left by machining with
conventional lasers. More on this topic
in the next section. Simply put, CW
lasers remove material by melting it, and
USP lasers remove material by vaporiza-
tion. The options for industrial USP
lasers today include pulse durations
from tens of picoseconds (ps) down to a
few hundred femtoseconds (fs). There
are three ranges with the greatest num-
ber of supplier options:
• Standard pico lasers: 5 to 10 ps
• Long femto lasers: 700 to 900 fs
• Short femto lasers: 300 to 500 fs
The optimal pulse duration for a given
manufacturing challenge depends upon
multiple factors, including the required
post-machining quality. Beyond preven-
tion of HAZ, kerf taper and sidewall aver-
age roughness are common figures of
merit.
Kerf taper is the narrowing of the
kerf width down through the material
thickness owing to the Gaussian power
distribution of the laser beam at focus
and the distinct threshold for ablation
of material to occur. Empirically, we
have seen reduced taper in metals
when reducing pulse duration from 6
ps to 900 fs, but no additional benefit
in further reducing to 400 fs. It is not
clear exactly why this happens,
although it is thought to be related to
the relative change in ablation thresh-
old fluence between the pulse ranges.
The average roughness (Ra) for the
sidewall surface also shows a strong
dependence on pulse duration. As an
example, we measured average
roughness versus pulse duration
for cutting Durnico, a maraging
steel, at several fluences. The
data, as shown in Figure 1,
reveals that 900 fs pulse dura-
tion consistently produces lower
roughness than either 6 ps or
400 fs. This phenomenon is not
rigorously studied at this point,
and the pulse duration depend-
ence may vary with other metals
or experimental conditions.
Along with machined-part
quality, machining rate is a crit-
ical factor in determining the
best laser source for a manufacturing
process. Of course, generally more
power means faster material removal,
to a point. When trying to avoid any
HAZ, the net heat deposit in the finite
volume comprising the part will limit
actual power used on the target. Even
short femto lasers deposit a certain
amount of heat with each pulse. This
tiny amount of heat will accumulate
over many pulses to result in HAZ if the
process is not optimized. Nonetheless,
for a given power range, the machining
rate can be increased before seeing
HAZ by selecting the best pulse dura-
tion.
To illustrate this effect, we measured
material removal rate versus fluence for
stainless steel at the same pulse dura-
tions used above. As shown in Figure 2,
there is the expected trend of greater
material removal with increasing fluence
(more material removed with each
pulse), but there is also a clear indica-
tion that 900 fs removes material faster
than 400 fs and much faster than 6 ps.
The reason for this is not yet obvious.
Aside from the fundamental laser-mater-
ial interaction, beam propagation effects
inside the kerf likely play a significant
role in material removal rate. However,
researchers have consistently observed
of Medical Devices Using Ultra-Short Pulse Lasers
Fig. 1 – Sidewall average roughness versus laser pulse flu-ence for Durnico at pulse duration of 400 fs (green), 900fs (red), and 6 ps (blue).
Precision Manufacturing
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AIntro
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that shorter pulses produce faster
machining until the benefit levels off, or
reverses, for shorter femto pulses.
The information presented here was
gathered using typical conditions for
micro machining with USP lasers, e.g.,
150 mm focal length lens, nitrogen
purge gas, and several hundred kilo-
hertz pulse repetition rate. A manufac-
turer’s results will directly depend on
material type and thickness, focusing
conditions, purge gas type and pressure,
and tool path. These factors will
be described in greater detail in
the last section of this article.
First, we will examine practical
benefits to medical device man-
ufacturing by using USP lasers.
Precision Stent MachiningOne of the first commercial
success stories for USP lasers in
precision manufacturing is
machining of cardiovascular
stents. Manufacturing these
devices requires extraordinary
precision to achieve micron
level geometrical tolerances and
avoid defects, like stress risers
from heat build-up during machining.
Since metal stents are usually intended
as permanent implants in the body,
defects can have catastrophic conse-
quences. Moreover, as new designs for
smaller stents emerge, e.g., for cranial
and peripheral stents, the challenges
imposed on the manufacturing process
grow ever greater.
When micro machining metals with
conventional lasers, there can be several
deleterious side effects, including recast
of molten material, prominent burr
along the kerf, and HAZ. Even when
recast and burr can be minimized, con-
ventional lasers always leave HAZ that is
a few microns to tens of microns wide
adjacent to the machining area. This can
be easily discerned as a region of modi-
fied crystal structure when the part is
examined under high magnification.
One or more post-processing steps must
remove each side effect before the final
device is polished and assembled.
Bead blasting and manual honing
are common post-processing steps to
remove recast. Chemical etching, also
called acid pickling, is typically neces-
sary to remove HAZ and burrs.
Although these have worked effectively
for previous generations of stents, they
impose both additional expenses and
limitations in the end-to-end manufac-
turing process. For example, manual
honing results will vary depending on
the technician performing the opera-
tion, and the expense of manual labor
is often dominant in per-part costs.
Chemical etching rates depend upon
localized material quality and shape,
and the handling of the caustic chemi-
20 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-805
Precision Manufacturing
Fig. 2 – Material removal rate versus laser pulse fluencefor stainless steel at pulse duration of 400 fs (green), 900fs (red), and 6 ps (blue).
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AIntro
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AIntro
cals represents consumables expense
and safety requirements for the manu-
facturing site.
Manufacturers examine both capital
expense (CapEx) and operating
expense (OpEx) for the equipment in
their production line. In comparison to
conventional lasers, USP lasers can cost
2x to 10x more for the initial CapEx,
with cost increasing for shorter pulses
and higher power. This should not be a
deterrent from using USP lasers, howev-
er, since the OpEx can be substantially
lower due to the elimination of post-pro-
cessing steps and improvements in man-
ufacturing determinism. The OpEx sav-
ings can lead to a return on investment,
or payback period, of less than one year.
Another important factor is the more
universal efficacy of USP lasers for
machining different materials and stent
patterns. Figures 3 and 4 show a stent cut
from an extruded tube of Nitinol (NiTi)
using a USP laser. NiTi, and other com-
mon metals used for implants, such as
chromium cobalt, stainless steel, and tita-
nium, have sufficiently similar laser-mate-
rial interaction properties to make them
accessible to a single USP laser source.
USP laser machining employs photo-ion-
ization as the initial activation mecha-
nism, as opposed to linear absorption in
the case of CW lasers. Material removal
with USP lasers is more wavelength-inde-
pendent and utilizes a narrower range of
power and pulse energy parameters for
optimal results. In practice, this means a
single laser workstation can be used for
producing a variety of medical devices.
(See Figures 3 and 4)
The financial benefit of manufactur-
ing medical devices with USP lasers is
becoming more and more obvious.
Nevertheless, the change from conven-
tional lasers to USP lasers in production
is large enough that manufacturers will
only invest in USP lasers when they
absolutely have to, i.e., they are com-
pelled by new product designs that are
enabled by the newer technology.
In the case of stents, USP lasers enable
machining of smaller diameters, narrow-
er struts, and more complex flexure pat-
terns. The lower limit on stent diameter
has traditionally been imposed by back-
wall damage using conventional lasers.
Owing to the finite threshold for photo-
ionization, this can be avoided for diam-
eters <100 μm by using USP lasers. The
improved machining tolerances with
USP lasers means struts can be as narrow
as 10 μm, while still achieving acceptable
part yield. The lower taper and minimal
HAZ with USP lasers means stent lattice
patterns can have tighter radii of curva-
ture or sharper angles while avoiding
part breakage or latent stress risers.
These enabling factors have dramatically
broadened the design space for stents.
How to Achieve the Best ResultsEven though USP lasers are becoming
more common in manufacturing settings,
it must be understood that using USP
requires specialized knowhow. That is, a
manufacturer cannot simply drop in a
USP laser where a CW laser was used
before and expect great results. The impli-
cation here is that manufacturers must
work with an expert in USP laser machin-
ing and bring enough knowledge in-house
to optimize the process in full production.
Table 1 offers a summary of some of the
better understood rules of thumb for
selecting laser parameters. These must be
combined with other process parame-
ters—like beam polarization and focusing
conditions, part or beam motion, process
gas type and pressure, and debris manage-
ment—to achieve the desired outcome
in manufacturing.
Pulse characteristics were discussed in
detail in the first section. Here, we
extend that discussion to state that there
are ranges of pulse characteristics that
will potentially work for manufacturing a
given part. Despite the speed and quality
improvements provided by femto lasers,
pico lasers may provide a “good enough”
result and are still somewhat less expen-
sive. This is where careful collaboration
with laser suppliers will reveal the best
choice. The higher energy requirement
for thicker-walled material comes from
the evolution of the machining kerf
through the material thickness. The kerf
forms as a deepening V-shape down
through the material that spreads the
beam and reduces the effective fluence,
or energy density. Hence, greater energy
is required to machine through the wall.
www.medicaldesignbriefs.com Medical Design Briefs, February 2016
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Precision Manufacturing
Fig. 3 – Photograph of a Nitinol (NiTi) stentmachined with a USP laser.
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AIntro
The average power guideline is more
straight-forward. The process should
use sufficient pulse energy to cut
through the material, usually in a sin-
gle pass, and then the pulse repetition
rate should be increased to advance
the feed rate. With the high power
industrial USP lasers available today,
limitations on average power usually
stem from the part size and motion
control system. Since even the shortest
pulses deposit a finite amount of their
energy as heat, a large enough number
of pulses delivered to a very small part
will create HAZ. The part or the beam
can be moved around faster, to an
extent, but then the part size becomes
the constraining factor. In practice,
manufacturers will sometimes tolerate
a certain amount of HAZ in order to
hit a desired part processing time.
Laser suppliers typically specify laser
beam quality as the M-squared parame-
ter (M2), or how closely their product
matches an ideal Gaussian beam
(M2 = 1). Laser sources with M2 < 1.4
seem to be accepted by most of the
industry as sufficient for precision micro
machining. Nonetheless, beware of
lasers with elliptical beams, astigmatism
or other distortions that are not necessar-
ily revealed by the M2 figure. These beam
defects lead to direction-dependent kerf
width and other problems. A good way to
test a laser source is by measuring abla-
tion spots through focus of a known lens.
The laser’s wavelength does not cur-
rently play a large role when users select
the right laser for manufacturing metal
stents and other medical devices. As
mentioned above, the common metals
used for stents and other implants are
white metals (those that are silvery in
hue). For devices that use red metals
(i.e., gold or copper), wavelength may
play a more significant role. In addition,
polymer machining has much greater
dependence on laser wavelength owing
to the higher photon energy and the
role of multi-photon ionization in poly-
mer ablation. Polymers are also more
heat sensitive than metals, and wave-
length strongly impacts residual linear
absorption of laser energy that creates
heat. As device features become smaller
in future designs, the laser’s wavelength
may become more important for reduc-
ing spot size on the part.
Here we mentioned polymer machin-
ing for the first time, and indeed, the
industry’s knowledge about USP machin-
ing of polymers is much less mature.
Though we include some guidance on
polymer machining in Table 1, these are
early learnings and are the subject of
considerable debate in the technical
community. On the other hand, there is
potentially even greater value offered by
USP processing of polymers, given their
heat sensitivity and difficulty in precision
micro machining. We expect rapid devel-
opment in this area in the next few years.
Medical Design Briefs, February 2016 23Free Info at http://info.hotims.com/61058-846
Fig. 4 – SEM image of a Nitinol (NiTi) stentmachined with a USP laser.
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AIntro
24 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-850
The competitive landscape for med-
ical devices is evolving rapidly, forcing
manufacturers to adapt to new demands
for precision and determinism. USP
lasers—with pulse duration in the range
of hundreds of femtoseconds to tens of
picoseconds—have emerged as critical
tools to make next generation medical
devices more reliably and cost-effective-
ly. Along with the new tools, however,
manufacturers must develop a deeper
understanding of USP laser machining.
This article was written by Michael Mielke,TruMicro Program Manager, TRUMPF,Inc., Farmington CT. For more information,visit http://info.hotims.com/61058-162.MD&M West, Booth 3254
Parameter Rules of Thumb
Pulse Duration
• <10 ps to achieve negligible HAZ at modest machining rates for common metals
• <1 ps to achieve negligible HAZ at fastest machining rates for most metals
• <1 ps to achieve negligible HAZ for polymers
• Pulse duration <500 fs offers rapidly diminishing quality improvements with
rapidly increasing process complexity
Pulse Energy• Add 10 μJ for every 100 μm of metal thickness (up to 1 mm thick)
• Add 20 μJ for every 100 μm of polymer thickness (up to 1 mm thick)
Average Power• Once optimal pulse energy is achieved, increase average power (via repetition
rate) to increase feed rate until HAZ is not acceptable
Beam Quality• M2 < 1.4 is standard for predictable Gaussian beam focusing conditions
• Beam circularity >80% is critical for direction independent results
Wavelength
• White metals, e.g., NiTi, show little dependence on wavelength for speed or quality
• Red metals, e.g., Cu, benefit somewhat from green laser wavelength
• Polymers benefit from shorter wavelengths on a case by case basis
Table 1 – Rules of thumb for selecting laser parameters.
