Archives for December 2012

There’s a new player in the game for medical device development in the U.S.: The Medical Device Innovation Consortium.

The U.S. Food and Drug Administration, under criticism from the medical device industry for its burdensome review process, announced last week its intention to collaborate with private companies through the consortium. The new nonprofit is intended to find, test, and implement new ideas.

This comes as good news for medical device innovators, some of whom have begun launching their cutting edge products in Europe rather while waiting for approval to enter the U.S. market.

The impetus for the Medical Device Innovation Consortium (MDIC) came from LifeScience Alley, the largest state-based life sciences trade association in the U.S. The Minnesota-based group includes Medtronic, St. Jude Medical,  Mayo Clinic, Boston Scientific, Cargill, and the University of Minnesota.

LifeScience Alley worked with the FDA’s Center for Devices and Radiological Health (CDRH) to develop the new non-profit organization. Dr. Maura Donovan, who has been vice president of therapy research and development with Medtronic, has been loaned by Medtronic to serve as interim executive director for the MDIC.

The Medical Device Innovation Consortium will function in the pre-competitive medical device research space, with initial objectives focused on the creation of scientific tools to assist stakeholders in developing and assessing the safety and effectiveness of new medical device products.  The ultimate goals of the MDIC are to enhance the quality and performance of medical devices;  improve the timeline of availability of these products to patients; and validate and qualify new methods, tools, approaches and standards in order to increase transparency and effectiveness for industry stakeholders.

— Dec. 3 announcement from LifeScience Alley

All the comments we’ve seen about the new consortium are cautiously optimistic. Its success would mean some very positive change for the medical device field. You can bet we’ll be hearing a lot about it at the 10x Medical Device Conference in April.