MEDS August 2010

MEDS MEDICAL ELECTRONIC DEVICE SOLUTIONS

Medical Expertise Harnesses Machine Intelligence UP FRONT WELCOME

A NEW ERA: MEDS ADVANCE

FOCUS A COLLECTION OF WHAT’s NEW, WHAT’S NOW AND WHAT’S NEXT

PULSE TECHNICAL EXPERTISE FROM THE SOURCE

An RTC Group Publication

MEDS · August 2010 · 1

MEDS MEDS C NTENTS MEDICAL ELECTRONIC DEVICE SOLUTIONS

August 2010

MEDICAL ELECTRONIC DEVICE SOLUTIONS

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edical Electronic Device Solutions (MEDS) uncovers how embedded technology will bring the biggest breakthroughs in electronic medical devices design. Whether large or small—MEDS is the most influential source of information for engineers, designers and integrators developing the newest generation of complex and connected medical devices. MEDS is currently a supplement of RTC magazine distributed in print to 20,000 engineers, and electronically to 17,000 in the embedded computing market. Learn more about MEDS at www.medsmag.com

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Tom Williams

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PUBLISHER’S LETTER

A New Era: MEDs Advance John Koon

FOCUS

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PRODUCTS

Computing Conference

Wind River Systems, Inc.

Welcome to MEDS

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

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NEWS

Newest Medical Electronic Technology Used by Industry Leaders

PULSE

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Medical Device Safety: Make Software Part of the Solution

Jens Wiegand, Wind River

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Reflective Motion Feedback Sensors for Portable, Precise and Affordable Medical Devices

Gaven Teo, Avago Technologies

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Creating a Secure Open Platform for Health Information

Robert Day and George Brooks, LynuxWorks

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Health Care 24/7/365 the new world of home Health Telemonitoring

Alan Cohen, Logic PD

2 · MEDS · August 2010

Debug with Confidence WaveAce Oscilloscopes 40 MHz – 300 MHz ™

MEDS

August 2010

MEDICAL ELECTRONIC DEVICE SOLUTIONS

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

Editorial EDITOR-IN-CHIEF Tom Williams, tomw@rtcgroup.com MANAGING EDITOR Marina Tringali, marinat@rtcgroup.com COPY EDITOR Rochelle Cohn

Art/Production CREATIVE DIRECTOR Jason Van Dorn, jasonv@rtcgroup.com ART DIRECTOR Kirsten Wyatt, kirstenw@rtcgroup.com GRAPHIC DESIGNER Christopher Saucier, chriss@rtcgroup.com GRAPHIC DESIGNER Maream Milik, mareamm@rtcgroup.com WEB DEVELOPER Hari Nayar, harin@rtcgroup.com

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4 · MEDS · August 2010

Untitled-9 1

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Published by The RTC Group Copyright 2010, 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.

UP FRONT

Greetings from the Editor • August 2010

Welcome to MEDS

Welcome to Medical Electronic Device Solutions, a new and dynamic technical publication serving the medical device industry. We here at MEDS bring a unique perspective in that our familiarity with embedded computer systems is a natural fit into the world of medical devices—the fact that they all gather and process information. Medical devices are, of course, special in that they are often life-critical and must face strict regulation and certification issues.

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omputer-based electronics are, of course, not new to the medical field. We have seen the wonders of advanced imaging technologies like MRI and CAT scan and newer methods that open up vistas for diagnosis and treatment. We are witnessing forward strides in robotic surgery. The list goes on. As specialists coming to this field from the embedded computing arena, we find the medical field of applications particularly exciting because it combines many aspects of control, sensing and advanced intelligence in the same devices. We also know that what may seem prohibitively expensive today will soon become much less so.

Today, for example, a dentist can afford a digital X-Ray system, but the price for one that could be used in a clinic for routinely taking images of bones, muscles, etc., would cost in the multiple hundreds of thousands of dollars, primarily due to the cost of the image sensor arrays. However, as applications for imaging expand and the demand for the underlying sensor technology increases, these devices are being manufactured in greater volume, the expertise at fabricating them is increasing and costs will come down. The ability to have what used to be normal X-Ray images on transparencies that a doctor would put on a light panel and examine, and perhaps call a colleague into the room for another opinion, will soon be multiplied. Soon that same doctor will be able to email the image to a remote specialist and consult over the Internet. Multiply this one example by all the diagnostic and clinical information that will eventually be available in digital form, and the possibilities appear limitless.

The additional promise of embedded intelligence to this field is that it is possible to embed not only compact electronics but also certain aspects of medical expertise that extend and enhance the ability of the qualified MD to apply his or her knowledge and experience. Not only can lower-level medical technicians apply these devices for a “green light” or “alert” reading that would require the attention of a physician; they are often also applicable in the home for use by the patient. This will translate not only into the

broader application of medical knowledge, but also into the ability to recognize impending danger signs and being able to intervene much quicker—which really means it will translate into the ability to save lives and prolong the quality of life. That quality of life will be further enhanced by enabling elderly patients to stay longer in their own homes due to network-connected monitoring devices.

This ability to capture data on a daily or routine basis as opposed to the need to make appointments and go to a medical facility for the procedure has huge advantages. First, it can be evaluated at one level on the device, which can signal alerts if needed. However, it is also then available for further analysis and consultation. It will further be preserved in a patient’s electronic medical records once that system has become better established. This, of course, comes with myriad security and privacy issues. And all this depends on device connectivity and the compatibility of data. There are currently major efforts underway to be able to establish and certify the interoperability of medical devices and their data.

The latter, making the devices interoperable, is one of the important topics we will be exploring here—along with the design considerations, both hardware and software, certification hurdles, and the almost endless possibilities for the use of embedded computer intelligence to improve and expand health care.

We think these pages will bring a fresh look to the subject given our extensive experience in the world of embedded systems.

Contributions from leading players in the medical arena along with those of experts in semiconductor and digital technology will make every issue of MEDS an exciting and stimulating read. It is often that through such cross-discipline dialog that brand new ideas and innovations arise. We are intending that MEDS will be one of those places and invite our readers to comment and offer insight so that we all—along with the public in need of ever better health care— can benefit from the exchange.

Tom Williams Editorial Director / Editor in Chief MEDS · August 2010 · 5

UP FRONT

Publisher´s Letter • August 2010

A New Era: MEDs Advance

The world of electronics has changed tremendously over the years. Much like computing technology, medical electronics have become more intelligent, compact, portable and wireless. Contrary to the high volume consumer electronic products that are driven by cost, application and style, medical electronics are less cost sensitive but demand quality, safety and reliability. What are the solutions being sought today? They break down to a number of issues.

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omponent suppliers need to understand why a developer selects one silicon product over another.

For example, what features are needed in a blood pressure monitor vs. an ultrasound scanner? For the developer (OEM), the need is to understand the design criteria, the best design technique, the best design tools and the best components available to get the job done. For example, what FDA or ISO requirements are relevant when they launch a product? The design tool supplier needs to understand what the developers want in terms of features and functions to shorten their time-to-market. And finally, the contract manufacturer (CM) must understand the requirements the developers (OEMs) have when they choose a CM. For example, what other things are important besides ISO 13485 certification?

