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MEDICAL ELECTRONIC DEVICE SOLUTIONS MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

WEARABLE

MEDICAL ELECTRONIC DEVICE SOLUTIONS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

DEVICES

MEDICAL ELECTRONIC DEVICE SOLUTIONS

Connect Patient to Care System

MEDS MEDICAL ELECTRONIC DEVICE SOLUTIONS

UP FRONT

Small I/O Modules Power Portable Monitors

FOCUS

Meeting the Software Quality Challenge

PULSE

Active Management Technology Smoothes the Connected Hospital An RTC Group Publication

A Supplement to RTC magazine


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INNOVATORS START HERE.


MEDS CONTENTS

MEDICAL ELECTRONIC DEVICE SOLUTIONS

JANUARY 2012 UP FRONT

PULSE

5

14

publisher’s letter

The Body Gateway: mHealth Platform for Wearable Devices Vanni Saviotti, STMicroelectronics

Hopes and Dreams for 2012 John Koon

6 editorial

Dealing with Data—Put it in Pictures... on My Phone Tom Williams

FOCUS 8 NEWS & products

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

18 Pico-I/O Powers Portable Patient Monitors Chris Persidok, ACCES I/O Products

24 Meet Embedded Software Quality Challenges in Medical Device Development Ido Sarig, Wind River

30 Active Management Technology Takes the Pain out of Connected Healthcare Clayton Tucker & Keith Williamson, Emerson Network Power

M

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

SPONSORS Acces I/O Products...................................13 Axiomtek.................................................................22 Exl Pharma..........................................................23 Express Manufacturing...................36 Green Hills Software.................................7 Hittite Microwave.........................................21 Innovative Integration........................27 MSC Embedded Inc..................................11 One Stop Systems..................................... 9 RTECC...........................................................................33 SynQor........................................................................35 TDI Power...............................................................28 Wind River................................................................2

digital subscriptions available

www.medsmag.com

January 2012 MEDS Magazine

3


GO ONLINE FOR MORE ARTICLES FROM MEDS www.medsmagazine.com

MEDS MEDICAL ELECTRONIC DEVICE SOLUTIONS

PRESIDENT

John Reardon, johnr@rtcgroup.com

Wireless Health

PUBLISHER

John Koon, johnk@rtcgroup.com

Special Report: Wireless Health 2011 Conference, San Diego

EDITORIAL

Robots

MANAGING EDITOR Sandra Sillion, sandras@rtcgroup.com

Robots Designed to Look Like a Train as They Deliver Food to Sick Children throughout the Hospital Innovation Hittite’s New Octal ADCs Enable Significant Power Savings in Next Generation Medical Ultrasound Systems RFID Can Medical Devices and RFID Peacefully Coexist? Safety Compliance

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

COPY EDITOR Rochelle Cohn

ART/PRODUCTION ART DIRECTOR Kirsten Wyatt, kirstenw@rtcgroup.com GRAPHIC DESIGNER Maream Milik, mareamm@rtcgroup.com WEB DEVELOPER Hari Nayar, harin@rtcgroup.com

ADVERTISING/WEB ADVERTISING VP OF MARKETING Aaron Foellmi, aaronf@rtcgroup.com WESTERN REGIONAL ADVERTISING MANAGER Stacy Mannik, stacym@rtcgroup.com (949) 226-2024 MIDWEST & INTERNATIONAL ADVERTISING MANAGER Mark Dunaway, markd@rtcgroup.com (949) 226-2023 EASTERN REGIONAL ADVERTISING MANAGER Shandi Ricciotti, shandir@rtcgroup.com (949) 573-7660

BILLING

Executive Overview of FDA Medical Device Approval Requirements

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

Interview

To Contact RTC Group and MEDS magazine:

Interview with Chuck Parker, Executive Director of Continua Health Alliance

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

Guidelines FDA to Seek Public Comment on IOM Recommendations

4

MEDS Magazine January 2012

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.


UP FRONT

Hopes and Dreams for 2012

N

obody likes to stay in the hospital. Not adults. Not kids. That’s why it was so wonderful to learn that the Boston Children’s Hospital has added some fun to the otherwise dreadful experiences. Disguised as a choo choo train, a robot cart delivers meals and medicines to various patients in the hospital. They are also very polite; when they detect the busy nurses running around the hallway, they stop and let them pass first. These trains are the brainchild of Aethon. [www.youtube.com/watch?v=AfLxsxlMXao] Physical rehabilitation can also be difficult, but now it can include fun and games. A recent joint research project between USC and UCLA (yes, they actually cooperated together!) demonstrates a software game called “Jewel Fetching” in which the patient moves both the arm and the fingers in a three-dimensional motion to fetch the jewel that appears on the display monitor. Once the jewel is retrieved, the display makes a celebratory sound and displays shining light. This positive feedback encourages the patient to continue to play, and therefore, rehabilitate his/her injury. I like to call it the “magic glove” and I hope to keep track of the development of the project. I wish them great success. ]www.wirelesshealth2011.blogspot.com] On the device side, we will see new innovations solving big problems in 2012. At the recent Wireless Health Conference 2011, Belgium-based Imec demonstrated a new ECG patch that allows clinicians to remotely monitor the ECG rhythm of a patient almost 24 hours a day. Patients are no longer required to stay in the hospital for observation. The hope and dream I have is that bright developers will continue to work tirelessly to come up with brilliant medical device ideas that solve big problems. A panel discussion from the recent Innovate California symposium on medical innovation encouraged the community to work together to preserve its leadership in the biomedical segment of the world. There was a tradeoff between risk and safety. One can test a product/drug for a long time to increase its safety margin, but might lose the advantage that same product/drug may bring to the community. There may be a need to start a dialog about risk management and tradeoffs in the medical community.

JOHN KOON Publisher

2012 2012 is now upon us. MEDS will work with our medical electronic community (Continua, AAMI, MD PnP, FDA, IEC, Sterling Smartware and many others) to continue to search for solutions for current medical problems. We learn from our community that the key to solving problems is good information. Below are the four areas on which MEDS will focus in 2012: • Medical Electronic Device Design • Safety and FDA Compliance • Medical Electronics Innovation • Product Reliability and Quality of Service (QoS) Additionally, for information on our four MEDS events in 2012, please visit www.medsevents.com. Join us in the search for great MEDS solutions.

Call to Action: Subscribe to the informative print and online magazine: www.medsmag.com. Attend the MEDS events and connect with your peers: www.medsevents.com. Stay informed and get involved.

January 2012 MEDS Magazine

5


UP FRONT

Dealing with Data—Put it in Pictures... on My Phone

I

Tom Williams Editor-in-Chief

6

MEDS Magazine January 2012

recently accompanied my wife to a doctor appointment after which I was chatting with the doctor about some of the advances we were seeing in medical electronics. One cannot always expect a working physician to be up on the latest developments even in equipment that is currently on the market, let alone the sort of advanced technologies that are being discussed in publications like MEDS. So I was telling him about some of the device interfaces and imaging technologies that are starting to link medical instruments with commonly available consumer devices like smartphones and tablets. He calmly pulled out his iPhone, punched in something on the screen to a series of beeps, passed it up and down in front of my wife’s body, and to my amazement showed me a set of graphs and images on the phone’s screen. When he saw that I was suitably impressed, he confessed that it was a toy Star Trek tricorder app that he had downloaded. But the lesson I take from that little incident is that for a brief moment there, he had me believing it. I am reminded that the very idea that we could have powerful, handheld medical devices actually came from a pair of stainless steel salt and pepper shakers that were used to portray a diagnostic device in the early episodes of that TV show in the mid-1960s. Now we simply accept and expect such technology. And we expect to see it presented graphically. The old saying that a picture is worth a thousand words is being turned around to go something like, “Ten megabytes is only useful as a picture.” By that I mean that we are experiencing a trend where even small sensors and devices, many of which may be wearable, present huge amounts of data that can best be presented in graphical form or as images for diagnostic comprehension. Fortunately we are being aided by a generation of very small, low-power processors that incorporate sophisticated graphics processing on chip. It is a truism that the highest-end graphics were developed for the gaming industry and only such volumes made them affordable for high-end military applications. By the same token, the proliferation of such consumer devices as smartphones and tablets has spurred the development of processors like Intel’s Atom family, the very low-power and high-performance variations in the ARM arena. The resulting volumes have made such devices affordable, and they can now be used for the much lower-volume world of medical electronics. With the technology and its proliferation has come the level of expectation. Medical personnel, like any other consumers, expect at least the same level of performance that they know from their phones and tablets to be available on the devices they use in their profession. Now they even expect to be able to use those same phones and tablets in their work. How this will all play out with regulatory issues appears to still be an open question, but the trend is happening and it will have to be dealt with as well. It is not only a matter of expectations; it is also a matter of necessity. Our devices are producing vast amounts of data that is vital to healthcare and life-saving procedures. We have the technical capability to process and present it in useful form for medical professionals. We must do so in a safe, reliable and certified manner.


