Medical Devices

FDA creates first public-private partnership to develop regulatory science for medical devices

partnership. collaboration

The U.S. Food and Drug Administration announced Monday that it is partnering with a medical device trade group to create the first-of-its-kind, public-private partnership to advance regulatory science that will help streamline and expedite patient access to new medical technologies.

The trade and lobbying group it is joining forces with to create the the independent, nonprofit  Medical Device Innovation Consortium  is LifeScience Alley, which is based in Minnesota.

The announcement comes more than a year after a preliminary partnership between the FDA and LifeScience Alley was announced in August, 2011.


Regulatory science is a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices. The goal of the partnership is to get novel, innovative medical devices early and speedy assessments by funding projects that will benefit the industry as a whole as opposed to one technology or one company’s efforts over another, explained Shaye Mandle, vice president of government and affiliate relations at LifeScience Alley, in a phone interview.

Industry representatives, government and other nonprofit organizations will be able to provide input to the consortium and the group will prioritize regulatory science needs of the medical device community and fund projects to help simplify the process of medical device design and pathway to market for these innovations.

Former Medtronic executive Maura Donovan will serve as interim executive director of the consortium.

“Given the magnitude of the impact regulatory science can have on the creation and approval of safe and effective medical devices, we believe Maura is an excellent choice to lead this effort, and we are glad that we are able to support LifeScience Alley by lending Maura’s time and expertise to the consortium,” said Rick Kuntz, senior vice president and chief scientific, clinical and regulatory officer, Strategic & Scientific Operations at Medtronic, in a LifeScience Alley news release.

Donovan takes over from former Medtronic CEO Bill Hawkins, and Mandle  said that Hawkins’ role in the partnership is to be determined.

Mandle added that, so far, LifeScience Alley has funded the creation of the nonprofit and a board will be created in the future that will determine regulatory science projects that the industry can benefit from. While government entities like the FDA and Centers for Medicare & Medicaid Services, who are members of the consortium, have not committed any money, grants may be available from government agencies once projects are identified.

The interim director has begun courting device firms to become members who will pay dues based on their annual revenue, Mandle said. Device industry members so far are Boston Scientific, Medtronic, Abiomed, CVRx, Cyberonics, Immucor, Terumo BCT and Becton Dickinson, while CMS, Pew Charitable Trust and National Organization for Rare Disorders are also members.






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