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

ake Continuous M Integration a Software Team Process emiconductor Devices S Target Medical Applications

An RTC Group Publication

oost Device Security B with Mainstream Technologies

A Supplement to RTC magazine

SAFE RELIABLE SECURE

TRU S T E D S O F T WA R E FOR MED I C A L E L E C TRO NI CS For nearly 30 years the world’s leading medical companies have trusted Green Hills Software’s secure and reliable high performance software for life-critical and safety-critical applications.

From infusion pumps and defibrillators to ventilators and anaesthesia systems, Green Hills Software has been delivering proven and secure underpinning technology.

To find out how the world’s most secure and reliable operating system and software can take the risk out of your medical project, visit www.ghs.com/s4m

Copyright © 2011 Green Hills Software. Green Hills Software and the Green Hills logo are registered trademarks of Green Hills Software.

All other product names are trademarks of their respective holders.

MEDS CONTENTS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

APRIL 2012 UP FRONT

PULSE

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EDITORIAL

Helping the Blind to See Rob Hilkes, eSight Corporation & Kim Rowe, RoweBots Research

Your Tricorder Is Not My Holodeck Tom Williams

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6

Continuous Integration of Software Medical Device Projects – It Is a Must!

Matthew T. Rupert

PUBLISHER’S LETTER

The Ever Changing World of ECG Devices John Koon

FOCUS 8 NEWS & PRODUCTS

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

28 Increasing Medical Device Security with Mainstream IT Platforms and Technologies Michael Taborn, Intel & Santhosh Nair, Wind River

32 Overview of the Medical Semiconductor Market and Applications John Koon, Publisher

M

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 Acces I/O Products.................................35 AMD......................................................................................11 Axiomtek.................................................................22 Commell.................................................................. 30 Corvalent.................................................................23 Cyth Systems.....................................................9 Digia...................................................................................13 Express Manufacturing Inc.........21 Green Hills Software................................2 Intel.....................................................................................31 Medical Development Group......4 One Stop Systems......................................7 STMicroelectronics.................................... 17 Vector Software............................................15 Wind River............................................................36

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April 2012 MEDS Magazine

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MEDS MEDICAL ELECTRONIC DEVICE SOLUTIONS

PRESIDENT

John Reardon, johnr@rtcgroup.com

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To Contact 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 245-M Mt. Hermon Rd., PMB#F, Scotts Valley, CA 95066 Phone: (831) 335-1509 Fax: (408) 904-7214

Published by The RTC Group. Copyright 2011, 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.

You’re Invited We invite subscribers of MEDS magazine to attend an upcoming MDG forum

MDG holds monthly forums on the first Wednesday of each month at the Foley Hoag Emerging Enterprise Center in Waltham, Mass.

meddevgroup.org 4

Untitled-9 1

MEDS Magazine April 2012

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01– 2 01

1

Spring 2012 Forum Panels April 4 Pre-Clinical Testing: What We Need to Know for Medical Device Development May 2 Wireless Devices: Communicating in the Medical Device Space Today June 6 Aging in Place: Technology to Keep People Home

celebrating

New England’s premier organization for individual professionals in the medical device and related fields

About MDG

MDG’s mission is to contribute to the continuing development of medical devices and other medical technologies by enhancing the professional development of its members, fostering and supporting entrepreneurial thinking, serving as a forum for exploration of new business opportunities and promoting best practices in enterprise management.

4/5/12 10:33:43 AM

UP FRONT EDITORIAL

Your Tricorder Is Not My Holodeck

I

n a news item appearing elsewhere in this issue there is an announcement of a very interesting and intriguing competition—the design and construction of a real tricorder. A tricorder, for those below a certain age, is a device from the 1960’s science fiction TV show, “Star Trek.” The character Dr. Leonard, “Bones” McCoy would pass it over the body of a subject and instantly discover whatever exotic malady was ailing the person. Now the X Prize Foundation and the Qualcomm Foundation have announced a $10 million prize for the team that can actually build and demonstrate such a device. It is a testimony to the state of technology as well as to the vision of developers in the medical field that such a thing can actually be seriously proposed and attempted.

There is, however, one small disturbing item in the context of the contest, and that is the use of the word “diagnose.” The contest stipulates that, “the winner will be a device that can most accurately diagnose a set of 15 diseases across 30 consumers in three days.” It further states that these diagnoses will leverage technology innovation in areas such as artificial intelligence and wireless sensing to make medical diagnoses independent of a physician or healthcare provider. While I’m not a lawyer, it appears that this could be getting into questionable legal territory—like practicing medicine without a license. Of course, just saying, “My tricorder says you have beri beri,” is not going to get anyone in trouble, but acting on that judgment without the input of a physician just might. After all, even in the Star Trek series the tricorder was always wielded by Dr. McCoy, who was a medical doctor—as in, “Dammit Jim, I’m a doctor, not a bricklayer!”

The ever-growing number of today’s medical electronic devices give us data. They do not contain the large amount of artificial intelligence gleaned from four years of medical school, internship, residency and experience, to shape that data into a reliable diagnosis for much of anything beyond the sniffles. There is some further hubris in the contest material that talks of, “transforming healthcare by turning the ‘art’ of medicine into a science.” Now, really. Anyone who has seen even a few episodes of “House” should be able to appreciate how subtly difficult it can be to arrive at a reliable diagnosis even with vast amounts of data and test results. I can easily imagine MDs taking offense at such a suggestion.

Interestingly, though it appears that the Competition Guidelines will soon state the full details, there does not presently appear to be a list of exactly which diseases are to be diagnosed. It does say, “This diagnosis must be performed in the hands of a consumer independently of a healthcare worker or facility.” That’s where things could potentially get dicey.

I think it is important that we understand just what these devices are supposed to be. They are extensions of the physician’s knowledge, skills and art—not substitutes for it. They can be extremely valuable in a world where those skills are at a premium and where we can delegate large amounts of routine data gathering and, yes, some analysis to machines. But until we arrive at the stage where we have actual medical knowledge and experience in the form of a virtual doctor on our holodeck, as in the later series, “Star Trek Voyager,” let us please keep perspective.

I am excited to see what comes out of this ambitious competition. I am certain the effort will result in some very impressive advances, and we will be looking forward to reporting on them in these pages. But if we get too arrogant about our devices, we may face Spock looking down his nose and shaking his head at our obsession with our “beads and rattles.”

Tom Williams Editor-in-Chief

April 2012 MEDS Magazine

5

UP FRONT PUBLISHER’S LETTER

The Ever Changing World of ECG Devices From Functional to… Portable…

Handheld… Wearable…

JOHN KOON Publisher

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MEDS Magazine April 2012

I have witnessed Mobile Health in action. Many ECG devices are portable, but now I have started to see wearable ECG. Last year I saw one by Imec. This year at CES I saw another wearable ECG using clothing as a sensor. It is made by Cardiosport based in the UK. (I like the company name). A small device worn by a person will transmit ECG signals to another device, presumably used by a caretaker. When a person with a heart problem is placed in the “under observation” category, for the most part, the person is required to stay in the hospital or at a facility where the monitoring equipment is located. Now with this new device, the person can stay home in a familiar environment, wearing the device and move around freely knowing that the data signal can be monitored remotely. What a noble idea! Another company, AliveCor, has introduced a new device called the AliveCor Smartphone ECG using the iPhone to read the ECG signal. A special phone case was made with two electrodes built in.

The electrodes can touch the hands or the chest for it to work. Once a proper connection is made, the ECG signal will be read on the iPhone using a special app. The device is going through the FDA clearance process and the company hopes to have products on the market this year.

The implantable defibrillator is in a class all by itself. A friend of mine has an implantable defibrillator, and I have learned a lot from him about how his life depends on it. I came to appreciate the human aspect of it. The battery has limited life. Changing the battery means a hospital visit, where the doctor has to cut the body open to replace the battery or the unit. Average battery life is 5 years. I have heard new batteries with a 10-year battery life are being worked on. This means an additional 5 years without surgery. What about the concept of charging the unit wirelessly much like charging a cell phone wirelessly by placing it in a cradle? I imagine the user would only need to lie in a magnetic field to get charged up after a night’s sleep. But then I don’t know enough about how that magnetic field would affect the body.

Even though I am talking here about how the ECG devices are changing, the pattern of change applies to all the other medical electronic devices as well. This is partly due to the magic of semiconductors, which pack a lot of functions into a very small package. (See this issue’s “Overview of Medical Semiconductor Market and Applications.”) However, the brain of all these medical electronic devices is, in fact, in the software. It is a very important part of medical electronic device design. We will investigate this further in our next issue.

FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Prize Offer to Develop Working Tricorder Recently at CES, Qualcomm announced the launch of a $10 million global competition, XPrize, aimed at empowering personal healthcare. The goal is to produce a working “tricorder,” a device similar to the gadget first used on the 1960’s television and later film franchise Star Trek. The stated goal is to produce “the equivalent of a board of physicians in your pocket, wireless sensors and imaging device.” In this competition, teams will leverage technology innovation in areas such as artificial intelligence and wireless sensing to make medical diagnoses independent of a physician or healthcare provider. The goal of the competition is to drive development of devices that will give consumers access to their state of health in the palm of their hand. The winner will be a device that can “most accurately diagnose a set of 15 diseases across 30 consumers in three days.”

The XPrize Qualifying Round will last approximately 27-28 months after the January 2012 announcement. Teams must show a “controlled demonstration of sensor validity; and an evaluation of supporting studies, multimedia and prototypes.”

After, 10 teams will advance to the Final Round (approximately 39-40 months after the prize launch).

GE Healthcare already has something similar on the market today. Known as VScan, it uses ultrasound to render black and white anatomic and color-coded blood flow images on a handheld device. However, VScan is intended only as a diagnostic aid for physicians; the new tricorder will be designed to automate the diagnostic process.

“This competition will accelerate the development of tools that can empower consumers to take charge of their own bodies and manage their own care,” said Qualcomm CEO Dr. Paul Jacobs during his CES keynote.

Brooks Automation Acquires Celigo Cell Cytometer Product Line Brooks Automation has announced that it has completed the acquisition of the Celigo Cell Cytometer product line for approximately $9.2 million from Cyntellect, a privately held life sciences company based in San Diego. Introduced to the market in early 2010, Celigo has become one of the most rapidly adopted cell imaging systems based on its unique combination of high-throughput, ease-of-use and affordability. The installed customer base for Celigo includes many of the top pharmaceutical, biotechnology and academic institutions worldwide.

As part of the transaction, the majority of Cyntellect’s employees who have supported Celigo since inception are being moved to Brooks’ nearby facility in Poway, CA, providing for a seamless transition of the key engineering, manufacturing and R&D capabilities, as well as the field-based sales and support personnel.

Dr. Steve Schwartz, president and CEO of Brooks, stated, “The Celigo cellular imaging product line is an impressive addition to our family of stand-alone instrumentation products used by many of our automated sample management system life sciences customers. It joins a growing portfolio of high productivity automated solutions for the analysis, handling and testing of biological and compound samples prior to and following their storage in our automated sample management systems.” Dr. Schwartz continued, “The Celigo cell cytometer enables microplate-based high-throughput, high-content, brightfield and fluorescence cellular imaging and analysis, with minimal sample manipulation.”

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MEDS Magazine April 2012

2.2 Million Patients are Remotely Monitored Today According to new a research report from the analyst firm Berg Insight, around 2.2 million patients worldwide were using a home monitoring service based on equipment with integrated connectivity at the end of 2011. The figure does not include patients that use monitoring devices connected to a PC or mobile phone. It only includes systems that rely on monitors with integrated connectivity or systems that use monitoring hubs with integrated cellular or fixed-line modems. Berg Insight forecasts that the number of home monitoring systems with integrated communication capabilities will grow at a compound annual growth rate (CAGR) of 18.0 percent between 2010 and 2016, reaching 4.9 million connections globally by the end of the forecast period. The number of these devices that have integrated cellular connectivity increased from 0.42 million in 2010 to about 0.57 million in 2011, and this is projected to grow at a CAGR of 34.6 percent to 2.47 million in 2016.

Some of the most common conditions being monitored today are chronic diseases including cardiac arrhythmia, sleep apnea, diabetes and chronic obstructive pulmonary disease (COPD). These conditions cause substantial costs and reduce both life expectancy and quality of life. Berg Insight estimates that more than 200 million people in the EU and the U.S. suffer from one or several chronic diseases where home monitoring can become a treatment option.

Leveraging connectivity technologies in the healthcare industry can lead to decreased costs, more efficient care delivery and improved sustainability of the healthcare system.

New care models enabled by these technologies are also often consistent with patients’ preferences of living more healthy, active and independent lives. Progress is being made in the adoption of wireless technology among manufacturers of medical monitoring equipment. However, there is still a long way to go before remote monitoring becomes a standard practice in the healthcare sector.

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Copyright Š 2012 Cyth Systems, Inc. All rights reserved.

FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Continua Health Alliance Releases Free Design Guidelines; Gains Android Support The Continua Health Alliance, an international not-for-profit organization of healthcare and technology companies dedicated to creating an eco-system of interoperable personal connected health products and services, has announced it will make its Design Guidelines publicly available for download free of charge. This public availability will follow an internal 8-month interoperability/pilot phase that will collect and issue errata prior to the public availability.

Public access to the Continua Design Guidelines will help a larger number of developers build end-to-end systems that provide seamless connectivity between personal connected health products and services, facilitating critical interoperability among devices and applications to drive down data collection and management costs to significantly streamline and simplify the development process for technology companies.

“Allowing a large audience to access Continua Guidelines will be healthy for the industry” said Clint McClellan, Continua Board President and Sr. Director of Strategic Marketing, Qualcomm Life, Inc. “This is a vital step in enabling a collaborative system of interoperable plug-and-play healthcare technologies, which will ultimately decrease time-to-market and drive down deployment and maintenance costs—core components of Continua’s mission.”

The Alliance recently made its 2011 Design Guidelines available to university students as part of its commitment to support the 2011-2012 GSMA Mobile Health University Challenge. Having access to Continua’s Guidelines has allowed University Challenge participants the opportunity to accelerate their application development by rapidly integrating a wide variety of Continua compliant health and medical devices.

In addition, the recent release of Android 4.0 includes the Bluetooth Health Device Profile, which supports Continua Certified devices such as heart-rate monitors, glucose meters, blood pressure cuffs, thermometers and scales. This is the first time that applications can be loaded into an unmodified Mobile OS with the levels of security needed for healthcare data transactions.

High-Density 300 Watt Medical Power Supply with UL60601-1 3rd Edition Approvals A series of 300 watt U-Frame Switchers safety approved to the 3rd Edition of UL60601 and single outputs ranging from 5~54V, consists of 10 standard output models designed for the latest medical applications requiring the “Possess Risk Analysis Report” to comply with MOPP applications.

Standard features of the APS303Mx line from Advanced Power Solutions include 600 watt peak load operation for up to 5 seconds; Universal AC Input with Active Power Factor Correction; dual-fused input protection; low leakage of only 120uA @ 264 VAC; Power-Good, Fan Fail, Inhibit and 12V Fan control; and a 2 year warranty. Options include a perforated top-mount cover; top-mount fan cover, end-mount fan cover; industrial operating temperature range of -40° ~ +85°C; and Molex or terminal block connections.

Products are now in full production with evaluation quantities available from stock and production deliveries of less than 8 weeks. Pricing is $85 each for 100 piece quantities.

Advanced Power Solutions, Livermore, CA. (925) 456-9890. [www.advpower.com].

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MEDS Magazine April 2012

Industrial/Medical Grade Combination WiFi/Bluetooth Modules Summit Data Communications, the leader in industrial and medical grade wireless, today announced two new modules that deliver support for the latest WiFi standards as well as fully integrated Bluetooth. These combination modules enable manufacturers to reduce device size, current consumption and build cost resulting in less expensive, more ergonomic products with improved battery life.

Two modules are available; the SDCMSD40NBT is a PCB module measuring 32 x 22 mm with a board to board host device connector, and the SDC-SSD40NBT is a System in Package (SiP) module measuring just 15 x 15 mm.

Both are based on the popular Broadcom BCM4329 chip and support 802.11a/b/g/n via an SDIO interface and Bluetooth 2.1 via a UART interface.

The modules provide all of Summit’s hardware and software capabilities including optimized transmit and receive range, dual band antenna diversity, an expanded operating temperature range, a fully integrated software suite and advanced Wi-Fi/ Bluetooth coexistence. The SDC-MSD40NBT and the SDC-SSD40NBT are pin and dimensionally compatible with legacy Summit modules, providing current Summit customers with an easy migration path.

Both modules are now generally available and in full production.

Summit Data Communications Akron, OH. (330) 434.7929. [www.summitdatacom.com].

