MEDS #2 by RTC Media

MEDS MEDICAL ELECTRONIC DEVICE SOLUTIONS

Software Connectivity Team Patients with Their Doctors AND

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Software and ConneCtivity: two Holy GrailS

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Small moduleS at tHe Heart of Powerful Portable deviCeS

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toolS HelP build Safe and Certified Software

An RTC Group Publication

A Supplement to RTC Magazine

MEDS 路 August 2010 路 1

MEDS MEDICAL ELECTRONIC DEVICE SOLUTIONS

contents

May 2011

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 20,000 engineers, and electronically to 17,000 in the embedded computing market.Learn more about MEDS at

www.medsmag.com

UP FRONT

Editorial

Software and Connectivity: Two Holy Grails Tom Williams

FOCUS

6 NEWS

Newest Medical Electronic Technology Used by Industry Leaders

PRODUCTS

A Collection of What’s New, What’s Now and What’s Next in Medical Electronic Devices

Advantech

Axiomtek

Emerson

EMI

Innovative Integration

Microsoft Windows Embedded

Portwell

Real-Time & Embedded

Harnessing the Power of Mobility for Healthcare: Why We Need a “Medical Grade Wireless Utility”

Easing the IEC 62304 Compliance Journey for Developers to Certify Medical Devices Anil Kumar, LDRA

Developing Safe and Effective Medical Device Software

Steffan Benamou, Stryker Endoscopy and Jim McElroy, Green Hills Software

Medical Design Innovations Reflect the Need for High Performance, Portable Devices

Green Hills

Ed Cantwell, West Wireless Health Institute

Sponsors

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Christine Van De Graaf, Kontron

Computing Conference TDI Power

WDL Systems

Cover Photo: Infusion Development’s application allows a physician and patient to collaborate over digital health records, radiology images, prescriptions and other health records. Graphical images of the human body and videos help a physician explain and diagnose.

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2 · MEDS · August 2010

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MEDS

May 2011

MEDICAL ELECTRONIC DEVICE SOLUTIONS

PRESIDENT John Reardon, johnr@rtcgroup.com PUBLISHER John Koon, johnk@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.

4 路 MEDS 路 May 2011

UP FRONT

Software and Connectivity: Two Holy Grails

dvances in processor technology, in graphics processing and display, highly reliable and standardized networking electronics have given us platforms with the intelligence, low power consumption, small size and attractive pricing that will allow the development of a vast array of medical devices. The hardware component is in place in terms of sensors, processors, power supplies and displays for OEMs to assemble systems that would put Dr. Leonard McCoy to shame. What is not yet fully in place is the ability to clearly and reliably implement the functionality— otherwise known as software—and a fully reliable and ubiquitous network infrastructure with the necessary bandwidth to deliver the promise of all the devices that are coming out of the creativity of developers. Advances and enhancements to a given device’s software content can significantly change and improve its functionality and value, often with no changes to the underlying hardware. Connectivity bestows two major benefits. The first is increased patient independence and mobility along with constant monitoring of selected conditions that allows instant alerting of medical personnel without a scheduled office visit. The second is the aggregation of data from different devices or the combination of inputs to a central clinical decision center where specialists and more advanced diagnostic analysis can quickly be applied to the data. The problem with software is that it is difficult to test fully and exhaustively. Nonetheless, we have extremely reliable software in the aerospace arena thanks to standards such as DO 178B. Now, in addition to software testing, there is a growing trend toward static analysis—initiating a sometimes rancorous debate among proponents and opponents of both approaches. Standards such as IEC 62304 require extensive documentation of traceability and of the development process as a prerequisite to certification. This is especially important in view of the need to reuse previously developed code that may not have originally been subjected to such requirements. Universal connectivity for medical devices is a combined hardware/software challenge. There needs to be an eradication of “dead zones,” first within buildings such as hospitals and medical facilities, but eventually overall, which is a prime objective of such organizations as West Wireless. Given a reliable wireless infrastructure, there is then the need for standards for protocols that will make the vast number of wireless devices interoperable and give them the ability to seamlessly exchange data safely and reliably. This is the mission of the Continua Health Alliance, which now counts more than 230 member companies. Certifiably reliable software on reliable hardware with the ability to seamlessly communicate and interact and to do so at a level at which a non-technical patient can intuitively participate, represents a shelf full of Holy Grails. But these are prizes well worth the quest.

Tom Williams Editorial Director / Editor in Chief

MEDS · May 2011 · 5

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News and Products: A Collection of What´s New, What´s Now and What´s Next STMicroelectronics, LifeNexus Team for iChip on the Personal Health Card

TMicroelectronics and LifeNexus, the developer of the iChip and Personal Health Card, have announced that STMicroelectronics will produce the iChip microprocessor for the LifeNexus Personal Health Card. The Personal Health Card is the first multipurpose electronic health card utilizing the embedded iChip for securely maintaining an individual’s personal health record, with a payment card option on the same card. The LifeNexus Personal Health Card was designed specifically to secure and maintain an individual’s Personal Health Record (PHR) on a card in their wallet. The patented iChip, “Individually Controlled Health Information Platform,” utilizes “mobile server” technology embedded on a chip card, which is both encrypted and password-protected, providing a highly secure environment to store comprehensive health information for individuals and their family members. Christopher Maus, CEO of LifeNexus said, “For years, consumers have trusted the cards in their wallet to transact personal finances. Now these same cards can maintain their health records, providing physicians vital and potentially life-saving information from a computer chip on your card.” “When consumers are in control of their personal health records, the exchange of health information becomes considerably more convenient and secure. An optional traditional payment card feature is available, giving individuals extraordinary flexibility,” said Christopher Maus. Consumers ensure privacy between themselves and their healthcare provider through consumer-authorized access. An individual’s information stays in their wallet, not on a webbased server. This eliminates consumer concerns about storing sensitive data on an unrelated third-party web server, while also supporting the adoption of electronic medical records by their health care providers.

350 Watt Medical Safety Approved Switching Power Supplies The Cincon CFM351M Series of 350 watt switching power supplies from PowerGate comes in a 6.50 x 4.00 x 1.51'' open-frame package featuring active PFC and medical safety approvals. The CFM351M series consists of four models with main output voltages ranging of 5 / 12 / 24 / 48 VDC and auxiliary outputs of 5 VSb @ 300 mA and 12V Fan @ 300 mA. All models features remote on/off control; remote sense; universal AC input (90-264 VAC); high efficiency operation 89-93%; active power factor correction; full load operation up to 50°C with 10 cfm airflow; up to 300 watts convection-cooled operation; and reliability in excess of 100k hours. The series has been qualified for Class B Emissions and is safety approved to UL/cUL 60601-1, EN60601-1 standards and bears the CE Mark. Evaluation quantities are available now with manufacturing lead times of 8 weeks. The 500 piece price is as low as $119 for the 24V/48V versions and $139 for the 5V/12V versions. PowerGate, Santa Clara, CA. (866) 588-1750. [www.powergatellc.com].

