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Welcome to

your Digital Edition of

Medical Design Briefs

February 2016

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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




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From the Publishers of

www.medicaldesignbriefs.com February 2016







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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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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

[email protected]


From the Editor

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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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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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“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


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.


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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.


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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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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-



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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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

Unimed SALausanne, Switzerlandphone +41 21 624 21 51 fax +41 21 624 53 32 www.unimed.che-mail: [email protected]

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medical devicesneedles and probes



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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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


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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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


Fig. 3 – Shoe insole utilizing a force sensor tohelp assess balance issues in patients.

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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.


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



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-


Fig. 2 – This diaphragm valve is dispensing low-viscosity fluid onto a heart pump component.

9 Tough Questions

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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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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



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.


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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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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■ 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.


■ 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”.


■ 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.


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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■ 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.


■ 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.


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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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


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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


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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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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



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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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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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.


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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


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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



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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


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.

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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


■ 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


■ 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


■ 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



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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



■ 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.



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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.

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■ 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.



■ 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.



■ 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.



ew ProductsN And Services

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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


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.


■ 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.


■ 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.


■ 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.


■ 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.



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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/61058-840 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


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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ADVERTISERS INDEXFor free product literature, enter advertisers’ reader

service numbers at www.techbriefs.com/rs, or visit the

Web site beneath their ad in this issue.

Reader ServiceCompany Number Page

Publisher ....................................................................Joseph T. Pramberger

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(908) 300-2538

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(908) 300-2539

Editorial Director ........................................................................Linda L. Bell

Editor .....................................................................................Beth G. Sisk

Managing Editor, Tech Briefs TV.................................................Kendra Smith

Production Manager .............................................................Adam Santiago

Assistant Production Manager.................................................Kevin Coltrinari

Creative Director ......................................................................Lois Erlacher

Senior Designer ...................................................................Ayinde Frederick

Marketing Director...............................................................Debora Rothwell

Marketing Communications Manager ...........................................Monica Bond

Digital Marketing Coordinator .................................................Kaitlyn Sommer

Audience Development/Circulation Director .........................Marilyn Samuelsen

Audience Development Coordinator............................................Stacey Nelson

Subscription Changes/Cancellations [email protected]

TECH BRIEFS MEDIA GROUP, AN SAE INTERNATIONAL COMPANY

261 Fifth Avenue, Suite 1901, New York, NY 10016

(212) 490-3999 FAX (646) 829-0800

Chief Executive Officer ..................................................Domenic A. Mucchetti

Executive Vice-President .........................................................Luke Schnirring

Technology Director ................................................................Oliver Rockwell

Systems Administrator ..............................................................Vlad Gladoun

Web Developer........................................................................Karina Carter

Digital Media Manager ............................................................................Peter Bonavita

Digital Media Assistants ..................................Keith McKellar, Peter Weiland,

......................................................................Anel Guerrero, Maria Sevilla

Digital Media Audience Coordinator.............................................Jamil Barrett

Credit/Collection ......................................................................Felecia Lahey

Accounting/Human Resources Manager ......................................Sylvia Bonilla

Office Manager.....................................................................Alfredo Vasquez

Receptionist ..............................................................Elizabeth Brache-Torres

MEDICAL DESIGN BRIEFS ADVERTISING ACCOUNT EXECUTIVES

MA, NH, ME, VT, RI, Eastern Canada.............................................Ed Marecki

.........................................................................................Tatiana Marshall

(401) 351-0274

CT.......................................................................................Stan Greenfield

(203) 938-2418

MI, IN, WI..............................................................................Chris Kennedy

(847) 498-4520 ext. 3008

NJ, PA, DE...............................................................................John Murray

(973) 409-4685

Southeast, TX ...........................................................................Ray Tompkins

(281) 313-1004

NY, OH..................................................................................Ryan Beckman

(973) 409-4687

MN, ND, SD, IL, KY, MO, KS, IA, NE, Central Canada .......................Bob Casey

(847) 223-5225

Northwest, N. Calif., Western Canada.........................................Craig Pitcher

(408) 778-0300

CO, UT, MT, WY, ID, NM .............................................................Tim Powers

(973) 409-4762

S. Calif., AZ, NV ............................................................................Tom Boris

(949) 715-7779

Europe — Central & Eastern.......................................................Joseph Heeg

49-621-841-5702

Sven Anacker

49-202-27169-11

Europe — Western......................................................................Chris Shaw

44-1270-522130

Integrated Media Specialists.....................................................Patrick Harvey

(973) 409-4686

Angelo Danza

(973) 874-0271

Scott Williams

(973) 545-2464

Rick Rosenberg

(973) 545-2565

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(973) 545-2566

Reprints .....................................................................................Jill Kaletha

(866) 879-9144, ext. 168

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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mailto:[email protected]













































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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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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