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Welcome to

your Digital Edition of

Medical Design Briefs

July 2016

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From the Publishers of

www.medicaldesignbriefs.com July 2016

SPECIAL SECTION:Technology Leaders in Motors & Motion Control

Helping Startups Solve theCompliance Puzzle

Interpreting ElectromagneticCompatibility Requirements

IoT and UDI Compliance

Setting the Standard for “Medical-Grade” Foot Controls™

(203) 244-6302 www.steutemeditech.com [email protected]

The design of your medical device’s foot control can greatly affect your customer’s user-experience. Excessweight, poor sealing, user-fatigue, difficulty in cleaning/handling, or cracked/peeling finishes can compromisetheir satisfaction and your product’s image.

Such consequences can easily be avoided.

Steute has pioneered the design and manufacture of fully-compliant, medical-grade foot controls.We have satisfied medical device OEMs’ unique needs with thousands of application-specific foot controls …each functionally, ergonomically, and aesthetically-optimized to the OEM’s requirements.

We would be pleased to do the same for you. Call or write for a no-obligation design consultation, a free copyof our white-paper, “Design Differences of a Medical-Grade Foot Control”, or to discuss receiving acomplimentary sample for evaluation.

Technical Support & Warehousing Center — Ridgefield, Connecticut

It’s your customer’severyday user experience.

It’s much more thana foot control...

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From the Publishers of

www.medicaldesignbriefs.com July 2016

SPECIAL SECTION:Technology Leaders in Motors & Motion Control

Helping Startups Solve theCompliance Puzzle

Interpreting ElectromagneticCompatibility Requirements

IoT and UDI Compliance

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4 Medical Design Briefs, July 2016Free Info at http://info.hotims.com/60163-733

■ COLUMN

6 From the Editor

■ FEATURES

8 Solving the Compliance Puzzle for Medical DeviceStartup Companies: The Entrepreneur’s Basic Guideto Understanding Product Regulations & Testing

12 The Internet of Things and UDI Compliance

15 New Medical Device EMC Requirements

18 Transdermal Drug Delivery Poised for GrowthThanks to Microneedle Technology

40 Advancing Ablation Technology Using Simulation Science

42 A Guide to Thermoforming Heavy-Gage, ComplexParts: From Material Selection to Custom Tooling

■ TECH BRIEFS

36 Soft Tissue Robotic Surgery Outperforms StandardSurgery

37 Developing Mini Artificial Lungs

37 Creating Super Stretchy Artificial Muscles

38 How Sensors Can Help Save Preterm Babies

39 Finding Flaws in 3D-Printed Titanium

■ DEPARTMENTS

34 R&D Roundup

44 New Products & Services

47 Advertisers Index

48 Global Innovations

■ SPECIAL SECTION

Technology Leaders in Motors & Motion Control

22 Surgical Robotics: The Evolution of a Medical Technology

25 An Overview of the Most Popular Rotary MotionTechnologies

■ ON THE COVER

Most start-up medical device manufacturers lacktheir own testing capabilities, and few, if any, pos-sess up-to-date knowledge of international regula-tions, yet they are still legally responsible for ensur-ing that their products comply with all legislation orimport regulations. Fortunately, independent test-ing laboratories can be engaged early in the prod-uct development process. To learn more abouthow startup companies can approach regulationsand testing, please read the article on page 8.

July 2016

Published by Tech Briefs Media Group, an SAE International Company

© 2016 The Lubrizol Corporation, all rights reserved.

All marks are the property of The Lubrizol Corporation.

The Lubrizol Corporation is a Berkshire Hathaway company. 16-27710

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Good News/SadNews

For much of our recentEditorial & Sales Meeting,we discussed trends that

we are seeing in the marketplace, in thenews, and in discussion with contribu-tors to evaluate coverage for this yearand to help sharpen our editorial focusfor next year. Manufacturing will con-tinue to see greater coverage as weincrease the frequency of our highly

successful Medical Manufacturing &Fabrication supplement.

Areas that will see more extensive cover-age next year will include a stronger focuson miniaturized devices and their compo-nents, connected health and data man-agement, and of course, cybersecurity.Our August issue this year will feature sev-eral articles on new frontiers in health-care, wearable medtech, managing risk inconnected devices, and how miniaturiza-tion is driving creative solutions.

Real-time monitoring of health willcontinue to grow even as some currentfitness trackers like Fitbits are being dis-carded in favor of more advanceddevices. Apple just announced plans fora smartwatch that has special featuresfor people using wheelchairs.

Even Dean Kamen’s iBOT wheel-chair, which can “climb” stairs but wasdiscontinued in 2009 due to its highcost, has found new life. DEKAResearch and Development has joinedforces with Toyota Motor NorthAmerica to support mobility solutions,which will help to develop the next-gen-eration iBOT motorized wheelchair andits launch. The deal also allows Toyotato license DEKA’s balancing technologyfor rehabilitative therapy and other pur-poses. This is all great news.

Which is why it’s so sad for me to tellyou that I will not be here as Editor tobring you all of the exciting develop-ments in healthcare going forward. Ithas been my honor to be the Editor ofMedical Design Briefs for the past fouryears, bringing you the latest R&D andmanufacturing news in the medicaldevice fields. I’ve learned so much fromour readers about advances in technolo-gy, materials, components, and regula-tory issues.

Every good thing must come to anend, and the time has now come for meto say goodbye to our readers. I want tothank everyone who contributed timely,informative articles to MDB, and all whoshared their industry insights with me.

Leaving is difficult but necessary as Ibegin the next phase of my career in thefield of hospital administration.

Let me leave you with this lastthought—one thing that I have learnedfrom everyone whom I met in the med-ical products and components indus-tries and device contract manufacturingthat will keep me in good stead is toalways keep the patient in mind. All ofthe work you do results in products andinnovative technology used to save lives,reduce suffering, and restore health. Iam certain that I will be seeing many ofyour devices and cutting-edge technolo-gy around me every day in the hospitalsystem. Thank you for the great workyou do.

Beth G. Sisk, [email protected]


From the Editor

Ask Smalley.

smalley.com

Smalley Edgewinding

Process

Traditional Stamping Process

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THERMOPLASTIC

ABS (Acrylonitrile Butadiene Styrene)

ABS/PC (Acrylonitrile Butadiene Styrene / Polycarbonate)

ETPU (Engineered Thermosplastic Polyurethane)

HDPE (High-Density Polyethelene)

LCP (Liquid Crystal Polymer)

LDPE (Low-Density Polyethylene)

LLDPE (Linear Low Density Polyethylene)

PA (Nylon)

PBT (Polybutylene Terephthalate)

PC (Polycarbonate)

PC/PBT (Polycarbonate / Polybutylene Terephthalate)

PEEK (Polyetheretherketone)

PEI (Polyether Imide)

PET (Thermoplastic Polyester Resin)

PETG (Copolyester)

PMMA (Acrylic)

POM (Acetal)

PP (Polypropylene)

PPE/PS (Polyphenylene Ether / High-Impact Polystyrene)

PPS (Polyphenylene Sulfide)

PS (High Impact Polystyrene)

PSU (Polysulfone)

SB (Styrene Butadiene)

TPE/TPV (Thermoplastic Elastomer / Thermoplastic Vulcanizate)

TPU (Thermoplastic Polyurethane Elastomer)

INJECTION MOLDING Material Selector

MATERIAL PROPERTIES

Tensile Strength

Impact Strength

Heat Deflection

1,200–4,000 psi 130 �-lb/in2 130-190º


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8 www.medicaldesignbriefs.com Medical Design Briefs, July 2016

Often, the last thing first-time andeven serial entrepreneurs think

about is how the result of their passion-ate, innovative imagination is going tostand up to product testing and regula-tory compliance requirements, such asefficacy and usability evaluations. Yet, itis impossible to introduce a medicalproduct without such steps.

As an American medical device start-up, the issue you face is how is to makeyour device not just effective at what itdoes, but also compliant with the myriadof local and international standards andregulations required in order to legallysell the product.

The compliance puzzle has many

pieces. Above and beyond the stringentrequirements for the medical function ofthe products, medical device manufac-tures also have to deal with product safety,electromagnetic and/or radio frequencyinterference (EMI/RFI) issues, environ-mental regulations (WEEE/RoHS), cybersecurity and other requirements.

Pre-Compliance and You: Planningfor Success

Suitability of components and materi-als, compliance with technical standardsand fitness for use and manufacturabili-ty are just a few of the points that mustbe considered by the manufacturers dur-ing the design and development stages.

Most start-up manufacturers lack theirown testing capabilities, and few, if any,possess up-to-date knowledge of interna-tional regulations, yet they are still legal-ly responsible for ensuring that theirproducts comply with all legislation orimport regulations.

Fortunately, start-up medical devicemanufacturers have a resource they candraw upon: independent testing labora-tories, which should be engaged early inthe product development process. (SeeFigure 1)

There are a number of very good rea-sons why a start-up medical device man-ufacturer should strongly consider pre-compliance engagement with a qualifiedtesting laboratory. First is the dynamic,ever-changing nature of the regulatoryenvironment. Keeping up with thechanges and knowing their downstreamimplications incredibly challenging foany organization other than a registrar,let alone a busy entrepreneur. Secondly,partnering with an independent labora-tory means the results will be unbiased,and more akin to what the actual certifi-cation tests will be. Often such evalua-tions in the early design phase can iden-tify and help eliminate non-compliancesissues to provide significant cost andtime savings.

The Riddle of Product SafetyMost of us take product safety as a

given. We hardly ever consider that thecool new gadget in the office or kitchenmight damage property, cause injury oreven death. We are confident that ourproducts are manufactured in such a

Fig. 1 – When launching an innovative new product, regulatory compliance should be considered atthe early design stage. If not, it could become an obstacle, and your company’s incredible tool couldbe dead in the water.

The Entrepreneur’s Basic Guide to UnderstandingProduct Regulations & Testing

SOLVING THE COMPLIANCE PUZZLE FORMEDICAL DEVICE STARTUP COMPANIES:

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TEST YOUR MEDICAL PRODUCTS FOR EXPORT

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The Interpower International Power Source can also be ordered for international use with a country-specific input power plug.

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way that they will not set fire to ourhomes or electrocute us as we brew cof-fee, blow-dry hair, or send an email. Whydo we have such confidence? Theanswer lies in product safety standards.

For medical devices, the standards areeven more stringent than consumerproducts. A medical device makes physi-cal or electrical contact with a patient,transfers energy to or from the patientand/or detects such energy transfer toor from a patient. Because such a deviceis used for diagnosing or treatingpatients or monitoring patients, higherexpectations are placed on its safety andoperability. A medical device is expectedto not only perform as intended, but itmust be safe to patients, healthcareproviders, medical personnel, and otherdevice operators. (See Sidebar)

Whether in the US, Asia, or Europe,manufacturers must not only build theirproducts to comply with the local orinternational safety regulations but mustalso have their products approved orcertified by an independent third partylaboratory.

To make this less cumbersome to allparties, the IECEE Certification Body(CB) Scheme was developed. The CBScheme became the first truly interna-tional system for mutual acceptance oftest reports and certificates dealing withthe safety of electrical and electroniccomponents, equipment, and products.It is a multilateral agreement amongparticipating countries and certificationorganizations.

The FDA’s RoleWhile the CB Scheme may, at first

glance, simplify the certificationprocess—manufacturers only have to testand certify for electrical safety once togain access to 65 countries—the evolvingmarket has added new complications.

For example, the U.S. Food and DrugAdministration (FDA) is responsible forprotecting the public health by assuringthe safety, efficacy, and security of med-ical devices. The scope of the FDA’s reg-ulatory authority is very broad: it cur-rently covers more than 1,700 distincttypes of medical devices. Each of thesedevices is assigned to one of three regu-latory classes based on the level of con-trol necessary to assure the safety andeffectiveness of the device.

For medical products there are addi-tional requirements. According toSection 510(k) of the Food, Drug andCosmetic Act in the United States, the

FDA requires device manufacturers tonotify them of their intent to market amedical device at least 90 days inadvance. This is known as PremarketNotification, also called PMN or 510(k).Specifically, medical device manufactur-ers are required to submit a premarketnotification if they intend to introduce adevice into commercial distribution forthe first time or reintroduce a devicethat will be significantly changed ormodified to the extent that its safety oreffectiveness could be affected. Suchchange or modification could relate tothe design, material, chemical composi-tion, energy source, manufacturingprocess, or intended use.

Today’s Devices and Cyber SecurityThe FDA has also weighed in on

cybersecurity concerns in today’s med-ical devices. Because this is an ever pres-ent and ongoing issue, a robust cyberse-curity posture is necessarily part of adevice’s initial market assessment andapproval by the FDA. The FDA focusesdistinctly on the steps that companiesmust take to ensure that their device notonly delivers data securely, but that itstays secure throughout the productlifespan. (See Figure 2)

One security methodology empha-sized by the FDA is the use of iterativethreat modeling: the systematic assess-ment of risks, threats, and mitigationssurrounding a device. Now, the FDA ispromoting the concept of iterative andcomprehensive threat modeling as aleading practice in its post-market assess-ment management guidelines.

Key to this process is the monitoringof external cybersecurity informationsources for collaborative identificationand detection of device vulnerabilitiesand risk.

In conjunction with the Premarketguidelines released in October of 2014,the FDA is covering the complete gamutof product development and mainte-nance. It is not enough to simply assessthe medical device itself for security vul-nerabilities prior to its launch. Iterativethreat modeling, vulnerability assess-ment and sharing, and internal controlprocesses become key parts of the cyber-security framework around medicaldevices—both before and after theirmarket launch. Actionable ThreatIntelligence and coordination arounddata sharing models are valuable com-ponents of the exercise.

Risk ManagementSpeaking of threats and risks, there

are two ways to think about risk manage-ment in regards to product manufactur-ing: one can look at it as a business con-cern, or as a product concern.

Examining risk management as a busi-ness concern means all responsible par-ties within your company need to knowwhere the buck ultimately stops, who hasresponsibility if something goes wrong,and, in most cases, this rests firmly at thetop. This means that the CEO must makerisk management a priority, and then giveeveryone the right and the directive topoint out where risks lie, whether it is inthe supply chain, the manufacturingprocesses, or management. Another way

Fig. 2 – Because cybersecurity threats are an ever-present and ongoing issue, the FDA has issuedguidelines companies must take to ensure a device stays secure throughout its lifespan.

SOLVING THE COMPLIANCE PUZZLE

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to think about this would be to answerthe question, “Who is responsible if X, Y,or Z fails, and why?”

One can also look at risk managementfrom a product standpoint. In this case,you must be proactive instead of reac-tive. You know how your device is sup-posed to operate under optimal condi-tions. Product risk analysis will look atwhat could potentially happen in worst-case scenarios in order to build preven-tive failsafes into the product before anysuch scenario could happen.

