MEDS Magazine

MEDICAL ELECTRONIC DEVICE SOLUTIONS MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDS MEDICAL ELECTRONIC DEVICE SOLUTIONS

Radio Links for Body Implants and Sensors An RTC Group Publication

MEDS Interviews Philips’ Dr. Brian Rosenfeld A Supplement to RTC magazine

Cloud-Based Video Leaps the Boundaries

MEDS CONTENTS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

january 2013 UP FRONT

PULSE

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EDITORIAL

Healthcare without Boundaries Peter Eggleston, SBR Health

A New Class of Programmable/Configurable Devices Can Boost Medical Development

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publisher's letter

More than Design: Tips for Successful Medical Device Development Russ King, MethodSense

Who Really (Health) Cares?

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Tom Williams

8 John Koon

FOCUS 10 NEWS

The Latest in the Medical Electronic Device World 14 innovation higlights

A Collection of What's New, What's Now and What's Next

MEDS Magazine Interviews Dr. Brian Rosenfeld, VP and Chief Medical Officer for Telehealth, Philips Healthcare

28 Ultra-Low-Power Radio Technology in Healthcare Reghu Rajan, Microsemi Corporation

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edical Electronic Device Solutions (MEDS) uncovers how embedded technology will bring the biggest breakthroughs in electronic medical devices design.

Whether large or small—MEDS is the most influential source of information for engineers, designers 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 computing market. Learn more about MEDS at www.medsmag.com.

SPONSORS Advanced Micro Devices...................2 congatec......................................................................7 LogicData...................................................................9 MEDS Events........................................................11

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MethodSense...........................................12, 13

Z-Wave Powers New Generation of Connected Aging Solutions Mark Walters, The Z-Wave Alliance

Microsoft Windows Embedded Evolve 2012...............................................................5 RTECC................................................................................4 VersaLogic..............................................................16 Via Embedded................................... 35, 36

digital subscriptions available

www.medsmag.com

January 2013 MEDS Magazine

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PRESIDENT

John Reardon, johnr@rtcgroup.com

PUBLISHER

John Koon, johnk@rtcgroup.com

ADVERTISING/WEB ADVERTISING VP OF MARKETING Aaron Foellmi, aaronf@rtcgroup.com MEDS SALES ACCOUNT MANAGER Jasmine Formanek, jasminef@rtcgroup.com (949) 226-2004

EDITORIAL EDITOR-IN-CHIEF Tom Williams, tomw@rtcgroup.com MANAGING EDITOR/ASSOCIATE PUBLISHER Sandra Sillion, sandras@rtcgroup.com COPY EDITOR Rochelle Cohn

ART/PRODUCTION ART DIRECTOR Kirsten Wyatt, kirstenw@rtcgroup.com GRAPHIC DESIGNER Michael Farina, michaelf@rtcgroup.com WEB DEVELOPER Justin Herter, justinh@rtcgroup.com

BILLING

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 Group Copyright 2013. 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.

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

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MEDS Magazine January 2013

1/8/13 12:16 PM

Microsoft to Introduce Intelligent System Strategy With Windows Embedded 8 YOU ARE INVITED: 34 CITIES ONE POWERFUL TECHNOLOGY UPCOMING EVENTS AMERICAS

Atlanta, GA - Jan. 29 Melbourne, FL - Jan. 31 Montreal, QC - Feb. 5 Toronto, ON - Feb. 7

ASIA

Mumbai, India - March 2013 Bangalore, India - March 2013

EMEA Reading, United Kingdom - Jan. 17 Stockholm, Sweden - Feb. 5 Moscow, Russia - Feb. 7 Tel Aviv, Israel – March 2013 Cologne, Germany - Mar. 5 Munich, Germany - Mar. 26 *Dates and locations are subject to change

Windows Embedded Summit What Is It? A half-day technical brieďƒžng highlighting the Microsoft intelligent system strategy and how engineers and technology leaders can leverage existing WES7 and upcoming WES8 technology to increase embedded OEM business more effectively.

Who Is Invited?

Business leaders and technology decisionmakers will be invited to join Microsoft and key partners at over 30 global locations.

Questions Answered: What game-changing technology does Windows Embedded 8 bring to embedded design?

How to best select an embedded software platform for next generation intelligent systems?

How to get started today and prepare your business for the future?

evolve2012tour.com

UP FRONT EDITORIAL

A New Class of Programmable/ Configurable Devices Can Boost Medical Development Devices that integrate multicore CPUs on the same die with an FPGA can open doors to designs that were formerly closed due to cost-prohibitive ASICs.

Tom Williams Editor-in-Chief

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MEDS Magazine January 2013

T

he inexorable trend in medical electronics, as in digital electronics generally, is to pack ever more computing power, I/O and memory into ever smaller packages, and to run them on ever smaller supplies of power. The more highly integrated you can obtain a module or a device, the less integration work is needed to produce the desired design.

That is, of course, a fairly naïve notion because, especially in the medical field, there are all kinds of specialized I/O and display requirements that never make things easy.

Still, the availability of powerful, small and low-power processor modules in the form of COM modules or even smaller, more specialized form factors has been a boon to developers. Now, however, the world is poised to take advantage of a new form of highly integrated devices that are also highly programmable and configurable. The barrier to the medical device world in terms of taking advantage of ASIC or traditional SoC technologies has been volume. The volume of the medical market in no way compares with that of the consumer market, which can spread the high cost of specialized device development over a vast sea of sales. That, however, appears to be changing.

A new class of devices—introduced under various names—combines a 32-bit, often multicore, processor on the same silicon die with an FPGA fabric. The processor is supplied with its most familiar set of peripherals—UART, display interfaces, SPI, I2C, EPROM, etc. It is also connected via a high-speed interface to the FPGA fabric where custom IP can implement specialized peripherals as well as accelerated processing paths such as DSP routines or other numeric computations to name a few. The important thing about these devices is that they come out of the fab both programmable and configurable. There is no need as in the case of an ASIC, to send a design to the fab and pray that it’s correct, and then if not, to spend another huge amount of money and time on a revision. The result is that the development cost can be justified by a much smaller volume of sales.

Of course, there are some inherent difficulties as well. One major issue is that these devices bring together two disciplines that have not always teamed together—the software programmer who mostly works in C or C++, and the programmable logic developer who mostly thinks of himself as a hardware engineer and works in RTL or Verilog. Now these two worlds must come together to jointly develop a common architecture and communicate regarding such things as design goals and trade-offs between their two worlds on the same device. Efforts are currently under way to develop tools and methodologies to help make this happen but we are not totally there yet. However, the motivation definitely is there, so we should see some pretty positive results soon.

For the medical device community, there still appears to be one other issue and that is compliance and certification. With the line blurring between what is hardware and what is software, are current certification processes adequate to deal with these devices? They actually should be since there are plenty of current devices that include FPGAs, which are not integrated into single devices but are still integrated into the system at the board and component level.

The ability to process specialized sensor input on the same die as the processor and to be able to incorporate custom peripherals may pose development and compliance challenges. However, such devices present possibilities for small, even implanted functions that may well open brand new paths for medical applications.

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UP FRONT PUBLISHER’S LETTER

Who Really (Health) Cares?

JOHN KOON Publisher

Figure 1 A n iPhone can be converted as a portable ECK machine.

Figure 2 T his small pill camera can be swallowed and take photos using an internal radio from Microsemi.

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MEDS Magazine January 2013

2013 is upon us. What is ahead of us?

Recently I asked a friend who is about to have his physical checkup, “Do you feel that your doctor really cares about you?” “No,” he responded without hesitation. I also read that some patients complain that their doctors (the primary physician) spent more time staring at the terminal or desktop instead of looking at the individual to have a real conversation. I know we all want to stay healthy, and deep down in our hearts we do want to care for each other. Having spent quite a bit of time studying and attending health and medtech-related conferences talking to many individuals and interviewing many leaders in the field, I asked myself this question: What does “healthcare” really mean?

Taking the top-down view, I see two groups of people: those who are healthy and the not-sohealthy. We want the former to stay healthy. We encourage them to use whatever tools they have to stay that way: personal trainers, fitness devices, fitness machines, eating well and resting well, etc.

For the latter, we want to “fix” them. If the person has a heart problem, we want to put an implantable defibrillator in the body. If there is a blood clot, we can use a balloon to enlarge the blood vessel to prevent the person from having another heart attack. We now have all the remote or telemedicine ideas to make things easier. There is a whole host of portable medical electronic devices such as ultrasound and handheld EKGs (using an iPhone). Not only do they save lives, they make access to medical resources in a remote region easier. Overall, however, the system is set up to do more “health-fixing” than “health-caring” today.

Why? The answer is simple. In a free society, people can eat what they want and not exercise if they don’t want to. Keeping hundreds of millions of people healthy is a big job and a very costly one. Insurance companies try their hardest to stay profitable and screen everything to determine if the “fixing” should receive reimbursement. We don’t need to be reminded of today’s unsustainable trillion dollar healthcare budget. That is why many organizations are working hard to tackle the problem. Each is proposing a different solution. Some are taking the approach of using remote connectivity to cut down the office visit time. Others are trying to use robots to deliver meals and medicine. I visited a hospital in Northern California and saw a bunch of robots running around in the hospital. Today there are robots that can help the surgeon with operating. Robots can enable patients to recover faster and reduce costs. Many are optimistic that technology is a promising solution to help reduce costs in the future.

There is some caring going on. Many individuals now rely on technology to live independently.

With built-in sensors and remote communication capability, grandma or grandpa feel more cared for. Children living in another city feel more at ease knowing there is a 24/7 care and communication system for their loved ones. Additionally, think about the convenience of recovering at home instead of staying in the hospital for a long time. Even though there are still a lot of challenges ahead of us, I feel we are living in a time when we could witness many new breakthroughs. I am also grateful that there are so many wonderful organizations aiming to make this whole ecosystem work together successfully. The goal of MEDS remains the same. We want to keep you (medical device developers) creating even better products and keep users better informed. Therefore, we will be connecting with many leading organizations (AAMI, CMIA, Continua, DeviceAlliance, FDA, MDISS, MD PnP, OCTANe, West Health and WLSA, etc.) to provide you with relevant industry information and to share our knowledge.

The market is changing rapidly and there are a lot of challenges ahead. Safety is definitely at the top of the list. Security, interoperability and innovation are also among the topics we are focused on. As we enter 2013, we will share the voices of medical industry leaders such as Philips Healthcare and others to show you where the market is heading. If you have an insight or know someone who has an innovative idea, let us know and we will report it. We will include these ideas and solutions in our print edition, online and in our e-newsletters. We will continue to work with you to make the ecosystem better. Let’s work together to bring real care to the healthcare market.

Medical Device Solutions...

Your Regulatory Compliance Partners Ensure Compliance with Part 11

Infor SyteLine ERP is a comprehensive suite of applications focused on the features Medical Device Manufacturers need to control operations and support growth requirements.

Here are just a few things Infor SyteLine ERP Helps Medical Device Manufactures Support: • Ability to cost effectively manage Regulatory Compliance (FDA 21 CFR Part 11 / SOX) • Quality Control-Suppliers, Manufacturing and Customers • Complete Lot & Serial Tracing & Tracking • Current Good Manufacturing Practice, cGMP • Secure Clock-in/Clock-out Biometric Scanning (ngerprints, hand geometry) • Electronic Signatures and Audit Trails • Tools to Support Compliance and Process Documentation Requirements

LogicData is an Infor Gold Partner with 25 years of experience working with SyteLine ERP software. LogicData has over 250 successful implementations of SyteLine ERP. We understand the issues Medical Manufacturers experience when deciding to move to a world class ERP. Medical Manufacturers come to LogicData for SyteLine ERP software, consulting, training, programming, add-on software, conversion assistance and Internet integration.