There is much to learn from the USB technology development. During the early days, I was asked this question over and over again by the USB developers, “When will USB become a standard?” Before USB became a household word, seven companies established the USB Implementers Forum to drive the development of USB. Numerous USB Developers Conferences and “Plugfests” were held worldwide to train the developers to create products to achieve “universal operability.” During these Plugfests, members representing different product categories in the ecosystem whether they were software, silicon, boards or devices, all met to plug their “gears” together. More often than not, there would be incompatibility and everyone would spend time in private meetings to sort out whether the problems were caused by the Microsoft Windows Operating Systems, the device drivers or, sometimes, the silicon cycle timing. Then everyone would go home and fix the suspected problem. All would come to the next Plugfest to do this again until every issue was fixed. I still remember the cheers from the crowd when USB successfully connected 127 devices without crashing the Microsoft Windows Operating 6 · MEDS · August 2010

System (no blue screen) for the first time. USB made history!

Today, the medical electronics community is in search of the knowledge and the best practices in delivering the best products FAST, much like what USB did. In response to such demand, RTC is adding an addendum, Medical Electronic Device Solutions (MEDS), to focus on the development, test and manufacturing solutions for medical devices. MEDS will interact with the medical electronic community by interviewing the leaders and innovators for the best practices and solutions. We will share that knowledge with the community and invite developers and other solution providers to ask questions and share ideas.

This issue will cover design considerations in silicon, software design, safety and applications in medical electronic products and healthcare. We would like to invite you to join us in search of the best Medical Electronic Device Solutions!

John Koon Publisher John Koon has worked in the electronics industry for over 30 years and has managed many software, hardware and silicon products. He started publishing about 16 years ago when USB 1.1 first came out. (Publications include USB Technology and Market Reports: version 1.1, 2.0, USB On-the-Go, and Wireless USB). Besides speaking at various conferences, Koon has contributed articles for magazines like Electronic Design, EDN, USA Tech and Product Design and Development.

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8 · MEDS · August 2010

FOCUS

News and Products: A Collection of What´s New, What´s Now and What´s Next Intel and GE Form New Healthcare Joint Venture

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ntel Corporation and General Electric have announced entry into a definitive agreement to form a 50/50 joint venture to develop and market products, services and technologies that promote healthy, independent living at home and in assisted living communities around the world. The new company will be formed by combining assets of GE Healthcare’s Home Health division and Intel’s Digital Health Group, and will be owned equally by GE and Intel.

The new company will focus on three major segments: chronic disease management, independent living and assistive technologies. The latter are designed to help those with learning disabilities or visual impairments. To support independent living the venture will work on wireless passivebehavioral monitoring to keep elderly persons living longer in their homes.

Intel’s healthcare contributions will include its remote patient monitoring and assistive technology products as well as its independent living concepts, including the Intel Health Guide and the Intel Reader. Intel will also bring its expertise in the development of user-friendly technology interfaces for products, and tools for online cognitive assessment and social interaction. Additionally, Intel will continue to develop the foundational architecture for healthcare IT innovation with processors, platform definition and system architecture, which will help enable the industry to drive toward lower costs and a higher quality of life for patients GE Healthcare’s Home Health Division will contribute its technology for elder care, GE QuietCare, which is a remote passive activity and behavioral monitoring system for seniors, which alerts caregivers to changes that may signal potential health issues or emergency situations. It is used primarily in assisted living facilities across the U.S.

Cardiograph Helps Clinicians Deliver Earlier Diagnosis

A new cardiograph aims to help clinicians meet demands and shift the focus to patients.

Its ability to handle up to 16 leads provides a more complete view of the heart, and its anatomically designed patient interface module makes attaching lead wires quick and intuitive, contributing to timely triage.

As heart disease manifests itself in different patients in different ways, physicians always face the challenge to quickly and accurately diagnose heart attacks.

For this reason, Philips has packed the PageWriter TC50 with a variety of tools to aid clinicians with this task, including those enabled by the innovative DXL 16-lead ECG Algorithm. The DXL Algorithm’s ST Maps provide a graphical representation of ST elevation in patients, a key measure in the diagnosis of ischemia. STEMI-CA can identify which coronary artery is blocked, aiding the clinician in planning the appropriate intervention. In addition, since heart disease in women often occurs in smaller vessels with less obstruction and more subtle symptoms, the ECG analysis program used by the PageWriterTC50 uses gender-differentiated criteria to help interpret cardiac symptoms in women, including the identification of acute global ischemia.

Philips Home Healthcare, Andover, MA.(800) 453-6860. [www.healthcare.philips.com]

Intelligent Sleep Apnea Therapy System for Home Healthcare A new line of sleep therapy systems brings significant advancements in therapy for millions of sleep apnea sufferers, along with solutions to healthcare providers to help meet today’s healthcare challenges. The new system provides a range of therapy options for mild to severe sleep apnea patients and helps providers recognize changing patient conditions that may require different treatment.

With new advanced event detection software and expanded reporting capabilities, Philips Respironics Sleep Therapy System has the ability to recognize and report when a patient may be experiencing symptoms beyond OSA. A three-layer algorithm distinguishes between obstructed and clear airway apneas and periodic breathing, such as Cheyne-Stokes Respiration.

Medical professionals now have easy access to sleep assessment parameters typically found on diagnostic equipment.

These respiratory events can be verified by looking at detailed patient flow waveform data. There are multiple options for data transfer, including standard SD cards and new wireless and wired modem connections. The devices now include onboard memory storage for six months of compliance data (7 and 30 day averages) and five days of patient flow waveforms.

Philips Home Healthcare, Andover, MA. (800) 453-6860. [www.healthcare.philips.com]

MEDS · August 2010 · 9

UP FRONT FOCUS

News and Products: A Collection of What´s New, What´s Now and What´s Next Pocket-sized Visualization Tool for Point-of-care Imaging

A new, pocket-sized visualization tool provides physicians with imaging capabilities at the point-of-care. Roughly the size of a smart phone, the Vscan from GE Healthcare houses powerful, ultra-smart ultrasound technology that provides clinicians with an immediate, noninvasive method to help secure visual information about what is happening inside the body. Vscan is portable and can easily be taken from room to room to be used in many clinical, hospital or primary care settings.

Vscan leverages GE’s high-quality black and white image technology and color-coded blood flow imaging in a device that fits into a pocket and weighs less than one pound at 3 inches wide and 5.3 inches long.

Other features include an online portal provides Vscan users with training tools for the product and basic clinical applications with sections about imaging technique, anatomy and trouble shooting. An intuitive user interface can be controlled using the thumb. A USB docking station provides a link to a PC for organization and export of data, and gateway software with services tools and remote diagnostics also allows voice annotation.

GE Healthcare, Chalfont St. Giles, UK. [www.gehealthcare.com].

PCIe 1080p Frame Grabber Targets Medical Imaging Designs A PCI Express frame grabber offers uncompressed image acquisition and video streaming in full 1080p HD. The HDV62 from Adlink Technology provides 1920x1080p resolution, progressive scan, and noise reduction for greater image quality, as well as a wide aspect ratio that is more comfortable to the human eye. Equipped with an FPGA and 512 Mbytes memory buffer, the HDV62 offers the ability to stream uncompressed images to the host PC, in addition to color space conversion in real time via on-board hardware in order to offload repetitive tasks from the host CPU. Based on the PCI Express x4 form factor, the HDV62 is specifically designed for medical imaging, scientific imaging and high-end video surveillance system integrators, by providing uncompressed video streaming up to 1920x1080p at 60 fps and lossless pixel information for both spatial and frequency domain analysis.