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FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Philips Opens Hospital Research Area to Develop Innovative Healing Environments Royal Philips Electronics has announced that it is stepping up its healthcare research into healing environments by opening a dedicated research facility at its Eindhoven-based Research Laboratories. Based on Philips’ understanding of the hospital patient experience and implemented through the intelligent use of technology, the healing environments concepts aim to accelerate and improve treatment outcomes, while simultaneously reducing the stress and anxiety associated with hospitalization and hospital-based treatment. One of the concepts that is being studied uses soothing lighting and calming video images and sounds, and is aimed at reducing the stress levels of patients who are in the preparation room awaiting a PET-CT scan, an imaging technology that is predominantly used to facilitate the diagnosis and staging of cancer. The PET-CT preparation room has been identified as one of the most stressful environments for cancer patients. “There is an increasing body of evidence to suggest that patient-friendly comforting environments not only reduce anxiety levels but also promote the healing process itself,” said Henk van Houten, general manager Philips Research. “The opening of the Hospital Area is a clear expression of our commitment to this important new area of healthcare research, which leverages Philips’ unique expertise in healthcare, lighting and consumer lifestyle. It is further evidence of Philips’ aim to deliver meaningful innovations that improve people’s lives.” As people’s access to information continues to increase, a new generation of patients is emerging who are knowledgeable about their medical conditions and therapy options, and therefore demand greater choice in where and how they are treated. As a result, hospitals are becoming increasingly people-focused to satisfy those demands. Offering an environment and an experience that helps patients cope with a difficult period in their lives is one way in which hospitals can achieve that objective.

Continua Health Alliance Releases 2011 Design Guidelines The Continua Health Alliance, the international non-profit, open industry organization of healthcare and technology companies, has announced the release of its 2011 Design Guidelines. The new guidelines further enhance the pathway for complete solutions based on Continua-certified products and services aimed at cultivating the ecosystem of personal connected healthcare solutions. The updated design guidelines outline industry standards and new specifications selected by the Alliance for devices, services and communications to ensure interoperability, further elaborate on Continua-specific implementations, and clarify options in underlying standards or specifications. The limited release is currently available to members, allowing them firsthand access to the international technology standards that the Alliance is founded upon. Among other features, the Continua 2011 Design Guidelines incorporate a Bluetooth Low Energy temperatures sensor device profile along with ZigBee networking functionality, which is extended to enable a single sensor-local area network (Sensor-LAN) device to communicate with multiple application hosting devices at the same time. There is also improved user identification guidance on the Wide Area Network (WAN) interface and improved consent management and non-repudiation on the Health Record Network (HRN) interface. The 2011 Design Guidelines are available to members or for purchase by non-members at www.continuaaliance.org.

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MEDS Magazine January 2012

Siemens’ Iterative Reconstruction Protocol Cleared by FDA A new generation of image reconstruction software and hardware has reportedly been developed within Siemens Healthcare’s initiative Agenda 2013, which allows for a robust reduction of radiation dose in CT examinations. And recently, Siemens Healthcare has announced that its computed tomography (CT) iterative reconstruction algorithm SAFIRE—Sinogram Affirmed Iterative Reconstruction—has been cleared for domestic sale by the U.S. Food and Drug Administration (FDA). Additionally, the use of projection raw data during the iterative image improvement process enables a reduction of subtle image artifacts and therefore a further improvement in general image quality. SAFIRE helps users reduce dose by up to 60% compared to previous filtered back projection techniques, as documented in the FDA clearance letter. SAFIRE’s extremely fast reconstruction speed of 20 images per second enables reconstruction of a typical high-resolution thorax examination of 30 cm in just 15 seconds. With this as-yetunmatched reconstruction performance, SAFIRE can be applied routinely in clinical practice. SAFIRE ties into the Siemens Healthcare global initiative Agenda 2013, which among other measures, focuses on driving the development of next-generation healthcare IT. “From a clinical perspective, SAFIRE helps to significantly reduce radiation exposure across the whole portfolio of clinical applications and continues to demonstrate Siemens’ commitment to deliver the best possible patient care at the lowest possible radiation dose,” said Elliot Fishman, MD, CT section chief of radiology at Johns Hopkins Medical Institutions in Baltimore, and a member of the SIERRA (Siemens Radiation Reduction Alliance) dose expert panel.


FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT GE’s Radiology Mobile Access Receives FDA Clearance for Advanced, Diagnostic CT and MR Image Review GE Healthcare has demonstrated new capabilities for its Centricity Radiology Mobile Access platform, enabling radiologists to use their iPad and iPhone devices to remotely diagnose select patient images from Centricity PACS. Centricity Radiology Mobile Access 2.0 is a mobile product with clearance for primary diagnosis that accesses images and reports from Centricity PACS. This new mode of access removes a sizable productivity barrier for an increasingly mobile field. “This application and its diagnostic clearance provide further validation of our continued investment in our Centricity PACS platform,” said Don Woodlock, vice president and general manager of GE Healthcare IT. “As a native application for the Apple iOS and Android operating systems, Centricity Radiology Mobile Access requires very little training and, we believe, provides a more productive user experience versus an emulated Windows application that was designed to be driven by a mouse. Today, Centricity PACS stores one in five exams in the U.S. These advanced wireless capabilities will only expand its utility.” The diagnostic clearance for Centricity Radiology Mobile Access 2.0 is limited to computed tomography and magnetic resonance exams on an iPad or iPhone when not in proximity to a PACS workstation.

250 Watt Medical Power Supply in Low Profile 3” x 5” Package A new series of AC/DC power supplies offers 250 watts of performance-packed design and is compliant to UL/cUL60601-1 and TUV 60601-1 medical safety standards. Units also bear the CE Mark and are RoHS compliant. This lowprofile PPWAM250 Series from Power Partners is suitable for a variety of patient vicinity medical and dental applications. The PPWAM250 Series accepts a 90-264VAC universal input. Single output models have regulated voltages ranging from 12 VDC to 48 VDC with no minimum load. The compact, 3” x 5” x 1.38” footprint (open frame model) makes the PPWAM250 Series an attractive choice for designs with space constraints. Units provide up to 250W of power with 17 CFM of forced air. The Series boasts high efficiencies greater than 85%, leakage currents as low as 300 µA at 264 VAC. Comprehensive protection circuitry, including overvoltage and short circuit protection, is inherent in the design. EMC Performance meets FCC and EN55011 Level B standards and units have an MTBF of 100,000 hours at full load. Units are priced with the PPWAM250 Series starting at $87.00 in OEM quantities. Power Partners, Hudson, MA. (978) 567-9600. [www.powerpartners-inc.com].

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MEDS Magazine January 2012

Full-flat Patient Terminal for Patient Bedside Systems A new flat panel patient terminal runs an Intel Atom D510 processor and is designed with a 15.6” wide, projective capacitive touch (PCT) full-flat glass panel. It has a sleek iPad look and feel, with customizable colors and icons. The PIT-1503W from Advantech is durable and easily cleanable with antibacterial cleaners, suitable for use in hospital patient rooms. It is lightweight and slim, easy for patients to move and personnel to stow, and it can bring entertainment as well as information to the patient bedside, increasing efficiency, improving patient wellbeing, and even adding revenue streams to the hospital. PIT-1503W features PCT touch technology, a quick and highly accurate multitouch system. Running Windows 7 or Linux, two-finger multi-touch can be used to rotate, flick images off-screen or zoom in and out. This allows for easy zooming and rotation of X-ray or patient images during a patient consultation. The full-flat panel is 7H-rated. It is highly resistant to scratches and can be kept clean with hospital-grade anti-bacterial cleaning solutions. Function keys are also accessible from under the glass panel and not subject to the wear and tear that can afflict membrane-covered keys. Light transmission of PIT-1503W’s PCT screen is excellent (90% compared to 80% from resistive touch technologies) and the increased multi-touch sensitivity makes it responsive as well as intuitive. Pricing starts at $1,092 per unit. Advantech, Irvine, CA. (949) 789-7178. [www.advantech.com].