Bentley Biomedical Consulting, LLC is a full service regulatory compliance firm that satisfies Part 11 validation requirements for use of electronic records for all sizes of medical device manufactures. Bentley Biomedical, lead by Shep Bentley, consists of a dynamic team of certified regulatory professionals with years of experience in bringing cutting edge medical technologies to the marketplace.

Infor SyteLine ERP provides the foundation to improve business efficiency, customer service, and overall manufacturing productivity for a broad range of industries, including medical device, metal fabrication, industrial equipment and machinery, and high-tech and electronics. It delivers the complete package, with tight integration to tools for management.

Contact Us Today: Information@LogicData.com or 1-800-694-4401 x109

FOCUS

NEWS

THE LATEST IN THE MEDICAL ELECTRONIC DEVICE WORLD Dutch Study Indicates Advantages of Digital Mammography Advanced digital radiology is a growing technology even though it is more expensive than traditional X-Ray technology that relies on images developed on film. Yet there has been some disagreement as to its advantages for such areas as mammography. Now a study out of the Expert and Training Center for Breast Cancer Screening in Nijmegen, Netherlands had strong indications that digital mammography has definite advantages, most prominently its ability to detect the more aggressive early stages of some breast cancers.

Although there have been steady advances in traditional X-Ray technology, its digital counterpart has the ability to take an image once and store it on the computer where it can be subjected to enlargement and other forms of image enhancement. One of the main goals has been to reduce the number of false positives. It was exactly an increase in false positives that critics of digital mammography had feared.

However, the study not only found that the false positives did not increase but the number of early detections of actual cancer in a sample of 1,000 women came to 6.8%, where the traditional X-Ray method had yielded only 5.6%. Especially encouraging was the early detection of such aggressive forms as ductal carcinoma in situ (DCIS), in which the digital technology was better able to detect microscopic deposits of calcium that are an indicator of this condition. The study has been published in the journal, Radiology.

McKesson to Acquire PSS World Medical for US$2.1 Billion Healthcare services company McKesson Corp. has announced it will acquire all outstanding shares of PSS World Medical, a company marketing and distributing medical products and services. The transaction is valued at approximately US$2.1 billion. The transaction has been approved by the company’s board of directors and is subject to customary closing conditions.

The combined business will be reported as part of McKesson’s Distribution Solutions agreement, reporting to Paul Julian, executive vice president and group president of McKesson Corp. McKesson expects to realize annual pre-tax synergies in excess of $100 million by the fourth year of the transaction, according to a press release from PSS World Medical.

McKesson is ranked as number 14th on the Fortune 500 list and supplies medicines to retail drugstore chains. PSS focuses on products and solutions for physicians, laboratories, dispensing and home care and hospice.

Moog Medical Devices Group Announces Completion of Curlin Pump Recall Moog Inc. announced that on August 6, 2012 the company received written notification from the Food and Drug Administration (FDA) indicating the termination of the Class I Recall on Curlin Ambulatory Infusion Pumps. The affected pumps include: Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart and PainSmart IOD. The recall was announced in February 2011 and was issued as a result of a software anomaly that generated a software Error Code 45 (EC45), resulting in a shutdown of the pump. To date there continues to be no adverse patient events associated with the recall reported to Moog Medical Devices Group.

While the Company is pleased with the notification from the FDA, the Company is aware that there may be affected pumps still in service that are still subject to the recall. Any remaining customers who have the affected pump(s) should remove the pumps from service and return the device to Moog Medical Devices Group. For information on the recall, or to obtain details on returning your pump for service, please contact the Moog Customer Advocacy department at 800-970-2337.

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MEDS Magazine January 2013

LDRA Tool Suite Selected

by Esprit Lean to Prove IEC 62304 Medical Compliance LDRA has been selected by Esprit Lean to prove compliance of medical technology being developed to assist in cancer treatment. Esprit Lean chose the LDRA tool suite to provide the static analysis and standards verification needed to achieve compliance to IEC 62304.

Esprit Lean is a France-based company focused on developing custom electronic and software systems for satellites, automotive, medical and industrial control applications.

They wanted a verification tool that not only implemented coding rule compliance, but also enabled the team to boost productivity, adopt standardized style and code comments, and eliminate errors at the programming level. The LDRA tool suite was chosen to prove compliance to the IEC 62304 medical standard and implement the stringent quality techniques and practices Esprit Lean wanted to adopt.

The Esprit Lean team began development by configuring the LDRA tool suite to meet company programming standards as well as those of IEC 62304. The LDRA IEC 62304 template streamlined configuration, detailing the steps for process workflow and standards compliance. LDRA’s graphically displayed analysis made it easy to identify sub-functions and quickly perform a thorough analysis, helping the team work iteratively toward compliance.

With process documentation an inherent part of the LDRA tool suite, all aspects of Esprit Lean’s development were fully documented.

LDRA documentation provided a tangible proof-of-process, improving team communication and helping document specific details when members of the team moved on to other projects.

Since the FDA found defects introduced after software upgrades in 79 percent of 3140 medical device recalls between 1992 and 1998, medical device regulators stipulated in IEC 62304 that the software maintenance process be considered as important as the software development process. Esprit Lean harnessed the LDRA tool suite to enforce common process, methodology and coding practice. Armed with LDRA technology, the company established a consistent process workflow in which errors were quickly identified and addressed, and software designed using an easily maintainable architecture.

MEDICAL ELECTRONIC DEVICE SOLUTIONS MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

Technical Training Series

MEDS Safety

MEDICAL ELECTRONIC DEVICE SOLUTIONS

Come see.

Come learn.

Review of Human Factors Requirements for Medical Devices Examination of ISO 60601-1 and 62304 Requirements Streamlining the FDA Clearance Process

March 11, 2013 – Irvine, CA: Brandman University www.medsevents.com/irvine use the code MEDSJAN when registering to get 50% off

COMPANY INFORMATION

The medical technology market is evolving rapidly, what is the vision of your company in this arena and where do you fit into the medical devices eco system?

MethodSense, Inc. Company Size: under 25 people 3200 NC HWY 54 Cape Fear Building, Ste 101 Research Triangle Park, NC 27709 www.methodsense.com

Regulatory affairs, quality assurance and even patient safety are often viewed as impediments to business profitability and are frequently not fully integrated activities within a medical device company. The vision of MethodSense is to enable medical device companies to fully integrate their innovative technology with quality, safety, and regulatory activities as part of their business operations throughout the product life cycle and position them in a unified way to target their business goals and enable overall efficiency and company profitability. Our vision spans across all our services including 510(k) approval, CE Mark, ISO 13485 Certification, Safety Testing Management and documentation for 60601-1 3rd Edition, and on-going quality management system maintenance.

What are the challenges that the medical device market faces today and how does your technology or company help to overcome them?

MethodSense has seen two predominant trends in the medical device industry: greater regulatory scrutiny of products and companies by regulators and changing regulations to address advances in medical technology. We help clients directly address these trends by ensuring on-going compliance and auditability with products and services geared specifically toward enabling teams to operate more efficiently. This is reflected in professional services that combine support to maintain Quality Management System records and proprietary innovative software to securely automate critical document management. By addressing these challenges head on, MethodSense helps clients avoid costly setbacks, minimize their risks and prepare for regulatory inspections.

How will the safety (FDA clearance) and security aspects impact the development of the medical technologies and applications, if applicable?

There is heightening pressure from regulators for medical device companies to demonstrate that their technologies perform as intended. While software technologies create tremendous opportunities to expand the convenience and power of medical devices, they also create favorable circumstances for increased risks, ranging from design risks to software vulnerabilities. We help clients identify, and most importantly help them mitigate, risks that can stall their commercialization strategy. This may come in the form of refining processes and design controls or even retooling Risk Management programs.

Networked medical devices are the way of the future, how does your technology enhance the patient experience?

In short, our mission in our regulatory and quality role with clients is to support their product safety and efficacy goals, both of which directly impact the patient’s experience, as well as the medical device user’s experience. Our experience with the management of networked technologies and software in general helps pioneering medical device companies bring their networked medical device products to market.

What innovative technology will make a difference for medical devices in the coming year?

We believe we will continue to see the convergence of software and networked devices with new applications that create more intelligent devices and device applications. The merging of these technologies will potentially redefine the medical device world as we currently know it. In support of our clients, we ensure on-going compliance and auditability with products and services geared specifically toward enabling teams to operate more efficiently.

Rita King CEO and Senior Consultant of MethodSense, Inc. Rita King has served as a regulator, technologist and professional auditor for more than 23 years, garnering a well-deserved international reputation as a regulatory expert.

Rita is a founding member of the Underwriters Laboratories team that defined, launched, and managed the operations of the first US program to evaluate safety critical software used in commercial and medical devices and developed the ANSI approved Standard for Safety Critical Software, UL 1998.

FOCUS

INNOVATION HIGHLIGHTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Personal Monitors/Coaches Provide Wearable, Wireless Health and Fitness Monitoring A variety of small, wearable wireless devices are appearing on the market that are able to monitor and record various health-related activities such as walking, running and even sleeping. These devices are connected via such things as smartphones and/or Bluetooth to centers that can analyze the activities and provide feedback in the form of congratulations, suggestions and records to help encourage a healthy lifestyle. We present three such systems here.

Bluetooth 4 Activity Tracker Syncs Health Data to Smartphones A low-energy Bluetooth device makes it easy and affordable for anyone to achieve their personal health goals. “Fitbug Air” from Fitbug offers seamless, wireless connectivity to the latest generation of mobile devices, from smartphones like the Apple iPhone 4S and the new iPhone 5, to the new iPad and iPod touch, and other tablets and desktops that are Bluetooth Smart Ready. Connectivity to other leading devices such as the Samsung Galaxy S III will follow shortly.

Fitbug Air automatically syncs users’ activity achievements from anywhere at anytime, giving users the ability to track their progress and receive feedback and motivational support from Fitbug. Fitbug can send a message when you get to work congratulating you on your walk to the office, or a reminder to motivate you to go out for a quick walk at lunch time, to ensure you stay on track to hit your daily Fitbug target.

Fitbug Air gives users the choice of three wireless modes: Push, which is syncing on demand at the press of a button; Beacon, where Fitbug Air automatically syncs at regular intervals throughout the day, and Stream, which enables the Air to “talk” to your smartphone in real time, allowing you to view your progress as you walk. Streaming enables a unique “Walking Zone” feature that lets users see their walking speed and optimize their pace on-the-go, to help achieve the best health benefits.

Using a highly accurate 3-axis accelerometer, the Fitbug Air records every step taken, calorie burned, distance covered and more. It uses that information to create personalized daily activity and healthy eating targets. The service adapts dynamically based on a user’s activity and nutrition progress, so that members can gradually build realistic changes into their lives. Fitbug also encourages users to hit “aerobic step” targets, which are activities that are more than 10 minutes in duration. The goal is to help users improve the quality of their daily steps, in addition to accruing more steps, over time, each day. Fitbug is available with a number of plans starting at $29.99.

Fitbug, London, UK. +41 0845 688-3348. [www.fitbug.com].

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MEDS Magazine January 2013

Two New Digital Health Trackers Aim to Get People Moving and Monitored Two new digital health and fitness trackers now offer Bluetooth 4.0/Smart compatibility and have been redesigned to fit more seamlessly into people’s everyday lives, making it easier than ever to count steps taken, distance traveled and calories burned; track your fitness trends, challenge and share with others; and earn fitness badges. In addition to the Zip Wireless Activity Tracker and the Fitbit One Activity + Sleep Tracker from Fitbit, there is also the release of an updated iPhone app to allow these trackers to sync through Bluetooth Smart devices, like the iPhone 4S. The free Fitbit app, available on all iPhones and Android devices, now allows you to track activity charts and leaderboards and log food and other workouts on the go.

