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Welcome to

your Digital Edition of

Medical Design Briefs

February 2017

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From the Publishers of

www.medicaldesignbriefs.com February 2017

2017: Project ManagementTrends to Follow

Hi-QE Photocathodes forMedical Diagnostics

Ultrafast Lasers forMedical Manufacturing

Managing Risk for Li-IonBatteries

Specialty Polymers forToday’s Market

Sealing the Next Generation of Insulin Delivery Devices






As an OEM, you know that a product designed for the medical market is fundamentally

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Examination Chair Positioning Control

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SILPURAN®

High purity silicone elastomers for devices in and outside the operating room, such as insulin pumps, enteral feeding, catheters and tubing.

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U VC LE DS AC C E LE R AT E I N N OVAT IO N S I N DISI N F E C T IO N

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4 Medical Design Briefs, February 2017Free Info at http://info.hotims.com/65848-855

■ COLUMN

6 From the Editor

■ FEATURES

10 High-Quantum Efficiency Photocathodes for Medical Diagnostics

16 Ultrafast Lasers for Medical Manufacturing

20 Quality Assurance: Risk Mitigation for Lithium-IonBattery Packs

24 Medical Plastics: Meeting Today’s ChangingRequirements

28 Advanced Sealing Technology Enables the NextGeneration of Insulin Delivery Devices

31 Project Management: Four Trends to Follow in 2017

■ TECH BRIEFS

36 New Graphene-Based System Could Help ‘See’Electrical Signaling in Heart and Nerve Cells

39 ‘Liquid Biopsy’ Chip Detects Metastatic Cancer Cellsin a Drop of Blood

40 Advanced Mobility Aid Addresses Failings of Current Devices

41 Hydrogel Dressing Could Eliminate TraditionalBandages for Burns

43 Bionic Wheelchair Breaks New Barriers

■ DEPARTMENTS

34 R&D Roundup

46 New Products & Services

53 Advertisers Index

54 Global Innovations

■ ON THE COVER

People confined to a wheelchair are still confrontedwith insurmountable obstacles in everyday life —even in today’s more wheelchair-accessible society.While there are already wheelchairs that can climbstairs, persons with physical disabilities still requireassistance to prevent them from tipping over.Researchers at the Technical University of Munich(TUM) have now developed a stairclimbing wheel-chair with the ability to stabilize itself. To learn moreabout this bionic wheelchair of the future, pleaseread the article on page 43.

(Image courtesy of Uli Benz/TUM)

February 2017

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MULTIPHYSICS FOR EVERYONE

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Medical Device Tax: Goodbye andGood Riddance

When the controversial medical deviceexcise tax was introduced more than sevenyears ago as part of the Affordable CareAct, industry criticized it as a “jobs killer”and predicted that such a tax would essen-tially wipe out investment in R&D.

Now with a new administration usher-ing in a more favorable political environ-ment, Congressman Erik Paulsen (MN)has introduced the “Protect Medical

Innovation Act,” which would perma-nently repeal the burdensome 2.3 per-cent medical device excise tax. The Actwas introduced with broad bipartisansupport and 221 cosponsors.

In the 114th Congress, a two-year sus-pension of the medical device tax passedin both the House and the Senate withbipartisan support and was signed by thePresident.

“As we predicted, the temporary sus-pension of the tax has led medical tech-

nology companies to reinvest funds thatwould have gone into new R&D, infra-structure improvements, and new hiring,”says Scott Whitaker, president and CEOAdvaMed. “With the suspension set toexpire in 2017, for these benefits to con-tinue for the long term, companies needthe certainty of permanent repeal to sup-port future job growth and sustainableR&D investment.” Whitaker says a perma-nent repeal will help ensure a strongpipeline of continued medical innovationfor patients worldwide.

Medtech companies are leveragingthe 2015 suspension of the medicaldevice excise tax to expand their busi-nesses and investments, according to anew survey from AdvaMed.

The study explored various impactsfrom the tax’s suspension — from jobretention and creation to elevated R&Dinfusions — and suggests a broad rangeof strong economic activity. Industryanalysts believe, however, greater eco-nomic growth would occur with perma-nent device tax repeal.

“Our members are bullish on futureindustry growth and job creation, asthese numbers indicate,” says Whitaker.“But the one factor that concerns everymanufacturer — both large and small —is the continued uncertainty regardingthe medical device tax. With congres-sional action now, we can take the neces-sary steps to give this economy the shotin the arm it really needs.”

“The current suspension of the tax hasallowed medical technology companiesto reinvest funds into new R&D, restartdelayed projects, build infrastructure,and support new hiring,” says JC Scott,senior executive vice president, govern-ment affairs at Advamed. “The soonerthis onerous tax is gone for good, thesooner these benefits can be made per-manent. That’s crucial for patients andfor continued medical innovation.”

Paulsen says repealing the tax protectsAmerican manufacturing, spurs innova-tion, and ensures that the latest and bestmedical technology is affordable forpatients. “We are already seeing newAmerican jobs and increased investmentin research and development as a resultof the temporary suspension of this tax.With overwhelming bipartisan supportin the past, permanent repeal should bea top priority for Congress.”

Sherrie TriggEditor and Director of Medical Content

6 Medical Design Briefs, February 2017

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8 www.medicaldesignbriefs.com Medical Design Briefs, February 2017

Sponsored Content

Eurofins Scientific (Brussels) may be an unfamiliar company to many U.S. device manufacturers —but maybe not for long. Eurofins is an international laboratory services company that provides anarray of testing services, annually performing more than 150 million tests to establish the safety, com-position, traceability, and purity of chemical and biological substances, components, and manufac-tured products. The company’s network of more than 250 laboratories in 39 countries includes a newbusiness unit — Eurofins Medical Device Testing — that has already become an emerging force in life-cycle testing for medical products worldwide. To find out more about the expertise that Eurofinsbrings to this area, and the company’s plans for expansion into the United States, Medical DesignBriefs recently spoke with Christopher Scott, vice president of Eurofins Medical Device Testing.

I N S I D E S T O RY

MDB: In Europe, Eurofins laboratorieshave performed analytical testing fora wide range of industries. How hasthis experience contributed to thecompany’s acknowledged expertise intesting for life sciences companies?

Scott: The core competencies thatEurofins has demonstrated in support-

ing these other industries provide a strong basis for its increas-ing focus on medical device testing. With more than 120 experi-enced PhDs specializing in bioengineering, chemistry, microbi-ology, and toxicology across 16 facilities, each of our laborato-ries contributes an element of technical expertise and capabili-ty that strengthens the overall network, and in-depth knowl-edge of the local operating and regulatory environments spe-cific to the medical device industry.

MDB: What opportunities led Eurofins to launch its newbusiness unit focused on medical devices, and why was theUnited States selected for its headquarters?

Scott: The device industry is becoming more global. For exam-ple, a device company based in the United States might manu-facture its product in Asia, and seek CE marking in Europe. Inorder to address logistical and local regulatory considerations,clients require a qualified testing partner that operates in all ofthose regions. With many of the world’s largest device manufac-turers located in the United States, it was a logical decision toheadquarter Eurofins Medical Device Testing at our state-of-the-art 71-acre campus in Lancaster, PA.

MDB: What types of testing services offered by Eurofins willbe most in demand by medical device manufacturers?

Scott: FDA recognizes more than 1,000 consensus standards asrelevant to medical devices, with some standards comprisingwell over a dozen individual tests. Additionally, innovative prod-uct designs require many customized test methods. With corestrengths in analytical chemistry, biocompatibility, mechanicaland electrical testing, and microbiology, Eurofins is uniquelycapable of addressing a wide range of needs for this industry.

MDB: Let’s talk about a few of these areas in more detail.Physiochemical analyses are often a company’s first line ofdefense against improperly formulated materials and compo-nents. What kinds of tests does Eurofins perform in this area?

Scott: Eurofins Medical Device Testing can perform the full rangeof ASTM, ISO, and USP tests to thoroughly characterize the phys-iochemical properties of a raw material or finished device. Thesetests are necessary for meeting the verification requirements fora new product design, including assessments of the effects ofsterilization techniques, long-term aging, and in vivo stability.This type of testing is also relevant for qualifying new raw mate-rials suppliers, or for ongoing product release testing.

MDB: Biocompatibility has always been a major concern formedical products — and especially for implantable devices.What kinds of services does Eurofins offer in this area, andwhat kinds of testing are involved?

Scott: As described in the series of standards for the biologicalevaluation of medical devices compiled by the InternationalOrganization for Standardization (ISO 10993), the general work-flow for biocompatibility begins with a full chemical characteri-zation, including extractables and leachables testing, followedby a toxicological risk assessment to determine what additionalanimal testing may be necessary.

MDB: For many types of devices, including implantables,microbiology and sterility testing are essential for productrelease. But validation of package integrity for maintainingsterility is just as important. What types of testing doesEurofins perform in these areas?

Scott: The connection between package and sterility testing iscritical when validating any device that is shipped sterile to theend-user. Confirmation of appropriate dosing for a terminallysterilized product must be combined with a robust testing pro-gram to ensure that the packaging design will enable the prod-uct to survive the rigors of the entire distribution chain with itssterile barrier intact.

Eurofins has a state-of-the-art package testing facility capableof assessing the entire range of packaging, from primary ster-ile-seal integrity through full pallet-level transit testing, andintegrity testing for unique device identifier labeling.Additionally, with nearly 200,000 ft3 of continuously monitoredenvironmental chambers, we offer tremendous capacity foraccelerated and real-time shelf-life studies.

To find out more about Eurofins Medical Device Testing, visit thefull-length version of this interview, available online atwww.medicaldesignbriefs.com/InsideStory0217.

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Detection of a single photon is arequirement for many research

and medical applications, such asfluorescence imaging, single mole-cule imaging, and luminescenceapplications. The sensitivityrequired for single photon detec-tion has traditionally been providedby a photon amplification tube,such as an image intensifier, amicrochannel plate photomultipliertube (MCP PMTs), or a hybrid pho-todiode. Improvements to both thequantum efficiency (QE) of thephotocathode and dark count rate(DCR), as well as some other fac-tors, can improve both sensitivityand performance of any photonamplification tube, in turn improv-ing the sensitivity of medical diag-nostic imaging equipment.

Improvements to the sensitivityand performance of photon amplifi-cation tubes has largely beenfocused on the MCP includingreducing pore sizes (as small as 2μm), using a chevron or Z stack configu-ration, or by using larger surface areas inan effort to improve resolution oracquire more photons.

Yet the properties of the photocath-ode (QE, DCR, response rate) definethe quality of the detector. The photondetection probability is mainly definedby the QE, while the noise contributionis usually dominated by thermionicemission from the photocathode.Indeed, these thermionic electrons areamplified in the same manner as thephotoelectrons, which often makes itimpossible to separate dark counts fromsingle photon events. Although the pho-tocathode is a critical component to suc-cessful extreme low light imaging, signif-icant technological advancements in thisarea have largely been missing to date.

Traditionally, S20 photocathodesdetect spectral ranges spanning fromultraviolet (UV) through green. The QE

of these photocathodes is typicallyaround 20 percent and the dark count isgenerally low as well. When trying todetect low intensity signals, photoncounters are used to amplify the output.Because photon detection probability ismainly defined by the QE of the photo-cathodes, it is critical that this property ismaximized as much as possible.

Many researchers in medical diagnos-tic applications are primarily concernedwith very narrow spectral responseranges, focusing on UV, blue, green,red, or IR in order to ensure that theyare using the highest QE available fortheir application. Once the photocath-ode is chosen, other factors such as reso-lution, timing, and dark count rates arebalanced to select a photon amplifica-tion tube to most closely match therequirements of the spectra being exam-ined. In this manner, they can be suretheir results are as accurate as possible.

Higher QE ValuesHigh quantum efficiency (Hi-QE)

photocathodes increase the QE of thedetector by as much as 50 percent.These Hi-QE photocathodes, developedby Photonis, were grown on a fused silicainput window, which has a high-energycutoff at 170 nm. In addition to thehigher QE values, these photocathodeshave extremely low dark rates (typically30 cts/cm2) and a response time below50 ps. This represents an improvementof more than 10X.

The Hi-QE series of photocathodesare offered in three distinct types includ-ing UV, blue, or green options with eachspecific range showing overall improve-ments when compared to the broaderspectral response range of the S20 pho-tocathode (See Figure 1)

All testing presented here was doneusing an MCP-PMT with a dual-MCPchevron configuration. Improvements

Fig. 1 – Quantum efficiency spectra for newly developed Hi-QE photocathodes: Hi-QE UV (dark blue), Hi-QEblue (light blue), and Hi-QE green (green) in comparison with a conventional S-20 photocathode (CNV S-20, dashed red).

High-Quantum EfficiencyPhotocathodes forMedical Diagnostics

High-Quantum EfficiencyPhotocathodes forMedical Diagnostics

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to the photocathode were based on astandard S20 to increase spectralresponse in specific ranges. The newHi-QE photocathodes were thenassembled into the detector for quan-tification. Each Hi-QE photocathodewas optimized to peak across a narrow-er spectral range than the traditionalS20 photocathode.

Hi-QE UV photocathodes are opti-mized for the UV range with a maximum QE at 270 nm of typically31–34 percent. These photocathodes can also be grown on specially pre-pared sapphire cathode substratesallowing extension of the sensitivityspectral range down to 150 nm (not shown here).

Hi-QE blue photocath-odes were designed to pro-vide the highest QE in the260–410 nm spectral range.The QE spectrum shows abroad plateau in this range,again with a typical QEabove 30 percent. Thedecrease of QE below 260nm (compared with Hi-QEUV) is the trade-off forhigh sensitivity in bluespectral range.

Hi-QE green photocath-odes demonstrate a veryhigh QE value above 30percent in the range of390–480 nm. At 500 nmthe QE is still about 25 per-cent. Comparing withother Hi-QE photocath-odes, the sensitivity of Hi-QE green is much higherat a longer wavelength upto 700 nm. It is importantto note that despite highsensitivity at high wave-length, the dark rate ofthese photocathodes staysextremely low (the same asother Hi-QE cathodes),which makes Hi-QE greenunique for photon count-ing in this spectral range.

Low Dark Rate CountsWhen monitoring the

DCR of low-rate single pho-tons, it is critical that thedark rate is kept as close tozero as possible. HighDCRs often interfere withthe accurate identificationof a single photon event,which can result in false-positive tests in medicalimaging applications. Inorder to test the perform-ance of the Hi-QE photo-cathode, it was comparedto the evolution of thestandard S20 cathode.Figure 2 shows the dark

rate versus time at room temperature(23 °C) for a standard S20 and the Hi-QE blue S20 photocathode. It wasobserved that an extremely low darkrate of <30 cts/cm2 can be achievedwith the Hi-QE series photocathodes.

Figure 2 illustrates that it takes about2–3 hours to reach the low-rateplateau. The high dark rate measured

Fig. 3 – Pulse height distribution recorded with Photonis dual MCP-PMT and Hi-QE photocathode with single photonillumination (blue). The Gaussian curve (black) is a fit to experimental results.

Fig. 2 – After 10 minutes in the dark, the dark count rate drops below 50 Hz/cm2. Tests indicate that all Hi-QES20 series photocathodes (UV, blue, green) behave similarly and exhibit nearly the same values of dark count rate.