Both methods of examining risk inorder to minimize undesirable effectsrequire a verification review or qualitysystem assessment by a qualified audi-tor/expert. Self-reporting product riskmanagement is not accepted as legiti-mate. A company cannot just self-declare their risk is appropriate and startto market their devices. Rather, in orderto gain certification, the risk manage-ment (of both management and prod-uct-related aspects) needs to be assessedunder the quality management systemprinciples—such as ISO 13485—by pro-fessionals. (See Figure 3)

Putting All the Compliance PiecesTogether

When launching a new product,everyone on the startup team strives todo so on time and on budget. If regula-tory compliance is not considered at theearly design stage, it could become anobstacle instead of a means to assurequality and safety. Too often, compli-ance matters are an afterthought, onlyconsidered when a product is completeor near-complete, and it may or may nothave been designed to the regulations ofa target market. Considering compli-ance and involving a regulatory serviceprovider during the R&D phase will help

avoid costly compliance oversights. If a new product fails safety tests at the

laboratory because of regulatory over-sight, the startup team may need toredesign the product partially or com-pletely. A manufacturer is not going toknow if their product fails or passes untilthe lab performs the test. If the productfails, it will either need a jury-rigged solu-tion paired with hopes that it will notcompromise the product’s performance,safety, or cost aspects, or it will need to goback to the drawing board for a redesign.This scenario can be disastrous for astart-up company trying to get a productoff the ground on a limited budget.

However, if the product design takesthe above areas of concern into consid-eration, either through pre-tests or con-sultations with a lab, a startup will notonly have a well-designed product for itstarget market(s), but will also be confi-dent that the compliance step of theproduct development cycle will notthrow a wrench into the launch sched-ule and budget.

The evolving market, technological,regulatory, and ecological drivers makethe overall certification process rathercomplicated. In order to successfullynavigate the complex regulatory envi-ronment, today’s medical device startupsare strongly advised to enlist the servicesof an accredited Nationally RecognizedTesting Laboratory (NRTL) in the earli-est possible stages of product develop-ment. These certifying bodies have theskills and experience needed to ensurethe finished product will be allowed onthe open market, and will bear certifica-tion marks attesting to this fact.

There are many certification marksout there and they can certify anynumber of things: from the region oforigin to materials of construction.

Certifications verified by an independ-ent third party carry more credibilitywith both regulators and consumers.These products are allowed to bear themarks of the particular certificationbody that tested the product, inspect-ed the factory where the final assemblyof the product takes place, and performed random sample testsand surveillance to assure ongoing compliance.

This article was written by Uwe Meyer,Business Field Manager - Medical Test, at TÜVRheinland, Newtown, CT. for more informa-tion, visit http://info.hotims.com/61063-162.

Medical Design Briefs, July 2016 www.medicaldesignbriefs.com 11

Fig. 3 – Higher expectations are placed on the safety and operability of medical devices because theyare used for diagnosing, treating, or monitoring patients. Such devices must perform as intendedwhile also being safe to patients, healthcare providers and medical personnel.

The Standard IEC 60601-1 for Medical

Electrical Equipment, Part 1: General

Requirements for Basic Safety And

Essential Performance addresses the

following hazards that may result in a

noncompliance rating for a product if it

is properly applied:

• Electric shock: Does your product have

sufficient protection or isolation not to

cause an electric shock hazard to an

ordinary user, service person or to a

patient?

• Excessive (Energy) Output Hazard:

Are there sufficient precautions to

reduce exposure caused by inaccuracy

of operating data or the accidental

high setting of an output?

• Mechanical hazards: Is your product

designed to avoid the contact with

sharp edges, rotating parts, or pinch

points if not specifically used for its

intended application?

• Excessive temperatures: Are

components getting too hot to create a

hazard?

• Radiation Hazards: Is your product

designed to reduce the risk of X-

radiation, microwave radiation, laser-,

LED-, IR-, UV radiation, or other

visible electromagnetic radiation?

• Fire and Other Hazards: Is there

exposure to excessive temperatures,

liquid spillage, or pressure vessels; are

human errors and other potential

hazards properly covered?

For safety evaluations, all safety-relevant

components are evaluated for suitability

of electrical rating, construction

requirements and other necessary

approvals. The choice of a suitable

standard or combination of standards

depends on the type of equipment and

is determined on a case by case basis.

For medical products there are many

collateral and Part-2 standards of the

IEC60601-series to choose from. If a

product is strictly intended for

laboratory use without any patient

contact, then IEC 61010-1 may need to

be considered.

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Consider for a moment the modernautomobile. A car’s computer can

pinpoint for a mechanic exactly what’sgoing wrong, and provide a thoroughhistory of how things have been working(or not) in recent weeks. Data networkskeep tabs on recalls and alert driverswhen parts need to be replaced. In somecases, operating software can be updat-ed wirelessly to address performance oremissions issues, without the driver lift-ing a finger.

Now ask: Shouldn’t my grandfather’sinsulin pump do that, too? (See Figure 1)

The U.S. Food and DrugAdministration (FDA) thinks someone’sreplacement hip or artificial heart valveshould respond in much the same fash-ion. So in 2013, they introduced theUnique Device Identification (UDI)requirements. These have had great bear-ing on the medical device industry—butthey have also provided that industrygreat promise in terms of leveraging theemerging technology of the Internet ofThings (IoT). Compliance with UDI willalso provide an unprecedented level ofdata gathering across manufacturing,distribution and end use that will offerall stakeholders the promise of greaterefficiency and other benefits.

More than Just ComplianceMedical device manufacturers are

nearly three years into compliancewith the UDI requirements. The FDAhas set the next two deadlines forSeptember of 2016 and 2018, withthe last deadline in September 2020.The specific requirements for each ofthose deadlines depend on the classof the device, whether it has FDAapproval already, and whether thedevice must be marked directly onthe part or just on its packaging. (SeeFigure 2)

But whether you are labeling andpackaging of Class III medical devicesor permanently marking a device tobe used more than once, the mainthrust for this mandate is to ade-quately identify medical devicesthrough their distribution and use.

The FDA assures there will be bene-

fits of a UDI system, be it improvingpatient safety, modernizing device surveil-lance (especially postmarket) or facilitat-ing medical device innovation. These ben-efits will specifically apply to industry, theFDA, consumers, health care providersand health care systems in the followingways:• Allowing more accurate reporting,

reviewing and analyzing of adverseevent reports so that problem devicescan be identified and corrected morequickly.

• Reducing medical errors by enablinghealth care professionals and others tomore rapidly and precisely identify adevice and obtain important informa-tion concerning the characteristics ofthe device.

• Enhancing analysis of devices on themarket by providing a standard andclear way to document device use inelectronic health records, clinicalinformation systems, claim datasources and registries. A more robustpostmarket surveillance system canalso be leveraged to support premar-

ket approval or clearance of newdevices and new uses of currently mar-keted devices.

• Providing a standardized identifier thatwill allow manufacturers, distributorsand healthcare facilities to more effec-tively manage medical device recalls.

• Providing a foundation for a global,secure distribution chain, helping toaddress counterfeiting and diversionand prepare for medical emergencies.• Leading to the development of a med-ical device identification system that isrecognized around the world.

It’s understandable that most devicemanufacturers will view the UDI mandateas something that must be met. However,some forward-thinking companies haveseized upon the fact its arrival coincideswith the maturity of Internet of Things(IoT) platforms, which allow communi-cation and data within your products.This convergence offers those companiesa rare singularity: The opportunity toexplore technologies and solutions thatnot only meet the UDI mandate, but alsodeliver on the IoT promise that analytics

will drive better decision making.

IoT and the Promise of DataData is already the currency of the

modern economy, but the IoTemphasizes just how much impactthat data can have, improving every-thing from manufacturing to distri-bution to the entire supply chain.This is emphasized by Industry 4.0and the digitization of things, inother words, your products andassets, which allows businesses to besmarter as they go about creating anddelivering safe products to the mar-ketplace.

UDI compliance for medicaldevices is a natural extension of thistrend. It is first and foremost abouthow having a small amount of identi-fication information creates benefitsfor all stakeholders, whether they aremanufacturing, distributing or usingthe product.

Manufacturers benefit in many ways.For instance, automating the processfor all their products allows them to

The Internet of Thingsand UDI Compliance

Fig. 1 – Shown is a typical insulin pump and CGM system.(Credit: Alden Chadwick, NIDDK, flickr)

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avoid manual pick/packs. Costs canalso be reduced through the efficientelectronic management of a product’smovement through the distributor tothe hospital, turning them into bene-ficiaries, as well. And, patients benefitfrom UDI, because the shared dataprovided by the ID of their medicaldevice eliminates risk and makes iteasier to recall.

This is a natural extension of earlyincarnations of the IoT, whose initialconcept was everyday objects shar-ing data and taking action across anetwork… though initial scenariostrended toward the domestic. Run -ning low on milk? Don’t worry, therefrigerator already noticed and hasarranged for a delivery from the closestgrocery store. Today, however, we aremuch closer to that singularity, whereeverything—products, assets, things—willcontinue to get smarter and become richwith localized data gathered over time.

Opportunity Knocks forManufacturing and Distribution

For medical device companies, infor-mation will become the foundation for

their manufacturing, and it will be aug-mented by more data about the prod-uct’s distribution, condition, and direc-tions for use, re-use, and upkeep. Inother words, devices will ship with apedigree and become embedded with adigital record of their entire life history.That local information will be the ben-efit made available for all stakeholders.

Consider the following case studies ofcustomers looking to use asset intelli-

gence solutions to gather data thatimproves their business.

A large pharmaceutical manufac-turer is looking to embed data onclean room materials, automatingthe environmental condition moni-toring during production. Auto ma -tion and embedding of in for ma -tion inside those materials savestime, reduces exposure to con -taminants, and offsets risk of onebad manufacturing batch, which isvital when a bad batch can cost$500,000.

A medical device manufacturerwants to embed data on disposabledevice that must be gamma sterilized.The data on the disposable provides

two benefits. Firstly, it provides authentica-tion at the time of use that the right dispos-able is connecting to and operating withthe right system within. Secondly, addi-tional data exchange between the dispos-able and the device sets operation param-eters of use, such as the rate of flow of flu-ids or speed of rotator blades. This dataexchange ensures that the disposable andthe system will be used in conjunction,reducing likelihood of counterfeit parts

Medical Design Briefs, July 2016 13Free Info at http://info.hotims.com/61063-738

Fig. 2 – Shown is an example of a UDI label.

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that can cause harm, and eliminates inac-curacies of human entry error by settingparameters digitally and automatically.

A manufacturing service provider isembedding detailed data about theproduct with its packaging. As the prod-uct moves through different stages of itsproduction—assembly, sterilization, andfinal packaging—it gathers confirma-tion of completion of each stage. Theembedded record of quality, sterilizationconfirmation, and release is carried with

it into the distribution channel. Eventhen, digital data continues to be gath-ered on the product so when it is eventu-ally opened for use, a digital chain ofcustody is visible. Manufacturers canmonitor and act just in time dependingon whether the device used in the hospi-tal is consigned or not consigned, bring-ing unprecedented visibility.

Now, the FDA is agnostic to the tech-nology that provides the non-humanreadable identification on the medical

device. Whether this part is a bar code orRFID matters not, as long as it meets thelabeling requirement. Each solution hashad their challenges, though. Bar codesmay not print well, they are difficult toread when subjected to frost or insideplastic wrapping, and they require laborintensive unpacking and packing forline-of-sight reading of the information.Traditional RFID technology had its lim-itations, too, because the data written tothe tag couldn’t survive rugged process-es or manufacturing conditions. Thisforced the tagging of products muchlater in the manufacturing cycle, therebylessening the impact of this data to pro-vide value add analytics and feedback tothe manufacturer.

Smart assets, however, are made intelli-gent with the capability to gather andcommunicate digital informationthroughout a device’s entire lifecycle.Installed at the time of manufacture,their rugged memory structure gathersdata constantly through all processes,including irradiation and harsh storageenvironments. If cold transport is a con-cern, for example, a sensor can be addedto track environmental conditions.Authentication can be assured by apply-ing a digital certificate. It will automati-cally create an audit trail and electronicpedigree, which in turn enables real-timereordering and more accurate revenuerecognition. All of these add value acrossthe spectrum of stakeholders, whilesimultaneously addressing the UDIrequirements being rolled out by FDA.

ConclusionIf you believe the premise of the

Internet of Things—that data anddevices will continue to becomesmarter—then you must believe datastored locally on your product, at yourfingertips, will continue to drive busi-ness innovation beyond mere compli-ance mandates.

By bringing intelligence to your prod-ucts and assets, you provide a platformto leverage localized data across all cur-rent and future infrastructure, businessunits, and among stakeholders. Onceyou have realized the IoT through asmart factory, a smart supply chain, asmart you-name-it, you will also realizethe data at your fingertips is changingthe way the world does business.

This article was written by TimothyButler, Founder and CEO, Tego, Inc.Waltham, MA. For more information, visithttp://hotims.com/61063-160.


The Internet of Things

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Implementation of IEC 60601-1-2, 4thedition is on the horizon. This collat-

eral standard to the IEC 60601-1 med-ical safety standard specifies the electro-magnetic compatibility (EMC) require-ments for medical devices and systems.The fourth edition was issued by the International ElectrotechnicalCommission (IEC) in February 2014.The FDA is requiring compliance fornew products after April 1, 2017, and inEurope, the EN 60601-1-2:2007 3rd edi-tion withdrawal date is currently set forDecember 31, 2018. It is expected thatthe EN 60601-1-2:2015 (4th) edition willbe in effect in the EU before that date.

Notable in the 4th edition is that riskmanagement is expanded. In addition,the “Life Supporting” category hasbeen removed, and the introduction of“Professional Healthcare Facilities”,“Home Healthcare”, and “SpecialEnvironments” have been added. Thenew edition has significant impact tothe medical industry in terms of prod-uct design, testing, and documentation.Immunity requirements have increasedand new requirements added.

This article does not go into detailabout this EMC standard, but rather out-lines the major changes in the IEC 60601-1-2, 4th edition and provides a comparison

to the third edition standard. Althoughthis is a medical device or system level stan-dard, components such as power suppliescan play an important role in aiding in sys-tem-level compliance. Areas where powersupplies may be impacted by this standardand the changes to the standard areemphasized.

ChangesThe new 4th edition EMC standard

better harmonizes with the risk conceptsand basic safety. Life-support equipmentis no longer referenced; rather, emphasisis made for the Risk Management File(RMF) and the expectation of the med-

New Medical DeviceEMC Requirements

Fig. 1 – Shown is Table 4 Enclosure Port.

IEC 60601-1-2, 4th Edition IEC 60601-1-2, 3rd Edition

Table 4 - ENCLOSURE PORT

Phenomenon

Basic EMC

standard or test

method

IMMUNITY TEST LEVELS

Professional Healthcare

FacilityHome category

ELECTROSTATIC

DISCHARGEIEC 61000-4-2

± 8 kV contact,

± 2 kV, ± 4 kV, ± 8 kV, ± 15

kV air

± 8 kV contact,

± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

± 2 kV, ± 4 kV, ± 6 kV contact,

± 2 kV, ± 4 kV, ± 8 kV air

Radiated RF EM fields a) IEC 61000-4-3

3 V/m, f)

80 MHz - 2,7 GHz, b)

80% AM at 1 kHz, c)

10 V/m, f)

80 MHz - 2,7 GHz, b)

80% AM at 1 kHz, c)

3 V/m for non-life supporting

ME equipment 10 V/m for life-

supporting ME equipment 80

MHz - 2,5 GHz 80% AM at 1 kHz

Proximity fields from RF

wireless communications

equipment

IEC 61000-4-3 See 8.10 / Table 9 None

RATED power frequency

magnetic fields d) e)IEC 61000-4-8 30 A/m, g) 50/60Hz 30 A/m, g) 50/60Hz 3 A/m 50/60Hz

Low-frequency magnetic

fields

IMMUNITY to

inhomogeneous

magnetic fields

Under consideration

Table 5 - Input AC power PORT

IEC60601-1-2, 4th EditionIEC60601-1-2

3rd Edition

Voltage dips. Notes

a) f) p)IEC 61000-4-11

0% UT; 0,5 cycle g) At 0, 45,

90, 135, 180, 225, 270 and

315 degrees q)

0% UT; 0,5 cycle g) At 0, 45, 90,

135, 180, 225, 270 and 315

degrees q)

< 5 % UT; 0,5 cycle

0% UT; 1 cycle ) degrees 0% UT; 1 cycle ) degrees N/A

70% UT; 25/30 cycles h)

Single phase: at 0 degrees

70% UT; 25/30 cycles h) Single

phase: at 0 degrees

70% UT; 25/30

cycles null

No requirement No requirement 40% V nom for 100mS

Fig. 2 – Shown is Table 5 - Input AC Power Port.