Zip captures and provides everyday activity stats in real time, including steps taken, distance traveled and calories burned, to encourage you to walk more and be more active, wherever you are. About the size of a quarter, Zip easily slips into your pocket for the day and comes with a small silicone clip that the Zip tracker snaps into and can be clipped snugly onto the inside or outside of your clothes.

Key Fitbit Zip features include Tap for your stats—a simpleto-use “tap interface” that lets you see different stats right on the display simply by tapping on Zip, so you’ll know where you stand in your daily steps, distance and calories burned instantly and effortlessly. Zip comes in five vibrant and diverse colors—Magenta, Lime, Blue, Charcoal and White and is “oops-proof” against splash, rain and sweat, designed to handle a rainstorm or a sweaty run. Zip has a standard replaceable battery that lasts for up to 6 months and is easy to read in sunlight.

The Fitbit One Wireless Activity + Sleep Tracker encourages people to be more active and helps them learn how to sleep better—two keys to a healthy, active life. It tracks steps, distance, calories burned, even stairs climbed, and also monitors how long and how well you sleep. The Fitbit One also has a Silent Wake alarm that gently vibrates when worn on your wrist at night to wake you without waking your sleep partner.

Both Zip and One now can update stats to a Bluetooth Smart Ready device, like iPhone 4S and iPad (third-generation), via the Fitbit app. While the Fitbit app works on all iPhones and Android smartphones, those using an iPhone 4S or iPad (thirdgeneration) can update their stats on the go. Syncing via Bluetooth 4.0, this technology prevents significant phone battery drain and syncs automatically, without opening an app. By syncing to your phone, you can tap into social and motivating features on the Fitbit platform, like checking stats, earning badges and monitoring your leaderboard. Zip is offered in retail stores and at Fitbit.com for $59.95; One, which will replace the best-selling Ultra, will be available for sale later this fall at $99.95.

Fitbit, San Francisco, CA. (877) 623-4997. [www.fitbit.com].

FOCUS

INNOVATION HIGHLIGHTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Wearable Coaching System for Improving Diet, Fitness and Stress A wearable diet, fitness and sleep tracking and coaching system includes two tracking wristbands and a free iOS application that coaches people to feel more energized and productive through science-based, personalized recommendations from a team of experts. Larklife from Lark Technologies was designed with an interdisciplinary team of scientists and experts that includes a Stanford neuroeconomist, a pro-sports sleep coach to NBA, NFL, NHL stars, and a Harvard psychologist and sleep expert.

Almost two-thirds (64 percent) of Americans agree that they would have a better chance at getting healthy if they had a wellness program personalized to them.

Based on each user’s unique information captured by using the product, larklife’s interdisciplinary experts are able to gently coach them through a unique and completely individualized process that is proven to result in real, sustainable benefits at a manageable pace. Larklife is made up of three parts: a daytime smart wristband, a nighttime sleep wristband, and a free iOS app that provides real-time coaching on all the areas it tracks.

First, larklife tracks the user’s daily fitness, diet and sleep activity via the wristbands. Second, it provides advance notice or real-time suggestions via the iOS app for small changes users should make to feel better. The individualized suggestions are a results of the user’s data being analyzed on the back-end by sophisticated techniques, developed by larklife’s team of experts and based on the science of circadian rhythms, or how individuals’ energy levels peak and dip. Third and most importantly, it celebrates improvements in the user’s diet, fitness and sleep activities to keep motivation high. Users experience this celebration through a fun light show on the wristband and reward icons in the data feed in their iOS app.

Larklife helps people achieve better health by working on two levels: it simplifies activity tracking through intuitive technology, and uses the data to provide expert coaching in a way that is psychologically proven to create real change. Larklife is built to continually grow smarter for each user through automated machine learning in all three tracking categories. The more people wear it, the more the system will know about them, allowing it to better map their activities to their performances.

Lark Technologies, Mountain View, CA. (408) 915-5275. [www.lark.com].

Wireless Muscle Stimulator for Lower Back Pain A remote controlled consumer muscle stimulator employs clinically proven Transcutaneous Electrical Nerve Stimulation (TENS) technology to specifically target low back pain. The WiTouch from Hollywog uses a pair of Nordic nRF24LE1 2.4 GHz System-on-Chips (SoCs) to provide the wireless connectivity.

Low back pain is both one of the most common forms of pain people experience in the developed world, and one of the most common reasons for visiting a doctor. For example, a 2004 study found close to 3 in 10 members of the adult population in the U.S reported experiencing low back pain, and for around half of them—totaling 40.5 million people—the symptoms were severe enough to seek professional medical help (see tinyurl.com/bkpain).

The annual cost of treating back pain in the U.S. in 2004 was estimated to be almost $200 billion.

In operation the low-cost WiTouch comprises a thin (18 x 191 x 90 mm), lightweight (136g) pad that the user attaches to their lower back using replaceable adhesive gel pads whenever they experience back pain. A completely automatic 30-minute treatment using a patented TENS waveform is then activated via a small remote control that also allows the user to increase or decrease the treatment intensity from the remote. The device is small enough to be worn discretely under clothing (so can be used anywhere—including at work or when traveling), and contours to the user’s back to maintain comfort and full surface contact.

TENS is a non-invasive, drug-free method of controlling pain by the transmission of electrical stimulation to the body’s nerve or muscle fibers through the skin. Pain relief or suppression in TENS can be achieved via one of two clinical theories: one that suppresses the transmission of pain in nerves using high frequencies above 80 Hz (called Gate Control Theory); and one that increases the discharge of the body’s endorphins, which reduces the sensitivity to pain in the central nervous system while prolonging pain relief after treatment using low frequencies below 10 Hz (called Opiate Release Theory). The Hollywog WiTouch’s exclusive waveform incorporates both of these clinical TENS theories to provide pain relief via an exclusive 3-stage waveform developed specifically for pain relief.

Hollywog, Chattanooga, TN. (423) 305-7778. [www.hollywog.com].

January 2013 MEDS Magazine

15

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ne of the most important decisions a medical OEM makes is their choice of an

embedded computer. It’s at the heart of any system. At VersaLogic, we design our embedded computer products to ensure high reliability and long-term availability. That’s why our single board computers can be found in a long list of medical products. And because we understand that medical customers have special requirements, every board we make is run through exhaustive quality tests, ensuring that we deliver only the best. Whether you need one of our standard products or a version customized to your needs, our skilled technical staff will work with you to PHHW \RXU H[DFW VSHFL¿ FDWLRQV &RQWDFW XV WR ¿ QG RXW KRZ IRU PRUH WKDQ \HDUV ZH¶YH EHHQ SHUIHFWLQJ WKH ¿ QH DUW RI

extra-ordinary support and on-time delivery: One customer at a time.

1-800-824-3163 1-541-485-8575 www.VersaLogic.com / med

FOCUS

INNOVATION HIGHLIGHTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Dual-Band Wi-Fi Modules for Interference-Free Connectivity A dual-band 802.11 a/b/g/n Wi-Fi solution utilizes both the 2.4 GHz and 5.0 GHz spectrum, enabling customers to access a cleaner spectrum for applications requiring relatively interferencefree bandwidth. The new GS1550M/MD family from Gainspan provides reliable wireless connections, particularly in challenging environments such as healthcare facilities.

According to ABI Research, with a skyrocketing number of Wi-Fi devices crowding the 2.4 GHz band, users are looking for dual-band products that leverage the 5 GHz band given its superior performance in an environment with lots of potential interference.

The GS1550M/MD provides a quick, easy and cost-effective way for manufacturers to add dual-band wireless capabilities.

The new GS1550M/MD family consists of two modules: the GS1550M, which supports a dual-band stamped antenna, and the GS1550MD, which supports two dual-band external antennas for antenna diversity. The antenna diversity enhances signal coverage.

A complete solution for 802.11a/b/g/n Wi-Fi applications, the GS1550M/MD family features two UART and SPI interfaces for ease of integration with any 8/16/32-bit microcontroller and comes preloaded with serial to Wi-Fi firmware for communication with the MCU and complete Wi-Fi functionality. The modules offer advanced networking features and capabilities not readily available with other Wi-Fi modules including easy provisioning from a smartphone or web browser, over-the-air firmware updates, personal and enterprise wireless security, embedded DHCP, DNS and HTTP(S) servers/client software, XML parser, advanced mDNS/ DNS-SD-based device and service discovery and more.

The modules support data rates up to 150 Mbit/s, can operate in infrastructure or Limited AP mode, and are fully compliant with 802.11a/b/g/n specifications. The modules provide support for peer-to-peer networking, allowing devices to connect to one another without an access point. The modules will be fully certified for major worldwide regulatory regions.

The highly integrated architecture of the family provides effective and dynamic power management. With both a Sleep and Deep Sleep option, the modules can be rapidly put to sleep to reduce power consumption without loss of data and can then recover from the Deep Sleep state back to full operation in a few milliseconds. The modules also support a very low-power Standby mode, which reduces power consumption to a few microseconds.

Gainspan, San Jose, CA. (408) 627-6500. [www.gainspan.com].

“Fit” Shirt Monitors Vital Signs for Continuous, Real-time Physical Data and Immediate Diagnosis A new vital signs monitoring shirt allows medical professionals to perform frequent and less costly fitness monitoring, which will lead to more effective preventive medical care. The highly integrated shirt measures 3-lead ECG, body temperature and motion. All diagnostic tools are packaged in a shirt that is comfortable to wear.

The new “Fit” shirt integrates dry ECG sensor technology, complex signal processing technology, a temperature sensor, a motion sensor, an ultra-lowpower microcontroller and wireless electronics. The design is the result of the combined experience, expertise and inventive synergies from three collaborating companies: Maxim Integrated, Clearbridge VitalSigns and Orbital Research. The shirt represents an advance in preventive medical care that could reduce health care costs by as much as 10x.

Key contributions from Maxim include the ultra-low-power MAXQ622 microcontroller for easy-to-use and easy-to-program interfacing of multiple technologies, and the MAX8671 powermanagement IC that delivers quiet supplies and efficient switching to the various sensors. In addition, the MAX6656 ultralow-power temperature sensor enables plug-and-play integration into the system while the MAX3204 USB protector ensures safe handling and eliminates shock and ESD hazard from the electronics.

Clearbridge VitalSigns has contributed the ultra-low-power, multichannel CBVS1202 ECG-on-a-chip for an extended period of 3-lead ECG data acquisition along with its advanced motion artifact rejection algorithms. These effectively separate the ECG signal from the noise, solving the mechanical challenges of making the shirt comfortable for almost any shaped wearer while ensuring good electrode placement and good quality signals. Clearbridge VitalSigns also developed a fully integrated GUI application that runs on desktop and mobile devices.

Orbital Research developed, patented and integrated FDAcleared dry electrodes that enable the capture of all the nuances of ECG waveform morphology with no discomfort to the wearer of the shirt. The dry electrodes do not require skin preparation or adhesives, which allows reading continuous clinical-grade ECG signals from the host wearer for extended periods of time.

Maxim Integrated Products, San Jose, CA. (408) 6011000. [www.maximintegrated.com].

January 2013 MEDS Magazine

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Healthcare without Boundaries Video Communications—from room to desktop to cloud, it’s enabling a new wave of video-enabled healthcare applications.

by Peter Eggleston, SBR Health

O

nce a complex expensive technology, video communications has gone from being a scarce resource that needs to be scheduled, to one that is inexpensive, pervasive and available to all through the cloud. Advances in soft CODEC technologies, adaptive compression schemes, and out of the box support for video on a wide variety of computing and communication devices are allowing the virtual delivery of health services inexpensively with a minimum of dedicated equipment.

