A new government council that is encouraging device innovations to address unmet public health needs will hold a public meeting June 24, FDA announced May 26.
Article preview from "The Gray Sheet"- May 31, 2010
A new government council that is encouraging device innovations to address unmet public health needs will hold a public meeting June 24, FDA announced May 26.
The Council on Medical Device Innovation was formed earlier this spring, with members from FDA, CMS, the National Institutes of Health, the Centers for Disease Control and Prevention, the Agency for Healthcare Research and Quality and the Department of Defense, among others.
The expert council is part of an FDA device center initiative to identify and eliminate unmet public health needs by spurring the development or redesign of medical devices. FDA launched the project in January.
Industry representatives frequently lament that device innovation has been stymied in recent years by regulatory uncertainties, reimbursement snags or a lack of adequate venture capital financing.
The multi-agency council aims to kick-start innovation by identifying the most important unmet public health needs and delineating the barriers to the development technologies to treat these illnesses and injuries. It will also zero in on obstacles to patient access.
"A predictable and consistent regulatory pathway can encourage would-be innovators to invest in the development of an innovative device," the agency states in a May 26 Federal Register.
In addition to regulatory considerations, FDA notes that payment practices can also inhibit the financial incentives for manufacturers to develop new or improved technologies.
The group has held one private meeting, and now wants to hear from the health care community, CDRH Director Jeffrey Shuren told reporters at the annual meeting of the Medical Device Manufacturers Association in Washington, D.C.
"[We're] trying to change the culture in the center," Shuren said during a May 25 session. "Much of the focus that I found coming in was about one side of our public health mission, and that's to protect patients, assuring that devices on the market are safe and effective, and using our enforcement tools wisely."
"But our mission has two sides. It also has to 'promote public health,'" Shuren continued. "That was a piece that I found missing rolling into the center."
"My challenge back to the center was, 'Why are we sitting back and waiting for industry to solve problems?'" he concluded.
At the June 24 workshop, to be held in Gaithersburg, Md., the council hopes to get input from the device industry, academia, patient and consumer advocacy groups, professional organizations and other state and federal bodies with a public health focus.
Participants are being asked to comment on priority areas where device innovations "can have the highest impact on public health," and on "devices not being developed or redesigned due to barriers that the federal government can and should" remove, according to the meeting announcement.
Criteria For "Unmet Public Health Needs"
Devices falling under the council's charge are those that can help with illnesses and injuries that are serious or affect many people; could be cured, improved or prevented by the development or redesign of a device; and for which such a device has not been developed or redesigned because of government barriers that "are out of proportion to what is warranted based on the public health needs," FDA says.
Comments to FDA are due by July 23 on the most important unmet needs, developmental barriers and government actions that would help.
According to CDRH's 2010 agenda, published in January, the council has until the end of September to identify steps to minimize barriers to developing devices that address at least two of the top unmet medical needs.
- Jessica Bylander
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