Image acquisition and deployment of the HDV62 are greatly simplified through Microsoft DirectShow, a user-friendly Windows-based application development software package that allows system developers to shorten time-to-market. The HDV62 is currently available for a list price of $999.

ADLINK Technology, San Jose, CA (408) 495-5557. [www.adlinktech.com].

10 · MEDS · August 2010

Rugged Atom-Based SBC the Size of an iPhone Targets Medical Apps

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new Intel Atom-based rugged SBC offers extremely low power consumption combined with an exceptionally small footprint and high performance. The Atom XPC40x (extended temperature, conduction-cooled) and Atom XP40x (standard temperature) from General Micro Systems satisfy the intense demand for an ultra-small com­puter with full-size processing power.

Easily accommodating 64 gigabytes of storage via onboard solid-state disk in its miniature 3.5 x 2.5 x 0.5” package, the Atom XPC40x and XP40x boast 533 MHz DDR-2 SDRAM and are powered by a 1.6 GHz Intel Atom processor that provides 512 Kbytes of cache. With full laptop functionality, the module offers high-performance graphics with 3D accelera­tion, and includes five USB 2.0 ports and support for two Express Mini Cards for Wi-Fi, CanBus or other user I/O. As the smallest form-factor currently produced by GMS, Atom XPC40x and XP40x are sutiable for applications that extend far beyond the military to fields such as medical and law enforcement. GMS also offers fully integrated systems based on this module.

General Micro Systems Rancho Cucamonga, CA. (800) 307-4863. [www.gms4sbc.com].

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PULSE

Technology Drives Down Cost and Complexity

Medical Device Safety: Make Software Part of the Solution Today’s embedded software technologies are fully capable of cutting the cost and complexity of safe medical devices. Three key steps can put developers on the path to safer, more reliable and longer-life medical solutions.

by Jens Wiegand, Wind River

H

uman lives depend on the safety of medical devices.

That is why the primacy of safety in medical device development will not diminish, and why developers (and regulators alike) will always go the extra mile for safety. But more and more safety-related functionality now depends on software, and as software technologies and processes grow increasingly complex, safety compliance becomes increasingly difficult, time-consuming and expensive.

How can developers of medical devices add innovative new capabilities while remaining compliant with all relevant safety requirements? How can they harness the power of new software technologies such as multicore processors and embedded virtualization without jeopardizing certifications—or risking product liability lawsuits? How can they tame the increasing complexities of development, testing and compliance while meeting cost and time-to-market goals?

One thing is clear: Medical device developers will need to find a way to make software part of the solution rather than part of the problem.

It is equally clear that today’s embedded software technologies are capable of

12 · MEDS · August 2010

reversing the upward spiral of cost and complexity in safety compliance. The right software platform and the right development tools, used in the right way, can deliver a solid foundation to meet the most stringent safety certification standards—on time and on budget.

A Closer Look at the Regulatory Challenge Software is proving to be a key source of differentiation for medical device manufacturers. Embedded software is now a crucial element in everything from CT scanners and X-ray devices to dialysis machines, medical imaging systems, blood analyzers, intensive-care ventilators, confocal microscopy systems and clean machines.

The growing importance of software—and the impact on safety and security—is not lost on regulators. Manufacturers who have not yet adopted robust software development processes will likely face greater pressure to do so as new legislation is introduced in the years ahead. Consequently, device manufacturers who are already struggling to meet existing or emerging regulatory requirements, such as IEC 62304, IEC 61508, IEC, and standards such as ISO 14971 on

medical device risk management, could find themselves facing a whole new set of challenges (see International Electrotechnical Commission Standards, p.14).

The U.S. Food and Drug Administration’s approach has been to impose pre-market and post-market requirements, which has led to confusion. For pre-market approval, the FDA requires valid scientific evidence to support a reasonable assurance of safety and effectiveness of the device. Products that demonstrate such evidence can be placed on the market, but if they fail in service they can then be removed pending investigation against requirements not imposed before the product was placed on the market. Thus, certification can get your product to market but won’t necessarily keep it there. For device manufacturers, this represents a significant risk in terms of product liability.

Conversely, new specifications that are in development to assist in the life cycle of software for medical devices, such as IEC 62304, may not go far enough.

Many manufacturers of medical devices feel they could and should be doing more to limit their liability in lieu of more robust regulatory requirements.

A Surge in Design Challenges Further complicating the issue is that both medical systems and software development processes are growing increasingly complex. Most significantly, software content in intelligent devices is doubling every two years, according to analysts.

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Figure 1: A hypervisor allows two or more different operating systems to run on the same multicore processor. This enables the designer to isolate critical functions, such as would run under an RTOS, from supervisory and other functions that would run under another operating system. Such separation eliminates tampering from outside and interference from a software malfunction on the other core.

In the embedded world, many products now use 32-bit and 64-bit multiprocessor architectures and run multiple operating systems within a single device. In addition, iterative or “agile” development has replaced one long development cycle with a lot of shorter ones, making testing a nonstop exercise aimed at a moving target.

As more and more functionality is delivered via software, developers are struggling to integrate piecemeal legacy tools and development processes with new tools and technologies without jeopardizing safety certifications. For example, in many designs some elements of the software have to remain fixed, providing verified safety-critical functions, while other parts can add new features, functions and innovations while keeping the hardware fixed in order to maintain safety compliance.

Technology convergence is the traditional solution route to cutting cost and complexity, but for medical device manufacturers there are complications. For products that need to demonstrate compliance with IEC 61508, technology consolidation can raise certification issues. This can subsequently increase the cost and time of placing a revised product in the market. The demand for more connectivity—both wired (Ethernet) and wireless (Bluetooth, WLAN)—has created additional interoperability challenges in terms of

the communication stacks required. On top of that, many suppliers have a huge installed base of legacy applications (which require maintenance), and need to find new ways to innovate without sacrificing these investments.

Against this backdrop of multidimensional challenges, let’s take a look at solutions. Here are three specific steps medical device manufacturers can take to leverage the power of new embedded software solutions to reduce cost and complexity, remain compliant with safety requirements, and derive new sources of competitive advantage.

Step 1: Consolidate Using Multicore and Embedded Virtualization Two developments in the embedded market provide a real solution for those who wish to reap the rewards of consolidation without jeopardizing compliance with safety and security standards: multicore processors and embedded virtualization (hypervisor) technology.

The latest multicore processors significantly boost overall performance and increase performance-per-watt over single-core processors. They also improve application scalability and protect software investments by allowing processors with more cores to be substituted to meet future demand. The trend toward multicore is well underway, and multicore-

optimized operating systems, middleware and tools are now available. Using the latest multicore architectures, suppliers are now able to combine multiple operating systems on a single, safety-compliant aggregation platform.

The second concept, embedded virtualization, provides the ability to run multiple operating environments separately from each other on the same physical device. For example, it is possible to run a real-time operating system such as Wind River’s VxWorks and a generalpurpose OS such as Linux on the same device (Figure 1). This separation or partitioning makes resource allocation far more flexible. Processing cores can be allocated exclusively to one virtual board or shared across multiple virtual boards.

Memory can be partitioned so that each board has its own unique and enforced memory space; and enforced memory space cannot affect any other virtual board. Embedded virtualization also makes it possible to separate safety-related functionality from other functionality.