The net effect is that now the scarce resources are the clinicians themselves, and the next driver for adoption and growth will not be video technologies, but rather technologies that seamlessly integrate video communications into existing clinical workflows to enhance quality and efficiencies.

For medical device manufacturers, advances in video communication technologies are providing market opportunities that go far beyond simply providing devices that exist only to serve as imaging endpoints. The evolution of cloud-based video communication is enabling manufacturers to provide video-enabled services as part of their products as well as opportunities to provide video applications. The latter are applications built around video devices and platforms that enable a new frontier of interactive treatment. Until now, this was not practically feasible due to the cost and

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complexity needed for capturing, encoding, routing, transmitting, decoding and displaying a moving image of high quality. Additional hurdles were the need for dedicated networks for carrying this data, the lack of unifying standards for cross network/device interoperability, and the need for dedicated IT staff to set up, operate, support and maintain these systems. However, video has now entered the cloud, and Video as a Service (VaaS) promises to be the next wave of what’s new and hot in cloud technologies.

The notion of cloud-based applications is as old as the computer itself (think timeshare). However what is new is how all the right forces have finally come together: inexpensive HD capable cameras, scalable and adaptable CODECs that can run efficiently on even modestly powered PCs and handheld devices, open standards and services that allow cross-platform interoperability, cheap bandwidth, and new ways to map video routing and switching in the cloud itself. We are now at the precipice where video communications have evolved from the dedicated room-based hardware systems of yesterday, to the software-based desktop and handheld devices of today and on to the cloud-based systems of tomorrow.

Amnon Gavish, SVP Vertical Market Solutions at Vidyo, a company paving the way to the cloud, states that he sees several technology drivers supporting the move toward cloud-based video. First, the quality is moving

toward TelePresence, defined as low latency and high definition video, which is crucial to get a natural interaction (Figure 1). “In healthcare this is crucial to get the trust of the patient to get a meaningful interaction—it’s really key not to have the delay of latency so you can carry on a natural conversation,” he explains. The second driver Amnon sees is the change from hardware to software, which cuts the cost of endpoints, switches and routers by many orders of magnitude. “A traditional Tele-room may cost several tens to hundreds of thousands of dollars. Now you are talking about tens of dollars or less for every endpoint by software-enabling desktops, laptops, tablets and mobile devices. This means you can now use existing hardware as endpoints and that opens doors for very large scale deployments. This is essential for health delivery organizations that want to scale up virtual visit programs to their entire patient populations, which can run into the millions of patients.”

Amnon goes on to say that another new technology enabler is the ability to overlay video networks onto existing data networks. “Video communication used to require dedicated networks with quality of service mechanisms,” he explains. “However, these are not scalable. You cannot provide a T1 connection to each patient at home, so you need to overlay the video network with any connection a patient has. And, since these are highly variable networks in terms of quality, you need a way to maintain quality over public networks if you are going to maintain TelePresence quality across existing platforms and networks. If you can do this you can make a huge step to video in the cloud.” Vidyo has accomplished this through the use of scalable video coding technology that allows optimizing the utilization of available network quality and bandwidth, as

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well as factoring in hardware capabilities of the sending and receiving devices.

Furthermore, to utilize the existing Internet for video transmission and enable VaaS, there is additional “infrastructure” that needs to be put into the cloud. The video CODEC needs to be physically adjacent to the camera itself. Once captured, compressed and encoded, the video signal needs to be routed to the receiving party. Previously, organizations had to purchase, install and maintain portals and routers on their local networks, or even lay dedicated cables to connect them. This required large cash outlays, dedicated IT teams, a lot of operating expense and closed networks. Now, routers can be entirely software-based and run on general purpose servers in the cloud, thereby making the infrastructure much leaner with the net effect of reducing deployment costs by a factor of 100. With these changes, cloud-based services can now be constructed to provide a virtual video infrastructure for any organization, thus enabling low-cost video communications for any person, any device, any network, at any time.

The move toward private virtual clouds as well as public cloud services (e.g., Amazon) makes it easy to put software instances of video routers anywhere and gives you the ultimate flexibility in terms of IT management—you can move your infrastructure at the click of a keyboard. But it isn’t entirely that utopian. Moving to the cloud brings up issues of security, manageability and privacy, which are especially important issues for healthcare institutions. Since they are not operating on networks with secure connectivity and access, VaaS providers need to provide mechanisms for each institution to have its own siloed access to the system in such a way that there is no communication between the virtual video communication networks unless it is intended for them to communicate.

This is why healthcare organizations are hesitant to utilize Skype with their patient populations. What encryption is being utilized? How are the calls being routed? How do you authenticate an end user? How do you prevent an unwanted communication link? In contrast, some

Figure 1 VidyoWay,

a free cloud-based interconnectivity service from Vidyo, is as easy to set up as a telephone call and frees organizations from network, location and device constraints to enable true “any device, any network, any time” video communications.

companies such as Vidyo provide tools that allow the construction and management of completely secure virtual video networks, and thus many healthcare organizations are starting to develop large scale telehealth programs on their technology platform.

Jonathan Schlesinger, president of Connexus, a provider of on premise and cloudbased video communications, cautions that once institutions go beyond their walls, there are some potential availability caveats that need to be planned for. “Unless everyone is in the same building,” states Schlesinger, “it is a cloud. So, you don’t want to seriously depend on it and not have it be there anymore. Many of the cloud providers have backup systems

for failures, but if there is a system wide failure around them, then even though your local network may be up and running, you still can’t get to others.” Schlesinger advises that if you can keep all your infrastructure close to you, this is a good thing. But when healthcare institutions start video conferencing with remote hospitals, clinics and patients in their homes, you are by definition, connecting with people that are not on your network.

Schlesinger goes on to say, “With video conferencing there is no option, you have to be aware of the risks and plan accordingly.”

This could include selecting a VaaS provider that offers geo-physically dispersed hosting networks such as the Amazon January 2013 MEDS Magazine

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Figure 2 Video

as a Service (VaaS) is enabling a new category of software termed Video Applications such as this video call and skills routing management solution from SBR Health, shown here running on the ubiquitous iPhone as well as the new Google Nexus7. Now healthcare workers can be brought into video calls on-the-go for less than $200!

cloud. Even then, Amazon, Yahoo and everyone in this space have experienced problems with their cloud computing services.

These are companies that have spent very large sums of money on getting their act together, and they have experienced major problems even in the last year. If the Internet goes down in the customer’s location or the host location, it is an inconvenience, people do not die. In healthcare, there could be situations that are life threatening.

As an example Schlesinger notes, “If Domain Name Service (DNS) is down you are in a very difficult situation. There are a lot of DNS attacks and this could affect video connectivity.” Therefore, Connexus has its own DNS servers, and does not rely on the major providers because these are often the very providers being targeted and attacked.

However, the cloud adds some distinct operational advantages to ensure failsafe operation. Where system hardware and software upgrades need to be cautiously managed in on-site deployments to maintain

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compatibility across sites, in cloud-based systems when you upgrade software it happens simultaneously across the network and compatibility is always maintained. And cloud deployments make it easy to ensure everything is up and running by allowing constant monitoring of endpoint readiness status and connectivity to the network, thus ensuring resources are on line and reachable when needed. Furthermore, it also provides greater connectivity across devices, allowing users to engage in video communications on whatever device they are carrying, rather than relying on being at a specifically, preprovisioned endpoint. In healthcare where clinicians are especially mobile and needed 24/7, this means clinical resources can be reachable and convertible into a workflow both where and when needed.

In fact, the implications for healthcare are enormous once video communications can be integrated into the care delivery workflow (Figure 2). Traditional hardware-based systems are very inflexible in terms of work-

flow integration, but once you move into software-based endpoints you open the door to embedding the video into the workflow you are trying to enhance. And therein lies the opportunities for medical device manufacturers who can now leverage the power of VaaS to deliver innovative new products, or video-enable existing devices utilizing Video Web Services APIs. These APIs utilize standards such as SOAP over HTTP and can be easily integrated by developers to create customized video communication experiences that are interoperable with any type of video portals or endpoint applications.

One health IT company creating these customized experiences is SBR Health, a developer of clinical and consumer applications that enable video communications to be utilized seamlessly in the delivery of existing or new care delivery models. When asked about the opportunities VaaS is creating, SBR Health’s CEO and co-founder Christopher Herot explains “Video conferencing offers great potential in medicine, but despite decreasing equipment costs and advances in cloud-based deployments, it still remains difficult to integrate video communication into healthcare workflows. This is creating new opportunities for companies like SBR Health to create applications that support the dynamic nature of healthcare delivery organizations, and solve the problem of how to utilize VaaS technologies seamlessly in existing IT and clinical processes so as to facilitate the delivery of care in a more efficient and effective manner.”

The company’s first product, ResourceManager, is a true enterprise client/server application that intelligently matches patients to care providers to achieve optimal relationship pairing and real-time resource-based workforce scheduling and optimization. This SBR technology when combined with video communications infrastructures enables healthcare organizations to deploy more efficient care models that improve patient satisfaction, increase access to specialists, raise the overall levels of patient care and improve delivery of treatment. “The ResourceManager also allows care providers to work virtually anywhere at any time they choose,” explains Chris, “and gives companies and organizations access to an on-demand global workforce to address staff shortages, serve hard to reach patients, control costs and ultimately increase the level of patient care.”

Another manufacturer leveraging the cloud is InTouch Technologies, a pro-

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Figure 3 InTouch

Technologies, Inc. leverages cloud-based video conferencing to create FDA-cleared remote presence products allowing physicians to be available on demand whenever and wherever their expertise is needed.

vider of remote presence medical devices.

InTouch’s CEO, Yulun Wang, believes cloud-based video communication will profoundly restructure healthcare delivery. “When healthcare providers have high quality and greater access all at a lower cost, then you can deliver care when and where it’s needed at greater efficiencies.

While current systems make you be at specific locations at specific times, where these locations have been pre-provisioned and connected, remote presence, cloud-based televideo can instantly connect disparate entities without requiring two IT departments to collaborate in advance.” Wang further explains, “In some instances such as a stroke, it is literally life and death if you can provide the right therapy within a 3 hour window—it is that significant. In many rural and community hospitals, you simply cannot get a stroke neurologist in quickly, which may be one of the contributing factors that make stroke the highest reason for disability in the U.S.” Expanding on the impact that cloudbased systems have on healthcare workflows, Tim Burke, CEO of Quest Systems states, “Hospital IT staff simply have an over abundance of tasks and objectives such as getting electronic medical records systems up and running, and many do not have the expertise for video and do not know where to find it. People who

understand how to configure and deploy video communications networks are not in the hospital, but can provide this expertise quickly and cost-effectively from the cloud.” Quest is actually not a newcomer to cloud-based services for healthcare, having provided hosted data and computing solutions to numerous large hospitals for the better part of a decade. Burke further explains, “Hospitals have the expertise of what they are trying to do with virtual care models from a clinical standpoint, but are challenged to design and support this from a user perspective. With VaaS, IT departments can be focused on their clinical end-user requirements and deliver support for virtual care much more quickly.” He goes on to say that VaaS options also allow health delivery organizations to avoid making large commitments to video communication technologies. If they want to try it out they can try this from the cloud using one department or a limited number of doctors with limited investment—they do not need to capitalize equipment and hire people in-house to manage and support such an endeavor.