High-Quantum Efficiency Photocathodes

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at the beginning is believed to origi-nate from population by ambient lightof long-living surface and bulk states,lying above Fermi level. It takes time todischarge these states, with a decaytime also an important criterion of thedetector performance. For Hi-QE pho-tocathodes, the growing process wasadjusted to keep a low dark rate and toensure quick discharge of surface andbulk states.

The pulse height distribution (PHD)demonstrates the sensitivity and noise ofa detector. The PHD was recorded usinga charge sensitive preamplifier CSP10(1.4 V/pC), a shaping amplifier CSA4(gain = 10, shaping time of 250 ns), anda multichannel analyzer MCA3 (scale =0.89 mV/chn). The threshold was set at32 chn. For the dark-rate measure-ments, as presented above, the tubeswere placed into dark conditions, theMCP voltages were set to obtain a gainof 1-2E05, and the count rates versustime were measured. Figure 3 presents aPHD obtained using a dual MCP-PMTwith a Hi-QE photocathode, illustratingthe ability for single photoelectrondetection.

The PHD shown in Figure 3 was meas-ured with low input background light illu-mination, keeping the count rate below afew hundred hertz. The MCP voltage of1625 V (for dual MCP) yields electrongain of 1.1 × 105. The DCR originatingfrom the photocathode was approximate-ly 30 Hz/cm2, while the MCP contribu-tion was negligible at <0.2 Hz.

In the resulting PHD (blue curve), thepeak is well separated, with a low-energyvalley and noise below the threshold.The peak is described well by a Gaussiandistribution (solid black curve). Thegain point (G) corresponds to the meanenergy of the PHD and is just slightlyabove the position of the PHD peak.Both the peak-to-valley (P/V) ratio andthe full width half maximum-to-gain(W/G) ratio are typically used to charac-terize photon counting detectors. Herethe measured values are P/V ≈ 6 andW/G ≈ 0.86, which are the best availablefor dual MCP-PMTs.

ConclusionAs previously discussed, photon ampli-

fication tubes (image intensifiers, MCP-PMTs, and hybrid photodiodes) are

used across a wide variety of scientificapplications ranging from physicsresearch to medical imaging. In manycases, these tubes are combined withemerging and evolving technologiessuch as electron multiplying charge cou-pled device (EMCCD) or scientificCMOS (sCMOS). While traditional pho-ton amplification tubes have improvedover time, much of the improvementfocused on the MCP or the externaldiagnostic processing.

By developing the new Hi-QE photo-cathode, Photonis has increased the QEby 50 percent while reducing the darkcount by a factor of more than 10. It wasdetermined that extremely low DCRs,down to 30 cts/cm2 and a quickresponse time, well below 100 ps, makethese Hi-QE photocathodes ideal forphoton counting devices. When thesefactors are combined, sensitivity is great-ly increased, which could mean the dif-ference between a false-positive or adefinitive diagnosis.

This article was written by Dmitry Orlov,applications engineer at Photonis NetherlandsB.V. For more information, visit http://info.hotims.com/65848-161.

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Ultrafast or ultrashort pulse lasersoffer unique material processing

possibilities, because the laser’s pulseduration is less than the target material’sconduction time. Essentially this meansthat cold machining of parts is possible— with material being removed by subli-mation. This vaporization machiningmethod offers advantages that simplycannot be produced by any otherprocesses, including near zero heataffect; minimal burring and debris,which reduces or eliminates post pro-cessing; high-dimensional accuracy; andthe ability to produce high-quality smallfeatures in metals, plastics, ceramic, andglass. However, these systems are expen-sive, so the laser and system choice mustbe carefully considered.

Like so many other laser technologies,the ultrafast laser came to life in aresearch lab. However, it was not longbefore the ultrafast laser’s pulse dura-tion (significantly shorter than commer-cially available nanosecond lasers),drove interest in its use for microma-chining and material processing. Theability to process almost any materialwith almost no heat signature offered aunique manufacturing tool that enablesproduct innovation and development.In some cases, it even results in costreduction.

Picosecond vs. FemtosecondLasers

Ultrafast lasers are divided into twomain categories. A picosecond (PS)laser emits optical pulses with a pulseduration around 10 picoseconds —just over one trillionth (10–12) of asecond, or one millionth of amicrosecond. A femtosecond (FS)laser emits pulses that are one around400 femtoseconds, less than one tril-lionth of a second in duration.

It is worth noting that the term ultra-fast does not refer to the materialremoval rate. In fact, quite the oppositeis true, which is why these lasers excel atprocessing material thicknesses of less

than 0.01 in. (250 μm). Thicker materi-als can be processed, but if so, one mustconsider cycle time more closely.

The processing differences betweenPS and FS lasers can in some instancesbe subtle and in others very apparent.When used to process metals, the differ-ence is subtle; the FS laser offers zerotopside burr with slightly better definedfeatures and lower surface roughness.The FS laser can also process a greaterrange of plastics. PS lasers typicallyrequire green or ultraviolet (UV) wave-lengths to process plastics effectively.Quality comparison between PS and FSis material dependent. When theabsolute best quality is needed, FS is theclear choice. However, PS lasers tend tomachine faster, so the questionbecomes, “How good is good enough forthe process?”

Understanding which laser works bestfor the application can only be deter-mined through parts testing. As part ofdefining the application and system,

Amada Miyachi America typically runssamples on both FS and PS lasers and onmultiple wavelengths for both lasers, asneeded.

Analysis of the process quality,removal rates, and cycle time all needto be weighed carefully between thetwo lasers. The typical price of an ultra-short pulse system is in the range of$400,000 and above. So, beforeembarking down that road, usersshould clearly understand their returnon investment so that they can justifythe investment in terms of cost reduc-tion, unique processing capabilities, or,in many cases, both. The final decisionon which one to select is made after aniterative process, which usuallyincludes a number of short runs ofparts. Figure 1 compares PS and FSlasers machining a 100 -μm -wide chan-nel in metal. Using a similar materialremoval method and cycle time, the FSlaser produces cleaner edges and asmoother base.

Fig. 1 – A comparison of picosecond (PS) and femtosecond (FS) lasers machining a 100 μm widechannel in metal. Using a similar material removal method and cycle time, the FS laser producescleaner edges and a smoother base.


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Ultrafast Wavelength Choices Both PS and FS lasers offer wave-

length choices of infrared (IR), green(GR), and UV. Certain wavelengths workbest for specific materials and/or onecan also select the wavelength based ona particular feature size required. Thesmallest focus spot size achievable isdirectly related to the wavelength.Therefore, if all things are equal, a UVlaser will focus to a spot size one-thirdthe diameter of an IR laser. In this arti-cle, the wavelength is referred to byname (IR) rather by wavelength number(1030 nm), since different laser tech-nologies operate at slightly differentwavelengths.

Each of the FS and PS lasers can beoffered with multiple wavelengths avail-able from a single laser. This option istypically used more for research anddevelopment rather than productionsystems, where single wavelength point-of-use machines are used for a specificmaterial and process. Examples ofwhere different wavelengths matterincludes picosecond IR for glass cuttingand picosecond GR for medical plasticslike PEBAX.

The use and argument for differentwavelengths matched to different mate-rials is less obvious for FS lasers. Manypeople originally thought that the nor-mal absorption dependency to wave-length would no longer apply with sucha short pulse duration, and that “multi-photon absorption” would dominate.This has not proven to be the case forcertain plastics — polymer stents are agood example. Not only is the process-ing quality and cutting speed betterusing FS GR, but the processing windowis also larger using green compared withIR. When machining small or blind fea-tures on plastics down to the micronlevel, the green wavelength can providea more stable process.

Figure 2 shows a comparison of blind

drilling polyethylene terephthalate(PET) with picosecond IR (left) andpicosecond UV (right). Processing timeis the same; hole depth is three timesbetter for picosecond UV, with less char-ring. The only reason to select a differ-ent wavelength for both PS and FS laserprocessing of metals would be for fea-ture size. From a processing perspective,there is little difference between IR, GR,and UV. Table 1 provides a generaloverview of the best wavelength choicefor particular materials.

Integration of Ultrafast Lasers The key feature of the ultrafast laser is

its ability to process material to highdimensional accuracy. Therefore, thefirst system requirement is to supportthat level of precision. However, all thebest hardware in the world will not pro-vide a stable system if the environmentin which the system is placed is not sta-ble — specifically for temperature vari-ance. In the world of microns of preci-sion, temperature variance beyond a fewdegrees will cause issues, not only to fix-tures and stages, but also to the laser’spointing stability. For example, each ºCdegree of temperature change wouldchange a 12-in. (300 mm) length of alu-minum by 0.0003 in. (7 μm). Therefore,the machines need to be housed in awell-controlled and air conditionedspace.

An ultrafast laser system is composedof several elements: the laser, an opticalpath to deliver the laser to the focusingoptics, focus optics, motion, vision,debris control, and tooling. Each mustbe carefully considered as part of theoptimal system solution.

The laser is guided to the focusingoptics using mirrors and a variablebeam expander, which provides flexibil-ity in changing the beam diameterentering the focus optics and thereforethe size of the focus spot. There are two

reasons this is needed. First, eachlaser’s output is a little different, sounless the process was qualified withthe exact same laser to be used with thesystem, the variable beam expander canbe used to tune the final focus spot size.Second, mostly with regard to flexiblesetup machines, the variable beamexpander can change the focus spotsize for different applications.

Knowing and maintaining the posi-tion of focus on the part is very impor-tant, because in many cases the laser’sdepth of focus or z height tolerance canbe less than 0.01 in. (250 μm). If toolingcannot maintain this tolerance, noncon-tact laser distance sensors can be used toclose the loop with a z stage to keep thepart in focus.

The focusing optics can be a fixedfocus head or a scan head. The fixedfocus head focuses the beam only andrelies on stages to move the part oritself, whereas the scan head has smallmoving mirrors that direct the beam ina certain sized xy area and also focusesthe laser. The advantage of the scanhead is that it can move the laser veryquickly over small areas, which is typi-cally required for many micromachin-ing applications. All stages are alwayslinear drives. For scan heads, the partremains stationary during processing,but can be indexed to another process-ing area as needed. The area that thescan head can process is usually rela-tively small — around 40 × 40 mm. It isimportant to select scan heads with dig-ital feedback. Otherwise, the positionalerrors (particularly from thermal drift)can push up the processing positionaltolerances.

To process features exactly where theyneed to be, machine vision is usually anintegral part of these systems. The visionin itself can require significant develop-ment with regard to camera resolution,lighting style, and wavelengths. In most

cases, features can bepositioned to within ±5μm of a target location,and even better whenthe fiducial location isclose to the featurelocation. As noted earli-er, there can be somewander of the laser, sothis also has to be con-sidered. A datum pro-cedure is needed toknow where the beam isin space.

Ultrafast Lasers

Fig. 2 – A comparison of blind drilling PET with picosecond IR (left) and picosecond UV (right). Processing time is thesame; hole depth is three times better for picosecond UV, with less charring.

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Debris management is one aspect ofthese systems that can be easily over-looked. Where does all the removedmaterial go, and does it matter if it landsback on the part? The ultrafast lasersproduce nanoparticles that tend to becharged, and so they tend to stick to sur-

faces. In some cases, these particles canbe cleaned using an ultrasonic bath, butin other cases, the system may requireuse of extraction, possibly using multipleextraction methods.

As with any precision process, toolingis a key factor. For thin planar parts, vac-

uum chucks are commonly used.Nonplanar parts usually need customtooling. In each case, location featuresand fiducial features can be used forpart location and feature-to-feature loca-tion for vision systems.

Summarizing System NeedsBefore moving to system fulfill-

ment, manufacturers must satisfy anumber of milestones, includingapplication feasibility, applicationdevelopment for production, pro-ducing a sufficient number of pre-production parts, and, mostimportantly, developing a cleartechnology solution route for aproduction machine. There isvalue in completing these stepswith a single company, because thesystem concept and design are exe-cuted from the foundationalknowledge associated with devel-oping the application process.

This article was written by GeoffShannon, PhD, Manager of AdvancedTechnology at Amada Miyachi America,Monrovia, CA. For more information,visit http://info.hotims.com/65848-163.Table 1 – Ultrafast laser wavelength comparison.

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Safety and reliability are the key con-cerns when determining the right

power source for a medical device.Lithium-ion (Li-ion) batteries are oftenconsidered for their higher energy den-sity, lighter weight, longer cycle life,superior capacity retention, and abilityto withstand a broad range of ambienttemperatures. However, with an increas-ing number of potentially dangerousincidents — including fires and explo-sions — from Li-ion batter-ies, qualityassurance is more important than everfor error and risk prevention, particular-ly for medical devices that use thesepower sources. Having a holistic qualityapproach across the battery product life-cycle is essential for achieving safe, high-quality, and environmentally friendlyproducts.

Quality AssuranceQuality and your safety are the main

requirements of Li-ion battery packs.For the development and manufactureof Li-ion battery packs, many factorsmust be considered from a quality assur-ance perspective in order to ensure basicrequirements.

Battery pack definition. Quality assur-ance should already be a part of the cre-ation and definition of the requirementsproposal for the Li-ion battery pack to bedeveloped. Therefore, the markets, cus-tomer needs, and application require-ments must be considered. All applicablestandards and regulations must also beincluded in the proposal. In addition, itis important to consider future require-ments, recognizing which standards andregulations might change or be addedduring the development.

Supplier/manufacturer’s qualifica-tions. The qualification of suppliersand manufacturers runs parallel to thedevelopment process. The selectionand qualification is driven by the stan-dard requirements and the previouslydefined requirements document. Atthis stage, fundamental quality man-agement standards, as described inISO 9001, ISO 13485, TS 16949, andISO 14001, must be adhered to by sup-pliers and manufacturers.

The correct choice of suppliers to bat-tery manufacturers and OEMs is crucial.Good supplier management includessupplier selection, supplier qualifica-tion, supplier development, and suppli-er assessment. This starts with an appro-priate supplier selection process. Once asupplier has been chosen, it is necessaryto assess, develop, and improve this sup-plier over time according to the require-ments (see Figure 1).

For components and assemblies thatdo not conform to a standard, the man-ufacturing processes must be viewed inmore detail and, where required, theseprocesses must be validated and/or theresults must be verified. Outsourcedprocesses are also included in this assess-ment. The flowchart in Figure 2 pro-vides the steps to follow and questions toask to help identify when processes needto be validated.

Fig. 1 – The supplier management cycle.

Quality Assurance: Risk Mitigation for Lithium-Ion Battery Packs

Fig. 2 – This flowchart indicates the steps for validating the process.

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The statistical process control, whichis the recording of process key figuresand the actions for correction andimprovement derived from this work,should be used as an aid for controllingthe manufacturing process.

Product DevelopmentProduct development is based on the

requirements catalog and runs parallelto the supplier development processnoted above. Based on the requirementscatalog, the battery is developed andtested and then verified by an internaldepartment or external independentbody. The requirements catalog caninclude everything from essential opera-

tional requirements and related func-tional requirements to features and ben-efits of the device. This qualificationapproach will determine whether thebattery has met the criteria according tothe V-model, a verification and valida-tion model that reviews the implementa-tion process over time from project defi-nition through test and integration.

The battery is subjected to differenttests and testing standards (e.g., electri-cal safety, temperature, shock, and vibra-tion tests) in various environmental con-ditions (humidity, temperature, pres-sure). Charging and discharging cyclesare performed with various currentflows. The battery is then checked in the

overall application system, making sureit meets all requirements.