Together, multicore processors and embedded virtualization allow medical device manufacturers to consolidate more functionality onto fewer physical systems, cut cost and complexity, and keep the focus on meeting the requirements that are challenging safety certification processes.

Step 2: Standardize on Open Platforms With the increased focus on differentiating via embedded software, the ability to standardize hardware platforms has become a key consideration for medical device manufacturers.

For example, the use of real-time kernels in programmable logic controllers is now commonplace. However, convergence and consolidation are occurring further up the value chain. Device manufacturers are now counting on software to provide an overall environment for safety, security and connectivity. They are in a position to consolidate functionality, but they also need a lot of support at the software layer.

At the same time, the issues of safety and security are also moving up through the value chain, creating the need for more strategic partnerships with suppliers MEDS · August 2010 · 13

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I N T E R N AT I O N A L ELECTROTECHNICAL COMMISSION STANDARDS n IEC 61508 is the international standard for electrical, electronic and programmable electronic safety related systems. It sets out the requirements for ensuring that systems are designed, implemented, operated and maintained to provide the required safety integrity level (SIL).

ISO 14971 specifies a process n for a manufacturer to identify the hazards associated with medical devices. n IEC 60601-1-9 is the new international standard for environmentally conscious design of medical electrical equipment. n IEC 62304 defines the life cycle requirements for medical device software.

of embedded software development tools, operating systems and middleware. As frameworks become more open and standardized, manufacturers have enormous opportunities to aggregate and smoothly integrate a variety of subsystems.

These trends also have the potential to help manufacturers resolve life cycle issues. Typically, the design cycle is two to three years, with a shipping cycle of up to eight years—and a need for more than 10 years of support. The life cycle, which is already more than 20 years in some cases, is under pressure to be extended even further through more frequent upgrade programs, demanding greater support from suppliers.

Device software vendors can help customers overcome these and other challenges, such as protecting market share, intellectual property and time-to-market, while reducing the total cost of ownership.

A modular software approach, for instance, helps with time-to-market issues but raises 14 · MEDS · August 2010

the problem of paying to repeatedly certify elements, such as a UDP stack. Through modular certification, standard software components can be delivered as part of a certification package, thus becoming a trusted component. Customers can then rely on this evidence package for certification against IEC 61508, allowing not only a faster approvals process but greater flexibility at the design phase and more predictability in the business.

With many device manufacturers now looking at using Linux, the issue of support arises. The complexity of Linux and the business challenges are totally underestimated. Too often manufacturers attempt to cobble together free Linux distributions instead of choosing a supported and validated commercial distribution.

Training on Linux, stability of the distribution, open standard compliance, indemnification, documentation and scalability are just some of the benefits of choosing a professionally managed distribution and should therefore be considered during the decision process.

Open technology, combined with embedded virtualization and multicore concepts, creates powerful new capabilities. For example, an important part of using Linux is the ability to partition safety- and non-safety-critical elements of the same application on a single hardware platform. As an open operating system, Linux provides high potential for features and innovative middleware, which often adds a layer of complexity if safety is required. Hypervisor technology makes it possible to consolidate Linux and real-time operating systems at the software layer, allowing safety- and non-safety-critical applications to run on the same hardware platform. Multicore processor technology, together with hypervisors, now additionally enables multiple operating systems to run concurrently on the same hardware platform but in partitioned, protected spaces.

Step 3: Build on a Foundation that Can Support Change One of the key reasons software processes are often perceived as part of the problem rather than part of the solution is that they are built in a piecemeal fashion from ad hoc tools and technologies, resulting in

enormous complexity. Standardizing on open platforms will help to make software development processes more adaptable and future-ready, but it is also important to build on a framework that can support comprehensive requirements and keep pace with fast-changing safety certification mandates.

Specifically, look for a combination of operating system agnosticism, safety and security solutions, and a rich set of middleware that offers a robust commercial off-the-shelf (COTS) foundation.

A flexible, agile software platform will make it possible to take advantage of new technologies as they emerge without sacrificing previous investments.

For example, it will allow you to use hypervisor technology to consolidate Linux and real-time operating systems at the software layer, allowing safety- and nonsafety critical applications to run on the same hardware platform; it will allow you to combine embedded virtualization and multicore technologies so that multiple operating systems can run concurrently on the same hardware platform (in partitioned, protected spaces); and it will allow safety-critical tasks to operate within a certified application in a real-time OS such as VxWorks, with communication protocols running under the RTOS or Linux, providing supervisory functions on the same machine.

The primacy of safety is the only constant in the development of medical devices. Design requirements, tools, hardware architectures, development processes and safety regulations will all remain in a state of flux for the foreseeable future. To remain competitive, manufacturers must find a way to deliver safe devices on time and on budget, using a mix of legacy and next-generation tools and processes.

It can be done.

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

Medical Electronic Technolgy

Showcase Engineering Your Success A2e Technologies is an Electronic Design Services firm providing embedded systems design and complete turnkey product development through our multiple on-shore and near-shore design centers. We provide everything you need to develop your embedded technology based product or system.

Turn-key medical product design Concept to production Hardware, firmware, FPGA, analog & RF FDA design process expertise Manufacturing & support

A2e Technologies Phone: (877) 223-8359 Fax: (858) 225-0188

Getting into the Medical Device Industry?

The Medical Development Group (MDG) is a community of individuals professionally committed to the Medical Device and other Medical Technology Industry segments united by the belief that innovation and advances in technology lead to substantial improvements in health care.

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.

MDG pursues this mission through the organization of educational programs and forums: the facilitation of cross-disciplinary dialogue and collaboration; the creation of venues for networking and information sharing for current and aspiring professionals, clinicians, and entrepreneurs; and the development of alliances with complementary organizations.

Medical Device Group E-mail: info@a2eTechnologies.com Web: www.a2eTechnologies.com

E-mail: info@meddevgroup.org Web: www.meddevgroup.org

Manufacturers of OhmegaPly® Embedded Resistive Material

Turn to the trusted source Get your Windows Embedded Standard or .NET Micro Framework project off the ground. For 5 years, SJJ Embedded Micro Solutions is one of the leading resources for WES and .NET Micro Framework training, consulting, and development kits. Our expertise covers a wide range of market segments.

OhmegaPly RCM® is a thin-film nickelphosphorous resistive alloy that is plated onto copper foil. The material is bonded to a variety of substrates, including FR4, PTFE and flexible polyimide films.

OhmegaPly is etched subtractively by the PCB manufacturer to create copper circuitry/resistive elements that can be embedded within multilayer printed circuit boards or used in flexible circuit applications. Elimination of discrete chip resistors improves reliability, increases circuit density, lowers cost and/or improves electrical performance.

Ohmega Technologies, Inc. Phone: (310) 559-4400 Fax: (310) 837-5268

SJJ Embedded Micro Solutions, LLC

E-mail: bmahler@ohmega.com Web: www.ohmega.com

Phone: (714) 970-7523 Web: www.sjjmicro.com

MB-80100 Platform for Medical Imaging

ADS1298 from Texas Instruments – Complete Analog Front End for ECG/EEG

Dual Intel® 4/6-Core Nehalem/ Westmere 5500/5600 Xeon Processors Dual x16 (electrical) PCI-Express Gen 2.0 graphic ports Full 64-Bit PCI-X Intel® 5520 Chipset Compact, modular PICMG 1.3-style Form Factor SAS and SATA RAID Storage FireWire, USB 2.0, Dual GbE LAN

The eight-channel, 24-bit ADS1298 is the first in a family of fully integrated analog front ends (AFEs) for patient monitoring, portable and high-end electrocardiogram (ECG) and electroencephalogram (EEG).