6 · MEDS · May 2011

Continua Health Alliance Elects Qualcomm Executive to Board President

ontinua Health Alliance, the global non-profit, open industry alliance of more than 230 leading healthcare and technology organizations, has announced that it has elected Qualcomm’s Senior Director of Market Development, Clint McClellan, to President and Chair of Continua’s Board of Directors. McClellan has represented Qualcomm on the board since 2009. Healthcare professionals, researchers, world-class companies, entrepreneurs, policy makers, health ministries and other stakeholders came together during a recent Continua-hosted symposium for an in-depth look at a variety of personal connected health solutions and how the these will fit into Europe’s current and future model of healthcare. “Our symposium kicks off the new year with a focus on how the design, adoption and use of personal connected health solutions will impact chronic condition management, living independently, and health and wellness,” said Chuck Parker, executive director, Continua Health Alliance. “We are excited to welcome Clint as board president as we continue our focus on creating and implementing solutions that lower healthcare costs and improve outcomes as well as looking at new use cases in both the traditional and mobile health spaces. Qualcomm has tremendous expertise in the mobile personal connected health technology industry, and Clint has been a vital part of the Continua board.” Continua’s Board of Directors works together to ensure that Continua achieves its mission to develop a global system of interoperable personal connected health solutions that foster independence and empower individuals and organizations to better manage health and wellness.

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News and Products: A Collection of What´s New, What´s Now and What´s Next Next-Generation Wireless, Digital X-Ray Detector Runs on UWB With growing demands on healthcare, cost pressures are increasing around the world. At the same time, dosage scrutiny has increased among governments and consumers. In short, you need to do more with the equipment you have—now and in the future. A new wireless digital X-ray detector from GE Healthcare provides up to 8 percent more coverage for applications and enables high image quality at lower dose levels. Wireless devices are proliferating in the healthcare space, resulting in more Wi-Fi traffic. Digital images are large and must compete for the same space—forcing even more congestion. FlashPad is the first wireless detector to operate with Ultra-Wideband (UWB) connectivity. Rather than compete with other information on Wi-Fi networks, it communicates independently on a dedicated, high-priority 60 GHz band channel—so data is routed with speed and reliability. This enables operators to have confidence that real-time information is transmitted where it is needed and that they are operating within standard, FCC-authorized protocols. It also enables them to be equipped to handle large file sizes. With GE Healthcare’s commitment to the future of digital X-ray, FlashPad is designed specifically for its needs. Its square shape allows for easy maneuvering. Dual handles help avoid dropping and ease staff fatigue. A single-panel, non-tiled construction helps eliminate blind zones, while readout electronics enable advanced applications. With floater imager assembly and carbon graphite materials, its glass is protected, minimizing the risk of breakage and replacement. GE Healthcare, Chalfont St. Giles, UK. [www.gehealthcare.com].

Module Improves Security and Software Management of Hospital Digital Devices A proof-of-concept from Emerson Network Power, based upon the Intel Core i7 processor and Altiris Client Management Suite from Symantec, demonstrates how hospital IT professionals can secure and administer embedded medical devices centrally in the same way as PCs and servers. As healthcare providers digitize their medical records and integrate clinical systems and diagnostic data, opportunities are emerging to simultaneously reduce cost, redundancy, administrative burden and medical errors, all while increasing the quality of care. The drive toward the “Connected Hospital” concept spans patient administration, health monitoring and care, imaging and diagnostics, and records management. However, network vulnerabilities expose a hospital to the risk of breaching patient confidentiality, of impairing patient care due to non-availability of data, and of attack by cybercriminals. The new proof-of-concept has been implemented as both an automated medication dispensing system called MedDispense and a wireless mobile workstation—both from Metro, an Emerson company. The technology behind this proof-of-concept can easily be replicated in other connected hospital applications such as a medical delivery cart or a mobile diagnostic system. At its heart is the Matxm-Core-411-B from Emerson Network Power, a MicroATX format motherboard based on the Intel Core i7 processor. The system runs Altiris Client Management Suite from Symantec, a systems management solution that helps provision, manage and support clientbased systems. The proof-of-concept also demonstrates how the Symantec technology provides a familiar user interface for the Intel Active Management Technology (AMT) feature that the Intel Core i7 processor provides. This enables the IT administrator to remotely connect to, troubleshoot and restart a device on the network even if its operating system has crashed, its hard drive has failed, it is in Sleep mode, or software agents have malfunctioned. This feature only operates in client devices that contain an Intel processor with Intel AMT features enabled. Emerson Network Power, Tempe, AZ. (602) 438-57220. [www.emersonnetworkpower.com].

8 · MEDS · May 2011

Wireless Real-Time Patient Monitoring Connects to Central Decision Support

A new patient monitor expands the capabilities of a telemetry unit, offering parameters and functionality for vital signs spot checks, bedside monitoring and transport. The IntelliVue MP5T from Philips is rugged and reliable, and gives a clear view of all patient measurements with an 8.4” (21.3 cm) intuitive touch screen. Industry-standard measurements include ECG via the IntelliVue Telemetry System transceiver, non-invasive blood pressure, predictive temperature, SpO2, and the sinus tachycardia segment and arrhythmia monitoring (ST/AR) arrhythmia algorithm. Clinical decision support tools such as ST Map and Drug Calculator reveal more information when it counts most, enhancing clinician confidence. Additional advanced features include a redesigned user interface for improved visibility of patient data, greater ease of use and enhanced compatibility with standard software. The Dynamic Wave area features waves that automatically adjust in size depending on the number of waves configured. Each NBP measurement now generates a column in the vital signs trend table. Measurements for other values are added to provide a comprehensive vital signs data set for the NBP measurement time, offering a more complete picture. The Smart Alarm Delay algorithm helps reduce the number of pulse oximetry nuisance alarms, allowing the operator to focus attention where needed. The system automatically pairs measurements from the IntelliVue MP5T and telemetry transceiver and sends them wired or wirelessly to the IntelliVue Information Center where the real-time monitoring surveillance of a central station is paired with clinical decision support tools and the ease of touch screen operation. Philips Healthcare. Andover, MA. (800) 453-6860. [www.healthcare.philips.com].