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ical equipment to provide Basic Safetyand Essential Performance withoutbeing interfered by or interfering withother equipment in the electromagneticenvironments in which they are intendedto be used. With more and more elec-tronics in medical equipment and wire-less devices expanding in the market-place, ensuring proper function ofdevices like infusion pumps, electrocar-diograms (ECGs), defibrillators, pace-makers, electrical surgical equipment,and other devices is paramount.

The fourth edition requires clearpass/fail criteria prior to testing. This islinked to the “Essential Performance andBasic Safety” outlined in the RiskManagement File. A test plan is requiredwhich includes what is to be monitored inthe equipment during testing. There areincreased test levels for the immunityrequirements. There are also new immu-nity requirements that take into consider-ation the effects from radio frequency(RF) wireless communications equipmentas detailed in Table 9 of the standard.These are not all encompassing as themedical device manufacturers need totake into account other possible sourcesof interference that may affect theirequipment. The electromagnetic immu-nity requirements are detailed in Tables 4through 9 of the standard.

Immunity Requirement Changesand Comparison to 3rd edition

Tables 4 to 8 of the standard list onlythe requirements that are different com-pared to 3rd edition and do not list allthe immunity requirements due to thespace limitation for this article. Refer tothe complete standard for the full listing. Fig. 1 shows Table 4 from the standardand provides the immunity requirementsapplicable to all the enclosure ports. Themost significant changes where the input

power supply plays a role are in theElectrostatic discharge (ESD) and RFelectric fields immunity. The path toground from an ESD may be through thepower supply. Given that the power supplyis to provide isolation from the AC utility,

and in many cases from ground, the highvoltage discharge can discharge inside thepower supply and disrupt the output oreven cause permanent damage. Theincreased RF electromagnetic (EM) fieldsmay cause the output voltage to change or

Table 6 - Input DC power PORT

Phenomenon

Basic EMC

standard

or test method


Professional Healthcare

FacilityHome category

IEC 60601-1-2,

3rd Edition

Conducted disturbances

induced by RF fields a)

c) d) j)

IEC 61000-4-6

3 V i) 10 V i) in ISM and

amateur radio bands

between 0,15 MHz and 80

MHz k) 0,15 MHz and 80

MHz 80% AM at 1 kHz e)

3 V i) 10 V i) in ISM and ama-

teur radio bands between 0,15

MHz and 80 MHz k) 0,15 MHz

and 80 MHz 80% AM at 1 kHz e)

3 V 0,15 - 80 MHz for non-life-

supporting ME equipment, 3 V

frequency excluding 0,15 - 80

MHz 10 V 0,15 - 80 MHz for

life-supporting ME equipment

Electrical transient con-

duction along supply

lines f)

ISO 7637-2 - test

pulse 1Not applicable

As Specified in ISO 7637-2 (12V

vehicles DC

powered)

Not applicable

Table 7 - PATIENT COUPLING PORT

Phenomenon

Basic EMC

standard or

test method


Professional

Healthcare

Facility

Home categoryIEC 60601-1-2,

3rd Edition

ELECTROSTATIC


± 8 kV contact,

± 2 kV, ± 4 kV, ±

8 kV, ± 15 kV air

± 8 kV contact,

± 2 kV, ± 4 kV, ± 8

kV, ± 15 kV air

± 2 kV, ± 4 kV, ± 6

kV contact,

± 2 kV, ± 4 kV, ± 8

kV air

Conducted distur-

bances induced by

RF fields a)

IEC 61000-4-6

3 V b) 0,15 - 80

MHz 10 V b) in

ISM and ama-

teur radio bands

between 0,15

MHz and 80

MHz 80% AM at

1 kHz

3 V b) 0,15 - 80

MHz 10 V b) in

ISM and amateur

radio bands

between 0,15

MHz and 80 MHz

80% AM at 1 kHz

3 V 0,15 - 80 MHz

for non-life-sup-

porting ME equip-

ment, 3 V fre-

quency excluding

0,15 - 80 MHz 10

V 0,15 - 80 MHz

for life-supporting

ME equipment

Table 8 - SIGNAL INPUT/OUTPUT PARTS (SIP/SOPS) PORT

Phenomenon

Basic EMC

standard or

test method


Hospital category Home categoryIEC 60601-1-2,

3rd Edition

ELECTROSTATIC


± 8 kV contact,

± 2 kV, ± 4 kV, ± 8

kV, ± 15 kV air

± 8 kV contact,

± 2 kV, ± 4 kV, ±

8 kV, ± 15 kV air

± 2 kV, ± 4 kV, ± 6

kV contact,

± 2 kV, ± 4 kV, ± 8

kV air

Conducted distur-

bances induced by

RF fields b) d) g)

IEC 61000-4-6

3 V h) 0,15 - 80

MHz 10 V h) in

ISM and amateur

radio bands

between 0,15

MHz and 80 MHz

i) 80% AM at 1

kHz c)

3 V h) 0,15 - 80

MHz 10 V h) in

ISM and ama-

teur radio bands

between 0,15

MHz and 80

MHz i) 80% AM

at 1 kHz c)

3 V 0,15 - 80 MHz

for non-life-sup-

porting ME

equipment, 3 V

frequency exclud-

ing 0,15 - 80 MHz

10 V 0,15 - 80

MHz for life-sup-

porting ME

equipment

Fig. 4 – Shown are Table 7 - Patient Coupling Port and Table 8 - Signal Input/Output Parts(SIP/SOPS) Port.

Fig. 3 – Shown is Table 6 - Input DC Power Port.

New Medical Device EMC Requirements

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oscillate if not designed for these levelsof interference. Design changes maybe needed to ensure the power supplywill perform properly under these con-ditions. Additional component or PCBtrace spacing or increased insulationmay be needed. Additional shieldingor RF decoupling may also be neces-sary.

Figure 2 shows Table 5, which focus-es on the device’s AC input ports. Here,more detailed investigation of ACmains distribution at different phaseangles is added as well as a full linecycle drop out. One area that is lessstringent is the omission of the 40%nominal AC mains operations. However,given that the third edition is still used andwill continue to be in some countries foryears to come, it is prudent to continue toplan for this condition.

Figure 3, which shows Table 6, addresseschanges to the DC input ports. For anexternal power supply, this applies to theDC output cables as they are connected tothe medical device’s DC input port.

Figure 4, showing Tables 7 and 8,apply to patient coupling ports and sig-nal input and output ports. The

increased ESD requirements can chal-lenge designers as they reduce the prod-uct size and spacing between compo-nents. What once may have easily passedthe 3rd edition requirements may nowresult in arcing and malfunction or dam-age to components and circuitry.

Table 9, not shown here due to its com-plexity, specifies 15 test frequencies forseven different frequency bands. The car-rier frequency may be pulse modulated orFM modulated and the maximum powerlevel varies from 0.2 watts to 2 watts

depending on the test band. Immunitylevels are as high as 28 Volts/Meteralbeit at a 0.3 meter distance. This newrequirement will add significant testtime and analysis during product devel-opment. The risk management shoulddetermine which services are applica-ble in the application or device.

SummaryThe IEC 60601-1-2, 4th edition will

be required in the US in the secondquarter of 2017 and is expected in the European Union in 2018.Implementation throughout the globewill occur at different times so consid-

eration to both 3rd and 4th edition isneeded. There are significant changeswhich require testing to verify compliance.Some fourth edition requirements are notbackward compatible with the third edi-tion. Tests are system level requirements.However, the power supply is an importantpart of the system to achieve compliance.(See Figure 5)

This article was written by Lorenzo Cividino,Director, Field Technical Support, SL PowerElectronics, Ventura, CA. For more informa-tion, visit http://info.hotims.com/61063-161.

Medical Design Briefs, July 2016 17

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Fig. 5 – Here is an example of external power suppliesthat adhere to the 4th edition Medical EMC standard andprotect home healthcare devices with Class B EMI andClass I & II wide range AC input.

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When science and nature combinein just the right amounts, the

results can be astounding. Take trans-dermal drug delivery, which is expectedto grow substantially in the next decade,with microneedle-based delivery devicesexpected to reach annual sales of 485million units by 2030, according toresearch published by Roots AnalysisPrivate Ltd., Microneedles for Transdermaland Intradermal Drug Delivery, 2014-2030.

That figure is no surprise to thoseinvolved with transdermal drug delivery,which is one of those perfect blends oftechnology and medicine. The benefitsof transdermal delivery over other meth-ods are numerous—it provides a vastlysuperior experience for the patient in alarge number of cases.

One reason for the expected marketgrowth is advances in microneedletechnology, including the use of liquidsilicone rubber (LSR), which providessmaller, stronger polymers that aremore stable and, thus, last longerthrough more uses. Details on engi-neering and manufacturing advancesare outlined later in this article.

Microneedles Solve LongstandingMedical Challenges

There are several types of transder-mal devices, including patches that areplaced on the skin, allowing medica-tion to be absorbed through the skininto the bloodstream, and implants,which create a port through whichmedicine can be delivered. (SeeFigure 1)

Essentially, transdermal delivery is anydrug administration that involves activeingredients being delivered across theskin for systemic distribution.

Perhaps the most promising devicesbeing introduced today are those involv-ing microneedles, which are dividedinto four types.

Hollow: These infuse a drug throughthe bores with adequate flow.

Solid: These puncture holes in the

skin to increase permeability where adrug can then be delivered.

Coated: These are coated with a drug-containing dispersion.

Polymer: These are made from specialpolymers that offer dissolving, non-dis-solving, or hydrogel-forming options.

Transdermal devices using micronee-dles solve a long-standing medical prob-lem: the skin’s anatomical peculiaritiesmake it difficult to cross. The skin’smajor barrier consists of the stratumcorneum, the outermost layer. However,the layer underneath, the viable epider-mis, also plays a protective role.According to research from TouroUniversity published in the journal,Pharmaceutics, only compounds that areable to get through the stratumcorneum and diffuse through both lay-ers of the epidermis have the potentialto reach circulation and achieve sys-temic effects.

Benefits of Transdermal DrugDelivery

One obvious benefit of transdermalmicroneedle delivery is that it reducesthe need for hypodermic injections.Although they’re effective, hypodermicneedles can cause discomfort, bruising,and even hypersensitivity at the injectionsite. For patients receiving an occasionalvaccine, this is a minor inconvenience.The effects are much more serious forpatients requiring daily or weekly injec-tions. A transdermal patch is virtuallypain free and can be self-administered,resulting in improved medication com-pliance, according to research pub-lished in the journal, RespiratoryMedicine.

Another benefit is improved drugdelivery, especially over an extendedperiod. Orally-administered drugs musttravel through the metabolic system ofthe liver, which eliminates a substantial

Transdermal Drug Delivery Poised for Growth Thanks to

Microneedle Technology

Fig. 1 – Transdermal patches provide an excellent option for effective drug delivery, reaching the bodymore systemically than hypodermic injection.

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amount before widespread distribution.Less drug is needed when administeredthrough a transdermal device. In addi-tion, a transdermal patch can deliver aneven flow of the active ingredient overan extended period, ranging from 24hours to 7 days.

Many oral medications do not absorbwell in the gastrointestinal tract, result-ing in low bioavailability. The bioavail-ability of a patch is also fairly low, butplaced correctly, it can avoid first-passmetabolism and partial elimination.

Microneedle patches also permit site-specific dosing. For example, placingthe patch on or near an injuredappendage can reduce inflammationlocally, rather than having the drug cir-culate throughout the entire body.Studies have shown that changes in theabsorption and distribution of drugsadministered via patches are quite differ-ent from those take orally.

Patches provide a different way to con-trol a drug’s pharmacokinetics. Taking apill once a day is relatively easy toremember. However, to reduce sideeffects or offset a metabolism issue,patients sometimes need to take a pillmultiple times a day at precise intervals.This is inconvenient for patients andespecially difficult to manage overnight.Patches allow for exact control of bothdose and time. Twice the size of a patchmeans twice the dosage. When you needto stop dosing, you remove the patch.

Finally, there is evidence that transder-mal microneedle methods are moreeffective than hypodermics for immu-nization. Certain cells in the epidermisand dermis (Langerhans and dermaldendritic, respectively) are part of theskin’s unique immune system. Becausethese cells are designed to initiateimmune responses to protect the body,less vaccine is needed to initiate a defenseresponse when administered via a trans-dermal patch than intramuscularly.

Microneedle Development andManufacturing

Large strides have been made inrecent years in the design and manufac-turing of microneedles, in part due tomaterials advances. Specifically, siliconehas become an excellent materialsoption because of its haptic properties.In addition, silicone does not cause skinirritation, is biocompatible, and is com-pliant with medical industry regulations.

Liquid Silicone Rubber (LSR) tech-nology has proven particularly suitable

for transdermal drug delivery, providingsmall, strong polymers that are stableand long wearing. Microfabrication ofneedles requires the incorporation ofparts weighed in micrograms ornanograms, and LSR allows complex,high-precision components to be pro-duced in large volumes in these dimen-sions with relative ease and precise accu-racy. (See Figure 2)

Keep in mind that transdermaladministration is not appropriate for all

types of drugs. The optimal physico-chemical properties of the drug and itsbiological properties must be consid-ered, along with the pharmacokineticand pharmacodynamic properties of thedrug. The most important requirementis the need for controlled delivery, suchas short half-life, adverse effect associat-ed with another route, or a complex oralor IV dose regime.

The parameters for ideal candidates canbe divided into physicochemical proper-


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AIntro


ties, biological characteristics, and poly-mer variables.

Physicochemical Properties• The drug should have a molecular

weight less than approximately 1000Daltons.

• The drug should have affinity for bothlipophilic and hydrophilic phases.Extreme partitioning characteristicsare not conducive to successful drugdelivery via the skin.

• The drug should have a low meltingpoint.

• Since the skin has a pH of 4.2 to 5.6,solutions within this pH range areused to avoid damage to the skin.However, for a number of drugs, theremay also be significant transdermalabsorption at pH values at which theunionized form of the drug is pre-dominant.

Biological Characteristics• The drug should be potent with a

daily dose of the order of a fewmg/day.

• The half-life of the drug should beshort.

• The drug should be non-irritating andnon-allergic.

• Drugs that degrade in the GI tract orare inactivated by hepatic first-passeffect are suitable candidates fortransdermal delivery.

Polymer VariablesAdvances in transdermal drug deliv-

ery technology have been rapid becauseof sophisticated polymer science thatallows incorporation of polymers intransdermal systems in adequate quanti-


Fig. 2 – LSR technology allows the fabrication of unique shapes and smaller sizes. It works well formicroneedle patches because it does not cause skin irritation.

