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By Lawrence Ricci
Applied Data Systems 10260 Old Columbia Road Columbia, Maryland 21046 Phone 301-490-4007 Fax 301-490-4582
Introduction
The new challenges of medical device design include proscriptive compliance to regulations, extended product lifecycles, reduced product development time, and of course, product safety. The challenge is to meet these goals and still achieve modern communication, device reliability, and sometimes battery power/power management. These new designs, once achieved, will not only improve the devices within clinics and medical centers, but will facilitate the transition of monitoring and therapeutic devices into the patients home.
Mobile Radio and TV stationsi. Since 1997, with the FCC assigning more bandwidth for HDTV, some devices in hospitals have been reset to use channels still left unoccupiedii. However, this is only a small change in the landscape, affecting mostly legacy devices and their one-to-one replacements. The most popular new communications technology is 802.11 and its variants. Here is where the interface between FDA regulations, FCC regulations, and FIPS regulations (Federal Information Protection and Security) collide with the reality of fast-moving, high-tech consumer hardware, and software. Keeping abreast with these issues, the Food and Drug Administration has recently published a Draft Guidance for comment, where the evolution of the various 21 CFR device design guidelines is being discussediii.
AP Protocol: RADIUS
EAP (Extended Access Protocol) of a WiFi net might be managed. This figure is a extreme simplification; in practice, multiple 802.11 devices adhering to different access protocols will contend for the in the same airspace and spectrum. All of these, including invited and uninvited guests with PDAs in their pocket, need to be administered. Diligent third party testing and application focused implementation tends to mask all this complexity from the consumer/user. The designer of a laptop knows that it is typically operated from a desk, so its connection to an access point should be sticky. The designer of a PDA knows that it will be used by a moving user, and needs to frequently reconnect from one AP to another (slippery). For a medical
Applied Data Systems 10260 Old Columbia Road Columbia, Maryland 21046 Phone 301-490-4007 Fax 301-490-4582
device, the engineer needs to design these properties in, and for some devices, properties like stickiness are mandated by regulation. Getting this design right is not as simple as selecting the right CF card. The problem is the standards change so fast, that the com chip selected in January may be EOL by the fall, and approval cycles may take up much of the time in-between. Careful coordination between design, and supply chain management are needed to effectively apply technologies like 802.11 in medical devices.
New Regulations And Technologies Will Shape Future Devices regulated and protected by the FCC, Not Too Far Away-Metro Area and all of them require certain design Health
and testing standards. Most critical, of course, are the recently proposed FCC standards for Medical Device Radiocommunication Service or MedRadiov. This term refers to expanded bandwidth for implanted and body-worn medical radio communication devices. The older rules for Medical Implant Communications Standards (MICS) are still largely in place, including the rules for low frequency, inductively coupled sensors. The promise of MedRadio is great. Patients can wear various vital sign monitors, and even therapeutic devices like insulin pumps, yet still have reasonable mobility within the facility or even at home. It is hoped that as more wearable and implantable devices are developed, more of the chronic care process can be moved out of the hospital and costly nursing home to lower cost assisted-living and at-home care. These networks require additional testing for susceptibility, for emission, and for certain protocol behaviors, such as checking for a frequency before using it. We have found this testing well advised as the clock frequency of modern PDA/cellphone components is in the range of MedRadio, and the frequency of the low-frequency inductively coupled MICS devices is in the range of the switched mode power supplies that power this class of device. The specs for susceptibility and emissivity can be tight, and design features may have to be adjusted to meet them. Health care professionals can be hard to find in the rural areas of the United States. As an experiment, the Federal Communications Commission (FCC) established in September 2006vi a pilot program that will assist in the development and deployment of regionwide broadband networks dedicated to the provision of healthcare services.
Figure 2: Some day soon, devices like this, located in homes, will perform much monitoring now done by vesting nurse services
This is an exciting development. So called 3G and 4G network technologies like Intel WiMax exist now and provide broad band speed and easy connection across wide areas. Some of these preWiMax networks have already been deployed over multi-county areas for specific functions like homeland security. The use of such a metro area LAN will solve the last mile problem for connection to the house, and in fact, could solve the last yard problem for connection to the device. Many of the target households for such health care devices are not broad band equipped
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Figure 3- This is part of an actual FMEA study done for a mobile, embedded computer to monitor implanted devices
Reliability
From the designers point of view, it seems that the Hippocratic pledge to do no harm is ninety percent of medical device design. The other 10% is documenting compliance to the 90%. Safety of the device typically focuses on power supply design, software design and overall FMEA considerations (Failure Mode and Effects Analysis) Power supply safety is, for the most part, regulated by IEC 60601-1. Design to this spec is, among other things, a good assurance that high or unsafe voltage will never reach the patient. IEC 60601 also stipulates proper device performance in the face of power interruptions and surge wave
Applied Data Systems 10260 Old Columbia Road Columbia, Maryland 21046 Phone 301-490-4007 Fax 301-490-4582
interference. The standards for RFI emission and immunity are likewise inside this and related IEC regulations. The net effect of these regulations is to significantly increase the size and cost of the power supply elements in the device. Cost and size of the device is reduced if less power is consumed, so application of power-thrifty RISC processors is a good way to keep device size and cost in line.
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Figure 4- Process for Hazard Mitigation, Off-The-Shelf Software Use in Medical Devices, September 9, 1999 See
http://www.fda.gov/cdrh/ode/guidance/585.html
Applied Data Systems 10260 Old Columbia Road Columbia, Maryland 21046 Phone 301-490-4007 Fax 301-490-4582
Figure 5: A computer board like this might cost 10,000 development man-hours. Yet, it provides only 'commodity' specs and is far from the value proposition of medical device
This is not to diminish the difficulty in meeting various communication and power supply design specs. It can be very difficult and require experienced engineers, test facilities and so forth. Any one of these can take man-months to engineer and to test to compliance. But in the end - all of these specs, like 802.11, IEC 60601-1, 21 CFR 820 compliance, etc - are simple commodities, in the most part tested for their commodity nature by third party labs. This dichotomy between the core value of a medical device and the effort required to commoditize elements of its design is causing companies to
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Applied Data Systems 10260 Old Columbia Road Columbia, Maryland 21046 Phone 301-490-4007 Fax 301-490-4582
Summary
Medical device design is advancing on two fronts. Proprietary technology like better sensors, measurements, and analytical techniques are moving to market. Emerging commodity specifications for connectability and portability allow these devices to better integrate with a broader healthcare network. Getting the best devices to market will require new partnerships and development of new supply chains.
Copyright , Applied Data Systems, Inc, 2006. All Rights Reserved. This document may not be used for commercial gain without permission of Applied Data Systems, Inc. Any trademarks used within are the property of their respective owners. This document contains technical descriptions that may not be representative of Applied Data Systems product or services
Applied Data Systems 10260 Old Columbia Road Columbia, Maryland 21046 Phone 301-490-4007 Fax 301-490-4582
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