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Harnessing the Power of Mobility for Healthcare: Why We Need a “Medical Grade Wireless Utility” A huge opportunity exists to lower health care costs by accelerating the availability of wireless medical solutions. In order to achieve this, a ubiquitous and reliable wireless infrastructure is needed—a utility that will build a framework for offering the right care, at the right time, wherever a patient may be. by Ed Cantwell, West Wireless Health Institute

ealth care has yet to harness the full power of the wireless revolution that has transformed other aspects of our lives, including the way we work and play. Yet wireless medical technology offers one of the greatest opportunities to materially lower health care costs and extend care to a patient regardless of physical or geographic location—“the right care, at the right time, wherever a person may be.” What will it take to get this obvious benefit from this ubiquitous technology? With the proliferation of wireless devices—both medical and consumer— in health care settings, it is critical for hospital administrators and all of those engaged in the health care enterprise to feel confident that using wireless technologies within patient environments is safe and reliable. However, unlike the wired network, wireless connectivity comes with added levels of complexity— coverage, signal strength and capacity concerns, among others—and impressions about performance and robustness have doubtlessly been seeded with individual experiences surrounding quality of service issues in consumer wireless devices.

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To address this complexity and the associated concerns, there is a pressing need to create a reference architecture where the numerous wireless standards and protocols can be deployed with a known level of assurance. Ultimately, what is required is a ubiquitous medical grade wireless utility for wireless health care delivery, specifically within hospitals and other medical facilities. What Do We Mean by “Medical Grade Wireless Utility”? First, let’s define the term medical grade wireless utility, keeping in mind four principles inherent in the term: coverage, signal strength, capacity and certainty. Within this context medical grade means a known level of assurance to support mission- and life-critical wireless medical devices and applications. A wireless sensor or downloadable “app” to help a marathon runner track his or her daily calorie expenditure does not require a medical grade utility to ensure proper function. Conversely, a known level of assurance may be required for a wireless medical device that is being relied upon to send an alert about a lifethreatening condition.

Wireless refers to telecommunications connectivity, typically via radio waves, and encompasses both licensed and unlicensed spectra for health care. The wireless network is considered an extension of the wired network, and when deployed fully and correctly, creates an end-to-end level of assurance via ubiquitous coverage, signal strength and capacity. Such capability allows for true mobility, which in our opinion has the potential to transform health care. Finally, in our definition, utility is any basic, expected resource. Just as electricity, plumbing, and heated and cooled air are necessities within a hospital, wireless connectivity is increasingly “expected” and must be deployed as a base-building utility with the same level of engineering and control. The number of wireless devices inside a hospital is growing exponentially, and a medical grade wireless utility (MGWU) is required to ensure these devices work with a known level of assurance. So, how do we get there? In response, the West Wireless Health Institute (WWHI) is working closely with ecosystem stakeholders to help create an MGWU that will be used as a platform for wireless health care delivery. Together, the vision is to establish the reference architecture for a reliable, utility-like resource that will address the four principles of assurance mentioned above: coverage, signal strength, capacity and certainty. In its role as an independent, non-

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802.XX Bluetooth — Zigbee — ANT Future Wireless Local & Personal Area Network Convergence WWAN & WLAN

Convergence WWAN & WLAN & WCDN

PCS & Cellular Paging Fire/Life/Safety 2 Way Radio

WMTS Wireless Wide Area Network

MGWU

Wireless Clinical Data Network

WMMS Future

Future

Location Outside & Inside Location Local Area Network

Passive & Active RFID Ultrasound — Ultra Wideband — 802.XX — Infrared Future

Figure 1:

Clockwise starting on the left, the “four pillars” of what will constitute a medical grade wireless utility.

profit medical research organization, WWHI is currently convening stakeholders including hospital CIOs, CTOs and CMOs, as well as wireless service, infrastructure, equipment, sensor and application providers. The initial focus will be to develop the reference architecture (the basic building blocks) for open and carrier-neutral infrastructure, as well as to create processes that will facilitate end-to-end interoperability and quality of service. In conjunction with these activities, WWHI will also proactively engage with regulatory organizations to define and stratify levels of assurance needed for wireless health applications that are considered to be medical grade. These activities will fully contemplate and embrace existing standards created by bodies such as Continua Health Alliance, IEEE, WiFi Alliance and others working diligently in this space.

Developing a Reference Architecture for the MGWU There are a number of “success factors” or best practices inherent in developing a reference architecture for the MGWU. First, it must closely align with other base-building utilities. It should not only incorporate current requirements, but also anticipate future requirements. It must be designed with the discipline needed to ensure such requirements are met. It must also include processes for proper installation, verification and validation. Lastly, policies should be established to ensure devices and applications work together without interference. Now consider the distinct “pillars” of the reference architecture (Figure 1). The first pillar is the Wireless Wide Area Network (WWAN). The WWAN will address most wireless services that are intended to work outside the premise—if

it works outside, it should work inside. This includes, but is not limited to, PCS & Cellular, First Responder, Paging and Two-Way Radio services. The MGWU reference architecture will ensure that each wireless service works inside the hospital to the performance standards agreed to between the service provider and the hospital user. The second pillar is the Wireless Local Area Network (WLAN), which includes the traditional 802.11 Wi-Fi network, Personal Area Networks and Body Area Networks. This pillar will proactively address the increasing use of the unlicensed spectrum for wireless health applications. Since this spectrum is available to all, there are quality problems that can occur related to capacity or interference. The MGWU reference architecture will specifically address how each of the WLAN-based networks should be used to ensure interoperability standards are being met, with a known level of assurance. The third pillar could be referred to as the Wireless Clinical Data Network. This is a new term meant to represent those wireless networks that are specifically designed to be a protected clinical data network. Today, this includes the protected spectra allocated to Wireless Medical Telemetry System (WMTS). In the future, the MGWU may include additional spectrum that will be used inside the premise for mission- and lifecritical clinical applications. Creating “protected” clinical networks will be an ongoing priority for the reference architecture. The fourth and final pillar is the Location Local Area Network (LLAN). This is also a new term that refers to the desire to use wireless to locate assets and people inside the hospital. Location is a critical part of the MGWU reference architecture. The LLAN will be a portfolio of technology and solutions to address the numerous location requirements. When deployed, the LLAN will be capable of producing location information, which will be made available without prejudice to those applications that need the data (Figure 2). When the four pillars of the reference architecture are in place, true conMEDS · May 2011 · 11

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Figure 2:

Within the hospital environment, the local network will need to accommodate a large number of mobile, stationary, wired and wireless devices as well as produce location information.