WIN Enterprises, Inc.

Texas Instruments, Inc. Phone: (972) 644-5580 Fax: (972) 927-6377

E-mail: sales@sjjmicro.com.

Web: www.seanliming.com

E-mail: www.ti.com Web: www.ti.com/ads1298

Phone: (978) 688-2000 Fax: (978) 688-4884

E-mail: sales@win-ent.com Web: www.win-ent.com

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Reflective Motion Feedback Sensors for Portable

Precise and Affordable Medical Devices For small, portable and safety-critical medical devices that can be used at home by nonprofessionals, many require exacting motor control to, for example, administer medication. The choice of a reflective motion controller can positively affect size, power, cost and accuracy considerations.

by Gaven Teo, Avago Technologies

I

n the highly complex medical device market, device manufacturers strive to develop products that offer value to patients and practitioners as well as advantages over competitive products or solutions. For instance, due to the growing awareness of self-administered medical care benefits, people want home-managed therapy options.

Today many people attempt to watch and control their medical expenses much as they manage their energy costs. Therefore, the trend toward outpatient treatment instead of inpatient treatment to reduce high medical fees should continue as the populations of many developed countries age. Demographic trends and the need for affordable health care for a population with decreasing purchasing power will push the market to products that are portable, cost effective and user-friendly.

At present, there are various diagnostic and therapeutic devices that are readily available in the market for outpatient treatment. These include dialysis equipment, portable insulin pumps, insulin inhalers, diabetes management systems and many more.

The introduction of more self-help medical devices is expected to push device manufacturers toward introducing more new and innovative product offerings.

To meet aggressive time-to-market strategies, product designers actively seek new components that support innovative

16 · MEDS · August 2010

ideas or future product visions. Miniature reflective encoder technology is becoming increasingly popular among portable medical device manufacturers who seek to challenge the limits of precision, power consumption, size and cost. With the introduction of reflective encoder technology, major encoder and motor manufacturers have begun to incorporate a reflective encoder into their product design and development programs (Figure 1).

Designers have begun to adopt reflective optical encoders as an answer to questions about electromagnetic interference (EMI) and precision that can lead to safety issues resulting from device failure. In addition, reflective encoders remain small, relatively inexpensive and easy to design into end products and equipment.

Figure 1. Reflective encoder mounted on back of motor.

Optical Encoder Technology Two types of optical encoders can be used in portable medical devices. There are transmissive optical encoders and reflective optical encoders (Figure 2). It is conceptually easier to understand the transmissive encoder first and then look at the differences and advantages of the reflective encoder.

Transmissive and reflective optical encoders, such as those developed by Avago Technologies, consist of three core components. They are the emitter, detector and code wheel/code strip.

The emitter or light source consists of a lens and an LED that emits an infrared light beam. The detector is a set of photodiodes connected to a detector IC. The code wheel or code strip is an opaque material designed in a circular shape or as a straight strip. The code wheels and code strips are patterned with tracks. These tracks consist of a series of openings called “windows” and opaque areas called bars. In a reflective encoder, the windows are a reflective and the bars nonreflective.

In a transmissive encoder, the light emitter and detector are located on the opposite sides of the code wheel or strip and are positioned to face each other. The emitter functions as a light source and light travels across to the detector. This light beam will have to pass through the code wheel first, before landing on the detector. The code wheel or code strip, which is now spinning or moving in linear motion, can block the light beam from getting through except when a window is present. The windows located on the moving code wheel or code strip enable beams of light to reach the detector.

Intervals of light and shadow fall on

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Transmissive Encoders

Reflective Encoders

Figure 2. Transmissive vs. reflective encoders.

the photodetector array. The encoder’s detector IC circuitry then picks up this signal, processes it and translates it into more recognizable outputs called channels.

The core components in a reflective optical encoder are similar to the transmissive optical encoder. However, in a reflective optical encoder the emitter and detector are on the same side of the code wheel or strip. The reflective code wheel or code strip uses materials that reflect light for the window. To create the shadow effect, the code wheel is etched and chemically treated to create an opaque, non-reflective area that acts as a bar to light transmission/ reflection. The light beam is then reflected by the moving code wheel or code strip.

The bars located on the reflective code wheel now absorb the light beam and prevent it from being reflected.

Reflective encoders have advantages over transmissive encoders that make them popular in motor control applications. They include: low height profile, high accuracy, surface mounting and high volume production that decreases cost Reflective encoders attached directly to a motor housing, make a compact, integrated feedback control system possible in space-constrained equipment. A reflective code wheel /code strip is directly attached to the measuring surface. Direct monitoring of the position information increases accuracy due to the actual position measurement of the moving surface. By reducing the effects from mechanical slippage and gear backlash, overall performance is also improved. Smooth motion with real-time velocity

feedback is possible with a small diameter code wheel for compact size.

Reflective encoders with two channels have two digital pulse output streams, Channels A and B (Figure 3). The rising edge of the pulses is 90 electrical degrees out of phase from each other. Direction can be determined from these two quadrature channels. For example, clockwise rotation has Channel A leading Channel B, but a counterclockwise rotation will result in Channel B leading Channel A. A three-channel encoder is similar to the two-channel encoder but with an additional channel. This additional channel marks the index position and is referred to as channel ‘I’ and is sometimes called channel ‘Z’.

A pulse occurs on this channel once for each full revolution of the code wheel. Essentially, this pulse marks a singular position of the code wheel. This is an absolute reference added to an incremental encoder.

The quadrature output signals are sent to ICs, which can perform the quadrature decoder, counter and bus interface function, or the quadrature signals can be decoded by a microcontroller and software. The microcontroller’s program controls system operation and can even issue alarms and make other decisions based on system operation or status. Usually the microcontroller also sends data for display to the patient or medical professional. Remote monitoring via the Internet is also possible for more complex systems.

The channel signals can be directly connected to a decoder IC/microcontroller, or if transmission over a long distance

is required, differential line drivers can be used to send data. Some reflective encoders include the differential line drivers, which also decrease transmission errors caused by noise spikes and other interference.

Selecting the Right Motion Feedback Solution The marketplace for portable medical devices is increasingly competitive, with a focus on product segments where each offering has a distinct advantage or differentiator against competitors or alternate technology offerings.

From the feedback and reviews received, decisions about tradeoffs must be made.

Prioritizing design requirements are the key in selecting affordable components that meet most critical priorities while at the same time satisfying financial objectives. The selection method for most typical portable medical devices is critically associated with a set of criteria. However, this is not presented in order of priority.

Size and weight considerations are critical to product design because the designer will have limited space and weight allowance for components. Portable medical devices that require precise mechanical position or speed data need an encoder or an electromechanical motion feedback device to translate mechanical motion to electrical output for precise position or speed tracking.

A rotary encoder attached to the back of a motor turns motion into electrical signals that give position and speed information, making closed loop feedback systems with alarm capability easy. Alternatively, a linear encoder may be used with a code strip, a strip that has a series of black and white tracks on it, and have it mounted on the moving part of the system for motion tracking (Figure 4).

