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2005-1481

Educating the Medical Device Professional

Ronald J. Bennett, Ph.D.

School of Engineering University of St. Thomas St. Paul, Minnesota

Abstract

The medical device industry is robust and thriving in Minnesota, particularly in the Minneapolis- St. Paul metropolitan area. Education on medical device issues is available to employees of the larger corporations, but not readily available for smaller medical device company employees and professionals from other industries that want to enter this area.

To address this situation, several years ago we began offering a course in medical device FDA regulations in our graduate program. Demand was high, and this single course has now evolved into a series of courses ranging from pre-market approval of devices to anatomy and physiology for engineers. These courses are offered in our evening part-time graduate program and can be taken as individual courses, be combined into a graduate certificate or used toward one of our Master’s degrees.

The wealth of resources provided by adjunct faculty who are practicing and keeping up to date in this rapidly changing area have resulted in a high-quality, readily available program that has attracted students from a variety of companies and backgrounds and created opportunities for job enhancement and professional growth.

History and Background

The medical device industry had worldwide revenues of $195 billion and US revenues of $95 billion in 2003 and is growing at 6% per year. The industry employs 1 million or more people in the US, Europe and Japan. Ten companies control 35% or the US market, with five of those companies located in Minnesota.i There are 800 registered medical device firms and more than 520 FDA approved medical device establishments currently in Minnesota.ii About 2,500 medical device related patents were registered to Minnesota companies between 1997 and 2001, and Minnesota has the nation’s highest number of investigational medical devices and FDA premarket approvals of medical devices per 100,000 residents. Medical device employment increased 31% between 1992 and 2002 in Minnesota compared to 10.2% nationwide. Minnesota

“Proceedings of the 2005 American Society for Engineering Education Annual Conference & Exposition Copyright @ 2005, American Society for Engineering Education”

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Bennett, R. (2005, June), Educating The Medical Device Professional Paper presented at 2005 Annual Conference, Portland, Oregon. 10.18260/1-2--14461