Temperature and the value of charg-ing/discharging currents has shown tobe a special stress factor for the lifecycleand charge cycles of Li-ion batteries.Each battery carries its own risk, whichmust be assessed. There is a risk on thebattery-cell level, and there is also therisk that the Li-ion battery poses in themedical device application. The use ofprocess failure modes, effects, and criti-cality analysis (P-FMECA) is a common

Medical Design Briefs, February 2017 21Free Info at http://info.hotims.com/65848-757

Fig. 3 – The barcode label includes all of the information necessary for traceability of the individualcells, the assembled PCBA, and the relevant battery pack production data.

Fig. 4 – Battery packs must be tested accordingto the UN38.3 testing method for transportand must be marked with the UN symbol whenthis test is passed.

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method of risk assessment, risk analysis,and risk/error. This method can be usedto determine the cell-level risks as well asthose that may be encountered onceintegrated into the medical device.

The materials used for the batteriesmust also be qualified during develop-ment. The battery supplier or an inde-pendent test laboratory must provideproof that the materials meet therequirements. The requirements catalogand the FMECA determine what thoserequirements must be.

Furthermore, the material flow — theflow and stock of materials betweenprocesses through the system — is alsosubject to quality assurance. Materialflow analysis software is an example ofone tool that has proven suitable for thistask, which starts with the qualificationof the material by means of initial sam-ple inspection reports within the frame-work of the battery development.

Manufacturing. In the battery manu-facturing process, the incoming materi-al is subjected to an incoming materialstest. It may also have been inspected atthe manufacturer when it was shipped.For an incoming materials test, randomsamples are taken according to thedefined acceptance quality limit (AQL)and tested according to predeterminedtest specifications.

In battery manufacture, a relevantquality control (QC) inspection is per-formed after each production step. It isimportant to distinguish between 100percent QC testing and random sampletesting, which consists of in-process qual-ity control steps (IPQC). For IPQC steps,random sample quantities are tested atregular predetermined intervals,defined by quantity or time, in order tomonitor the production process.

All assembled battery packs shouldundergo a 100 percent materials outgo-ing control (OQC). This multistep test-ing method provides for different quali-ty gates through which a Li-ion batterypack must pass, thus ensuring the manu-facturing and product quality.

Traceability. Each individual batterycell has its own serial number, which, incombination with the serial number ofthe assembled printed circuit board(PCB) in the memory chip of the pack,can also be linked to an ID number on theoutside of the pack. This linking of thedifferent numbers creates a unique deviceidentifier (UDI). Additionally, the datecode must be printed on the battery packlabel. This marking allows for the identifi-cation of the assembly groups used.

This battery pack information, includ-ing manufacturing information, isstored, together with the results of theoutgoing testing, in a separate externalsecured database. The traceability of theindividual cells, the assembled PCBA,and the relevant battery pack productiondata, is therefore ensured (see Figure 3).

Logistics. Before lithium-metal or Li-ion cells and battery packs can be trans-ported, they must be tested according tothe UN38.3 testing method for trans-port. When this test is passed, the batterypacks are marked accordingly with theUN symbol (see Figure 4). For the trans-port of Li-ion batteries, the correct pack-aging, package size, and quantity mustbe observed. Only Li-ion packs markedwith the UN symbol may be transported.Without this marking, a transport per-mit is required.

Quality Assurance in the MarketplaceAfter the batteries enter the market

in finished medical devices, qualityassurance measures continue. A com-plaint management system according tothe requirements of ISO 13485 guidesthis process.

All complaints related to batteriesfrom the market are analyzed. For this,the frequency of the individual error

indication is analyzed. For each errorindication, the error causes are deter-mined via an 8D error report (a struc-tured corrective action process), whichinitiates correctional or preventative andimprovement measures. The errors mostcommonly identified during analysis are“Ichikawa” and “5W” error codes.

The actions for improvement followthe PDCA (plan, do, check, act) cycle, asystematic series of steps for the continualimprovement of a product or process,also known as the Deming Cycle (seeFigure 5).1 In addition, the error risk andits effect on persons and property mustbe assessed for each error. Finally, marketobservations help all manufacturers inrecognizing and preventing errors beforetheir own products or the battery packs intheir devices display these errors.

Environmental considerations. With anincrease in environmental awareness andthe impact of batteries on the environ-ment, a functioning environmental man-agement system is becoming more impor-tant than ever. Batteries contain a varietyof chemicals and are toxic to the humans,wildlife, and the environment. Manufac-turers of Li-ion battery packs and theirproduction processes are checked todetermine whether they comply with thecurrent quality management standards(e.g., ISO 14001) and regulations (e.g.,RoHS, REACH). In addition, the issues ofecological balance and the carbon foot-print must be taken into account in themanufacture of Li-ion batteries.

In the EU, entities that put batterieson the market are obliged to take themback and must inform consumers whereand how they can dispose of batteries forrecycling. Li-ion batteries must bemarked with the WEEE (Waste ofElectrical and Electronic Equipment)label (represented by a crossed-outgarbage bin) as well as with the Li-ionrecycling symbol.

Furthermore, each country has itsown recycling and statutory environ-mental requirements, which must be met. For Europe, these are theRestriction of Hazardous Substances(RoHS) Directive 2002/95/EC, theRegistration, Evaluation, Authorizationand Restriction of Chemicals (REACH)regulation, and the Battery Directive(2006/66/EC). For China, the ChinaRoHS directive applies. Figure 6 showsan example of a battery with variouscountry approvals and recycling symbols.

U.S. manufacturers follow the EU’sRoHS Directive. Also in the United

Fig. 6 – An example of a battery marked with dif-ferent country approvals and recycling symbols.

Plan

Do Check

Act

Fig. 5 – The PDCA cycle according to Deming.

Quality Assurance

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States, the Rechargeable Battery Recy-cling Corporation (RBRC), a nonprof-it organization dedicated to recharge-able battery recycling, has launchedthe Call2Recycle program with morethan 30,000 Call2Recycle drop-offlocations throughout the UnitedStates and Canada (see Figure 7).More than 175 manufacturers andmarketers of portable rechargeablebatteries and products fund theCall2Recycle program to help preventrechargeable batteries from enteringthe solid waste stream.

Social responsibility. The UnitedStates is considered the pioneer insocial responsibility. In 2010, the Unit-ed States set new requirements for theminerals used in products, based onthe OECD “Due Diligence Guidance”within the meaning of social responsi-bility.2 The regulation was codified inthe Dodd-Frank Wall Street Reformand Consumer Protection Act –Conflict Minerals. All companies thatcommit to this regulation declare thatthe minerals tantalum, tin, tungsten,and gold that are used in their prod-ucts (components) do not originatefrom the countries DemocraticRepublic of the Congo, Angola,Burundi, Central African Republic,Republic of the Congo, Rwanda, SouthSudan, Tanzania, Uganda, or Zambia.Many U.S. and globally active compa-nies have committed to the Dodd-Frank Act.

SummaryDevelopment, design, testing, pro-

ducing, and delivering a high-qualityLi-ion battery pack requires a comit-ment to and an embracement of quali-ty assurance. By following the guide-lines above, companies can move

toward developing exceptional prod-ucts that are also safe and environmen-tally friendly. Moreover, batteries thatmeet these stringent requirements aresuitable for integration into medicaldevices from neurostimulators andother implantables to portable moni-tors and infusion pumps.

References1. Deming, W.E.: Out of the Crisis.

Massachusetts Institute of Technology,

Medical Design Briefs, February 2017 23

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Fig. 7 – RBRC promotes recycling of Li-ion bat-teries.

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This article was written by Ulrich Sonndag,director of corporate quality, QMR, for RRC Power Solutions GmbH, Homburg,Germany. For more information, visit http://info.hotims.com/65848-165.

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Today’s medical device designers andOEMs are challenged to meet a wide,

and sometimes conflicting, range ofrequirements. These targets stem notonly from regulatory restrictions, but areequally likely to arise based on marketperceptions, pressures to contain costs,and the changing materials supply land-scape.

Specialty polymers designed for med-ical devices can provide solutions tothese and other hurdles by supplying theoptimum balance of properties, per-formance, and compliance for eachapplication.

Current TrendsRegulatory compliance, while frustrat-

ing and challenging, is also creating newopportunities. In fact, designers can usethis body of constraints as a means todrive positive change within their prod-ucts. Remember that while a regulationmay be in force in just one state, country,or region, globalization means that itcan have far-reaching impact.

With the increase in regulationsgoverning plastics additives fromflame retardants to plasticizers, oppor-tunities can be found by anticipatingnew requirements and selecting com-pliant materials that speed theapproval process.

Sometimes, there may not be an actu-al regulation in place, but consumerdemand alone will force changes inmaterial selection. One example is thecurrent anxiety over bisphenol-A, orBPA. While there are no national lawsrestricting the use of BPA in medical orconsumer applications, consumers wantBPA-free baby and child products, andthe market is responding.

Anticipating future regulations isalso having an impact on devicedesign. To address RoHS regulationsthat ban the use of lead in medicaldevices, manufacturers and designerswhose products generate radiation arelooking for alternative materials thatcan provide the equivalent radiationshielding to lead.

Among material suppliers, consolida-tions are taking place to streamline pro-duction and improve efficiency. However,as grades are discontinued, OEMs needto substitute equivalent materials andrequalify their products with the appro-priate agencies.

Improving Product Design withMaterials

Changing demographics are drivingnew opportunities for plastics in med-ical devices. The growing ranks of agingpopulations globally are having a signif-icant impact on product design. Seniorsare living longer and requiring morevaried healthcare devices. They alsowant comfort and ergonomic design.Materials such as soft-touch thermoplas-tic elastomers (TPEs) and technologiessuch as overmolding can help meetthese requirements.

Another impact of this demographicshift is increased demand for betterhealthcare services. Not only do olderpatients want improved hospital care,but active seniors are calling forincreased medical home care, leading torequirements for consumer-friendlyhealth equipment.

Plastics that can provide thin-wallmolding capability, high performance,and great appearance for home use willhelp designers to win in this market.

Finally, scientific breakthroughs inmedicine continue to create the needfor new materials. Noninvasive or less-invasive surgical techniques, for exam-ple, require miniaturized devices andspecialized equipment. Plastics canoffer the design freedom to createultrasmall devices with complex func-tionality. Endoscopic surgical instru-ments with soft-touch, overmoldedhandles, syringe components, gaskets,and seals are just a few examples.

Minimally invasive medical devicestend to be recession-resistant, and areslated for more than 8 percent growthbetween 2016 and 2021.1 In addition,demand is rising for radiopaque plasticsused to make cardiac and urologicalcatheters, further examples of the trendtoward less-invasive surgical procedures.

Antimicrobial polymers that resistbacteria, fungus, and algae are yetanother tool for the designer’s palette.As the death rate for hospital-borneinfections rises to roughly 100,000 peryear in the United States and posts gains

Medical Plastics:

Fig. 1 – Plastics used in the exam room must meet a variety of color and durability requirements.

Meeting Today’s Changing Requirements

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in other countries, hospitals are seekingto control the spread of infection andreduce their legal liability. This trend isdriving growth, currently estimated at15 percent for these materials.Application areas include bed rails,infusion sets, equipment housings, vir-tually any surface that the patient, doc-tor, or nurse might touch.

Material Selection Guidelines andSuggestions

Specialized engineering thermoplas-tics, developed specifically for healthcareapplications, can offer designers andOEMs a set of powerful tools for optimiz-ing products, increasing speed to market,and improving product function. Forexample, today we have a multitude ofoptions for flexible applications — tradi-tional vinyl, nonphthalate vinyl, thermo-plastic polyurethanes (TPUs), TPEs,copolyesters, and ethylene vinyl acetate(EVA). In terms of innovation, OEMs anddesigners are looking at biomaterials thatnow feature property enhancementsunavailable in the past.

To help designers decide which materi-als are best for specific applications, this

article follows various healthcare environ-ments — from doctor’s office and x-rayroom to laboratory and operating room.

Exam room. Patients first step onto ascale that is covered with a mat. Thesemats can be formulated to meet color and

durability requirements, in part throughthe choice of a cross-linked thermoplasticvulcanizate or an elastomer based onstyrenic block copolymers. There are nowgel-soft TPE materials available as well.These materials can be formulated with


Fig. 2 – Angiography equipment often requires materials that address comfort and reliability.

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antimicrobial additives to protect the sur-faces from contamination.

Examination tables can consist of mul-tiple polymer components. For instance,housings that cover motors can be mold-ed from a flame retardant compounddesigned with vibration dampeningcharacteristics to reduce noise. A varietyof traditional and halogen-free alterna-tive flame retardants are available,depending on the resin system chosen.

A housing for a light stand may be over-molded with a soft touch TPE. TPEs offera good balance of softness and bondability.Recent developments allow TPEs to bondto a variety of substrate plastics rangingfrom nonpolar olefins to more polar mate-rials like polyester or even nylon. Thematerials can be formulated to meet thedesired softness rating and provide bothgood wet grip and dry grip performance.

Some applications require USP ClassVI rating. One example is an oxygenmask and tubing, where high perform-ance vinyl or TPE compounds provideboth economical and highly functionalofferings. They achieve required softnesslevels combined with resilience, highelongation, and ease of manufacture.

A caster wheel represents traditionalmetal-to-plastic conversion where theprimary driver is system economics. Forthe wheel hub, the plastic compoundcan be made from a variety of resins andfiller systems. Moving from talc fillers toglass fibers to carbon fibers and evenlong glass and long carbon fibers pro-vides increasing strength and practicalimpact performance.

For the wheels themselves, thermo-plastic elastomers and especially ther-moplastic vulcanizates can provide thegood compression set performancerequired and can be formulated withcarbon black or other fillers and resinsto provide electrostatic dissipation pro-tection, tailoring the surface resistivityof the filled polymer system.

To create a material that is antistaticrequires reducing the surface resistivity ofthe polymer from 1012 or 1013 Ω/sq by afew orders of magnitude to 1010–1012. Todissipate static charge, surface resistivitymust be reduced another couple of ordersof magnitude to 105–1012. The most strin-gent requirements of conductivity andelectromagnetic interference shieldingmust be down as low as 10–1000 Ω/sq.

Angiography room. In a typicalangiography room, comfort and relia-bility also apply, but material modifica-tions bring specific benefits to equip-ment performance.

Electronic equipment gains function-ality when the right polymeric material isselected. Plastics with high flow and hightemperature resistance such as liquidcrystal polymers and polyphenylene sul-fide, traditionally used to mold connec-tors and other electrical devices, haveenabled connectors to get smaller andmore intricate. In addition, advance-ments in filler technology, includingmetal fillers and metal-coated fibers,allow compounding of electrically con-ductive materials that provide electro-magnetic interference (EMI) shieldingperformance.

While this example refers to x-rayelectronics, these types of shielding con-nectors are used in a broad array ofmedical electronics, particularly as thedevice frequency increases or the devicesize decreases. CT scanners and other x-ray generating equipment usuallyinclude components machined fromlead or lead alloys that collimate, orguide, the x-ray photons. In addition, x-ray rooms are often lined with lead andthe patient is draped in lead to mini-mize exposure to radiation.

Tighter restrictions on the use of leadare expected in the future. Advances inpolymer systems can provide an alterna-tive. By using tungsten fillers, specificgravity of 11 can be achieved in a rigidnylon compound, reaching the samedensity as lead alloys. In comparison test-ing for shielding efficiency, these materi-als show comparable performance tolead across a variety of radiation sources,including 100 and 125 kV x-rays. In test-ing for shielding efficiency, high specificgravity compounds showed equivalentperformance to lead in shielding 35 keVgamma radiation from iodine-125 iso-topes, 71 keV gamma radiation from thallium-201 isotopes, and 152 keVgamma radiation from technecium-99m isotopes.

