Medical Devices Expert Witnesses

This expert has over 40 years of experience as a mechanical engineer. In addition to contributing to over 200 presentations in 38 countries, he has been extensively published in his field and is an established expert in forensic mechanical engineering. His expertise includes accident investigation and medical device liability. He now serves as a Senior Forensic Consultant for a biomechanics and biomedical engineering consulting firm.

This expert received a Ph.D. in Biomedical Physics and is board certified in Radiology. She is a certified Radiation Safety Officer and a member of the American College of Medical Physics and American Nuclear Society.

This expert has over 40 years of experience as a mechanical engineer. His research in tribology, machining of advanced materials, medical device design, dental materials, and high temperature coatings is widely recognized in the scientific and engineering communities. He has published over two hundred fifty papers and reports related to machining of ceramics, mechanisms and mechanics of interfaces, wear and friction, boundary lubrication, and biotribology; and has given more than three hundred lectures on these subjects. He has served as President and CEO for a heart pump developer, a subsidiary for a product company where he served as Vice President of Biotechnology.

This expert has over 15 years of experience in the medical device industry as a quality engineer, quality systems and complaint investigator with emphasis on cardiovascular devices. A Certified Quality Engineer and Biomedical Auditor, his expertise includes managing quality systems, design and development of new product lines, product risk management and complaint investigations. He currently serves as Principal quality management systems and business Consultant for an independent consulting firm in both medical device and other industries. His understanding of medical device firm operations and intimate familiarity with medical device requirements in both the US and other geographies make him an ideal expert to provide advice in determining both legal and regulatory requirements for medical device firms as well as users (clinicians).

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 highly qualified expert specializes in engineering and regulatory affairs for medical device commercialization. She earned a BS in mathematics from Oregon State University and a MS in Medical Device and Diagnostic Engineering from the University of Southern California. This expert currently owns and operates her own medical device company where she prepares and submits FDA regulatory services 510k applications.

This expert has been working in regulatory affairs for nearly 25 years. As a Regulatory Affairs Associate with Bayer Healthcare Pharmaceuticals, he gained significant experience in all facets of drug life cycle, from coordinating, evaluating, and filing submissions for new and marketed products, to responding to Health Canada requests and negotiating with Health Canada scientific reviewers, to preparing and following clinical trial applications. He wrote and revised Product Monographs in consultation with medical and marketing departments, reviewed labeling and promotional material to ensure compliance, and conducted product label audits. He is a member and former Director of the Canadian Association of Professional Regulatory Affairs and also holds membership in the Regulatory Affairs Professional Society. Currently, this expert is the Principal of his own regulatory affairs consulting firm, providing regulatory expertise and services in the pharmaceutical, biotech, and medical device industries.

This highly qualified expert has both an MA and a PhD in Biomedical Engineering from Vanderbilt University. He completed 2 fellowships, and he is a member of numerous professional societies including the 'American Biomedical Engineering Society' and the 'American Association for the Advancement of Science'. He is extensively published with numerous peer-reviewed journal articles, books, and monographs, and he has been a presenter and lecturer at multiple professional conferences. He currently serves as an Assistance Professor of Bioengineering at a major university.

This highly qualified pathologist and cancer research scientist has more than 45 years in active clinical medical practice delivering patient care and conducting laboratory-based biomedical research. This places him in a unique position to evaluate causation of disease, including occupational exposures. He also has considerable medico-legal experience. Board-certified in the UK, his clinical proficiency includes expertise in specialized areas including pulmonary, cardiac, breast, urological, and neurological diseases at a number of prestigious university medical centers. He is the former director of the University of California - San Diego's comprehensive cancer and has authored more than 300 publications in the field. This expert is currently a professor of pathology at a major university medical center in California.

This expert has been working as a mechanical engineer and testifying expert witness for over 30 years. He holds both an M.S. and Ph.D. in Mechanical Engineering from Stanford University and a BES from Georgia Tech. He is a Fellow of the American Society of Mechanical Engineers (ASME), a Senior Member of the Institute of Electrical and Electronics Engineers (IEEE), and a Member of SAE and ASM. This expert is a licensed Professional Mechanical Engineer (PE), providing expertise across a wide range of engineering topics and fields. He has deep experience in medical devices including cardiovascular, orthopedic, and spinal applications and applications of nitinol shape memory materials. He has experience as an Expert Witness, has testified in trial and deposition, and authored expert reports and IPR declarations. He works in patents and product failure analysis and forensics. He was previously Faculty in the Department of Mechanical Engineering at Santa Clara University as well as a Visiting Associate Professor in the Department of Mechanical Engineering at Stanford University.