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AIntro
Data drives results. Today, medical
devices give feedback and insight
like never before. Advances in engi-
neering medical devices has led to
smarter devices, improved consistency
amongst practitioners, and faster recovery
times for patients. Force feedback is an
increasingly valuable feature in the med-
ical device market, providing doctors and
patients with quantifiable data. This data
allows for a more systematic approach to
treating patients efficiently and effectively.
One of the most important elements
of a medical device is the feedback it
provides the person using the tool,
whether it is a primary care physician,
surgeon, or patient. The device design
must support a flow of communication
between the patient’s body, the tool
used, and the doctor reading and analyz-
ing the output. There are a few ways that
force can be measured, but depending
on the context of the application, some
force sensing technologies prove more
ideal than others do. Load cells, strain
gauges, and piezoresistive elements are
popular devices used to measure force.
Load cells can use a variety of tech-
nologies to sense loads, but are bulky in
size; making them difficult to design
into an application where lightweight
and small size are priority. Strain gauges
are smaller than load cells, but require
highly skilled technicians to install and
yield measurements that are a result of
indirect force drawn by correlating the
strain of an assembly with a load.
Microelectromechanical systems
(MEMS) sensors are also smaller than
load cells and measure force indirectly.
These sensors typically require a
plunger-type of load device embedded
into the MEMS package. Additionally,
MEMS require a large upfront invest-
ment and price per piece is only cost
effective with very high volumes.
In recent years, a different approach to
force sensing technology has become
increasingly popular and commercially
available. The generic term for this
device is the tactile force sensor. Thin
film tactile force sensors consist of a spe-
cial, proprietary, piezoresistive material
sandwiched between two pieces of flexi-
ble polyester. The sensors are resistors
that vary linearly in terms of conductance
vs. force under an applied load, and can
come in off-the-shelf standard shapes for
test and measurement, as well as proof of
concept. In addition, they can be cus-
tomizable for specific original equipment
manufacturer (OEM) applications.
Tactile force sensors are easier to inte-
grate into medical products and systems
as compared to the other force sensing
options due to their thin, flexible
nature. This type of component is ideal
for a design engineer looking to design
a lightweight, unobtrusive medical
device that provides feedback to its user.
Force feedback is important in vari-
ous medical settings, such as in a hospi-
tal, operating room, as well as the
patient’s home or during hospice.
Tactile force sensors are used in a vari-
ety of medical applications including:
infusion pumps, robotic surgery, pros-
thetics, and shoe insoles. Below are a
few applications highlighting how force
sensor integration enhances the design
of the medical device.
Drug Delivery: Infusion PumpsCustom force sensors, designed into
wearable, drug-delivery infusion pumps,
help detect potentially life-threatening
blockages. These automated pumps con-
tinuously deliver vital drugs to the patient
on a daily basis. When designing the
delivery system, engineers concluded that
the detection of blockages and functional
problems within the pump was critical.
When a blockage occurs in the pump, the
tubing within the pump expands. The
custom sensor, located where the tubing
meets the housing, in turn detects this
expansion by monitoring the force
applied to the sensor by a section of the
tubing. The sensor then triggers an alarm
Medical Design Briefs, February 2016 www.medicaldesignbriefs.com 25
Changing the Medical Device Design Game
Thin Film Force Sensors:
Fig. 1 – Infusion pump utilizing a customforce sensor to detect potential blockages.
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AIntro
www.medicaldesignbriefs.com Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-807
to alert the user of a detected blockage,
and to take the necessary steps to correct
the problem in order to reduce any neg-
ative effects. (See Figure 1)
Robotic SurgeryA key contributing factor to a success-
ful surgery is sensory feedback. In recent
years, with the help of modern surgical
tools, robotic surgical procedures have
become increasingly less invasive. Today,
surgeons using robotic controls must
depend on tactile cues and visual confir-
mation to direct the robot.
Design engineers are challenged
with creating devices containing senso-
ry force feedback that ultimately relay
force measurements to the operator, so
he or she can properly control the
robot performing the surgery. For
example, some robotic systems have
grippers used to hold very small and
extremely sensitive parts of the body,
such as veins and soft tissues. This tool
allows surgeons access into parts of the
body not easily accessed by the opera-
tors themselves. Integrating force sen-
sors allows the surgeon to detect how
much force is being applied during sur-
gery. This insight is key.
ProstheticsAccording to the Amputee Coalition,
approximately 185,000 amputations
occur in the United States each year.
This large number drives the need for
enhanced prosthetics. Medical design
engineers aim to create prosthetic
devices that provide force feedback to
the user. The engineer’s goal is to create
a communication between the prosthe -
tic and the user, allowing them some
kind of sensory ability. Sensors can be
used to accomplish this communication.
Sensor feedback allows users to know
how much force they are applying to
objects and to practice day-to-day activities.
For example, force sensors are used in an
artificial hand; the sensors are located at
the tip of the thumb, index finger, and
middle finger. The sensors help the user
understand how much force is applied
when grasping and releasing objects. The
hand is connected to a PC that is also con-
nected to a nerve stimulator. The nerve
stimulator sends electrodes to the user’s
upper arm. This system allows the pros-
thetic to relay back to the user, creating a
smart medical device. (See Figure 2)
Shoe Insole Monitoring systems are a way for doc-
tors, patients, and their loved ones to
keep constant track of a patient’s day-to-
day activities in the comfort of their own
natural environment. New medical
devices are allowing doctors 24-hour
access to this insightful information
regarding a patient’s progression and
everyday routine. Real-time monitoring
systems are becoming increasingly pop-
ular in geriatrics, specifically keeping a
close eye on elderly patients. For exam-
ple, force sensors can be designed into
non-invasive medical devices either
worn or used by the patient. For
instance, sensors can be designed into
shoe insoles. (See Figure 3)
Fig. 2 – A variety of commercial prosthetic hands, all shown without cosmetic glove. (Credit: U.S.Department of Veterans Affairs)
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AIntro
The force sensors designed into these
products provide continuous data for
relay to the doctor or the patient’s family
members via a wireless hub. This data pro-
vides insight into the patient’s daily activi-
ty or lack thereof, which, in turn, would
alert doctors or family members to check
in on that patient. These medical devices
allow doctors to stay informed and con-
nected to their patients, resulting in more
precise treatment methods.
Foot Drop SystemAnother type of assistive living device
is one whose main purpose is to commu-
nicate with the patient’s body itself.
Functional electrical stimulation is a
technique that uses electrical currents to
activate damaged nerves, due to a stroke,
neural damage, etc. Foot drop systems
are wearable devices to help those affect-
ed by muscle and nerve damage to
regain mobility and improve their quality
of life. These devices senses when your
foot is on or off the ground and helps
the foot adjust to changes while walking.
The device consists of a lightweight
cuff worn below the knee, a gait force
sensor attached to the inside of the shoe,
and a portable, wireless control unit. The
force sensor placed within the shoe relays
wireless signals to the leg cuff, which then
produces electrical stimulation to specific
leg muscles. This stimulation of nerves
and muscles signals the foot to lift off the
ground and helps the user walk more nat-
urally. The user also has the ability to
adjust the level of stimulation with the
hand-held portable unit, which is small
enough to carry in a pocket or bag.
The combination of this lightweight,
flexible sensor and the wireless design
results in a noninvasive device that can
be used by the patient in their natural
environment and easily integrate into
their daily routine. This type of assistive
device is liberating to its users because
they have the ability to not only adjust
the stimulation levels to meet their per-
sonal needs, but it gives them a sense of
control, which they did not have before.
Conclusion As stated before, data drives results.
In the medical field, medical devices
equipped with force feedback capabili-
ties ultimately result in better medical
practices, improved patient outcomes,
and patient experiences. The quantita-
tive and qualitative data provided by
these devices enhanced by force sen-
sors is invaluable. These smart devices
give practitioners and patients better
insight into their overall health, bodies,
and rehabilitation. As the medical mar-
ket evolves, tactile force sensors provide
OEM design engineers a durable, cost-
effective solution that helps them cre-
ate an intelligent and valuable product.
This article was written by JeannineCroteau, Marketing Specialist, Tekscan,Inc., South Boston, MA. For more informa-tion, visit http://info.hotims.com/61058-161. MD&M West, Booth 3255
Medical Design Briefs, February 2016 27Free Info at http://info.hotims.com/61058-808
Fig. 3 – Shoe insole utilizing a force sensor tohelp assess balance issues in patients.
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AIntro
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AIntro
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AIntro
Dispensing plays an important role in
medical device manufacturing.
There are many stringent requirements
for accuracy, reliability, repeatability, dis-
pensing speed, and throughput. In addi-
tion, the dispensing processes require a
wide variety of fluids with a broad range
of viscosities. With all the complexities
of medical device manufacturing, the
performance of something as simple as a
dispense valve often gets overlooked.
Here are some questions to consider
when evaluating medical technology dis-
pensing processes.
Are You Using the Best DispenseValve for Your Fluid Application?
For many dispensing applications, a
well-designed general-purpose diaphragm
or piston valve can handle a range of fluid
viscosities. In most situations, however,
best results will be obtained with a valve
style and configuration carefully matched
to the specific properties of the fluid
being dispensed.
Thick Fluids: Thick materials like RTV
silicone or heavy grease, for example,
pose different challenges than thinner
fluids like adhesives or threadlockers.
When using thick fluids, a high-pressure
valve with a balanced spool design will
provide good control. Look for a snuff-
back feature. It will prevent drooling
and tailing and help reduce the rework
and cleanup.
Thin to Medium Fluids: Thin fluids
like solvents and watery adhesives, espe-
cially when very small deposits are need-
ed, work best with needle valves because
shutoff occurs close to the valve outlet or
dispense tip. This is an important design
feature because it minimizes dead vol-
ume that can cause dripping or oozing.
For critical applications, there is a nee-
dle valve that seats the needle in the dis-
pense tip instead of the valve body. By
virtually eliminating dead volume, this
design makes it possible to produce even
smaller and more consistent micro
deposits. (See Figure 1)
Tricky Fluids, like Cyanoacrylates:Wetted internal parts, as well as any fit-
tings and tubing that come in contact
with the fluid, should always be carefully
chosen for compatibility with the fluid
being dispensed. When working with
cyanoacrylates (CAs), for example, wet-
ted parts made of inert, ultra high
molecular weight (UHMW) polymer are
a good choice because they will not react
with the fluid. Nylon or metal fluid fit-
tings should never be used with CAs
because they absorb moisture and will
promote premature curing. Use polyeth-
ylene or polypropylene fittings instead.
Chemically inert, polyethylene-lined or
polytetrafluoroethylene (PTFE) fluori-
nated ethylene propylene (FEP) tubing
are good choices for fluid feed lines.
Are You Using a Dispense ValveSystem or Just a Dispense Valve?
Taking a system approach to fluid
dispensing and carefully evaluating all
the details, even something as small as
a fluid fitting, will help prevent many
problems on your device assembly line.
A dispense valve system has four main
components:
• The dispense valve,
• A precision dispense tip,
• A means of initiating the dis-
pensing cycle, and
• A fluid reservoir.
The greatest accuracy, relia-
bility, and production yields will
be obtained when all four com-
ponents are engineered to
work together as an integrated
system. This approach will also
simplify qualification and vali-
dation processes. A valve paired
with a dedicated valve con-
troller will typically provide
faster response time than a
valve triggered by mechanical
means or a remote programma-
ble logic controller (PLC).
Is Your Dispensing LineRunning as Fast as It Can?
If your dispense valves are not
cycling fast enough, the valve
control system may not be com-
patible with the dispense valve.
Most automatic assembly
machines use PLCs to sequence machine
functions, but a PLC’s primary purpose is
not to control dispense valves. When
faster cycle times and more precise con-
trol of deposit size are required, a dedi-
cated valve controller with a fast-acting
solenoid and a digital timer can be a sim-
ple and cost-effective way to achieve
these objectives. The controller can also
be interfaced with the PLC, if desired.
However, a PLC may or may not offer
online programming of dispensing func-
tions. Without this capability, entire pro-
duction lines have to be shut down just
to make simple adjustments to deposit
size. Even if a PLC can program valve
functions, the valve may not be within
the line of sight of the engineer or oper-
ator trying to adjust it. A dedicated con-
troller mounted at the dispensing sta-
tion will simplify initial setup, make it
faster and easier to purge the valve after
refilling the fluid reservoir, and allow
adjustments to be made and checked
“on the fly” without shutting down the
production line.
