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Return to Article: Roundtable: Medtech's Outlook in Regulatory Affairs

GOVERNMENTAL & LEGAL AFFAIRS

Susan Alpert, PhD, MD, is senior vice president and chief quality and regulatory officer at Medtronic Inc. (Minneapolis), a position she has held since 2005. She is responsible for all Medtronic quality, regulatory, and clinical compliance efforts, including overseeing health policy and payment. Alpert joined Medtronic in July 2003 as vice president for regulatory affairs and compliance from C. R. Bard Inc., where she had been vice president of regulatory sciences.

Before joining Bard, Alpert served at FDA, where she held a variety of positions in the centers dealing with drugs, devices and radiological health, and foods, including six years as director of the Office of Device Evaluation.

Bradley Merrill Thompson is a member of the healthcare and life sciences practice of Epstein Becker & Green (Washington, DC). There, he counsels medical device and drug companies on a wide range of FDA regulatory, reimbursement, and clinical trial issues. For trade associations, Thompson serves as counsel to AdvaMed for payment issues, as general counsel to the Combination Products Coalition and as counsel and secretary for the Indiana Medical Device Manufacturers Council.

From 1994 to 1997, Thompson was an active advocate for the citizens’ petition that pushed for FDA to adopt good guidance practices. In 1997, Congress codified the good guidance practice requirement in FDAMA, and FDA later implemented those practices through rule making.