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ty. The release rate from transdermal sys-tems can be tailored by varying polymercomposition. Selection of a polymericmembrane is important in designing avariety of membrane-permeation con-trolled transdermal systems.• The polymer should be chemically

nonreactive or an inert drug carrier. • The polymer must not decompose on

storage or during life span.• Molecular weight, physical characteris-

tic, and chemical functionality of thepolymer must allow the diffusion ofthe drug substance at a desirable rate.

• The polymer and its decomposedproduct should be nontoxic. It shouldbe biocompatible with skin.

• The polymer must be easy to manu-facture and fabricate into desiredproducts. It should allow incorpora-tion of large amounts of active agent.

Future UseSilicone elastomer blend networks,

sugar siloxanes, amphiphilic resin linearpolymers, and silicone hybrid pressuresensitive adhesives are showing promisefor potential performance advantagesand improved drug delivery efficacy.

Early on, transdermal delivery systemswere used mainly for delivery of small,lipophilic, low-dose drugs. More recent-ly, delivery systems began using chemicalenhancers, non-cavitational ultrasound,and iontophoresis to enhance the effica-cy of transdermal patches. Today, theability of iontophoresis to control deliv-ery rates in real time is providing addedfunctionality in a number of instances.

At the same time, microneedles com-bined with thermal ablation are progress-ing through clinical trials for delivery ofmacromolecules and vaccines, includinginsulin, parathyroid hormone, andinfluenza. With these enhancement strate-gies, transdermal delivery is poised to sig-nificantly impact drug delivery choices.

Both chemical enhancers and thenewest physical enhancers (ultrasound,thermal ablation, and microneedles)have begun expanding transdermaldelivery of macromolecules and vac-cines. These scientific and technologi-cal advances enable targeted disruptionof the stratum corneum while protect-ing deeper tissues, positioning all typesof transdermal drug delivery to have awidespread impact on medicine.

This article was written by Luis Tissone,Director of Life Sciences, Trelleborg SealingSolutions, Fort Wayne, IN. For more informa-tion, visit http://info.hotims.com/61063-163.

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TECHNOLOGY LEADERS Motors & Motion Control

Surgical Robotics: The Evolution of aMedical Technology

For a long time, the ability of robotsto interact with humans in our dailylives was more myth than reality—and the idea of robotics performing

exceptionally complex tasks such as neu-rosurgery seemed like science fiction.However, in the mid-1980s computertechnology started to catch up with designengineering, and the field of roboticsbegan to truly evolve. The PUMA 560(Programmable Universal Machine forAssembly or Programmable UniversalManipulation Arm), a standard industrialrobotic arm, was initially developed by anengineer at Unimation, which became asubsidiary of Westinghouse Corp.

In 1985, Dr. Yik San Kwoh of MemorialMedical Center, Long Beach, CA, whodeveloped a computer program thatmakes the arm work, shattered previousconceptions about robot-assisted surgeryby successfully placing a needle for ahuman brain biopsy using ComputedTomography (CT) for guidance. Thissuccess effectively launched the “Age ofMedical Robotics” around the world.The past 35 years have seen an explosionin the industry, with a global forecast of$11.4 billion by the year 2020.

A Brief HistoryThe successful implementation of the

PUMA 560 led to the development ofthe PROBOT at the Imperial College,London, UK, where, in 1992, Dr. SenthilNathan completed the first entirelyrobotic surgery in history. Across thepond in Sacramento, CA, IntegratedSurgical Supplies was already in theprocess of developing ROBODOC, arobot designed to mill out precise cavi-ties in the femur, which would insert fit-tings during hip replacement surgery.ROBODOC became the first robot toassist in a Total Hip Arthroplasty (THA)and was subsequently cleared by theFDA for wide use in THA surgeries.Today, the ROBODOC is still the onlyactive robotic platform approved by theFDA for use in orthopedic surgery.

These breakthroughs were closelywatched by US military and NASA, whothen funded private research companiesto further investigate the capabilities ofrobots in the field. Telesurgery, the abil-ity for a doctor to perform remote sur-gery, spurred several NASA scientists tojoin the Stanford Research Institute(SRI) with the goal to utilize virtual real-

ity to develop a manipulator that couldbe used by a surgeon to operate fromacross a room.

The U.S. Army also had an interest intelesurgery for its potential to lowerwartime casualties by bringing a virtualsurgeon to an injured soldier who maybe located on the battlefield. In 2005,DARPA, the Defense Advanced ResearchProjects Agency, envisioned and fundedresearch that would allow an injured sol-dier to be loaded onto a vehicle or podwhere a surgeon, located in a safe loca-tion, could use telepresence to makereal-time medical decisions until the sol-dier could reach proper medical atten-tion. Individuals working on the NASA-SRI team later formed commercial proj-ects understanding the value of theemerging robotic market, and in 1995,Dr. Frederic H. Moll acquired the licenseto the NASA-SRI telepresence surgicalsystem and started Intuitive Surgical Inc.

Today’s Surgical RobotsThe most technologically advanced

surgical robot in operation today is theda Vinci Surgical System by IntuitiveSurgical Inc., Sunnyvale, CA. The system

Fig. 1 – The da Vinci Xi Patient Side Cart (© 2016Intuitive Surgical) Fig. 2 – Shown is the neuroArm in use.

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consists of three main components thatwork together seamlessly during surgicalprocedures: the Vision System, whichincludes a high-definition 3D endoscopeand a large viewing monitor: the Patient-side Cart that contains three or fourrobotic arms that carry out the surgeon’scommands; and the Surgeon Console,where the surgeon utilizes 3D imageryfrom the endoscope, as well as handmanipulators with Endowrist instru-ments (which provide seven degrees ofmotion, more than a human wrist) toperform the surgery. (See Figure 1)

In 2000, the da Vinci system becamethe first robotic surgical system to becleared by the FDA for general laparo-scopic (abdominal) surgery. The daVinci’s capabilities continued to evolve,and the FDA certified the robot for usein thoracoscopic (chest) procedures, aswell as laparascopic removal of theprostate and a variety of urologic, gyne-cologic, pediatric, and otolaryngologyapprovals followed.

The technology used to developthese systems has grown exponentiallysince its introduction in 1985. A greatexample of merging robotics andmotion control can be found in theneuroArm, developed in 2007 by ateam led by Dr. Garnette Sutherland,Professor of Neurosurgery, Universityof Calgary. (See Figure 2) TheneuroArm, a Magnetic ResonanceImaging (MRI)-compatible image-guid-ed computer-assisted surgical robotdesigned for neurosurgery, was fundedby the Canada Foundation forInnovation, Western EconomicDiversification, Alberta AdvancedEducation and Technology and thephilanthropic community of Calgary.

In 2008, this surgical system madehistory by performing the first brainsurgery to remove a tumor through theuse of its MRI-compatible robotics aswell as an intraoperative MRI. The com-bined use of these technologies allowsan MRI scanner to move into the oper-ating room, providing in-depth imag-ing during the actual procedure with-out having to stop the surgery to reviewscans as before.

Previously, combining these tech-nologies was not thought to be feasibleas the magnetic field produced by theMRI equipment is in the range of 1.5 to

3 Tesla or 15,000 to 30,000 gauss (forreference the Earth’s magnetic field isonly 0.50 gauss). This means anythingmetallic inside of this field could poten-tially become a dangerous projectile aswell as produce artifacts on any imagesthe doctor would use to make criticalsurgical decisions.

To address this issue, Dr. Sutherlandworked closely with engineering groupwho, in turn, succeeded in customizinga solution. They were able to modifymotors specifically designed for use in avacuum environment for semiconductormanufacturing by substitut-ing ceramic parts, wherestainless was previously used,and adding ceramic bear-ings. Using piezoelectricceramic in the specializedmotors allows motion to becreated strictly through fric-tion and filters to ensure thedigital signal of the motorsdid not interfere with theMRI scanner.

Increasing Patient SafetyThrough Precision Robotics

An inherent risk of anysurgery is uncontrolled orunwarranted motion—byrobot or human hand—dur-ing a procedure, where

even a slight misstep can be cata-strophic. A surgeon’s hand is stable toroughly 100 microns, while a surgicalrobot is stable to roughly 25 microns.Many medical robots today are built toboth aerospace and medical standardsin order to guarantee quality control.Ensuring patient safety is always thetop priority in the design. Externalbrakes, haptic feedback hand controls,no-go zones, motion scaling, tremorfilters, and battery backups have allbeen utilized on medical robots toincrease patient safety.

Fig. 3 – Spring engaged nrake with splined hub.

Fig. 4 – Permanent magnet brake with rotor/friction disc attachedto armature plate.

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Zero Backlash Brakes New technologies are being devel-

oped to manage complementary issuesthat became apparent during thedesign and development of precisionrobotics. For example, one problem isthe presence of backlash, or lostmotion, caused by small gaps betweena mechanism’s parts. Standard spring

set power-off brakes, similar to thoseused in the original PUMA 560, arereadily available and common inrobotics, but generally have splined orhex-shaped hubs. These brakes experi-ence considerable backlash becausethe design requires the hub and rotor(the friction disc in this case) to“float.” In order for the drive hub to

float, sufficient clearances arerequired which consequently createbacklash in the brake. (See Figures 3and 4)

One solution to the issue of backlashis the electromagnetic permanentmagnet power off brake (PMB).Electromagnetic PMBs have true zerobacklash (no free play, no lostmotion), making them ideal for robot-ic surgery equipment. Essentially,PMBs lock joints into place withabsolutely zero radial movement.

In place of a “spring” that createsthe normal force to transmit torque(as in Spring Engaged Brakes) thePMBs use Permanent Magnets to cre-ate the normal force. When the brakeis energized, there is a reverse magnet-ic flux path created and the “returnspring” disengages the braking sur-face, so when the power is “on” thebrake is released. The “return” springforce is extremely low compared to thespring force required to transmittorque in a Spring Engaged Brake,therefore the PM brakes are very quietin comparison—an important consid-eration in the operating room.

Permanent magnet brakes are alsohighly customizable, due to simpleconfiguration and fewer parts, makingthem well suited for the numerousdesign iterations needed in order toengineer the best robotic surgery sys-tem possible. Other issues in roboticmedical applications can also beresolved with the use of a PMB. PMBsare compact in size and have a low pro-file as well as high torque versus bodysize. Integral in the design of PMBs isa large inner diameter, which allowswires and cables to be run through thebodies.

PMB brakes operate at low voltageand have low current draw (to release).This is especially important if the equip-ment is portable or battery operated.PMB brakes are also environmentallyfriendly and UL, CSA, and RoHS com-pliant.

This article was written by Craig Harvey,Sales Engineer, and Rocco Dragone, SeniorSales/Application Engineer, at SEPAC,Inc., Elmira, NY. For more information,visit http://info.hotims.com/61063-165.

24 Medical Design Briefs, July 2016

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An Overview of the Most Popular RotaryMotion Technologies

The ability to provide accuraterotary motion is critical in a widerange of applications in theautomation equipment, medical

device, machine tool, energy, welding,robotics, automotive, aerospace, semi-conductor, and heavy equipment indus-tries, as well as many others.

Some of the key rotary motion tech-nologies available to address these appli-cations include belt drives, cam index-ers, planetary gearheads, direct drives,and precision ring drives. It’s importantto look carefully at the pluses and minus-es of each of these technologies in orderto ensure that you select the approachthat provides the right mix of accuracy,economy, durability, speed, noise, etc.,for each specific application.

A systematic selection and applicationprocess can help ensure that the rotarymotion technology that is selected meetsof all of the requirements of the applica-tion while maximizing the performanceand minimizing the cost of this criticalcomponent. (See Figures 1 and 2)

Belt DrivesBelt driven rotary tables generally

offer the advantages of high speed andlow cost in rotary positioning applica-tions. Belts are typically made of fiber-reinforced elastomer and contain teeththat interface with rotor pulleys to effi-ciently transfer torque and prevent slip-ping. Typical belt-driven tables offerspeeds up to 1,000 rpm, continuoustorque to 6.6 N-m, and resolution downto 0.16 arc-second using ring encoders.

Additional advantages of belt-drivensystems include the fact that they generaterelatively little noise and that they requirerelatively little maintenance. Due to thepotential for elongation of the belt, posi-tioning accuracy of belt drives is ofteninferior to other alternatives, such as plan-etary gearheads or precision ring drives.

In summary, belt drives are a goodchoice for applications that require highspeed and low cost, however, have sever-al limitations including limited loadcapacity, limited accuracy, limited rigidi-ty, and relatively poor life.

Cam IndexersCam indexers have been used in

rotary positioning applications for manyyears and are frequently used in dialmachines, conveyors, and linkages.There are two types of cam indexers.The most common is the fixed indexcam indexer, which does not use a servomotor. With fixed index cam indexing, amathematical motion curve is machinedinto the cam to provide accurate posi-tioning to a discrete number of definedpositions. During rotation of the camindexer, maximum displacement veloci-ty usually occurs around the midpoint ofthe index cycle.

Any fluctuation in cam speed tends togenerate increased output torque at thehigh displacement portion of the cycle.These torque fluctuations sometimesgenerate irregular rotary motion duringindexing, as well as audible noises whenthe indexer approaches a station. Theseproblems can be avoided by maintainingshaft speed within a very narrow range.Fixed index cam indexers provide high-precision positioning at a reasonablecost for applications that will alwaysindex to the same angle and do notrequire high acceleration.

Fully programmable cam indexerscombine a servo motor with a cam-dri-ven index drive. This type of cam index-er is advantageous when a flexiblemotion pattern is required, such aswhen two different products thatrequire different indexing patterns arerun on the same machine. A fully pro-grammable cam indexer is also benefi-cial for applications where extremelyfast positioning is required followed by along dwell period.

Planetary GearheadsPlanetary gearheads are frequently

used on motion control applications thatrequire a high torque to volume ratio.Planetary gearheads utilize an arrange-ment in which one or several planet gearsrotate around a pinion or sun gear. Theplanetary gears rotate within an internalgear that is most often cut into the inter-

Fig. 1 – 12 Station Dial Plate Indexing Design on Compact Ring Drive (CRD)-DD Product (with inspection camera)for high accuracy and repeatability. (Credit: Nexen)

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nal diameter of the gearhead. The plane-tary gear decreases the reflected loadinertia at the motor shaft by the inverse ofthe square of the gearhead ratio, whichincreases the control system responsive-ness and generally provides more consis-tent and accurate motion response.

The planetary gearhead offers theadvantage of a wide range of gear ratioswhich, in many applications, will make itpossible to operate both the motor andthe application at their ideal speed.Single-stage planetary gearheads typical-ly provide ratios from 3:1 to 10:1. Helicalgearing improves the performance of aplanetary gearhead over spur gears byincreasing the contact load line. Thepotential drawbacks of planetary gear-heads include their relatively high costand the fact that they contain backlashand can be damaged by shock loads.

Direct DriveA direct drive rotary motor is typically

a large diameter permanent magnetservo motor. The unique characteristicof direct drive rotary positioning systemsis that the motor is connected directly tothe load, eliminating all mechanicaltransmission components. Rotary posi-tioning systems built around direct driverotary motors are widely used in the fac-tory automation, medical equipment,and energy industries. (See Figure 3)

Direct drive systems generate energysavings by operating at high levels of effi-ciency because the elimination of thepower transmission system provides a sub-stantial reduction in friction. Direct drivesystems also have fewer components,which often reduces maintenancerequirements and provides quieter opera-tion because there are fewer parts that canvibrate. The elimination of the gear trainalso reduces backlash and compliance.