30 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
to Ask About Your Dispense Valves
Fig. 1 – Shown is a needle valve dispensing adhesive ontomedical part.
9 Tough Questions
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AIntro
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AIntro
Do Your Valves Leak and Drip?Leaking is a common problem with
valves that have complex designs or
seals and O-rings that wear out over
time. The most reliable diaphragm
designs entirely eliminate the need for
seals and O-rings. The best valves will
easily handle many different fluid appli-
cations and provide tens of millions of
cycles without maintenance. Carefully
choosing the valve seat materials will
also prevent many problems.
UHMW polyethylene, for example,
provides exceptional wear characteris-
tics and chemical compatibility with a
wide range of assembly fluids, keeping
the valve system working longer with-
out downtime or maintenance.
Using valves small enough to be
mounted at the point of fluid applica-
tion reduces the risk of drooling. (See
Figure 2)
Is Your Current Valve SetupTrapping Air?
Entrapped air can cause oozing and
variations in shot size. Be sure to purge
all air and fluid lines whenever setting
up a system, refilling the fluid tank, or
performing maintenance. Also be sure
to note:
• Keeping air lines shorter than five feet
reduces the risk of trapped air and
improves valve response time.
• The proper tip can help prevent air
entrapment. When using metal tips,
use 21 gauge (0.020") or larger if the
application permits, as they will allow
small air bubbles to purge through.
• Tapered polyethylene tips are good in
any size. They allow fluid to flow freely
through the tip to purge and prevent
air bubbles from collecting. Tapered
tips typically range from 14 gauge to
27 gauge.
• Use a valve controller with a purge
function that allows the user to bleed
any air in the system quickly and easily.
• Install a filter/regulator between the
plant air supply and the dispense valve
to remove any residual moisture from
the system—this is especially impor-
tant when working with cyanoacrylates.
Is It Difficult to Produce ConsistentShots?
Valve open time is the most precise
way to adjust shot size. A dedicated con-
troller is an efficient approach to estab-
lish shot size and regulate valve opera-
tion. Open time can be adjusted in
increments as small as 0.001 seconds for
exceptional control over the amount of
material applied. On production lines
with multiple dispensing stations, using
a dedicated valve controller at each sta-
32 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-811
Fig. 2 – This diaphragm valve is dispensing low-viscosity fluid onto a heart pump component.
9 Tough Questions
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AIntro
Medical Design Briefs, February 2016 www.medicaldesignbriefs.com
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tion can make it simple to adjust each
valve's open time independently and
obtain an identical shot from each valve.
How Often Do Your Valves RequireMaintenance?
All valves require maintenance, but
some designs require more frequent
repair than others. Here are some things
to consider:
• How many cycles can it go without
degradation? A well-engineered valve
design will go tens of millions of cycles
without any degradation in perform-
ance or accuracy.
• Can maintenance be performed on
site, or does the valve have to be
returned to the manufacturer?
• If service can be performed on site, how
complicated is it? Can the fluid head be
removed without dismounting the valve
or does the valve have to be removed
from the mounting fixture and taken
apart? With some high-performance
designs, routine maintenance is as sim-
ple as replacing the dispense tip.
Are You Cutting Corners on YourDispense Tips?
Correct tip selection is very important
to dispense valve performance. The best
choice is using a tip with the largest pos-
sible internal opening for the intended
application. This will prevent air bubbles
from forming. Tip quality has a surpris-
ingly large effect on the accuracy and
uniformity of fluid deposits, especially in
critical applications where very small
deposits are required. Even the most
precise dispensing system will not pro-
duce consistent results if the tip—the
last path the fluid travels before it reach-
es the part—is obstructed by debris from
the molding or machining process.
Would High-Speed Jetting Fit YourApplication Needs?
Non-contact jetting systems are capa-
ble of dispensing a wide variety of fluids
at speeds of up to 500 shots per second.
By combining high speed with excep-
tional accuracy, these systems allow prod-
ucts to be built more cost-effectively with
consistently high quality. Additionally,
since jet valve systems are non-contact, it
is possible to apply fluid in hard-to-access
areas or onto uneven or delicate sub-
strates where dispensing needles cannot
be used. Jetting can be used with a wide
range of fluids. (See Figure 3)
If your dispense valve system is not giv-
ing you accurate deposits with minimal
maintenance or you are applying incon-
sistent amounts of fluid and wasting too
much time and money on downtime,
rework, and cleanup, valve performance
might be the culprit. Re-evaluating the
valves used in your medical device man-
ufacturing processes could help you
achieve substantial material waste reduc-
tion, higher productivity, and better
final product quality.
The article was written by ClaudeBergeron, Global Product Line Manager –Valves, Nordson EFD, East Providence, RI.For more information, visit http://info.hotims.com/61058-163. MD&MWest, Booth 2835
Fig. 3 – A jet valve is shown dispensing conductive material onto a printed circuit board.
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34 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
When it comes to medical equip-
ment, nothing is more important
than the safety of patients and health
care personnel. From diagnostic tools
such as ultrasound devices to home
health equipment like dialysis machines,
human safety is top priority. To ensure
that devices and equipment are not haz-
ardous, strict standards are in place to
help guarantee global compliance.
For power supplies, one of the most
important is IEC 60601-1, MedicalElectrical Equipment, Part I: GeneralRequirements for Basic Safety and EssentialPerformance. This standard covers essen-
tial safety-related specifications and val-
ues, such as isolation voltage, leakage cur-
rent, and creepage/clearance distances
that must be met to protect people from
electrical shock.
In addition to safety concerns, med-
ical equipment designers also must
consider a host of other factors when
choosing the best power supply for the
application. Some of these include
input range, output voltage and power,
standby power, temperature and alti-
tude constraints, and product war-
ranties. Understanding how various
power supplies compare to one anoth-
er in terms of each of these factors will
enable equipment designers to make
the right design decision for the proj-
ect at hand.
Safety FirstBecause safety is such an impor-
tant—and highly regulated—aspect
of medical equipment design, it
pays to have an understanding of
the main terms and requirements
within the third edition of IEC
60601-1. To get an idea of what the
standard covers, one can simply
review a list of typical tests for med-
ical electrical systems. Some of these
include testing for leakage current,
grounding impedance, isolation volt-
age, and electromagnetic compatibility.
Compared to industrial power supplies,
the levels required for medical power
supplies are much stricter. As an exam-
ple of what IEC 60601-1 codifies, isola-
tion is required between the AC input,
internal high-voltage stages, and DC
output in order to prevent electrical
shock to the operator or patient. To
ensure correct and sufficient isolation,
either double insulation or reinforced
insulation should be used in medical
power supplies instead of a protective
earth (Class II isolation). Class I electri-
cal equipment only calls for basic insu-
lation and uses a protective earth to
avoid electrical shock, and is suitable
for certain equipment.
Other terms within IEC 60601-1 to
become familiar with include the means
of protection used, describing the isola-
tion protection between the electrical
circuits and equipment that may contact
the device. Isolation protection includes
creepage/clearance distances, insula-
tion, and protective earths.
Subcategories for this term include
MOOP (means of operator protection)
and MOPP (means of patient protec-
tion). (See Figure 1)
The standard sets the following crite-
ria for medical power supplies: For
MOOP, one layer of insulation at 240
VAC requires test voltage of 1500 VAC
and 2.5mm creepage, while double insu-
lation at 240 VAC requires test voltage of
3000 VAC and 5mm creepage. For
MOPP, one layer of insulation at 240
VAC requires test voltage of 1500 VAC
and 4mm creepage, while double insula-
tion at 240 VAC requires test voltage of
4000 VAC and 8mm creepage. (See
Figure 2)
Leakage current, or touch current, is
another issue covered within IEC
60601-1. Touch currents are defined as
the leakage paths from an enclosure
that may contact a patient or operator.
Because medical patients are often in a
weak state, even a small amount of leak-
age current can have an adverse health
effect. The standard specifies maxi-
mum levels of 100 μA for normal oper-
ation and 500 μA for a single fault con-
dition. Closely related to the leakage
current concept is the test that meas-
ures it: The total patient leakage cur-
rent test measures the leakage current
when all “applied parts” required to
operate the medical device are in con-
tact with the patient.
Applied part means the part of the
medical device that may contact the
patient during normal operation and
includes three classes: B (body/least
stringent), BF (body floating/more
stringent than B, less than CF), and
CF (cardiac floating/most strin-
gent/in direct contact with heart).
For example, B-rated parts such as
hospital beds require 4000 VAC
input to output isolation, 1500 VAC
input to ground isolation and 500
VAC output to ground isolation. In
contrast, BF/CF-rated parts require
4000 VAC input to output isolation,
1500 VAC input to ground isolation
and 1500 VAC output to ground iso-
lation. An example of a Type BF part
Fig. 1 – This is an example of a 100-watt AC/DC power sup-ply for medical applications, featuring a universal input rangeand 2MOPP isolation with Class I and II protection.
Selecting Power Supplies for Medical Equipment Designs
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AIntro
Medical Design Briefs, February 2016 35Free Info at http://info.hotims.com/61058-813
is a blood pressure monitor, whereas a
CF example is a dialysis machine. Be
sure that your medical power supply
adheres to the values spelled out in IEC
60601-1. Not all power supplies meet
these criteria. (See Figure 3)
Performance Factors and Design Flexibility
Beyond strictly enforced safety stan-
dards, designers must also consider how
different power supplies stack up when
it comes to performance. For example,
many DC-DC converters feature a 2:1
input voltage range and handle limited
voltage, such as 4.5 to 36V. When possi-
ble, look for power supplies that offer
additional design flexibility, such as a 4:1
input range and expanded voltage val-
ues of 4.5 to 75V. Having a wider input
range translates to much greater flexibil-
ity for unforeseen design iterations
requiring higher input voltages or the
need to develop several versions of the
same basic equipment model.
Standby power is another considera-
tion. As hospitals, health care facilities,
and patients themselves become more
concerned about energy efficiency and
conserving resources, the amount of
standby power consumed by various
devices becomes an important issue.
Some medical power supplies use stand-
by power as low as 0.15W, whereas simi-
larly sized devices consume as much as
0.48W. Be sure to look at this specifica-
tion when making apples-to-apples com-
parisons of various power supply choices.
Environmental factors are yet anoth-
er area to take into consideration. For
example, many DC-DC converters are
Fig. 2 – Under the IEC 60601-1 safety standard, proper creepage and clearance distances helppower supplies achieve sufficient isolation protection between the electrical circuits and equipmentthat may contact the device.
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AIntro
limited to operating within ambient
temperatures of -40º to 60ºC at full load
operation. Yet others can handle -40º to
77ºC at full load, offering a substantial
improvement in design flexibility. The
same idea holds true for AC-DC convert-
ers: Some can handle ambient tempera-
tures to 70ºC, while equivalent designs
from other suppliers can withstand
80ºC. Read specifications carefully or
ask your potential supplier about these
engineering values in order to make the
most informed decision. Beyond tem-
perature constraints, be sure to consid-
er operating altitude as well. While
many DC-DC and AC-DC power sup-
plies are designed for altitudes of 3,000
m or less, others can function to 5,000
m. This value can limit where the med-
ical equipment can reliably operate.
Finally, don’t forget to ask about prod-
uct warranties. Many medical power
supplies feature a standard three-year
warranty, while some offer full five-year
warranties. When deciding on a power
supply, it is wise to understand warranty
details before purchasing.
Electromagnetic interference (EMI) is
another challenge that must be consid-
ered. Because devices such as patient
monitors operate with low-level signals
within hospital settings, this type of equip-
ment is more sensitive to EMI than typical
industrial equipment. Due to this reality,
electromagnetic compatibility is another
area that is regulated by standards and
tested for performance. Whenever possi-
ble, look for medical power supplies
(both DC-DC and AC-DC converters) that
feature built-in EMI filters.
Finally, one more design considera-
tion for AC-DC converters is packaging
style. While most power converters come
in open frame styles, others are also
available in chassis mount, DIN rail
mount, and enclosed configurations.
Depending on the medical equipment,
power supply packaging may be a key
factor in the overall design.
SummarySelecting the right power supply for
your next medical equipment design is a
matter of knowing which engineering
values to look at when making product
comparisons. Top priorities include safe-
ty-related specifications and values, such
as isolation voltage, leakage current and
creepage/clearance distances that must
be satisfied to protect people from elec-
trical shock. Beyond safety, equipment
designers also must consider factors
such as input range, output voltage and
power, standby power, operating temper-
ature and altitude, and product war-
ranties. Knowing how medical power
supplies compare to one another in
terms of these values will help equip-
ment designers make appropriate
design decisions.
