Medical device makers have ongoing concerns about the speed and transparency 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.
The consortium will be administered through a new non-profit organization and will be governed by a national board of directors, including industry executives and government leaders. Articles of Incorporation for the Consortium have been filed with the state of Minnesota, and the organization will be applying for a 501(c)(3) designation with the IRS.
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 inaugural board of directors and build the consortium’s membership. She will also initiate the first subcommittees to identify and lead specific projects. Medtronic is supporting the project by loaning Donovan.
"Maura has provided excellent leadership to Medtronic over the years," said Rick Kuntz, M.D., senior vice president and Chief Scientific, Clinical and Regulatory Officer, Strategic & Scientific Operations 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, and we are glad that we are able to support LifeScience Alley by lending Maura's time and expertise to the Consortium."
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.”
Dale Wahlstrom, CEO of LifeScience Alley, on Monday said: "The establishment of the Consortium is an impactful step in the advancement of medical device regulatory science. We have been working closely with Dr. Jeff Shuren, Dr. Michelle McMurry-Heath and CDRH staff over the past year to build a mechanism to solve pre-competitive technical issues. This is an exciting partnership that will have a profound impact across the nation's medical technology industry."