Sometimes, a direct drive system iscombined with an encoder mounted onthe rotary table to provide precisionpositional feedback and a high stiffnessbearing to improve positional accuracyand repeatability. However, thisapproach is quite expensive relative toother technologies discussed here.While direct drive motors provide highlevels of performance and efficiency,they are limited by low load capacity,high cost, and relatively low accuracywithout costly ring encoders.

Roller Pinion SystemsThe precision ring drive is a relatively

new type of rotary positioning system fea-turing a unique roller pinion/toothedrack combination that delivers highaccuracy positioning with zero backlashand virtually eliminates cumulative error.

Precision ring drives, at first glance,look similar to ring and pinion sets but,instead of spur gear teeth, bearings sup-ported rollers engage the ring teeth.The rollers engage a tooth profiledesigned to match the pinion’s path,providing friction-free meshing thatallows the pinion to be pre-loaded into

the ring, eliminating mechanical clear-ance. The rollers approach the toothface on a tangent path and thensmoothly roll down the face. Each toothis precisely measured relative to thefirst, eradicating cumulative error andmaintaining high positional accuracy.The resulting smooth rolling frictionprovides 99 percent efficient rotarymotion. Due to the smooth way therollers engage the rack teeth, the newapproach generates very low noise andvibration. The system is whisper quiet atlow speeds and produces less than 75db noise at full speed. Drives are


Fig. 3 – CRD Rotator Robotic Arm with PRD Product for headstock type indexing. (Credit: Nexen)

Fig. 2 – Rotary automated transfer with access “hole” through center for wiring and plumbing. (Credit: Nexen)

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offered with ratios ranging from 64:1 to220:1. Peak torque goes from 563 to1,936 Nm. Accuracy ranges from ±11 to±35 arc-sec, with repeatability of ±4.2 to±1.2 arc sec.

Unlike traditional cam-drive systems,the precision ring drive can start andstop at any incremental position. Userscan change the motion profile simplyby loading a new servo drive program.The roller pinion system driving theprecision ring drive also allows theapplication of maximum accelerationor deceleration at any point withoutrisking damage. The precision ringdrive is capable of speeds up to 300 rpmand can handle peak torque inputs atany time, resulting in index speeds upto two times faster than other types ofpositioning systems.

A given size product in a premiummodel can support a maximum dynam-ic load (N) of 1,000. The drive mountson a table supported by cross-rollerbearings rated for 1,575-kN loads. The

roller pinion system requires littlemaintenance. The pinion consists of 10or 12 needle-bearing supported rollersthat are sealed and lubricated for life.The ring is lubricated with a high-per-formance light grease at installationand then every 6 months or 2 millionpinion revolutions. No messy oil bathsare required. Pinion life is rated at 60million revolutions and the piniongear can usually be replaced numerous

times before the ring gear needsreplacement. The ring drive has a largeopen center that allows users to easilymount equipment and cabling in thecenter of the rotating plate. (SeeFigure 4)

ConclusionRotary motion technologies, such as

belt drives, cam indexers, planetary gear-heads, direct drive systems, and rollerpinion systems each offer their ownunique mix of advantages and disadvan-tages. In order to apply the correct typeof rotary motion technology in a partic-ular application, the design engineershould carefully consider the specificcapabilities of each alternative. Selectingthe right technology can improve per-formance, ensure long life, and reducethe overall cost of the assembly.

This article was written by David R. Bickert,Regional Sales Manager, Nexen Group, Inc.,Vadnais Heights, MN. For more information,visit http://info.hotims.com/61063-164.

Fig. 4 – CRD System with precision grade, highcapacity bearing, and drive mechanism in sealedhousing. (Credit: Nexen)


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Aerotech, Inc.101 Zeta DrivePittsburgh, PA 15238Phone: 412-963-7470Fax: 412-963-7459E-mail: [email protected]

Company Description

Since 1970, Aerotech has designed and manufactured the high-

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Aerotech manufactures motion control and positioning systems

and components including automated direct-drive and piezo

nanopositioners; planar and rotary air-bearing stages; high-speed

gantries; mechanical-bearing linear, rotary, and lift stages; brush-

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Bring Your Machine To Life With Custom MotorsAerotech can partner with you to design a custom motor optimized for your specifi c application at a minimized price. In our concept machine above, the legs utilize both rotary and linear motion requiring special motor designs. For both the rotary and linear motion, we would customize the motor’s mechanical characteristics (torque/force, length, width, height) as well as the electrical characteristics (bus voltage, resistance, inductance, pole pitch, and current) required for the application. Aerotech can accommodate your custom motor requirements even for low-volume projects. If you have an application requiring minor customization, major customization, or a completely new motor design, contact Aerotech today.

Contact our Control Systems Group at 412-967-6839 or [email protected] to discuss your application today, or see aerotech.com/csg68

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maxon drives set the world in motion.maxon motor combines electric motors,gears and DC motor controls into high-precision, intelligent drive systems thatcan be custom-made to fit the specificneeds of customer applications. maxonmotor helps provide innovative solutionsat competitive prices for numerousapplications in various markets.

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■ Engineers Fabricate Super-Fast Silicon Transistor Using a tiny knife and huge rolls

of flexible plastic, engineers fromthe University of Wisconsin–Madison fabricated the world’sfastest silicon-based transistors. Thesemiconductor devices operate at arecord 38 gigahertz.

Under low-temperature process-es, the researchers patterned thecircuitry on their flexible transistor;single-crystalline silicon was ulti-mately placed on a polyethyleneterephthalate, or PET, substrate.

After blanketing the single crystalline silicon with a dopant, theteam added a light-sensitive photoresist layer. Employing electron-beam lithography techniques, the engineers used a focused beamof electrons to build shapes as narrow as 10 nanometers wide.

To create a photoresist pattern, the mold was applied to anultrathin, bendable silicon membrane. A dry-etching process—essentially, a nanoscale knife—cut precise, nanometer-scaletrenches in the silicon. Wide gates, which function as switches,were added atop the trenches.

With a unique, three-dimensional current-flow pattern, thehigh-performance transistor transmits data or transfers powerwirelessly, a valuable capability for wearable electronics and sensorapplications.

For more information, visit www.medicaldesignbriefs.com/component/content/article/1104-mdb/news/24558.

■ Liquid-Metal Particles Support Heat-Free Soldering Martin Thuo, an assistant professor

of materials science and engineeringat Iowa State University, Ames, andhis team used a high-speed rotary toolto sheer liquid metal into dropletswithin an acidic solution. The result-ing micro-sized liquid-metal particlescan be used to provide heat-free sol-dering and the fabrication, repair,and processing of metals.

The liquid-metal particles consistof Field’s metal—an alloy of bismuth,

indium, and tin—and are 10 micrometers in diameter, about thesize of a red blood cell.

After the liquid-metal droplets are formed, the particles are nat-urally exposed to oxygen; the resulting oxidation layer essentiallycreates a capsule containing the liquid metal. The layer is thenpolished until it is thin and smooth.

The liquid-metal could have significant implications for manu-facturing. The researchers demonstrated healing of damaged sur-faces and joining of metals, all at room temperature.


■ Researchers Blend Materials to Produce 3D-PrintedBoneEach year, birth defects, trauma, or

surgery leave an estimated 200,000people in need of replacement bonesin the head or face. By blending pul-verized natural bone with man-madeplastic, researchers at The JohnsHopkins University, Baltimore, MD,produced 3D-printed replacementskeletal structures, including thelower jaw of a female patient. Theteam’s composite material combinesthe strength and printability of plasticwith the biological “information” contained in natural bone.

The scientists began with polycaprolactone, or PCL, abiodegradable polyester used in making polyurethane. PCL’slower melting point—80 to 100 degrees Celsius—worked wellwith the sensitive biological materials that suffer damage underhigh temperatures.

The polyester was mixed with increasing amounts of “bonepowder,” made by crushing the porous bone inside cowknees after stripping it of cells. The pieces of bone providean ideal scaffold.


■ Dissolvable Electronics HoldPromise for Brain MonitoringDissolvable silicon electronics

offer an unprecedented opportuni-ty to implant advanced monitoringsystems, according to members ofthe Perelman School of Medicineat the University of Pennsylvania,Philadelphia. An implantable braindevice literally melts away at a pre-determined rate, minimizing injuryto tissue normally associated withstandard electrode implantation.

The sensor, made of silicon andmolybdenum layers, measures

physiological characteristics and dissolves at a known rate, asdetermined by its thickness. The implant recorded brain wavesin rats under anesthesia. The type of neurophysiologic featuresdetected by the technology are commonly used for treating suchdisorders as epilepsy and Parkinson’s disease.

The electrophysiological signals were recorded from devicesplaced at the surface of the brain cortex and the inner spacebetween the scalp and skull. Chronic measurements weremade over a 30-day period, while acute experiments demon-strated device operations over three to four hours.


Using a unique method theydeveloped, a team of engineershas fabricated the world’sfastest silicon-based flexibletransistors, shown here on aplastic substrate. (Credit:Jung-Hun Seo, UW – Madison)

Martin Thuo holds a vial ofthe liquid-metal particlesproduced by his researchgroup. (Credit: ChristopherGannon/Iowa StateUniversity)

A sample 3D-printed scaf-fold that matches the lowerjaw of a female patient.(Credit: Johns HopkinsSchool of Medicine)

Shown is a schematic explod-ed-view illustration of a biore-sorbable actively multiplexedneural electrode array basedon patterned silicon nanomem-branes as the conducting com-ponent. (Credit: The lab ofBrian Litt, MD, PerelmanSchool of Medicine, Universityof Pennsylvania)

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■ Five-Fingered Robot Gets a Grip Equipping robots with intricate handling tasks, such as

rolling, pivoting, bending, and sensing friction, is a chal-lenge for today’s engineers. Computer scientists from theUniversity of Washington, however, have built a robotic handthat performs dexterous manipulation and “learns” from itsown experience. Thefive-fingered robot, forexample, can spin atube full of coffeebeans without needinghuman direction.

Initial algorithmsallowed a computer tomodel highly complexfive-fingered behaviorsand plan movements toachieve different out-comes—like typing ona keyboard or catchinga stick—in simulation. The researchers recently transferredthe models to work on the five-fingered hand hardware.

As the robot gripper performs tasks, the system collectsdata from various sensors and motion capture cameras. Thecustom-built device employs the machine learning algorithmsto continually refine and develop more realistic models.


■ Ingestible Origami Robot Unfolds from CapsuleResearchers at Massachusetts Institute of Technology

(MIT), Cambridge, the University of Sheffield, UK, and theTokyo Institute of Technology, Japan, have demonstrated a

tiny origami robotthat unfolds itselffrom a swallowed cap-sule. Steered by exter-nal magnetic fields,the robot can crawlacross the stomachwall to remove a swal-lowed button batteryor patch a wound.

The robot propelsitself using “stick-slip” motion. Itsappendages stick to asurface through fric-

tion, but slip free again when the body flexes to change itsweight distribution.

Slits in the robot’s outer layers determine how the origami-inspired implant will fold when its middle layer contracts. Toenable compression to the size of a capsule, the researchers devel-oped a rectangular design with accordion folds perpendicular tothe robot’s long axis.

Within one of the accordion folds is a permanent magnet thatresponds to changing magnetic fields outside the body. Appliedforces control motion and allow the robot to spin in place or pivotaround one of its fixed feet.




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UW computer science and engineering doc-toral student Vikash Kumar custom-built thisrobot hand, which has 40 tendons, 24joints, and more than 130 sensors. (Credit:University of Washington)

The new robot consists of two layers ofstructural material sandwiching a materialthat shrinks when heated. (Credit: MelanieGonick, MIT)

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Soft Tissue Robotic Surgery Outperforms Standard SurgeryRobot plans and performssurgical suturing Children’s National HealthSystem, Washington, DC

Surgeons and scientists at theChildren’s National Health System’sSheikh Zayed Institute for PediatricSurgical Innovation have demonstratedthat supervised, autonomous roboticsoft tissue surgery on a live subject in anopen surgical setting can outperformstandard clinical techniques.

Their research reports the results ofsoft tissue surgeries conducted on bothinanimate porcine tissue and living pigsusing a proprietary robotic surgical tech-nology called Smart Tissue AutonomousRobot (STAR), developed at Children’sNational. This technology utilizes thesurgeon as a supervisor, with soft tissuesuturing autonomously planned andperformed by the STAR robotic system.Soft tissues include tendons, ligaments,fascia, skin, fibrous tissues, fat, synovialmembranes, muscles, nerves and bloodvessels. Currently more than 44.5 mil-lion soft tissue surgeries are performedin the US each year.

The research was performed to showthat autonomous robots can improvethe efficacy, consistency, functional out-come and accessibility of surgical tech-niques, not to replace surgeons, but touse the enhanced vision, dexterity, andcomplementary machine intelligence toimprove surgical outcomes.

■ How It WorksWhile robot-assisted surgery (RAS)

has been increasingly adopted in health-care settings, soft tissue surgery hasremained entirely manual, largelybecause the unpredictable, elastic, andplastic changes in soft tissues that occurduring surgery, requiring the surgeon tomake constant adjustments.

To overcome this challenge, STARuses a tracking system that integratesnear infrared fluorescent (NIRF) mark-ers and 3D plenoptic vision, which cap-tures light field information to provideimages of a scene in three dimensions.This system enables accurate, uninhibit-ed tracking of tissue motion and changethroughout the surgical procedure. Thistracking is combined with an intelligentalgorithm that guides the surgical plan

and autonomously makes adjustments tothe plan in real time as tissue moves andother changes occur. The STAR systemalso employs force sensing, submillime-ter positioning and actuated surgicaltools. It has a bed-side lightweight robotarm extended with an articulatedlaparoscopic suturing tool for a com-bined eight degrees-of-freedom robot.(See Figure 1)

To compare the effectiveness of STARto other available surgical procedures,the study included two different intes-tinal surgeries performed on inanimateporcine tissue, linear suturing, and anend-to-end intestinal anastomosis,which involves connecting the tubularloops of the intestine. The results ofeach surgery were compared with thesame surgical procedure conductedmanually by an experienced surgeon, bylaparoscopy, and by RAS with the daVinci Surgical System.

The Children’s National researchteam conducted four surgeries on livingpigs using STAR technology and all sub-jects survived with no complications.The study compared these results to thesame procedure conducted manually by

an experienced surgeon using standardsurgical tools.

All surgeries were compared based onthe metrics of anastomosis including theconsistency of suturing based on averagesuture spacing, the pressure at which theanastomosis leaked, the number of mis-takes that required removing the needlefrom the tissue, completion time andlumen reduction, which measures anyconstriction in the size of the tubularopening.

The comparison showed that super-vised autonomous robotic proceduresusing STAR proved superior to surgeryperformed by experienced surgeons andRAS techniques, whether on static porcinetissues or on living tissue. In the compari-son using living subjects, the manual con-trol surgery took less time, 8 minutes ver-sus 35 minutes for the fastest STAR proce-dure, however researchers noted that theduration of the STAR surgery was compa-rable to the average for clinical laparo-scopic anastomosis, which ranges from 30minutes to 90 minutes, depending oncomplexity of the procedure.

For more information, visit http://childrensnational.org.

Fig. 1 – Smart Tissue Autonomous Robot. (Credit: Sheikh Zayed Institute for Pediatric SurgicalInnovation, Children’s National Health System)

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Developing Mini Artificial LungsDevice mimics theresponse of lungs todrugs and toxins. Los Alamos NationalLaboratory, Los Alamos, NM

What if there were a way to test howlungs react to toxins without actuallyputting a subject at risk? That’s what sci-entists at Los Alamos NationalLaboratory are attempting to test bydeveloping a miniature, tissue-engi-neered artificial lung that can mimic theresponse of the human lung to drugs,toxins, and other agents.