Burke coaches medical device and HIT solution developers to think beyond video communication as a fixed offering. “The cloud sits out there, it’s a shared environment, the deliverable is fairly static such as an iTunes experience—It’s similar to all

users and the user cannot shape the experience of what they want. Unlike embedding static video communication hardware, VaaS does not have to be a canned, here it is, hope it works, experience. By utilizing today’s cloud-based video communications platforms, manufacturers of medical devices can deliver truly unique and flexible experiences and therefore can offer value comparable to an internal, custom-developed solution.”

Connexus Dallas, TX. (214) 443-2600. [www.connexus-evn.com].

InTouch Technologies Santa Barbara, CA. (805) 562-8686. [www.intouchhealth.com].

Quest Systems Sacramento, CA. (800) 326-4220. [www.questsys.com].

SBR Health Cambridge, MA. (617) 475-1662. [www.sbrhealth.com].

Vidyo Hackensack, NJ. (201) 289-8597. [www.vidyo.com].

January 2013 MEDS Magazine

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More than Design: Tips for Successful Medical Device Development Medical device company executives seeking a 510(k) pre-market approval path, or who have electronics or software included in their product, need to be aware of the most common regulatory affairs, quality and safety components, as well as some frequently overlooked tips that will save money.

by Russ King, MethodSense

S

ince 2008, the economic landscape has created numerous challenges for emerging medical device companies, especially when it comes to available capital. Economic and political uncertainties continue to temper enthusiasm for medical device markets.

While a significant number of medical device innovations never make it to market for logical reasons, we’ll never know what lost opportunities have occurred due to the poor economy.

That being said, there appears to be a light at the end of the tunnel for emerging medical device companies. The capital market seems to be loosening up, with baby boomers and technology transfer accounting for expanding opportunities for Med Tech companies. In support of an aging population that hungers for an improved quality of life as they grow older and our thirst for bigger and better technology solutions, universities and businesses are emphasizing technology transfer. Technology transfer ensures scientific and technologi-

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MEDS Magazine January 2013

cal developments are accessible to a wide range of people who can further develop technology into new products, processes, applications, materials and services. There are entire university departments that focus on identifying research with potential commercial interest, especially as it relates to healthcare.

Consequently, our life science consulting practice is seeing a growing number of emerging companies with executives who are new (or nearly so) to the business of medical devices. The fresh executive talent coming to the medical device industry might benefit from a few guiding tips as they think through a framework for their company.

Tip #1: There’s More to Being a Medical Device Company than IP and R&D Most emerging medical device companies tend to focus their energy on product development and R&D. This is understandable because medical device founders are often experienced innovators with

limited business experience. As innovators, there’s a natural affinity to maintain a continued focus on R&D. Having a clear IP position and strategy is an important factor for attracting capital, which could further emphasize the importance of R&D, product development and market analysis.

Nevertheless, being, living and growing as a viable medical device company catering to the U.S. market requires much more than R&D, positioning your IP and measuring how big your market is. It involves developing an operational framework that structures your organization as a medical device company (Figure 1) and enables the commercialization of your product. This includes: • Regulatory Affairs · 21 CFR Part 820 · 21 CFR Part 11, if your device incorporates software • Quality Management · Design Controls that are included in Part 820 · QMS requirements you might find in Part 820 and ISO 13485 · R isk Assessment and Risk Management found in FDA Guidances and ISO 14971 • Safety · IEC 60601-1 testing · Clinical data or a clinical trial When wrestling with regulatory, quality and safety issues, executives fresh to the medical device industry often take uncertain or delayed steps as they navigate the path to becoming a medical device com-

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Most medical device executives know they need FDA approval to legally market and promote their product in the U.S. Beyond FDA approval, understanding how to effectively commercialize a medical de-

UCT APPROVAL PROD

Sales, Licensing & Business Development

Regulatory A ffai rs

Quality Manag System eme nt

ro

Intellectual Property & Innovation

du

Safety

Tip #2: Know the Industry Expectations for a Medical Device Company

Maintenance, Monitoring & Improvement

P

pany. The biggest mistakes we see emerging medical device company executives make include delaying the development of their regulatory strategy and their quality system, which are critical components to the structure of Med Tech companies. Failing to attend to their development will only increase costs over time.

It is also vital not to misgauge the complexities and nuances of commercializing medical devices from a regulatory and quality perspective. Misunderstanding what it takes to comply with the regulations, build an adequate quality system or neglecting to adequately plan for demonstrating product safety will increases costs.

It is also a mistake to take regulatory or quality “short cuts.” In our experience, we’ve never seen a short cut in this industry that didn’t increase costs. For example, it sounds like a time saving step to buy a set of quality system templates and “fill in the blanks.” However, most packaged templates exhaustively represent the entire regulations line-by-line and tend to be built for organizations with at least a couple of dozen employees. The work required to integrate a system of templates to your particular product, company size and practices usually costs much more than the anticipated savings.

Ultimately, executives will save money by developing the infrastructure and processes that qualify their business as a viable medical device company. To save time, money and stress, develop and deploy the appropriate regulatory strategy, the most efficient and compliant quality management system (QMS), aggressively perform actions needed to demonstrate product safety… then keep it up.

Regulatory Authority

ct DR & D e v elo p m e nt

Manufacturing

Figure 1 The

framework is not intended to represent a roadmap or commercialization pathway, but instead a conceptual framework that every medical device company must work within. It works itself from the inside out first and then, if the company is working, all the functions should inform the others.

vice product means adapting to industry and legal expectations for operating as a medical device company. These expectations ensure that you deliver safe and effective products. Knowledge and experience is required to do this effectively and to avoid costly mistakes.

At this point, it’s important to realize that although we talk about the FDA as a regulatory body, it is, in fact, a law enforcement agency with the powers associated with such authorities. The FDA can cite, fine and prosecute for violations of laws, such as 21 CFR Part 820 or 21 CFR Part 11. The laws the FDA enforces are administrative laws that are part of a national regulatory scheme, like police law and international trade.

Medical device companies not compliant with 21 CFR Part 820, and other applicable regulations, make themselves vulnerable to FDA enforcement practices.

The tricky part is that the FDA doesn’t tell you how to operate as a compliant company. You have the flexibility to implement the necessary processes to satisfy the applicable regulations and support them with your own compliance practices. However, you’re expected to fully understand the intent of the regulations and meet those expectations—regardless of your size and resources.

While FDA enforcement actions rarely result in jail time for executives, they can force expensive corrections and cause significant damage to your reputation. Truly, January 2013 MEDS Magazine

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PULSE Medical Device Classification in the US Class I

Class II

gloves, bandages • Simple in design • Pose little to no potential risk • Self-register with FDA • Most are exempt from pre-market requirements • QMS must comply with 21 CFR Part 820 • Some are exempt from GMP regulation

Class III

x-rays, needles

pacemakers, heart valves

• More complicated in design • Pose a minimal risk • 510(k) pre-market approval process is required for most • GMP required

• Intricate in design • Pose the greatest risk • 510(k) pre-market approval process is required • GMP required • Clinical trials likely • Malfunction is absolutely unnacceptable

Figure 2 Medical

devices fall into a class that reflects the device complexity, the potential risk and the major certification steps that are required for acceptance.

it’s best to comply willingly and faithfully and view the regulations as a way to create a more streamlined and efficient company.

Tip #3: An Early, Practical Handle on 21 CFR Part 820 Improves Your Company The purpose of regulatory affairs is to ensure that your company complies with applicable laws and regulations. These regulations, such as 21 CFR Part 820, are intended to ensure devices entering the marketplace are safe and effective. If you don’t fully understand 21 CFR Part 820 and how to apply it properly to your company, find someone who does. Having experience in this area is critical to efficiently implementing compliance that supports your business goals.

21 CFR Part 820 focuses on current good manufacturing processes (cGMP) and controls used for the design, packaging, labeling, storage, installation and servicing for all finished devices intended for human use. You should know that 21 CFR Part 820: • Is an FDA-mandated system of product design • Requires you to document the evolution of the life of your product • Applies a market-first product development focus • Requires a team-oriented approach to product commercialization • A s a process, tends to challenge product design to the point of improvement

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MEDS Magazine January 2013

Compliance is a necessary expense; don’t put yourself in a position where it costs more in dollars or opportunity than it should. Take extra care early on to develop processes that, when followed, meet your compliance obligations in a way that supports your business goals and personality (Figure 2).

Tip #4: An Early, Practical Handle on Design Control Ensures a Quality Product that Safely and Effectively Meets a Real Market Need 21 CFR Part 820 prescribes specific design controls, or processes, for bringing medical devices to market. The objective of design controls is to develop and implement a sound process for reaching an acceptable level of efficacy and safety for medical device products. Generally speaking, design controls implementation occurs in phases that move a product along a commercialization path and are often characterized in the following way: • Design and Development Planning • Design and Development Input / Output • Design and Development Verification • Design Validation • Design Transfer • Design Changes • Design History File

If implemented well, design controls create a number of surprising benefits, including a better documented product that is more attractive to buy or acquire. They result in a more efficient development cycle due to a reduction of mistakes thanks to early analysis of key questions and a clear distribution of a team’s responsibilities.

Design controls should work as a preventive approach to the quality of your medical device and the mitigation of risk.

Prevention is an efficient and cost-effective way to control manufacturing processes and maintain quality. While it may not be possible to eliminate all potential risks, we consistently observe in our clients a very poor appetite for realized risk that was otherwise mitigable.

Tip #5: Don’t Forget Safety Testing and the Value of Risk Management In our experience, the most frequently forgotten aspect of medical device development and commercialization from emerging companies is establishing a safety profile of a product. While clinical data or clinical trials may be necessary for establishing safety for some products, many Class II devices that follow a 510(k) clearance pathway require minimal, if any, clinical data to support safety claims. Once the need for clinical data is either planned for or eliminated, establishing the safety of a medical device through additional testing tends to be less of a priority.

Depending on the technology incorporated into your medical device, applicable safety standards need to be identified during the design stages of the product.

The most widely accepted benchmark for establishing safety for electrical medical devices is a standard called IEC60601-1, where compliance has become an acceptable means for satisfying electrical safety requirements for the commercialization of electrical medical devices in the European Union.

60601-1 has undergone revision recently. The third edition is enforced now in the EU and the second Edition is currently applicable in the U.S. The FDA will require the use of the third Edition of the standard for new devices as of June 30, 2013. In this new edition of the standard, there is strong emphasis on risk assessment, ISO 14971

PULSE and, in the U.S, a focus on device usability as an important factor contributing to the safety of the device.

Product testing to 60601-1 is a very technical exercise that involves laboratory testing against the standard by a test house, such as Underwriters Laboratories. If you are complying with the third Edition, there is the additional task of demonstrating safety through extensive, component-bycomponent, risk assessment.

While complaints about the complexity and cost of safety testing in general and 60601-1 in particular have many sympathetic ears, safety testing has significant benefits. Meeting the demands of safety testing is a necessary step for electrical medical devices in the commercialization process. Through test house examination and risk assessment, it forces a very deep understanding of your product, which can be invaluable for product improvement, market positioning and sales, and exit strategies.

Tip #6: All Software Has Bugs – Manage Them Improved technologies and automation capabilities continue to be applied to medical devices, benefiting both patients and device users. With the addition of sophisticated electronics, PLCs, off-theshelf software components, custom software applications, and the proliferation of mobile devices, software-driven devices now permeate medical device markets (Figure 3).

As previously noted, 21 CFR Part 820 includes a requirement for validation. In this instance, validation means confirmation that the product is capable of meeting its particular requirements for intended use. 21 CFR Part 11 is the FDA regulation that applies specifically to software.

Proper software validation dramatically reduces the occurrence of software incidences. By thoroughly testing a product against actual use cases, and correcting incidences before releasing the product to the public, you will prevent potential product recalls and field fixes, control the need for new software builds and releases while reducing the need and expense of help desk support.