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FOCUS

NEWS & PRODUCTS

A COLLECTION OF WHAT'S NEW, WHAT'S NOW AND WHAT'S NEXT Ultra-Low-Dose CT Technology with Greatly Improved Image Clarity GE Healthcare has announced 510(k) clearance of its new Computed Tomography (CT) technology, called Veo, which may help physicians deliver accurate diagnoses by enabling profound CT image clarity at dramatically lower dose. Veo represents what is called Model-based Iterative Reconstruction (MBIR) technique, and is already available on GE Discovery CT750 HD systems in Europe, Canada and regions of Asia. In fact, Veo has already been clinically shown to offer highly improved image clarity at yet unseen low dose levels. Current Veo users in Europe report successful chest CTs done with an equivalent amount of medical radiation dose as a chest x-ray, or less than one-tenth of one mSv. “With a clinical chest CT at 0.05 mSv, we produced images where we could see and analyze pathology,” said Professor Johan de Mey, Chair of the Radiology Department at University Hospital in Brussels, Belgium. “With Veo, we can conduct lower dose CT scans in children, too, and this is particularly important in groups that require continued follow-up, such as those with cystic fibrosis or lymphoma.” While complementing the robust imaging capabilities of GE’s advanced Adaptive Statistical Iterative Reconstruction (ASiR) technique, Veo represents a significant technological leap forward just as the topic of diagnostic medical radiation levels has come into the national spotlight. In clinical practice, the use of Veo may reduce CT patient dose depending on the clinical task, patient size, anatomical location and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task. GE Healthcare. [www.gehealthcare.com].

Software Platform for Medical Devices Complete with Compliance Documentation A new software platform for medical devices is part of a comprehensive software portfolio designed for medical device development, including those devices requiring premarket notification, U.S. Food and Drug Administration’s (FDA) 510(k), or the more stringent premarket approval. The Wind River Platform for Medical Devices is a commercial off-the-shelf (COTS) development and run-time platform enabling safety and security for medical devices. The Platform is built on Wind River’s VxWorks real-time operating system (RTOS), which has a track record for use in regulated medical devices that demand the highest levels of safety, reliability and performance. It also includes Wind River Workbench, a collection of embedded software development tools, as well as critical networking and middleware run-time technologies, such as IPsec, SSL, IPv6 and USB. Wind River Complementary Add-on Componets An essential component of the Platform is a comprehensive vendor qualification summary (VQS), which includes documented descriptions of the controls and processes Wind River uses to design and develop its platform components. The VQS is prepared in accordance with FDA quality system regulation 21CFR820.50 Purchasing Controls, which require manufacturers to evaluate suppliers for their ability to meet specified requirements, Wind River Platform for Medical Devices Components including quality requirements. Wind River offers a broad portfolio of technology products that form a complementary solution to Wind River Platform for Medical Devices, including: • Wind River Hypervisor, a high-performance embedded virtualization solution • Wind River Simics, a full system simulator enabling developers to simulate the functional behavior of their target hardware • Wind River Test Management, a test automation system • Wind River Tilcon Graphics Suite, a solution for the development and deployment of rich graphical user interfaces for embedded medical devices • Wind River Workbench On-Chip Debugging, a hardware-assisted debugging solution Wind River, Alameda, CA. (510) 748-4100. [www.windriver.com]. Wind River Workbench On-Chip Debugging Wind River Test Management

Wind River Services

Vendor Qualification Summary* Wind River Workbench

Networking, Middleware

• Core stack – TCP, IPv4/IPv6, UDP, QoS • Security – IPsec, IKE, SSL, cryptography • Connectivity – USB, WLAN • Management – SNMP, CLI, web server

VxWorks Core OS

• File systems, I/O subsystem • Drivers and driver management • Veritos Volume Manager services, error detection and reporting • Debug and instrumentation services

VxWorks Kernel

• Multi-core – SMP, AMP • Tasks, processes • Interrupts, exception handling • Timers, semaphores, mutex

Board Support Packages

* Available upon request

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MEDS Magazine January 2012

Partner Ecosystem Hardware/Software

Wind River Tilcon Graphics Suite • Host – GUI builder • Target (run-time) – Wind River Tilcon GUI Engine, API library low level • Graphics library – Media library, OpenGL 3D rendering library


PULSE

The Body Gateway: mHealth Platform for Wearable Devices Wearable medical devices offer a huge advantage in monitoring and early detection of symptoms. In order for them to fulfill their potential, they need a number of features to make them scalable, interoperable and more. by Vanni Saviotti, STMicroelectronics

T

he skyrocketing costs of healthcare have given rise to a rapidly growing segment: Mobile Health, or mHealth. mHealth technology is helping establish a continuum of care that encompasses genetic and dietary predisposition, risk factors, asymptomatic and active diseases. This enables new levels of efficiency in healthcare management by improving affordability, accessibility and quality of care with the final result of curbing costs for healthcare companies, providers and patients. Microtechnology companies ease this process by defining products, strategies and road maps that improve the capability of healthcare to address specific needs and personalization of services. Within the same context, platforms that ease the development of devices and that standardize their approval process are clearly needed. Such a platform, a general remote health monitoring system, would integrate a variety of components including a suite of sensors, a patient-wearable device for data processing and connectivity or body gateway, a host communication device along with a system of service and data repository

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MEDS Magazine January 2012

devices (Figure 1). The sensors suite is a set of on- and off-body sensors that monitor vital signs and physiological parameters such as electrocardiogram (ECG), heart rate, body activity, blood pressure and weight to name a few. The body gateway device (BGW) is a wearable processing and connectivity unit that collects data from the sensors, performs initial processing, stores the data and prepares data for transmission over a network to the remote application server. The BGW device is responsible for sending alarms and messages to the user as well as for managing the overall interface between the user and the service provider. A host communication device is needed to form the bridge between the BGW device and the remote server. It is used by the BGW device to establish a network connection when data transmission is required. The network link is used by the host device to transfer data to and from the patient location to the remote application server. The device can host a user graphic interface for patient consultation purposes. Finally, the server repository and services architecture represents the hardware

and software remote processing unit that is responsible for establishing secure connections and authenticating the user, for collecting the data received by the BGW as well as for providing the functions of querying, monitoring and issuing alerts or messages to the user. These servers represent the aggregation center for service provision.

Framing a Wearable Device Platform Wearable devices are one of the pillars of an mHealth system. Their architecture integrates and shares a number of distinctive features that need to comply with defined rules and procedures through the design, verification and validation phases of the project. The most obvious feature of a wearable device platform is wearability, which relates to size, weight and ergonomic characteristics of devices. Microtechnologies and packaging solutions don’t pose severe limits to device miniaturization and form factors. Today devices can weigh less than 0.5 oz and body size is easily contained within 1.5”x 1.5”. This overcomes most of the ergonomic limitations presented by human body morphology. Examples are “wrist watch” devices for vital signs in fitness and wellness and “Electronic Patches” for monitoring chronic diseases. Solutions must be capable of following the course of the disease through on-thefly reconfiguration and without the need of on-site installation and service support.