Fueling Innovation for Tomorrow’s Technology……Today AMD is ushering in a new era of embedded computing. The AMD Embedded G-Series processor is the world’s first integrated circuit to combine a low-power CPU and discrete-level GPU into a single embedded Accelerated Processing Unit (APU).

AMD is also proud to offer extended availability of the AMD Geode™ LX processor family until 2015.

Learn more about new levels of performance in a compact BGA package at: www.amd.com/embedded © 2011 Advanced Micro Devices, Inc. All rights reserved. AMD, the AMD Arrow logo, ATI, the ATI logo and combinations thereof are trademarks of Advanced Micro Devices, Inc. Other names are for informational purposes only and may be trademarks of their respective owners. Features, performance and specifications may vary by operating environment and are subject to change without notice. Products may not be exactly as shown. PID# 50599C

FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Critical-Care Patient Monitoring Data Available on Doctors’ iPads and iPhones GE Healthcare and AirStrip Technologies have announced AirStrip Patient Monitoring, which securely delivers patient monitoring information to critical-care physicians’ iPhones and iPads. AirStrip helps physicians interact with, manipulate and zoom in on more than 100 clinical measurements and access physiologic data and monitoring waveforms, anytime and anywhere. AirStrip Patient Monitoring is designed to help mobile physicians make efficient, informed clinical decisions across and beyond hospital boundaries.

Critical-care physicians must make timely treatment decisions for the hospital’s sickest patients. However, they face increasingly hectic patient care responsibilities, making it difficult to continuously be at the bedside. AirStrip Patient Monitoring can serve as an important clinical decision support tool and help expand physicians’ access to patient information. If a nurse requires immediate consultation, physicians can be located anywhere and access critical patient information before determining appropriate care approaches. According to a Manhattan Research survey, 75 percent of U.S. physicians own some form of Apple device, such as an iPhone or iPad. Because physicians can directly view and zoom in on live clinical measurements, AirStrip Patient Monitoring offers physicians greater decision support than traditional mobile viewing applications, which do not enable this level of interaction and provide only limited subsets of data.

AirStrip Patient Monitoring is a native application specifically designed for environments where mobile access to critical patient data is essential.

AirStrip Patient Monitoring helps clinicians access near real-time data and historical patient information up to 24 hours old. It links with GE Healthcare’s portfolio of comprehensive patient monitoring platforms, such as the Carescape Monitor B850, Carescape Monitor B650, Solar and Dash monitors, to give physicians access to patient waveforms, vital signs and other critical clinical measurements on interactive iPad and iPhone displays. This connectivity is powered via Carescape Gateway, which interfaces biomedical devices with hospital information systems to streamline otherwise disparate clinical information.

Airstrip Technology, San Antonio, TX. (210) 805-0444. [www.airstriptech.com].

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MEDS Magazine April 2012

Health and Wellness Management Android Solution for Medical Wind River Solution Accelerator for Android, Medical implements a system of interoperable connected health solutions on top of the Android platform. Following the Continua Health Alliance guidelines, Wind River Solution Accelerator for Android, Medical provides the opportunity for device manufacturers and service providers to efficiently build and deliver a personalized, interoperable and compliant health and wellness management solution at a controllable cost.

IEEE 11073 is the first open standard that “addresses a need for an openly defined, independent standard for converting the information profile (of personal health devices) into an interoperable transmission format so the information can be exchanged to and from personal telemedicine devices and computer engines.”

The Continua Health Alliance specifies using IEEE 11073 as the format for information exchange between personal health devices such as weighing scales, blood pressure monitors and blood glucose monitors.

Compliant devices, whether they are smartphones, personal computers, tablet computers, personal health appliances, or settop boxes, can readily exchange information with each other. This standard is incorporated into Wind River Solution Accelerator for Android, Medical and allows all devices running it to communicate seamlessly with each other, delivering patient health information quickly where it is needed.

Wind River Solution Accelerator for Android, Medical supports the IEEE 11073 stack and can work with 11073-104xx sensor devices including the following: • IEEE 11073-10404 pulse oximeter • IEEE 11073-10406 heart rate monitor (pulse) • IEEE 11073-10407 blood pressure monitor • IEEE 11073-10408 thermometer • IEEE 11073-10415 weighing scale • IEEE 11073-10417 glucose meter • IEEE 11073-10441 cardiovascular monitor • IEEE 11073-10442 strength monitor • IEEE 11073-10471 activity data monitor • IEEE 11073-10472 medication monitor Wind River, Alameda, CA. (510) 748-4100. [www.windriver.com].

FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT UPS in a Chip Billed as Drop-In Solution or Life-Of-Product Power Backup Cymbet Corporation today announced the availability of the EnerChip CC CBC3105 smart solid state battery. The CBC3105 combines the award winning EnerChip battery with integrated input power conversion, battery management and regulated output capabilities.

A smart rechargeable solid state battery uninterruptible power supply (UPS) in a chip provides power backup to microelectronic devices when main power fails. The EnerChip C3105 from Cymbet provides power supply monitoring and switches over to the internal solid state backup battery when the supply drops below a set threshold. The EnerChip CC product family can provide anywhere from several hours to several weeks of backup time. The CBC3105 is a solution for design engineers who need a compact device to back up a real-time clock or microcontroller during power failure where coin cell batteries or super caps will not work due to size, reliability, no battery doors, no battery replacement, battery disposal issues, or need for life-of-product power. The CBC3105 uses surface mount/reflow solder assembly and is RoHS tested-compliant.

The EnerChip CC device family can accomplish all this in a footprint as small as the CBC3105 4 mm x 5 mm x 0.9 mm package that is priced as low as $0.50 in high volumes.

Cymbet makes it easy to design EnerChips into new products by offering two EnerChip CC evaluation kits: • CBC-EVAL-05 EnerChip CC Evaluation Kit, which contains everything needed to test EnerChip 12uAh and 50uAh thin film batteries, EnerChip CC CBC3112 and CBC3150 batteries with Integrated Battery Management, and to test multiple batteries in parallel. This kit will also include a CBC3105 evaluation board for experimenting with this device. • CBC-EVAL-06 Real-Time-Clock Evaluation Kit, which includes a Microcrystal NV2123 Real-Time Clock device and a CBC3112 EnerChip CC for battery backup. This kit also includes a Windows based Graphical User Interface to set the clock & test operation in RTC back up and count-down modes.

Cymbet, Elk River, MN. (763) 633-1780. [www.cymbet.com].

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MEDS Magazine April 2012

Health Care Cloud Environment Enables Secure Collaboration, Enhances Patient Care A secure, cloud-based environment is designed to help everyone involved in patient care communicate and collaborate more effectively to improve health outcomes. The Optum health care cloud simplifies the lives of caregivers, innovators and health IT management professionals by helping them communicate and access essential health intelligence more efficiently, create and deploy health applications quickly and manage technology in their offices or across networks with ease. The environment features an intuitive dashboard that helps users access the information and applications they need throughout their day to support medical decisions. This supports fully informed, better-coordinated care and treatment decisions.

The Optum health care cloud features secure text and video chat capabilities to help health professionals connect, communicate and collaborate with other health professionals and with patients. These capabilities are necessary for full participation in Accountable Care Organizations and other emerging care models that require more effective collaboration. It also includes productivity tools that easily integrate with a range of health IT systems to help doctors, nurses and other clinicians and health administrators organize their information and resources in one simple interface, accessible securely from any Internet-connected device.

For example, the health care cloud from Optum can integrate the applications that patients use, such as biometric monitors, with the health information systems used by physician practices, hospitals and health plans. This keeps electronic medical records up-todate and automates delivery of progress notes to members of the care team. Working from a common set of complete patient information, physicians and patients can make treatment decisions together, track progress and stay connected between appointments.

Health professionals and other innovators can leverage the Optum health care cloud to create and host their applications. A Developer Toolkit includes HIPAA compliance modules, collaboration tools and other health care technology essentials. A Chief Information Officer Toolkit supports deployment of internal and external applications, and provides templates for creating a master patient index and other resources that support population health management.

In the second quarter of 2012, a software development kit (SDK) optimized for health care will be available to health apps developers. This open toolkit will help a large, growing community of innovators quickly turn their ideas into working solutions that health professionals can deploy quickly and inexpensively.

The health care cloud from Optum also features a marketplace where entrepreneurs can market and deliver their solutions to hundreds of thousands of health professionals and thousands of health organizations.

