Healthcare Business News

Consortium aims to speed device reviews

By Rich Daly
Posted: December 3, 2012 - 3:30 pm ET

The Food and Drug Administration has joined a public-private partnership to fund new evaluation tools and methods for assessing medical devices, according to a news release.

The agency will provide an indeterminate amount of funding to the not-for-profit Medical Device Innovation Consortium, which was created by a biomedical science trade association.

The group of industry, government and other not-for-profit organizations aims to fund projects that simplify the medical device design and approval process. The funded projects would include new “tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.”

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“Advancements in regulatory science not only aim to improve how products are developed and evaluated, but also could reduce the cost and time it takes for a promising device to come to market,” the news release said.

The FDA's support for the initiative may extend to its staff collaborating on partnership-supported research.

“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,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in the news release.

The FDA will determine later the amount of federal funding to provide to the partnership and the number of tools it aims to develop through the partnership.

In October 2011, the FDA launched an “innovation initiative” to encourage innovations that will promote public health as well as strengthen the American economy. That was followed by campaigns and initiatives to identify barriers to advances in medical technology and to clarify actions needed to overcome obstacles to innovation.

The initiatives follow growing complaints in recent years from investors that innovation is suffering because the FDA medical-device approval process has become increasingly expensive and time consuming.

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