LifeScience Alley, which represents the medical device industry in Minnesota, announced Wednesday that former Medtronic CEO Bill Hawkins will be the inaugural chairman of a new public-private partnership to advance regulatory science.
Regulatory science is a set of tools and methods for evaluating the safety, effectiveness, quality and performance of medical devices.
The three entities that are collaborating are Minnesota’s life science community through LifeScience Alley, the University of Minnesota and the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).
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The announcement comes six months after LifeScience Alley’s president and CEO Dale Wahlstrom said that the association will collaborate with the FDA to see how innovative medical products can get quick, regulatory approval.
“Bill has the experience, reputation and vision to help lead this initiative,” Wahlstrom said in a news release. “We now have an opportunity to play an important part in improving the process for evaluating medical technology for market clearance.”
Aside from Hawkins, who is currently the CEO of Immucor, Amy Peterson, senior director, clinical & regulatory affairs, men’s health division, American Medical Systems (AMS), will provide executive management of the partnership and will oversee the administration of projects. In another month, LifeScience Alley will name members to the partnership’s Steering Committee for which Hawkins and Peterson are trying to get commitments from experts in industry and academia.
One main objective of the partnership will be to set up a center for the advancement of regulatory science in Minnesota.
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Aside from running Immucor and chairing this partnership, Hawkins is working with the Entrepreneurs-in-Residence program at CDRH, which is part of a government effort to improve the regulatory environment.
“I am very excited about the global impact that I believe this Minnesota initiative will have,” Hawkins said in a statement. “Working closely with Dr. [Jeffrey] Shuren [director of CDRH], the University of Minnesota and industry executives, I know we can improve our approach to ensure U.S. leadership in medical technology innovation and to save and protect lives.”