vergence can be achieved. This includes the convergence of the WWAN and the WLAN to ensure that voice, data and video applications work together on the most efficient wireless networks. When combined with the WCDN, devices and sensors can be developed to allow the patient to be continuously monitored inside and outside the hospital with a known level of assurance. Lastly, at such time as location data can be delivered when and where needed, the effectiveness of the wireless applications will dramatically increase. So, How Will This Task Be Achieved? As mentioned above, West Wireless Health Institute is convening a variety of ecosystem stakeholders to undertake this task. To start, WWHI is bringing together health care leaders such as CIOs who represent the “customer” and have extensive experience in establishing wireless connectivity within their facilities. This group will work with WWHI to create a reference architecture suitable for both new and existing venues. This reference architecture will be owned and self-governed by these healthcare champions over time. The next step is to proactively engage regulatory agencies and relevant standards bodies for mutual guidance, as we work to define the various levels of assurance needed for wireless health applications that are considered to be medical grade. Think of this stage as “rational risk stratification.” Once there is consensus from these groups, Wireless Service Providers (WSPs) will be engaged to ensure that the MGWU reference architecture meets the technical and economic requireUntitled-1 1

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ments for both licensed and unlicensed providers. WSPs are critical to the future of wireless health because of their ability to create a ubiquitous platform both inside and outside the premise of health care facilities. The overall quality of the MGWU will be heavily influenced by Wireless Equipment Providers (WEPs), and stakeholders will work closely with WEPs to ensure the desired outcomes can be achieved and maintained over time. As noted above, it will be vital to develop a reference architecture that meets requirements today and into the future. Concurrently, wireless medical device manufacturers will be engaged, to ensure their devices operate according to the requirements and standards set forth by the reference architecture. Methods to both validate and verify performance under that architecture must be established. The Mandate before Us Although it is hard for most of us to imagine, consider what the United States was like before there was a national highway system or an electrical grid. Once these systems took root, inventors and entrepreneurs unleashed a wave of innovation—from automobile manufacturing to refrigeration and a host of conveniences we take for granted today. Innovation soared, as did our nation’s productivity. Similarly, in the last decade, our wireless communications networks have made it possible for us to live and conduct business in whole new ways. Mass adoption of cell phones and smart phones is leading to another wave of extraordinary innovation—which is just beginning to take shape for health care. The ability to provide “the right care, at the right time, wherever a patient lives” is within reach. Wireless sensors are being integrated into medical devices, with the capability to remotely measure and monitor a host of physiological parameters—including heart rate, blood pressure, respiratory rate, weight, temperature, oxygen saturation, activity, sleep quality, blood electrolytes, fetal heart rate, uterine contractions, and a wide and growing array of biomarkers.

But how is all of this data going to travel and flow with a known level of assurance, particularly within hospital and health care settings where some usecases may not tolerate interruption? Making wireless connectivity a medical grade utility in those venues is a critical step in removing barriers that are inhibiting the development and adoption of wireless medical devices—and to making their deployment inexpensive

and ubiquitous. Once in place like the electrical utility, wireless health will be a profound and low-cost solution for delivering care within hospitals and health care settings. West Wireless Health Institute San Diego, CA. [www.westwirelesshealth.org].

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MEDS · May 2011 · 13 4/6/11 8:53:31 AM

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Easing the IEC 62304 Compliance Journey for Developers to Certify Medical Devices By adopting the quality software processes of IEC 62304, companies are better able to develop a safe product, avoid expensive recalls, and ensure that the same development process underpins the maintenance and upgrade process. by Anil Kumar, LDRA

he use of sophisticated medical devices now more than ever helps medical practitioners diagnose with ease and accuracy. Their level of dependency on devices, however, has raised concerns about ensuring the safety and quality of the devices. Notably, medical devices rely heavily on third-party and legacy software, often referred to as software of unknown pedigree (SOUP). This SOUP forms the basis of new developments, which may now be subject to new medical device requirements or modern coding standards imposed by government, client demands or simply a policy of continuous improvement within the developer organization. The need to leverage the value of SOUP, while meeting new standards and further developing functionality, presents its own set of unique challenges. An analysis of 3140 medical device recalls conducted between 1992 and 1998 by the FDA reveals that 242 of them (7.7%) are attributable to software failures. Of the software recalls, 192 (or 79%) were caused by software defects introduced after software upgrades. The high percentage of errors introduced during product upgrade has caused government agencies for medical devices to focus not only on development, but

14 · MEDS · May 2011

also on subsequent maintenance and the impact of software change on the existing system. Because of this, many companies are changing their approach to improve their software processes as well as to adopt IEC 62304, a standard for design of medical products recently endorsed by the European Union and the United States. IEC 62304 introduces a riskbased compliance structure that ensures that medical applications comply with the standards suitable for their risk assessment. This compliance structure is classified into Class A through C where the failure of Class C software could result in death or serious injury. IEC 62304 Software Development Lifecycle IEC 62304 focuses on the software development process, defining the majority of the software development and verification activities. This process includes activities like software development planning, requirement analysis, architectural design, software design, unit implementation and verification, software integration and integration testing, system testing and finally software release. This standard not only outlines requirements for each stage of the development lifecycle, but also takes care of

the maintenance process, the impact of software change to the existing system, and the risk involved in implementing the software change. IEC 62304 also deals in detail with the effect of the SOUP items right from planning, requirement analysis, architectural design, maintenance and risk management phases. IEC 62304 & SOUP SOUP software that can be reused in the development of new devices has become prevalent since medical devices now tend to be built on generalpurpose embedded hardware, along with an operating system, device drivers for USB, Ethernet, or graphics, file systems, network stacks, etc. The use of SOUP in medical devices has its advantage in that the manufacturer can concentrate on the application software. However, since the applications need to run device-specific functions, SOUP in medical devices adds challenges. Most SOUP modules are provided by third-party vendors, who don’t follow any software process, software standards or even document the code. And while it addresses platform challenges, SOUP is developed under stringent time schedules where the emphasis is on productivity, not standards compliance. When subjected to system tests that check functionality, SOUP projects typically show very poor code coverage, leaving many code paths unexercised. The blue curve in Figure 1 represents functionally tested code. When that code is deployed, the different data and

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DATA Functional Test In service - initial application In service - enhanced application

Figure 1: Traditional functional testing can leave many parts of the code unproven. The blue line shows the parts of code exercised with traditional testing for correct functionality; the red dotted line demonstrates the parts of code that are used when the application runs in the field; the green dotted line demonstrates the code enhancements that are prone to call into service combinations of data previously unencountered, resulting in the possibility of tapping into those previously unexercised paths.

circumstances are likely to use many untested paths for the first time, potentially creating unexpected results. The red dotted curve in Figure 1 illustrates the part of the code used when the application is run in the field. The European System and Software Initiative “Performance of Errors through experience-driven Test” (PET) investigated this phenomenon and agreed that deployed code often possesses many errors. PET aimed to reduce the number of bugs reported after release by 50% and to reduce the hours of test effort per bug found by 40%. Interestingly, PET exceeded this, achieving 75% fewer reported bugs and 46% improvement in test efficiency. PET’s findings demonstrated that the number of bugs that can be found by newer methods of testing, such as static and dynamic analysis, is large, even if that code has been through functional system testing and subsequently been released. The SOUP previously subjected to functional test is then deployed for further tests. Even if it worked well, some part of the code may not be exercised, even when the product is in the field.