Laboratory. Pipette tips are used inconjunction with robotic pipettors formeasuring and dispensing liquids inlaboratory and production settings, withthe goal of transferring a precise quan-tity of liquid. In situations where arobotic pipettor is used, the machinepicks up a set of pipette tips, transfers aprecise amount of liquid from one loca-tion to another, ejects the now usedpipette tips, and begins the cycle again.The tips are often used only once due toconcerns that contamination may hin-der measurement accuracy.

In these automated systems, pipettetips are often made of conductive poly-meric materials that enable the tip tosense the liquid and therefore accurate-ly measure the correct amount of liquidbeing transferred. In certain applica-tions, some amount of conductivity isrequired to avoid static buildup thatcould give an inaccurate transfer.Typical applications required surfaceresistivity values of less that 106 Ω/sq,and often as low as 104 Ω/sq and below.

Operating room. Respirator bulbscan be molded from vinyl, which stillmakes up a significant portion of med-ical plastics used today. Vinyl products

Fig. 3 – Laboratory equipment is often made from conductive polymeric materials.

Medical Plastics

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display excellent clarity and chemicalresistance, are easily processed, andcan be formulated in a range of colorsand durometers. They are sterilizablein steam, gamma radiation, and ethyl-ene oxide and provide an economicaloption. For this reason, they are used

in many fluid container applications,from IV and dialysis fluids to bloodstorage bags. In these bags, the lowoxygen permeability and good claritymakes vinyl ideal. Medical vinyl com-pounds are also used in a broad rangeof tubing, such as wound and chest

drainage tubes, catheters, and endo-tracheal tubing

In the OR, formulated polymer sys-tems can be used in reusable versions offormerly disposable items. There arenow materials that have the tempera-ture and mechanical performanceproperties required for multiple usesand sterilizations. Materials such aspolyphenylsulfone and polyetherether-ketone (PEEK) can withstand over athousand steam sterilization cycles,making them useful in surgical anddental instruments or in sterilizationtrays. Not only are these materialsresilient in steam sterilization, but theirexcellent chemical resistance extendsto many common hospital disinfec-tants, giving longer life for these multi-ple use applications.

Reference1. “Global Minimally Invasive Devices Market –

Growth, Trends and Forecasts (2016–2021),”Modor Intelligence, November 2016.

This article was written by Jared Goble,strategic accounts director for healthcare atPolyOne, Avon Lake, OH. For more informa-tion, visit http://info.hotims.com/65848-164.


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Fig. 4 – Formulated polymer systems offer chemical resistance, which is often needed in theoperating room.

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Diabetes is not only one of the mostcommon chronic diseases, it is also

complex and difficult to treat. Insulin isoften administered between meals tokeep blood sugar within target range andat mealtimes based on the number ofcarbohydrates to be ingested. A variety ofinsulin types are used to regulate blood-sugar levels, including fast acting, shortacting, intermediate acting, long acting,and premixed. With more than 400 mil-lion adults worldwide suffering from dia-betes and 1.5 million deaths directlyattributed to the disease each year, it’s nowonder so many scientists, inventors, andpharmaceutical and medical device com-panies are turning their attention toimproving insulin delivery devices.

Insulin is introduced into the body via awide variety of devices, including tradition-al syringes, injection ports, insulin pens,conventional insulin pumps, and patchpumps. This article examines the currentstate of insulin delivery and the technolo-gy requirements for the next generation ofdevices to address this chronic disease. Inparticular, it focuses on the insulin pumpsealing technology — including sealdesign and material selection. Thesepumps will require strong seals that notonly have a long life but that also providean adequate friction rate, sufficient break-away forces, and material biocompatibility.New complex seal designs enabled by ver-satile materials are allowing engineers tocreate insulin delivery devices that arelighter and smarter than ever.

Insulin Delivery OptionsCurrently, insulin delivery devices

range from basic to cutting edge.Following are overviews of each typeserving this patient population.

Syringes. Direct, subcutaneous insulininjection through a needle and syringeremains the most common form of deliv-ery. Selection of needle gauge, needlelength, and syringe capacity are made bythe patient together with his or herhealthcare provider.

Patch pumps and other progres-sive methods of drug deliveryare making insulin delivery muchmore convenient for diabetics.

Pens. Insulin pens transport insulinand allow patients to discretely adminis-ter a dose. Pens are available as dispos-able one-shot devices and as long-termdevices with replaceable or refillable car-tridges. Eli Lilly and CompanionMedical recently received FDA approvalof a Bluetooth-enabled insulin pen thatcommunicates dosing information to asmartphone app.

Insulin injection aids. These aids aredesigned to make injecting insulin easi-er, for example, for children and thosewith needle phobias. Once a device isinstalled, it is used as the injection sitefor a three-day period.

Inhaled insulin devices. Several otherdelivery device types are in develop-ment, including those that allow an

insulin dose to be inhaled through themouth, going directly into the lungswhere it’s absorbed and passes into thebloodstream. Dry insulin devices haveyet to become widely used because ofdosage issues, but “wet” devices arebeing developed that deliver an individ-ualized liquid dose to the lungs via newvibrating mesh micro-pump technology.

External pumps. External insulinpumps remain relatively expensive, butmany people with diabetes prefer themfor their precision and, thus, their abilityto provide strong control over blood glu-cose (measured by A1C levels). Whenconnected to continuous glucose moni-toring, these devices deliver a continu-ous basal dose of insulin as well as abolus dose at mealtimes.

Advanced SealingTechnology Enablesthe Next Generationof Insulin DeliveryDevices

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Implantable pumps. Research teamsworldwide are developing implantableinsulin pumps that measure blood glu-cose levels and provide a precise insulindose. The small, lightweight pumps aresurgically implanted and can deliverboth a continuous basal dose of insulinand a bolus dose (through an outsidecontroller).

An exciting development in pumptechnology is the ability to use pumpstogether with glucose sensing technolo-gy (known as an artificial pancreas),which administers insulin based on actu-al glucose levels as determined by theglucose sensor. Insulin delivery is haltedonce a preprogrammed glucose levelthreshold is met.

Insulin Pump TechnologyInsulin pumps — especially newer

devices — have several advantages overtraditional injection methods. Theseadvantages make using pumps a prefer-able treatment option. In addition toeliminating the need for injections atwork, at the gym, in a restaurant, and soon, pumps are highly adjustable, allow-ing the patient to make precise changesbased on exercise levels and types offood being consumed.

These delivery devices comprise aninsulin cartridge, a battery-operatedpump, and a computer chip that allowspatients to control dosage. The currentgeneration of insulin pumps are smallenough to be worn discretely undermost clothing, and newer pump modelsdon’t require tubing. The device isplaced directly on the skin, and dosageadjustments are made through a con-troller that can be carried in a purse orpocket (a 6 ft range is typical).

However, manufacturing the newinsulin pumps requires a high degree oftechnical precision, especially when itcomes to selecting elastomeric compo-nents — in particular, seals. Not only arethere stringent regulatory requirementsto consider, but also factors such as com-patibility to the insulin and to the steril-ization process. Other considerationsinclude lifecycle expectancy, friction,breakaway forces, cost, and ongoingmaterial availability. Although all ofthese factors are important, this articlefocuses on seal geometry, specificallymaterial selection.

The seal is designed to interact seam-lessly with the hardware and preventleakage or inaccurate dosage. Geometryis an extremely important factor when

selecting seals for insulin pumps. Thegeometry determines the degree offorce, the coefficient of friction, and itshydrodynamic qualities.

The correct material choice is essentialto ensuring that the seal will not degradeprematurely or fail due to an incorrectlymatched application condition. Anincorrect material can cause unwantedeffects to contact media. For example, ifthe selected material is not adequate forthe expected storage time before thedevice is used, the insulin can affect itschemical stability, making it “go bad,”losing its potency and effectiveness.

The sterilization method selected bythe OEM or contact with the hardwareand coatings can also cause undesiredeffects. It is important to select the cor-rect material for your design becausethousands of configurations of polymer-ic compounds are available. For insulinpumps, materials include but are notlimited to liquid silicone rubber (LSR),ethylene propylene diene monomer(EPDM), and polytetrafluoroethylene(PTFE). LSRs, for example, have provenparticularly suitable for transdermaldrug delivery, providing small, strongpolymers that are stable and long wear-ing. When selecting a material, considerthe following factors:• Sterilization (steam, dry heat, ethylene

oxide, electron beam, and gammaradiation) — each material reacts dif-ferently to various sterilization meth-ods, so it is essential to ensure that thematerial selected is compatible withthe method specified.

• Availability — if polymers are discon-tinued or modified, OEMs may needto requalify a material, which maymean longer time to market.

• Extractability/leachability — thepotential release of toxic materialsmust be determined to ensure that the

Custom molded LSR components allow insulindevices to perform well due to the precisionthey provide.

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media does not become contaminated.• Applicable regulatory requirements

— some compounds used within theseal material may require USP Class VIcertification, or OEMs may want themanufacturing facilities in which theseals are made to have FDA or ISO13485 certification.In addition, many USP Class VI-

compliant coating and surface treatmentoptions are available to provide antimicro-bial, lubricity, membrane, and other prop-erties to seals. These coating options alsoaffect device design and will influencehow engineers think about the sealgeometries that will enable lighter devicesand smarter wearability. It is important tonote that coatings are usually a secondaryprocess on a seal. In addition to testingthe seal, the coating must be rigorouslytested to ensure that it will not negativelyaffect the insulin pump’s functionality.

As with the finished device, it is equallyimportant to fully vet a proposed sealdesign through prototyping to ensurethat it will pass regulatory scrutiny andwithstand the manufacturing process. It isessential to choose a supplier with expert-ise in seals designed specifically for insulin

pumps and with an understanding of theregulatory requirements with regard toengineering, quality control, and materi-als. The supplier must have adequateresources to help determine the optimalsealing solution for the pump design,including but not limited to material com-patibility testing, prototyping options,non-linear finite element analysis (FEA),and lifecycle testing capabilities.

ConclusionFor people struggling with the com-

plexities of insulin-dependent diabetes,the idea of more automated, less-intrusive ways to manage their disease is

a welcome change. Technology partner-ships hold particular promise, such asMedtronic’s announcement that it isworking with IBM Watson to develop anapp called Sugar.IQ, which acts as a per-sonal assistant for people with diabetes.

Selecting the proper seal for an insulinpump application ensures the adequatedesign, functionality, and compliance todeliver safer and more precise dosages ofinsulin. Device manufacturers that takeadvantage of new seal technologies willdrive the growth of the insulin deliverydevice market. Lighter, smarter devicespaired with sophisticated drug-deliverysystems will accelerate the pace of inno-vation. The increasing number of peopleaffected with diabetes is bringing focusto the market and the resulting need tomanufacture safe insulin devices withdefect-free sealing technology. The goalis to ensure that patients with this chron-ic disease can be as active, healthy, andcomfortable as possible.

This article was written by Drew Rogers,global director, healthcare & medical, TrelleborgSealing Solutions, Fort. Wayne, IN. For moreinformation, visit http://info.hotims.com/65848-160.

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Advanced Sealing Technology

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Medical Design Briefs, February 2017 www.medicaldesignbriefs.com 31

We are living through an era of pro-found change. Technology is

affecting this change in ways unthink-able only a decade ago and none moreso than in the medical device industry. Atour of life sciences conferences over thepast year revealed a number of techno-logical advances that are now driving awhole new set of trends in project man-agement in order to deliver the nextgeneration of medical devices.

Among the most significant develop-ments were wearable health monitoringdevices for an aging population, theadvent of miniaturization of implantabledevices, and connected health — con-necting doctors and patients to transmitreal-time data. There was an emphasis ofpreventive care over clinical treatments,and surgeons praised the benefits oftelemedicine, which enabled them toperform remote surgeries as far as thou-sands of miles away. Information tech-nology specialists reiterated the increas-ingly critical role of electronic healthrecords, and big data was a big topiceverywhere.

The rapid integration of nanotechnol-ogy, cloud connectivity, smartphoneaccess, and personalized medicine is alsoshifting the delivery of healthcare. AsOEMs address this changing healthcarelandscape, they will benefit from follow-ing four key project management trends:implementing an agile product develop-ment process, taking advantage of thecloud and employee’s personal devices,customizing reports, and modifying therole of their project managers. This arti-cle looks at each of the four trends andexplores how to use them to address thechanging healthcare landscape.

Trend #1: Agile ProductDevelopment

The time has come for the medtechindustry to move away from old school

pro jec t management methods .Successful companies will completeprojects in an agile way — splitting intocross-functional, self-organizing, self-responsible teams, consisting of scrummasters, product owners, and develop-ment teams. Traditional requirementswill now be delineated into user storiesand burn-down charts, and “show andtells” will be used to report progress.

Be careful, though. Some executivesmay misinterpret the agile manifestoand may subscribe to a misguided beliefthat team members stop producing doc-umentation and that scrum is an excuseto do whatever you want. They may feelthat the method is too loose to workwithin tough regulatory controls andthat the quality of the delivered productwill be jeopardized.

“In a sense, agile is like jazz,” saysFrank Balogh, principal agile/organiza-tional coach for AOL Platforms. “It’s likeimprov in a way. It’s not sheet music.”

Balogh says that we now work in a worldthat asks us to deliver products morequickly than traditional models allow.

But what does that mean for medicaldevice development? Scrum team mem-bers will still have to master the technol-ogy and know regulatory guidelines suchas FDA regulations and IEC standards.Agile practices and more self-directed teams will enable project man-agement teams to develop more visualrepresentations of project information.Regulations and guidelines will beembedded into project managementsoftware, keeping team membersfocused and aware of applicable regula-tory information.

Guidelines are available to help medical OEMs adapt to agile processes. In 2012, the Association for theAdvancement of Medical Implementation(AAMI) released TIR45, which guidesmedical device development companieson how to use agile under stringent qual-

Agile development entails splitting into cross-functional, self-organizing, self-responsible teams, con-sisting of scrum masters, product owners, and development teams.

Project Management:Four Trends to Follow in 2017

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ity regulatory processes. TIR45 is a good referenceand also aligns with IEC 62304, “Medical device soft-ware — Software life cycle processes.”

Expect to see agile practices expand to nonsoft-ware-based projects. The challenge in adoptingan agile approach lies in the organization’s readi-ness to accept its simplicity. The principles arestraightforward, but cultural and behavioralchanges often are not. Agile relies heavily on hav-ing a good tool for managing workflow, so OEMSwill benefit from investing in one that they can customize.

Trend #2: The Cloud and BYODMobile collaboration will be critical, and compa-

nies are moving toward a concept known as BYOD,or bring your own device. BYOD is the practice ofallowing or even encouraging employees to usetheir own computers, smartphones, or other devicesfor work purposes. It is becoming a key enterpriseinfluencer for moving project management applica-tions from inside the firewall to third-party hostedcloud solutions. Mobile devices will socialize a pro-ject’s status to the entire team, displaying project schedulesand tasks for wider understanding and discussion by teams.Using personal laptops, tablets, and smartphones to connectwith corporate resources will facilitate access anytime any-where for all project stakeholders. Embracing BYOD will affectthe selection of project management software.

