Biomedical Expert Witnesses in Massachusetts

This qualified expert has been involved in the field of medical technologies for over forty years and is experienced with matters concerning FDA compliance on which he has authored several articles and papers and given talks on FDA compliance worldwide. He is also the vice president of a private medical technologies firm, making him intimately qualified to comment on the case at hand.

This highly qualified expert has almost 30 years of experience as a perfusionist. He received a B.S. in Biology from Nazareth College of Rochester and a M.S. in Education from the State University of New York in Albany. He is board certified in Cardiovascular Perfusion and has been elected as a Fellow to the American Academy of Cardiovascular Perfusion where he previously served as President. He has published many articles on various perfusion methods and currently serves as Associate Professor and Clinical Coordinator in the Department of Cardiovascular Perfusion at a medical university in New York.

This expert has experience in Medical devices since 1992. Design experience since 1986. Areas of expertise include full life cycle product development of medical devices from conception through development including manufacturing, bench testing, verification, validation, packaging, labeling, clinical trials, regulatory approval, marketing, and sales training. Granted 28 patents (others pending), 7 awards, designs published by Life Magazine, was recognized as one of 100 notable people in the medical device industry by the Medical Device & Diagnostic Industry (MD&DI) publication in June 2008. This expert recently served as chairman of the Medical Device & Manufacturing Conference in 2014.

This highly qualified expert earned his BS and MS in biochemistry from Victoria University of Wellington and his PhD in microbiology from Lincoln University. After completing his education, he moved to the United States to pursue a career in medical device manufacturing. He held roles as a manager of microbiological services, pharmaceutical quality control, and market product stability at Lederle Laboratories. He then worked as a director of quality control the New York blood center, director of global quality assurance and microbiological development at Wyeth and director of pharmaceutical microbiology at Merck & Co research laboratories. Most recently, he has been a senior principal scientist at Merck & Co and is currently a microbiologist at an independent consulting firm. This expert has over 70 peer-reviewed publications in microbiological journals addressing factors of contamination in medical devices. He is also a member of the United States Microbiology and Sterility Assurance Committee.

This expert has extensive experience in the field of biomechanics and human factors. He earned his BS and MS from the Colorado School of Mines and his PhD in biomedical engineering from Oregon Health & Science University. He is certified in prosthetics and a member of the International Society for Posture and Gait Research. He previously served as a design engineer for JR Engineering, LLC, as a graduate research assistant at Oregon Health & Science University and as an assistant professor at the University of Hartford. He is currently an associate professor at a university in Connecticut.