Before the medical device industry can fully adopt wireless technologies, it must surmount a range of hurdles, not least those posed by regulatory agencies.

Bob Michaels

The proliferation of smartphones means that small, inexpensive sensors, low-energy Bluetooth, and analytic software are enabling patients and doctors to capture all kinds of data to improve healthcare, comments Nias Puthenveettil, director of the chief technology office at Cerner Health Services. As a result, patients can play a more active role in their own healthcare, while doctors and nurses can make house calls without ever leaving the office.

At the same time, physicians are using apps as an equipment supplement, and advances in mobile sensors are helping them identify potential health problems. The findings can then be geo-located, synced to patient records, and shared with partner physicians. Physicians are also tapping into medical apps to record and access patient information on the spot. They are also using apps as disease-management and drug-administration tools.

Sounds great, but many challenges remain before the medical device industry can fully embrace wireless technology. At BIOMEDevice Boston on May 7, Puthenveettil will grapple with some of these challenges in a presentation focusing on "Business Paradigms for Bringing Wireless Devices to Market."

Three main factors influence the success of wireless medical devices, according to Puthenveettil: compatibility, safety, and cost. "The device must be compatible with other uses of the electromagnetic spectrum, patient safety must be ensured, and cost must justify the outcome." In turn, regulating these requirements falls under the purview of three federal agencies: the Federal Communications Commission (FCC), which manages the electromagnetic spectrum; FDA, which regulates the marketing of all medical devices; and the Centers for Medicare and Medicaid Services (CMS), which determines who will pay for the devices.

"From a medical standards perspective, devices must be capable of receiving and transmitting data in a secured format, whether they use HL7 or DICOM encryption," Puthenveettil explains. "From a wireless technological protocols perspective, the device manufacturer must choose a protocol that fits well with the device's intended use. Common technologies used in medical devices include short-range radio frequency, Wi-Fi, Bluetooth, Zigbee, Ultra-Wideband, and WiMAX."

Wi-Fi, Bluetooth, and Zigbee, he adds, continue to be the leading technologies used in short-range patient monitoring, control, and diagnostic devices. However, FCC has been allocating new spectrums to accommodate the operation of implantable medical devices. WiMAX and LTE are also being used in long-range medical telemetry applications.

"Several technologies are available in the market, and they are continuing to evolve," Puthenveettil says. "But in order for medical device manufacturers to adopt them and bring new wireless devices to the market, they will need clearance from FCC, FDA, and CMS. Achieving this clearance will continue to be a bottleneck to innovation in the medical device industry for the foreseeable future."

Bob Michaels is senior technical editor at UBM Canon. Reach him at [email protected].