PULSE

From the device manufacturers’ perspective, this requirement for scalability translates into a platform whose hardware can be incrementally upgraded and diversified to address different disease conditions. Finally, scalability will allow easy FDA approval procedures thanks to a pre-approved platform development process that avoids the need for repetitive and expensive tests and trials to validate each device. There must be a common medical nomenclature through all devices. This means interoperability among devices that translates into easy access for patients to interchangeable solutions and into more costcompetitive solutions. Continua Health Alliance (CHA) represents an ecosystem of more than 240 companies with the mission to develop interoperability guidelines to harmonize mHealth communication processes and data flow from patient to service provider. Along with interoperability must come connectivity. In mHealth this has two concurrent and interrelated characteristics: one is supporting technical requirements including data rate capacity, response/wake up time and reliable communication. The second is supporting functional requirements for optimal power management and longest battery life according to the type of service and specific application requirements. By adopting CHA-approved radio communication stacks (i.e., BT, BTLE, Zigbee) or those under approval (i.e., AZT, NFC, WIFI), it is possible to connect with a vast family of devices from different vendors and to get access to the large mHealth devices market. Since no two patients are alike, there must be an ability to provide solutions that can address each patient’s physiological diversity within the same disease conditions by leveraging the adjustment of parameters and control functions. Such personalization can be supported through technologies that allow on-the-fly adjustment of medical protocol parameters depending on drug efficacy and patient adherence. Personalization is enabled by technologies that allow the downloading and reprogramming of

Host Device Body Gateway

WAN

PAN

Care Server Internet

PAN

Internet

ADSL

PAN

Off-body sensors User IP Box

Doctor/User PC

Figure 1 mHealth system architecture

Category

CHF BGW Device

Platform

Physiological Parameters

ECG, HR, BR; ActLvl/BdyPos; Wt., BP;

ECG, HR, Arrh., BR; Wt., BP; ActLvl, BdyPos; temp, microphone, SaO2.

Data Recording

full disclosure: ECG,

configurable as needed

Data Offload

at least once per hour

configurable as needed

Clinical Protocol

configurable, integration

integration/programmable

Medical Compliance

IEC 60601 reviewed

Supporting FDA approval requirements

Battery Life

8-16 hours

1-4 weeks

Rechargeability

rechargeable by study staff

rechargeable by user | disposable

Impermeability

splash proof

water proof

Packaging

plastic box

flex circuit

Industrial Design

Square Box/“okay”

Appropriate

Patient User Interface

Laptop, Remote

SmartPhone app v9.0

Infrastructure

BT>Laptop>Single Database

Wireless >SmartPhone >G3|WiFi|Other >Server Infrastructure

Biocompatibility

allergenic/irritation potential

non-allergenic/non-irritant

Table 1 Device Platform Features

memories or through device disposability. Health care systems must provide a safe level of security, including patient privacy, through robust data encryption while avoiding temporary or local decryption of data that can affect the safety of the information chain. Security may also be handled

by adopting hardware solutions such as crypto card or dedicated smart cards that authenticate devices and patients. Also important is the proper implementation of disposability. Single-use solutions are more practical and user-friendly than non-disposable ones. The decision to January 2012 MEDS Magazine

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PULSE

Hardware block scheme

Battery charger

+ 3V

Voltage Regulator (analog)

Energy manager

2.8 V MicroSD

Voltage Regulator (digital)

128Mbit/1Gbit Flash

2.8 V INPUT

switch lead select

OUTPUT

3 Axis Accelerometer

I2C

Button

ADC

Electrogram V sense Bioimpedance V sense

SPI DAC RGB LED

STM32 Microcontroller

Buzzer Bioimpedance I inject

Photodiode or CMOS camera

Red/IR LED

MEMS mic. or accelerometer Temp/HeatFlux

USART3

(a)

Bluetooth module

Heart Rate

Breath Rate

Z meter Bioipedance

V meter ECG front-end

3axis accel.

Activity (walk)

Heart Rate

Breath Rate

Activity (muscle noise)

Breath Rate

Electrode noise

RED/IR led + Photodiode

Microphone

Heart Rate

Breath Rate

Heart Rate

Breath Rate

Temp/Heat flux

Sp O2

Metabolic Activity

Fusion Signal fusion (b) Reliable HR, BR, A

Figure 2 Electrical block diagram of BGW (a) and the fusion of signals from the sensor suite to the gateway (b).

go disposable is a trade-off process that involves costs, efficacy and effective patient advantage. Currently there is a clear trend toward a mixed solution that keeps the valuable and more expensive part (i.e., data memory, intelligence, connectivity parts) reusable and keeps the less expensive part or any part that needs to be frequently

16

MEDS Magazine January 2012

removed for physiological reasons (i.e., patches) disposable. Given the battery-operated nature of a wearable platform, energy efficiency falls within a general trend for microtechnology to provide highly efficient solutions with almost zero power consumption. This may be achieved through different converging

strategies, which includes reduction of the operating voltage, adoption of lower leakage technologies, proper partitioning of active/standby time, optimization of data handling and transmission. Finally, of course, there is regulatory compliance. Wearable medical devices must meet a number of rules and stan-


PULSE dards: EN 60601 dictates conditions for safety (electrical, electromagnetic, mechanical hazards); EN 62304 for software life cycle; EN 980 for labeling; EN 60529 for IP protection; ISO 14971 for risk management; ISO 10993 for biological evaluation; EC38 for ambulatory ECG performances and EC57 for algorithm testing. Having a flexible, scalable platform that conforms to all these standards is a demanding requirement but it adds the benefit of having both the platform and its hardware and software components compliant so that devices generated by that platform can easily go through the approval processes and procedures requested for FDA or EC.

Platform for mHealth Devices mHealth devices already on the market monitor vital signs as well as one or more physiological parameters addressing single (active or preventive) disease conditions. Most common target diseases are heart related such as atrial fibrillation, arrhythmia, or sleep apnea while parameters under observation are a combination of electrocardiogram (ECG), heart rate, body activity, blood pressure, temperature, respiration rate, SPO2 and/or weight. These devices can be either single or multiuse, and batteries may last from a minimum of one day to up to two or more weeks depending on the monitoring conditions. Most of these devices are not interoperable, nor scalable, with limited flexibility for personalization and in some cases do not support wireless connectivity. Accompanying each of the devices is a list of procedures, sometimes repeated for each device, which must be implemented to achieve full compliance with the application’s specifications and patient safety. Therefore, considering an architecture that could facilitate integration of the entire process would add remarkable value to a device’s project and validation process. This means a set of hardware and software components of a scalable architecture prevalidated according to regulated procedures and requirements must be defined. In this way, platform implementation becomes a recommended passage to generate devices with the extended capability to address multiple disease conditions through a diversified sensor suite and by both signal

fusion and parameter fusion processing capability to improve efficacy and ultimately the outcome of monitoring diseases. At the same time, compatibility among different solutions that may need to be adopted and implemented to address the early stage of a disease or for preventive purposes is preserved. All of the above is reflected through an alignment to the features presented in the device platform section above. The main areas of activity that need to be considered while developing a platform include packaging, the framework of the design and modularity. The packaging issue has two parts. One is for items that are for single use such as the patch itself, to allow easy replacement of parts that come in contact with the skin. The second part—the module—can be reused to keep memory of the evolving health conditions and allow further data post processing. The patch and module need to comply with robustness, humidity and wetness requirements according to standards. The design framework needs to be based on a layered architecture. The software part with all its sub-layers including connectivity stack, RTOS, interoperability layers, medical protocols, data aggregation library, etc., must be 510(k) pre-approved and compliant with healthcare device safety and design robustness standards. The hardware part must be composed of components and boards compliant to the required quality and safety rules. And the solutions must be modular in order to scale both software and hardware components according to application needs. From a hardware perspective, this means having access to a scalable family of microcontrollers compatible in terms of firmware and pinout and that can be tailored around application requirements to meet an optimal power budget. A sensor suite to extend its capability would include accelerometer, temperature sense, microphone, impedance measurement, ECG, IR and photodiode and/or weight scale. This same scalability applies to the software cells library modularity. An example of such a platform is exemplified by a first BGW device targeting CHF applications as shown in Figure 2. The platform is intended to support singularly, or in combination, disease conditions

such as Metabolic Syndrome (Obesity) diagnostics, Obstructive Sleep Apnea (OSA), Atrial Fibrillation (AF) and Biofluidic Analytes. Table 1 lists the complete features of the platform.

