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May 2013 Issue

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  • An RTC Group Publication A Supplement to RTC magazine

    MEDICAL ELECTRONIC DEVICE SOLUTIONS

    MEDICAL ELECTRONIC DEVICE SOLUTIONS

    MEDS

    MEDICAL ELECTRONIC DEVICE SOLUTIONSMEDICAL ELECTRONIC DEVICE SOLUTIONS

    MEDICAL ELECTRONIC DEVICE SOLUTIONSMEDICAL ELECTRONIC DEVICE SOLUTIONS

    MEDICAL ELECTRONIC DEVICE SOLUTIONS

    Using Human Factors to Shape

    Device Development

    Meet FDA Compliance with Lifecycle Management

  • The Industry Leader in Embedded ComputingCorporate names and trademarks stated herein are the property of thier respective companies. Copyright 2013 IBASE Technology, Inc. All rights reserved.

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  • May 2013 MEDS Magazine 3

    MEDICAL ELECTRONIC DEVICE SOLUTIONS

    MEDSmay 2013

    CONTENTS

    digital subscriptions availablewww.mEdSmag.COm

    Medical Electronic Device Solutions (MEDS) uncovers how embedded technology will bring the biggest breakthroughs in electronic medical devices design. Whether large or smallMEDS is the most influential source of information for engineers, design-ers and integrators developing the newest generation of complex and connected medical devices. MEDS is currently a supplement of RTC magazine, distributed in print to 18,000 engineers, and electronically to 12,000 in the embedded com-puting market. Learn more about MEDS at www.medsmag.com.

    SPONSORSaxiomtek ..................................................................19

    Commell ...................................................................18

    congatec ................................................................ 20

    iBase ..................................................................................2

    Intelligent Systems Conference and Pavilion ...................4

    mSC Embedded ..............................................4

    UL ...........................................................................................11

    PULSE8Bluetooth Health Device Profile: Compatible Communication for Specialized DevicesPart 1Florian Herrmann and Karsten Aalders, Stollmann

    12FDA Human Factor Requirements Change the Landscape of Medical Device DevelopmentDavid Hirning MS and Virginia A Lang, PhD, HirnLan, Inc.

    16Medical Device Manufacturers Address Compliance Mandates with Product Lifecycle ManagementEric Marks, Price Waterhouse Cooper

    UP FRONT5EDITORIALMedical Devices and Remote AccessExtending the Reach of Medical ExpertiseTom Williams

    6PuBLISHER'S LETTERThe Med Tech Food ChainJohn Koon

    FOCUS7InnOvATIOn HIgLIgHTSA Collection of What's New, What's Now and What's Next

  • 4 MEDS Magazine May 2013

    MEDICAL ELECTRONIC DEVICE SOLUTIONS

    MEDS

    To Contact the RTC Group and MEDS Magazine:

    HOME OFFICE The RTC Group, 905 Calle Amanecer, Suite 250 San Clemente, CA 92673 Phone: (949) 226-2000 Fax: (949) 226-2050 www.rtcgroup.com

    EDITORIAL OFFICE Tom Williams, Editor-in-Chief 1669 Nelson Road, No. 2, Scotts Valley, CA 95066 Phone: (831) 335-1509

    Published by The RTC GroupCopyright 2012. The RTC Group. Printed in the United States. All rights reserved. All related graphics are trademarks of The RTC Group. All other brand and product names are the property of their holders.

    PRESIDENT John Reardon, johnr@rtcgroup.com

    PUBLISHER John Koon, johnk@rtcgroup.com

    EDITORIALEDITOR-IN-CHIEF Tom Williams, tomw@rtcgroup.com

    MANAGING EDITOR/ASSOCIATE PUBLISHER Sandra Sillion, sandras@rtcgroup.com

    COPY EDITOR Rochelle Cohn

    ART/PRODUCTIONART DIRECTOR Kirsten Wyatt, kirstenw@rtcgroup.com

    GRAPHIC DESIGNER Michael Farina, michaelf@rtcgroup.com

    WEB DEVELOPER Justin Herter, justinh@rtcgroup.com

    ADVERTISING/WEB ADVERTISINGVP OF MARKETING Aaron Foellmi, aaronf@rtcgroup.com

    MEDS SALES ACCOUNT MANAGER Jasmine Formanek, jasminef@rtcgroup.com (949) 226-2004

    BILLING Cindy Muir, cmuir@rtcgroup.com (949) 226-2021

    Ultimate graphics and video performance

    The MSC C6C-A7 module is based on AMDs Embedded R-Series platform delivering high-performance processing coupled with a premium high defi-nition visual experience in a power efficient solution. Supporting OpenCL it can boost the computing performance using the graphics engines for parallel processing.