Optum, Eden Prairie, MN. (888) 445-8745. [www.optum.com].

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Supports Compliance with

FDA / IEC 62304 Standards

Customers Using VectorCAST Boston Scientific COGNIS® Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Impact Instrumentation Uni-Vent® Portable Ventilator

Sirona Dental Systems GALILEOS™ Digital 3D Imaging Systems

Biosafe Sepax® Cell Separation System

Terumo Heart DuraHeart™ Left Ventricular Assist System (LVAS)

vectorcast.com

FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT IEC 62304 and ISO 14971 CertificationReadiness Services for Medical Devices LDRA Certification Services (LCS), a division of LDRA, is announcing a fully compliant IEC 62304 and ISO 14971 certification solution for medical device manufacturers. This offering brings together a team of certification industry experts fully accredited in medical standards along with certification-readiness tools tailored to meet the demands of IEC 62304 and its related ISO 14971 risk management standard.

The safety and effectiveness of software in a medical device relies on proof that the software fulfills its specifications without causing unacceptable risks. The IEC 62304 standard requires compliance to ISO 14971, which details what is needed for the development and maintenance of risk and quality management systems for medical devices at a systems level. Building on the ISO 14971 foundation, IEC 62304 focuses on guidelines specific to software.

For medical device manufacturers implementing these new standards for the first time, there is considerable challenge in interpreting the guidelines of these complementary standards. Correct interpretation of the software and system objectives outlined by the standards is one of the areas where LCS adds its greatest value to the producers of medical device systems. The LCS comprehensive solution encompasses software, hardware and systems expertise.

An FDA analysis of 3140 medical device recalls from 1992 to 1998 revealed 79% of the recalls related to software failures were caused by defects introduced after software upgrades. This extreme level of incidents related to service or maintenance of medical device systems has driven regulators to stipulate a software maintenance process considered to be as important as the software development process in IEC 62304. The most effective way to bridge the gap between development and maintenance processes is through a comprehensive lifecycle traceability and verification management system such as the LDRA tool suite as prescribed by LCS. The LCS team implements the certification process using the LDRA tool suite, a comprehensive software analysis and validation solution. The LDRA tool suite automates all stages of the verification process to achieve compliance readiness from requirements traceability to analysis, unit testing and validation. Using a broad range of qualifiable verification capabilities that support IEC 62304 certification objectives at all class levels, the LDRA tool suite manages and tracks lifecycle artifacts to achieve bidirectional traceability, as well as automated regression testing, through the development and maintenance phases.

LDRA, Wirral, UK. +44 (0)151 649 9300. [www.ldra.com].

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MEDS Magazine April 2012

High Flex Silicone Cables for Surgical Robotics A line of flexible and durable flat silicone cables is designed for use on surgical robotic systems that require absolute reliability in routine and life-critical procedures. The proprietary silicone cable from Cicoil is naturally more flexible than round PVC or stiffer flat PTFE cables, which allows for a tighter bend radius, weight/space savings, greater current carrying capacity, noise reduction and longer flex life.

Each element in Cicoil’s solid, onepiece construction is completely surrounded by silicone, ensuring that they do not rub against each other and wear during a lifetime of more than 10 million cycles. This unique silicone is “self-healing” from small punctures and cable jacket damage can easily be repaired in the field. In addition, the halogen-free silicone encapsulation will not delaminate or degrade due to exposure to steam, water, alcohol, UV light, mechanical abuse, autoclave and many chemicals.

Cicoil’s lightweight cables can incorporate any variety of power, data and video conductors in a single compact cable design. In addition to every type of electrical conductor, the cables can also include single and multi-lumen tubing for air or liquid transfer, fiber optics and other design elements like Cicoil’s patented StripMount fastening strip, all in the same cable.

The cables are 100% contaminantfree, as they are rated for Class 1 clean room use. Cables are available in continuous lengths, cut to order, or as assemblies, complete with connectors of your choice, 100% tested and inspected.

Cicoil, Valencia, CA. (661) 295-1295. [www.cicoil.com].

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Helping the Blind to See A set of eyewear combining small cameras and configurable image processing in a small, real-time package, is able to take advantage of remaining functional vision capabilities to help improve the lives of the legally blind.

by Rob Hilkes, eSight Corporation and Kim Rowe, RoweBots Research

N

ot all people who are legally blind have completely lost their sight. In fact many retain enough vestibular functional vision to perform various tasks, provided the image entering their eye is sufficiently enhanced and optimized for their unique retinal and neurological visual processes.

Using a combination of advanced hardware, advanced software and innovative design, these people can now see. eSight Corporation and RoweBots worked together to produce the ultimate pair of augmented imaging glasses—Alvios Intelligent Eyewear.

Alvios Intelligent Eyewear (Figure 1) incorporates a miniature ophthalmic quality video camera mounted at the bridge of the nose, a standalone processor to modify and enhance the video, and two tiny highresolution video screens in front of the user’s eyes.

By wearing Alvios in an elevated position, people with low vision can use their often healthy peripheral vision to easily capture objects of interest in the world around them. Then, once the wearer spots an object they wish to observe more carefully, simply glancing up into the computer image shows the same object with various video enhancements that stimulate what remains of their impaired central vision.

Alternatively, the wearer can place the video screens in a more immersive orienta-

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MEDS Magazine April 2012

tion, viewing the computer generated images full time. This mode is better suited for more stationary activities such as reading, watching television, doing crafts, or viewing a presentation or the theater.

Each individual has a very unique remaining visual function and personal goals and activities they wish to pursue. Alvios is configured by trained optometrists and ophthalmologists to make the most of what remains of a person’s specific functional visual performance.

Figure 2 shows the physical layout of the intelligent eyewear. You can see the camera receiving an image from the outside world coupled into a unit with two tiny displays—one for each eye. This headmounted unit connects to a belt-mounted unit with a bidirectional serial data stream.

The belt-mounted unit provides the processing power, batteries and various control features.

The video camera transmits the image to an FPGA located in the belt unit.

The FPGA provides initial processing on the image in real time and relays the augmented image into the camera subsystem.

The Unison RTOS is used from this point to set up a signal processing software pipeline to further transform the image and finally output it through the cable to the head-mounted display subsystem.

The display subsystem uses additional signal processing in the FPGA to prepare the image for display. The data flows from

the FPGA directly to the tiny screens, which the visually impaired person sees roughly 1 cm in front of his or her eyes.

The key signal processing functions are: • Image capture • Autofocus • Zoom • Color correction • Image enhancement • Image display The FPGA performs the first and last functions: initial image capture and display.

The remaining functions are performed on an OMAP processor under software control with special data acquisition and image processing hardware.

The signal processing starts with the setup of the processing and transformation environment during initialization.

The flash resident software eliminates the boot phase, speeding startup. The FPGA’s firmware loading and the various hardware components initialization follows this under control of the Unison OS. The Unison OS is the core software component that does the initialization and provides the key software elements for the underlying I/O and processing system.

The Unison image driver supports a full range of functions and provides queued buffers for processing with a variety of algorithms. The zoom function allows a portion of an image to be selected and examined in greater detail inside the driver.

Real-time image statistics allow the application to provide auto-focus, auto-contrast and automatic color correction by accessing special features of the image driver.

The buffer queuing system provides minimal buffer copying during the signal processing functions. These buffers eventually end up directly in the display system for output through the FPGA to the

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micro displays. Maximization of the available processing power and minimization of bus bandwidth directly results from this approach, making it a significant design feature.

The application software provides overall control to the user, setup and selection of the signal processing functions and overall coordination of the various application components. The user controls the device from a set of controls on the belt unit.

The most commonly used commands can be easily selected by the user. Futhermore, the trained clinician can customize the user interface, providing access to those features that provide the most benefit, and hiding those inappropriate for the specific user.

For a person unable to see for many years, using Alvios Intelligent Eyewear can be a powerful experience. This unique and powerful solution allows blind people to see again and mitigates one of the most significant losses one can experience.

Critical Design Issues Just like many other products, size, weight and power (SWAP) are critical in the design. Careful tradeoffs were made to maximize utility while minimizing power consumption and weight.

One critical design issue that the team grappled with was the weight of the headset. Alvios needs to feel more like a pair of glasses rather than a head-mounted helmet.

To enhance vision, careful adjustment is required for each patient and the equivalent of a pair of glasses needs to be included in the headset.

Battery life directly affects usability in real life situations making it a critical function. High-performance image processing provides the image transformations regarded as the realm of FPGAs and DSPs窶馬either particularly power miserly.

