FDA to hold workshop on medical device innovation to address unmet public health needs

Participants will explore how federal agencies can encourage medical device development

Each day, medical devices from renal dialysis machines to implantable defibrillators help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. It then takes even more time for them to be adopted into clinical practice and for patients to realize the benefits.

Can the government do more to encourage the development of the next generation of medical devices? That is the question that the U.S. Food and Drug Administration and participants from other federal agencies will examine this week at a workshop titled "Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development." The workshop is scheduled for June 24, 2010, from 8 a.m. to 5 p.m. at the Hilton Washington DC North/Gaithersburg in Gaithersburg, Md.

"The FDA and its partners in the federal government each play an important role in the life cycle of a device. Working collectively, rather than independently, and bringing together industry, practitioners, patients, and other members of the public, we can get better devices to patients faster," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health (CDRH).

As part of this initiative, CDRH established a Council on Medical Device Innovation composed of participants from federal agencies. Agencies represented include the National Institutes of Health, the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Defense, the Defense Advanced Research Projects Agency, and the Department of Veterans Affairs.

The meeting is part of an initiative from the FDA's device center to proactively facilitate device innovation to address unmet public health needs. For the purposes of this initiative, unmet public health needs are defined, in part, as illnesses and injuries that are serious or have moderate adverse impact on health but affect many people; and could be cured, significantly improved or prevented by a new or redesigned device.

This initiative also is designed to identify potential barriers in the development of devices that the federal government can directly or indirectly remove or minimize to meet a public health goal.

The meeting will be an opportunity for the FDA and its federal partners to listen to academics, industry, and users.