Drivers to mHealth Devices Platform Evolution Electronic patches used for long-term monitoring of multiple parameters will bring important benefits, including early warnings based on detection of rare but significant anomalous events, verification of long-term effects of therapy and medication, and statistical analysis for medical research. Further analysis of the application’s requirements will reduce the amount of data transmitted and increase the amount of data pre-processing in the device. Power management granularity is another key avenue of exploration driving the development of lower power libraries to reduce the energy per bit figures. We can envisage an order of magnitude lower power consumption, which would open the door to devices powered by energy harvesting technologies rather than batteries. The introduction of System on Chip (SoC) solutions will help contain costs and reduce both size and weight of BGW devices. Healthcare consumerism will lower costs, providing access to a larger number of people. In the prevention and prediction domain, there is a clear need for monitoring physiological parameters to detect the presence of risk factors and of asymptomatic diseases. Most such devices will not need an FDA approval and possibly will not be constrained by traditional reimbursement practices. Diabetes management, where the ratio between population at risk and population suffering from diabetes is 10 to 1, and sleep apnea, are examples of the potential of healthcare consumerism. More patches will become disposable when the cost becomes low enough and the increasing volumes will accelerate this process. STMicroelectronics Geneva, Switzerland. [www.si.com].

January 2012 MEDS Magazine

17


PULSE

Pico-I/O Powers Portable Patient Monitors Advances in x86 processors, combined with a right-sized Pico-I/O peripheral card ecosystem based upon USB, make it feasible to meet the major requirements of portable patient monitors with fully off-the-shelf building blocks. by Chris Persidok, ACCES I/O Products

P

ortable medical devices have used custom CPUs and custom I/O blocks for years. From the analog front end to the microcontroller or RISC processor back end, the only way to meet cost, size and feature requirements was with full custom hardware and software. But now, stretched engineering resources, consideration of core competencies, time-to-market pressures, and ubiquitous wired and wireless network connectivity expectations are forcing OEMs to reconsider development methodologies and processor architectures. Fortunately, a new series of tiny PicoI/O modules (Figure 1) is poised to allow next-generation patient monitors to take on all the desirable graphics and connectivity characteristics of notebook or tablet computers, using a standardized bus interface to integrate with small, long lifecycle embedded x86 single board computers. Pico-I/O modules stacked on top of tiny x86 SBCs can provide the modularity, signal conversion, isolation (protecting the patient from voltages), and compact feature density to take patient monitors, bedside monitors, instruments and similar products down to the next level.

Requirements Portable patient monitors must be small, very lightweight and draw very little

18

MEDS Magazine January 2012

power to run continuously for hours on an internal battery. They must interface to small to mid-size LCDs preferably with LED backlight instead of CCFL, and share data and generate alerts over the hospital’s secure wireless network. Sensors and transducers in the form of attached probes supply analog voltage waveforms (DC to several kilohertz) to be captured and displayed on the monitor, and any irregularities need to trigger alerts and alarms. The electronics must fit into a cavity inside the enclosure that is essentially the dimensions of the LCD and just several inches deep. The depth is large enough to allow the monitor to sit on a bedside table or a counter without easily tipping over. So rather than a large flat custom motherboard assembly, a stack-up of several boards better fits the rectangular prism cavity. Pin header connectors on the boards allow just the needed I/O to be cabled to external connectors. Until recently, the size, weight and power draw of x86 embedded processors kept them away from these designs. The combination of new off-the-shelf low-power embedded x86 SBCs and Pico-I/O modules allows a complete monitor solution to be developed, utilizing robust PC networking, graphics and audio circuitry, yet providing additional expansion and customization opportunities for the OEM to differentiate.

Developers would like to leverage the robust desktop PC platform for shorter development cycles, long-term code maintainability and ever-increasing OS features. RISC-based designs typically require greater up-front design and tool costs, which pay for themselves years later in per-unit cost savings only after thousands of units have shipped. Due to cost and time-to-market considerations, developers’ needs carry much more weight in architecture decisions now. Operating systems like Linux and Windows Embedded Standard 7 (WES7) can be scaled down to a footprint appropriate for a lightweight portable device, and yet still offer the luxuries of robust desktop-class operating systems. All that’s needed is an off-the-shelf embedded computer with a flexible expansion interface for Pico-I/O, and design cycles can be reduced substantially while desktop-style features can be introduced into this product category. Advances in x86 processors, including low-power Intel Atom and VIA Nano CPUs, combined with a new Pico-I/O offthe-shelf analog and digital I/O card ecosystem based upon USB, make it finally feasible to reduce size, weight, power and cost of off-the-shelf x86 building blocks in order to meet all major requirements of portable patient monitors.

Pico-I/O Unveiled At the heart of Pico-I/O is its standardized Stackable Unified Module Interconnect Technology (SUMIT) expansion interface. In late 2007 a group of embedded SBC and I/O manufacturers formed the Small Form Factor Special Interest Group (SFF-SIG) to help proliferate the


PULSE

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Figure 2 Space-saving  yet stackable, Pico-I/O provides sufficient inputs and outputs without undesirable bulk and weight.

Figure 1 At less than 2.9” x 2.4”, Pico-I/O is the tiniest and lightest stackable I/O standard. The SUMMIT I/O connector is on the bottom edge.

success of USB-based industrial I/O into deeply embedded applications. SUMIT is the latest, smallest, stacking form factor for embedded I/O since the PC/104 standard. Created for the long lifecycle high-reliability embedded systems market, SUMIT features 52-pin fine pitch 0.635 mm connectors from Samtec’s high-speed board-toboard family with built-in ground plane. A board-to-board mated pair (one connector on the SBC, the other on Pico-I/O) forms gas-tight reliable connections over shock and vibration without the concerns of thin gold plating rubbing off of gold-plated card edge mezzanine cards. In addition to four USB channels, the SUMIT-A connector shown at the bottom center of Figure 1 also brings out standard PC buses including a PCI Express x1 link, LPC Bus, SPI Bus and I2C / SMBus, all in the lowest pin count stackable standard on the market to conserve space. PicoI/O cards are available with serial ports

(UARTs), analog in/out, digital I/O, input and output isolation, relays and counters/ timers. The size, only 60 x 72 mm, puts Pico-I/O at exactly half the area of the previous smallest stackable I/O standard (Figure 2). Up to four Pico-I/O modules can be mounted together, and more if some of the additional SUMIT buses are used. The I/O cards and SUMIT-expandable SBCs provide for end-to-end USB full-speed and high-speed compatibility.

Interfacing to USB While USB has greatly simplified the way peripherals attach to desktop and laptop PCs, its use in the small form factor embedded arena is just emerging. Fortunately, USB data acquisition (DAQ) “dongles” that attach to PCs are growing rapidly in all types of environments from factories to warehouses to labs. The benefit to the medical community is a wealth of proven, rugged, reliable USB analog and

digital I/O from the industrial automation market. The proven circuits and x86-hostbased device drivers carry straight across to the long lifecycle embedded computer market, as long as a mezzanine-style mounting is available to eliminate the USB cable while moving the I/O inside the system as required for medical patient monitors. USB DAQ devices are perfect for a variety of applications requiring monitoring, control and industrial serial communications. USB is by far the most popular and compatible standard data interface for directly connecting to PCs. New features are added and tested in hours or days, not months. Initial proof-of-concept testing, demonstrations and application development are immediate, starting with a standalone USB DAQ dongle connected to a laptop computer via a USB port. USB is the preferred I/O interface because of its popularity and ease of use. Unlike a bus, USB can be used in a star configuration where each I/O board does not have to be together or share the same bandwidth. USB 2.0 easily has the data bandwidth and latency to handle analog sampling at a mere kHz rate. Also, all USB dongle products can interface with all PCs, January 2012 MEDS Magazine

19


PULSE

26-PIN INPUT CONNECTOR

SBCs and even microcontrollers that support the USB standard. When it’s time to finalize the new patient monitor, the dongle is replaced with the corresponding Pico-I/O card and the laptop is replaced by a mobile- or ultra-mobile-based embedded SBC, leaving just the mechanical design for mounting the LCD, backlight, boards, power supply, speaker and external probes connectors.