The project manager will need to lead the BYOD initiativeand manage the technology, policy, security, and regulatory,and other factors that must converge in order to support theproject team. Developing data ownership policies mayrequire input from multiple stakeholders, including legal,information security, and management teams. Project man-agers will be responsible for access rights to all project infor-mation — therefore, a tool that has different access rightswill be essential.

Enterprise mobility and BYOD influence over project man-agement platforms should be embraced. Project managers canno longer hide in the project management office. Providingcollaborative access anytime and anywhere is a trend wellworth following.

Trend #3: Customizable ReportsCustomizability will be at the center of enterprise project man-

agement software. The information that the chief informationofficer requires on technical progress differs greatly from thedata required by finance. The information often resides in differ-ent programs, and the format of the reports that are generatedvary greatly. As medtech project managers adapt to a changinghealthcare landscape, stakeholders will expect customizedreports that enable them to respond to changes quickly and eas-ily. Project management systems will need to be able to harvestdata from different sources and produce them in single, customreport and in a variety of formats.

This trend will lead medical OEMs to merge their customerrelationship management (CRM) software and project manage-ment systems. Open application programming interface func-tionality will become an industry standard as opposed to a fea-ture. Project management and CRM platform integration willbridge the gap between finance and operations by exchangingdata between disparate systems, helping to provide transparencyand build trust between the two teams.

Trend #4: The New Change ManagersIn the new healthcare landscape, project managers will need to

be more involved in change initiatives than in the past.


Project Management Trends

BYOD — bring your own device — is a concept that allows employees to use theirown computers, smartphones, or other devices for work purposes, enabling proj-ect management applications to move from inside the firewall to third-party hostedcloud solutions.

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Traditionally, the project manager’s taskwas to drive deliverables and focus on prod-uct development. By contrast, the changemanager was dedicated to driving changemanagement projects; assessing risk; track-ing, managing, and monitoring changeproject details; reporting key performanceindicators (KPIs); and facilitating teamcommunication. In the future, executiveswill want more buy-in and support fromproject managers in respect to all changeinitiatives. The focus will need to shift fromdefining what the project is to deliver towhy the project has been initiated.

Project managers will manage themechanics of projects. They will be theearly adopters, and their project reportswill present detailed assessments ofchange initiatives. In the new era, project

managers will be accountable for drivingchange not just within their teams, butacross the entire organization. Projectmanagement tools will need to handle thechange management story. These toolswill have customized interfaces, and theywill capture and track business goals,KPIs, change guidelines, and new work-flows or processes.

ConclusionJohn F. Kennedy said, “Change is the

law of life. And those who look only to thepast or present are certain to miss thefuture.” There will always be unknownswhen delivering medical device projects,but an agile response helps manage proj-ects successfully, particularly in a rapidlychanging healthcare landscape. The key

to staying ahead of your competitors isassessing the latest technological advancesand developments and aligning your proj-ect management practices to respondquickly and intelligently.

Technological advances are dictating anew approach to project management.Four key trends will be at the heart ofaddressing the changing landscape:implementing an agile approach to prod-uct development, taking advantage of thecloud and employee’s personal devices,customizing reports, and modifying therole of project managers.

This article was written by Justin Kelleher,Ph.D., a project management office consultantwith Cora Systems, Leitrim, Ireland. For moreinformation, visit http://info.hotims.com/65848-162.

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■ Engineers Reveal Fabrication Process for TransparentSensors

See-through sensors from theUniversity of Wisconsin–Madisonwill provide neural researchers witha better view of brain activity. Thescientists hope to use the transpar-ent, implantable micro-electrodearrays in applications beyond neu-roscience, including research ofstroke, epilepsy, Parkinson’s disease,and cardiac conditions.

In a recent paper, published inthe journal Nature Protocols, theUW–Madison team described how

to fabricate and use the transparent graphene neural electrodearrays in scenarios such as electrophysiology, fluorescentmicroscopy, optical coherence tomography, and optogenetics.

"Our technology demonstrates one of the key in vivo appli-cations of graphene,” said Zhenqiang (Jack) Ma, the Lynn H.Matthias Professor and Vilas Distinguished AchievementProfessor in electrical and computer engineering.

Ma's group, a leader in the development of flexible electronicdevices, patented the technology in 2014, with collaboration fromJustin Williams, Vilas Distinguished Achievement Professor in bio-medical engineering and neurological surgery. Many researchgroups then began asking how to create the clear sensors.

For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/features/26103.

■ Smart Patch Release Blood Thinner as NeededA new smart patch from

North Carolina StateUniversity, Raleigh, NC, pre-cisely releases blood-thinningdrugs as needed. The devicemonitors a patient's blood toprevent thrombosis, the occur-rence of blood clots.

Current thrombosis treat-ments often rely on the use ofblood thinners like the drugheparin, which require patients to test their blood on a regularbasis in order to ensure proper dosages.

The patch incorporates microneedles made of a polymerthat consists of hyaluronic acid (HA) and heparin. The poly-mer responds to thrombin, an enzyme that initiates clottingin the blood.

When elevated levels of thrombin enzymes in the blood-stream come into contact with the microneedle, the enzymesbreak the specific amino acid chains that bind the heparin tothe HA, releasing the drug into the blood stream.


■ Shape-Memory Polymer Promises 'Programmable'ApplicationsIn partnership with General Motors, researchers from Purdue

University, West Lafayette, IN, have revealed that honeycomb“cellular” materials support a range of new applications, such asbiomedical implants. Without any additional reprocessing, effec-

tive mechanical properties of theshape-memory polymer can bemodified after fabrication.

“The idea is that you might massproduce the basic material, and ithas many potential uses becauseyou can change it later for applica-tion A or application B,” saidPablo Zavattieri, an associate pro-fessor in Purdue University’s LylesSchool of Civil Engineering.

The researchers demonstratedthat they could create programma-ble cellular materials by introduc-

ing deliberate defects to the unit cells. Heating allows the alter-ation of the shape-memory polymer's geometric “unit cells.”

Material properties depend on the shape of the unit cells,and the makeup and thickness of the walls separating eachcell. Compressing the materials by 5 percent results in a 55percent increase in stiffness.


■ Headgear Targets Brain ActivityThe City University of New York (CUNY), New York, NY, and

Soterix Medical, New York, NY, have released an image-guidedneuromodulation device. The EEG-Guided High-Definition tES(HD-tES) targets brain regionsassociated with neuropsychiatricdisorders such as depression andchronic pain.

HD-tES, a technology devel-oped by Dr. Marom Bikson andDr. Lucas Parra at CUNY, deliv-ers targeted, low-intensity elec-trotherapy noninvasively. Byembedding electrodes within a removable cap, the proprietaryEEG-Guided HD-tES combines research-grade brain monitoringwith clinical-grade brain stimulation.

According to the CUNY researchers, a low-intensity targetedelectrical current is known to promote the brain's plasticity, orability to change with learning.

The system detects brain activity, diagnoses the brain target, anddelivers mild electrotherapy (HD-tES) to the region. Research-grade EEG ensures reliable identification of brain targets whileclinical-grade HD-tES supports reliable brain modulation.



A blue light shines through aclear, implantable medicalsensor onto a brain model.(Credit: Justin Williams)

Schematic of thrombin-respon-sive patch that releases heparinin response to thrombin. (Credit:Yuqi Zhang)

New research has shown thathoneycomb “cellular” materialsmade of a shape-memory poly-mer might be programmed forspecific purposes, from shock-absorbing football helmets to bio-medical implants. (Credit: PabloZavattieri, Purdue University)

The MultiChannel NeuromodulationSystem. (Credit: CUNY)

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http://www.medicaldesignbriefs.com/component/content/article/1104-mdb/features/26103





■ Extracellular Matrix Offers Stable Coating forImplants

Each cell produces a tissue-specificextracellular matrix (ECM), depend-ing on the environment needed. Abone matrix, for example, containsminerals to provide firmness; a skinECM consists mostly of collagen andelastic fibers. The ECM participates inthe assembly and regeneration of tis-sue, regulating all important cell func-tions and triggering cell growththrough chemical messengers.

Researchers from the FraunhoferInstitute for Interfacial Engineeringand Biotechnology (IGB), Stuttgart,Germany, have developed an ECM.The biomaterial contains artificial

chemical groups, which support natural cell behavior outside ofthe body. The functional ECM can ultimately be applied as a sta-ble coating on implants, or used in cell culture dishes.

Within the clickECM project, the scientists developed the condi-tions and parameters needed for the cells to incorporate relativelyhigh levels of labeled sugar into their ECM during their metabo-lism. The team then characterized the cell matrix and examinedthe influence of the functionalized matrix on cells.

According to the Fraunhofer team, the new materials couldalso be used to support healing in bones or wounds.


■ ECT Imaging Detects Infections in ProsthesesCurrent ways of detecting infections in prostheses require

patients to undergo burdensome imaging procedures, such asan MRI, CAT scan, or x-rays. Engineers at the University ofCalifornia, San Diego havedeveloped a new, noninvasiveway of providing amputees withquantitative, diagnostic-rele-vant information about theextent and locations of theinfection.

The enhanced electricalcapacitance tomography (ECT)imaging method measures thehuman tissue and prosthesis’electrical properties, using safeelectrical fields. An algorithm processes the data, allowingphysicians to reconstruct a predetermined area’s electricalcharacteristics. Infection causes changes in the field, which canbe detected via ECT.

Ken Loh, a professor of structural engineering at the JacobsSchool of Engineering at UC San Diego, and PhD student SumitGupta refined the algorithm and developed a thin-film sensorthat could be sprayed onto a prosthesis to improve the imagingtechnique’s ability to detect infection. Loh envisions thin-filmsensors coated onto prostheses, where each layer detects differ-ent signals that indicate various conditions, such as stresses, loos-ening, and pH changes.


A scientist fromFraunhofer IGB culturescells to form a function-alized extracellularmatrix — the clickECM.(Credit: Fraunhofer IGB)

Engineers have created a newmethod to detect infections inprostheses for amputees and jointreplacements. (Credit: iStock)

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New Graphene-Based System Could Help ‘See’ ElectricalSignaling in Heart and Nerve CellsNew method allows moreextensive and preciseimaging.Lawrence Berkeley NationalLab, Berkeley, CA

Scientists have enlisted the exoticproperties of graphene, a one-atom-thick layer of carbon, to function likethe film of an incredibly sensitive cam-era system in visually mapping tiny elec-tric fields in a liquid. Researchers hope

the new method will allow more exten-sive and precise imaging of the electricalsignaling networks in hearts and brains.

The ability to visually depict thestrength and motion of very faint elec-trical fields could also aid in the devel-opment of so-called lab-on-a-chipdevices that use very small quantities offluids on a microchip-like platform todiagnose disease or aid in drug devel-opment, for example, or that automatea range of other biological and chemi-cal analyses.

The setup could potentially be adaptedfor sensing or trapping specific chemicals,too, and for studies of light-based elec-tronics (a field known as optoelectronics).

■ A New Way to Visualize Electric Fields“This was a completely new, innovative

idea that graphene could be used as amaterial to sense electrical fields in a liq-uid,” said Jason Horng, a co-lead authorof a study published in NatureCommunications that details the firstdemonstration of this graphene-basedimaging system. Horng is affiliated withthe Kavli Energy NanoSciences Institute,a joint institute at Lawrence BerkeleyNational Laboratory (Berkeley Lab) andUC Berkeley, and is a postdoctoralresearcher at UC Berkeley.

The idea sprang from a conversationbetween Feng Wang, a faculty scientist inBerkeley Lab’s Materials SciencesDivision, whose research focuses on thecontrol of light-matter interactions atthe nanoscale, and Bianxiao Cui, wholeads a research team at StanfordUniversity that specializes in the study ofnerve-cell signaling. Wang is also a UCBerkeley associate professor of physics,and Cui is an associate professor ofchemistry at Stanford University.

“The basic concept was how graphenecould be used as a very general and scal-able method for resolving very smallchanges in the magnitude, position, andtiming pattern of a local electric field,such as the electrical impulses producedby a single nerve cell,” said Halleh B.Balch, a co-lead author in the work.Balch is also affiliated with the KavliEnergy NanoSciences Institute and is aphysics PhD student at UC Berkeley.

“One of the outstanding problems instudying a large network of cells isunderstanding how information propa-gates between them,” Balch said.

Other techniques have been developedto measure electrical signals from smallarrays of cells, though these methods canbe difficult to scale up to larger arrays andin some cases cannot trace individual elec-trical impulses to a specific cell.

Also, Cui said, “This new method doesnot perturb cells in any way, which is fun-damentally different from existing meth-ods that use either genetic or chemicalmodifications of the cell membrane.”

This photo shows the setup for a system known as CAGE (Critically coupled waveguide-AmplifiedGraphene Electric field imaging device) that is designed to precisely record the properties of faintelectrical signals using an infrared laser and a layer of graphene. The CAGE platform can be usedto image the electrical signals of living cells. (Credit: Halleh Balch and Jason Horng/Berkeley Laband UC Berkeley)

This chart, produced using imaging data from the CAGE system, maps out a tiny electrical field in a fluidas the field dissipates over time. The strength of the field is color-coded, with yellow showing its peak anddark blue showing the weakest field strength. This chart covers the first 70 milliseconds (thousandthsof a second) after the field is generated, and the area covered by the field is represented in microns, ormillionths of a meter. (Credit: Halleh Balch and Jason Horng/Berkeley Lab and UC Berkeley)

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The new platform should more easilypermit single-cell measurements of elec-trical impulses traveling across networkscontaining 100 or more living cells,researchers said.

■ Tapping Graphene’s Light-Absorbing PropertiesGraphene, which is composed of a

honeycomb arrangement of carbonatoms, is the focus of intense R&Dbecause of its incredible strength, abilityto very efficiently conduct electricity,high degree of chemical stability, thespeed at which electrons can moveacross its surface, and other exotic prop-erties. Some of this research is focusedon the use of graphene as a componentin computer circuits and display screens,in drug delivery systems, and in solarcells and batteries.

In the latest study, researchers firstused infrared light produced at BerkeleyLab’s Advanced Light Source to under-stand the effects of an electric field ongraphene’s absorption of infrared light.In the experiment, they aimed aninfrared laser through a prism to a thinlayer called a waveguide. The wave-

guide was designed to precisely matchgraphene’s light-absorbing properties sothat all of the light was absorbed alongthe graphene layer in the absence of anelectric field.

Researchers then fired tiny electricalpulses in a liquid solution above thegraphene layer that very slightly disrupt-

ed the graphene layer’s light absorption,allowing some light to escape in a waythat carried a precise signature of theelectrical field. Researchers captured asequence of images of this escaping lightin thousandths-of-a-second intervals,and these images provided a direct visu-alization of the electrical field’s strength

This diagram shows the setup for an imaging method that mapped electrical signals using a sheetof graphene and an infrared laser. The laser was fired through a prism (lower left) onto a sheet ofgraphene. An electrode was used to send tiny electrical signals into a liquid solution (in cylinder atopthe graphene), and a camera (lower right) was used to capture images mapping out these electricalsignals. (Credit: Halleh Balch and Jason Horng/Berkeley Lab and UC Berkeley)

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and location along the surface of thegraphene.

■ Millionths-of-a-Volt SensitivityThe new imaging platform — dubbedCAGE for “Critically coupled waveguide-Amplified Graphene Electric field imag-ing device” — proved sensitive to volt-ages of a few microvolts (millionths of avolt). This will make it ultrasensitive tothe electric fields between cells in net-works of heart cells and nerve cells,

which can range from tens of microvoltsto a few millivolts (thousandths of a volt).

