Spring 2001

ME/IE 8773-8774

Breakthrough Implanted Biomedical Devices:
An Exploration of the Bench-to-Bedside Process

by

Paul Citron
Vice President, Science and Technology
Medtronic

Wednesday, March 14, 2001
3:30-4:30 p.m.
Room 108 ME
Broadcast on UNITE Channel A
Coffee and cookies will be available in 152 ME following the seminar

The innovation process for implanted medical devices follows two relatively distinct pathways: one for next generational technologies; one for breakthrough innovations. Next-generational advances build on the foundations established in earlier product iterations. Safety and effectiveness profiles are generally established as are regulatory requirements and clinical protocols. Consequently, uncertainty and project risk are significantly lower than for initiatives that are heretofore untested (in humans) implanted innovations. This presentation will explore some of the unique challenges and other considerations that affect the process of taking a new implanted technology from the idea stage to the clinical setting. Specific case studies will be used to illustrate key factors, sometimes unanticipated, that can affect the success or failure of potential breakthroughs.

Paul Citron is Vice President of Science and Technology at Medtronic. He has responsibility for corporate-wide assessment and coordination of technology and for establishing and prioritization of corporate research. Citron was awarded a B. S. degree in electrical engineering from Drexel University in Philadelphia in 1969 and a M. S. degree in electrical engineering from the University of Minnesota in 1972. Citron was elected Founding Fellow of the American Institute of Medical and Biological Engineering (AIMBE) in January 1993, has twice won the American College of Cardiology Governor's Award for Excellence and, in 1980 was inducted as a Fellow of the Medtronic Bakken Society. He was voted IEEE Young Electrical Engineer of the Year in 1979. He has authored numerous publications and holds eight U.S. medical device patents. In 1980 he was given Medtronic's "Invention of Distinction" award for his role as co-inventor of the tined pacing lead. He sits on a number of advisory boards and committees including:

Minnesota Medical Foundation Board of Trustees (10/97 - present)
MIT Center for Biomedical Engineering Advisory Board (1996- present)
Georgia Tech. Petit Institute Advisory Board (10/96 - present)
Johns Hopkins Biomedical Engineering Advisory Council (1997-present)
Chair of AIMBE's Industry Council (1997-present)
University of Minnesota Biomedical Engineering Institute Governing Board (appointed 1996 - present)
University of Minnesota Biomedical Engineering Institute Advisory Committee (1996 - present)

Informal Faculty Luncheon: Wednesday, March 14, 2001, 12:00 noon. A table is reserved at McCormick's Restaurant, Radisson Hotel Metrodome. Dr. Paul Citron will not be able to attend.