A year ago, St. Cloud State University launched a masters degree program in regulatory affairs. The idea was to address a glaring hole in the state’s medical device industry: the lack of people with expertise in guiding companies through the often arduous and complex task of obtaining regulatory approval from the Food and Drug Administration, not to mention securing Medicare reimbursement. As any entrepreneur, executive, or venture capitalist will tell you, regulatory and reimbursement issues are the biggest challenges to getting a promising medical device to market.

Minnesota “is a Mecca for medical devices,” said Mark DuVal, managing director of DuVal & Associates law firm in Minneapolis who also serves on the program’s advisory board. “We get calls from CEOs who tell us there is shortage of good professionals in clinical and regulatory affairs.”

As the program enters its second year, DuVal has high hopes. 15 students enrolled in the inaugural class; DuVal expects that number to double to 30 to 40 come September.

The program already boasts some impressive industry heavyweights. Chuck Swanson, the retired regulatory chief at Medtronic, is program director; advisory board members include Steve C de Baca, vice president of quality at Boston Scientific, Suzanne Danielson, director of regulatory affairs and quality at 3M Medical Division, and Debra Kridner, former vice president, clinical research and regulatory affairs at St. Jude Medical Cardiovascular Division.

Classes like “Legal Basis for Medical Device Product Regulation” and “Reimbursement for Medical Technology”are taught by industry veterans.

“Academia needs to get tied in with the business community and this is a practical way to do it,” DuVal said. “St. Cloud State is very attached to reality.”

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