Researchers found that they couldpinpoint an electric field’s locationalong the graphene sheet’s surfacedown to tens of microns (millionths of ameter), and capture its fading strengthin a sequence of time steps separated byas few as five milliseconds, or thou-sandths of a second.

In one sequence, researchers de -tailed the position and dissipation, or

fade, of a local electric field generatedby a 10-thousandths-of-a-volt pulse overa period of about 240 milliseconds, withsensitivity down to about 100 millionthsof a volt.

■ Next Up: Living Heart CellsBalch said that there are already plans

to test the platforms with living cells.“We are working with collaborators totest this with real heart cells,” she said.“There are several potential applicationsfor this research in heart health anddrug screening.”

There is also potential to use otheratomically thin materials besidesgraphene in the imaging setup, she said.

“The kind of elegance behind this sys-tem comes from its generality,” Balchsaid. “It can be sensitive to anything thatcarries charge.”

The research team included partici-pants from Berkeley Lab, UC Berkeley,and Stanford University. The work wassupported by the U.S. Department ofEnergy Office of Science, the NationalScience Foundation, the David andLucile Packard Foundation, and theStanford University Bio-X GraduateFellowship Program. The AdvancedLight Source is a DOE Office of ScienceUser Facility.

For more information, visit http://newscenter.lbl.gov.


Another view of the CAGE system, with thegraphene sample at lower right. (Credit: HallehBalch and Jason Horng/Berkeley Lab, UCBerkeley)

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http://newscenter.lbl.gov


‘Liquid Biopsy’ Chip Detects Metastatic Cancer Cells in aDrop of BloodMechanical method ismore effective in trappingcancer cells.Worcester PolytechnicInstitute, Worcester, MA

A chip developed by mechanical engi-neers at Worcester Polytechnic Institute(WPI), Worcester, MA, can trap andidentify metastatic cancer cells in a smallamount of blood drawn from a cancerpatient. The breakthrough technologyuses a simple mechanical method thathas been shown to be more effective intrapping cancer cells than the microflu-idic approach employed in many exist-ing devices.

The WPI device uses antibodiesattached to an array of carbon nan-otubes at the bottom of a tiny well.Cancer cells settle to the bottom of thewell, where they selectively bind to theantibodies based on their surface mark-

ers (unlike other devices, the chip canalso trap tiny structures called exosomesproduced by cancers cells). This “liquidbiopsy,” described in a recent issue of the journal Nanotechnology, couldbecome the basis of a simple lab test thatcould quickly detect early signs of metas-tasis and help physicians select treat-ments targeted at the specific cancercells identified.

The prognosis for metastatic cancer(also called stage IV cancer) is generally

poor, so a technique that could detectthese circulating tumor cells before theyhave a chance to form new colonies oftumors at distant sites could greatlyincrease a patient’s survival odds.

The device developed by Pancha -pakesan’s team includes an array of tinyelements, each about a tenth of an inch(3 mm) across. Each element has a well,at the bottom of which are antibodiesattached to carbon nanotubes. Each wellholds a specific antibody that will bind

The bound cells trigger an electrical response, which is detected by the electrodes.

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selectively to one type of cancer cell type, based on geneticmarkers on its surface. By seeding elements with an assortmentof antibodies, the device could be set up to capture several dif-ferent cancer cells types using a single blood sample. In the lab,the researchers were able to fill a total of 170 wells using justunder 0.3 fl oz (0.85 ml) of blood. Even with that small sample,they captured between one and a thousand cells per device,with a capture efficiency of between 62 and 100 percent.

A video of the technology is available at www.youtube.com/watch?v=qClFEzRtPMg. For more information, visit www.wpi.edu.

Advanced Mobility AidAddresses Failings ofCurrent DevicesSix key failings of current devices areaddressed with new device.Medical Advanced Manufacturing ResearchCentre/University of Sheffield, Sheffield, UK

Researchers from the Medical Advanced ManufacturingResearch Centre (ARMC), Sheffield, UK, are developing anadvanced mobility aid that could change the lives of millions ofdisabled people. With funding support from the Royal MarinesCharity, Conquering Horizons called in the Medical AMRC —part of the University of Sheffield Advanced ManufacturingResearch Centre with Boeing — to assess whether the conceptwas feasible and to create the beginnings of the design.

To design the device, they are working with a former soldierwho caught a devastating disease in Afghanistan. Corporal PhilEaglesham contracted Q Fever — also known as Helmand Fever— during active service. The former Royal Marine Commando,who was part of Britain’s Paralympic Squad in Brazil, is forced torely increasingly on mobility devices as his condition deteriorates.His reliance has led him to try to create something more suitablefor mobility device users.

Eaglesham, his wife Julie, and businessman Brian Meaden, afather of a mobility device user, set up Conquering Horizons tocreate a mobility device that would address the drawbacks ofconventional wheelchairs and scooters.

Eaglesham identified six key failings affecting current mobilitydevices, all of which are being addressed by Victor, the new devicebeing developed at the Medical AMRC. Victor incorporates anadjustable lifting device that can raise users to a “social height,”enabling them to look people in the eye and to sit at the rightheight to eat or work.

It is designed to tackle difficult terrain, mount curbs, fitthrough standard doorways, and maneuver easily, thanks tomultidirectional wheels that give it a turning circle just slightlylarger than its wheel base. Victor is also modular, so that it canbe modified as a user’s condition changes.

It is designed to be aesthetically pleasing. Marcus Crossley ofMedical AMRC said, “Victor has a completely fresh, modernappearance that is far removed from the stigmatizing, institution-alized image of existing devices. Our aim, from the outset, hasbeen to create a device that able-bodied people would want to beseen on.”

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https://www.youtube.com/watch?v=qClFEzRtPMg

https://www.youtube.com/watch?v=qClFEzRtPMg

https://www.wpi.edu

Medical Design Briefs, February 2017 www.medicaldesignbriefs.com

Hydrogel Dressing Could EliminateTraditional Bandages for BurnsGel-like solution keeps the wound moistand can be washed offpainlessly.Boston University,Boston, MA

For patients with second-degreeburns, it’s not always the initial injurythat hurts most. The daily, sometimeshours-long bandage changes can be themost excruciating ordeal.

A new development from BU’sGrinstaff Group could soon makethose painful bandage changes obso-lete. Enter the hydrogel burn dressing,a gel-like solution that acts as a barrierto infection for burns, keeps the

wound moist, and — most important— can be washed off painlessly with aseparate solution.

The burn dressing is the latest projectto emerge from the multidisciplinary labrun by Mark Grinstaff, a College ofEngineering Distinguished Professor ofTranslational Research, who says his labmembers are challenged to solve prob-lems that have the greatest needs andwhere current technology doesn’t per-form well.

The new dressing doesn’t just spareburn victims pain — it saves medicalstaff hours of time spent rebandaging,and since many children cannot sit stillduring the painful dressing change, itcan eliminate the need to anesthetizeyoung patients during rebandaging. For

“Having this device will enable Phil,millions like him, to gain a more active,independent and normal life,” said JulieEaglesham. “This will not only givethem an amazing physical advantagebut will also have a hugely positiveimpact on their mental health and allowthem to lead a more active and involvedlife. For Phil, in his role as a father ofthree lively boys, the ability to travel onmost surfaces or terrains and the sup-port, comfort and control of a devicethat he has complete confidence in, willbe revolutionary.”

Researchers from the Medical AMRCrecently traveled to London to speak at afundraising event at the Imperial WarMuseum. The goal is for Victor to costno more than £10,000 (~$12,350).

Marcus Crossley added, “Phil is aninspirational person and raising money

to develop Victor could have a majorimpact on the lives of millions who needto use mobility devices and their families.

“Victor needs more development workin order to get to a position where it canbe sold to the public, and we are activelysupporting Conquering Horizons as itseeks to raise the necessary financethrough its crowdfunding appeal.”

For more information, visit www.amrc.co.uk/news.

Samuel Rees (left) and Marcus Crossley, fromthe Medical AMRC, with Phil Eaglesham at thefundraising launch at the Imperial War Museumin London.

Samuel Rees (seated) and Marcus Crossley,from the Medical AMRC, outline the principlesof the new mobility device, using a prototype.

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second-degree burn patients, theremoval of dressings is extremelypainful, because nerves are still exposed.With more severe third-degree burns,the nerves are burned away.

“Even if you could save half the tripsto the OR to change dressings, it wouldbe a significant improvement,” saysEdward K. Rodriguez, chief of theDivision of Orthopaedic Trauma at Beth

Israel Deaconess Medical Center, whoworked on the project. “Imagine if youcould just cover the wound directly withan aerosol-applied gel with antisepticand pain control medication on it, andremove it at the bedside without havingto take the patient to the OR.”

“In medicine, a lot of questions remainunanswered,” says Marlena Konieczynska,National Institutes of Health Ruth L.Kirschstein Postdoctoral Fellow and aGrinstaff Group member since 2013. “It’sa brainstorming activity.”

The burn dressing problem came tothe fore when researchers at the BethIsrael Deaconess Medical Center lab ofAra Nazarian, a Harvard MedicalSchool assistant professor in orthope-dic surgery, failed to get funding for adifferent project — a gel to stop bleed-ing on the battlefield. The researcherslooked around for another problemthat might be tackled with the sameconcepts.

The partnership is typical of the waythe Grinstaff lab members and the med-ical doctors interact. Sometimes, groupmembers approach medical profession-als with an interesting material and askhow it might be used in the clinical set-ting. Other times, the medical doctorsapproach the Grinstaff Group with aproblem they need help solving.

“It’s a two-way street,” says Nazarian,who is also a Worcester PolytechnicInstitute visiting assistant professor ofelectrical engineering.

For the new burn dressing,Rodriguez says, the Grinstaff Groupbrought expertise in chemistry, and theNazarian Lab offered its small animallab for physiological testing. “We’re for-tunate to live in a city where there is somuch creative and intellectual talent,”he says. “Many times, the most creativeadvances happen when people withcompletely different backgroundscome together.”

For researchers like Konieczynska,who defended her PhD thesis lastspring, working with biologists, medicaldoctors, and other specialists is a majoradvantage. “From a student perspective,it’s extremely educational,” she says. “Ithelps you understand your project frommany different perspectives. I think ourlab is quite special.”

Now that the researchers under-stand the material and have proven itworks on small animals, Grinstaff says,the next step is a large animal model,where they compare the technology to

Mark Grinstaff (Chemistry, BME, MSE) and members of his lab, among them Marlena Konieczynska,have developed a new hydrogen gel that could eliminate the need to anesthetize children for burndressing changes. (Credit: Jackie Ricciardi)

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Bionic Wheelchair Breaks New BarriersStairclimbing wheelchaircan stabilize itself.Technical University ofMunich, Munich, Germany

People confined to a wheelchair arestill confronted with insurmountableobstacles in everyday life — even intoday’s more wheelchair-accessible socie-ty. There are often no elevators in abuilding — or if so, they’re often out oforder. And while there are alreadywheelchairs that can climb stairs, per-sons with physical disabilities stillrequire assistance to prevent them from

tipping over. Researchers at theTechnical University of Munich (TUM)have now developed a stairclimbingwheelchair with the ability to stabilizeitself. It is part of a larger mobility con-cept that enables wheelchair users tomove independently for short and medi-um distances.

Whether visiting friends, goingshopping, or participating in eventsoutside the home, mobility is the pre-requisite for a self-determined life.People who are mobile also do notneed to be looked after or attended to.However, something as simple as leav-ing their home without assistance can

be a major hurdle for some peoplewith disabilities.

It quickly became clear to the scien-tists: A wheelchair must be developedthat can climb stairs. It should also beagile and narrow. The researchers thuslimited the chassis to one axis. In con-trast to a two-axle wheelchair chassis,this wheelchair can move forward andbackward and rotate around its own axisalmost simultaneously. The wheelchairholds itself up according to the invertedpendulum principle. “Each small posi-tional change is recognized and imme-diately compensated by the drive sys-tem,” says Prof. Bernhard Wolf of the

current products. If that larger animalstudy works as well as the small animalone, next is getting it into a clinicalsetting and figuring out how to manu-facture it.

Within two years, patients could feel aspray, instead of a painful cut, when itcomes time to change their bandages.

The Grinstaff Group includes PhD stu-dents and postdoctoral researchersstudying chemistry, pharmacology, andbiomedical and mechanical engineering,all tasked with coming up with solutionsto real-world problems. Grinstaff, also anENG materials science and engineeringprofessor, a College of Arts & Sciences

chemistry professor, and a School ofMedicine professor of medicine, is thedirector of the BU NanotechnologyInnovation Center as well. The GrinstaffGroup members count on one another’sspecialties to pose the best questions andchallenge solutions.

For more information, visit www.bu.edu.

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Heinz Nixdorf Chair for MedicalElectronics at TUM.

■ Navigating Narrow StaircasesSo how exactly does the new wheel-

chair conquer staircases? Previous con-

cepts have utilized crawler chassis orcastor configurations. “But those wheel-chairs have to be monitored during theprocess,” explains Wolf. In other words,another person has to be on hand toensure that the chair does not topple

over. In addition, such wheelchairs havea large turning circle — making themunsuitable for use on narrow staircases.

The scientists decided on a bionicconcept for their new chair. Two feetthat have a similar configuration tohuman legs — with an upper and lowerleg — are attached to the wheelchair. Ifthe chair’s ultrasonic sensors detectstairs in the path of travel, the wheel-chair reverses itself with its back to thestairs until the two wheels have physicalcontact with the first stair. Then thefeet are extended, and the wheelchairlifts itself up the step. Powered by anelectric motor, the legs push the wheel-chair to the next higher step.Meanwhile, a camera system monitorsthe “staircase topography” to ensurethat the wheelchair is firmly on a stepand not, for example, on the edge.

This technology also makes it possible tomanage very narrow staircases — with theexception of spiral staircases. When thechair is done ascending the stairs, it retractsits legs and swings back into forwardmotion in drive mode. The wheelchair canthus also go down the stairs again.

■ Comprehensive Mobility ConceptUsing a prototype, engineers were able

to show that their principle works. Theconcept goes beyond the climbing ofstairs, however. “We want to give people atruly viable mobility alternative with thiswheelchair,” says Wolf. The chair couldalso be used as a car seat in the future,for example, dispensing with the need tofold and stow the wheelchair prior todeparture. It would also not be necessaryfor the user to be lifted from the car seatback into the wheelchair upon arrival.Since it has an internal drive, it is narrow-er than a standard wheelchair.

Potential industrial partners are stillreluctant, however. “I think it is becausethe principle is technically a little com-plex, and of course, there are alreadystandardized wheelchairs,” says Wolf. Heis convinced that the demand for thebionic wheelchair would definitely behigh. Although it costs more than a stan-dard wheelchair, it offers its users thepossibility to move around more freely.

Cooperation partners in the projectare CoKeTT Zentrum at KemptenUniversity (Prof. Petra Friedrich) andthe Chair of Ergonomics at TUM(Professor Klaus Bengler).

A video is available at www.youtube.com/watch?v=TwQopm_G3C0&feature=youtu.be.For more information, visit www.tum.de.