These ideas are not possible with conventional encoders as they cannot meet the size, weight, resolution and cost target requirements. Reflective encoders are very small, just 3 mm in length and width and are nearly weightless. Additionally, the reflective encoder is priced relatively low, while providing greater resolution at a higher accuracy than magnetic encoders.

A feedback sensor must have the resolution, frequency/speed performance and accuracy to match the system. The term resolution determines the total number of MEDS · August 2010 · 17

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Figure 3. Quadrature output signals contain directional information.

steps that represent one revolution of motion from a rotary system. Resolution is often measured as Counts per Revolution (CPR) for a rotary application or Lines per Inch (LPI) for a linear application. Higher CPR does not necessarily imply better accuracy. On the contrary, it only provides more count per revolution for your application and does not reveal details about potential cycle errors. Cycle error is the difference between shaft rotation, which causes one electrical cycle, and 1/N of a revolution.

A 6 mm-diameter housed optical encoder such as that in Figure 1 can offer at least 50 CPR pre-quadrature resolution or higher. This could be further multiplied by four times with external electronics or a microcontroller. The frequency rating of an encoder determines how fast a motor can spin without having the encoder lose count.

A typical miniature DC motor is rated at around 20,000 RPM, or lower at a no-load condition, with typical applications running at around 6,000 to 10,000 RPM. At the stated motor speed, a typical 50 CPR encoder will need to have a frequency rating of at least 16.7 kHz A typical magnetic-based encoder with interpolator has about 3-4 times higher cycle error than an optical-based encoder.

Encoder technology is critical to system accuracy. For high accuracy—less than ±20 electrical degree cycle errors—optical encoder technology is the best option.

Motion control solutions constitute a large portion of the design

Figure 5. Miniature motor with encoder.

18 · MEDS · August 2010

budget because the options for precision motion control components are limited and tend to be expensive. Another concern is the mechanical mounting of the encoder device, due to the need for expertise and/or tools to assemble the encoder to the intended application. The most common practice is to rely on motor manufacturers for a complete encoder and motor assembly. However,

immunity against EMI interruption and are easy to adopt as manufacturers often offer mounting tools and demonstration kits.

There are many ways to assemble the reflective encoder solution into a portable medical device. The most common method mounts the reflective encoder at the back of the motor. See Figure 5 for an example of a miniature motor with an encoder. The encoder provides position and speed feedback data based on the motion (rotation) of the motor shaft. The data is transferred via two digital signals that operate in quadrature. A microcontroller or dedicated IC can decode the quadrature signals for control feedback, status display and alarm functions.

Figure 6. Volumetric dispenser.

Figure 4. Linear motion tracking.

this has often limited the solution to the magnetic-based encoder solution. With the introduction of the reflective encoder technology, engineers now have more options for their applications while ensuring that component cost remains low and accuracy high. Transmissive optical encoder suppliers often offer development and mounting kits to speed the design process. Incorporating components that consume less power can prolong battery life and give more flexibility in selecting other components. The reflective encoder’s low power consumption of less than 30 mW from a 3V supply is comparable to or lower than existing technology.

EMI issues have become more significant in recent years as more sensitive electronics have appeared in products.

Cell phones, Wi-Fi and wireless computer peripherals are potential EMI sources.

Ironically, many motor manufacturers continue to design with custom discrete magnetic encoder solutions that are sensitive to EMI. Optical-based encoders have better

Figure 6 shows a typical geared motor with a rotary encoder. The motor acts to drive the lead screw through gears and pushes against the plunger head at programmed rates. The motion control encoder senses the motion of the motor shaft and sends the corresponding output signal to the controller, forming a closed loop system. Properly setting your overall system priority and the respective component requirement is the key to project success and fast time-to-market. The reflective encoders are ideal for medical device applications such as drug delivery devices, syringe motion control, endoscope systems and many more.

Avago Technologies San Jose, CA. (800) 235-0313. [www.avagotech.com].

Your Products Enhance the Quality of Life Our products help you do it

O

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

embedded computer. It’s at the heart of any system. At VersaLogic, we design our embedded computer products to ensure high reliability and long-term availability. That’s why our single board computers can be found in a long list of medical products. And because we understand that medical customers have special requirements, every board we make is run through exhaustive quality tests, ensuring that we deliver only the best. Whether you need one of our standard products or a version customized to your needs, our skilled technical staff will work with you to meet your exact requirements. Contact us to find out how for more than 30 years we’ve been perfecting the fine art of extra-ordinary support and on-time delivery: One customer at a time.

1.800.824.3163 1.541.485.8575 www.VersaLogic.com/med

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Complex Secure Medical Systems

Creating a Secure Open Platform for Health Information The increasingly complex requirements of medical systems can be met using a new secure open platform built on multicore hardware with hardware-assisted virtualization with the use of hypervisors and separation kernels.

by Robert Day and George Brooks, LynuxWorks

C

hanging requirements in the healthcare industry are creating interesting consequences for the developers of tomorrow’s medical devices. For instance, there is a growing need for proactive healthcare providing prevention rather than cure, particularly for our aging baby-boomer population. Persistent monitoring and analysis of patients at hospitals, doctors of-

fices, and even at home is the way of the future. The devices that service these needs will also be connected to the patient’s medical records. Doctors and specialists will be able to combine and analyze new information from the devices with the patient’s past history. This connected world opens up some interesting challenges with the government regulated Health Insurance Portability and Accountability Act

Figure 1. The ability to run different operating systems in secure partitions ensures that data transfers from one subsystem to another are done in a controlled way and a controlled direction. It also prevents intrusions or malfunctions of the user interface or the network from jeopardizing the security of the patient-critical applications.

20 · MEDS · August 2010

(HIPAA), which protects patient privacy.

HIPPA appears to run counter to the openness and easy access to information that is needed to effectively monitor and analyze a patient’s progress.

To bridge these challenging issues, the government, the healthcare providers and the healthcare industry need to partner and to work with technology companies. This way we can develop new treatments and devices using advanced technologies to ensure the safety of the patient and the security of personal health information. The healthcare industry looks to advanced technologies to address a plethora of complex problems.

To stay competitive, medical device manufacturers must bring products to market that address the needs of healthcare while dealing with time-to-market pressures, cost constraints and more.

Trends in Medical Devices Medical device functionality is on a path similar to that of the consumer electronics industry. As is the case with consumer and other industries, size, weight, performance and mobility are top priorities. Many medical devices are now implemented with wireless technologies in order to extend the portability of healthcare and reduce the clutter in the healthcare facility. For example, most European hospitals have telemetry units where patients can be monitored for vital parameters through patient-worn transmitters that connect to a central station.

Healthcare providers also want to reduce the number of devices needed to

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Figure 2. The LynxSecure hypervisor and separation kernel running on the Intel Core2 Duo supported by Intel hardware-assisted virtualization technology, provides a multicore foundation for adding security to legacy systems and securely reusing legacy Windows and Linux applications alongside real-time systems.

adequately treat patients by combining once disparate devices. For example, all the various sensors used to monitor a patient during surgery could be wirelessly connected to a single integrated graphical display on a single workstation. This would eliminate a tangle of wires and numerous pieces of monitoring equipment. Finally, as providers move from a paper-based patient information system to a connected electronic health information world, they need to develop systems that ensure the security and privacy of patient information.

As device manufacturers move forward, they look to technology companies to provide commercial-off-the-shelf (COTS) products. These hardware platforms and integrated software solutions can offer the advanced technologies in standard and optimized form factors.

