A familiar industry face will head up a new partnership to advance medical device regulatory science.
Bill Hawkins, former CEO of Medtronic and current CEO of Immucor Inc., will serve as inaugural chairman of a new public-private partnership among Minnesota's medical technology community, the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and the University of Minnesota. The partnership was initiated following a LifeScience Alley-hosted visit of senior CDRH members to the Twin Cities in August last year, and was formalized in the signing of a Memorandum of Understanding between LifeScience Alley and FDA on Dec. 7. LifeScience Alley is one of the largest state-based life sciences trade association in the United States.
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. Among other initiatives, local members of the partnership will lead efforts to establish a center for the advancement of regulatory science in Minnesota.
Hawkins and Peterson, in collaboration with LifeScience Alley and the University of Minnesota, are in the process of securing commitments from industry and academic leaders to serve on the partnership’s steering committee. Full committee membership will be announced within 30 days. Dale Wahlstrom, president and CEO of LifeScience Alley, announced the agreement after several conversations with Hawkins and various stakeholders.
“Bill has the experience, reputation and vision to help lead this initiative," said Wahlstrom. "We now have an opportunity to play an important part in improving the process for evaluating medical technology for market clearance.”
In addition to his duties as CEO of Immucor, an in-vitro diagnostics company based in Norcross, Ga, Hawkins is working with the entrepreneurs-in-residence program at CDRH as part of a White House and FDA initiative to improve the regulatory environment.
“I am very excited about the global impact that I believe this Minnesota initiative will have,” said Hawkins. “Working closely with Dr. [Jeffrey] Shuren [director of the 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.”
The University of Minnesota and industry's advanced research, testing and modeling capabilities are a critical component in the creation of the regulatory science center, organizers said.
"The members of this partnership bring a wealth of scientific and medical technology knowledge to the table," said Tim Mulcahy, vice president for research at the University of Minnesota. "The University is eager to lend our research expertise to the advancement of regulatory science and the development of life-enhancing technologies."
Amy Peterson brings extensive regulatory leadership experience to the partnership, including senior positions with large, midsize and startup companies, such as AMS, St. Jude Medical, Northstar Neuroscience and Lumen Biomedical.
“We are so pleased to have Amy’s leadership and the support of AMS as we move forward on defining the work of this partnership,” said Wahlstrom. “Amy’s role will be critical to defining the projects that can advance regulatory science and building new collaborations among the FDA, industry and academia.”