This article was written by Sheri Lynn,Technical Sales, Polytron Devices, Inc.,Paterson, NJ. For more information, visithttp://info.hotims.com/61058-160.
36 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-814
Fig. 3 – This 10-watt DC/DC converter for med-ical applications features a single and dual out-put with a regulated, 4:1 wide input range andminiature DIP package.
Power Supplies
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Medical Design Briefs, February 2016 www.medicaldesignbriefs.com 37
GLOBALL INNOVATIONSI
Apostgraduate research student,
Devesh Mistry, in the University of
Leeds School of Physics and
Astronomy, UK, is working with liquid
crystal to create a truly adjustable artifi-
cial eye lens, made from the same materi-
al found in smartphone and TV screens.
The new lens, he said, could restore sight-
edness caused by presbyopia. Presbyopia,
which is common in people over 45 years
old, can require the use of optical aids,
such as reading glasses.
Mistry explained: “As we get older, the
lens in our eye stiffens, when the mus-
cles in the eye contract they can no
longer shape the lens to bring close
objects into focus. Using liquid crystals,
which we probably know better as the
material used in the screens of TVs and
smartphones, lenses would adjust and
focus automatically, depending on the
eye muscles’ movement.”
■ How It Would WorkUsing liquid crystal-based materials,
Mistry is developing a new generation of
synthetic replacement lenses and intra-
ocular lens implants to rejuvenate sight.
He is researching and developing the
lens in the lab and aims to have a proto-
type ready by the end of his doctorate in
2018. (See Figure 1)
The research could see the new lens
being implanted into eyes in a quick
and straightforward surgical procedure
under local anesthetic. Mistry said that
the first commercially available liquid
crystal lenses could be available for sale
within ten years’ time.
Eye surgeons would make an incision
in the cornea and use ultrasound to
break down the old lens. The liquid crys-
tal lens would then be inserted, restor-
ing clear vision, and potentially eliminat-
ing the need for reading glasses. The
lens could also be useful in combating
cataracts, which affect many people in
later life and which can seriously affect
vision. A common treatment is to
remove and replace the natural lens.
“Liquid crystals are a very under-
rated phase of matter,” Mistry said.
“Everybody’s happy with solids, liquids,
gases, and the phases of matter, but liq-
uid crystals lie between crystalline
solids and liquids. They have an
ordered structure like a crystal, but
they can also flow like a liquid and
respond to stimuli.”
Mistry is working in collaboration
with the Eurolens Research at the
University of Manchester and with
UltraVision CLPL, a specialist contact
lenses manufacturer. His research
builds upon previous work by the same
collaborators, who developed a proto-
type contact lens with an electrically-
controllable focus using liquid crystals.
(See Figure 2) Fig. 1 – Liquid crystal being tested under heat-ing. (Credit: University of Leeds)
Fig. 2 – A prototype of an electrically switchable contact lens previously developed by the same groupof collaborators. The lens makes use of liquid crystals, a material used in the vast majority of TV andsmartphone screens
GLOBALL INNOVATIONSI
Liquid Crystal Artificial Eye Lens University of Leeds, UKwww.leeds.ac.uk
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38 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
■ Water-in-Salt Battery Powers PacemakersAn aqueous “Water-in-Salt”
battery developed by engineers
from the University of
Maryland, College Park, and
the U.S. Army can provide a
safe, non-flammable alterna-
tive for batteries used in med-
ical devices like pacemakers.
The researchers employed a
type of water-based electrolyte
containing ultra-high concen-
trations of lithium salt. The
electrolyte transformed the
battery’s chemistry, resulting in
a thin protective film on the anode electrode.
Known in battery science as a “Solid Electrolyte
Interphase,” the stabilizing film supports the performance of
lithium-ion batteries.
The power of the aqueous battery doubled to approximately
3 volts. The formation of an anode/electrolyte interphase in
the “Water-in-Salt” electrolyte allowed the engineers to break
the inverse relationship between cycling stability and high volt-
age, and to achieve both simultaneously.
For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/news/23530.
■ Electronic-Embedded Hydrogel Can Deliver DrugsAn elastic water-based bandage from the Mas sachusetts
Institute of Tech nology, Cambridge, MA, senses temperature and
delivers medicine to the skin when needed. The stretchy hydrogel
can be embedded with various
electronics.
The hydrogel sheet is bond-
ed to a matrix of polymer
islands that encapsulates elec-
tronic components such as
semiconductor chips, LED
lights, and temperature sen-
sors. The rubbery material,
mostly composed of water, can
join strongly to surfaces like
gold, titanium, aluminum, silicon, glass, and ceramic.
Hydrogel-coated electronics may be used not only on the
surface of the skin, but also inside the body, for example as
implanted, biocompatible glucose sensors, or even soft, com-
pliant neural probes.
Additional pathways were created for drugs to flow through
the hydrogel, by either inserting patterned tubes or drilling
tiny holes through the matrix.
One immediate application may be as a stretchable, on-
demand treatment for burns or other skin conditions.
For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/news/23555.
■ Materials Scientists Create NacreScientists from Cornell University, Ithaca, NY, have uncov-
ered the process by which mollusks manufacture nacre. The
development could lead to new, layered, advanced materials.
Using a high-resolution scanning transmission electron
microscope (STEM), the researchers examined a cross section
of the shell of a fan mussel. With a diamond saw, the team cut
a thin slice through the shell, then sanded the material down
to a sample less than 30
nanometers thick, suitable for
STEM observation.
Images with nanometer-
scale resolution revealed that
the mollusk builds nacre by
depositing a series of layers of
a material containing
nanoparticles of calcium car-
bonate. Moving from the
inside out, the particles are
seen coming together in rows
and fusing into flat crystals
laminated between layers of
organic material. As the particle density increases over time,
the nanoparticles fuse into large flat crystals embedded in lay-
ers of organic material, forming “mother of pearl”.
For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/news/23596.
■ Imaging Device Draws 3D Maps of Cell CompositionsAn imaging instrument built at Colorado State University,
Fort Collins, lets scientists map cellular composition in three
dimensions. Researchers will use the tool to watch how cells
respond to new medications.
The technology’s central features are mass-spectral imaging
technology and an extreme ultraviolet laser. The laser is guid-
ed through chambers using mirrors and special lenses. In a
chamber at the far side of the spectrometer, the laser hits a
sample cell placed with the aid of a microscope.
Once the laser drills a miniscule hole in the cell, the emit-
ted charged ions are drawn into a side tube using electrostat-
ic fields. A set of special pumps
removes all air from the tube,
removing any foreign particles.
A computer program generates
the data in a color spectrum of
masses, which is then used to iden-
tify the ions’ chemical identities
and create a topographical cell
composition map.
According to the research team,
the imager supports the examination
of cells at a level 1,000 times smaller than that of a human hair.
For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/news/23600.
This image compares the differ-ence between the new “Water-in-Salt” electrolyte vs. the “Salt-in-Water” electrolyte typical of otheraqueous battery systems.
A new stretchy hydrogel can beembedded with various electron-ics. (Credit: Melanie Gonick/MIT)
The organism builds its shell fromthe inside out by depositing layersof calcium carbonate nanoparti-cles. As the particle densityincreases over time they fuse intolarge flat crystals embedded inlayers of organic materials.
A sample has to be perfectlypositioned in the instrumentto gain proper readings.
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AIntro
Medical Design Briefs, February 2016 39Free Info at http://info.hotims.com/61058-815
■ Endoscope Robotics Offer Better Way to Open AirwaysWhen a patient is critically
injured or ill, paramedics, nurses,
or doctors must open his or her
airway quickly. A laryngoscope,
invented in the late 19th century,
requires human visual guidance
to perform the procedure. A team
at The Ohio State University,
Columbus, has developed a robot
that can intubate patients quickly
and with greater accuracy.
Having just completed proof-of-concept testing, the robot-
ic endoscopic device is propelled by an electric motor and
controlled by a small computer. The device receives 3D infor-
mation about its anatomical location by means of a small
speaker placed on the skin near the patient’s Adam’s apple.
The emitted sound and magnetic waves are detected by
accelerometers and magnetic fields, respectively.
“With machine vision and automatic controls being what
they are today, it is not out of the question that a robotic
device could more accurately perform intubations than a
human,” said Mechanical Engineering Professor Emeritus
Bob Bailey.
Next steps include refining computer software, optimizing
the motor, and embarking on human tests.
For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/news/23599.
■ Calibrating EEG Machines With ‘Phantom Head’While electroencephalography (EEG) is used to measure
voltage fluctuations in the brain, “there are really no set
standards within the EEG community of how you confirm
the equipment is working the way you really think it is,” says
David Hairston, a neuroscientist at the Army Research Lab’s
Human Research and Engineering Directorate.
A lot of electrically unwanted noise is generated when the
EEG is in use. The neurons in the brain produce tiny electri-
cal voltages that the EEG detects as patterns and electrical
interference can overlay those patterns.
So the Army is building
a molded “phantom head”
containing recorded brain
waves from a human that
are played back through
wires inside the head to
sensors on the outside.
When the phantom head
is hooked up to an EEG
machine, aberrations to
the wave patterns can be
detected and electrical
interferences can be
accounted for and subtracted during testing so that a pure
EEG reading of the test subject can be made.
For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/news/23726.
Robotic intubation device indevelopment at The Ohio StateUniversity.
The image shows a phantom headand its blue mold based on a subject’sactual head.
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40 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
LED Probes to Map the Brain
Tiny LEDs light up neuralpathways.
University of MichiganAnn Arbor, MI
A team of researchers at the
University of Michigan (U-M), Ann
Arbor, are using light-emitting diodes
(LEDs) as small as neurons to begin to
unlock the secrets of neural pathways in
the brain. They have built and tested in
mice neural probes that hold what are
believed to be the smallest implantable
LEDs ever made. (See Figure 1)
The new probes, they explain, can
control and record the activity of many
individual neurons, measuring how
changes in the activity of a single neuron
can affect its neighbors. The team antic-
ipates that experiments using probes
based on their design could lead to
breakthroughs in understanding and
treating neurological diseases such as
Alzheimer’s Disease.
“This is a very big step forward,” said
Kensall Wise, the William Gould Dow
Distinguished University Professor
Emeritus, who was involved with the
research. “The fact that you can gener-
ate these optical signals on the probe, in
a living brain, opens up new doors.”
A network of around 100 billion neu-
rons power the human brain, and figur-
ing out how they work together is a mon-
umental and important task, the
researchers say.
“Hundreds of millions of people suf-
fer from neurological diseases, but treat-
ment methods and drugs are currently
very limited because scientific under-
standing of the brain is lacking,” said
Fan Wu, a postdoctoral researcher in
electrical engineering and computer sci-
ences. “We have developed a tool that is
needed to better understand how the
brain works—and why it doesn’t work—
to try to solve to these problems.”
In genetically modified rodents, neu-
rons can be turned on and off with light.
Typically, neuroscientists using this
“optogenetics” technique to shine light
on a region of the brain through
implanted optical fibers and record the
response with a second device. This
helps to reveal which regions of the
brain are responsible for which behav-
iors. But that can’t reveal how the neu-
rons communicate with one another.
These new probes can, they say.
■ How It WorksEach probe array contains 12 LEDs
and 32 electrodes. The micro LEDs are
as small as a neuron’s cell body, so they
can turn single neurons on and off.
Meanwhile, the microelectrodes meas-
ure activity at the single-neuron level,
reporting how a change in one neuron’s
behavior affects the surrounding net-
work. (See Figure 2)
“Now we can know how a group of
cells, both adjacent and farther away, are
responding to the activation of a single
cell. This will help us better understand
how these cells are communicating with
each other,” Wu said.
While the probes were made at U-M,
the experiments to demonstrate them
took place at New York University in the
lab of György Buzsáki, a leader in exper-
imental neuroscience. Eran Stark, who is
currently an assistant professor of neuro-
science at Tel Aviv University, used them
to measure how signals pass through the
brains of mice. He focused on the area
of the brain responsible for short- and
long-term memory.
“Using micro-LED probes, we may
tease out how the signals propagate
inside the neural circuitry so that we can
understand how memories are formed,
retrieved and replaced,” said Euisik
Yoon, a professor of electrical engineer-
ing and computer science at U-M and
the project leader.
The proof-of-concept experiment
found that superficial and deep neurons
in the hippocampus produce different
kinds of brain waves when stimulated.
Future experiments will explore how
these waves are related to memory.
For more information, visit www.engin.umich.edu.
