fbpx Elaine Duncan | University of Kentucky College of Engineering

Elaine Duncan

Adjunct Professor

Appointments

Adjunct Professor, F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, College of Engineering, University of Kentucky, Lexington, KY, 2018-Present

President, Paladin Medical, Inc., Stillwater, MN, 1987-Present

Vice President of Research and Development, Vice President of Regulatory Affairs and Quality Assurance and Vice President of New Ventures, Possis Medical, Inc. St. Louis Park, MN, 1984-1987

Director of Regulatory Affairs and Quality Assurance, Symbion, Inc. , Salt Lake City, UT, 1982-1984

Senior Research Engineer, 3M Health Care Group, St. Paul, MN, 1974-1982


Education

B.S., Mechanical/Biomedical Engineering, University of Kentucky, Lexington, KY, 1974

M.S., Mechanical/Biomedical Engineering, University of Minnesota, Minneapolis, MN, 1981

R.A.C., Regulatory Affairs Certification, Regulatory Affairs Society, 1994 to present


Recognitions

Outstanding Contribution to the Healthcare Industry, Medical Alley Association, 1992

William Hall Award for Service to the Society For Biomaterials, Society For Biomaterials, 1999

Hall of Distinction, College of Engineering, University of Kentucky, 2002

Fellow, American Institute for Medical and Biological Engineering (AIMBE), 2019

Research Interests:

Ms. Duncan enables large and small companies alike to acquire US FDA clearance and approval by guiding teams to establishing programs of Design Control and Review, teaching and establishing Quality Systems, developing protocols and reports of pre-clinical and clinical studies for new devices and planning biocompatibility testing, verification, validation and human factors studies.  From her wide experience in medical device technology, encompassing implantable devices, biomaterials such as bone void fillers, textiles and magnetic materials, software and electronics and assistive device technologies, she serves as a trainer and instructor to medical device development peers and university students. Ms. Duncan has given numerous lectures, written many trade-journal articles and authored book chapters, including, most recently, three chapters in the 4th Edition of Biomaterials Science (C 2020.)