When SOUP code needs ongoing development for later revisions or new applications, previously unexercised code paths are likely to be called into use by combinations of data that had never previously been encountered, potentially creating unexpected results. The green dotted curve in Figure 1 illustrates the part of the code used when enhancements are made to SOUP code. To counteract this potential weakness, a detailed structural coverage analysis needs to be done to ensure that there is no unexercised code in the legacy software. IEC 62304 mandates functional coverage and structural coverage of the legacy software along with a detailed analysis of the risk that could be introduced by the addition of such software. Functional coverage ensures that the software functions according to the system design requirements, while structural coverage ensures that all code sections are exercised and shown to work properly. IEC 62304 requires that all SOUP items to be incorporated in the medical device design be identified along with the specification of their functional and

performance requirements. The medical device manufacturer needs to ensure proper operation of any SOUP items and that they meet the functional and performance requirements. The IEC 62304 software development process begins with software development planning, which includes a detailed plan on the SOUP items to be used. These details define how SOUP items are to be integrated within the existing system, how to manage the risk associated with the SOUP, and how software configuration and change management affect the system. This is followed by software requirement management, architecture design, integration testing, system testing, risk management, maintenance and change management phase. At each phase of the software development lifecycle there is a need to maintain the traceability between all phases. The traditional view of software development shows each phase flowing into the next, perhaps with feedback to earlier phases, and a surrounding framework of configuration management and process. Traceability is assumed to be part of the relationships between the phases. However, the mechanism by which trace links are recorded is seldom stated. In reality, while each individual phase may be conducted efficiently thanks to investment in up-to-date tool technology, these tools seldom contribute automatically to any traceability between the phases. As a result, the links between them become increasingly poorly maintained over the duration of projects. The net result is absent or superficial cross checking between requirements and implementation and consequent inadequacies in the resulting system. To gain true automated traceability requires a Requirements Traceability Matrix (RTM). The RTM sits at the heart of every project and is a key deliverable within many development standards, including IEC 62304. Requirements Traceability and SOUP The Requirements Traceability Matrix— a widely accepted practice for managing MEDS · May 2011 · 15

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Figure 2: The requirements traceability matrix (RTM) plays a central role in a development lifecycle model even when SOUP items are part of the system. Artifacts at all stages are linked directly to the requirements matrix and changes within each phase automatically update the RTM.

and tracing requirements—plays a vital role in managing the software requirements as well as the SOUP items to be used in the system. RTM helps to establish traceability between the high-level requirements pertaining to SOUP with the architectural design of the medical device application (Figure 2). To ensure that SOUP can meet the system-level requirements outlined by IEC 62304, the medical device manufacturer needs to specify: • Functional and performance requirements for the SOUP item necessary for its intended use • Manufacturer specifications for the system hardware and software necessary to support the proper operation of the SOUP item • Details to verify that the medical device architecture supports proper operation of any SOUP items

16 · MEDS · May 2011

In most cases, the SOUP items are delivered as source code but without design documents, which makes it difficult to analyze them. Use of modern test tools helps in visualizing the legacy code design. The system visualization facilities provided by modern test tools are extremely powerful, whether applied to statement blocks, procedures (or classes), applications and/or system wide. The static call graph shown in Figure 3a depicts a hierarchical illustration of the application and system entities, and the static flow graph in Figure 3b shows the control flow across program blocks. The use of color-coded diagrams provides considerable benefit in understanding SOUP. Such call graphs and flow graphs are just part of the benefit of the comprehensive analysis of all parameters and data objects used in the code. Requirement management and traceability have already proven their advantage in the software development lifecycle to ensure that all requirements are implemented and that all development artifacts can be traced back to one or more requirements. Similarly, requirement management and traceability ensure that SOUP items are added and verified based on system requirements. RTM provides traceability between the architectural design and the SOUP items. Since these items are delivered in source code and are now required to fulfill system-level testing for compliance to IEC 62304, it becomes the manufacturer’s responsibility to verify the code. The sloppiness of most SOUP items adds stress to the requirement of rigorous verification and risk analysis for the system integrator. Because verifying SOUP is so time-consuming, developers typically address a subset of the coding standard initially, gradually adopting additional rules. While test tools only identify but do not correct the violation and latent errors present in the code, they do speed correction of code by pinpointing problem areas. IEC 62304 expects the medical device manufacturer to evaluate the software anomaly lists published by the supplier of the SOUP item to determine if any of the known anomalies could create

a sequence of events that could result in a hazardous situation. The static analysis capability of the test tools identifies the anomalies and their impact on the software system. If any additional anomalies that are not part of the list published by the supplier of SOUP are identified, they should be conveyed to the respective vendor to address the problem. After static analysis and correction of anomalies is complete, dynamic analysis, including system, integration and unit testing, is performed to verify the functional and structural coverage of the SOUP items. Although systemwide functional testing provides the functional overview of the SOUP items, it does not test all code paths. Test tools identify the exercised parts of the software highlighting the areas that require attention, and these areas are put through unit tests to ensure each unit functions correctly in isolation. Running functional tests and structural coverage analysis makes sure all code paths are exercised and the interfaces between multiple units are verified. It also helps to ensure the system functions per the design, even with the integration of the SOUP items. Notably, IEC 62304 requires that verification of the SOUP items follows the integration plan made during software planning, again indicating the elevated emphasis IEC 62304 places on ensuring upgrades to medical software do not introduce errors. RTM provides traceability between the various analyses performed on SOUP items against the test plan established earlier. This test plan contains test cases to be carried out and their expected results based on the system requirements. Using RTM, project managers can estimate the impact of SOUP items to be incorporated and how they affect the safety of the system. Maintenance of SOUP Items Many incidents in the medical device industry are related to service or maintenance of medical device systems including inappropriate software updates and upgrades. SOUP items also play a major role here since these items are delivered by different vendors and

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Figure 3: The static call graph (a) and flow graph (b) represent the structure and the logic of the code in graphical form.

