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FDA, industry team up to speed up medical device approvals

by Brendon Nafziger, DOTmed News Associate Editor | December 03, 2012
The Food and Drug Administration and a Minnesota trade lobby said Monday they launched a public-private partnership to discover ways to make the approval of new medical devices cheaper and more efficient.

The new organization, the Medical Device Innovation Consortium, will initially work on creating scientific tools to help regulators assess the safety and effectiveness of new devices, according to LifeScience Alley, a Minneapolis-based trade group and one of MDIC's co-founders. LifeScience said, if successful, the group could help new products come to market sooner.

The FDA said an example of the sort of project they could do is developing a computer model to test implantable devices on "virtual patients", to iron out kinks before a manufacturer takes the trouble to run an expensive clinical trial on actual, human patients.
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On its website, MDIC said one of the advantages of doing research with the organization is the ability to share data and best practices among industry, government and academic researchers. The FDA said its own staff could work on MDIC projects.

LifeScience and FDA first signed papers announcing their plans to work together in December 2011, and LifeScience filed incorporation papers in August, MDIC said.

MDIC said once the board of directors convenes its first meeting sometime early next year, it will commission sector subcommittees to draw up project plans. Maura Donovan, a Medtronic employee and the interim executive director of MDIC, is recruiting the board now, LifeScience said in its press release. Donovan is on "loan" from Medtronic to help get MDIC off the ground, LifeScience said.

Founding companies of MDIC include Abiomed, BD, Boston Scientific, CVRx, Cyberonics, Immucor Gamma, and Medtronic.

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