Alvios Intelligent Eyewear needs to be used for hours without recharging. This type of processing and time duration precluded including the battery in the head-mounted portion of the system as it would be too heavy. Lithium Ion battery choices can re-

Figure 1 Kim Rowe, the founder of RoweBots, demonstrates Alvios Intelligent Eyewear.

duce the size and weight of the battery, but the requirement for a significant amp hour rating remains. With the battery having significant weight, it needs to be mounted

where the user can more easily tolerate carrying the weight.

Originally Alvios utilized the Linux OS. The application code consisted of a April 2012 MEDS Magazine

19

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Optics

Camera Subsystem Memory

Image Sensor

Camera Module

FPGA

Image Modification

Display Subsystem microdisplay

Optics

CPU INPUT DEVICE

Control Unit (Belt Worn)

microdisplay

Optics

Display Module Alvios Eyewear (Head Worn) Figure 2 System architecture with head-mounted camera and display along with belt-mounted processor and battery.

multithreaded single process application.

The main issues with Linux were the high complexity of drivers and driver development and the separation imposed by Linux between user space and kernel space.

This involved a large amount of buffer management and copying between user space and kernel space. In addition, with Linux there was a lot of required maintenance with many specialized drivers and a moving set of kernel versions. Significant effort was required to integrate DSP functions and boot times were inconveniently lengthy.

The complexity of the Linux environment required substantial full time resources to track releases and various specialized drivers. Often the effort of developing drivers and integrating them fell on the team, and as soon as they were done, new changes forced immediate redevelopment. The cost and delays of this approach were prohibitive.

Real-time, low latency performance is critical for Alvios users. Linux’s nonhard real-time performance creates a limitation as a solution in this instance; hard real-time performance creates an

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MEDS Magazine April 2012

enhanced user experience. By getting more out of the same hardware, the user experience can be substantially enhanced without an increase in the bill of materials (BOM) cost.

Seamless integration of DSP processing makes design, maintenance and system understanding much simpler. While DSP was partially integrated into the off-theshelf Linux environment available with the OMAP, driver integration of these DSP functions would be required to achieve optimum performance. This amounted to significant additional work at the Linux driver level where undue complexity was already a huge burden.

The Software Solution After carefully evaluating several alternatives, the decision to replace the Linux OS with the Unison OS from RoweBots proceeded as the low-risk and low-cost approach with the biggest long term benefits. Selecting the Unison OS platform for this application promised a number of advantages. The simplified OS architecture would make developing and maintaining specialized drivers much

simpler. Given the real-time response of Unison and the elimination of substantial complexity and overhead, the performance was expected to improve. The drivers from Unison could replace the Linux drivers, offering identical functionality without any maintenance and support burden. In addition, DSP functions could be seamlessly integrated without penalty, without buffer copying and with an integrated debug solution. Unison features the capability for a flash-based image and nearly zero boot time. It was possible to rapidly port the application with only minor changes.

The Unison software architecture is shown in Figure 3. The microkernel or nanokernel-based approach separates and modularizes the operating system.

The Unison OS modularity, easily understood architecture and POSIX compatibility give Unison much of its power to quickly solve Linux performance and support problems.

By adopting the Unison OS for Alvios Intelligent Eyewear, eSight achieved its performance goals while eliminating a major source of project cost, delays and on-

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8

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Unison Services

I/O Servers Nanoexec

Hardware

H/W & Interrupt management

Figure 3 The Unison OS nanokernel architecture offers a simple architecture with complete modularity and POSIX compatibility. Very easy and lowcost adoption results as it avoids knowledge of proprietary systems while addressing all the major problems associated with embedded development.

going development effort. The Unison philosophy of providing releases for the complete Unison OS once every 18 months, and upgrades to components as required, eliminated the support burden for eSight and lead to a much faster and lower cost development.

By switching to the Unison OS and the image, communications, control and display drivers that Unison provides, the performance of the system was substantially enhanced while reducing development costs.

• Image processing latency was reduced by more than 50%.

• File system performance was doubled.

• Interrupt response improved by up to 20X. • Communications throughput doubled depending upon system setup.

• Boot time was reduced from about a minute to a few seconds.

The performance of Alvios Intelligent Eyewear improved significantly, while boot time dropped to the point of insignificance.

Development time and expense were dramatically improved because of reduced driver development, software maintenance and time spent managing the “open source” aspects of the product design.

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Untitled-8 1

MEDS Magazine April 2012

4/9/12 10:02:27 AM

RoweBots Research Inc. Kitchener, ON, Canada.

(519) 208-0189. [www.rowebots.com]. eSight Ottawa, ON, Canada.

(613) 271-9535. [www.eSightCorp.com].

We

Bridge the Gap Between

Design

and

Manufacturing

“Corvalent provided Alfa Thermo with the right set of tools and capabilities to provide a true, turnkey solution for our medical device requirements.

Their experienced electrical, mechanical and manufacturing team joined forces with us in the early stages to help define and develop a world class Infra Red Regulation Thermography System (IR2T).

The Corvalent team led the effort in passing ISO 60601-1 and most recently worked diligently with us on a 510K submission, CE Technical File and ISO 13485 Certification.

We could not be more pleased with the consistent high quality effort and results we have received from Corvalent.

Corvalent provide us with turnkey service, from customer order entry to full fulfillment, allowing us to focus on marketing, selling and developing our next generation products.�

Curtis Davis CEO Alfa Thermo, Inc.

Corvalent is a leading industrial and electronic designer and a

custom manufacturer of medical devices, specializing in durable, revision-controlled, long-life, industrial motherboards and computing solutions.

All Corvalent systems are manufactured and supported in the USA. Products carry a 7-10 year production life-cycle guarantee, ensuring medical manufacturers a reliable, long-term supply of dependable, high-quality computing technology.

s WWW.CORVALENT.COM

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Continuous Integration of Software Medical Device Projects – It Is a Must!

An automated continuous integration system can provide a thorough design history through triggered builds, status reports and alerts. It can promote a team process that smoothes the complex process of managing a complex software design project.

by Matthew T. Rupert

T

hese days a continuous integration (CI) tool is much more than “nice to have” during software development. And when it comes to the design and development of a software medical device, good continuous integration practices are even more imperative.

I say this as someone who has spent excessive amounts of time wading through documents and double checking references, checking traceability, versions and making sure design outputs are properly documented in a Design History File (DHF). CI shouldn’t be thought of as nice to have, rather, it is a key process in making software medical device manufacturing possible.

A CI tool can take the sometimes feeble attempts of humans to make large amounts of documentation consistently traceable and force the computer system to do what it does best—continuously.

The use of a CI tool is not simply an esoteric practice for those who are fond of its incorporation. CI is an activity that successful development teams have al-

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MEDS Magazine April 2012

ways attempted, but they have too often failed to utilize software tools to ease the process. Going a step further, development teams can use a CI tool to simplify steps that they may never have dreamed of before!

Continuous Integration refers to the continuous compiling and building of a project tree as well as continuous testing, releasing and quality control. This means that throughout the project, at every stage, the development team will have a build available with at least partial documentation and testing included. In general, CI builds are performed in an environment that closely matches the actual production environment of the system. A CI environment should be used to provide statistical feedback on build performance, tests and incorporation of a version control system and ticketing systems. In a development environment, the team may use a version control tool to link to tickets. In this way, any CI build will be linked to a specific change set, thereby providing linkage to issues, requirements and, ultimately, the trace matrix.

CI builds should occur frequently enough that no window of additional version control update occurs between commit and build, and such that no errors can arise without developers noticing them and correcting them immediately. This means that for a project that is in development, it should be configured that a checking triggers a build in a timely manner. Likewise, it is generally a good practice for the developer committing a change set of code to verify that his or her own change set does not break the continuous integration build. There is little overhead to creating many CI builds. There is, however, potential downside to not performing CI builds frequently enough.

Most software engineers think of a build as the output of compiling and linking. I suggest moving away from this narrow definition and expanding it. A “build” is a completion (in both the compiler sense and beyond) of all things necessary for a successful product delivery. A CI tool runs whatever scripts the development team tells it to run. As such, the team is free to use the CI tool as a build manager. It can compile code, create an installer, bundle any and all documents, create release notes, run tests and alert team members about its progress.

