Jun 9, 2011

The Medical Device Venture Council, an informal group of venture capitalist firms focused on life sciences investing, has undertaken efforts to convince US lawmakers and Obama Administration officials that the Food and Drug Administration’s medical device review process needs to be reformed.

The Wall Street Journal’s Venture Capital Dispatch blog reports that the group has recently met with the White House’s Council of Economic Advisers as well as Senate committees to argue that the FDA’s current device review process has slowed commercialization of innovative products in the US as well as discouraged increasing numbers of investors from providing much-needed capital to manufacturers.

Improving those alleged trends, the group contends, entails setting up more efficient, transparent and predictable medical device clearance and approval processes—an argument very much in line with that made by industry trade groups also making the rounds and getting attention on Capitol Hill. The group cited reforms implemented for the US patent process as good precedents on which FDA reforms should be built.

According to Mike Carusi, a council member and partner at Advanced Technology Partners interviewed by Venture Capital Distpatch, the group’s discussions with government officials focused on deal flow as well as declining numbers of medical device start-up activity in the US relative to Europe.

Carusi emphasized, however, that pressing for a more efficient and predicable review process should not equate to lowering quality and safety standards. Instead, he argues that regulators should more consistently apply standards already in place.


  • Stewart Eisenhart