Scientists at TUM developed a wheelchair thatcan climb stairs. (Credit: Uli Benz/TUM)

Powered by an electric motor, the legs push thewheelchair to the next higher step. (Credit: UliBenz/TUM)

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https://www.youtube.com/watch?v=TwQopm_G3C0&feature=youtu.be

https://www.tum.de


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■ Analog Front EndAnalog Devices, Norwood, MA, has announced a low-power biopo-

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smaller, lighter, and less-obtrusive cardiac monitoring devices with

longer battery life. The AD8233 AFE is a fully integrated, single-lead

electrocardiogram (ECG) front end designed in a single, compact,

easy-to-use component. The out-of-the-box AFE eliminates the need to

design ECG front ends from individual components. The AFE’s 2.0 1.7

mm size enables the design of wearable health devices that are smaller,

lighter, and easier to wear. The AFE’s low microamp-range power consumption results in greatly

extended battery life.


■ Etched and Formed Micro Metal PartsTech-Etch, Plymouth, MA, combines photochemical etching

with precision metal bending to create extremely small formed

features in thin metal parts. Tool and die makers use state-of-

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■ Development PlatformDesigned for health, wellness, and high-end fitness applications, the

ultra-small hSensor Platform is offered by Maxim Integrated Products,

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Emerson leads the medical global assembly market with the premier technology of Branson Ultrasonics. The Branson portfolio offers the broadest range of advanced solutions for materials joining and precision cleaning in the medical industry.

• The right solution for your specific application through our process neutral approach• Laser welding for the utmost in freedom for complex, contoured shapes• 2000Xc ultrasonic welders with secure process controls and detailed weld data

to assist with medical FDA 21 CFR part 11 regulations compliance

BransonUltrasonics.com l Americas 203-796-0400 l Europe 49-6074-497-0 l Asia 86-21-3781-0588

Unmatched expertise in materials joining and precision cleaning

© Branson Ultrasonics Corporation 2017. The Emerson logo is a trademark and service mark of Emerson Electric Co.

See us at MD&M West, Booth #2439 MD&M East, Booth #1939


■ Circular Cold SawBehringer Saws, Morgantown, PA, has added the VA-L 500 to its line

of high-performance circular cold saws for production cutting of alu-

minum and nonferrous materials. The VA-L 500 can saw the full range

of aluminum alloys and other nonferrous materials in solids, thin-

walled pipe, and profiles. The saw

comes standard with a 32 HP fre-

quency-controlled drive motor with

800–3400 RPM speed range and a

servo-driven downfeed with an

adjustable rate from 0.39 to 19.6

in./sec, to ensure the fastest possi-

ble cut times. The fully automatic

circular cold saw has a cutting

range of 6.0 in. (152 mm) for

round materials or 6 × 6 in. (152 × 152 mm) for square materials at 90°

using a carbide-tipped circular saw blade with a diameter of 19.6 in.

(500 mm).


■ High-Performance DC FansCUI, Tualatin, OR, has added a high-performance dc fan line to its

existing thermal management portfolio. The CFM series with frame sizes

of 40, 50, 60, 70, 80, 92, and

120 mm delivers airflow

ranging from 10 CFM in the

40 mm series to over 200

CFM in the 120 mm series.

Available with rated voltages

of 5, 12, 24, and 48 VDC, all

dc fans feature dual ball

bearing construction for

maximum reliability and

come as standard with auto restart protection. Static pressure values for

the CFM series range from 2.79 up to 19.8 mmH2O with low rated cur-

rents from 0.1 to 1.4 A. Options for tachometer signal, rotation detector,

and PWM control signal are also available depending upon the model.


■ Standoff FastenersPennEngineering, Danboro,

PA, offers self-clinching stainless

steel standoff fasteners with

bright nickel plating. The PEM®

standoff fasters provide corro-

sion resistance and contribute to

an attractive finish in stainless

steel assemblies. These 400

Series stainless steel threaded

fasteners allow for the mounting, spacing, or stacking of panels,

boards, or components and install reliably into thin stainless host

sheets by pressing them into prepunched and properly sized round

mounting holes. After installation into sheets with hardness up to

HRB 88/HB 183, they become permanent parts of an assembly and

will not loosen or fall out. A mating screw completes the attachment

process.


■ Media Isolation ValveClippard Instrument Laboratory, Cincinnati, OH, offers a media

isolation valve that uses a flexible diaphragm to isolate the actuation

mechanism from the fluid path. The NIV series solenoid-operated

valves are commonly used

in applications that require

precise, repeatable dispens-

ing of media for analytical

instrumentation. All wetted

areas of the valve are PTFE,

making this series ideal for

use with corrosive media. A

one-piece valve stem func-

tions as a sealing mem-

brane while also supporting and centralizing the poppet in the seat-

ing area. This multifunctional poppet/diaphragm/stem results in a

simplified design with fewer parts for the two- and three-way valves,

longer life, and zero dead volume.


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FREEDesigner’sSample Kit

FREE

• High accuracy and repeatability, with tolerances to ±0.00254mm. Surface finish to 8 micro inches. Available uniform I.D. and O.D. Gold Plating or Cladding

• Slotting, flaring and hole punching for intricate designs with no additional handling

• Braxton can deep draw most conventional and exotic metals and alloys, plated or unplated, to 57mm max length

• Diameters as small as 0.215mm O.D. with a wall thickness as little as 0.0127mm. Length to diameter ratios up to 57:1

Braxton Manufacturing Co., Inc.Watertown, CT 06795 • Tel: 860-274-6781

Braxton Manufacturing Co. of California, Inc.Tustin, CA 92780 • Tel: 714-508-3570

ISO 9001:2008CERTIFIED

BRAXTON Deep-Drawn Micro Components

To order, go to:braxtonmfg.com/kitor call 877-262-5958

From implantable parts made of commercially pure Grade 1 or 2 titanium to nicely finished dental implant packaging components, Braxton’s manufacturing expertise should be an essential element in precision medical parts.

MD&M West - Booth 3340

■ Embedded ComputerVersaLogic, Tualatin, OR, has

released the next generation of the

company’s embedded processing

unit (EPU) format. The Osprey com-

bines processor, memory, video, and

system I/O into an extremely compact

full function embedded computer. The

EPU was engineered to meet require-

ments for smaller, lighter, and more powerful embedded systems.

Roughly the size of a credit card and less than 1.1 in. (28 mm) thick,

the Osprey combines the new fourth generation Intel® Atom™ Bay Trail

processor, with new system interfaces, in a form factor designed to

withstand extreme temperature, impact, and vibration.


■ Fiber Optic Micro SwitchMicronor, Camarillo, CA, has

launched a fiber optic micro

switch designed to meet the

requirements of MRI, medical,

and industrial applications. The

MR386 ZapFree™ Microswitch is

interchangeable with industry

standard V15-series electrical

micro switch. The MR386 is said to outperform conventional electrical

micro switches and limit switches. The entirely nonelectrical, totally

passive sensor provides EMI and RFI immunity, isolation from high

voltage and lightning and inherent safety in explosive atmospheres. It

can operate interference-free over distances up to 1500 m.


■ SPDT PIN Diode SwitchesFairview Microwave, Allen, TX, has intro-

duced a new line of single pole dou-

ble throw (SPDT) PIN diode switch-

es. The switches are designed to offer

exceptional reliability and repeatable

performance in compact and rugged

coaxial packages. Fast switching

speed performance is critical in appli-

cations where multiple switches are being

used in series, or where highly sensitive transmit and receive switching rates

need to be established. The line includes 23 models, covering frequencies

from 10 MHz to 67 GHz. Isolation levels up to 80 dB ensure that unwanted

signals will not leak into the desired signal path.


■ Automated DispensingGraco Advanced Fluid Dispense (AFD),

North Canton, OH, has released a fully auto-

mated precision dispense solution that pro-

vides a single source for motion, fluid dispense,

and process monitoring for thermal interface

management (TIM) applications. The Graco

UniXact helps electronic manufacturing cus-

tomers shift from thermal pads to dispensable

material, which is widely used for thermal man-

agement of smaller electronic devices. The unit

is designed to handle TIM materials that are

highly viscous and highly abrasive. It features a 1-gal Dynamite Pump

and Graco rod-positive displacement valves, which eliminate the draw-

backs associated with time-pressure valves.


Extend The Life of Tools and Wear Surfaces Up to 1000%.

Improve and renew Micro-Electronic Tools, Surgical Instruments and Micro- Laboratory Instruments with the Hunter Carbitron 300. This simple easy-to-use process applies tungsten-carbide to tools and wear surfaces extending the life up to 1000%.

The Carbitron 300 system, consisting of an adjustable power supply and vibrating hand-tool is a heavy-duty unit incorporating the features of units selling for 5 – 10 times its low price.

Used for Tissue Forceps, Needle Holders, Micro Needle Holders, Micro Pliers etc.

Hunter Products Inc.908-526-8440

www.hunterproducts.comE-mail: [email protected]

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INSIGHT - INNOVATE - INTEGRATE

Precision dispensing from 10 l to 1682 ml/min with discharge pressures to 100 PSI. Accuracy to +/- 1% and repeatability at +/- 0.5% CV. Precision dispensing

pump clean and operating smoothly even while pumping high saline or other crystalline solutions.

Visit us at MD&M West in Anaheim CA Feb 7-9 2017Booth #1511

IWAKI’s V-Series

IWAKI Precision ValvelessCeramic OEM Dispensing Pump


■ Power SupplyPower Partners, Hudson, MA,

has released a new series of

AC/DC desktop power supplies.

The 72-W Level VI PEAD72 series,

which has a package size of 4.45 ×1.93 × 1.37 in., can have either a

Class I or Class II configuration.

The power supplies have a universal input of 90–264 VAC and are offered

in single output models of either 12, 15, 18, 19, 24, 36, or 48 V. Features

include <210 mW no load power consumption, LED on indicator, and over-

load and short circuit protection. The power supplies have an operating

temperature of 0–40 °C full load and an operating altitude of <5000 m oper-

ational and storage, with a mean time between failure of >100,000 hours per

MIL-HDBK-217F at full load and 25 °C ambient.


■ Laminar Flow CabinetsLaminar flow cabinets from Air Science, Fort

Myers, FL, are designed to protect the work surface,

products, and materials from particulate contamina-

tion. Room air first passes through a HEPA filter

then uniformly through the cabinet interior by lam-

inar flow to protect work from unfiltered air. Airflow

is oriented to exhaust airborne particulate intro-

duced by the user. The Purair FLOW series employs

the company’s Multiplex™ HEPA filtration technolo-

gy to sustain the contamination-free environment. The ISO Class 4 cabi-

nets are available in three model sizes with various options.


■ Position HingeA position hinge from Reell Precision

Manufacturing, St. Paul, MN, incorporates unique

engineering in a compact design to hold the angle

of mounted components reliably in any position

in especially small assemblies. The RT-50 hinge’s 5

mm size and constant torque capabilities (1–3 lb-

in/0.11–0.33 N•m) are suitable for demanding

applications with limited footprints where precise

position control for components is necessary and

critical. An optional dual-ended mounting config-

uration enables a single hinge to be used in place

of two. Hinge shaft-end attachment styles include flag, straight, and

exposed knurled shaft.


■ Metal Injection Molding ServiceSmith Metal Products, Center

City, MN, offers metal injection

molding (MIM), an alternative to

machining parts out of raw metal

stock. MIM is often a more effec-

tive process to achieve precision

parts while eliminating machin-

ing because MIM parts are pre-

cise, net-shaped parts that are

produced faster and usually with no secondary operations. Parts that

are suitable for MIM processing include those that have annual vol-

umes of 10,000 pieces or more and a finished part weight of less than

100 g (3.5 oz). All dimensions of the component should be 3 in. or less,

and the maximum wall thickness should be 3 mm (0.125 in.) or less.

MIM products must be ferrous metals.


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■ Wound-Care AdhesivesLohmann, Orange, VA, has launched a custom adhesive specif-

ically designed for manufacturers of wound-care products. The

DuploMED Soft-Stick™ Series features gamma-sterilization sta-

ble, gel-like pressure-sensitive adhesives with all the advantages of

traditional silicone adhesives for pain-free, easy-off adhesion —

important for patients with fragile skin. Soft-Stick is permeable to

water vapor, and is painless and residue-free. Dressings can be

contoured to the wound and sealed around the edges. They can be applied, repositioned, and

removed without pain or the risk of damaging fragile skin.


50 Medical Design Briefs, February 2017

■ Machining CenterMethods Machine Tools,

Sudbury, MA, has added a

horizontal machining center

with a column traverse struc-

ture to its current KIWA line.

The KIWA-Japan Triple H40

supports flexible mounting

of various fixtures and rotary

tables based on the applica-

tion. The stationary table design enables long

workpieces to be clamped firmly to the table,

eliminating the back and forth action of moving

parts with special guarding and allowing machin-

ing access to either end of long workpieces. The

compact machining area measures 43.3 × 23.6 ×31.5 in. (1,100 × 600 × 800 mm).

For Free Info Visit


■ Dual Channel BuffersIntegrated Device Technology (IDT), San

Jose, CA, has introduced four high-performance,

low-power, LVDS dual-channel fanout buffers.

The new 1.8 V buffers in the IDT® 8P34S fam-

ily enable the simultaneous fanout of high-fre-

quency clock and data signals, with very

low additive phase jitter of typically <45 fem-

toseconds. Each of

the devices’ two in -

dependent buffer

channels offers up

to eight low-skew

outputs. Effective

isolation between

channels minimizes noise coupling. AC char-

acteristics such as propagation delay are

matched between channels. The dual-chan-

nel buffers allow board designers to reduce

power consumption while maintaining clock

performance.

For Free Info Visit


■ Linear DC Micro WelderAmada Miyachi America, Monrovia, CA, has

added a linear DC micro welder to its existing

product line. The UB29A

provides a larger current

range, greater control,

and markedly faster rise

time for micro-miniature

resistance welding than

existing micro welders. It

features closed-loop feed-

back, fast response times,

and a controlled precise

energy waveform. The welder delivers an out-

put power range of 15–1500 A in four control

modes: current, voltage, power, and V-A (volt-

age-current). It delivers a precisely controlled,

repeatable waveform with an ultrafast rise time

of less than 200 microseconds.

For Free Info Visit


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Free Info at http://info.hotims.com/65848-787Free Info at http://info.hotims.com/65848-786Free Info at http://info.hotims.com/65848-785

Free Info at http://info.hotims.com/65848-782 Free Info at http://info.hotims.com/65848-783

Free Info at http://info.hotims.com/65848-780Free Info at http://info.hotims.com/65848-779

SWABABLESTRAIGHT MALETHREADEDVALVESHalkey-Roberts needlefreeswabable male threadedvalves utilize a female luerlock connector and a maleluer lock adaptor to matesecurely with all standardluer syringes and connec-

tors. The valves are available with a clear or red hous-ing and a clear or blue septum in both polycarbonateand BPA-free copolyester. www.halkeyroberts.com

Halkey-Roberts

MOLEX SMP RFSUBMINIATURECONNECTORSMaximize performance ineven the most compact spaceswith SMP Connect ors, reduc-ing system weight while deliv-

ering superior reliability. Features include: • DC to 40 GHz • Subminiature design • Push-on orsnap coupling • Compact size • Up to 0.50 mm radialmisalignment • Up to 0.70 mm axial misalignment • Cable-mount versions for both flexible and semi-rigid cableIn Stock at Heilind; 800-613-6723. www.heilind.com/rpages/molex_smp_ntspot

Heilind

BIOCOMPATIBLEEPOXY PASTESYSTEMMaster Bond EP3HTND-2Med Black is a one-partsystem that combines easyprocessing with excellent

physical strength and bonding properties. This epoxyfully meets USP Class VI specifications and is widelyused in the manufacturing and production of bothdisposable and non-disposable medical devices.www.masterbond.com/tds/ep3htnd-2med-black

Master Bond

TPR TUBING —FREE SAMPLESuprene® thermoplastic rub-ber tubing resists flex fatigueand offers outstanding com-pression characteristics —ideal for peristaltic pump

applications. Offered in FDA-grade material in 64Ahardness; raw material complies with NSF-51 stan-dards. Autoclavable and suitable for a variety of cleanuses. Withstands temperatures from –76 °F to 275 °F(–60°C to 135°C). Industrial grade also stocked. Madein USA. www.newageindustries.com/sample-mdb4

NewAge® Industries Inc.

