Little Guys Can Make Medical Products Too

July 1, 2003
Hospitals and clinics around the world are adopting wireless medical products at an ever-increasing rate. In the U.S., the reservation of frequencies for both implantable and telemetry devices has spurred growth to high levels. Yet the same few...

Hospitals and clinics around the world are adopting wireless medical products at an ever-increasing rate. In the U.S., the reservation of frequencies for both implantable and telemetry devices has spurred growth to high levels. Yet the same few vendors dominate the supply of medical equipment. These vendors are driving the changing landscape of wireless medical technologies. Opportunities still exist, however, for enterprising companies. They just need to possess both the technology and know-how in wireless systems design.

In December 1999, the FCC allocated a spectrum band for the use of implantable medical devices. The medical implant communications services (MICS) spectrum is 402 to 405 MHz. It was set aside to allow patients with implantable medical devices, such as cardiac pacemakers, defibrillators, and blood-glucose monitors, to have their devices checked by medical professionals without the inconvenience of a trip to a hospital or clinic. In addition, MICS devices allow doctors to evaluate the status of an implantable medical device at the first sign of a potential problem.

It is estimated that in the U.S. alone, 75,000 pacemakers are implanted in new patients each year. Millions of other types of medical devices also are implanted annually. They benefit patients in many ways, such as pain control, improved motor functions, treatment of neurological tremors, medication administration, and control of incontinence.

In February 2000, the FCC voted to allocate a total of 14 MHz of interference-protected spectrum for the use of wireless medical telemetry services (WMTS). The FCC's WMTS order set aside the following frequencies for use by licensed physicians, healthcare facilities, and certain trained and supervised technicians: 608 to 614 MHz, 1395 to 1400 MHz, and 1429 to 1432 MHz. Generally, wireless medical telemetry is used to monitor patient physiological parameters over a distance via an RF link. The communication occurs between a patient-worn transmitter and a central monitoring station. These devices give patients the advantages of full mobility while they're in a hospital or clinic. They don't have to be hardwired and tethered to a bed.

Given the growing opportunities for wireless equipment in medical applications, competitors should be flooding into the market. Yet the same few heavyweight medical-equipment suppliers also rule this part of the market, which takes advantage of the recent spectrum allocations. For example, look at patient-monitoring WMTS devices. It's clear which companies are the leading players. Siemens Medical, Philips Medical, and GE Medical all offer similar patient-monitoring devices. Behind them, however, competitors in the market fall off quickly. Medtronic, Guidant, and St. Jude Biotronics continue to lead the market for implanted medical devices.

NEW IDEAS MUST BE PLANTED A few small companies are starting to develop innovative implantable devices. These devices perform treatments on conditions ranging from epilepsy to back pain. Given the opportunities that exist, however, such devices and functions are remarkably few.

Some key factors make the medical market unique. They also make it a potentially more difficult market in which to compete. One such factor is product liability. Say an electronic component in a VCR fails, preventing the device from working properly. The average consumer would be irritated. But the VCR would be replaced and the problem would then be rectified. But if an electronic component in a pacemaker fails, the patient's heart stops beating. The level of product liability is entirely different. It is one that could potentially result in millions of dollars in damages. This issue raises a big barrier to companies that might be looking to enter this market.

The FDA approval cycle is another factor that prevents companies from designing medical wireless products. Typically, it takes an average of three months for a new product to be approved. Depending on the particular details of the design and the device application process, however, this process can take from one month to two years or even longer. If a company is not accustomed to the FDA-approval cycle span when bringing a new product to market, the potential entrant may miss the window of opportunity entirely.

What will it take to become a player in the area of medical-equipment manufacturing? One requirement is product innovation. If a company is bringing an innovative product to market, the major equipment suppliers won't be able to use the advantages of size and experience to out-compete the smaller entrant.

Existing providers of medical equipment often rely on process—rather than product—innovation. They migrate existing designs to smaller semiconductor process geometries, thereby gaining speed, density, and power-consumption advantages over the competition. But most medical applications do not require leading-edge processes. Wireless-data transfer-rate requirements are very low in medical products, as are the average demands for design complexity.

It seems like the medical-equipment market is poised for smaller, more nimble competitors. Only they have access to older technologies, which will enable them to innovate their way into the spotlight. Isn't it time for smaller companies to step into the medical industry and change the supplier landscape?

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