Elaine Duncan, adjunct professor in the University of Kentucky F. Joseph Halcomb III, M.D. Department of Biomedical Engineering, has been elected a Fellow of Biomaterials Science and Engineering (FBSE) by the International Union of Societies for Biomaterials Science and Engineering (IUSBSE). This designation is the highest honor bestowed upon outstanding scientists from the global biomaterials community. Duncan's election makes her one of less than 500 biomaterials scientists internationally to hold the title of FBSE.
The IUSBSE is a body that brings together national and multi-national groups dedicated to the advancement of biomaterials, surgical implants, prosthetics, artificial organs, tissue engineering and regenerative medicine. These fellowships recognize those who have gained a status of excellent professional standing and high achievements in the field of biomaterials science and engineering.
Duncan, a Lawrenceburg, Kentucky native, is the founder and president of Paladin Medical, Inc., a consulting company specializing in regulatory and clinical strategies for new medical technology development, out of Stillwater, Minnesota.
Her expertise has enabled large and small companies alike to acquire FDA clearance and approval. Duncan's vast experience in medical device technology has positioned her to be an invaluable trainer to her medical device development peers and instructor to university students. Her experience encompasses implantable devices, biomaterials (e.g. bone void fillers), textiles and magnetic materials, software and electronics, and assistive device technologies.
Duncan began her career at 3M Health Care Group as a senior research engineer. There, she was responsible for new product development and new technology assessment. She completed the successful integration of a number of implantable devices into the 3M product line, as well as development of a disposable wound drainage system. Duncan was awarded two United States Patents for this work.
As the director of regulatory affairs and quality assurance at Symbion, Inc., she oversaw the clinical programs and regulatory submissions for the JARVIK-7 artificial heart and the Utah cochlear prosthesis. She developed the surgeon implant training program for the artificial heart and assisted in taking the company through its initial public stock offering. Her analysis of the failure modes of the Bjork-Shiley valve in the JARVIK-7 played a supporting role in FDA and Congressional investigations, leading to the retrieval of the faulty valve from the marketplace.
At Possis Medical, Duncan held the titles of vice president of regulatory affairs and quality assurance and vice president of new ventures. The mock-circulatory loop she designed and the resultant coronary circulatory modeling data led to design enhancements and documentation of engineering performance that subsequently supported FDA approval for the Possis venturi-vascular graft.
Duncan received the Medical Alley’s Outstanding Contribution to the Healthcare Industry Award in 1992, and the C. William Hall Award from the Society for Biomaterials in 1999. She was inducted into the UK College of Engineering Hall of Distinction in 2002 and was named an American Institute for Medical and Biological Engineering Fellow in 2019.
Duncan has been a member of the Association for the Advancement of Medical Instrumentation, American Society for Testing and Materials, Surfaces in Biomaterials Foundation, Biomedical Engineering Society, the Regulatory Affairs Professional Society, ASAIO and Medical Alley. She is editor emeritus for the publication Biomaterials Forum, and served on the editorial review board for the Journal of Biomedical Materials Research. She has published numerous articles and book chapters and frequently presents in the fields of biomaterials, medical device development and regulation.
A formal induction ceremony for IUSBSE's newest class of fellows will be held in May at the World Biomaterials Congress in Daegu, South Korea.