This is a cost-saving measure and is a move away from proprietary systems that in the past were custom built to the specifications of the medical device manufacturer. Recently, a new COTS solution has become available that enables new highly integrated platforms to provide more processing power, lower energy consumption and the potential to dramatically reduce bill-of-material costs. Even more importantly, though, it provides the means to keep systems and data secure by using virtualization technology to create a protected environment for running operating systems (OSs) and applications.

Virtualization for Medical Device Platforms Virtualization technology has been around for many years, mostly seen in data centers and the server world. Multiple applications are consolidated onto a single server or system to improve operational efficiencies and overall system performance.

A new generation of chip-level virtualization technology, which includes optimizations for embedded devices, can now be used to develop medical devices.

Additionally, in order to meet the more stringent requirements for safety-critical applications, a new type of software virtualization solution was developed.

This new software allows guest operating systems and their applications to run on top of it, in effect allowing multiple, and even dissimilar operating systems to share a single physical hardware platform. This is achieved by adding a new software layer, called a hypervisor or virtual machine monitor, which manages the execution of guest OSs in much the same way that OSs manage the execution of applications.

Each guest operating system is assigned certain dedicated resources, such as memory, CPU time and I/O peripherals. The software isolates each virtual instance by providing hardware protection to every partition with its own virtual addressing space. This makes it possible to safely run multiple applications on a single platform by isolating them into sepa-

rate partitions to prevent unintended or dangerous software interactions.

Additionally, it makes it possible to easily port existing or legacy applications to a new hardware platform, since these applications can run unmodified in the new environment.

Today’s medical device systems use a single operating system, typically a real-time operating system (RTOS).

However, as systems grow in complexity and feature set, developers may find advantages in using a general purpose operating system (GPOS) such as Linux or Windows for their user-interface and for connectivity to medical networks. In this case, the ideal scenario would be to use both a general purpose operation system for communications with the outside world and an RTOS for real-time functions such as patient monitoring.

This could be done using virtualization to run multiple operating systems on the same physical platform.

Virtualization works by abstracting the underlying processing cores, memory and devices. This is done by running virtual machines (VM) on top of an embedded hypervisor, with each VM running its own OS and related applications. A hypervisor is a software layer that either resides directly on the hardware (type 1 hypervisor) or hosted on top of a conventional operating system running on the hardware platform (type 2). A secure virtualization platform is one that combines a type 1 hypervisor with a small separation kernel to provide secure isolation of the MEDS · August 2010 · 21

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virtual machines and offer real-time performance and determinism when required.

The Wireless Patient Let’s look at a practical application of this technology. When monitoring vital signs such as EKG and blood oxygenation during a patient’s hospital stay, numerous sensors must be attached to the body. Frequently this results in an awkward and uncomfortable tangle of wires. To help untether patients, the wires could be eliminated by using Bluetooth wireless biometric sensors. These sensors could then communicate their data to a single workstation. Within that workstation would be a virtualized environment running one or multiple virtual machines dedicated to the real-time monitoring and analysis of the patient. The heart rate sensor would report its data in one VM while the blood oxygenation sensor would connect to another VM, and so on.

Each of these VMs would run either an RTOS or a GPOS like Linux, with real-time scheduling and determinism guaranteed by the underlying separation kernel. The information from all of the patient sensors could then be graphically portrayed for visual monitoring in a familiar Windows environment running in another VM. And all of them could run on the same workstation. The same Windows VM might also be used to connect local storage of patient data, or possibly the hospital network. The use of dedicated virtual machines means that the monitoring and analysis subsystem cannot be seen or compromised. Whatever occurs with the user interface or the network will not jeopardize the security or performance of the patient monitoring system. The data transfers from one subsystem to another are done in a controlled way and a controlled direction (Figure 1).

Software virtualization platforms are available for both single or multicore architectures. These platforms can take advantage of the hardware-assisted virtualization, available on modern Intel processor architectures for increased performance and security. The latest iterations of this platform, such as the LynxSecure 4.0 product from LynuxWorks, can sup22 · MEDS · August 2010

port both asymmetric multiprocessing (ASMP) and symmetric multiprocessing (SMP) virtualized (or guest) OSs offering optimized system performance.

To show how these technologies can be used, LynuxWorks and Portwell, Inc. teamed up to create a proof-ofconcept (PoC) wireless sensor platform for hospitals based on Intel technology, very much like the example above. The platform uses the Portwell WADE-8067, an Intel Core2 Duo processor-based Mini-ITX board. Running on the board, LynxSecure from LynuxWorks provides state-of-the-art software virtualization technology that makes it possible to securely run both a Linux operating system and an unmodified Windows operating system in parallel on the platform (Figure 2). The solution can connect more than 25 wireless biometric sensors and supports rich graphics display. Equally important, it leverages hardware-assisted Intel Virtualization Technology (Intel VT) to isolate and partition two different operating systems with their data and resources, and controls information flow between these partitions to ensure data integrity.

The PoC demonstrates a means whereby medical equipment manufacturers can quickly port legacy wired sensor applications to a new wireless multicore platform. The Windows operating system, for example, is used to provide the environment for graphical user interfaces (GUI) and other open applications.

The new virtualization technology offers medical device manufacturers a platform to safely and securely meet the complex requirements of the healthcare industry. Virtualization increases reliability by allowing developers to run safety-critical code in safe, virtualized execution environments that isolate different work loads and prevent them from interfering with one another. It improves data security and system integrity because the hypervisor adds a layer of protection by controlling memory boundaries and preventing an application (e.g., rogue software) from accessing the data regions of other applications. Virtualization enables reuse of legacy applications with little or no porting effort because applications can run on their native OS.

By using a COTS solution, manufacturers can start with a proven design that lowers development risk and shortens time-to-market.

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

LynuxWorks San Jose, CA. (408) 979-3900. [www.lynuxworks.com].

Portwell Fremont, CA. (510) 403-3399. [www.portwell.com].

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Health Care 24/7/365

The New World of Home Health Telemonitoring Monitoring patient vital signs in their homes can lead to better health care at lower cost. However, designers must be ready to address a set of design challenges that are unique among medical devices.

by Alan Cohen, Logic PD

T

oday’s increased quality of medical care comes with a price— higher costs. Remote diagnosis and treatment of illness is fast becoming the leading trend in the medical technology industry. Telemedicine promises increased health care quality while reducing costs. In particular, home health telemonitoring is a rapidly growing segment in both revenue and research & development funding.

Frost & Sullivan estimates the home telemonitoring market will see $260 million in sales in 2010, growing at 24% per year. Additionally, the American Recovery

and Reinvestment Act of 2009 provides for $20 billion in R&D funding for new medical technologies, with telemonitoring prominently called out as one of the target technologies Why Home Healthcare?

Regular automated monitoring of patient vital signs can alert health care professionals to emerging problems so that medical intervention can take place early, when it is typically the more effective and less costly.

Home telemonitoring is used for managing a variety of conditions. For example, patients with congestive heart failure

can have their weight monitored. A sudden spike in weight can indicate fluid buildup due to a worsening condition. If caught early, treatment is more likely to be easily managed and hospitalizations reduced.

Patients with diabetes can be monitored to make sure they regularly check their blood glucose levels and maintain these levels within a healthy range. Detected problems lead to a discussion with the patient on ways to improve their diet. Stable blood glucose control has been demonstrated to greatly reduce grave complications of diabetes, such as heart disease and blindness.