Fig. 1 – Each probe is less than a tenth of a millimeter wide. (Credit: Fan Wu)
Fig. 2 – The probes contain 12 LEDs that are no larger than a neuron's cell body, along with 32electrodes. (Credit: Fan Wu)
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AIntro
First of its kind gel repairscircuits.
University of Texas, Austin, TX
A team of engineers at the Cockrell
School of Engineering at The University
of Texas at Austin have developed a
novel self-healing gel that, they say, can
repair and connect electronic circuits,
which could lead to advancements in the
development of flexible electronics,
biosensors, and batteries.
They say that although commercial
technology is moving toward lighter,
flexible, foldable, and rollable elec-
tronics, currently available circuits to
power them are not built to flex freely
and repeatedly self-repair cracks or
breaks that can happen from normal
wear and tear.
While some self-healing materials are
available, they have relied on applica-
tion of external stimuli such as light or
heat to activate repair. The university’s
“supergel” material has high conductivi-
ty as well as strong mechanical and elec-
trical self-healing properties.
“In the last decade, the self-healing
concept has been popularized by people
working on different applications, but
this is the first time it has been done with-
out external stimuli,” said Mechanical
Engineering Assistant Professor Guihua
Yu, who developed the gel.
Yu and his team combined two gels—a
self-assembling metal-ligand gel that pro-
vides self-healing properties and a poly-
mer hydrogel that is a conductor to cre-
ate the self-healing gel. (See Figure 1)
The researchers used a disc-shaped
liquid crystal molecule to enhance the
conductivity, biocompatibility, and per-
meability of their polymer hydrogel.
They say that they were able to achieve
about 10 times the conductivity of other
polymer hydrogels used in bioelectron-
ics and conventional rechargeable bat-
teries. The nanostructures that make
up the gel are the smallest structures
capable of providing efficient charge
and energy transport.
The second ingredient of the self-
healing hybrid gel is a metal-ligand
supramolecular gel. Using terpyridine
molecules to create the framework and
zinc atoms as a structural glue, the mol-
ecules form structures that are able to
self-assemble, giving it the ability to auto-
matically heal after a break.
When the supramolecular gel is intro-
duced into the polymer hydrogel, form-
ing the hybrid gel, its mechanical
strength and elasticity are enhanced.
To construct the self-healing elec-
tronic circuit, Yu believes the self-heal-
ing gel would not replace the typical
Medical Design Briefs, February 2016 41
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Making Electronics More Flexible with Self-Healing Gel
Fig. 1 – Self-repaired supergel supports its ownweight after being sliced in half.
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AIntro
www.medicaldesignbriefs.com Medical Design Briefs, February 2016
OPTICS FOR
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3D-Printed Airways Continue to SaveLivesAdditive manufacturedtracheal splints provideslife-saving support asneeded.
C.S. Mott Children’s HospitalAnn Arbor, MI
Previously, Medical Design Briefsreported on a baby boy whose life was
saved using a custom 3D-printed tra-
cheal splint, a groundbreaking proce-
dure pioneered at the University of
Michigan. He is now nearly four years
old. Since that time, a 14-year-old girl
has now joined the list of three baby
boys and one baby girl who’ve received
novel 3D-printed tracheal splints to
treat a congenital breathing condition
called tracheobronchomalasia (TBM),
which causes tracheal walls to collapse.
All five are alive and thriving, thanks to
the technology and the surgical proce-
dures that helped their collapsed air-
ways function normally.
According to researchers at the
University of Michigan who used addi-
tive manufacturing (AM) to produce
the splints in their laboratory, the first
boy’s own tissues have successfully taken
over the job of the implant, which has
been almost completely reabsorbed by
his body.
The engineering and surgical team
that designed, built, and implanted the
splints is applying for an Investigational
Device Exemption from the FDA to treat
an additional 10 patients. They are also
preparing for a larger clinical trial that
will compare the splint’s performance
against the traditional solution of keep-
ing a child with TBM on a ventilator.
According to Dr. Scott Hollister, a
Professor of Biomedical Engineering
who’s part of the design team: “We
evolved the design a bit from the very
first patient so it’s now pretty automatic
to generate an individualized splint
design and print it. The whole process
only takes about two days now instead of
three to five.”
■ How It WorksCustomizing a tracheal splint for an
individual patient must be, of necessity,
extremely precise. The University of
Michigan bioengineering team starts
with patient data from magnetic reso-
nance imaging or computed tomogra-
phy scans to determine the extent of the
defect to be repaired and the dimen-
sions of the patient’s existing anatomy.
Computer models of this anatomy are
then made from the data using com-
mercial as well as custom software to
create a model of the splint that best
addresses each defect, with circular bel-
lows for support and flexibility, and
suture holes so the surgeon can fix the
implant in place.
The tem uses polycaprolactone
(PCL) for a number of reasons. It has a
long resorption time, which is very
important for the airway application
because the implant should remain in
place for at least two years and then
resorb. It’s very ductile so if it fails, it
won’t produce particles that could
puncture tissue. And, PCL could be
readily processed for, and fabricated on,
the university’s EOS FORMIGA P 100
laser-sintering system, which it pur-
chased in 2006.
The splints are designed with a highly
compliant, porous structure of intercon-
nected spaces. The researchers say that
in the future these could potentially be
infused with biologics to enhance tissue
ingrowth and slowly expand along with
the maturing airway over time. Topology
optimization software draws each com-
plex shape with the least amount of
material possible. (See Figure 1)
Next the function of the implant is
simulated, as attached to the airway with
sutures, with nonlinear Finite Element
Analysis to ensure that it will operate
properly and stand up to years inside the
metal conductors that transport elec-
tricity, but it could be used as a soft
joint, joining other parts of the circuit.
The team is also looking into other
applications, including medical appli-
cations and energy storage, where it
holds tremendous potential to be used
within batteries to better store electri-
cal charge.
For more information, visit http://news.utexas.edu.
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AIntro
Medical Design Briefs, February 2016 43Free Info at http://info.hotims.com/61058-818
Fig. 1 – Shown is an example of a 3D-printed tracheal splint and the actualairways modeled from digital scans of the patient.
body. Finally the splint is manufactured via the school’s
FORMIGA P 100 system.
Multiples are usually made, or “grown,” of the same device,
so they can be put through quality control analysis prior to
implantation. After fabrication, the researchers measure the
splint dimensions and then mechanically test them (compres-
sion, tensile opening, and three-point bending) to confirm
that the fabricated splints meet the quantitative design outputs.
Surgery to install a splint, which wraps around the outside of
a collapsed airway, usually takes about four to eight hours,
depending on the condition of the patient and if there are
other issues that must be addressed. The splint-supported tra-
chea expands and is functional right away so that when patients
are weaned off oxygen they are able to breathe normally.
■ Other AM UsesHollister’s group is also developing craniofacial, spine, long
bone, ear, and nose scaffolds and implants—and producing
them all using AM technology solutions from EOS to laser sin-
ter a material with characteristics that promote reconstruction
and regrowth following birth defects, illnesses, or accidents.
Since tracheal splints are generally needed for fewer than
4,000 patients per year in the US, the university is seeking a
regulatory path through the FDA’s humanitarian device
exemption.
However, Hollister says, “Even if a market is relatively small, this
doesn’t diminish the human need to be treated. Our additive
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AIntro
44 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-819
manufacturing process is very efficient,
and the cost is the same whether you are
making 1 or 1,000 splints.”
His team is already investigating the
use of other 3D-printed materials. “If we
can expand the number of biomaterials
used in laser sintering, we can tackle a
tremendous amount of problems cur-
rently faced in all field of reconstructive
surgery and make enormous strides for
patients,” he says. The group has already
collaborated with EOS customer Oxford
Performance Materials (OPM) to make
a non-absorbable tracheal splint out of
PEKK material, for patients who have
already completed growing.
For more information, visit www.engin.umich.edu.
Portable Acoustic Holography Systems for TherapeuticUltrasound Sources
Lyndon B. Johnson SpaceCenter, Houston, Texas
High-intensity focused ultrasound
(HIFU) is a rapidly developing medical
technology that relies on focusing acoustic
waves to treat remote tissue sites inside the
body without damaging intervening tis-
sues. HIFU can be used to treat benign
and malignant tumors, dissolve blood
clots, enhance drug delivery to specific
sites, and ablate brain tissue causing essen-
tial tremors. While standard practices for
characterizing diagnostic ultrasound are
well established, the lack of analogous
metrology techniques for therapeutic
ultrasound remains an impediment to
broader clinical acceptance of HIFU.
Because ultrasound consists of waves,
it possesses several basic features of wave
physics that are of practical utility. In par-
ticular, it is possible to reproduce a three-
dimensional field from a two-dimension-
al distribution of the wave amplitude and
phase along some surface transverse to
the wave propagation. This principle is
widely used in optics, and the correspon-
ding process is termed “holography.” A
similar approach is possible in acoustics.
For acoustic pressure waves, amplitude
and phase can often be measured direct-
ly with a pressure sensor, and a two-
dimensional distribution of such meas-
urements represents a hologram.
The present technology relates to
portable acoustic holography systems for
therapeutic ultrasound sources, and asso-
ciated devices and methods. A method of
characterizing an ultrasound source by
acoustic holography includes the use of a
transducer geometry characteristic, a
transducer operation characteristic, and a
holography system measurement charac-
teristic. A control computer can be
instructed to determine holography meas-
urement parameters. Based on the holog-
raphy measurement parameters, the
method can include scanning a target sur-
face to obtain a hologram. Waveform
measurements at a plurality of points on
the target surface can be captured. Finally,
the method can include processing the
measurements to reconstruct at least one
characteristic of the ultrasound source.
The system can include an input device
capable of receiving inputs related to sys-
tem components and/or operational
characteristics. Inputs related to the meas-
urement apparatus can include, for exam-
ple, the size of a hydrophone sensing
region, a hydrophone bandwidth, a geom-
etry of a test tank and associated fixturing,
a liquid temperature in a test tank, and a
reference position relative to a transducer
at which a hydrophone is initially located.
These can be received as user inputs from
a storage source (e.g., a database) or
directly from system components.
The algorithm can utilize numerical
and/or experimental studies of amplitude
and phase distributions of acoustic fields
radiated by representative clinical thera-
peutic ultrasound sources. Hologram
measurements can be recorded, and subse-
quent analysis and calculations can be per-
formed. The control computer can thus
identify standard parameters for a given
arrangement of a holography system.
A signal processor can receive the
acoustic waveform data from the data
recorder and perform signal processing
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AIntro
Medical Design Briefs, February 2016 45
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Keeping Prosthetic Legs from TrippingTechnology based onhuman reflexes can aidrobotic legs.
Carnegie Mellon UniversityPittsburgh, PA
While trips and stumbles leading to
falls can be common for amputees using
leg prosthetics, a new robotic leg prosthe-
sis being developed at Carnegie Mellon
University promises to help users recover
their balance by using techniques based
on the way human legs are controlled.
Hartmut Geyer, Assistant Professor of
Robotics, explains that a control strategy
devised by studying human reflexes and
other neuromuscular control systems has
shown promise in simulation and in lab-
oratory testing, producing stable walking
gaits over uneven terrain and better
recovery from trips and shoves.
Over the next three years, as part of a
$900,000 National Robotics Initiative
study funded by the National Science
Foundation, this technology will be fur-
ther developed and tested using volun-
teers with above-the-knee amputations.
The collaborative project includes col-
leagues from the Department of Me -
chanical Engineering and Robotics, as
well as a certified prosthetist orthotist
and instructor in the Department of
Rehabilitation Science and Technology
at the University of Pittsburgh.
“Powered prostheses can help compen-
sate for missing leg muscles, but if
amputees are afraid of falling down, they
won’t use them,” Geyer said. “Today’s
prosthetics try to mimic natural leg
on the data in order to define and out-
put a measured hologram from the raw
measurements. Based on the measured
hologram, the system can utilize a con-
trol computer to generate one or more
characteristics of an ultrasound source.
A series of holograms recorded over a
range of output levels can be used to
fully characterize source output levels.
This work was done by Oleg Sapozhnikov,Michael Bailey, Peter Kaczkowski, VeraKhokhlova, and Wayne Kreider of the
University of Washington for Johnson SpaceCenter. For more information, download theTechnical Support Package (free whitepaper) at www.techbriefs.com/tsp underthe Health, Medicine, and Biotechnologycategory. MSC-26064-1
Fig. 1 – The Robotic Neuromuscular Leg 2 is acable-driven device that can help determineforce feedback testing.
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46 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-822
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motion, yet they can’t respond like a healthy human leg would
to trips, stumbles and pushes. Our work is motivated by the idea
that if we understand how humans control their limbs, we can
use those principles to control robotic limbs.”