Pairing Pico with the Appropriate Platform Although a custom motherboard can be designed with a SUMIT expansion interface for Pico-I/O, new small form factor x86 SBCs are coming along that would make most designers take this option and stick to core competencies—their medical application. As shown in Figure 3, the Via C7-based

16-BIT ADC

ANALOG INPUTS

CHANNEL SELECT

COMPLIANCE VOLTAGE IN (PWR+) USB 2.0 / 1.1 INTERFACE

OPTO ISOLATOR Isolated Input Circuit (x8)

SCHMITT TRIGGER BUFFER

FET SWITCH

OUTPUT(+)

WITH MICROCONTROLLER

RETURN(-)

16-PIN OITPUT CONNECTOR

Figure 3 A  terraced approach with vertical headers simplifies headers while reducing overall volume occupied.

EPIA-P710 Pico-ITXe SBC (bottom) has both SUMIT-A and SUMIT-B expansion connectors. Pico-I/O modules are stackable for easy installation into OEM equipment and eliminate the labor and stabilization required with vertical plug-in boards. Products based on the Pico-ITXe specification act as the perfect base board, taking advantage of an intelligent board layout that greatly aids both heat dissipation and stackability, all within a remarkably small footprint. Intel’s processors and chipsets are just now reaching the small size and integration needed to fit on this SBC size. The Pico-ITXe Specification is also available from the SFF-SIG. The Pico-I/O module draws all required power from the SUMIT connector of the embedded computer. A USB power switch limits the entire current draw to 500 mA per the USB standard. The Pico-I/O size specification (60 x 72 mm = 4320 sq. mm) is exactly half of the PCB area of the popular PC/104 (90 x 96 mm = 8640 sq. mm) embedded board standard. The small size and easy connection makes the unit an excellent choice for a variety of embedded applications such as mobile, robotics, kiosks, and embedded medical and machine equipment. As an example, the Pico-II8IDO4A (by Acces I/O Products) is an OEM USB

Isolated Output Circuit (x4)

JUMPER SELECTED FILTER

SUMIT STACKING CONNECTOR

Figure 4 SUMIT’s USB interface and a USB-equipped microcontroller bridge medical I/O to embedded SBCs.

20

MEDS Magazine January 2012

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PULSE solution for adding embedded reliable and robust multifunction I/O capabilities to any embedded computer supporting a SUMIT expansion interface. Featuring four solid state FET outputs, eight optically isolated digital inputs and two high-resolution analog inputs, the unit is the smallest of its kind for multifunction control and monitoring using USB. The FET outputs can switch customer supplied voltages from 5 to 34V, at up to 3A. The outputs are deenergized at power-up to prevent an unintended control output signal. The output connections are available via a 16-pin IDC vertical header type connector. The digital inputs accept AC or DC signals as high as 32 volts and are interfaced via a 26-pin IDC-type vertical header. In addition, jumper selectable filtering per input channel provides for AC or voltage transients. The pinout allows a simple accessory cable to interface to one of the many available external screw terminal boards, or go cable-less and use a direct plug-in screw terminal like P/N TBK-26. Two analog inputs are also available on the 26-pin connector for a

well-rounded multifunction PICO solution.

compact

Embedded Software to Boot As an embedded operating system with rich GUI, file system, peripheral and connectivity features, Windows XP Embedded, along with its replacement, the new WES 7, can be reduced in memory footprint to keep down the cost of a flash-based system, while easing the utilization demands of the modest-performance low power and ultralow power processor series (below 10 watts). For efficiency, the Pico-II8IDO4A utilizes a high-speed custom function driver optimized for a maximum data throughput that is 50-100 times faster than the USB human interface device (HID) driver used by other USB-based acquisition products. This approach maximizes the full functionality of the hardware along with capitalizing on the advantages of high-speed USB 2.0. Linux support is also available, and all source code, for all operating systems, including drivers, utilities and sample programs—even the firmware source!—is always provided.

As conveyed by the block diagram in Figure 4, this example Pico-I/O product (Figure 1) taps the ubiquitous USB 2.0 microcontroller market for low cost and power and easy SBC interfacing. Two single-ended 16-bit analog inputs can be used for monitoring vital signs, with a sample rate of 4000 per second and a voltage range of 0 to 5 volts. Eight non-polarized “digital” inputs can handle 0 to 31 volts DC or even AC rms, making interfacing to sensors and transducers straightforward. Any voltage below 3.1V is interpreted as a logic low (0) while 3.1-31V is a logic high (1). The four digital outputs are implemented with FET N-Channel high-side switches using an external power source to switch even demanding loads with a level of 5 to 34 volts at 2 amps, even 3 amps peak for 50 milliseconds. These can be used to turn on and off local low voltage DC power sources, or drive motors, LEDs, buzzers or alarms. Multifunction analog input modules, digital I/O modules, counters, timers and serial ports are among the many PicoI/O modules entering the market from several manufacturers. Signal conditioning including filters and voltage dividers can be found, and vendors are willing to customize to meet specific requirements. Compared to previous design methodologies such as full custom RISC-based or full custom carrier boards for computer-onmodules, tweaking off-the-shelf modules is a small order. Waveform generator circuits for ultrasound can be implemented on a Pico-I/O module. Multiple peripherals such as POS, barcode scanners, scales, date-entry terminals, data acquisition (DAQ) modules and automation equipment can now be recognized and used on a single USB port. It is now easier than ever to add serial ports and serial devices to any application with the troublefree plug-and-play features provided by the USB standard. ACCES I/O Products San Diego, CA. (858) 550-9559. [www.accesio.com]. Small Form Factor Special Interest Group (SFF-SIG) [www.sff-sig.org].

22

Untitled-3MEDS 1

Magazine January 2012

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PULSE

Meet Embedded Software Quality Challenges in Medical Device Development The market opportunity for medical devices has never been greater. Rapid advances in software, hardware, networking and communication technologies are paving the way for dramatic innovations in device design and functionality. by Ido Sarig, Wind River

M

edical device makers today are producing machines with amazing new capabilities for saving and improving people’s lives. By doing so, they are contributing to a large and rapidly growing market. According to industry analysts, the medical device market in 2010 in the United States alone generated nearly $95 billion (“The Medical Device Market: USA,” February 2011, Espicom). To capitalize on growing opportunities in this market, device manufacturers must address a growing roster of challenges including regulatory compliance, the rapidly increasing complexity of devices and the ever-shrinking development cycles. A common thread that weaves through all of these challenges is software—or more precisely, software quality. The amount of software content built into devices doubles

24

MEDS Magazine January 2012

about every two years. Because software controls many of the most desired features and functions in devices today, it is a major source of product differentiation and competitive advantage. With better software, devices can offer standout capabilities, win more customers, and capture greater market share (Figure 1). Since lives depend on medical devices, safety has always been and remains the primary yardstick the U.S Food and Drug Administration uses to assess and validate these products. With their ever increasing amount of embedded software, these devices must be proved safe and effective by showing that their software components perform as they should. That boils down to software quality testing. With more software content utilizing increasingly complex architectures, and with truncated development cycles, effective software quality testing is a tall order

for many medical device manufacturers. With inadequate testing tools and processes, it’s easy for software quality problems to sneak into machines as they are being developed. These quality issues can lurk undetected inside devices and emerge late in the development cycle, during validation or—even worse—after a device has been shipped to customers. The result can be major financial problems and brand damage for device manufacturers. Executives and development team leaders at medical device companies are very busy people with many items competing for their attention. It’s natural for them to cull out and work on their most strategic issues while delegating the less strategic and tactical ones. So the question is, how does software quality testing rate in importance relative to the myriad other issues facing executives every day? The answer should be “critically important.” Beyond financial losses from product liability and civil law suits, quality problems that result in product malfunctions can be devastating to a company’s reputation and brand. When a company’s brand is negatively impacted, the financial damage can be incalculable. Traditional tools and processes are still valuable, but they are not enough to let teams keep pace with their growing requirements. The mismatches between tools, workloads, schedules and reality are result-


PULSE

ing in software quality problems that can easily turn into business problems. When problems happen, management teams are forced into reactive mode and are often left with no good options. In addition to operational disruption and revenue misses, these issues erode the confidence of all stakeholders in the quality, reliability and safety of a company’s products. Those three major issues—compliance, complexity and shrinking cycles—are what medical device makers must address and overcome to win in this market.