“We breathe in and out thousands oftimes every day. And while we have con-trol over what we eat or drink, we don’talways have control over what webreathe in,” said Jennifer Harris ofBiosecurity and Public Health at LosAlamos, “and so we’re making thisminiature lung to be able to test on actu-al human cells whether something in theenvironment, or a drug, is toxic or harm-ful to us.”

Nicknamed “PuLMo” for PulmonaryLung Model, the device consists of twomajor parts, the bronchiolar unit andthe alveolar unit—just like the humanlung. The units are primarily madefrom various polymers and are con-

nected by a microfluidic “circuitboard” that manages fluid and air flow.(See Figure 1)

“When we build our lung, we not onlytake into account the aspects of differentcell types, the tissues that are involved,we also take into account that a lung issupposed to breathe, so PuLMo actuallybreathes,” said Pulak Nath of AppliedModern Physics, who leads engineeringefforts for the project.

The PuLMo may also be used tomimic lung disease conditions, such asChronic Obstructive Pulmonary Disease

and asthma, and may be used to studylung air-flow dynamics to better under-stand the mechanisms of toxins anddrug delivery and the effects of smoking,particularly the less-understood effectsof e-cigarettes.

Major funding for the PuLMo projectis provided by the Defense ThreatReduction Agency. PuLMo is part of thelarger ATHENA program to design anintegrated, miniaturized surrogatehuman organ system that includes theheart, liver, lung, and kidney.

For more information, visit www.lanl.gov.

Fig. 1 – The PuLMo alveolar unit is readied for testing

Creating Super Stretchy Artificial MusclesSelf-healing material couldlead to artificial muscle. Stanford UniversityStanford, CA

Chemical engineers at StanfordUniversity discovered that a new elas-tomer synthesized there had too muchelasticity for the testing equipment thelab possessed. In fact, the clampingmachine typically used to measure elas-ticity could only stretch about 45 inchesfrom a one-inch sample of material.Similar materials can normally bestretched two or three times their origi-nal length and spring back to originalsize. However, the Stanford 1-inch poly-mer film sample was able to stretch tomore than 100 inches. The researchershad to manually hold the material and

walk across the room from each other tofind the stopping point.

In addition to the super-stretchinessof the material, the researchers foundthat they could make this new elastomertwitch by exposing it to an electric field,causing it to expand and contract, mak-ing it potentially useful as an artificialmuscle. (See Figure 1)

Artificial muscles currently have appli-cations in robotics, small holes ordefects in the materials can rob them oftheir resilience and they are not able toself-repair if punctured or scratched.

But, this stretchy new material also hasself-healing characteristics at room tem-perature, even if the damaged pieces areaged for days. Indeed, researchers foundthat it could self-repair at temperaturesas low as -4°F (-20°C), or about as cold asa commercial walk-in freezer.

■ How It WorksThe team attributes the extreme

stretching and self-healing ability oftheir new material to some criticalimprovements to a type of chemicalbonding process known as crosslinking.This process, which involves connectinglinear chains of linked molecules in asort of fishnet pattern, has previouslyyielded a tenfold stretch in polymers.

First they designed special organicmolecules to attach to the short polymerstrands in their crosslink to create aseries of structure called ligands. Theseligands joined together to form longerpolymer chains. Then they added to thematerial metal ions, which have a chem-ical affinity for the ligands. When thiscombined material is strained, the knotsloosen and allow the ligands to separate.But when relaxed, the affinity between

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the metal ions and the ligands pulls thefishnet taut. The result is a strong,stretchable and self-repairing elastomer.

The team discovered that they could“tune” the polymer to be stretchier orheal faster by varying the amount or type

of metal ion included. The version thatexceeded the measuring machine’s limits,for example, was created by decreasingthe ratio of iron atoms to the polymersand organic molecules in the material.

The researchers also showed that thisnew polymer with the metal additiveswould twitch in response to an electricfield. They plan to do more work toincrease the degree to which the materi-al expands and contracts and control itmore precisely.

In addition to its long-term potentialfor use as artificial muscle, the teamsays that this material may be useful tocreate artificial skin that might be usedto restore some sensory capabilities topeople with prosthetic limbs. Thiswork could also inspire the develop-ment of strong, flexible, electronicallyactive polymers that could spawn anew generation of wearable electron-ics, or medical implants that would lasta very long time without beingrepaired or replaced.

For more information, visit http://news.stanford.edu.

Fig. 1 – A new, extremely stretchable polymer film created by Stanford researchers can repair itselfwhen punctured, a feature that is important in a material that has potential applications in artificialmuscle. (Credit: Christoph Keplinger, University of Colorado at Boulder)

How Sensors Can Help Save Preterm BabiesSensing technology couldidentify preterm labor intime to reach help. The University of Alabama atBirmingham

“Preterm labor is related to high mor-bidity, high mortality, and significantcost,” said Rubin Pillay, MD, PhD, assis-tant dean for global health innovation atthe UAB School of Medicine. “If we candevelop a device that can predict when apatient is at risk for preterm labor, wecan prevent it or act on it before itbecomes an emergency. The reality nowis that very often it’s too late. When thepatient presents in the hospital, youcan’t do anything about it.”

Since smartphones are practically ubiq-uitous, the prices on electronic sensors,like the ones that let a phone count yoursteps, have become extremely affordable.Pillay and a team of researchers at theuniversity are working to harness thesecheap sensors to help save the lives ofsome of the 15 million preterm babiesborn each year worldwide. Preterm birth,defined as a baby born before 37 weeksgestation, is the leading cause of death in

children aged 5 and under. Using a $2.5 million grant from the

Bill & Melinda Gates Foundation’s AllChildren Thriving initiative, theresearchers are applying sensors, embed-ded in a silicone ring, and synced to anearby phone by WiFi, that can be fittedinto the cervix of high-risk patients in asimple procedure. The stretch sensorcan detect the slightest increase in diam-

eter, and send a warning to the patient’smobile phone. That early warning wouldgive patients time to get to the hospitalwell before birth, Pillay explains. The sil-icone ring will also be infused with prog-esterone, a drug that reduces contrac-tions and the opening of the cervix.

Another use for the sensor technologyis a patch, about the size of ECG patchesthat can be attached to a pregnant

Fig. 1 – When it detects the start of preterm labor, the device will transmit an alert to the patient’ssmartphone through Bluetooth, giving the mother a chance to reach medical care well before birth.

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Finding Flaws in 3D-Printed TitaniumPowder-based printing oftitanium can increasematerial breakage.Argonne National Laboratory,Argonne, IL

Titanium found its initial use in aircraftbecause it is strong but light. Today, it’sfound everywhere, from eyeglass framesand jewelry to sports gear, tools, surgicaland dental implants, and prosthetics.What’s making this manufacturing explo-sion of titanium parts possible is additivemanufacturing, or 3D printing. Printingtitanium alloys reduces waste and costswhile enabling a wide range of designs.However, the powder-based printingmethods used for titanium alloys alsoincrease porosity in the final product,which can decrease the material’s resist-ance to fatigue, leading to breakage.

To understand the cause of porosity in3D-printed titanium alloys and combatthe increased breakage, a team ofresearchers from Carnegie MellonUniversity, Pittsburgh, PA, approachedthe U.S. Department of Energy’sArgonne National Laboratory to applyintense synchrotron X-rays and a rapidimaging tool known as microtomographyat Argonne’s Advanced Photon Source(APS).

By inspecting Ti-6Al-4V, the most com-mon titanium alloy, at the micron-scale,researchers were able to quantify thenumber, volume, and distribution ofpores in samples of the metal printedusing a range of parameters. Additivelymanufactured Ti-6Al-4V includes six per-cent aluminum and four percent vanadi-um and is popular in the biomedicalindustry where speed of manufacture andunique designs are important.

For 3D printing, metals are usuallyatomized into powders first. Ti-6Al-4Vpowders are printed by using either selec-tive laser melting or electron-beam melt-ing (EBM), which uses the high powerand penetration of electrons to melt thepowders layer by layer, heating and com-

pressing them into the desired structure.(See Figure 1)

As the powder heats, gases trapped inthe material can create pores like bubblesthat are pinpoints of structural weakness.These pores can be anywhere from a fewmicrons to a few hundred microns in sizeand are not distributed uniformlythroughout the material. With Argonne’sAPS, the researchers were able to observehundreds or even thousands of pores at ahigh resolution of about two microns.

The team’s goal was to examine severalsamples printed at different specifica-tions, including changes in electronbeam power level, speed, and spacing.They expected that there would be a“sweet spot” at which they could set print-ing parameters to significantly reduce oreliminate porosity by controlling the sizeof the melt pool. By decreasing the powerlevel, the melt pool becomes too small,which could leave unmelted powder, cre-

ating porosity. However, they explained,increasing power level too much, riskscreating deep holes, called keyholes.

With a commercial EBM machine, theteam printed five cubes of Ti-6Al-4V withmelt pools ranging from four times toone-fourth the area of the relative meltpool. The larger the melt pool, the slow-er the speed function. Then they extract-ed 1-by-15-millimeter samples for imag-ing. They also imaged a sample ofpreprinted powder. For each Ti-6Al-4Vsample, 1,500 images in 2D were scannedin just 2 minutes.

When they quantified pore shape, vol-ume, and distribution for all of the 3D-printed samples, what they discoveredwas that there was no sweet spot for flaw-less printing Ti-6Al-4V. Porosity was pres-ent in every piece. While printing param-eters did significantly impact porosity,they did not eliminate it.

For more information, visit www.anl.gov.

Fig. 1 – This image shows microtomography reconstructions of Ti-6Al-4V samples printed at differ-ent speed functions with an electron beam melting machine. (Credit: Ross Cunningham, CarnegieMellon University)

woman’s abdomen to measure uterinecontractions and fetal heart rate. Thesetwo data points are crucial to monitor-ing a baby’s health in the womb. “Thepatch will sync to a doctor’s smartphone,and provide instant information,” Pillay

explained. “It will also have an analyticcomponent, so it can predict whichpatients will run into problems, andalert the doctor.” (See Figure 1)

The next step would be to combinedata from the ring and patch into “one

device to measure cervical dilation, fetalheart rate and contractions,” Pillay said.“A physician can have these on all herhigh-risk patients and monitor themfrom anywhere with a smartphone.”

For more information, visit www.uab.edu.

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Ablation, or the use of high-frequency electromagnetic(EM) energy to destroy soft-tissue tumors, has been in exis-

tence for a few decades, but in recent years its underlying tech-nology has evolved.

The benchmark of minimally invasive tissue treatment haslong been the application of electrical current to kill abnor-mal tissues. This is done by heating tissues until they breakdown, a process called thermal ablation. Energy is deliveredat 500 kHz, within the radio frequency (RF) range of the EMspectrum, hence these systems are called RF ablation systems.

In recent years, microwave (MW) ablation technology hasalso become commercially available and increasingly popu-lar. At MW frequencies, oscillating EM fields are utilized toperform thermal ablation. Medtronic plc, Dublin, Ireland,one of the world’s premier medical technology and servicescompanies, is a leader in both RF and microwave ablationtechnologies. With both RF and MW systems, the energy forablation is applied using one or more needle-like probes.

Medtronic’s latest innovation, the Emprint™ ablation sys-tem with Thermosphere™ technology, offers more predictableand repeatable results than other techniques and devices (SeeFigure 1). These advantages come from the fact thatThermosphere™ technology enables precise control of an EMfield independent of the surrounding tissue environment.

■ Striving for Better PredictabilityAccording to research, physicians rate predictability as their

number one concern with ablation performance. The higherthe level of predictability, the easier it is for a physician to plana treatment procedure that will be safer, more effective, andless time-consuming.

Because of its nature, it’s challenging to be certain that RFablation procedures will achieve the desired results. Giventheir different electrical conductivities, some tissues are lessamenable to effective RF heating than others. Moreover, as thetemperature in targeted tissue approaches 100°C, water in thetissue begins to vaporize and electrical conductivity rapidlydecreases. This can make it difficult to generate temperatureshigh enough to cause cell breakdown.

MW ablation technology attempts to overcome these limita-tions by using an EM field radiated into the tissue (See Figure 2).However, in practical application, tissue type and the vaporiza-tion of water during ablation cause the size and shape of the EMfield to vary.

The Emprint™ ablation system with Thermosphere™ tech-nology realizes the promise of predictability. It gives physiciansthe ability to easily control the thermal energy delivered by

allowing precise control of the EM field across tissues and tem-peratures. This allows clinicians to accurately predict theboundaries and characteristics of the ablation zone.

■ Real-Time Monitoring of Ablations“The challenge now is to monitor the ablation performance

in real-time,” said Casey Ladtkow, principal engineer in theEarly Technologies unit of Medtronic’s Minimally InvasiveTherapies Group (MITG). “At present, when performing abla-tions, physicians don’t have continuous real-time feedback onthe effectiveness of their procedure. If they could know exactlywhat is happening in real-time from start to finish, the effec-tiveness of ablation treatment would increase,” he said.

With some 40 staff members focused on interventionaloncology, the mission of his unit is to deliver procedural solu-tions that alleviate pain, restore health, and extend life.Ladtkow and his team are using COMSOL Multiphysics® soft-ware to develop new ablation probes in order to achieve evenhigher levels of predictable performance and effectiveness.

One development-stage project is to optimize the design ofthese probes so they can both create a more precise ablationzone and also provide real-time feedback using radiometers.

Radiometers measure EM radiation and enable the charac-terization of the spatial distribution of an EM field. Ladtkow’steam is incorporating radiometers into Medtronic probes inorder to give clinicians real-time feedback about the ablationzone. This will enable a clinician to fine-tune the zone as need-

Advancing Ablation Technology Using Simulation Science

Fig. 2 – The photo on top illustrates placement of an ablation probe. Thegreen circle delineates the target (where the lesion is located) and the redcircle delineates the margin the ablation is meant to achieve. The imagebelow shows the site after ablation has taken place.

Fig. 1 – At left, shapes of tissue ablation zones that can result unpredictablyfrom the use of various ablation technologies. At right, Medtronic’sEmprint™ ablation system with Thermosphere™ technology yields pre-dictable spherical ablations regardless of target location or tissue type.

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ed during the procedure, and to make sure the radiationdestroys the targeted tissues while minimizing effects on thesurrounding healthy tissue. (See Figure 2)

The team uses Multiphysics and its RF Module to help themmodel the probes and better understand and optimize theiremitting/radiating and receiving/monitoring properties. “Theperformance and accuracy of MW ablation systems are affectedby a number of dynamic factors that arise simultaneously inmultiple physics domains. COMSOL software gives us the abil-ity to perform the relevant complex modeling quickly and eas-ily, to help us understand these coupled effects and improveour design,” Ladtkow said.

■ Simulation Enables Fast and Safe Design,Optimization, and PrototypingFor such a complex device, the traditional approach of build-

ing and evaluating a series of physical prototypes is all but out ofthe question because of the complexity and relationships amongthe many physics-based factors that impact device performance.

The team used the software to model the energy radiator andtest designs that incorporated radiometric sensing in the samedevice. They simulated coupled thermal and electromagneticeffects around the radiative probe hardware to determine radio-metric performance under different conditions (See Figure 3).