Those principles might aid not only leg prostheses, but also
legged robots. Geyer’s latest findings apply the neuromuscular
control scheme to prosthetic legs and, in simulation, to full-size
walking robots. His observations include the role of the leg
extensor muscles, which generally work to straighten joints. He
says the force feedback from these muscles automatically
responds to ground disturbances, quickly slowing leg movement
or extending the leg further, as necessary.
Geyer’s team has evaluated the neuromuscular model by
using computer simulations and a cable-driven device about
half the size of a human leg, called the Robotic Neuromuscular
Leg 2. (See Figure 1)
The researchers found that the neuromuscular control
method can reproduce normal walking patterns and that it
effectively responds to disturbances as the leg begins to swing
forward as well as late in the swing. Powered prosthetics have
motors that can adjust the angle of the knee and ankle during
walking, allowing a more natural gait. These motors also gen-
erate force to compensate for missing muscles, making it less
physically tasking for an amputee to walk and enabling them
to move as fast as an able-bodied person.
For more information, visit www.cmu.edu/news.
Gaming Technology TakesAim at X-Rays
Xbox technology could make X-rays moreprecise.
Washington University School of MedicineSt. Louis, MO
A team of scientists at Washington University School of
Medicine in St. Louis have developed a new approach to imag-
ing patients, Based on the Microsoft Xbox gaming system, they
say that their research can produce high-quality X-rays with min-
imal radiation exposure, particularly in children who may not
be able to remain still long enough for normal X-rays to pro-
duce the clearest images.
Using proprietary software developed for the Microsoft
Kinect system, the team has adapted the hands-free technology
used for the popular gaming system to aid radiographers when
taking X-rays. The software coupled with the Kinect system can
measure thickness of body parts and check for motion, position-
ing, and the X-ray field of view immediately before imaging, said
Steven Don, MD, Associate Professor of Radiology at the univer-
sity’s Mallinckrodt Institute of Radiology. Real-time monitoring
alerts technologists to factors that could compromise image
quality. For example, “movement during an X-ray requires
retakes, thereby increasing radiation exposure,” Don said.
The technology could benefit all patients, but particularly
children because of their sensitivity to radiation and greater
variation in body sizes, which can range from premature
infants to adult-sized teenagers. Setting appropriate X-ray tech-
niques to minimize radiation exposure depends on the thick-
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AIntro
ness of the body part being imaged.
High-quality X-rays are critical in deter-
mining diagnoses and treatment plans.
Traditionally steel calipers have been
used to measure body-part thickness for
X-rays. However, calipers are “time-con-
suming, intrusive and often scary to
kids, especially those who are sick or
injured,” said Don, who is also a pedi-
atric radiologist.
“To achieve the best image quality
while minimizing radiation exposure, X-
ray technique needs to be based on
body-part thickness,” Don said. The
gaming software has an infrared sensor
to measure body-part thickness automat-
ically without patient contact.
“Additionally, we use the optical camera
to confirm the patient is properly posi-
tioned,” he explained. (See Figure 1)
Originally developed as a motion sen-
sor and voice and facial recognition
device for the Xbox gaming system,
Microsoft Kinect software allows individ-
uals to play games hands-free, or without
a standard controller. Scientists, com-
puter specialists, and other inventors
have since adapted the Xbox technology
for nongaming applications.
Don and his colleagues, for example,
combined the Microsoft Kinect 1.0 tech-
nology with proprietary software to
improve X-ray imaging.
■ Future UsesDon and his colleagues have received
funding from Washington University and
The Society for Pediatric Radiology that
they will use to continue research with
the updated Microsoft Kinect 2.0 and
seek feedback from radiological technol-
ogists to improve the software. While fur-
ther research and development are
needed, the eventual goal is to apply the
technology to new X-ray machines as well
as retrofitting older equipment.
For more information, visit https://medicine.wustl.edu.
Medical Design Briefs, February 2016 47
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Fig. 1 – The university’s research suggests thatthe Xbox gaming system could help improvemedical imaging.
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■ Quniton Highly Lubricious Material
Minnesota Rubber and
Plastics, Minneapolis, MN,
developed Quniton™ to
meet the need for a high-per-
formance lubricious product
with permanent, low coeffi-
cient of friction surface prop-
erties. It resists bonding or
sticking to a wide range of materials. Typical applications include
flow meters, syringe plugs, plunger seals, vial seals, rotary shaft and
actuator seals, and standard O-rings. MD&M West, Booth 2251For Free Info, Visit http://info.hotims.com/61058-166
■ “Bullet” Extrusion Head
Guill Tool & Engineering, West
Warwick, RI, announces The Bullet™,
a new extrusion head with fixed center
design, multi-port spiral flow design
and gum space adjustment, plus the
added feature of no fastening hard-
ware, which allows quick tooling
changes so cleaning and restart are
easier and faster than any convention-
al head currently on the market.
MD&M West, Booth 1842For Free Info, Visit http://info.hotims.com/61058-167
■ Design for Manufacturability Service
Albright Technologies, Leominster, MA,
introduces a “design for manufacturability”
service to ensure customers’ silicone part
designs will be manufacturable throughout the
product lifecycle. Albright engineers will
review customers’ designs for any changes
needed to make the part manufacturing-
friendly prior to prototyping and provide early-
stage feedback to the customer for additional
implementation. MD&M West, Booth 1083For Free Info, Visit http://info.hotims.com/61058-168
■ Disposable Liquid Flow Sensors
Sensirion AG, Staefa, Switzerland,
introduces a new series of intelligent,
compact, and cost-effective disposable
liquid flow sensors equipped with luer lock fittings
for easy integration into the fluidic line. The LD20-series
CMOSens®-based flow sensors offer fast, precise, and reliable measure-
ment of low and ultralow flow rates and are suitable for a wide range
of applications in the biomedical field. MD&M West, Booth 2282For Free Info, Visit http://info.hotims.com/61058-169
■ Flexible Printed Circuit Design Guide
Tech-Etch, Inc., Plymouth, MA, offers a
new Flexible Printed Circuit Design Guide
that describes its manufacturing capabilities,
including the ability to selectively plate a sin-
gle circuit with two different finishes, con-
toured circuits with variable metal thickness,
semi-additive and subtractive techniques to
manufacture trace patterns, BGA pad arrays,
and open window or cantilevered contact
leads, and more. MD&M West, Booth 1383For Free Info, Visit http://info.hotims.com/61058-170
■ Force Fiber OrthoTape Braid
Teleflex Medical OEM, Gurnee, IL, has
added an ultra-strong, ultra-thin tape to its
suture product line. Force Fiber®
OrthoTape™ Braid is prepared from ultra-
high molecular weight polyethylene so it is
durable, yet pliable and features a low pro-
file and broad footprint. The braid, indi-
cated for orthopedic procedures, is ideal for applications where tissue
pull-through may be a concern. MD&M West, Booth 3019For Free Info, Visit http://info.hotims.com/61058-171
■ NPV Series Miniature Pinch Valve
Clippard Instrument Laboratory, Inc.,
Cincinnati, OH, introduces the NPV Series
Miniature Pinch Valve, a solenoid-operated
device designed to open and close tubes for
controlling flow of liquids and gases.
Energizing the solenoid retracts or attracts
the plunger, which opens or closes the tube. The valves come in four
sizes with multiple pressure range options to 30 psig. MD&M West,Booth 1787
For Free Info, Visit http://info.hotims.com/61058-172
48 Medical Design Briefs, February 2016Free Info at http://info.hotims.com/61058-825
New Products & ServicesMedical Design & Manufacturing (MD&M) West, February 9-11, Anaheim, CA
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■ M 100 System for DirectMetal Laser Sintering
EOS of North America, Novi, MI, pres-
ents the EOS M 100, a new system for
Direct Metal Laser Sintering, which is an
ideal choice for those considering additive
manufacturing. With its small build vol-
ume, based on a round build platform with
a diameter of 100mm, the system focuses
on the cost-efficient production of small
quantities. MD&M West, Booth 3743For Free Info, Visit http://info.hotims.com/61058-173
■ Composite Medical Wire for Coils andMicro Coils
Anomet Products, Inc., Shrewsbury,
MA, announces custom engineered
composite medical wire that can com-
bine properties such as a high strength
interior and corrosion resistant exteri-
or. Medical Implant Wire combines
two or three metals on the interior
and exterior, which are metallurgically
bonded to achieve properties not
available in a single alloy. MD&MWest, Booth 3185
For Free Info, Visit http://info.hotims.com/61058-174
Medical Design Briefs, February 2016 49Free Info at http://info.hotims.com/61058-827
Creating Space for Your Ideas
With the World's Smallest Flow SensorSensirion consolidates incomparable accuracy, long-term stability and excellent repeatability in a tiny new device called the SDP3x – the world's smallest fl ow and differential pressure sensor. It's the perfect choice for cost-sensitive mass production, opening up new possi-bilities in integration and application.
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Free Info at http://info.hotims.com/61058-826
MD&M West Exhibitor Preview Continued
PRODUCT OF THE MONTH
■ P-Jet and P-Dot Non-Contact Dispensing Systems
Nordson EFD, East Providence,
RI, introduces a new series of pneu-
matic non-contact systems that
offer precise, repeatable micro
fluid dispensing. The P-Jet and P-
Dot valves and V100 controllers jet
low- to high-viscosity fluids with
great precision and repeatability.
They are designed for use in multi-
ple industries including medical, electronics, and aerospace.
Benefits of the P-Jet include dispensing frequencies of up to
280Hz with dispensable volume starting at 3 nL. Both the P-Jet and
P-Dot feature exchangeable nozzles and dispensing tappets to
adapt to different kinds of applications. Both are easy to use and
maintain featuring wetted parts that are separate from the actuator.
They require low voltage of 24 V and maximum fluid pressure of 87
psi to operate. In addition, the valves can be easily integrated into
production lines.
The P-Jet dispenses low- to medium-viscosity fluids such as sol-
vents, oils, greases, silicones, paints, and fluxes in beads and lines.
Common applications include filling, potting, sealing, and coat-
ing. The P-Dot dispenses higher viscosity fluids such as adhesives,
lacquers, oils, greases, silicones, and fluxes in dots, beads, and
lines. Attaching very small electronic components onto printed
circuit boards and substrates is a typical application. MD&MWest, Booth 2835
For Free Info, Visit http://info.hotims.com/61058-165
Extend The Life of Tools and Wear Surfaces Up to 1000%.
Improve and renew Micro-Electronic Tools, Surgical Instruments and Micro- Laboratory Instruments with the Hunter Carbitron 300. This simple easy-to-use process applies tungsten-carbide to tools and wear surfaces extending the life up to 1000%.
The Carbitron 300 system, consisting of an adjustable power supply and vibrating hand-tool is a heavy-duty unit incorporating the features of units selling for 5 – 10 times its low price.
Used for Tissue Forceps, Needle Holders, Micro Needle Holders, Micro Pliers etc.
Hunter Products Inc.800-524-0692
www.hunterproducts.comE-mail: [email protected]
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50 Medical Design Briefs, February 2016
MEDICALDEVICES
SUMMIT 2016
FEBRUARY 8-10, 2016
BOSTON MARRIOTTLONG WHARF,BOSTON, MA
For more information visitwww.opalgroup.net
Free Info at http://info.hotims.com/61058-828
■ Miniature Solenoid Actuated Poppet Valve
Parker Hannifin Precision Fluidics, Hollis, NH, announces the
release of its newest miniature solenoid poppet valve, the LX
Series, a latching valve based on the popular X-Valve family. The
LX significantly
increases battery
life in portable
medical devices to
provide efficient,
high performing
pneumatic on/off control in a compact 8mm size. MD&M West,Booth 2801
For Free Info, Visit http://info.hotims.com/61058-175
■ T-Port Swabbable Needleless Injection Sites
Qosina, Ronkonkoma, NY, has added three new t-port swab-
bable needleless injection sites,
available to fit 2mm, 3.1mm, or
4mm OD tubing. They feature a
swabbable luer activated female
luer lock for aspiration or injec-
tion. Made of a tinted polycar-
bonate housing and a latex-free
silicone valve, these injection
sites are EtO, and Gamma steril-
ization compatible. MD&MWest, Booth 2121
For Free Info, Visit http://info.hotims.com/61058-176
■ TomoCheck HA 200 Measuring Machine
Werth, Inc., Old Saybrook, CT,
presents the new TomoCheck® HA
200, a computed tomography
machine that provides previously
unmatched precision due to its
granite base paired with high-preci-
sion mechanics and air bearing
technology. The machine can be
configured with Werth multi-sensor technology. A patented soft-
ware process minimizes the probing deviation of the X-ray sensor.