need to be verified. In IEC 62304, the software maintenance process is considered as important as the software development process. This emphasis on maintenance aims at curbing the high percentage of medical device software defects introduced after product release, i.e., during software maintenance. The maintenance process requires that the manufacturer monitor the feedback of the released product from both within the organization and from the user. This feedback must be documented and analyzed to determine whether a problem exists. When a problem is found, a problem report is created and analyzed to determine whether SOUP items contributed to the problem. If SOUP is a problem, the issue has to be conveyed to the respective vendor to address the problem with upgrades or patches. IEC 62304 requires the manufacturer to establish procedures to evaluate and implement upgrades, bug fixes, patches and obsolescence of SOUP items. Each upgrade, bug fix and patch has to be analyzed and verified to determine whether additional potential causes are introduced by these upgrades contributing to a

hazardous situation. As always, it is necessary to determine whether additional software risk control measures are required. During maintenance, the manufacturer is required to analyze changes to the SOUP items to determine whether the software modification could interfere with the existing risk control measures. The manufacturer must establish a scheme for the unique identification of configuration items and their versions. For each SOUP configuration item used, the manufacturer needs to document the title, SOUP manufacturer name and unique SOUP designator. This identification identifies the software configuration items and the versions included in the medical device software. LDRA Wirral, UK. +44 0151 649 9300. [www.ldra.com].

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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.

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Developing Safe and Effective Medical Device Software Conforming to industry standards for software quality is essential to medical device development. The use of integrated development tools can greatly reduce development time and increase quality, safety and reliability. by Steffan Benamou, Stryker Endoscopy and Jim McElroy, Green Hills Software

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20 · MEDS · May 2011

cern for the safety of both the patient and device operator. To develop safe, reliable and secure devices, there are opposing forces of economy, i.e., time-to-market windows, competition, development costs, supplier costs, as well as regulatory

Syst em I

oday’s medical devices are growing exponentially in complexity as the market demands more feature-rich and costeffective solutions. The endoscopic medical device market is a perfect example of this global trend. As complexity increases, device manufacturers need the ability to reduce development time and release a safe and reliable product to the market, which is instrumental in gaining a competitive market advantage. Furthermore, experience demonstrates that if endoscopic surgery can be performed quicker, the patient is likely to recover faster and the surgeons and staff are able to perform more procedures in the same period of time. For device manufacturers, striving to achieve these higher-level goals, using the right software development tools for the construction, debugging and validation of critical software components in conjunction with a completely reliable and secure operating system (OS), is a necessity. For developers of Class II and Class III medical devices, the challenges in developing safe and effective devices in a timely fashion are wide ranging. At the heart of these challenges is the con-

compliance issues. To cope with these pressures, medical device software development organizations are transitioning from tools and procedures developed inhouse to industry-proven development tools, operating systems and industry standard software development practices. Until fairly recently (2009), most medical device software development organizations have relied on software development methodologies, tools and processes, or standards that may not be optimized for medical device software

Software Unit Verification

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Figure 1:

IEC62304 V-model approach requires traceability between system requirements and software implementation of a design.

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Separation Kernel Architecture Model.

development. However, now companies like Stryker Endoscopy leverage industry standards, such as IEC 62304, for software development and maintenance to develop safe and effective devices in the most expeditious manner possible without sacrificing product quality and more importantly, patient and operator safety. With IEC 62304, the software development organization can leverage an internationally recognized standard that provides a framework of life cycle processes, activities and tasks for the design and maintenance of medical device software (Figure 1). There are a few core elements contributing to the success of developing complex medical devices. First is the effective utilization of standards specifically tuned for medical device software development and mitigation of risk throughout the process. In addition, the proper selection of hardware and OS technology is fundamental to the success of the project as a whole. Knowing how critical this selection was, Stryker Endoscopy chose Green Hills Software’s Integrity real-time operating system (RTOS), an industry-proven OS technology, which Stryker Endoscopy believed would provide excellent safety and reliability. Above the operating system layer, the software applications are complex, so the development team also relies on the proven Multi software deve-

lopment tools from Green Hills to create, test and verify the applications to ensure patient safety. In addition to providing a solid framework for software development, which will ultimately lead to an abbreviated approval process, IEC 62304 implicitly enables a proper architectural software design by forcing the development team to “safety-classify” all software items. Software items are classified as ‘A’, ‘B’, or ‘C’ based on their potential hazardous effect on the patient or operator, with ‘C’ having the most detrimental potential effect, such as serious injury or death. Using these classifications, the development team can conceptually separate critical applications from non-critical applications. This conceptual separation can then be realized at run-time by leveraging the operating system’s separation kernel architecture to partition the various applications (Figure 2). As a result, the system is intrinsically safer and more reliable since a failure in one partition will be isolated and cannot affect an application running in another partition. Many developers have found this to be a significant safety and reliability improvement over using multi-tasking in a single address space. In addition, by leveraging separation, multiple applications can share the same processing resource, saving money on the overall bill of materials by

eliminating the need for separate physical hardware resources. For this architectural design, IEC 62304 helps break down the system into software units, better preparing the system for unit and system verification. It is important to note that the enabling OS technology also provides a very clean way for applications in separate address spaces to efficiently communicate with each other. This architecture maps very nicely to easily identify the interfaces between the software items to fulfill the requirements of IEC 62304. The chosen OS utilizes a true realtime scheduler that supports multiple priority levels. This allowed the team to use a rate monotonic algorithm to assign priorities to all the tasks to maximize the schedulability of the system and to ensure all critical time constraints were met. In addition, the team used the partitioning architecture of the OS to create a governing health monitoring application. Through the inter-address space communication platform provided by the OS, this application could easily communicate with all running applications to monitor the status of all critical and non-critical tasks in the system. This allowed the health monitor to continuously check for faults and put necessary critical tasks into safe states in the event of fault occurrences. Furthermore, the team used the partition separation to create an address space dedicated to handling communication to and from other Stryker Endoscopy devices in the operating room. Using a proprietary interface bus, Stryker Endoscopy products can communicate with each other to allow for seamless integration, data sharing and universal control from a centralized location. By implementing this as a partitioned address space, both the software and hardware become modularized and can easily be ported to any other device that utilizes the same OS in the future. Architecturally, although Stryker Endoscopy did not utilize this capability in the design of this specific device, the selected OS also supports virtualization, which enables various guest operating systems to run alongside the host operating system. With this capability Stryker could, in the future, utilize different operating systems for different levels of functional criticality. For example, Android could MEDS · May 2011 · 21

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Figure 3: The MULTI EventAnalyzer views operating system events over time to track down interactions that could cause undesirable behavior.

