Council mulls improvements to med device development

GAITHERSBURG, MD - Representatives of the Council on Medical Device Innovation gathered last Thursday in Gaithersburg, MD to discuss the government's role in fostering medical device development and addressing unmet medical needs. Many devices to help these needs aren't being developed because of barriers that the federal government can remove or minimize, attendees asserted.

CDRH recently established the council to determine the barriers of innovation. The panel includes participants from the NIH, CDC, CMS, the Agency for Healthcare Research and Quality, the Defense Department, the Defense Advanced Research Projects Agency, and the Department of Veterans Affairs.

A number of stakeholders spoke during the meeting, including Daivd Klonoff, medical director, Diabetes Research Institute. Klonoff's discussion focused on standards and interoperability for better diabetes technology. He mentioned a number of needs in the diabetes therapeutic area, including the more accurate, less invasive glucose sensors; better insulin delivery systems; and clarification of regulations affecting both telemedicine and the development of the artificial pancreas.

Jack Lasersohn spoke on behalf of the National Venture Capital Association, and pointed out that that virtually all revolutionary medical device development in the U.S. is funded by venture capitalists. But this part of the "innovation ecosystem" is at risk--investment in biotech and medical devices have declined. In fact, start up funding has been going down over the past four or five years. He recommended the creation of an innovation czar to help foster innovation.

During the open public comment session, Zen Chu of Harvard's Wyss Institute urged the creation wiki database of clinical needs that would list indications with prevalence and incidence. He said it would foster transparency and encourage debate.

Speaking on behalf of AdvaMed, Medtronic's Michael Morton discussed some of the trade group's recommendation, including the creation of an orphan and pediatric ombudsman within the agency's device center; improvement in CMS coding, coverage, payment processes; and expedited clearance on orphan and pediatric devices, as well as a clear path for reimbursement.

At the end of the meeting, the council said it would look at submissions to a docket, then determine following steps in moving forward. - Liz Hollis

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