Jenkins CI For the purposes of this article, the focus will be on one specific CI tool, Jenkins CI. This is one of the more popular open source tools available. Jenkins CI, the

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continuation of a product formerly called Hudson, allows continuous integration builds in the following ways: 1. It integrates with popular build tools (ant, maven, make) so that it can run the appropriate build scripts to compile, test and package within an environment that closely matches what the production environment will be.

2. It integrates with version control tools, including Subversion, so that different projects can be set up depending on projection location within the trunk.

3. It can be configured to trigger builds automatically by time and/or change set (i.e., if a new change set is detected in the Subversion repository for the project, a new build is triggered).

4. It reports on build status. If the build is broken, it can be configured to alert individuals by email.

Figure 1 gives an example of what a main page for Jenkins CI (or any CI tool) may look like. It can be configured to allow logins at various levels and on a per-project basis. This main page lists all the projects that are currently active, along with a status (a few details about the build) and some configuration links on the side. These links may not be available to a general user.

Clicking any project (“job”) links to further details on the build history and status. This image provides us details on what the overview screen in the CI environment might look like, but it is at the detailed project level that we see the real benefit of packaging that can be performed by a well set up CI environment.

DHF Requirements Medical device software is audited and controlled by standards defined by the FDA, specifically Code of Federal Regulation, Title 21, parts 11 and 820 (21 CFR). Many of the requirements laid out in this difficult-to-understand guidance can be made easy when we use a CI environment throughout the course of

Figure 1 The main page of a CI tool will allow the user to navigate to various projects and levels within projects. It will also establish a system of permission levels and allow users to quickly see information on project status.

project design and development. Looking specifically at the quality system requirements laid out by 21 CFR Part 820.30, Subpart C – Design Controls, it becomes apparent that a good CI environment can help to address each. A major consideration, perhaps the major consideration, is the completeness of the Design History File (DHF).

820.30(j) Design History File. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

The “or reference” part of this statement stands out. Traditionally, medical device manufacturers have thought of the DHF as a physical, self-contained item.

But with a project of any complexity, it isn’t difficult to imagine how quickly a DHF may grow into an unruly mess of “stuff.” Why not simply leverage software

tools to make the process seamless? Using a CI tool, development teams can pull together a baseline of all the elements of a DHF as frequently as they wish to. Furthermore, they can do so with a degree of accuracy that cannot be achieved through the diligent (yet distractible) legwork of a busy team.

I propose that the DHF need not be a single physical or soft folder with duplicate copies of items. Leveraging the CI environment along with the version control system, it is a much better idea to think of the DHF as a snapshot of all relevant design outputs at a given point in time. To that end, the development team can have many snapshots of the DHF throughout the project lifecycle.

To achieve this, they need simply to define this process in their standard operating procedures and work instructions.

To those who have only worked with a DHF as a particular folder with specific subsets of documentation within, this approach, while it makes sense, takes a bit of a leap from the traditional DHF mindset to attempt.

April 2012 MEDS Magazine

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Figure 2 The CI can present much more information than a simple build history; it can include almost any information relevant to the status and progress of an ongoing project.

Figure 2 shows what a (simple) project setup may provide in the way of such packaging. It is up to the team to determine how much or how little the CI handles, but it makes the most sense to allow it to do what computers do very well and what humans tend not to do as well: align things.

The sample in Figure 2 shows that more than simply the build package can be included in the CI output. Development teams can bundle other things that are required by the DHF, including any manuals, plans, requirements and so on. This environment is starting to look more and more like a DHF.

The CI Environment The CI build server should closely mimic the environment in which the final product will be deployed. This helps establish a level of confidence with regard to system compatibility prior to user acceptance and integration testing.

It must also have access (through the version control and/or ECM system) to all the design controls and documents necessary to build a complete DHF. It

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MEDS Magazine April 2012

is generally best to use a single version control system for everything. It doesn’t make sense, for example, to store source code in one version control system and documents in another. Doing so makes importing of all necessary items difficult, if not impossible.

There are a number of benefits to utilization of a CI server during project design and development. Do not think of CI as a tool only for software builds.

Integrated with the project version control system, it can serve as much more.

Within the CI build history we now have a mechanism by which we can recreate the precise environment and moment in time in which the build was generated.

From code to documentation, all design history (think DHF) can be traced to the build.

The CI build gives the development team prompt feedback on the build status. If compilation fails, tests fail or some requirement element cannot be packaged, the entire team is flagged immediately.

To this end, the entire team will know that a particular check-in has broken

something. This feedback will eliminate the fear that an unknown break could be so extensive that progress will come to a screeching halt. The near real-time feedback of the CI build saves valuable time (and stress!) throughout development and even design.

Project progress tracking (tickets, tests, etc.) gives the team and management the ability to see a quick overview of project trends, including completion of the project, test results, code quality, reviews, documentation and so on.

Along with project progress tracking, a major feedback loop is completed. Continuous integration provides continuous feedback for all team members. Even software peer reviews can be a part of this feedback loop, with every change set and/or ticket completion triggering a mini peer review.

When a team reviews smaller portions of code by paying attention to every change set, we have more manageable reviews as well as improved team understanding of each other’s work.

Triggering Builds and Keeping Them Healthy It is important for team members to focus on keeping the CI build in a “healthy” condition. CI builds can and do break for a number of reasons. This is to be expected.

As an example, we will use Jenkins-CI to automatically perform a CI build every hour if there is a change in the repository.

The system will be configured to send emails to the development team if there is a problem with the build—i.e., if a change set breaks the CI build. It is anticipated that the CI build will break from time-totime, however, a broken build should not be left unattended.

A common cause of a broken CI build is a lack of attention to the build script. Each developer is responsible for making certain that the ant build scripts are up to date with all required changes.

We cannot rely on the build scripts that are generated by an IDE. There are certainly more possible causes that could be added to the above list. It is a good idea for each developer to trigger a CI build immediately following any Subversion commit to ensure that the CI build has not been broken. If a CI build continues to be broken without being addressed, the

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Version Control System Standard Operating Procedures

Use Cases/ User Stories

Project Plan(s) & Schedules

Software Design Documents (SRS, SDS, etc.)

Work Instructions

Risk and Hazard Analysis

User and System Manuals

Manual Test Results

Source Code

Verification and Validation Plans and Protocols

Third Party Libraries

Misc.

Design Input

Deliverable Package:

• Installer • Documentation • Configuration Files • Trace Matrix • Validation Results • Other Deliverables

Continuous Integration Server (Jenkins CI)

Design Output

Design Review

Design Verification

Design Transfer

Design Changes Design History File (DHF) Figure 3 All the information—and more—that could be stored in a design history file can now be automatically stored and accessed for the life of a project through the use of a CI environment.

team leader and/or project manager may revert the offending change set and reopen any related issue.

Using a CI Environment to Replace the Traditional DHF Naturally, an important part of continuous integration is having a CI build that can be checked regularly for continued build success. This is probably what is commonly thought of as the key benefit, but there is much more to be gained. Any CI environment that is worth using will allow the team to incorporate packaging of key project items with each build. This includes important documents, tests (both manual and automated test outcomes can be packaged), requirements, design specifications and build results (deployment packages, libraries, executables, installers, etc.). The important thing to note here is

the fact that, used wisely, the CI environment can provide a snapshot of all project outputs at any given point in time (Figure 3). Hopefully it is becoming clear that this gives us the possibility of automated DHF creation. Not only that, but we have a much more detailed DHF throughout the life of a project and not merely at a point in time in which a particular freeze was performed.

The DHF is much more than a loosely controlled folder with a number of documents shoved in. The DHF, when properly defined, is now all of the history that goes into the design and development of the software product, and the continuous integration environment is the glue that holds it together.

Matthew T. Rupert. [www.matthewrupert.net].

Jenkins CI. [www.jenkins-ci.org].

April 2012 MEDS Magazine

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Increasing Medical Device Security with Mainstream IT Platforms and Technologies A layered security approach improves protection and eases the burden on Healthcare IT.

by Michael Taborn, Intel and Santhosh Nair, Wind River

M

edical devices, such as infusion pumps, patient monitors and MRI scanners, can be just as susceptible to malware as standard computers. Keeping them secure in any networked environment is certainly challenging, and the stakes are particularly high for these particular applications since they can affect patient care and outcomes.

Proving this point, McAfee and a medical equipment manufacturer recently raised awareness of security holes with potentially life or death consequences; they identified a networked insulin pump with a security flaw, which allows the device to be hacked and subsequently administer a potentially lethal amount of insulin to diabetes patients. Although not typically the target of cyber-attacks, medical equipment can become “collateral damage” in a malware outbreak, or even be the weak link that opens the door to a cyber-attack.