Once you’ve determined your innovative idea is indeed a medical device, it’s

Benefits of Medical Device Software Validation

FDA Compliance

Potential Reduction in Cost

User Need Met

Optimization of Quality & Process

Intended Use Satisfied Reduction in Defects

Figure 3 Software

validation. This is a graphical representation of the benefits of validation and the last tip.

time to start thinking like a medical device company, not just group of innovators. Using a framework of regulatory affairs, quality management and safety puts your business on the right road to meeting requirements. While at first blush it seems these three components might be separate functions, they don’t function well in silos. They do best when implemented as part of a company-wide compliance strategy. As you begin the process of designing your regulatory strategy, you may be surprised to find that by pulling a thread in one part of the framework, what was thought to be an unrelated part will move, too. It takes knowledge and experience with the components of the commercialization process to become and remain compliant. Be sure to think of regulatory affairs, quality and safety as an ongoing part of your business strategy for the most successful outcome.

MethodSense Research Triangle Park, NC. (919) 313-3962. [www.methodsense.com].

January 2013 MEDS Magazine

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MEDS Magazine Interviews Dr. Brian Rosenfeld, VP and Chief Medical Officer for Telehealth, Philips Healthcare MEDS: The medical technology market is

evolving rapidly in many areas especially in telehealth, technology use in hospitals and independent living. We would like to learn about Philips’ perspective in each of these areas, and what should developers and users expect to see in 2013 and beyond?

Dr. Rosenfeld: Philips connects care across the continuum from the hospital to home, focusing on critical transition points and risks. Advanced Philips technology includes telehealth in the emergency department (ED), intensive care unit (ICU), hospital ward and skilled nursing facility (SNF), and in home health monitoring and risk-based solutions to ensure that treatment is seamlessly provided throughout the care cycle.

In an era of unlimited access and universal connectivity, monitors must go anywhere that care is delivered whether it’s the ICU, hospital transport or the home. Philips monitoring technology provides immediate actionable patient data that supports predictive and preventive care.

In the hospital, it is important that clinicians are able to monitor their patients wherever they are, in order to intervene before complications occur. Philips’ cable-less sensors allow greater freedom of movement and more proactive monitoring of patients in the hospital environment, while Philips’ Intellivue Guardian Software detects patient deterioration and routes alert notifications to either the care team member’s mobile device or to a central telehealth team.

Additionally, Philips’ Enterprise Inpatient Telehealth eICU program enables 24/7 patient access to an intensivist-led care team allowing the care team to detect problems before they become complications, leverage limited clinical resources (intensivists and seasoned critical care nurses), and extend patient access to remote specialists.

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MEDS Magazine January 2013

Philips understands that healthcare delivery shouldn’t end when the patient leaves the hospital. Studies show that remote patient monitoring leads to better clinical care and reduced long-term healthcare costs due to fewer hospitalizations. Philips’ telehealth solutions enable experts to remotely monitor patient symptoms and vital signs to provide timely, focused interventions. Philips also offers a wide range of solutions that help patients live independently, including medical alert and medication dispensing services, as well as sleep apnea and respiratory solutions.

Philips will continue advancing technology across the continuum of care, bridging the gap from the hospital to the home.

Philips’ goal is to create solutions that are “high tech in disguise”—easy for patients and care providers to use, but built upon Philips’ robust technologies.

MEDS: What are the greatest challenges the

medical technology market faces today and what does it need to do to overcome them?

Dr. Rosenfeld: The path our current healthcare system is heading down is largely unsustainable—and we have no choice but to improve. Our rapidly aging population and rising demand for medical services contribute to soaring costs (56% of our 2.6 trillion dollars spent annually is for personnel) and ever more pronounced gaps in care.

Physician and nurse shortages only add to the challenge. The reality is that health systems are struggling to develop care models that leverage care providers enabling them to accommodate the expanding needs.

Gaps in care are also a serious health concern, especially for patients with chronic conditions. Poor communication between patients and doctors, and the technology that supports them, are both health and cost hazards.

BRIAN ROSENFELD VP and Chief Medical Officer for Telehealth, Philips Healthcare In order to overcome the challenges of today’s healthcare landscape, technology must help providers deliver more efficient and effective care, reducing and preventing errors of omission and redundancy, both of which hamper clinical operations. Medical technology must close the gaps in care and connect patient care from the hospital to the home, all the while helping providers simplify workflow, communicate more effectively and increase the efficiency of their clinical teams.

MEDS: How will the safety (FDA clear-

ance) and security aspects impact the development of medical technologies and applications?

Dr. Rosenfeld: Philips continues to work with industry and regulatory partners to put their solutions through rigorous tests and quality measures. Philips is proud of

PULSE the longstanding relationships cultivated with agencies such as the FDA, and will keep collaborating in order to make sure that technology meets patients and healthcare consumers needs and is as safe and secure as possible.

MEDS: How will networked medical de-

vices interact with medical records systems in the future?

Dr. Rosenfeld: Philips understands that medical device interoperability with electronic medical records (EMR) is a key component of improving clinical workflow and enhancing the quality of care. Philips’ solutions bring key information to patients and providers, facilitating enhanced data collection and information sharing to eliminate gaps in care. Philips hospital monitors export data to all EMRs through HL7, which is a standard convention that Philips was a leader in establishing years ago. Another way we accomplish this is by providing interoperability through IntelliBridge, a single, standards-based integration solution. IntelliBridge supports interoperability between Philips solutions and hospitals’ EMRs and other multivendor enterprise systems. Beyond bridging and transporting data, some of our solutions also actively integrate and process the data and alarms before forwarding.

In the future, there will be additional data coming from myriad devices and these will include monitors worn with continuous data input from ambulatory patients.

We are actively working to lead in promoting new technology (Medical Body Area Networks - MBANs) for acquiring this data so that they can be seamlessly acted on and then downloaded to the EMR. Our goal is to enable advanced clinical intelligence with a simplified way to access complete patient clinical data.

MEDS: Are future telehealth devices likely

to be worn constantly (and comfortably) by the patient or will they consist more of home terminals and devices that the patient uses on a regular basis to send data into a medical center?

Dr. Rosenfeld: Philips telehealth solutions will comprise devices that are constantly worn by the patient and terminals used in the home to send data to the telehealth center.

Philips currently offers the Lifeline with AutoAlert, which can be worn comfortably 24/7 and comes in the form of a small pendant or a wristband that is designed to detect motion and any fall, automatically calling for help. Philips is continuing to innovate in wearable devices that remotely send data to clinicians allowing them to catch early signs of deteriorating conditions and provide timely, focused interventions.

Philips also believes that patient interaction remains necessary for optimal care. Telehealth Solutions consist of home terminals that enable clinicians to remotely monitor patient symptoms and send short health status surveys and reminders. Philips Personal Healthbook promotes patient and family engagement and helps patient consumers take an active role in their health and wellness. The Philips Lifeline call center provides a “high touch” linkage to patients to facilitate aging in place and minimize loneliness, while providing necessary patient touchpoints.

MEDS: What will the medical technology

ecosystem look like in 2013 and beyond?

Dr. Rosenfeld: In today’s environment

of rising costs, an aging population and changes brought about by healthcare reform, the focus on accountability and efficiency has never been more important. Technology is expediting the evolution of the care delivery model from a traditional inpatient/ outpatient model for episodic illness management to a comprehensive program-based approach to keeping patients healthy.

The new health reality requires technology and process redesign that helps providers reach beyond the walls of the hospital or physician office and into patients’ homes, managing care transitions and enabling patients, families and providers to be true partners in health and healthcare, engaging and informing patients with the tools for better management. Leaders in true patient-centered care will excel in care coordination, better discharge planning and reduced readmissions, early detection and chronic condition management.

MEDS: What is Philips doing in these seg-

ments to prepare for the future?

Dr. Rosenfeld: Philips offers health sys-

tems the technology and process redesign for “end-to-end solutions” that enable con-

nected care, managing patients from the hospital to the home and at each transition point across the care continuum.

The Philips Healthcare Hospital to Home initiative builds a bridge across care settings and transition points with technology and redesigned workflows for seamless continuity, making it easier to treat and manage patients with chronic diseases, reduce hospital readmissions and costs, and increase provider efficiency.

Dr. Brian Rosenfeld, MD Dr. Rosenfeld is an internationally recognized intensive care specialist and healthcare entrepreneur who pioneered and developed the concept of remote intensive care unit management. He co-founded VISICU Inc. in 1998, and after its being acquired by Royal Philips Electronics, presently serves as Chief Medical Officer for Telehealth. Prior to founding VISICU, Dr. Rosenfeld was an Associate Professor of Anesthesiology and Critical Care Medicine, Medicine and Surgery at the Johns Hopkins University School of Medicine.

While at Hopkins he was Director of two critical care units and received the Shannon Award from the National Institutes of Health. He founded and directed the Perioperative Research Center—a government and industry funded research group, and he implemented the first-ever smart monitoring system for hospital-wide management of patients with myocardial ischemia.

He was Principal Investigator on numerous research trials and has published over 50 peer-reviewed articles and book chapters.

Dr Rosenfeld has been an invited lecturer at international and national meetings and is a Fellow in both the American College of Critical Care Medicine and the College of Chest Physicians. Dr. Rosenfeld has over 20 U.S. and international patents around remote patient management and has a strategic role in Philips Healthcare’s telehealth direction. He graduated magna cum laude, special honors-biology from the University of Pittsburgh in 1975. He graduated from Temple University School of Medicine in 1980 followed by post-graduate training in internal medicine, pulmonary medicine, anesthesiology, and critical care. He currently serves on the Board of The New England Healthcare Institute and Visual Telehealth Systems.

January 2013 MEDS Magazine

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Ultra-Low-Power Radio Technology in Healthcare In applications that involve body implants or body-worn wireless sensors, selection of the radio and its properties is a key consideration.

by Reghu Rajan, Microsemi Corporation

O

n average, we spend over 99% of our lives outside of the hospital or clinic.

Hence, healthcare outside of hospitals and the clinical environment becomes as important as care within. This is partly because increasing medical conditions, the aging population and rising healthcare costs constitute the driving factors for better healthcare solutions. Wireless technology plays a big role in improving healthcare and patient’s quality of life, while reducing the cost.

The healthcare cycle (Figure 1) includes monitoring for preventive care from infants to seniors, fitness monitoring, diagnostic care at hospital environments, rehabilitation and post procedure care.

Better remote monitoring helps reduce treatment cost by letting patients go home earlier, which also improves the patient’s quality of life and also helps early diagnosis in many cases. Monitoring physiological parameters has evolved a long way from bulky bed-side devices with bundles of wires connected to the patient, to ultrasmall wireless sensors that capture vital physiological parameters from the human body during normal daily activities.

In addition to monitoring, some of these devices are capable of delivering therapies as well. To help understand the requirements for the wireless aspect of medical

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devices, let us first broadly catagorize some of these devices based on the application (Figure 2).

It can be easily seen in Figure 2 that these devices range from appplications that demand a few bytes of data to streaming data, which requires larger radio bandwidth, depending on the physiological parameter that’s measured. Some applications demand long battery life. This is especially the case for implants, where changing the battery could involve surgery. Spot measurement devices, such as temeprature measurement patches, demand less from the radio as it is infrequently used in the application compared to the radio of an ECG monitor, which transmits a real-time stream of an ECG waveform. Each application has different requirements from the radio, which makes it obvious that “one size fits all” is not applicable.