Ladtkow analyzed heat transfer in living tissue using a bioheatequation, which included a perfusion term, to account for blood

flow cessation once the tissuecoagulated (See Figure 4).This helped his team under-stand heat transport to cellsaround the tumor and predictthe temperature distributionto ensure efficient and pre-dictable energy delivery.

He performed other stud-ies as well: investigations oftemperature dependence ofreaction rates (to understandthe size of the ablation zone);radiometry modeling todetermine how much energyenters the tissue and howmuch is reflected back intothe radiator; and liquid-to-gasphase-change dynamics (SeeFigure 5). “The latter is criti-cal to knowing what the wavepattern will look like, becauseknowing how much water isin the tissue is critical to

knowing how a radiometer will behave, because of the changein wavelength,” he said.

Simulation showed that lengthening the proximal radiatingsection (PRS) and shortening the distal radiating section (DRS)of an antenna would produce an efficient ablation radiator andan efficient receiver. These studies resulted in versions of a pro-totype ablation radiator with an integrated radiometer, alongwith results showing the performance of the integrated probe.(See Figure 6)

■ From Impossible to Possible“Without COMSOL to help us perform these analyses, it sim-

ply would be impossible to do enough experiments to find anoptimum solution that integrates an emitter and a receiver.COMSOL helps us see that certain architectures—which we’dnever have investigated otherwise—might make an integrateddevice possible,” Ladtkow continued.

His team uses COMSOL software in conjunction with MAT-LAB® software, and he said that the combination gives him apowerful ability to optimize complex models with highly sophis-ticated algorithms quickly and easily. He also hopes to integratethe Application Builder available in COMSOL Multiphysics intotheir modeling workflow. This would enable the team to createsimulation apps allowing partners to test and verify differentdesigns, while protecting their proprietary models.

“Based on our simulations, we are now realizing the poten-tial to introduce ablation devices that will allow clinicians tonot only deliver a precise energy dose, but also monitor abla-tions in real time,” Ladtkow said. “Multiphysics simulationenabled the rapid development, evaluation, and optimizationof our design, which would not have been possible otherwise.”

This article was written by Valerio Marra, Technical MarketingManager, COMSOL Inc., Burlington, MA. For more information,visit http://info.hotims.com/61063-166.

a

Fig. 3 – These results from a software simulation show the power dissipa-tion density, or the extent of the ablation, as determined by the thermaldamage calculation. The antenna and the surrounding tissue are initiallywell-matched, and the match (i.e., the antenna pattern) changes over timeas tissue temperature increases during the procedure (left to right).

Fig. 4 – This plot shows a crosssection of the predicted ablationvolume, or predicted tissue dam-age. The information is used tomodify the bioheat equation and,thereby, to modify perfusion condi-tions in the tissue. Red areas rep-resent coagulated tissue where noperfusion is present, and whiteareas represent areas of normalperfusion. This makes the modelmore accurate by creating a realis-tic on/off condition for the perfu-sion term in the bioheat equation.

Fig. 5 – COMSOL results show the change in heat capacity in the tissue sur-rounding the probe, dominated by phase change of water in that tissue.Knowing where water is boiling is important because the MW radiationwavelength is dramatically different for liquid water than for vaporized water.

Fig. 6 – A weighted error plot. Blue areas indicate regions where reflectedpower is low for delivered ablation energy and also where the receiver qualityis good. They represent antenna configurations that are both good ablationdevices and good radiometers.

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In many instances, thermoforming ofheavy-gauge plastics (thicknesses of 1.5

mm/.060 in. or greater) is the technolo-gy of choice for manufacturers and newproduct designers. Using this process ofvacuum forming heated plastic sheets isideal for many products and compo-nents required by medical device manu-facturing and countless other industries.

A wide variety of heavy-gauge plasticmaterials are available for this process,many of which can be used for com-plex parts that demand tight toler-ances, intricate geometries and specialproperties such as fire resistance.

At the same time, thermoformingtooling and prototypes are often devel-oped more quickly than many conven-tional molding methods and can beperformed through a number of eco-nomical processes. (See Figure 1)

These same attributes may also be thesource of confusion, wheel spinning, andthe expenditure of unnecessary costs ifcustomers are too self-reliant when they design parts for theheavy-gauge thermoforming process. What is often needed is acollaborative process that includes thermoforming specialistsearly in the design of the products that will be formed.

■ Get Design Support EarlyJesse Hahne, a highly experienced design engineer at the

Center for Advanced Design (CAD), Elk River, MN, found thatit is highly beneficial for the customer’s design engineers to col-laborate with their thermoforming vendor early in the process.He says that the vendor can help validate the geometry and fea-tures of the product design, confirm or assist with materialselection, determine how tooling should be developed, provideprototypes quickly, and economically, and, of course, confirmthe best process for meeting production volume requirements.

CAD is a design firm that focuses on the plastics industry,including design for vacuum forming, rotational molding, injec-tion molding and blow molding. Hahne consults with many in-house engineers of clients as well as with thermoforming special-ists and the molders of different plastic forming technologies.

■ Confirm the ProcessIn some cases, requests to evaluate the use of thermoform-

ing a product might best be produced by another process.It is vital to get support from a supplier’s technical staff early in

a project, especially if they are familiar with various forming andmolding technologies. This can be very valuable in helping thecustomer validate that they are considering the right process.

It’s beneficial to find a vendor that offers a variety of tech-niques, including pressure forming of heavy-gauge plastics,which is often times a suitable process. Pressure forming is simi-lar to the vacuum forming process, but with specific tooling canproduce parts with much greater definition. In instances wherevolumes are relatively low, pressure forming may be a viable

alternative to much more expensiveinjection molding.

With both thermoforming and pres-sure forming projects, a vendor can assistcustomers from design to materials selec-tion, tool development, prototyping or3D modeling and production.

■ Check Tooling SpecificationsIt is often vital that design engineers

validate tooling with thermoformingspecialists, particularly when the projectincludes design complexities. Thesecould include such requirements asundercuts, the use of breakaway molds,two-piece products involving manifoldsor ductwork, or products that requirespecial trimming or surface finishes.

Forming complexities can be problem-atic for some thermoforming shops. Theyare often achievable, but may requiremodifications in tooling that could resultin cost savings. (See Figure 2)

With thermoforming you have muchgreater flexibility with tooling than you have with technologiessuch as blow molding or rotational molding. For example, forsmaller projects you can 3D print and test the tool. If a largetool is required, then you build a wood pattern and producetest parts from it, then make changes to the pattern beforeyou finalize the tool design.

That tooling flexibility of the thermoforming process enablesthe right vendor to work with a wide range of sizes, using plasticmaterials from .010" to .450" thick to produce parts as large as 5feet x 8 feet, with a maximum draw or depth of 30", with drawratios to select the proper base thickness and forming process.

■ Validate Material SelectionWhile a wide variety of plastic materials are appropriate for ther-

moforming, it is wise to work with thermoforming specialists todetermine the availability of materials, volume requirements, andthe ability of materials to meet design requirements. (See Figure 3)

Materials such as acrylonitrile butadiene styrene (ABS) andpolyethelenes are suitable for many projects, but others

Fig. 2 – It is often vital that design engineers validate tooling with thermoform-ing specialists, particularly when the project includes design complexities.


A Guide to Thermoforming Heavy-Gage, Complex Parts: From Material Selection to Custom Tooling

Fig. 1 – Thermoforming allows much greater flexi-bility with tooling than you have with technologiessuch as blow molding or rotational molding.

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require more demanding properties that are available withmore advanced materials including thermoplastic polyolefins(TPOs), polycarbonate, and Kydex®.

Any of a number of factors could come into play when com-panies are considering material selection for products or com-ponents. Those could include the finish, impact resistance, fireresistance or scratch resistance and many others.

These advanced materials have properties that are excellentfor many specific applications, for example, polycarbonatewhen a tough, transparent product is needed; TPOs for stabil-ity; Kydex for its cleanability so that scuffs and scratches maybe removed from the surface of the material, as well as itsexcellent chemical and flame retardant properties

However, some of these materials may not be practical oreven available for low-volume projects. In those cases, sec-ondary processes may become part of the solution, whetherpainting or silk-screening or other cosmetic solutions. That’sone of the reasons why it’s important to consult with anexperienced thermoforming vendor about material selec-tion early in the design process.

■ Start-to-Finish FeedbackSeveral years ago Kent Olson, vice president of Packaging Plus,

Inc., Rogers, MN, had a special project for a large medical com-pany that required heavy-gauge thermoforming. Olson workedwith Alpha Plastics, Coon Rapids, MN, on the project. The prod-uct was a tray composed of R-63, a black, conductive material thatis static dissipative that would be used in a clean room.

The tray was a unique design and the tolerances needed tobe very precise, within thousandths of the medical company’srequirements.

The company has required additional sizes of the medicaltrays over the years, as well as a catch basin project thatrequired a fairly deep draw of approximately 12 inches.

Olson soon learned that working with a good thermo-forming vendor involves a highly comprehensive process. Atthe beginning of the project the vendor should meet withthe company’s technicians and go through the specificrequirements. They then should provide the necessarydrawings, and after review, should create a prototype for thecustomer. After that is approved, it should then go into pro-duction. It is very significant that the chosen vendor keepthe customer informed all along the way. That is one of thekeys to design success.

This article was written by Jeff Walczak, Executive Vice President,Alpha Plastics, Inc., Coon Rapids, MN. For more information, visithttp://info.hotims.com/61063-167.



See us at AACCBooth #3949

Fig. 3 – Your supplier can help validate the geometry and features of theproduct design prior to production to save money and time.

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■ Metallic Cable GlandLapp Group, Florham Park, NJ, introduces its

new SKINTOP Hygienic stainless steel cable gland,

which meets IP68 and 69K standards and is

designed to withstand high pressure and high tem-

perature washdowns. Special design features pre-

vent microorganisms and bacteria from sticking to

the surface, and Skintop Hygienic has a tempera-

ture range from -20° to 100°C.

For Free Info, Visit http://info.hotims.com/61063-169

■ CoolPerformance Plus MaterialRogers Corporation, Rogers, CT, announces

that its Power Electronics Solutions group has

introduced its latest high-performance cooling

material, curamik® CoolPerformance Plus—an

advanced liquid-cooled material designed to dis-

sipate large amounts of heat and provide reliable thermal management

of high-power laser diodes and other heat-generating optical devices.


■ Resbond Thread-Locker Gel Sealant Cotronics Corporation, Brooklyn, NY,

announces that its Resbond™ 907TS and

907TSG Thread-Locker and Pipe Sealant Gel

goes exactly where you apply it, eliminating

running and dripping usually caused from

standard thread-lockers. Resbond™ Gel is easy

to apply and cures at room temperature to

form thermally stable, electrically insulating, and chemically and cor-

rosion resistant seals.


■ 800W ATX Power SupplyRAM Technologies, LLC, Guilford, CT,

introduces the PFC800PCX, an 800 watt

ATX power supply unit intend for use in

medical imaging and data processing

applications. Proprietary multi loop

design ensures clean tight output regula-

tion and ensures ultra high reliability typ-

ically exceeding a demonstrated MTBF of greater than 500,000

hours. Custom output cables at no additional cost.


■ Wireless, Batteryless Limit SwitchesSteute Meditech, Inc.,

Ridgefield, CT, offers a comprehen-

sive line of wireless Limit Switches

featuring an internal electrodynam-

ic energy generator with no battery

required. Displacement of the actu-

ator generates power to send a uniquely coded signal to one or more

compatible, easily-programmed receivers. The Receiver accepts up to

10 discrete signals per channel.


■ 22ECP Miniature Motor Portescap, West Chester, PA, intro-

duces the new 22ECP two-pole motors

bringing performance to the most com-

monly specified brushless motor working

points. Part of Ultra EC™ platform of

brushless slotless mini motion solutions,

these cost-optimized motors can provide

30% more continuous torque and 100% more power over comparable

motors.


■ TruBend Series 5000TRUMPF, Inc., Farmington, CT,

announces that its TruBend Series

5000 universal machines come

equipped with a new On-Demand

Servo Drive with 4-cylinder drive tech-

nology. The Servo Drive is highly

dynamic, extremely quiet in operation,

and delivers significantly more productivity compared to a conven-

tional drive. It only consumes energy only during the bending

process.


■ Multi-Axis Piezo-Motor PositionersPI (Physik Instrumente), Auburn, MA, L.P. presents its miniatur-

ized, multi-axis linear, and rotary positioners. With 50 models in the

Q-Motion piezo motor

family, PI’s minute stages

represent varying sizes and

motion ranges. Vacuum

compatible stages, UHV,

and non-magnetic options

are also available. PI can

modify any standard stage,

or provide a fully customized OEM part.


PRODUCT OF THE MONTH■ J750 3D Printer

Stratasys Ltd., Minneapolis, MN, intro-

duces an industry first with its new 3D print-

er, the J750. This solution enables customers

for the first time to mix and match full color

gradients alongside an unprecedented

range of materials to achieve one-stop real-

ism without post-processing. This, together with the system’s versa-

tility, makes the J750 the 3D printing solution for product design-

ers, engineers, and manufacturers, as well as service bureaus.

The Stratasys J750, an addition to the Objet Connex multi-

color, multi-material series of 3D printers, allows customers to

choose from more than 360,000 different color shades plus

multiple material properties ranging from rigid to flexible

and opaque to transparent. Prototypes can include a vast array

of colors, materials, and properties in the same part, speeding

production of realistic models, prototypes, and parts for virtu-

ally any application need—as well as delivering 3D printing

versatility to produce tooling, molds, jigs, fixtures, and more.

Designers and engineers can physically experience product

prototypes within hours of developing an initial concept for

immediate design and function validation with internal stakehold-

ers and end users. Design decisions can be made instantaneously

and with full confidence to help accelerate product delivery.


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■ Linear Apodizing Filter Reynard Corporation, San Clemente, CA,

announces the Linear Apodizing Filter used

to eliminate undesirable intensity variations

in optical systems. They have a fixed ND coat-

ing in one direction and a variable ND coat-

ing in the other direction. The two types are: dark in the center to

clear on the edges, or clear in the center to dark on the edges.


■ Cyborg 3D SoftwareIntegrityWare Inc., San Diego, CA, introduces

Cyborg3D, a standalone 3D modeling software plat-

form that combines organic surface modeling with

precise, parametric CAD modeling. Cyborg3D is

built using modern software architecture techniques

(Object Oriented Modeling, C#, Managed Code, multi-threaded paral-

lel processing, OpenGL, etc.). Its multi-threaded architecture is suited

for large assemblies and compute intensive functionality.


■ Tridak Model 3200 Piston Inserter Dymax Corporation, Torrington, CT, announced

that its Tridak® Model 3200 Piston Inserter has

received the CE Mark, making this automatic air-

bleed system available in Europe. The Model 3200

Piston Inserter allows operators to insert pistons into

cartridges and syringe barrels accurately and quickly,

eliminates trapped air, and is adjustable for single or

dual cartridges.


■ Advanced Stencil Manufacturing Photo Stencil LLC, Golden, CO, provides high-

performance stencil printing solutions and

advanced stencils for printing the most demanding

PCB and semiconductor packaging designs. Its laser

direct imaging enables the creation of extremely

accurate stencils for solder paste printing of PCBs

and for high density interconnects, BGAs, CSPs, and flex circuits.


■ MU425S AC/DC Power Supply Family SL Power, Ventura, CA, introduces its 425 watt,

single output MU425 Series AC/DC power sup-

ply. Compact and highly efficient, up to 90%,

MU425S models are approved to

CSA/EN/IEC/UL60601-1, 3rd Edition 2 means

of patient protection (MOPP) isolation. For home healthcare devices, the

new power supplies meet EN61000-4-2, EN61000-4-3 and EN61000-4-6.