As the complexity of the network increases, securing devices becomes more

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MEDS Magazine April 2012

complex for both the manufacturers and hospital IT organizations. However, this complexity is reduced significantly when medical devices are designed for security using models similar to typical networked clients. This synergy enables hospital IT personnel to apply consistent security strategies across the network, making it easier to administer and monitor equipment. Moreover, as new technologies and methods roll out to thwart attacks, they can be implemented in a similar fashion across the network.

There isn’t a single security solution capable of addressing all future risks; instead, most would agree it’s necessary to implement a series of different defenses across the system. This can be done using properly implemented layered security that enforces security policy from the CPU to the application software, as outlined here and demonstrated by the Intel Medical Security Reference Platform. In the best case, devices will be fully protected; and in the worst case, malware is detected faster, allowing counteractive action to be taken before any harm is done.

Device Security Challenges Today One of the challenges facing hospital IT organizations is the large variety of hardware and software systems they must manage and secure. Further complicating matters, many equipment manufacturers develop unique security solutions, often as the result of designing purposebuilt solutions based on non-standard or proprietary components. Consequently, it can be difficult to determine whether they comply with the security policies of the purchasing hospital and if they will be maintainable for the expected life of the devices.

Devices based on non-standard platforms may present other drawbacks, including the need to send them to the manufacturer for upgrades, security or otherwise, making them unavailable for a period of time. Additionally, it may be more difficult to capitalize on the latest advancements developed to secure IT infrastructure built with standards-based computing technology. For instance, hardware-assisted virtualization offers security benefits by providing an additional layer of security protection that complements software-only solutions.

It can also be challenging for organizations to reach consensus on security

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policy due to conflicting viewpoints and goals of key stakeholders. As an example, security officers tend to advocate locking down systems to better protect the network, while IT managers gravitate toward opening up the network to deliver the best end user experience. A mutually acceptable course may be found with a layered security model implemented on standards-based platforms, which will improve device security and lower hospital IT support requirements.

Like other devices on the network, once compromised, medical devices could be the vehicle for launching all sorts of attacks. They can be used to harm patients, access patient records, initiate network attacks—like denial of service (DoS)—or spread malware to other systems on the network. To stop such actions, it is necessary to prevent hackers and malware from breaching the platform. While the basic principle behind securing a platform is conceptually easy to understand, it is far more difficult to realize in practice.

The guiding principle is to protect the system by ensuring that any malware that somehow infiltrated a system cannot execute; if malware is present on the system, it cannot be allowed to embed itself in system memory. In reality, however, the most problematic malware finds a way to load itself into memory and obscure its presence; consequently, the platform’s security mechanisms are unable to discover it and take appropriate action.

Layered Security Model Although there are no ironclad solutions, a layered security approach, with safeguards deployed throughout the platform, goes a long way toward providing robust protection against the vast majority of attacks. The basic premise is that by creating multiple barriers, a device has more opportunities to discover the malware before it causes harm, which forces hackers to write more sophisticated mal-

McAfee Device Control

Graphical User Interface

Interrogate incoming packets Prevent untrusted code execution

WindRiver or McAfee firewall

McAfee Embedded Control

Protect data and communications

Wind River Linux Secure

Stop unauthorized data copying

Wind River VxWorks

Microsoft Windows 7

Services Software

OSs

Reduce attack surface Wind River Hypervisor (thin)

Prevent unintended interactions between applications Prevent device performance degradation during an attack

Intel Processor with Multicore & Virtualization Technology

Virtualization Software Hardware

Figure 1 Device platform with layered security.

ware in order to circumvent all the lines of defense. Additionally, a well-designed layered defense helps contain malware, thus increasing the possibility that a device can continue to perform safety-critical tasks even when attacked.

Using a layered security model, Intel, Wind River and McAfee developed a secure platform for medical devices, demonstrated by the Intel Medical Security Reference Platform. This proofof-concept incorporates eight security safeguards spanning multiple layers: hardware, virtualization, operating system and services software, as shown in Figure 1. The platform is designed with off-the-shelf components, and it applies security policy consistent with standard IT practices.

Eight Safeguards for Protecting Medical Devices In healthcare, networked medical devices can fall victim to all types of perpetrators using a wide variety of methods. This section explores potential vulnerabilities and suggests safeguards, implemented across the platform, that either prevent attacks or minimize their impact until corrective action is taken.

Objective 1: Stop unauthorized data copying Data is the life blood of the connected hospital, and it has to flow freely to add value. But how accessible can sensitive data be, and can it really be protected in a world of outsourcing, portable storage devices, Facebook and Twitter?

Objective 2: Prevent untrusted code execution Medical devices, unlike tablets and laptops used by hospital staff, typically run a predetermined set of applications that are carefully controlled by the manufacturer. Two approaches for ensuring only the trusted applications can execute are called blacklisting and whitelisting.

PC users are familiar with blacklisting from running anti-virus software that searches for bad software and neutralizes it. Whitelisting is a “lighter” approach and is well-suited for embedded devices running only known, trusted software; the permitted code is enumerated, and any application or file not on the list is prevented from executing.

Objective 3: Interrogate incoming packets Viruses often gain access to medical devices through the network. This common method of attack can be curtailed by locking down access so only legitimate April 2012 MEDS Magazine

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Objective 4: Protect data and communications Once compromised, a medical device can become a base from which a hacker launches attacks on other devices and systems on the hospital network.

Objective 5: Prevent unintended interactions between applications A hacker can infiltrate one application with the intention of using it to gain access to another application’s data. After malware embeds itself in system memory, it will look for software applications and files to exploit by accessing their memory space. To reduce the harm malware can cause, restrict the number of software elements it has access to, thus greatly limiting a virus’ ability to move around. This can be achieved using virtualization technology to run applications in their own secured partitions.

Objective 6: Prevent device performance degradation due to poorly functioning code Wreaking as much havoc as a virus, a badly coded application or an inadequately tested patch can consume copious amounts of computing resources, and ultimately have the same effect as a DoS attack. Left to run on unchecked, poorly functioning code can take precious CPU cycles and memory away from a medical device’s safety-critical applications, whose performance may degrade to the point of putting the patient at risk.

Objective 7: Reduce attack surface Viruses frequently enter devices via network ports, so controlling this exposure can minimize security vulnerabilities.

Objective 8: Harden device against unexpected failures The software complexity of modern medical devices makes it nearly impossible to exhaustively test for all the possible ways in which a system can be compromised. Negative testing, using techniques such as Fuzz testing, can alleviate some of this risk.

As of today, no single security solution offers 100 percent protection. Liv-

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ing with this reality everyday, hospital IT organizations must sort through countless solutions and support a large number of them. The complexity is multiplied by purpose-built medical devices incorporating unique and sometimes obscure solutions, which increases support effort.

Security cannot be bolted on as an afterthought at the end of the development cycle. Addressing security concerns must be part of the design process—from an analysis of all attack vectors that might be used by a hacker, through the selection of secure building blocks, to thorough security-focused testing—which is made an integral part of the medical device release checklist.

Moving forward, medical devices using standards-based platforms based on IT infrastructure can greatly simplify security management while offering state-of-the-art security protection.

Another important criterion for security architecture is its effectiveness over the typical lifespan of devices—typically 10-15 years; such resiliency is enhanced by the Intel, Wind River and McAfee layered security approach outlined in this article.

Intel Santa Clara, CA. (408) 765-8080. [www.intel.com].

Wind River Alameda, CA. (510) 748-4100. [www.windriver.com].

Improved Medical Device Security with Proven Building Blocks As more medical devices become connected, the potential for security risks increases dramatically. Leveraging Intel’s proven building blocks provides a solid foundation for a secure yet manageable medical device for the next generation healthcare environment.

Learn more at intel.com/go/medical

Copyright

Š 2012 Intel Corporation. All rights reserved. Intel and the Intel logo are trademarks of Intel Corporation in the United States and/or other countries.

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Overview of the Medical Semiconductor Market and Applications The huge advances in medical devices, especially the new mobile and connected devices, are being driven by the latest developments in semiconductors. These include large scale integration and reduced power consumption, but also semiconductor devices specifically targeted at medical applications.

by John Koon, MEDS

T

Factors Driving the Growth The driving force for the growth comes from the need to reduce healthcare costs, provide greater accessibility to healthcare services, and a desire for greater convenience.