Radios for Implants The requirements for radios used in implants and ingestibles have the common constraint that the radio communication has to happen through body tissues, which attenuate RF signals at higher frequencies. The FCC has allocated frequency bands in the 400 MHz range for implant purposes for optimum performance inside the body (MICS and MEDS bands). Implanted radios also require extremely low power consump-

tion and leakage currents as well as efficient wake-up mechanisms to initiate communications. Microsemi’s implantgrade radios are specifically designed for such applications. Some of the applications for implant-grade radio are shown in Figure 3.

Radios in implant applications are heavily duty-cycled, meaning they are mostly in sleep mode. This requires extremly low leakage current as well as ultralow power consumption during operation.

The data rate requirements are not high for implant radio applications, although radios with higher data rates help reduce the duty cyle and extend battery life.

Ingestible applications include pill cameras, which transmit thousands of high-quality pictures of the gastro intestinal tract, and other applications such as those that deliver drugs and monitor acidity in the GI tract. Such applications also require radios and circuits that consume ultra-low power due to constraints on battery size even though the device life may be shorter than implants.

In addition to ultra-low power consumption, such radios also demand a highly efficient communication protocol with security. Standard protocols, such as Bluetooth Low Energy or Zigbee, require higher protocol overhead compared to proprietary protocols. Most implant radios therefore use proprietary protocols to optimize power consumption and improve communication efficiency and security.

Wireless Sensors External wireless sensors cover a wide range of applications from fitness monitors to diagnostic physiological parameter monitoring. Today’s sensing and

PULSE

monitoring solutions for wireless personal area networks (WPANs) and wireless body area networks (WBANs) can support continuous data streaming with extremely low power consumption. This is critical for wearable medical systems that are used in environments where frequent battery replacement would be difficult and expensive. While these systems previously required AA or AAA batteries, they can now run on micro-power batteries. Making this possible are ultralow-power, short-range radio transceivers whose circuit design has been optimized for power efficiency across a number of key parameters.

WPANs occupy a network space around an individual that covers the nearby living or working space—typically up to ten meters—and are implemented with protocols such as Bluetooth and Zigbee. WBANs occupy a smaller wireless space of approximately one meter around a person and are used for sensor communication associated with the human body.

Applications have expanded from heavily duty-cycled spot measurement to more data-intense continuous links. There are a variety of uses for this technology in hospital and clinical facilities, clinical home monitoring and ambulatory applications, and consumer health and fitness.

Treatment Treatment Diagnostics Diagnosis

Diagnostics Imaging

Prevention

Pre-Hospital/ Ambulance Monitoring

Personal Healthcare

Rehabilitation Management

Follow Up

Remote monitoring

Emergency Response Services

Source: Center for Disease Control and Prevention (CDC)

Figure 1 The

healthcare cycle.

Spot measurement

Physiological monitoring

Continuous measurement

External

Radio Requirements for WPANs and WBANs Many issues must be considered when selecting a short-range radio transceiver capable of optimizing power efficiency in WPANs and WBANs. Some of the key considerations for low-power radio are shown in Figure 4.

Among these, power supply voltage is particularly important. Most sensors run on a single battery cell, so sub2V supply voltages are preferable. This means that short-range radio transceivers must be designed for low-voltage operation—ideally, down to 1.1V in order to optimize design flexibility and reduce power management constraints.

Intensive Care Unit Monitoring

Operating room Monitoring Imaging

Therapy & drug delivery Drug delivery Wireless Medical devices

Permanent Implants

Electric stimulators Monitoring

Ingestible Therapy & drug delivery Figure 2 Categories

of wireless medical devices.

January 2013 MEDS Magazine

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Deep brain stimulation/ Neurostimulation Hearing assistance

Functional stimulation Wireless endoscopy Defibrillator Cardiac pacemaker/ Energy harvesting

Drug delivery/ Insulin pump Bladder control

Figure 3 Examples

of implant applications.

Key Considerations for Radios in Wireless Sensors Link Frequency

Antenna Impedence

Network protocol

Footprint

Peak & Average current Supply Voltage

Streaming Capability & data rate ULP Radio

Wake-up feature

Figure 4 Ultra

low power radio requirements.

Another key issue is peak current.

Almost all wireless-based sensor networks rely on some level of duty-cycling to save power and restrict the usage of radio space, which generates peaks in the current consumption profile of the sensor. Low peak current consumption in the radio transceiver reduces constraints on the wireless

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MEDS Magazine January 2013

sensor’s power supply. Output impedance is also important, as it has a major effect on power amplifier (PA) power consumption.

Matching network to interface radio with antenna can contribute to insertion loss that can be several dB. The choice of carrier frequency also influences power consumption. The two

available options within the medical (ISM) radio band are 2.4 GHz or subGHz frequencies. The most prevalent 2.4 GHz protocols are Wi-Fi, Bluetooth and ZigBee. In low-power and lower-datarate wireless medical monitoring applications, however, sub-GHz wireless systems offer several advantages, including reduced power consumption as well as longer range for given power due to lower free-space propagation loss. The quieter spectrum means easier transmissions and fewer retries, which is more efficient and saves battery power.

The communication protocol also has a major impact on the average power budget at the network level. Zigbee and Bluetooth offer highly sophisticated link and network layers, but these stacks can account for a large percent of the radio power consumption, with larger overheads. For ultra-low-power systems, the “one size fits all” standardized option is rarely the optimum solution.

Instead, designers developing solutions for ultra-low-power applications should consider using the protocol best suited for their need.

Finally, link data rate is one of the most important factors inf luencing power consumption in duty-cycled wireless links. The average power is almost inversely proportional to the link data rate; for instance, a 100 Kbit/s radio will consume almost half the power of a 50 Kbit/s radio for the same payload. When comparing RF transceivers, “energy per bit” is a better indicator of power efficiency than current consumption. But high data rate radios are often those with the higher peak currents, and these are highly undesirable for most small batteries as they result in large, leaky storage capacitors.

Each of the aforementioned factors is critical for applications where power is at a premium and payload is greater than 10 bit/s. Whereas previous body-worn wireless sensors could only be used for slowly varying parameters, new RF technologies can be used to help observe more rapidly changing physiological parameters, such as heart and brain electrical activity or blood oxygenation, which require data rates on the order of 0.5 to 5 Kbit/s to extract meaningful waveforms.

PULSE Microcontroller or DSP

Bias Gen

Mac

Xtal Osc & Clk Gen

Controller

Application Processing

ADC

Link Layer

DAC

Control

GPIO

Ctrl

ECG, Temperature, Shriver, EKG, SpO2, Movement/Vibration Sensing Analog Front End

USB Controller

Data

RF TX/RX

Data

Sensor Battery Figure 5 Wearable

wireless sensor based on ZL70250.

One example of a solution derived from a careful balance of these tradeoffs is the ZL70250 transceiver from Microsemi (Figure 7). Housed in an approximately 2 mm x 3 mm chip-scale package, it has standard 2-wire and SPI interfaces for control and data transfer using any standard microcontroller. The microcontroller’s analog-to-digital converter (ADC) connects to the ultra-low-power analog front-end device. Combined with the ZL70250 transceiver, the resulting solution can be used to develop a wireless ECG solution that can run continuously from a CR series coin cell battery for up to a week. Similar power efficiency can be achieved with such devices as a 3-axis accelerometer or pulse-oximeter for patient respiration measurement, as well as a variety of other wearable health monitoring platforms. Devices like this enable lowcost button cell or small lithium ion batteries to support continuous data streaming in WPANs and WBANs for up to two weeks before replacement.

With the advent of micro-power batteries plus advances in ultra-low-power transceiver technology, it is now possible to build flexible and smart wireless sensors. Proper transceiver selection is critical for addressing a variety of key design issues so that wearable wireless medical devices can perform continuous monitoring of bio-signals for long periods using a single small battery. Today’s ultra-lowpower transceivers deliver a combination of performance and power efficiency by balancing a number of trade-offs associ-

ated with the use of inversion techniques to achieve the highest possible gain from low current.

Microsemi Aliso Viejo, CA. (949) 380-6100. [www.microsemi.com].

January 2013 MEDS Magazine

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Z-Wave Powers New Generation of Connected Aging Solutions An exploding elderly population and the “Boomer Senior” caregivers that look after them are demanding technologies that redefine the experience of aging in place. The Z-Wave wireless protocol is at the center of this digital home health revolution.

by Mark Walters, The Z-Wave Alliance

D

emographics throughout the world point to a senior population bulge that will last for the next 20 years or more. Accessible technologies that assist the wellness and convenience of these new “Boomer Seniors”—along with the elderly family and loved ones they frequently care for—are a critical need for today’s and tomorrow’s worldwide market.

Z-Wave, a lightweight wireless RF mesh networking technology, ubiquitously deployed throughout the world and designed specifically for status and control applications, has become a centerpiece of the new digital aging and wellness paradigm. Integrators, service providers and end consumers are creating connected environments that monitor daily activity, allow remote control of key home systems (security, climate, lighting, etc.), alert caregivers to anomalies or emergencies, and in general provide peace of mind and convenience to all parties in the home health chain.

These connected environments solve a major problem for an aging population. According to the AARP, the vast majority of older adults prefer to “age in place,” so they can continue to live in their own homes or communities rather than in an institutional setting. Numerous surveys put this preference at 85% or higher. Given the expense and disruption of the alternatives, such as independent or assisted living facilities, making existing residences more senior-friendly has become a wide-scale imperative. This is where

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Z-Wave enters the connected aging picture.

Operating internationally in the subGHz ISM band (850-920 MHz) and efficient enough for battery operation, devices powered by the Z-Wave standard (ITU-T G.9959) provide not only the necessary intelligence for a connected aging and wellness environment, but also the transparency that makes such technologies discreet in daily use, and non-stigmatizing to the end user. This transparency is especially important to elderly individuals who are often resistant to changes in their home environment.

It is worth noting that the definition of end user is much broader in a connected aging application. The physical environment itself— usually one’s own home—interacts with one type of end user: the elderly resident. But in the larger sense, the actual end user is one of the 44 million Boomers in the U.S. alone who look after these elderly loved ones. These family caregivers are in many respects the true end users of connected aging solutions.

Systems and Components A Z-Wave-based control system for a connected aging environment can consist of a broad variety of inexpensive devices, such as motion, pressure and light sensors; access controls such as addressable door locks; monitoring and communication capabilities through cameras; natural lighting through shade/blind controls; and artificial lighting control through fixtures and plug-in modules, to name just a few. The lightweight and economical Z-Wave technology is easily

embedded into virtually any electronic device, and has become a standard feature in a broad spectrum of products where control and status applications are desirable.

Z-Wave devices are typically controlled by a gateway that incorporates the Z-Wave technology. Z-Wave functionality can be added to an existing gateway externally with a plugand-play controller connected to the gateway or router. However, in many cases the technology is built into gateways supplied through a telco provider such as Verizon or AT&T, a security company such as ADT or Vivint, or a home improvement chain, such as Lowes. All of these market leaders have committed to Z-Wave as their RF technology of choice for home control and monitoring applications.

The Z-Wave standard is interoperable, assuring that the many different device types in a connected aging solution can work together seamlessly regardless of brand or manufacturer.

This allows for system designs and capabilities that are scalable over time and as user needs evolve. A benefit of its sub-GHz frequency is that Z-Wave powered devices are impervious to interference from typical household technologies operating in the 2.4 GHz range. These include Wi-Fi, cordless phones and microwave ovens, all of which can wreak havoc with RF control technologies operating in this range and compromise reliable control applications.

In addition to its ability to co-exist with household 2.4 GHz without any loss of operational integrity, the Z-Wave protocol provides security with AES128 encryption (as used in online banking) and compatibility with IPv6. Up to 232 devices can exist on a Z-Wave network, and networks can be chained together for deployment in larger institutional environments. One Z-Wave deployment for the hospitality industry utilizes 65,000 devices in a single setting—the flagship Wynn Hotel in Las Vegas.