■ 14-Bit 16-Concurrent Channel A/D Board Ultraview Corporation, Berkeley, CA,

announces its AD14-65Mx16AVE, a 14-bit 16-

concurrent channel 65MSPS A/D board for

demanding large-system OEM uses, where

signals on multiple time-aligned channels

need to be observed with high SNR, such as imaging, ultrasound, spec-

troscopy, multiport RF component, and antenna testing. The unit can

record concurrent time-aligned single shot waveforms on each of up to

16 concurrent channels.


■ Series 6PF Positioning Feedback CylinderCamozzi Pneumatics, McKinney, TX,

designed the Series 6PF Positioning

Feedback Cylinder to increase both preci-

sion and control in its pneumatic actuators.

The sturdy design, high performance, and

flexible installation make the Series 6PF

ideal for use in applications including: tensioning cylinders, positioning

cylinders, and filling/cutting/measuring systems.


■ New Push Pull PL Series Connectors ITT Cannon, Irvine, CA, has launched a

new line of high-performance, plastic push pull

interconnects for medical and industrial applica-

tions. The PL Series offers a quick connect-and-dis-

connect capability for cable-to-cable and cable-to-

board applications. Its lightweight, sterilizable, and easy

grip design makes the connector series particularly well suited to the

medical device market.


■ TAZ Series HRC6000 Tantalum Capacitors AVX Corporation, Fountain Inn, SC, has

released a new series of next-generation med-

ical-grade, solid tantalum capacitors.

Delivering lower DC leakage values than com-

petitors, down to 0.0025CV, and requiring sig-

nificantly less voltage de-rating than the stan-

dard 50% recommendation for solid tantalum capacitors, the series is

ideal for use in a variety of medical implantable and life support devices.


■ maxiFLOW Heat Sinks Advanced Thermal Solutions, Norwood, MA,

provides a family of high performance

maxiFLOW™ heat sinks for cooling DC-DC

power converters and power modules. The power

brick heat sinks are available for full, half, quarter and one-eighth brick

sizes. Their patented maxiFLOW spread fin heat sink design maximizes

cooling performance in low airflow environments.


■ MultiDyne Corona Treating Heads 3DT LLC, Germantown, WI, has updated its

MultiDyne corona treating heads from a molded

head to an assembled one. This change assures a

sturdier platform for consistent surface treat-

ment. Components can easily and inexpensively

be replaced. MultiDyne improves adhesion on 3D

parts effectively and inexpensively treating numer-

ous substrates and a wide variety of applications with minimal set up.


■ 2110 Series Twin-Cylinder PumpGardner Denver Thomas, Inc., Sheboygan, WI, has

launched its 2110 series variable output twin WOB-L®

piston oil-less air compressor designed for medical,

instrumentation, and lab automation applications

requiring variable output and low power consumption.

The 2110 provides variable output, through its brushless DC motor and

motor controller design.


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■ TrueLase 10/130 OpticalFibers

OFS, Norcross, GA,

introduces its TrueLase

10/130 Active and

Passive LMA Double-

Clad Optical Fibers.

Based on OFS propri-

etary technology, the TrueLase family of ytter-

bium-doped gain and matching passive fibers

enable designers to produce high perform-

ance, reliable, and consistent lasers and ampli-

fiers utilizing true single-mode fiber designs.

For Free Info, Visit

http://info.hotims.com/61063-188

■ OmniCure AC5 Series UVLED Systems

Excelitas Technologies Corp., Waltham, MA,

introduces its new OmniCure® AC5 Series UV

LED systems for small area curing. Designed

with a unique combina-

tion of high output LEDs

and custom optics, the

OmniCure AC550/P and

OmniCure AC575/P air-

cooled UV LED curing

systems provide high irra-

diance, enabling manufacturers to achieve

better productivity while the LEDs reduce

running costs.



■ Near Net Shape TechnologyPiper Plastics, Chandler, AZ, has developed

a proprietary high pressure molding technol-

ogy that yields near net

shape polymers up to

2" thick without poros-

ity, voids, or sinks. The

process, which utilizes

molding equipment

designed and developed by Piper Plastics,

allows the company to mold high-perfor-

mance thermoplastics, filled or unfilled, with

isotropic mechanical properties.



■ SDP3x Differential PressureSensor

Sensirion AG, Staefa, Switzerland, has added

versions of the world’s smallest SDP3x differential

pressure sensor. Both

the digital SDP32 and

analog SDP37 enable

excellent accuracy in the

bi-directional flow range

of up to 125 Pa. In addi-

tion, the SDP32 allows the user to select from up

to three I2C addresses with the ADDR pin.



Free Info at http://info.hotims.com/61063-761 Free Info at http://info.hotims.com/61063-762


Free Info at http://info.hotims.com/61063-765 Free Info at http://info.hotims.com/61063-766


MULTIPHYSICSMODELING ANDSIMULATIONSOFTWARECOMSOL Multiphysics® is anintegrated software environmentfor creating physics-based mod-

els and simulation apps. Add-on products allow thesimulation of electrical, mechanical, fluid flow, andchemical applications. Interfacing tools enable itsintegration with major technical computing and CADtools. Simulation experts rely on COMSOL Server™product to deploy apps to their colleagues and cus-tomers worldwide. www.comsol.com/products

COMSOL, Inc.

SILICONE FORMEDICALAPPLICATIONS Master Bond MasterSil151Med is an opticallyclear, flexible pottingand encapsulation com -

pound. It exhibits superior electrical insulation proper-ties and very low shrinkage upon cure. MasterSil151Med is resistant to vibration and shock and has aservice operating temperature range of -65°F to +400°F.It meets USP Class VI requirements for medical appli-cations. www.masterbond.com/tds/mastersil-151med

Master Bond

HIGH PURITYSILICONE TUBING– FREE SAMPLEOffering the highest degreeof purity, platinum-curedSilcon® Med-X tubing isnonreactive to body tissues

and fluids and will not support bacteria growth. It’sflexible and translucent and withstands temperaturesfrom -100°F to 400°F (-73°C to 204°C). The elastomermeets USP Class VI requirements. Silcon® Med-Xcontains no phthalates. Made in USA; stocked in 17sizes. www.newageindustries.com/sample-mdb11

NewAge® Industries, Inc.

TRUPULSE:WHEN EVERYPULSE COUNTS The refined TruPulselasers provide everythingneeded to make a perfectweld, cut, or drilled hole.

TruPulse has high peak powers, superior pulse stabil-ity, and precise pulse shaping function. Low heatinput and high peak powers make the TruPulse aflexible and versatile tool for small part productionin medical, electronics, and automotive markets.www.medicaldesignbriefs.com/trumpf201607

TRUMPF Inc.

PRODUCT SPOTLIGHT


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

MEDICALCONTRACTMANUFACTURINGSOLUTIONS

Located in West Michigan, Medbio is an ISO13485:2003 certified contract manufacturer offeringinnovative medical device manufacturing solutionsfor the Life Sciences. We specialize in plastic injec-tion molded products, assembly, packaging, anddesign support. From components to full assem-blies, Medbio has the knowledge, passion, and expe-rience to solve your most difficult manufacturingchallenges. www.medbioinc.com

Medbio, Inc.

SCHOTT FIBEROPTIC IMAGEBUNDLESSuperior image bundles forsmall diameter endoscopes

are now available from SCHOTT, the leading inter-national supplier of image bundles. Our bundlesinclude the following features: • Higher resolution• Larger active area• Superior image quality• Special moisture barrier• More robust and flexible For more information, go to: www.us.schott.com/seemore

SCHOTT North America, Inc. —Lighting and Imaging

POROUS CERAMICVACUUMCHUCKPhotoMachining of -fers a porous ceramicvacuum chuck for use

with thin films and other flat samples. Pore sizesunder 25 microns assure uniform suction and holdingpower for even the smallest parts. PhotoMachiningalso provides contract laser-manufacturing services,and designs and builds custom laser-based manufactur-ing equipment. PhotoMachining, Inc., 4 Industrial Dr.,Unit 40, Pelham, NH 03076; Tel: 603-882-9944; Fax:603-886-8844; [email protected];www.photomachining.com

PhotoMachining, Inc.

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http://www.abpi.net/ntbpdfclicks/l.php?201607MDBP46A8A

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

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

(908) 300-2539Editorial Director ........................................................................Linda L. BellEditor .....................................................................................Beth G. Sisk 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

ADVERTISERS INDEX

ACCES I/O Products, Inc. ......................................739 ........................14

Aerotech, Inc. ..............................................745, 746 ..................28, 29

Anomet Products...................................................761 ........................46

ATI Industrial Automation ........................................738 ........................13

COMSOL, Inc. ..............................................734, 762 ....................5, 46

CPC - Colder Products Company ..............................755 ........................20

Fluid Metering, Inc. ...............................................757 ........................43

Helical Products Company ......................................756 ........................19

Interpower ............................................................737 ..........................9

John Evans’ Sons, Inc. ..................................747, 748 ........................30

Lubrizol LifeSciences ..............................................733 ..........................4

Magnetic Component Engineering, Inc. ....................741 ........................21

Master Bond ................................................759, 763 ..................35, 46

maxon precision motors, inc. .........................749, 750 ........................31

mdi Consultants, Inc. ............................................758 ........................43

Medbio, Inc. ........................................................764 ........................46

MICROMO ....................................................751, 752 ........................32

Nason..................................................................740 ........................17

Nelson Laboratories, Inc. .......................................714 ....................COV II

NewAge® Industries, Inc. .......................................765 ........................46

Nordson MEDICAL, Avalon Catheter Solutions............742 ........................21

PhotoMachining, Inc. .............................................766 ........................46

Portescap ....................................................753, 754 ........................33

Proto Labs, Inc. ...................................................736 ..........................7

Reell Precision Manufacturing, Inc. .........................760 ........................35

Schneider Electric Motion USA ................................769....................COV III

SCHOTT North America, Inc. ..................................767 ........................46

Smalley ................................................................735 ..........................6

Steute Meditech, Inc. ............................................770 ...................COV IV

Swiss Automation, Inc. ..........................................744 ........................27

Tech-Etch, Inc. ......................................................743 ........................24

Technimark Healthcare ...........................................730 ..........................1

Teleflex Medical OEM..............................................731 ..........................2

TRUMPF Inc. ...............................................732, 768 ....................3, 46

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

Medical Design Briefs, ISSN# 2158-561X, USPS 4865, copyright ©2016 in U.S., is publishedmonthly by Tech Briefs Media Group, an SAE International Company, 261 Fifth Avenue, Ste.1901, New York, NY 10016. The copyright information does not include the (U.S. rights to)individual tech briefs that are supplied by NASA. Editorial, sales, production, and circulationoffices are located at 261 Fifth Avenue, Suite 1901, New York, NY 10016. Subscriptions fornon-qualified subscribers in the U.S. and Puerto Rico, $75.00 for 1 year. Single copies $8.50each. Foreign Subscriptions 1 year U.S. funds $195.00. Single copies $21.75 each. Digitalcopies: $24.00. Remit by check, draft, postal, express orders or VISA, MasterCard orAmerican Express. Other remittances at sender’s risk. Address all communications for sub-scriptions or circulation to Medical Design Briefs, 261 Fifth Avenue, Suite 1901, New York, NY10016. Periodicals postage paid at New York, NY and additional mailing offices.POSTMASTER: Send address changes and cancellations to Medical Design Briefs, P.O. Box 47857, Plymouth, MN 55447.July 2016, Volume 6, Number 7.

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mailto:[email protected]














































GLOBALL INNOVATIONSIGLOBALL INNOVATIONSIGLOBALL INNOVATIONSI

Ateam of engineers fromHong Kong PolytechnicUniversity and the

University of Hong Kong(HKU) have collaborated onan innovative project to devel-op a novel surgical robotic sys-tem (NSRS) with haptic or tac-tile feedback that is capable ofsingle incision or natural ori-fice robotic surgery in order tominimize surgical trauma andimprove the safety of currentrobotic surgery. Led byProfessor Yung Kai-Leung,Professor and Associate Headof the Department of Industrialand Systems Engineering ofThe Hong Kong PolytechnicUniversity, the team appliedProfessor Yung’s expertise inmaking precision instrumentsin space to the system.

The team has developed anNSRS with surgical roboticarms that are driven by inter-nal micro-motors and capableof up to 10 degrees of free-dom in movement. The robot-ic system was successfully uti-lized in three consecutive ani-mal surgical experiments.(See Figure 1)

Currently, there is one domi-nant surgical robotic system onthe market today. The system is expen-sive and has some limitations, includingthe need for multiple incisions, lack offorce or tactile sensation feedback, andbulkiness. In addition, it is not designedfor natural orifice, also known as inci-sion-less, robotic surgery.

■ How It WorksHong Kong’s new NSRS robotic sys-

tem can be inserted through a single,small incision or even a natural orificeand expanded inside the human body toperform various surgical operations. Incontrast to currently available surgical

robots, which require multiple(three to six) abdominal inci-sions, NSRS has fully internallymotorized surgical arms whichcan enter the human bodythrough one tiny incision, or anatural orifice, for variousabdominal or pelvic surgicaloperations.

Since the robotic arms aredriven by custom-made micro-motors adjacent to the end-effec-tors, they can operate with highprecision and provide hapticfeedback of the force applied.NSRS is the first robotic systemin the world with arms having invivo motors that are both smallenough and able to generate suf-ficient force to perform varioussurgical operations inside thehuman body, paving the way forfuture non-invasive surgery.

Three consecutive successfulanimal surgical experimentsusing the NSRS prototype werecarried out at the Surgical SkillsCentre, Department of Surgeryat HKU since December 2015. Inthe most recent successful exper-iment conducted in February,robotic cholecystectomy was suc-cessfully completed within onehour in a live pig using the NSRS.

The team says that they planto continue to test the new robotic sys-tem in animal and cadaver models formore complicated procedures, using asingle-incision and natural orificeapproach, and hope to apply this systemto various robotic surgeries in humansin the near future.

Surgical Robotic System for Incision-Less Surgery Hong Kong Polytechnic UniversityHong Kong, Chinawww.polyu.edu.hk

Fig.1 – Animal trials conducted using the NSRS prototype were suc-cessfully carried out in December 2015.

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Free Info at http://info.hotims.com/ -7

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Setting the Standard for “Medical-Grade” Foot Controls™

(203) 244-6302 www.steutemeditech.com [email protected]

The design of your medical device’s foot control can greatly affect your customer’s user-experience. Excessweight, poor sealing, user-fatigue, difficulty in cleaning/handling, or cracked/peeling finishes can compromisetheir satisfaction and your product’s image.

Such consequences can easily be avoided.

Steute has pioneered the design and manufacture of fully-compliant, medical-grade foot controls.We have satisfied medical device OEMs’ unique needs with thousands of application-specific foot controls …each functionally, ergonomically, and aesthetically-optimized to the OEM’s requirements.

We would be pleased to do the same for you. Call or write for a no-obligation design consultation, a free copyof our white-paper, “Design Differences of a Medical-Grade Foot Control”, or to discuss receiving acomplimentary sample for evaluation.

Technical Support & Warehousing Center — Ridgefield, Connecticut

It’s your customer’severyday user experience.

It’s much more thana foot control...

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july 2016 welcome to your ...assets.techbriefs.com/eml/2016/mdb_digital/mdb0716.pdfcov toc + –...

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