• The healthcare industry is trying to keep healthcare costs from getting to-

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tally out of control. Healthcare costs are predicted to double the current $2.5 trillion in the next few years. This is not a sustainable model. $12,000 $10,000 $8,000 MU

he medical electronics market is heating up. According to Databeans, a market research firm that tracks semiconductor shipments in the medical market, total market revenue will grow from $6 billion to $10 billion by 2016, with unit shipment increasing from 6 billion to 10 billion units in the same time period (Figures 1 and 2). This reflects the demand for medical electronic devices using medical semiconductors. For the most part, the growth will be in FDA Class 2, and to a lesser extent, Class 3 products. Class 2 products are bench-top, portable and wearable devices that are not invasive, while Class 3 devices are implantable units such as defibrillators.

• Better accessibility to services is much needed by people in both industrial and developing countries. Technology can help solve “the distance problem” and make healthcare services available to more people, as well as assist with overall disease management to achieve better health for underserved populations.

The idea is simple—fewer doctors can serve more people with higher efficiency using medical devices that connect patients remotely to the caretakers.

• The idea of living better and more independently while staying in one’s own home (including homecare) is being promoted by many organizations including

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Figure 1 Worldwide Medical Semiconductor Shipment Forecast.

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Applications Continua has outlined how various devices would connect to Telehealth services (caretakers). A variety of devices are already available to monitor the condition of a person who wants to stay healthy and live independently. They include digital thermometers, pulse oximeters, pulse/blood pressure monitors, weight scales, glucose meters, cardio exercise machines, electrocardiogram devices and insulin pumps. Additionally, there are medical devices used in clinical applications such as ultrasound and scanning devices, digital stethoscopes, MRI and digital X-ray.

How have semiconductors shaped the design landscape? Over the years, the features of lower power combined with more functions, including the front-end input/output (I/O) into a single chip, have made medical devices more portable. See photos of portable ECG device (Figures 4) from Philips Healthcare and portable ultrasound scanners (Figure 5) from GE Healthcare. Homecare devices, such as blood pressure monitors and glucose meters, are frequently battery operated. Overall they are more compact and convenient to use.

Wireless technologies are becoming more and more commonplace with many new medical devices starting to integrate wireless features into the application. The Omnipod insulin pump developed by Insulet consists of two units: a pump worn by the patient with built-in wireless capability, and a handheld controller with built-in glucose meter. The user

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the Continua Alliance, a leading organization that released a specification on endto-end connectivity and interoperability (Figure 3) in health delivery systems.

Additionally, the Alliance has developed a certification program to help medical devices comply with the specification.

While treating patients using various medical devices is a big market, another growing area of opportunity is fitness and preventative health. This includes exercise gear and personal health monitoring gadgets. This market is aimed at consumers who want to stay fit, and the expected volume for devices is large.

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Figure 2 Worldwide Medical Semiconductor Market Forecast.

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Personal Device

Interfaces & Standards

Thermometer Pulse Oximeter

Telehealth Service Center

Pulse/Blood Pressure

Aggregation Manager

Weight Scale

Health Records

Glucose Meter Cardio/Strength Independent Living Activity Peak Flow Medication Adherence Physical Activity Electrocardiogram

Personal Area Network (PAN) Interface

Wide Area Network (WAN) Interface

Health Record Network (HRN) Interface

EHR PHR

Insulin Pump

Figure 3 Continua’s vision of personal medical devices.

can control the delivery of insulin wirelessly.

Omnipod provides great convenience to the user as it can be worn 24 hours a day and is especially desired by people with active life styles, including many athletes. To accomplish this, Insulet has used a microcontroller and wireless chip from Freescale, as shown in Figure 6.

With the advancement of semiconductor technology, there are plenty of solutions available from many suppliers for medical device designers to choose from. What should a designer expect from a semiconductor supplier?

Better support. Let us illustrate this with a thermometer design. Texas Instruments ofApril 2012 MEDS Magazine

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Figure 6 Insulet Omnipod insulin pump with wireless control.

Figure 4 Portable Pagewriter TC70 Cardiograph ECG Device from Philips Healthcare.

Figure 7 Texas Instruments thermometer (front and back): Complete reference design of single-chip digital thermometer from TI.

Figure 5 Portable

Vscan Ultrasound Device from GE Healthcare.

fers a single chip solution that includes a lowpower, single-chip AF4110 microcontroller with built-in LCD driver (Figure 7). It comes with a reference design circuit schematic, printed circuit board (PCB) layout and the bill of materials (BOM). The designer only needs to follow the design and make some custom adjustments to deliver a complete digital thermometer with an accuracy of +/0.1 degree centigrade and a reading range of 31 to 43 degree centigrade.

Overall, semiconductor suppliers have done a good job in integrating the front-end

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analog-to-digital (A/D) functions in a single piece of silicon. (For a detailed list of product offerings from various semiconductor suppliers, go to www.medsmag.com/sbb). Leading suppliers offer different solutions. Texas Instruments, Freescale and STMicro have the broadest portfolio including digital thermometers, weight scales, ECG/EKD/EEG electrocardiograms, glucose meters, insulin pump, pulse oximeters, blood pressure monitors and ultrasound/scanning devices. Separately, ADI and STMicro offer a MEMS motion detect solution for fall-detection and prevention devices. The innovation of ECG development is moving from portable to wearable.

This solution will directly reduce healthcare costs. By wearing an ECG device, a patient with a heart problem can be monitored remotely by the caretaker without being in the hospital. STMicro’s battery-powered ECG semiconductor will be a good fit. More and

more devices are connected to other devices/ controllers remotely using emerging wireless standards such as ANT+, Bluetooth, ZigBee and near field communication (NFC).

Companies like Renesas, TI and Freescale all offer products in these areas under the umbrella of Mobile Health (commonly known as mHealth), or Wireless Health.

Another important segment in medical electronic device design is that of sensors.

Most people know wide area network (WAN) or local area network (LAN). Now a new term called BAN is emerging. It is the body area network in which the body acts as a network to connect to a medical device. It works by having a sensor connected to the human body and communicating electronic signals to the receiving device much like electrodes are connected to a human body. The sensor can be a passive device (does not require power) or an active device (requires power). A new innova-

PULSE tion from STMicro can energize an active sensor without using a battery. The M24LR16ER product is based on RFID technology, which receives power from a remote controller sending RF signals to the sensor.

While all the companies above focus on many homecare devices, Intel is taking a different approach by offering point-of-care stations and hospital bedside entertainment systems based on the Atom processor. These are embedded devices with new applications.

Another vision Intel has is to enable developers to build high-end fitness machines where a PC-like display is mounted on a treadmill that would communicate with sensors or devices worn by the users. This provides feedback to the users while they are running on the machine. Additionally, the high-end graphics display can provide personal entertainment making exercising more fun.

scales for well under $50,” according to Chris Griffith, Medical Business Development Manager of Texas Instruments. “And further integration of more functions on a single chip is expected in the future.”

“There will be integration of wireless, configurable analog and embedded processing power on-chip enabling designers more flexibility in design,” commented Steve Dean, Global Healthcare Segment Lead of Freescale.

Expect to see device developers con-

tinue to race to bring new products to market putting more functions into more compact designs. The demand for medical electronic devices will continue to be strong not only in the U.S. but in many other regions such as Asia and Europe. The ongoing challenges will be designing products that are easy to use by non-technical users, and that these devices will be able to connect to each other and share data securely and reliably with ease. This is easier said than done.

Design Choice So among all these semiconductor suppliers, is there a clear winner? Choosing a chip to design a medical device is a complex process. According to design consulting firms Sterling Smartware and LogicPD, who specialize in medical product design, features and power requirements are the key factors in selecting semiconductors for medical devices. Additionally, life cycle management and supply chain management are important, as medical products do not change as fast as consumer products and require longterm vendor support. BCS Innovations, another design consulting company with offices in the U.S. and Australia, further suggested that the design cycle should cover component selection, design process and production support (with ISO 13485 certification) to be able to yield high-quality medical devices. “As users demand portability and more compact design, component counts and production processes such as package-on-package should be part of the design process,” suggested David Bull, CEO of BCS Innovations. (Package-on-package is a manufacturing process in which two chips are stacked together like a high-rise building to reduce space.)

Semiconductors have enabled medical electronic device reductions in size, cost and power consumption while boasting significant increases in overall performance. “Thanks to the semiconductor development, consumers can now buy pulse oximeters, blood pressure meters, blood glucose meters and bathroom Untitled-5 1

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