Medical Devices Expert Witnesses in Kansas

This expert is a world renowned Biomedical Engineer specializing in prosthetics. He received a BA in mathematics and a BAI in microelectronics and electrical engineering from Trinity College Dublin, Ireland, in 1983. After working as a control engineer in England, he moved to the USA and obtained his MS and PhD degrees in biomedical engineering from Northwestern University in Evanston, IL. He has extensive experience working with lower and upper limb prosthetics research. His recent research is focused on the development an artificial hand replacement capable of true dexterous manipulation for use by persons with upper-limb loss. He covers all aspects of the problem ranging from neural control and sensing, mechatronic design and development, novel actuator technologies, and clinical deployment of these systems. He is currently the Director of the Biomechatronics Development Laboratory at a university in CO. He is also a Research Healthcare Scientist for a VA Health Care System, and holds Research Associate Professor appointments in the Departments of Bioengineering and Physical Medicine & Rehabilitation.

This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.