run in one virtual machine controlling the user interface, whereas the selected OS running in another virtual machine would be responsible for all safety- or securitycritical functionality. From the architectural design phase to detailed design and implementation, the integrated development environment (IDE) enabled the team to rapidly develop, test and iterate, as necessary, the applications, i.e. the software items that would be plugged into the appropriate OS partitions. Of tremendous value was the ARM target simulator, which enabled early validation of the design by giving the team the ability to test and debug long before the hardware platform was available, saving significant time and money. The software items that operate within a partition naturally become reusable software components that can be leveraged in future medical devices. Furthermore, for user interface testing and prototyping purposes, the IDE and the OS enabled the team to quickly “mock up” the user interface to the design to ensure correct interactive operation through easy integration to Swell Software’s PEG+ GUI software 22 · MEDS · May 2011

solution and PEG WindowBuilder screen designer. Usability is a key element to safe operation of the devices, and UI prototyping enabled the team to ensure that the functionality was right. Code quality is influenced by many factors, including the quality of the engineers writing the code, the development tools, and the software development practices followed. Under IEC 62304, each unit has its own verification process. As part of that process, the team made use of the IDE’s optimized debugging and testing technologies. In accordance with recognized best practices, the team used a static analysis tool throughout the software development process, thereby eliminating a good number of obscure bugs, not easily uncovered by the compiler or through code reviews. Examples of such bugs include buffer overflows, resource leaks and NULL pointer dereferences. Moving forward, the team is utilizing the IDE’s built-in static analysis tool that provides tight coupling between the static analysis tool and the debugger, ensuring rapid iterative development. This provides the capability of performing static

analysis automatically during compile time instead of manually performing it after compilation. While static analysis tools contribute to higher quality code, alone they are not sufficient for ensuring the quality of the application. The team also takes advantage of the IDE’s code profiler tool, which gives a full report of line by line code execution coverage, specifying which lines of application code have been exercised. The team can use this information to design unit tests that accurately exercise all elements of the application code, saving time, energy and money in comparison with doing this manually. Furthermore, all documentation is easily accessible and automatically generated. As is typical in embedded software development, just a few bugs take the most time to fix. For those difficult situations, the capabilities of the debugging environment enabled the team to both resolve issues related to task priorities (Figure 3) as well as low-level issues. It provided the ability to use trace data to debug both forward and backward in time, easily identifying the cause of what normally would be a painful issue to identify. This capability was instrumental in solving safety-critical issues in the medical device. In general, these tools provided a way to easily examine event sequencing, data and control flow, resource allocation, self-diagnostics and memory management. Green Hills Software Santa Barbara, CA. (805) 965-6044. [www.ghs.com]. Stryker Endoscopy San Jose, CA. (408) 754-2000. [www.stryker.com]. Swell Software Port Huron, MI. (810) 982-5955. [www.swellsoftware.com].

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Medical Design Innovations Reflect the Need for High Performance, Portable Devices As sophisticated medical devices help shift medical procedures from curative to preventative, some of these devices may even be found in patient homes. Computer-onModules can help keep pace with innovative needs for quality care. by Christine Van De Graaf, Kontron

edical device manufacturers face a complex and competitive arena of regulation and market requirements. Quick innovation is the mandate, as medical markets follow a path similar to that of consumer electronics where smaller, faster, more functional devices forge the way to market leadership. Medical design is closely tied to advancements in CPU technology that must meet new data or performance requirements, such as higher resolution imaging or higher frame rates. These complex requirements coupled with time-to-market demands challenge designers to find solutions that meet application requirements and a slate of international medical standards for hardware, software and connectivity. Computer-on-Modules (COMs) have gained a significant stronghold in medical markets, based on their responsiveness to these issues and more. COMs support medical OEMs in minimizing engineering resources and development time, reducing total cost of ownership, allowing embedded systems suppliers to get to market quickly with a proven platform. Delivering both longevity and performance, COMs offer cutting-edge performance today and provide a solid foundation for evolving designs, scaling applications and maximizing customized design life through multiple product generations.

24 · MEDS · May 2011

The COM Express standard presents a significant milestone for developers of medical devices as well as for other OEMs. Defined in July 2005 by PICMG, it established uniformity for module dimensions, pin assignment and connector layout. The standard currently specifies module sizes as basic (125 mm x 95 mm), extended (155 mm x 110 mm) and compact (95 mm x 95 mm). The compact microETXexpress was developed by and proprietary to Kontron thanks in large part to more recent 45 nm chip technology. Beyond this, the newer

ultra nanoETXexpress (84 mm x 55 mm) is expected to become part of the PICMG standard shortly. Essentially the difference between basic and compact or ultra form factors is the physical footprint. The form factors are fully compatible with the COM Express standard in terms of interfaces, pin-out definition and connector placement. Mounting holes line up on each of the modules and the cooling solution concept is identical, so that basic and compact modules are interchangeable on carrier boards. In essence, the form factor has returned to the credit-card sized format of the DIMM PC, although with a new feature set and the greater performance capabilities necessary in today‘s broad range of embedded designs.

COM Express Basic Form Factor

Figure 1: This image illustrates the range of COM Express-compatible form factors, including compact, micro and nano options.

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Smaller Devices Drive Market Growth Applications designed for portability are driving medical equipment market growth. New smaller and more portable equipment is inspired largely by the shrinking of components that can go into a design, setting expectations for small, high-performance devices in many medical arenas. COMs support this design path very well, allowing developers to shrink applications by handling high-bandwidth processing that once required a much larger single board computer. In turn, “take everywhere” diagnostic tools are being pioneered due to small form factor advances in power and performance. These tools provide low power consumption, high efficiency through extended battery life, and fast, high-precision computing enabling fine detail activities such as precision laser control. While there are a number of options to consider, today’s medical device designers are consistently turning to COMs because of their ability to deliver high-level processing performance and I/O bandwidth within a compact form factor. Image Clarity Translates into Better Care Today’s portable medical devices cannot sacrifice image quality. In fact, they often are required to deliver superior graphics for use by medical personnel to make emergency diagnoses, in life and death situations. Designers have several options in the COM Express standard to achieve this level of performance, including the microETXexpress and nanoETXexpress families of COM Express-compatible modules following the Type 1 and Type 2 pinouts defined by PICMG (Figure 1). Equipped with space- and energy-saving 32 nm and 45 nm processors, the newest COMs offer higher performance-per-watt standards for medical imaging and diagnostic applications. These smaller and ultra-small COM form factors are well suited to environments with high demands on data processing and/or multimedia conversion and output. These form factors can also be used to facilitate even smaller handheld devices in the emergency vehicle or the technician’s pocket. Advanced processing technologies have brought about further improvements in the amount of performance

Figure 2: The Kontron microETXexpress-PV incorporates Dual Core Atom technology, and offers native LVDS (low voltage differential signaling) and simultaneous VGA (video graphics array) support in a compact COM Express - compatible, Pin-out Type 2 module.

