FDA To Play Role In Medical-Device Research Consortium.

 

The AP (12/4) reports that the Food and Drug Administration announced Monday that it will "collaborate with medical device manufacturers on a public-private partnership." The FDA "says it hopes to offer guidance" to the Medical Device Innovation Consortium (MDIC), which was "created by LifeScience Alley, a Minnesota-based industry group" to streamline the "design and testing of medical devices." The AP suggests that the agency's decision to play a role in the new consortium is a response to "criticism from industry and Capitol Hill" about its "overly burdensome review process."

        Reuters (12/4, Kelly) adds that the goal of the nonprofit MDIC is to improve the methods used during the medical-device development process so more products can reach the market faster. Industry members involved in the MDIC include representatives from Abiomed, Becton Dickinson, Boston Scientific, Cyberonics and Medtronic. Reuters quotes FDA Commissioner Dr. Margaret Hamburg as saying, during a press teleconference, that the MDIC "is going to represent a model that will be watched carefully, will be replicated. I know there will be real advances and new approaches that will emerge from it."

        The Minneapolis Star Tribune (12/4, Walsh) adds that Dr. Hamburg noted that many companies "don't have the research budgets to find more effective ways of testing their products." She said the MDIC would "pull information and ideas from industry, government and academia" to ensure "we're applying the best science to the task and bringing together the best minds." The consortium will be "governed by a national board of directors, including industry executives and government leaders."

        According to CQ (12/4, Adams, Subscription Publication), the "partnership will be funded largely by device companies, although the FDA and the Centers for Medicare and Medicaid Services may contribute funding later." Dr. Hamburg called the consortium the "first public-private partnership of its kind in the medical device area" and cited "interest from a wide variety of groups, including members of Congress, for the agency's ability to move forward with the initiative." The MDIC will "invest in projects" that could reduce the time and costs involved in medical-device development. The alliance has not yet decided on "specific projects" to fund but they could "include investments in research to improve computer models or other tools that can test the effects of potential devices." The MDIC is planning to hold its "initial meeting in the first quarter of 2013."

        Modern Healthcare (12/4, Daly, Subscription Publication) adds that the FDA's "support for the initiative may extend to its staff collaborating on partnership-supported research." The FDA's Center for Devices and Radiological Health Director Dr. Jeffrey Shuren said, "By sharing and leveraging resources, MDIC may help industry to be better equipped to bring safe and effective medical devices to market more quickly and at a lower cost."

        The Minneapolis-St. Paul (MN) Business Journal (12/4, Grayson, Subscription Publication) reports that the MDIC "will be led on an interim basis" by Maura Donovan, who recently served as "vice president of therapy research and development" at Fridley, Minnesota-based Medtronic Inc.

        Medscape (12/4, Lowes) says that in addition to the FDA, the CMS and the medical device firms, the MDIC's founding members include LifeScience Alley, the Pew Charitable Trust and the National Organization for Rare Disorders. HealthDay (12/4, Preidt) also covers the new public-private partnership.

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