Regulatory Compliance The regulatory environment for medical devices creates hurdles that are well beyond what most other device makers have to deal with. The reason is obvious-medical devices are routinely involved in life-or-death situations. Regulations are shaped to advance the primary goal of protecting the safety of patients and healthcare professionals who use medical devices and equipment. Software failures in medical devices can put people’s lives in danger. To minimize this danger, the FDA mandates that to market and sell medical devices in the United States, manufacturers have to prove that their devices—and the software that runs them—are safe and effective. Specific to medical device software, the FDA requires manufacturers to show that their software development process adheres to a well-defined quality assurance system. What is confounding to many manufacturers is that the FDA does not specify the nature, structure, or content of the required code-writing and testing processes. The FDA provides no benchmark. Instead, it provides only general guidance. For device makers, this leaves a lot of gray area and some confusion about exactly what is acceptable for software development processes and what is not. An additional source of confusion is the FDA’s differing premarket and postmarket requirements. For premarket approval, the FDA requires valid scientific evidence of a reasonable level of safety and

Figure 1 Embedded software is now the primary source of differentiation for medical devices.

effectiveness for a device. Winning such approvals allows devices to go on the market, but it doesn’t guarantee they’ll stay there. Lastly, there’s the confusion that comes with the likelihood that new legislation will significantly alter existing regulatory requirements, or create entirely new ones. As every manager knows, it’s very difficult to plan for and manage an unknown. In this complicated and changing regulatory environment, what are the smartest regulatory compliance strategies for software in medical devices? How can device makers ensure that the software they are embedding in their devices is safe and effective; can earn premarket approval; can pass postmarket testing if necessary; and can be delivered on time and within budget? How can device makers improve their software development and testing processes, automate the documentation of those processes, ensure that those processes are adaptable to change, and do it all efficiently and cost-effectively? There are many ways to accomplish these goals, but the most effective way for device makers to simultaneously address all of them is to adopt a next-generation software quality testing platform. By doing so,

device makers can create a single, cohesive and efficient environment that has the ability to seamlessly integrate legacy systems and processes as well as historical data. It should be able to efficiently produce evidence of device safety and effectiveness by automatically generating documentation of software development and quality assurance processes. At the same time such an environment could easily facilitate benchmarking, peer reviews and regulatory reviews with minimal disruption to normal operations. Given the complexity, pace of change and regulatory uncertainties in the market, automation is the only way to achieve the efficiency, cost-effectiveness and flexibility that medical device makers will need to remain competitive in this dynamic market.

Growing Complexity of Medical Devices The increasing complexity of medical devices has to do with the breadth, power and sophistication of technologies now being embedded in these devices. Devices are clearly pushing the envelope with higher performance, capacity and density. Many of them now feature 32-bit or 64-bit archiJanuary 2012 MEDS Magazine

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Build 6

Shrinking Development and Test Cycles

Build 7

Compare builds’ binaries to identify changed, new and deleted functions

TC1 TC3 TC2

Only a subset of test cases are testing the actual changes in the code

Figure 2 In  complex software systems it is important to understand which parts of the code have changed, and focus testing on changes only.

Due to the extremely competitive nature of the medical device market, product development teams are being tasked with delivering high-quality products in much less time—regardless of the increased content and complexity of the devices being developed. To handle this requirement, development teams at many medical device companies have transitioned to an iterative or “agile” style of development. In agile development methodologies, the lengthy single development and test cycle that characterized the traditional “waterfall” development method is replaced by many smaller and shorter cycles. These faster cycles are intended to give developers earlier, better and more frequent feedback about how well they are meeting functional and quality goals. They are also intended to drive greater flexibility into the development process so it can accommodate changes more readily (Figure 2). Faster time-to-market and a development process that can accommodate latebreaking changes are great advantages to a medical device company. This only holds true if the quality of the software being produced remains high. In an agile environment, however, software quality testing becomes a nonstop exercise aimed at moving targets. It is usually impossible to test every permutation and execution path for a device within the time allotted. Therein lies the risk.

Solution for Medical Device Developers

Figure 3 One advantage for test planning and management is the ability to find and identify untested code.

tectures that leverage multiprocessors and multicore technologies. They are utilizing technologies such as wireless connectivity, 128-bit encryption, web services and graphical user interfaces. Many are using multiple operating systems within a single product with hypervisor-based virtualization technology. Another element that is adding com-

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plexity is the “platform effect.” Devices are no longer fixed-function but are increasingly based on software platforms that are updated with new features that are downloaded from the manufacturer many times during the life of the device. Testing, tracking and maintaining all this new software adds another layer of complexity to the device software management task.

Addressing the challenges of quality and speed in a way that is precisely aligned with the business needs of medical device companies requires a next-generation automated software quality testing solution. Such a system must optimize test execution for any embedded device including those used for medical purposes. One example is Wind River’s Test Management. Test Management is a scalable system that complements existing test and development environments with enhanced automation, control, traceability and feedback. It leverages dynamic instrumentation technology to measure test coverage, map tests to the code to execute for traceability, profile performance, enable “white-box” visibil-


PULSE ity, and speed up diagnostics of complex devices—all at run-time. The system works on production binary code with no special build or debug information required. Users and managers can easily access the system through a web-based collaboration environment. Features of this environment include a test planning framework, an open test engine, a virtual lab device manager, a test database, and a robust reporting engine (Figure 3). Since Test Management is an open,

standards-based system, its features can be easily integrated with customers’ existing quality management or test environments. The supervisory nature of such a system enables test teams to effectively automate more of their time and resources by leveraging run-time visibility into devices under test. The system thus has the ability to give test teams real-time access to the internals of integrated medical devices while those devices are actively under test.

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MEDS Magazine January 2012

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To get products to market and keep them there, medical device makers have to demonstrate to regulators—with substantive documentation of software development, QA processes and testing results—that their products meet the higher standards of safety and reliability that are required. Unlike other industries or sectors, where software malfunctions due to odd edge cases or unusual usage circumstances can be more easily forgiven by customers or users, medical device manufacturers operate with much narrower margins of error— and much higher culpability if things go wrong. For medical device makers, these higher-order challenges are heaped on top of all the typical testing-related issues that face software developers today: burgeoning complexity, truncated development cycles, competitive “feature wars” and time-tomarket pressures. The bottom line in medical device software is that innovation, along with fast and reliable delivery, wins the day. Since safety is paramount, the development and testing processes must be “industrial strength” and well-documented. Traditional development methods and legacy testing tools simply will not support success. They are no longer adequate for today’s complex, software-driven medical devices. Development and software QA managers know their teams can’t simply work longer or harder. They must find a way to work smarter. They need better ways to deal with device complexity, shortened development cycles and regulatory compliance. They need to be able to leverage cuttingedge technologies without jeopardizing the approval process or risking product liability lawsuits. An automated software quality testing solution can ensure that any organization will be better positioned to meet the operational and regulatory challenges in the medical device industry. It can help achieve business objectives by reaching software quality goals—and documenting the results for compliance purposes—on time, within budget and with confidence. Wind River Alameda, CA. (510) 748-4100. [www.windriver.com].


