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Medtronic's Fridley headquarters.

Glen Stubbe, Dml - Star Tribune

Device makers partnering with FDA

  • Article by: JAMES WALSH
  • Star Tribune
  • December 3, 2012 - 8:13 PM

Medical device makers have expressed concerns about the U.S. Food and Drug Administration's approval process for new medical technology and therapy.

But those concerns haven't kept members of Minnesota's medical device community from working with the FDA to improve the process.

On Monday, LifeScience Alley, the nation's largest state-based life science trade association, announced the formation of the Medical Device Innovation Consortium (MDIC), a public-private partnership with the FDA's Center for Devices and Radiological Health (CDRH).  The move formalizes plans by LifeScience Alley and CDRH to bring leaders of industry, academia and government agencies together to advance medical device regulatory science.

FDA Commissioner Dr. Margaret Hamburg noted that many medical device companies are small businesses and don't have the research budgets to find more effective ways of testing their products. She said the new group would pull information and ideas from industry, government and academia.

"This can best be done by making sure we're applying the best science to the task and bringing together the best minds, no matter where they are found," Hamburg said in a teleconference with reporters.

The agency's pledge follows criticism from device industry advocates, who have lobbied Capitol Hill for more than a year to fix an FDA review process they say is forcing some companies out of business.

The consortium will be administered through a new nonprofit and governed by a national board of directors, including industry executives and government leaders. 

Dr. Maura Donovan will serve as interim executive director. Donovan most recently served as vice president of therapy research and development at Medtronic. As interim executive director, she will lead the recruiting of the board and build the consortium's membership. She will also initiate the first subcommittees to lead specific projects. Medtronic is supporting the project by loaning Donovan.

"Maura has provided excellent leadership to Medtronic over the years," said Dr. Rick Kuntz, a senior vice president at Medtronic. "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."

The Medical Device Innovation Consortium's initial objectives focus on creating scientific tools to help develop and assess the safety and effectiveness of new medical devices.  According to a statement, "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."

The Associated Press contributed to this report. James Walsh • 612-673-7428

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