MINNEAPOLIS, MN – (December 3, 2012) – LifeScience Alley, the nation's largest state-based life science trade association, announces the formation of the Medical Device Innovation Consortium (MDIC), a public-private partnership with the Food and Drug Administration's Center for Devices and Radiological Health (CDRH). The formation of the Consortium, which will be administered through a new non-profit organization, formalizes plans by LifeScience Alley and CDRH to bring leaders of industry, academia and government agencies together to advance medical device regulatory science. LifeScience Alley has provided leadership and support to the initial phase of the MDIC, which is now transitioning to an independent organization 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.
LifeScience Alley also announces that Dr. Maura Donovan will serve as interim executive director of the Medical Device Innovation Consortium. Most recently, Dr. Donovan served as vice president of therapy research and development at Medtronic, Inc. As interim executive director, Dr. Donovan will be leading efforts to recruit the inaugural Board of Directors to the Consortium, build the organization’s membership and initiate the first subcommittee teams to identify and lead specific projects. Medtronic will be providing the initial support for Dr. Donovan in this role as a loaned executive.
"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 will function in the pre-competitive medical device research space, with initial objectives focused on the creation of scientific tools to assist stakeholders in developing and assessing the safety and effectiveness of new medical device products. 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 establishment of the Consortium is an impactful step in the advancement of medical device regulatory science," states Dale Wahlstrom, CEO of LifeScience Alley. "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."
About LifeScience Alley
LifeScience Alley is an international leader in sharing best practices, and is the largest state-based life sciences trade association in the United States. With a 28-year track record of providing valuable services and results-oriented outcomes to its members, LifeScience Alley enables business success through educating workforces, influencing state and federal public policy, supporting advancement in research and technological innovation, and fostering industry connections. The Association’s membership employs approximately 250,000 Minnesotans and its reach extends throughout the Midwest and Canada. Through a strategic affiliation, LifeScience Alley partners with The BioBusiness Alliance of Minnesota and Minnesota Angel Network to strengthen the regional economy by assisting in the growth of established and emerging industries, and attracting new companies, talent and capital.