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Active Management Technology Takes the Pain out of Connected Healthcare The security, interoperability and manageability of large numbers of distributed medical devices are all obstacles to healthcare becoming more network-centric. Intel Active Management Technology offers an avenue to address those interoperability issues with a framework for management and security. by Clayton Tucker & Keith Williamson, Emerson Network Power

O

f the many models for healthcare evolution, connected healthcare (sometimes termed the digital hospital), is emerging as an effective solution to some of the challenges of an aging population, a deficit of medical professionals and the rising cost of healthcare. With connected healthcare, providers seamlessly share clinical information stored in vast databases rather than maintained on single-instance paper charts, which helps improve care delivery and quality along with patient safety. More intelligent and better connected medical devices can improve the data driven into the Electronic Medical Record (EMR), which is the cornerstone of connected healthcare. But, as the complexity and the number of devices within a clinical environment increase, so do the challenges

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associated with integrating, managing and securing them. There may be as many as 20,000 different pieces of technology and applications throughout a hospital and even more across a healthcare network. This dynamic and wide range of implemented technology creates a massive interoperability issue. There is little or no interoperability across multiple functions and applications across a hospital network environment. Intel Active Management Technology (Intel AMT), one element of Intel vPro technology, is built into select Intel processors and chipsets and offers an avenue to address those interoperability issues with a framework for management and security. It provides mechanisms for remote discovery, repair and protection of computing systems to improve the efficiency of remote management and asset inventory solutions by

providing persistent connectivity, either wired or wireless, that doesn’t require the computing system to be functional. Traditionally, remote management consoles communicated with devices using their standard networking capability, called the “in-band” link. The drawback to this approach is that the majority of a device has to be functional (e.g., operating system, hard drive, CPU and network drivers). In contrast, Intel AMT circuitry establishes a new communications channel, called the “out-of-band” link that operates independently of the computing system and enables communication with, and control over, non-functioning systems. Intel AMT enables the remote discovery of medical devices in any operational state. It stores hardware asset information in flash memory that can be read anytime, even if the device is currently shut down. Intel AMT also enables the management console to diagnose, control and repair devices after software or operating system failures. System security software is remotely updated with the most recent patches. The presence and operation of cyber-protection can be confirmed and monitored centrally. A working Intel AMT-enabled system consists of the Intel-based hardware, a management console and a provisioning system. The hardware can be a standard laptop, workstation, or server whose


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motherboard is based on any of the Intel chipsets that support Intel AMT technology. Increasingly, these motherboards are found embedded in medical devices such as intelligent nursing carts, pharmaceutical dispensing machines and medical tablets. The management engine (ME) is the brains of the AMT system and is made up of a computing core located in the system’s platform control hub (PCH). The management engine runs from the motherboard’s 3.3V standby power. As such, the management engine is active even when the system has been shut down. The management engine doesn’t depend on a running host operating system to perform its functions. The firmware that runs in the ME is known as the management engine BIOS extension (MEBx). The MEBx firmware contains a full TCP/IP network stack, drivers for the Intel AMT network interface(s), security protocols for both access and traffic such as 802.1X, TLS and SOAP/HTTPS, a full graphical keyboard-video-mouse (KVM) server, network filters and other Intel AMT applications discussed below. For a system to be Intel AMT-enabled, it has to be built using select Ethernet and/or WiFi interfaces whose drivers are included in the ME firmware. Intel AMT-enabled motherboards include a certain amount of NVRAM that is allocated for storage of the ME firmware image, hardware and software asset information, and storage of

Figure 1 The Intel Manageability Reference Console provides a graphical interface for Intel AMT functionality including remote power management.

network security keys. This NVRAM is typically shared with the overall system for the storage of the BIOS image and any optional ROMs needed for the network interfaces. The Intel AMT-enabled system reserves a portion of the system RAM for execution space much like the BIOS does.

Management Console For systems to be managed via Intel

AMT, some sort of external management console is needed. This management console runs one of many Intel AMT-aware systems management applications such as Symantec’s Altiris, Microsoft’s SCCM, or LANDesk. These management software packages are typically already used in a hospital IT environment. Additionally, an Intel AMT high-level API (HLAPI) is available that allows custom Intel AMT

Figure 2 The management console can run a KVM client to provide seamless control of target devices.

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PULSE network, that Intel AMT-enabled system must go through a one-time provisioning for it to be accessible to the management console. Intel AMT provisioning can be accomplished in a number of ways depending on the size of the network and the security policies enforced by the hospital’s IT organization. Many of the commercial management applications listed previously have Intel AMT provisioning functions built into them. Additionally, Intel provides software tools for Intel AMT provisioning that can be run on a central provisioning server or run directly on the system to be provisioned (host-based provisioning). Provisioning can also be run from a specially set up USB memory drive, or via direct entry into the Intel AMT system’s MEBx setup screens (much like BIOS setup). Figure 3 The  Remote Diagnosis and Repair function allows an administrator to boot the device from a known safe configuration, which could be located on the administrator’s system or CD drive.

Figure 4 A  hardware and software inventory stored in non-volatile memory simplifies asset management.

management applications to be built, and Intel provides fully functional reference management applications that allow for Intel AMT management for smaller businesses, technology trials and sample HLAPI code that helps in the development of customized Intel AMT management applications. In the following examples, the

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MEDS Magazine January 2012

Intel Manageability Reference Console will used to illustrate many of the features of remote out-of-band management using Intel AMT.

Provisioning System When a new Intel AMT-enabled system is introduced into the hospital’s IT

Intel AMT Features Even though Intel AMT enables outof-band management, it can still leverage host management agents to enhance management operations when the host OS is available and running properly (for instance graceful shut down). Remote Power Management, as shown in Figure 1, is a feature of Intel AMT that allows the Intel AMT-aware management console to request a graceful shut down of the host operating system, force a shut down of a non-responsive operating system such as one that has hung or “blue-screened,” or request a system that is currently shut down to power up either to the BIOS setup screen or the operating system. With systems based on Intel AMT versions 7.0 and greater, a fully graphical remote KVM was added to the ME firmware as shown in Figure 2. This allows the management console to run a KVM client such as RealVNC, UltraVNC, or pcAnywhere and attach to that ME firmware-resident KVM server. The IT technician gets a fully graphical view of the video console of the remote medical device and can start applications using the keyboard and mouse just as if he were at the device. Similar in intent to the KVM feature, the Serial-over-LAN feature (SOL) allows for the redirection of the remote device’s serial console to the administrator’s console. This is useful for medical devices that don’t have a graphical interface but a simpler serial interface for control and monitoring.


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PULSE ing the ironclad network security needed for HIPAA/HITECH compliance. Emerson Network Power, Intel and Symantec have developed a working proof of concept platform as an example of how the electronic medical record and Intel vPro can address connected healthcare (Figure 5). The proof of concept has been implemented as both an automated medication dispensing system called MedDispense and a wireless mobile workstation. At the heart of this proof of concept is an Emerson Network Power embedded motherboard based on the latest Intel Core i7 processor, supporting Intel AMT. The addition of Symantec’s Altiris Solution provides a large part of the management functionality. Figure 5 A proof-of-concept with multiple implementations illustrates how unified security and management reduces the effort and costs associated with deploying, managing and securing medical devices.

The IDE Redirection capability (IDER) within Intel AMT allows the IT administrator to redirect the remote device’s CDROM or floppy to a CDROM or ISO image on the administrator’s workstation. Once this IDE-R session is established, the administrator is able to boot the remote device using an ISO image on his local CDROM or disk. This is frequently used to boot a failed device with a diagnostic image or recovery image, as shown in Figure 3, and even allows the administrator to remotely reformat and reimage a device. This feature is usually used in conjunction with either the KVM or SOL feature. With Intel AMT, all network traffic to and from the host OS passes through the Intel AMT firmware’s watchful eye. This is accomplished using configurable Intel AMT filters that can block packets coming from or destined to the host OS. It also allows for specific Intel AMT management packets to be sent directly to Intel AMT firmware instead of going to the host OS. In normal operation, Intel AMT would allow all non-Intel AMT packets to flow unhindered between the host OS and the Ethernet or WiFi interface. However, if the host OS becomes corrupted with malware that starts spewing dangerous packets onto the network, the administrator can sever the network connection to the OS but still retain out-of-band network control. This

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MEDS Magazine January 2012

action can be taken manually by the administrator or automatically based on network threat detection policies configured into the management console. The administrator can then deal with the infected system remotely and thus prevent the potential spread of malware or denial-of-service attacks from threatening other systems on the hospital’s network. Intel AMT also includes hardware and software inventory data that is stored in the system’s NVRAM, as shown in Figure 4. This information can be queried anytime whether the machine is up or down. The management console can have policies configured to check this inventory information on a periodic basis to detect changes in things like amount of installed memory and raise alerts if that occurs. There is also an area in NVRAM for the system’s OEM to add OEM-specific inventory information such as device name, model number, or serial number. Intel AMT includes very strong security features for both access security and network traffic security. Most of the major network security protocols are supported. This guarantees that management traffic between the device and the management console can be both strongly authenticated and strongly encrypted. It also allows for the network traffic to be similarly secured using the SOAP/HTTPS protocol, provid-

Emerson Network Power Tempe, AZ. (602) 438-5720. [www.Emerson.com/EmbeddedComputing].


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