FDA Approval Expert Witnesses in Vermont

This expert received his undergraduate and doctoral degrees in Biomedical Engineering from Iowa State University. He has worked for and consulted with leading medical device, pharmaceutical & biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the FDA, Health Canada, the US & European Patent Offices, the Centers for Medicare and Medicaid Services, and other regulatory agencies around the world. As an internationally recognized expert, he presents frequently on cutting-edge medical technologies and conducts seminars for medical device, pharmaceutical and biotechnology companies.

This Boston based expert earned his Bachelor's of Science degree in electrical engineering from Tufts University. He began his career in medical device design at Siemens Medical Systems, thereafter serving as the Director of Engineering for Aspect Medical Systems, the developer of the world's first anesthesia monitor, which is now in 90% of operating rooms worldwide, and has served at least 200 million patients. He serves on the scientific advisory boards of several medical device firms including Safe-Op Surgical, a manufacturer of intraoperative nerve monitors.

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 extremely qualified expert is a certified pharmacist with years of experience in community pharmacy management and regulatory affairs. He received both his BS degree in pharmacy and his MBA degree from the University at Buffalo. He is a member of multiple professional associations, including the American Association of Colleges of Pharmacy, the American Pharmacists Association and the American Society for Pharmacy Law. He has given 100+ lectures statewide in NYS. His outstanding work has earned him several honors, including the Pharmacists Society of the State of New York's "Faculty Excellence Award" the Pharmacists Association of Western New York's "Pharmacist of the Year" award and the national Bowl of Hygeia award. He is the former coordinator of pharmacy services at the Community Health Center of Buffalo. He is also the former director of pharmaceutical care services at the University of Buffalo. Currently, he is a clinical associate professor of pharmacy practice and administration at a major university, where he also serves as the senior associate dean of the pharmacy school's student, professional and community affairs.

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 expert holds a Ph.D. in Biochemistry and Pathology, a Masters degree ion Environmental Health and Radiation Health Physics and a Bachelors degree in Biology. He worked for several years in academic research related to pulmonary injury and disease and pulmonary carcinogenesis. He also worked a the director of an environmental testing laboratory. In addition, this expert worked as an industrial Hygienist and as the Director of Safety at Massachusetts General Hospital in Boston. For the past 15 years he has been an independent consultant in Environmental Health, Safety and Toxicology. He advises attorneys and testifies in legal matters. This expert has written several publications and books on both scientific pulmonary research and on Healthcare Safety and Regulatory Compliance. he continues to write and lecture on topics related to healthcare safety, general safety and OSHA compliance.