This highly qualified, board certified expert earned his Bachelor's degree in Kinesiology from the California state University at Fullerton and then completed his Doctor of Chiropractic degree at the Los Angeles College of Chiropractic. This was followed by an internship at Glendal Chiropractic Clinic. This expert is a member of numerous chiropractic societies, and he was even elected as president of one of them. This expert has earned numerous awards for his contributions to the field of chiropractic. This expert has published 7 peer reviewed papers and 2 books and has been a reviewer for 2 chiropractic journals. This expert previously served as president of the International Chiropractors Association of California, and worked as a licensed chiropractor at multiple clinics. This expert also served as part of the sports medicine staff of numerous USA teams in cluding the LA Olympics. This expert currently serves as instructor of biomedical sciences and professional advancement at two different univeristies and also operates a chiropractic private practice.

This highly experienced biomedical engineer has directed comprehensive hospital-based biomedical engineering department at the largest medical center in the country, taught at both medical and technical post-secondary institutions, including the Baylor College of Medicine, West Virginia University, and a prominent Mexican university. He earned his undergraduate and graduate degrees in electrical engineering from West Virginia University. He is a licensed Professional Engineer and certified as a Clinical Engineer. He is member of technical standards writing bodies, and is widely published in his field and his expertise is frequently sought by hospitals, manufacturers, and litigators. He received numerous professional awards including the FDA Commissioner, Special Citation for protecting the public safety.

This expert joined the Departments of Bioengineering and Mechanical Engineering at a major TX University in June 2013 as an Assistant Professor. Prior to joining that university, he was a Research Scientist at the Rehabilitation Institute of Chicago and a Postdoctoral Fellow at Northwestern University. This expert investigates the control mechanisms of human locomotion for the development of high-performance wearable control systems (e.g., robotic prostheses and orthoses) to enable mobility in persons with disabilities. He is a recipient of the NIH Director's New Innovator Award and the Career Award at the Scientific Interface from the Burroughs Wellcome Fund. His work has been recognized with the Best Student Paper Award of the American Control Conference and the IEEE Conference on Decision & Control, the Best Technical Paper Award of the 2011 CLAWAR Conference, and the O. Hugo Schuck Award from multiple control conferences and councils, respectively. He is a Senior Member of the IEEE Control Systems Society and the IEEE Robotics & Automation Society.

This highly qualified expert is the current director of the Office of Technology Transfer and Licensing at a major college in Massachusetts. He previously served as assistant director in the Office of Technology Transfer at Cold Spring Harbor Laboratory in New York and was an assistant professor in Virginia Commonwealth University. He has 10+ years of biomedical science research experience and a broad background combining experience in the life sciences, business, and patent law. He is a long time member of the Association of University Technology Managers and the Licensing Executives Society. He was among the first to earn a Certified Licensing Professional credential, and now serves as a current CLP Exam Development Committee member and AUTM International Professional Development Committee member. He is also a Registered Technology Transfer Professional. As a United States Patent and Trademark Office Registered Patent Agent, he has extensive experience in patent application and prosecution. He holds a PhD in molecular biology from Nankai University in China and an MBA from the University of Richmond. He is also the President and Board Chairman of the World Association of Chinese Technology Managers (WACTM).

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.

This decorated expert has a quarter century of electrical engineering experience, earning graduate qualifications at MIT, where his work had important biomedical applications. He is a member of several professional societies such as the Institute for Electrical and Electronic Engineers and Virginia Academy of Science. Active in research, he has won numerous grants and has been published widely. He has consulted on IP issues in the past and holds several patents for his inventions.

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 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 expert is highly qualified and board certified. He attended Harvard University and graduated with a Bachelor of Arts degree. He pursued a Doctorate in Medicine at Harvard Medical School. He completed an Internship in Medicine and Surgery at Tufts-Newton Wellesley Hospital and attended a residency program in Ophthalmology at Massachusetts Eye & Ear Infirmary. He is currently serving as a Professor and Chair at a major medical university. In addition, he is a Director of Eye Institute at another major medical school. He is a professor of Biomedical Engineering.

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.