MD&M West, Booth 3590For Free Info, Visit http://info.hotims.com/61058-177
■ SetWORX Specialty Polymers
EpoxySet Inc., Lincoln, RI, has released the SetWORXTM line
of high performance materials developed to offer non-hazardous
shipping, reducing costs
while maintaining superi-
or performance. Included
are the SetWORXTM
USEAL 15FL, a clear, abra-
sion resistant urethane
sealant, and SetWORXTM
60, a toughened epoxy
exhibiting high bond and
peel strength to metals,
ceramics, and many hard
to bond plastics. MD&MWest, Booth 939
For Free Info, Visit http://info.hotims.com/61058-178
MD&M West Exhibitor Preview Continued
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■ LSM 880 with Airyscan Microscope
Zeiss, Jena, Germany,
introduces LSM 880 with
Airyscan, a new confocal
laser scanning microscope
that offers high sensitivity,
enhanced resolution in x, y,
and z, and high image-
acquisition speed in one system. Users achieve a 1.7x higher res-
olution in all spatial dimensions, 140nm laterally and 400nm axi-
ally. MD&M West, Booth 948For Free Info, Visit http://info.hotims.com/61058-179
■ Medical Extruder Direct Drive
Davis-Standard, LLC, Pawcatuck, CT, will be demonstrating its
tight tolerance medical tubing
capabilities. The running line will
be making urethane double D
taper tube used in pediatric dialy-
sis applications. It will also feature
Davis-Standard’s signature Medical
Extruder Direct Drive extruder,
which delivers more efficient oper-
ation as well as greater materials
flexibility, a replaceable feed sec-
tion liner, interchangeable barrel assembly and a Windows® PLC
control system. MD&M West, Booth 2346For Free Info, Visit http://info.hotims.com/61058-180
■ Athlonix 22DCP Brush DC Motors
Portescap, West Chester, PA,
announces the next generation of
Athlonix™ high power density
brush DC motors. Available in a
22mm diameter, the new 22DCP
motor will feature an energy effi-
cient coreless design with an opti-
mized self-supporting coil and
magnetic circuit, which delivers
maximized power density and sustained endurance over the life
of the motor. MD&M West, Booth 1292For Free Info, Visit http://info.hotims.com/61058-181
Medical Design Briefs, February 2016 51Free Info at http://info.hotims.com/61058-830
Free Info at http://info.hotims.com/61058-829
■ Multiphysics and COMSOL Server, Version 5.2
COMSOL, Inc., Burlington, MA, has released Multiphysics® and COM-
SOL Server™ 5.2 simulation software environment, which delivers new
features, improved stability
and robustness, and faster
execution. Major upgrades
to the Application Builder
include the new Editor Tools
for easy creation of user
interface components, com-
mands for dynamic updates
of graphics, and more con-
trol over the deployment of
simulation apps.
For Free Info, Visit http://info.hotims.com/61058-183
MD&M West Exhibitor Preview Continued
Skillful Solutions For Difficult Projects
CUSTOM MEDICAL DEVICE COMPONENTS Quality Wire, Cable and Assemblies Delivered
On Time at the Lowest Achievable Cost
See us at
MD&M West,
Booth #1942
Fast Online Quotes: www.mnwire.com
See iStretch in action on our website.
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52 Medical Design Briefs, February 2016
How will your business adapt and grow?
ENDLESS OPPORTUNITIES ARE JUST OUTSIDE YOUR INDUSTRY
Connecticut Convention Center | Hartford, CT
May 3-5, 2016
The aerospace, defense (including arms) and medical device industries face similar challenges; stringent regulations, mission-critical quality control and the need for cutting-edge technology. The demand for advanced manufacturing technologies is outpacingthe traditional R&D model.
Mfg4 is the Answer!
• Attend to find creative solutions and game-changing ideas from other industries that can be applied to your specific manufacturing challenges
• Exhibit to engage with high-level buyers from diverse industries and expand your customer base into new markets
The most promising manufacturing ideas and opportunities may be just outside your industry
To register or exhibit visit mfg4event.com
Free Info at http://info.hotims.com/61058-831
■ 260 Types of Strain Gauges
HBM, Inc., Marlborough, MA, now offers a
total of 260 types of
strain gauges in stock
for immediate deliv-
ery through its
HBMshop web order-
ing tool designed to
speed up ordering. Its
online catalog, “Strain Gauges: Absolute
Precision from HBM,” provides detailed speci-
fications on the full line and identifies the types
available for immediate delivery.
For Free Info, Visit
http://info.hotims.com/61058-184
■ Copper Oxide Coated FoamHeat Sinks
Goodfellow, Coraopolis,
PA, provides microp-
orous copper foam
coated with a thin,
hard layer of copper
oxide that provides outstanding performance as
a low-profile heat sink in passive cooling envi-
ronments. Goodfellow supplies copper oxide
coated foam in thicknesses of 4mm, 5mm, and
10mm, with other sizes available upon request.
For Free Info, Visit
http://info.hotims.com/61058-182
■ Hybrid Photon CountingTechnology
DECTRIS Ltd., Chicago, IL, announces its
Hybrid Photon Counting technology based
on the newest IBEX ASIC platform for X-ray
medical imaging equipment. The IBEX ASIC
senses every single photon in an X-ray, and
provides the
flexibility of
two readout
modes: a
high-resolu-
tion mode to
detect subtle details, and a spectral one to
add color information to grey-scale radiology.
For Free Info, Visit
http://info.hotims.com/61058-186
■ BENCH ProgrammablePower Supplies
Versatile Power, Inc.,
Campbell, CA,
announces the BENCH
family of 600 watt pro-
grammable DC power
supplies. Versatile Power offers six models of
these USA-built supplies with available power
output up to 600 Watts. The BENCH pro-
grammable power supplies are available for
online purchase directly from Versatile Power
or from its nation-wide distributors.
For Free Info, Visit
http://info.hotims.com/61058-187
ew ProductsN And Services
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Medical Design Briefs, February 2016 53Free Info at http://info.hotims.com/61058-833
IWAKI AMERICA Introduces New Exmire Line of Syringe and Piston Pumps
• Dispense rates from 0.0167μl to 1 ml• Accuracy to ±0.3%, Repeatability to ±0.03%• Compact size with chemically compatible materials• Ideal for Analytical and Lab Equipment, Aspiration
and Dispense Applications
See our new Exmire pumps from Iwaki America as well as our full line of OEM pumps at the MD&M West Show in Anaheim, CA, Feb. 9-11, booth 1511.
Iwaki America – Your Premium OEM Pump Partner
Please contact Mike Ketchum at [email protected] or
call 508-745-4041 for more information
Free Info at http://info.hotims.com/61058-832
See us at PITTCONBooth #625
■ Profile Guide Rail Brakes
Nexen Group, Inc., Vadnais Heights,
MN, introduces two new models of
Profile Guide Rail Brakes, Generation
II, increasing the range of sizes to 15
mm to 65 mm. These brakes provide
fast engagement, offer maintenance-
free operation, and are fully compatible with all 16 major rail manufac-
turers, making them an ideal redundant, spring set braking system for
a wide range of OEM and after market applications.
For Free Info, Visit http://info.hotims.com/61058-188
■ 40A iAH Surface Mount DC-DC Converter
TDK-Lambda Corporation,
National City, CA, announces
the TDK-Lambda iAH series of
POL (Point of Load) non-isolat-
ed, DC-DC converters. This sur-
face-mount part has an ultra-
low profile of 10.2mm. Rated at
40A, the iAH can deliver a wide
adjustable output voltage from either a 5V or 12Vdc bus. The convert-
ers occupy just 0.69 square inches of board space.
For Free Info, Visit http://info.hotims.com/61058-189
■ Airflow Temp and Velocity Scanner
Advanced Thermal Solutions, Inc., Norwood, MA, offers the ATVS-
2020 scanner which measures airflow
temperature and velocity of inside elec-
tronic devices. The ATVS-2020 scanner
accommodates up to 32 sensors for pre-
cise, multi-point field mapping of test
domains, including housings and PCB
surfaces. The ATVS-2020 scanner con-
nects to any PC for operation.
For Free Info, Visit http://info.hotims.com/61058-190
■ Dual-Band Flexible Internal Antenna
Pulse Electronics Corp., San Diego,
CA, introduces a new internal dual-
band flexible printed circuit antenna
to provide connectivity and data trans-
mission for IoT applications in med-
ical/telemedicine, sensors, wearables,
and more. The Plume Series
W3315B0100 WiFi very compact 6 ×45mm antenna has a maximum anten-
na gain of 2dBi on the low band and 5dBi on the upper band.
For Free Info, Visit http://info.hotims.com/61058-191
■ Fluid Automation F4-5 & F4-55 Equipment
Graco, Inc., North Canton, OH, announces
the release of the Fluid Automation F4-5 & F4-
55 liquid silicone rubber (LSR) dispensing
equipment. The systems are designed to keep
the dispensing of two-component LSR consis-
tently precise, with two flow meters ensuring
the material remains on-ratio. A helical gear
and unique flow meter construction allows
the systems to measure material in extremely
small increments.
For Free Info, Visit
http://info.hotims.com/61058-185
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Free Info at http://info.hotims.com/61058-835 Free Info at http://info.hotims.com/61058-834 Free Info at http://info.hotims.com/61058-836
Free Info at http://info.hotims.com/61058-839
Free Info at http://info.hotims.com/61058-842
Free Info at http://info.hotims.com/61058-843
Free Info at http://info.hotims.com/61058-840 Free Info at http://info.hotims.com/61058-841
Free Info at http://info.hotims.com/61058-838Free Info at http://info.hotims.com/61058-837
SWABABLE BARBVALVESHalkey-Roberts needlefree swab -able Barbs are ideal for use assampling ports in biopharma-ceutical applications and aredesigned for easy assemblydirectly to tubing without the
use of a luer connector or solvents and adhesives.The Barbs are available in a 1/4 inch, a 3/16 inch,and a 1/8 inch version. www.halkeyroberts.com
Halkey-Roberts Corporation
USP CLASS VIEPOXYWITHSTANDSREPEATEDSTERILIZATIONS
Master Bond EP46HT-2Med is a two componentmedical grade epoxy for high performance struc-tural bonding and casting. It is suitable for applica-tions where resistance to temperatures from -100°Fto +500°F is required and high mechanicalstrength and chemical resistance is needed.www.masterbond.com/tds/ep46ht-2med
Master Bond
DURABLE,FLEXIBLE TUBING –GET A SAMPLESuperthane® polyurethane tub -ing handles liquids and gasesand is naturally flexible—noleachable plasticizers. It’s made
from non-toxic ingredients that conform to FDAstandards and available in both ether and ester for-mulations. The ether formulation offers protectionagainst moisture, fungi, and ultraviolet rays and isNSF-61 listed for use with potable water. Made in USA.www.newageindustries.com/sample-mdb8
NewAge® Industries, Inc.
MEDTECH LEADERSFree annual publication fromMedical Design Briefs featuresinformative articles and pro-files of leading companies innine areas of technology:Disposables, Electrical Con -nectors/Wires/Cables, Elec -tronics, Gas & Fluid Handling,Materials/Coatings/Adhesives,Motors & Motion Control,Out sourcing, Test & QualityControl, and Tubing/Extrusion.
www.medicaldesignbriefs.com/techleaders15
TRUMPF TRUDIODELASERSTRUMPF TruDiode Lasers welda wide variety of materials, lowpower 150 or 300 watt fiber deliv-ered Direct Diode laser for pro-cessing thin metals and plastics.Includes TRUMPF TruControl
1000 interface with multi-mode 150μm diameterfiber or optional 200, 300, 400, and 600 μm fibersand a NA <= 0.12. Available with 11 HU 19" rack orcomplete system with chiller in a 19" rack cabinet. [email protected]; www.medicaldesignbriefs.com/trumpf201602
TRUMPF Inc.
PRODUCT SPOTLIGHT
54 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
COMSOLMULTIPHYSICS FORSIMULATION APPDESIGNCOMSOL Multiphysics deliverstools for modeling, simulation,and application design. With the
Application Builder, simulation specialists can buildand share simulation apps within organizations,from design and development to production andtesting. See what’s new in simulation technology atcomsol.com/release/5.2
COMSOL, Inc.