    AMD Embedded R-Series

    Accelerated Processing Units

    R-460L quad-core, 2.0/2.8 GHz R-452L quad-core, 1.6/2.4 GHzR-260H dual-core, 2.1/2.6 GHzR-252F dual-core, 1.7/2.3 GHz

    AMD Radeon HD 7000G Series graphics Up to 16 GB DDR3 SDRAM MicroSD card socket, bootable Three DisplayPort/HDMI/DVI interfaces VGA and LVDS/Emb. DisplayPort Four independent displays supported DirectX 11, OpenGL 4.2, OpenCL 1.1

    COM Express - MSC C6C-A7

    EMBEDDEDSOLUTIONS

    R-SERIES APU

    MSC Embedded Inc. Tel. +1 650 616 4068

    info@mscembedded.com

    www.mscembedded.com

    V-3_2013-WOEI-6376

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  • May 2013 MEDS Magazine 5

    UP FRONTEDITORIAL

    TOM WILLIAMS Editor-in-Chief

    Stepping back and taking a big picture look at the world of medical devices and how they are developing, both in technology and their influence on overall health care, re-veals a complex set of interactions. For one thing, the health care landscape is about to change dramatically. With the full implementation of the Affordable Care Act, the number of insured patients in California alone is predicted to increase by about four

    million. That means a huge demand on available physicians and their support personnel in the form of medical technicians, practitioners and nursing staff. This is both an opportunity and almost an impera-tive for the employment of technology to help meet the great increase in demand for care and services.

    There is talk, at least in the California legislature, of modifying certain laws to expand the areas in which non-physicians such as nurses and practitioners, as well as such specialized professionals as optometrists, can provide expanded treatment without the direct supervision of an MD. This has not unexpectedly caused some alarm among the medical community. Nonetheless, it is indicative of the urgency these developments are causing. Suggestions of legislation of this type reflect a need to extend the knowledge and expertise of physicians through less trained personnel. The question is how risky that might be, and it raises the parallel question of whether advanced technology in the hands of these less trained practitioners could reduce some of the anxiety and risk involved, and also whether it could help extend the reach of the licensed physician to confidently cover more patients. There is also the even more complex question of its effects on the overall cost of health care.

    It appears that the place that sophisticated medical electronic devices can really make a con-tribution to the coming situation is in conjunction with telemedicine. It might be nice to have an otoscope that produces a 32-inch high-definition image of the inside of a patients ear, but very few MDs are going to buy one to have in their office. However, in a remote or rural location or even in an urban clinic center where such an instrumentalong with other electronic devices for blood pressure, EKG, respiration and other diagnostic activitiescan be administered by trained person-nel who are not MDs, such activities can still be carried out under the ultimate supervision of an MD. Telemedicine can thus extend the reach of the MDs knowledge and experience by enabling technicians and practitioners to competently gather diagnostic information using medical electronic devices and also to perform certainhopefully well-definedprocedures under the direction of a licensed physician. Telemedicine also has tremendous potential in home monitoring to help patients live more independently, thus providing both a better quality of life and relieving the pressure on existing facilities and their accompanying expense.

    The above scenario differs from some more ambitious ideas such as the competition currently underway to develop a portable tricorder that would actually be able to provide diagnosis for some 15 diseases. Such an instrument supposedly would incorporate all the sensing, imaging and even non-invasive laboratory work along with enough integrated machine intelligence to actually arrive at a diagnosis. This holds promise, but it also raises questions about exactly which conditions would be targeted for diagnosis. Presumably these would be ones without ambiguous combinations of symp-tom