small form factors can deliver and the amount of power they can save. Ultra portable devices—warranting extremely low power coupled with exceptional graphics performance—are a good match for the power-to-performance ratios enabled by the 45 nm Atom processor. With clock speeds between 1.1 GHz and 1.6 GHz, the 45 nm Atom architecture achieves fast performance in a sub 5 watt thermal power envelope. The power-optimized front side bus (up to 533 MHz) provides faster data transfer, which has been a proven solution for “on the fly” imaging tools or fist-held devices that scan and transmit images of an injured person en route to the hospital or even while still at the scene. Overall, this processor technology enables the development of energy-saving, high-end graphics devices based on the Intel Atom processor and the Intel System Controller Hub US15W. For example, a compact COM Express Type 2-compatible Computer-on-Module with the new second-generation Atom processor, is used to accelerate the development of ultra-low-power embedded appliances such as compact ultrasound devices (Figure 2). Newer COMs that integrate the recently introduced Intel Core i7 architecture deliver even greater design flexibility in terms of both performance and onboard features. Based on the 32

nm manufacturing process, these COMs boast exceptional performance per watt, lower power consumption and heat dissipation. Core i7-based COMs solutions utilize an efficient two-chip solution for enhanced signal integrity and minimized board space that enable higher performance in smaller, power-constrained portable designs. Suitable for highbandwidth medical imaging applications, this technology also delivers significantly enhanced integrated graphics capabilities and data flow performance and can now support multiple graphical and multimedia functions. Devices that recharge more frequently, for instance a roomto-room patient monitor, can tolerate a little more power in their design. Core i7-based modules such as those based on the ETX specification, with an estimated 20W-40W power consumption, are appropriate for medical diagnostics where power is a concern, but where there is also a greater need for fast image capture and manipulation (Figure 3). Fast Product Development Given that development, testing, regulatory review and certification can take anywhere from 24 to 26 months from project inception to volume ship date, time-to-market is certainly a primary challenge for medical designers. Costs must be kept in control, which requires a keen eye on managing research and development cycles as well as the costly and time-consuming efforts that can go hand-in-hand with FDA review. Focusing on core competencies and leveraging tools that speed the process helps designers meet their application and market window goals, helping them build stand-out products and maintain a competitive edge in various areas of medical specialty. One such tool is the Kontron nanoETXexpress Starter Kit for Wind River VxWorks. This Starter Kit is optimized for the VxWorks Real Time Operating System (RTOS) and provides specialized hardware support that includes graphics requirements, which have become so critical to medical device manufacturers. Designed to enable easy and efficient development and validation of real-time appliances based on the smallest x86 soluMEDS · May 2011 · 25

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Figure 3: The Kontron ETXexpress-AI product family offers a comprehensive range of interfaces via the COM Express COM.0 Type 2 connector, supporting up to 2 x 4 Gbyte of dual channel DDR3 SO-DIMM modules with ECC. Graphics performance can be integrated via 1x PCI Express Gen 2 graphics (PEG), also configurable as 2x PCIe x8, 6x PCI Express x1, 4x Serial ATA, 1x PATA, 8x USB 2.0, Gigabit Ethernet, dual-channel LVDS, VGA and Intel High Definition Audio.

tions, the Intel Atom-based COM Expresscompatible Starter Kit is preconfigured with the Kontron nanoETXexpress-SP Computer-on-Module, featuring the Atom Z530 (1.6 GHz) processor. The Starter Kit for VxWorks allows developers to address critical issues such as integration costs, time-to-market and long-term support, right from the start of platform evaluation. Transitioning between ETX and COM Express To accommodate new features and performance in medical devices, a COMs-based design can be upgraded by switching out CPU cores. Upgrades can be made within a product family, such as switching cores within COM Express module to COM Express module. Alternately, the design can be upgraded within the overall COM specification—moving from legacy technology such as ETX into more current I/Os and interfaces found in COM Express. This type of upgrade is 26 · MEDS · May 2011

not a swap of the core CPU module, but a full exchange of the implemented COMs technology and would require a new carrier board. Similarities to the ETX layout ensure designers would be able to make this change and easily leverage the compatible software technology already developed. Designers may want to consider a deeper upgrade if the evolution of their device warrants greater performance and needs to be positioned for additional longer-term generations of product. ETX designs can be ported into COM Express. For the medical market, designs are most currently using the ETX-PM, which achieves high-end computing performance with low power consumption. Designers can transition to COM Express via the microETXexpress-PV, an economical Atom-based 45 nm solution that establishes a path forward including consistent feature support and options for increased performance and power savings. Also, COM Express heatspreader dimensions are standardized, ensuring easy control of heat dissipation and an important consideration in achieving true interchangeability for the long term. Proven COMs Move with the Market Medical designers have a long and complex list of preferences and requirements associated with the components designed into their products. With applications that require long life platforms available for ten years or more, lifecycle, program and supply chain management are critical to the long-term viability of any given device. Components are chosen not only for their appropriate lifecycle, but also for their availability and support through lengthy FDA approval processes and decades of anticipated production. As a result, active steps are being taken by manufacturers working to extend life beyond the basic ten-year requirement. Intel is effectively supporting this goal by offering an extended seven-year life commitment for selected processors and chipsets, improving availability over its previous five-year assurance. Special arrangements can extend component availability even further and some products are being developed spe-

cifically to fill this niche. For example, newer COMs include a CPU and chipset bundle slated to be available through at minimum 2015. Technology advances will continue to fuel evolution and growth for medical markets. Newer display capabilities, improved design flexibility with new UEFI BIOS incorporating code based on C programming language, and faster I/O such as USB 3.0 are likely to impact expectations for performance of even the smallest medical devices. Additional pinout options for COMs are anticipated along with lower-power features, enabling medical OEMs to deliver technology and devices geared to very specific application areas. For example, lower-power design can benefit devices that are smaller, more user-friendly and even more mobile—facilitating powerful computing abilities and new medical services to areas requiring emergency response even where conditions are rigorous or third world. With ongoing advances, medical devices—even the smallest ones—are becoming increasingly sophisticated. Ultrasound, for example, is no longer limited by two dimensional stationary performance, but can deliver 3D images on the go through portable cart-based devices or even handheld units. New processing technologies such as the Intel Core i7 and smaller form factor COMs such as nanoETXexpress are enabling a new generation of small form factor products, continuing the migration to smaller, lower-power devices. As sophisticated medical devices help shift medical procedures from curative to preventative, some of these devices may even be found in patient homes. Forward thinking that takes into consideration an aging population and ways to manage chronic health conditions will keep medical designers innovating, developing smaller, less intrusive devices that improve lives. Kontron Poway, CA. (888) 294-4558. [ www.kontron.com].

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