SAN JOSE, Calif. The proliferation of portable medical devices and the explosion of new patient data wrought by widely available imaging technologies are forcing medical electronics designers to devise new ways of integrating diverse biotechnologies with electronics while curtailing power consumption.
A panel of medical electronics experts described the challenges and opportunities here during the Embedded Systems Conference-Silicon Valley on Wednesday (April 28). They noted that management of patient data, the need for wireless connectivity to transmit an avalanche of new data in the form of medical images and other patient records along with data produced by implanted devices is increasingly being handled at the silicon level. Some players in the medical electronics market like Texas Instruments also are attempting to speed the time-to-market for new diagnostics approaches through development kits and embedded processor technologies.
"There is so much patient information right now," especially imagery from MRIs and ultrasound, said Dan Wallace, co-founder and vice president of Hansen Medical Inc. a developer of robotic catheter systems based in Mountain View, Calif.
Panelists said key challenges in the fast-changing medical electronics market are figuring out how to aggregate and manage real-time imagery and other medical data, how to mesh divergent technologies like electronic, mechanical and biological devices and then figure out a way to transmit the date wirelessly without running down the battery.
"Are [doctors] going to end up ignoring this data?" warned Freescale Semiconductor's Jon Adams, who also helped found a Zigbee health care standards group. "If so, we've already lost the battle."
The good news is that chip technology such as low-power embedded processors are being used to deal with growing complexity and soaring data rates. One area where silicon is being leveraged to ensure the efficacy of personal telemedicine devices, for example, is in creating "device IDs" that will help physicians and regulators determine whether patient data generated by a device is credible.
Chip technology can be used to establish the "pedigree" of a device so that doctors can trust the data it generates. Moreover, Adams said, the U.S. Food and Drug Administration (FDA), which regulates medical devices, increasingly wants to verify a device's pedigree through schemes like device IDs. Regulators want to know "who made it and how does it work?" Adams said.
Panelists also expressed mixed views on the impact of the new U.S. health care law on the medical electronics market. Concerns ranged from VCs fleeing the market due to a proposed tax on device maker revenues to uncertainty over which way the FDA is headed in regulating the device market.
Industry veteran Mir Imram, chairman of CEO of Modulus Inc., a developer of implantable medical devices, downplayed fears about the flight of investors, instead calling the health care law "mostly good news" for the medical electronic market. A big reason is that it expands coverage to 30 million Americans. Imram said his biggest concern is whether FDA reforms will raise the bar on regulatory approval of new medical devices.
Freescale's Adams said the U.S. health care law will likely stimulate the industry by creating more opportunities for developing technologies to manage patient information.
One area where work is needed is establishing standard formats for handling and transmitting medical imagery. "It's a mess right now," Wallace said. Imram of Modulus, based here, noted that common image formats will be difficult to achieve given the unique characteristics of individual imaging technologies and how they are used as diagnostic tools.