Unexplained fainting spells and other symptoms may indicate transient cardiac problems, which can be difficult to diagnose because they may occur irregularly, e.g. for only a few moments every few months.

By wearing a small electrocardiograph device that continuously sends data for review,

Figure 1. Block diagram of a typical home telemonitoring system. Data from a number of sensors in the home is aggregated and held by the base station, and eventually transmitted to the data center for storage and review.

24 · MEDS · August 2010

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medical professionals will catch patients having any cardiac problems in real time.

Telemonitoring: Systems View In a typical telemonitoring system (Figure 1), a patient generally uses various physician-prescribed devices as necessary, such as a blood pressure cuff and glucose meter to monitor their specific conditions— we’ll generically refer to these as sensors.

Different patients are prescribed different sensors as appropriate to their specific needs.

Sensors transmit collected data, either wirelessly or via cable, to a base station in the home. The base station, in turn, aggregates this data and regularly transmits it back to a central location for storage and analysis. In some implementations, patient questionnaires may also be sent to the base station, and results transmitted back.

For designers and manufacturers, home health telemonitoring systems occupy a unique niche. They are medical devices rigorously regulated by the FDA. However, this market segment, in certain respects, is a hybrid between medical devices and consumer products because end-users include patients and others, not just medical professionals. As a result, as insurance reimbursement for home telemonitoring evolves, these devices are more cost-sensitive than most other medical devices. Production volumes are typically higher than they are for most medical devices but lower than for typical consumer devices.

The “medical device” consists of more than just electronics in an enclosure—it includes a complex infrastructure featuring local- and wide-area networking, a sophisticated back-end database, analysis software used by medical professionals and so forth. Creating these devices presents several challenges that the designer must deal with.

The Product Experience Engineers and designers who develop medical devices are typically accustomed to addressing the needs of well-educated and expert medical professionals. Medical professionals have an important role in home telemonitoring, but two other constituencies must also be considered: the patients and the installers.

Figure 2. Classes of devices defined in the Continua design guidelines.

Patients include people who may have a high school education or less and are typically older and often have disabilities including visual and hearing impairment, and cognitive issues.

Installers and/or technical support are the individuals who will get the system up and functioning in the patient’s home.

Background and training of these people may vary greatly here, ranging from medical professionals to dedicated installation technicians. In some cases, the patient or family may perform the installation.

The case for a successful user experience is made stronger by the FDA’s growing emphasis on human factors as a key element in device design—in a growing number of cases, product recalls have been initiated solely due to a confusing design that makes errors likely. The general approach for success here is to follow a human-centered design and be empathetic to the users. Basic design principles include: • Delivering a user experience that integrates into the typical behaviors and environment of the end user. By lowering the effort required to adopt a device, users are more likely to stay in compliance and the device is better able to deliver the intended benefits.

• Providing timely feedback and status indication. Multi-sensory feedback is crucial for many elderly users because of their degrading physi-

ological functions. “Quick and at a glance” status screens are also highly desirable to people who need to constantly monitor their health condition.

• Testing with users early and frequently throughout the development process. Even the best design intent can sometimes create adverse effects. The only proven approach for reducing/minimizing design errors is to prototype the design and take it to the users for feedback.

Device Communications There are many brands and models of sensors for measuring vital signs (blood pressure cuffs, scales, etc.) that support wired or wireless connectivity. Unfortunately, the market is quite fragmented with regard to means of communication. USB, RS-232, Bluetooth and proprietary wired and wireless technologies are all in widespread use.

This poses a challenge to the designer of the base station that receives, aggregates and forwards measurement.

Fortunately, there is a growing effort toward standardizing the communications methods used by these devices. The Continua Alliance is an association of roughly 200 manufacturers of medical devices and supporting industries (contract design, software, electronic components, pharmaceutical, etc.), with a mission: “To establish a system of interoperable personal telehealth solutions that fosters indeMEDS · August 2010 · 25

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pendence and empowers people and organizations to better manage health and wellness.”

As part of its mission, Continua has developed standard protocols for communications between monitoring equipment and base stations. These protocols utilize USB and wireless Bluetooth, ZigBee and Bluetooth Low Energy technologies to support interoperability. For example, any base station that supports the Continua standard on Bluetooth should be able to operate with any peripheral that supports that standard. Continua adoption continues to ramp up with about 15 devices certified to date. The Continua design standards are ambitious and broad, including local- and wide-area communications in a number of usage cases. Figures 2 and 3 demonstrate the Continua model of interconnectivity.

One of the most challenging pieces of the home telehealth game is transmitting data from the base station to the central monitoring station. A variety of communication technologies can be used, including telephone modem, Internet (via Wi-Fi or Ethernet) and cellular modem. No single Figure 3. Interconnectivity between Continua device classes.

26 · MEDS · August 2010

technology will work in all situations so designs should support multiple technologies.

Care must be taken to ensure reliability as well as adherence to privacy standards such as the Health Insurance Portability and Accountability Act (HIPAA).

Controlling Cost As in many areas of medicine, insurance reimbursement for telemonitoring lags somewhat behind the technology. For this reason, controlling device costs is critical; there are several strategies that can be helpful here.

Particularly in the medical device world, bringing a product to market is often thought of as a two-step process—first design the product, then move to manufacturing. However, close collaboration between the designers and manufacturing during the development process can lead to important cost savings. Most obviously, this helps to ensure easy manufacturability, which translates into lower unit costs and higher reliability. Also, using a manufacturer’s supply chain resources during the design phase to negotiate volume component costs, before design-in, can lead to less obvious but potentially very substantial cost savings. For example, a manufacturer’s buyers can work with multiple vendors and distributors to obtain pricing for, say, Bluetooth modules, prior to a part being selected and designed in.

As with all medical devices, obtaining commitments on the extended availability of components is critical—the need to switch to a new part once manufacturing commences not only requires a change in design, it also requires a new round of verification testing. However, a conundrum exists in that the lowest-priced parts are often those that become obsolete the soonest. In many cases, it makes sense to use commercially manufactured modules that implement higher level functions rather than going with a “from scratch” approach. Some module manufacturers provide value through using low-cost parts yet guaranteeing availability for as long as 10 years by internally managing any changes due to part obsolescence.

Since changes are managed within the module, they have little or no effect on the rest of the device and reduce the need for redesign and reverification.

System Complexity and Verification In the case of a home telemonitoring system, the “medical device” is much more than a box that rolls out of the factory. Rather, it consists of many subsystems, often from many vendors.Various sensors and communications technologies may be employed for different patient installations. Computers and telecommunications equipment make up part of the picture, and these may need to be upgraded or otherwise altered over time, e.g., as bug-fix patches are released by a software manufacturer.

As these are FDA-controlled systems, the manufacturer of telehealth systems must ensure proper verification testing, and this can be a challenge that is not often appreciated in advance. Given the number of combinations of devices that can be used, and the regularity in which it may be necessary to change out at least some hardware and/or software, the testing burden can quickly become a very substantial chore. It’s best to craft a modular design and verification test strategy from the start of system design, so when the inevitable changes occur, testing is isolated as much as possible to only those parts that change.

Logic PD Minneapolis, MN, (612) 672-9495. [www.logicpd.com].

Continua Alliance Beaverton, OR. (503) 619-0867. [www.continuaalliance.org].

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