PULSE Obviously, a residential home will have no need for so many devices, but a typical connected aging application may use a dozen or more devices for activity monitoring, access control, safety lighting and emergency alerts.

Scenarios for Practical Use In a connected environment for independent aging, the two types of end users—caregivers and their loved ones—have the same aims, but seek to experience them in different ways. The caregiver wants comprehensive remote monitoring and control capabilities, while the loved ones often will only accept technology in their home that is unobtrusive and transparent in day-to-day living. The goals of security, convenience and, perhaps most importantly, data collection, remain the same and can be achieved through numerous applications of the Z-Wave technology.

A number of scenarios involve the intelligent monitoring, and often some control, of daily patterns. Utilizing inexpensive sensors, ZWave can accumulate and share data pertaining to daily activity that paints a highly detailed picture of overall wellness. Applications range from simple recording of ambulation patterns through motion sensors (did Mom or Dad walk around today?) to whether they have gotten out of bed (bed/mattress sensor), how many times a medicine chest has been opened, or how many times the toilet has been used during a day or night. This allows the remote caregiver to be alerted to any unusual changes in activity patterns for loved ones aging in place.

In many cases the elderly are visited on an ongoing basis by outside parties that contribute to their well-being, including home health aides, visiting nurses and family and friends that stop by for assistance and socialization. With Z-Wave controllable locks, caregivers can schedule times for doors to be opened for these parties and know when they have arrived and left. They can also remotely allow unexpected visitors, all without disturbing their loved ones. The use of electronic locks is especially important in a general sense because the elderly typically experience increasing difficulty with conventional door knobs and keys as their physical and perceptual capabilities diminish over time.

Monitoring and Controlling Interior Environments By intelligent placement of motion sensors and gating techniques set up by the

Figure 1 In this Z-Wave bedroom, sensors for the mattress detect sleep activity, pressure sensors on the floor record ambulation, and a Wi-Fi camera allows direct visual monitoring.

system installer, caregivers can implement interior “geofencing”—defining areas in the home that alert them to occupancy or nonoccupancy—thus being alerted to any dangers or signs of abnormal activity. For example, sensors can send notifications that a stairwell has been accessed going down but not up (indicating a possible fall), or know that no room outside of the bedroom has been accessed for an unusual period of time (indicating non-activity). Nodes on the Z-Wave network can be cascaded so that the tripping of one zone can set additional actions or alerts in other zones in the home. Naturally, caregivers can be alerted if the loved one crosses the geofence; this is especially important for elderly with conditions such as Alzheimer’s disease, where wandering off the premises is a concern. An example of a connected bedroom is shown in Figure 1.

With Z-Wave, light, temperature and other systems throughout the residence can be controlled automatically by time or activity, or manipulated remotely by the caregiver. This is an especially important application because visual acuity deteriorates with age; once-familiar surfaces and colors become more difficult to discern. Control of indoor lighting fixtures through motion detection and timers are obvious solutions, and this is easily accomplished through many different Z-Wave products.

At the same time, natural daylight control is also important to healthy, comfortable liv-

ing. Daylight (with its important Vitamin D) is essential to mood and wellness, and its effective control also minimizes energy bills.

Motorized shades controllable by Z-Wave ensure that loved ones aren’t sitting in the dark because shades or blinds are too heavy or too high or “too much trouble” to reach. Caregivers can also ensure that there’s appropriate heat or air conditioning with remote HVAC controls, and through moisture sensors know that Grandma or Grandpa hasn’t accidentally left the water in the bathtub running.

Extended Personal Emergency Response Systems (PERS) Many consumers are aware of popular “emergency buttons” for the elderly that are sold by security providers and offer a onetouch alert to emergency situations. Unfortunately, in practice these buttons, whether strategically placed throughout the home or worn on the body as a pendant, do not achieve their intended effect. Studies have shown that nearly 50% of the elderly do not activate this “help button” when needed— either through embarrassment, forgetfulness or unconsciousness. Naturally, there are Z-Wave-based emergency buttons that offer the same functionalities, but a connected Z-Wave environment extends this concept to other conditions that may indiJanuary 2013 MEDS Magazine

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PULSE cate an emergency, even when the button is never pushed. As one example, a chair sensor can alert the caregiver that their loved one has not sat in a favorite chair for an unusual period of time, or hasn’t risen from it. The alert allows the opportunity for a response; if the situation is actionable, the caregiver is now able to make immediate decisions that even a dedicated PERS system cannot provide.

These are only a few examples of what Z-Wave can do to empower independent aging in place, and the caregivers that oversee it. The devices and systems that make up this connected aging environment are discreet, accessible and easily integrated into the home. Together they create a sense of security for all parties that was previously unattainable outside of a senior care facility.

Set Up and Programming Because Z-Wave is a mature technology that has been deployed in residential settings throughout the world for over seven years, there is an extensive body of knowledge for the systems integrator to draw upon in designing a connected aging environment.

Many of the same techniques that an integrator might employ for a conventional home automation and control deployment are replicated in the connected aging solution. Motion, lighting and access sensors are plentiful from a variety of available sources; the newer pressure sensors that work for beds and chairs are integrated into the network in exactly the same way.

Each Z-Wave controllable device, whether the technology is built into the device or added on to it, is joined to the network via a simple pairing procedure and assigned a unique identity on the network.

Once the devices are recognized on the network, the programmer assigns conditional or automated behaviors and actions to each of the Z-Wave devices. In addition to individual devices, Z-Wave capabilities can also be added to AC wall outlets, which can make entire rooms or floors “smart.”

The front end interface for the integrator/ programmer is similar to what they would develop in a conventional home control system focused on entertainment or energy management. Device behaviors are assigned individually or in intelligent groups; zones are created, contact information for alerts is fed into the system.

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Figure 2 This

Z-Wave connected bathroom has been equipped with a variety of sensors that detect motion, water and toilet usage. A PERS panic button can also be placed in the bathroom.

The interface for the integrator is largely dependent on the software that’s resident in the gateway, whether Z-Wave is internal to the main gateway or added to it via an external controller module. As a result, a wide variety of interfaces and “skins” are offered by different vendors, more so as a result of Z-Wave’s cross-brand interoperability. All of these will be familiar to the professional integrator, and many systems now being marketed directly to consumers offer simplified interfaces that are identical whether viewed locally (in the home) or remotely (outside of it, via the Internet).

The User Experience As previously mentioned, there are two end users in a connected aging application, the caregiver and the loved one(s).

The former—usually one of the 44 million Boomers in the U.S. that already look after elderly family—is typically the driver of the system, not only in its purchase and deployment, but in the day to day operation and monitoring.

As is typical with conventional monitoring and control systems, the end user is able to view and manipulate device behaviors through remote access, via a smartphone or a PC connected to the Internet.

The remote capabilities can be interactive on several levels. At its simplest level, the end user receives alerts or status reports from the connected home via SMS text or email. These alerts can range from expected behaviors—a visiting home health aide has arrived on time—to conditional criteria, such as someone leaving the geofenced perimeter, or abnormal moisture readings in a bathroom, kitchen or basement.

Delving deeper into the system, the caregiver can view and evaluate status reports that have been aggregated over time, such as how many times the refrigerator was opened (is Mom or Dad eating properly?), how many times the loved one has risen during the night (is Mom or Dad sleeping properly?), or compliance/non-compliance with medications (how many times has the medicine chest been opened?). The level of granularity for this data can be determined by the programmer and selected by the end user.

The ability to monitor all this activity over time not only allows expedient responses to problem situations, it also serves as an invaluable preventative tool. For example, abnormal eating, sleeping or bathroom habits can all point to a problem that the senior might be reluctant to discuss or begin to remedy. “I’m fine, I don’t need to see the doctor” is a stock response that many Boomer caregivers have learned to not take very seriously. The ability to see for themselves how their elderly parents get by in dayto-day living results in greater health and security, fewer doctor visits and fewer costly hospitalizations. An example of node placement in a bathroom is shown in Figure 2.

Z-Wave technology has found itself at the center of the emerging connected aging space by virtue of its power and practicality. It is economical to embed into products; hence the broad array of Z-Wave controllable sensors, cameras and gateways already on the market. Its low energy consumption allows it to work with battery operated devices, which greatly simplifies and economizes a connected aging installation. Its cross-brand interoperability allows consumers to integrate a wide variety of product choices, rather than a closed, proprietary system.

There are already over 700 interoperable Z-Wave devices on the market.

As the population continues to age, and the demand for independent aging solutions expands exponentially, Z-Wave will continue to be a prime driver in both the residential and institutional health care spaces.

The Z-Wave Alliance [www.z-wavealliance.org].

Information on Z-Wave-compatible products: [www.z-wave.com].

COMPANY INFORMATION VIA Technologies, Inc. www.viaembedded.com What are the greatest challenges the medical technology market faces today and what is VIA doing to overcome them?

Portable computing is a top focus in the small form factor arena and medical devices lead the portable design revolution. Traditional medical devices implement an x86 architecture with Windows, but today’s ARM, with its increased compute power (1GHz+, along with dual and quad core capabilities) as well as Android support and energy efficiency, is quickly gaining traction among medical OEMs as the architecture of choice. VIA, with its license and products in both x86 (CISC) and ARM (RISC), is a unique solutions provider for portable medical devices, offering “Dual ISA (Instruction Set Architecture)” products at the silicon, board, systems and platform levels.

ARM, a.k.a. SoC (System on Chip), truly offers flexibility and extensibility to portable medical device designers today, as well as performance headroom, which was mostly associated and available with x86 architecture in the past. For example, Android is optimized for ARM at the moment, while various embedded Linux flavors and Windows Compact can run well on both x86 and ARM. With today’s constant pressure of time-tomarket, recurring costs, not to mention possible FDA, IEC and SIL (Safety Integration Level) requirements implicated with these portable medical devices, “choice” and flexibility are extremely important allies to an embedded designer.

There are two usages of portable medical devices: clinical and hospital settings devices and consumer geared devices: e.g. tele-health. Regardless of the end applications, one of the core objectives for these devices is to continue to drive down power consumption.

Lower power consumption will allow embedded medical engineers to create portable devices to increase the battery life (or a smaller battery to reduce weight and size) and reduce the overall power that needs to be dissipated. This will also contribute to longer mean time to failure and product lifecycles, which are other critical factors. VIA offers a full line of power efficient Compute Engine and aggregator solutions, in both x86 and SoC Another area of concern for portable medical devices is security and since portable medical devices are in service for multiple years, 10 to 15 years typically, the ability for these devices to implement future security policies is a must. VIA solutions offer various security solutions including various encryption technologies at the microprocessor-level such as AES-128 and AES-256.

Connectivity, including Wi-Fi, Bluetooth and 3.5G/4G wireless will be directly built into the portable devices, permitting easy access to and of electronic medical record databases or the future medical cloud. VIA, in anticipation of this paradigm, offers a plethora of these products at the hardware level along with a full suite of SDKs, tool chains and custom software engineering services, allowing medical OEMs to design and develop their portable medical devices, quickly and efficiently.

Cliff Moon Senior Director of Global Marketing Cliff Moon is the Senior Director of Global Marketing at VIA Embedded, a division of VIA Technology, Inc. In his role, he is responsible for driving the global roadmap and establishing product directions. He has over 28 years of experience in the IT industry in various roles, including Engineering, Marketing and Sales.

He has also volunteered his time as a PC/104 Consortium Technical Committee Chairman and has worked in various embedded companies. He can be reached at CliffMoon@viatech.com.

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