MEDICALCONTRACTMANUFACTURINGSOLUTIONS
Located in West Michigan, Medbio is an ISO13485:2003 certified contract manufacturer offeringinnovative medical device manufacturing solutionsfor the Life Sciences. We specialize in plastic injec-tion molded products, assembly, packaging, anddesign support. From components to full assem-blies, Medbio has the knowledge, passion, and expe-rience to solve your most difficult manufacturingchallenges. MD&M West show — Booth #1846;www.medbioinc.com
Medbio
CLAD METAL MEDICAL WIREAnomet Products manufac-tures clad metal medical wirecombining high-strength, high-ly conductive, biocompatible,and radiopaque alloys into one
material “system” with a complete metallurgical bondbetween layers. Typical wire combinations include316LVM, Gold, MP35N, Nitinol, Palladium, Platinum,Silver, Tantalum, Titanium, and others. Customized com-posite wire solutions to meet your unique wire challenges. www.anometproducts.com/content/medical-materials.
Anomet Products
TEMP-FLEX MICROMINIATURE WIREAND CABLETemp-Flex® provides insulat-ed wire, cable, and continu-ous coils for the medicalindustry using biocompatibleinsulation materials. We can
extrude a 0.0005" wall of pin-hole-free insulation overwires finer than a human hair. It offers a tight toler-ance, high dielectric withstanding voltage, and excep-tional concentricity. In stock at Heilind; 877-711-5096;www.heilind.com/rpages/molex_tempflex_ntes
Heilind Electronics
USED LABORATORYEQUIPMENTPhotoMachining, Inc. isa contract laser manufac-turer and custom systemsbuilder. We specialize inlaser micromachining
using lasers from the far IR through the UV. Inaddition, we sell used, refurbished, and “like new”laboratory equipment including lasers, optics, opti-cal hardware, electronics, microscopes, etc. [email protected], or phone 603-882-9944.www.photomachining.com
PhotoMachining, Inc.
SCHOTT OFFERSMONOLITHICFACEPLATES FORCMOS DETECTORSAs the demands for digitalimaging applications require
faster speeds and higher dosage levels, SCHOTT hasdeveloped its Large Format Fiber Optic Faceplate asthe protective X-ray barrier for CMOS/CCD detectors.With sizes up to 430 × 430mm, SCHOTT’s 47ARH, andnew RFG-92A glasses provide excellent X-ray absorp-tion and contrast, while transmitting high resolutionimages to the detector. For downloads, go to ourmicrosite: www.us.schott.com/seemore
SCHOTT North America, Inc. –Lighting and Imaging
FREE OUTSOURCING GUIDEMedical Design Briefs’ 2015Outsourcing Guide & Dir -ectory is now online. Findqualified sour ces for con-tract design and manufacturing, pro to typing, ma c h - ining, mold ing, materials,and more. Read the fea-ture article: “ConsideringManufacturability in EarlyPhase Product Development:Successful Scalability for
Medical Device Innovation”.
www.techbriefs.com/outsource
2015 OUTSOURCING DIRECTORYYour Guide to Medical Contract Manufacturers
Considering Manufacturability inEarly Phase Product Development:
Successful Scalability for MedicalDevice Innovation
page 18
Directory of Outsourcing Services page 67
www.medicaldesignbriefs.comFrom the Publishers of
www.medicaldesignbriefs.com
2015 Technology Leaders
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Medical Design Briefs, February 2016 www.medicaldesignbriefs.com 55
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(949) 715-7779
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Air-Logic ...................................................811 ....................32
Anomet Products .......................................834 ....................54
ATI Industrial Automation.............................808 ....................27
Branson Ultrasonics Corp. .........................819 ....................44
Braxton Manufacturing Co., Inc. ..................821 ....................46
COMSOL, Inc. ...................................796, 835 ................5, 54
Edmund Optics...........................................817 ....................42
Fluid Metering, Inc. ...................................832 ....................53
GRI Pumps................................................820 ....................45
Halkey-Roberts Corporation .................801, 836 ..............15, 54
Heilind Electronics ......................................837 ....................54
Hotwatt Inc. .............................................825 ....................48
Hunter Products, Inc. ................................826 ....................49
Indium Corporation .....................................802 ....................19
Interpower Corporation ...............................799 ...................8,9
INTROTEK International ...............................814 ....................36
Iwaki America ............................................833 ....................53
John Evans’ Sons, Inc. ...............................815 ....................39
Magnetic Component Engineering, Inc. .........824 ....................47
Master Bond Inc. ..............................822, 838 ..............46, 54
maxon precision motors, Inc. ......................816 ....................41
mdi Consultants, Inc. .................................829 ....................51
Medbio, Inc. .............................................839 ....................54
Medical Devices Summit 2016 ....................828 ....................50
Mfg4 2016...............................................831 ....................52
MicroLumen Inc. .......................................850 ....................24
MICROMO.................................................813 ....................35
Minnesota Wire.........................................830 ....................51
NewAge® Industries Inc. .............................840 ....................54
Nook Industries..........................................794 ......................3
Nordson MEDICAL .....................................818 ....................43
Novotechnik...............................................823 ....................47
Okay Industries ..........................................793 ......................2
Photofabrication Engineering Inc. - PEI...........844................COV III
PhotoMachining, Inc. .................................841 ....................54
Proto Labs, Inc. ........................................798 ......................7
ROFIN-BAASEL, Inc. ...................................804 ................COV II
SCHOTT North America Inc. .......................842 ....................54
Sensirion AG .............................................827 ....................49
Smalley Steel Ring Company ........................797 ......................6
Sony Electronics.........................................809 ..............28, 29
Specialty Coating Systems, Inc. ...................846 ....................23
Statek Corporation .....................................807 ....................26
Sterigenics ................................................795 ......................4
Steute Meditech, Inc. ................................845 ...............COV IV
Technimark ...............................................792 ......................1
The Lee Company ......................................806 ....................21
TRUMPF Inc. ....................................791, 843 ..............17, 54
Ulbrich Stainless Steels & Special Metals, Inc. ....................................805 .....................20
Unimed S.A. .............................................803 ....................22
Wacker Chemical Corp. .............................800 ....................13
Watson-Marlow Fluid Technology Group.........812 ....................33
Zeus, Inc. ................................................810 ....................31
Medical Design Briefs, ISSN# 2158-561X, USPS 4865, copyright ©2016 in U.S., is publishedmonthly by Tech Briefs Media Group, an SAE International Company, 261 Fifth Avenue, Ste.1901, New York, NY 10016. The copyright information does not include the (U.S. rights to)individual tech briefs that are supplied by NASA. Editorial, sales, production, and circulationoffices are located at 261 Fifth Avenue, Suite 1901, New York, NY 10016. Subscriptions fornon-qualified subscribers in the U.S. and Puerto Rico, $75.00 for 1 year. Single copies $8.50each. Foreign Subscriptions 1 year U.S. funds $195.00. Single copies $21.75 each. Digitalcopies: $24.00. Remit by check, draft, postal, express orders or VISA, MasterCard orAmerican Express. Other remittances at sender’s risk. Address all communications for sub-scriptions or circulation to Medical Design Briefs, 261 Fifth Avenue, Suite 1901, New York, NY10016. Periodicals postage paid at New York, NY and additional mailing offices.POSTMASTER: Send address changes and cancellations to Medical Design Briefs, P.O. Box 47857, Plymouth, MN 55447.February 2016, Volume 6, Number 2.
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56 www.medicaldesignbriefs.com Medical Design Briefs, February 2016
Controlling Backlash in Mammography Systems
Medical imaging equipment, water handling systems, con-
veyors, robotic systems, and rotary and linear actuators
are among the many devices that may be fitted with electric
friction brakes to hold their loads in place when the power is
off or disrupted.
Because the inclusion of a brake has significant implications for
the entire design, especially for the determination of size and the
selection of power supply, they must be designed in from the start.
One mammography system designer learned this the hard way,
not realizing the need for a braking system until he was testing the
prototype. Fortunately, engineering support and an express fulfill-
ment program from brake manufacturer Thomson Industries,
Inc., Radford, VA, enabled him to rescue a failing design and to
meet his schedule for the original design and prototype.
■ Why Mammography Systems Need BrakesMammography devices typi-
cally use a C-arm shaped appa-
ratus in which an X-ray tube
projects downward from the
top of the C to scan the body
generating a precise blur-free
image that could reveal indi-
cations of breast cancer. A
rotating ball screw bracketed
to the tube assembly turns
slowly—usually only a few
hundred revolutions per
minute—to move the scanner
evenly across the target area.
Because the carriage must
change direction many times
in any session, any play resulting from gaps between components
affects positioning precision and image quality. This loss of
motion, commonly called backlash or backdrive, is also a poten-
tial problem when the system is at rest, when it can cause noise,
vibration, and wear. (See Figure 1)
Electric brakes help control the backlash while the system is at
rest and help bring things to a smooth stop if there is sudden loss
of power from motor failure, power outage, or other event. Loss
of electric power de-energizes the brake linings to grip a rotating
plate, stopping it from turning or holding it in place once it is at
rest. Re-energizing the system disengages the brake, allowing the
shaft to rotate freely once again. However, the designer of the
device in this particular case study did not discover the need for
such a braking system until it was almost too late. (See Figure 2)
■ Tight SpecificationsNot considering the need for a braking system, the original
motion control component design called for the following
specifications:
• Backlash less than 0.5 degrees
• 2 Nm of holding torque
• Maximum diameter of 2 inches
• Voltage range: 16 VDC to 32 VDC range
• Ability to withstand 500 emergency stops
• Ability to operate in a radiation environment
When the designer discovered the
need for the brake, he also realized that
these specifications would limit brake
options. Further, given the requirement to
adhere to original production schedules, he
needed to move quickly, adding further
urgency to the situation.
■ Meeting the SpecAn Internet search led him to
Thomson whose brake line could be customized to meet all
technical specifications. The company was also able to ship a
custom-designed brake for prototyping within two days.
Thomson supplied a series spring set friction brake that met all
of the designer’s requirements, including:
• Low backlash: Precision machining helped meet the backlash
requirement. Play is all but undetectable when the system is at
rest due to the tightly machined tolerances of the spline design.
• Torque density: In most cases, the available 2" × 1.2" available
space would have limited the torque to around 10 inch
pounds (approximately 1 Nm). The Deltran brake, however,
provided 18 inch pounds (approximately 2 Nm). The
increased torque density is the result of a high performance
solenoid, which can overcome stronger spring force, and the
use of a proprietary high-coefficient of friction brake pad.
• Power: The 24 VDC fell well within the 16 to 32 VDC available.
• Emergency stopping: The proprietary friction brake pad enables
absorption of more than 500 hundred emergency stops.
• Radiation protection: The requirement was accomplished by
expert adjustment of the lead wires.
After finalizing all of the requirements with customer service
and product specialists, which included a customer/supplier
system data exchange confirming that the brake was fully capa-
ble of handling 500 emergency stops, the supplier was able to
ship a system for prototyping within 24 hours.
■ Prototype to Full ProductionThe prototype system had all the necessary adjustments other
than the lead wire for radiation protection. This did not interfere
with the initial prototyping and was completed the following week.
In six weeks, Thomson shipped 20 final systems, to be used in the
production of the first 20 mammography systems. The program is
now in full production, with the manufacturer shipping about 300
systems per month. Plans are also underway for modified brake
designs that will meet European power requirements as well.
This case study has a happy ending. If the design engineer
and his purchase team had not collaborated with the applica-
tion engineering team on a brake solution, it could have had a
very different outcome. The engineer might have had to make
major design adjustments, which would have delayed time to
market further and required additional budget. Additional
resources may have needed to be invested to modify the initial
design. All of these outcomes would have resulted in dealing
with “backlash” of a different sort.
This article as written by John Pieri, Sr. Product Line Manager,Thomson Industries Inc., Radford, VA. For more information, visithttp://info.hotims.com/61058-164.
Fig. 1 – Clutch brakes are used inmedical equipment like mammogra-phy machines as holding brakes toconsistently hold a load in positionat a specific stopping point.
Fig. 2 – A spring-setelectromagnetic power-off brake system.
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Free Info at http://info.hotims.com/61058-844Free Info at http://info.hotims.com/61058-844
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AIntro
As an OEM, you know that a product designed for the medical market is fundamentally different for one intended for industrial-commercial use. This is also true for the foot switch.
Critical design factors, typically not considered for non-medical applications, include:
• Weight
• Sealing
• Aesthetics
• Storage
Steute has satisfied medical device OEMs’ unique needs with thousands of application-specific foot controls… each functionally, ergonomically and aesthetically optimized to the OEM’s requirements. Most with no engineering design or tooling costs.
Contact us for a no-obligation design consultation, or to discuss receiving a complimentary sample for evaluation.
• Usability
• Cleaning needs
• Stability-in-use
• Tactile feel
Why compromise your medical device with an “industrial-grade”
foot switch ...
when you can offer your customers the benefits of a “medical-grade” design?
Examination Chair Positioning Control
Surgical Navigation Control
Electrosurgical Generator Control
www.steutemeditech.com [email protected](203) 244-6302
See us atAAOSBooth 1464
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