PRODUCTSPOTLIGHT

CLAD METAL MEDICAL WIREAnomet Products manufacturesclad metal medical wire com-bining high-strength, highlyconductive, biocompatible, andradiopaque 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

MULTIPHYSICS MODELING, SIMULATION, APP DESIGN ANDDEPLOYMENT SOFTWARE

COMSOL Multiphysics® is an integrated software envi-ronment for creating physics-based models and simula-tion apps. Add-on products allow the simulation of elec-trical, mechanical, acoustic, fluid flow, thermal, andchemical applications. Interfacing tools enable its inte-gration with all major technical computing and CADtools. Simulation experts rely on COMSOL Serverproduct to deploy apps to their colleagues and cus-tomers worldwide. https://www.comsol.com/products

COMSOL, Inc.

CLEAN ROOMMOLDING, ASSEMBLY, ANDPACKAGING

Medbio is an ISO 13485:2003 certified full-servicecontract manufacturer, specializing in precisioninjection molding, assembly, packaging, design sup-port, and project management. All manufacturing isdone in our certified ISO Class 7 and 8 clean rooms.From components to full assemblies, Medbio has theexperience to solve your most difficult manufactur-ing challenges. www.medbioinc.com

Medbio, Inc.

TRUMPF’S TRUMARK 5020NOW WITHVISIONLINE MARKThe TruMark image pro-cessing solution, VisionlineMark makes marking even

simpler by offering autofocus and enhanced retrace-ability. Paired with a TruMark laser and the TruMarkStation 5000, the TruMark 5020 with Visionline Markhas impressive processing speeds, adaptable pulsedurations, and a maintenance-free beam source, in acompact, ergonomic workstation. For more in -formation, please contact [email protected]. www.medicaldesignbriefs.com/trumpf201611

TRUMPF Inc.

LASER MICRO-MACHININGLaser systems and con-tract manufacturing,PhotoMachining hasthe latest technology –femtosecond, picosec-

ond and nanosecond lasers for heat free microman-ufacturing. From prototype to mass production,start-ups to Fortune 500 companies, our expertise isavailable for you. For a free analysis of your applica-tion, contact us today: [email protected],603-882-9944, www.photomachining.com.

PhotoMachining, Inc.

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WebinarsWhy Plastic Bearingsare Actually Superiorto Metal

Hope Mammone Product Specialist, iglide Plastic Bearingsigus Inc.

In this Webinar, discover the reliability of plastic bearings,uncover the extensive real-world testing they endure to provetheir strength and reliability, learn about a wide range of plasticmaterial options to suit even the most demanding applicationrequirements, and find tips and tricks for selecting the idealbearing for your application.

Speaker:

This 30-minute Webinar includes:• Live Q&A session • Application Demo • Access to archivedevent on demand

This 30-minute Webinar includes:• Live Q&A session • Application Demo • Access to archivedevent on demand

Please visit www.techbriefs.com/webinar403

Available On Demand!

Securing MedicalDevices in aHostile World: Challenges and Ideas for Manufacturers All around the world medical devices are being deployed inincreasingly unsecured environments. This Webinar will providea brief discussion of the top cybersecurity issues that medicaldevices face today and will also explore the most effective wayto assess the state of the device’s security, including a discus-sion on appropriate mitigations that can be used.

Chana O’LearySr. Application Security Consultant OpenSky Corp.

Speaker:

Please visit www.techbriefs.com/webinar398

When power is critical to your equipment as well as your patients, you can rely on MEGA Electronics to deliver.

Power supplies and cords to UL60601-1 and international approvals. Power supplies meet Energy Level VI, 4th edition and 2x MOPP.

Upon your next requirement, please keep MEGA in mind.

Power Supplies and Cords to 60601-1

MEGA Electronics Inc.4B Jules Lane

New Brunswick, NJ 08901tel. 732.249.2656 fax. 732.249.7442

[email protected]

Internationally Recognized Consulting Company to the MEDICAL DEVICE/IVD/PHARMACEUTICAL INDUSTRIES

mdi Consultants Inc. has the expertise and can provide you exceptional professional aid in the following areas:

FDA compliance – Regulatory strategy development, clinical trial development/ management, cGMP compliance, ISO, CE Mark, On-site audits, validation (process, software and sterilization)510(k)/PMA/ANDA/NDA/DMF/IDE Planning - Preparation and Submission, device listing and registrationCustomized Quality Systems for FDA QSR/cGMP/ISO ComplianceAssist with your MDSAP audit planningFDA Troubleshooting, Response to 483 and Warning lettersUDI & GUDID ComplianceOfficial Correspondent and United States Agent for Foreign CompaniesFDAAWARE – FDA database for all your FDA inspectional insights

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

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http://www.techbriefs.com/webinar403

http://www.techbriefs.com/webinar398

ADVERTISERS INDEX

Air-Logic...............................................................746........................ 39

Anomet Products...................................................779........................ 51

ATI Industrial Automation........................................ 752........................ 14

Branson Ultrasonics Corp. .....................................767........................ 47

Braxton Manufacturing Co., Inc. ............................. 776........................ 48

Clippard Instrument Company..................................855.......................... 4

COMSOL, Inc. .............................................. 747, 780.................... 5, 51

Crystal IS..............................................................744.......................... 2

Delstar/Argotec....................................................788....................COV III

Eurofins Lancaster Laboratories, Inc. ...................... 749........................8-9

Excelitas Technologies............................................ 791........................ 27

Fluid Metering, Inc. ...............................................770........................ 49

Fluortek................................................................745.......................... 3

Halkey-Roberts Corporation.............................766, 781.................. 43, 51

Heatron, Inc. ....................................................... 748.......................... 6

Heilind Electronics..................................................782........................ 51

Hotwatt Inc. .........................................................774........................ 40

Hunter Products, Inc. ............................................773........................ 48

International Manufacturing Services, Inc. ................ 761........................ 44

Interpower Corporation...........................................754........................ 17

Iwaki America........................................................771........................ 49

John Evans’ Sons Inc. ............................................763........................ 37

Magnetic Component Engineering, Inc. .................... 760........................ 42

Master Bond Inc. ......................................... 775, 783.................. 40, 51

maxon precision motors, Inc. ................................. 764........................ 38

mdi Consultants, Inc. ............................................ 778........................ 52

MedBio, Inc. ........................................................ 784........................ 51

MEGA Electronics Inc. ........................................... 777........................ 52

Micro Systems Technologies Management AG.....768, 769......................... 45

MicroLumen Inc. .................................................. 790........................ 33

MICROMO.............................................................755........................ 19

NewAge® Industries............................................... 785........................ 51

Nordson MEDICAL, Value Plastics Fluid Mgmt .......... 762........................ 35

Okay Industries......................................................751........................ 13

PhotoMachining, Inc. .............................................786........................ 51

Sensirion AG......................................................... 772........................ 32

SMC Ltd. .............................................................759........................ 30

Specialty Coating Systems, Inc. ...............................793........................ 25

Statek Corporation.................................................817........................ 46

Steute Meditech, Inc. ............................................789................... COV IV

TDK-Lambda Americas Inc. .................................... 856........................ 50

Teleflex Medical OEM..............................................750.......................... 7

The Bergquist Company..........................................756........................ 11

The L.S. Starrett Company......................................758........................ 23

The Lee Company.................................................. 753........................ 15

TRUMPF Inc. ............................................... 743, 787.................... 1, 51

Ulbrich Stainless Steels & Special Metals, Inc. ..........757........................ 21

Unimed S.A.......................................................... 765........................ 41

Wacker Chemical Corp ..........................................742.................... COV II

Watson-Marlow Fluid Technology Group ................... 792........................ 29

Zeus, Inc. ............................................................794.........COV IA-COV IB

For free product literature, enter advertisers’ readerservice numbers at www.techbriefs.com/rs, or visit theWeb site beneath their ad in this issue.

Reader ServiceCompany Number Page

Publisher....................................................................Joseph T. PrambergerAssociate Publisher....................................................................Helene Beck

(908) 300-2538Sales Director........................................................................Desiree Stygar

(908) 300-2539Editorial Director........................................................................Linda L. BellEditor & Director of Medical Content..........................................Sherrie Trigg Managing Editor, Tech Briefs TV.................................................Kendra SmithProduction Manager............................................................. Adam SantiagoAssistant Production Manager.................................................Kevin ColtrinariCreative Director...................................................................... Lois ErlacherSenior Designer...................................................................Ayinde FrederickMarketing Director...............................................................Debora RothwellMarketing Communications Manager...........................................Monica BondDigital Marketing Coordinator................................................. Kaitlyn SommerAudience Development/Circulation Director......................... Marilyn SamuelsenAudience Development Coordinator............................................Stacey NelsonSubscription Changes/Cancellations............................... [email protected]

TECH BRIEFS MEDIA GROUP, AN SAE INTERNATIONAL COMPANY261 Fifth Avenue, Suite 1901, New York, NY 10016(212) 490-3999 FAX (646) 829-0800Chief Executive Officer.................................................. Domenic A. MucchettiExecutive Vice-President......................................................... Luke SchnirringTechnology Director................................................................Oliver RockwellSystems Administrator.............................................................. Vlad GladounWeb Developer........................................................................Karina CarterDigital Media Manager............................................................................ Peter BonavitaDigital Media Assistant Manager............................................................Anel GuerreroDigital Media Assistants...............Peter Weiland, Howard Ng, Md JaliluzzamanDigital Media Audience Coordinator.............................................Jamil BarrettCredit/Collection...................................................................... Felecia LaheyAccounting/Human Resources Manager......................................Sylvia BonillaOffice Manager.....................................................................Alfredo VasquezReceptionist..............................................................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 Heeg49-621-841-5702

Sven Anacker 49-202-27169-11

Europe — Western......................................................................Chris Shaw44-1270-522130

Integrated Media Specialists.....................................................Patrick Harvey(973) 409-4686

Angelo Danza(973) 874-0271

Scott Williams(973) 545-2464

Rick Rosenberg(973) 545-2565

Todd Holtz(973) 545-2566

Reprints................................................................................ Rhonda Brown(866) 879-9144, ext. 194

Medical Design Briefs, ISSN# 2158-561X, USPS 4865, copyright ©2017 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 2017, Volume 7, Number 2.


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GLOBALL INNOVATIONSIGLOBALL INNOVATIONSI

3D Printed Lens Enhances Images in New Ultrasound DeviceNanyang Technological UniversitySingaporehttp://media.ntu.edu.sg

GLOBALL INNOVATIONSIGLOBALL INNOVATIONSI

Scientists from Nanyang Techno -logical University (NTU),Singapore, have developed an

ultrasound device that produces sharp-er images through the use of 3D print-ed lenses. With clearer images, doctorsand surgeons can have greater controland precision when performing nonin-vasive diagnostic procedures and med-ical surgeries.

The innovative ultrasound device isequipped with superior resin lenses thathave been 3D printed. The new devicewill allow for more accurate medical pro-cedures that involve the use of ultra-sound to kill tumors, loosen blood clots,and deliver drugs into targeted cells.

In current ultrasound machines, thelenses that focus the ultrasound waves arelimited to cylindrical or spherical shapes,restricting the clarity of the images. With3D printing, complex lens shapes can bemade, resulting in sharper images. The3D printed lenses allow ultrasound wavesto be focused at multiple sites, or the lens-es can shape the focus specifically to suita target, which current ultrasoundmachines are unable to do.

The novel ultrasound device was devel-oped by a multidisciplinary team of scien-tists, led by Claus-Dieter Ohl, an associateprofessor in NTU’s School of Physical andMathematical Sciences. The ultrasounddevice has undergone rigorous testing,and the findings have been published in apaper titled, “Laser-Generated focusedUltrasound for Arbitrary Waveforms,” inApplied Physics Letters, a peer-reviewed jour-nal published by the American Institute ofPhysics.

■ How it WorksIn the paper, the researchers describe

how transducers for laser-generatedfocused ultrasound can achieve photo -acoustic waves with several hundred barspositive pressure in water, whereas previ-ous designs have employed concaveglass substrates decorated with catalyti-

cally grown carbon nanotubes. Thepaper discusses how their process showsthat arbitrarily shaped surfaces made ofpolymers and printed with 3D printersallow the generation of waveforms withcomplex temporal and spatial shapes.

They present three different polymermaterials together with a simplified depo-sition technique, which was achieved by“painting layers of carbon-nanotube pow-der and polydimethylsiloxane.” Using aclear resin, the researchers obtained pres-sure amplitudes of 300 bar peak positive.The researchers note that the flexibilityof polymer substrates enabled complexwaveforms to be generated. Theresearchers say that this is demonstratedwith a stepped surface, which launchestwo waves separated by 0.8 μs. In thepaper, detailed pressure measurementsare supported with shadowgraph imagesand simulations of the wave.

■ Overcoming Current LimitationsUltrasound waves are produced by fir-

ing sound waves at a glass surface or “lens”to create high-frequency vibrations. Inconventional ultrasound machines, theresulting heat causes the lens to expandrapidly, generating high-frequency vibra-tions that produce ultrasound waves.

With lenses that are 3D printed, thenew ultrasound device overcomes thelimitations of glass. Customized andcomplex 3D printed lenses can be made

for different targets, which results in bet-ter imaging. In addition, the 3D printedlenses are cheaper and easier to producethan conventional glass lenses.

“3D printing reinvents the manufac-turing process, enabling the creation ofunique and complex devices. In turn,the way medical devices are createdneeds to be rethought. This is an excit-ing discovery for the scientific communi-ty as it opens new doors for research andmedical surgery,” said Ohl.

With this breakthrough, the NTUteam has begun discussions with variousindustry and healthcare partners look-ing to develop prototypes for medicaland research applications.

“In most medical surgeries, precisionand noninvasive diagnosis methods arecrucial. This novel device not onlydetermines the focus of the wave butalso its shape, granting greater accura-cy and control to medical practition-ers,” said Ohl.

This breakthrough taps into an ultra-sound market that is expected to grow toabout US $6.9 billion by 2020. Theresearch is also expected to promotenew medical techniques and researchopportunities in health sciences such assurgery and biotechnology. Researcherscould use the sound waves to measureelastic properties of cells in a petri dish,seeing how they respond to forces. Thiswould be useful, for example, to distin-guish between harmful and benigntumor cells.

“This is a very promising break-through, potentially offering significantclinical benefits to the field of cancerimaging. This technology has the poten-tial to reduce image distortions andmore accurately differentiate cancerousfrom noncancerous soft tissue,” said TanCher Heng, adjunct assistant professor,LKC medicine lead for anatomy andradiology, and senior consultant with theDepartment of Diagnostic Radiology atTan Tock Seng Hospital.

GLOBALL INNOVATIONSI

A new ultrasound device produces sharperimages through 3D printed lenses. (Credit:Nanyang Technological University)

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