Biomedical Expert Witnesses

This highly qualified expert in biomechanics has over 20 years of professional experience in areas such as use of force, bulletproof vests, sports, and many more. She received her BS in nursing from Nazareth College, her MS in bioengineering from the University of Michigan and her MS in mechanical engineering from Wayne State University. This expert then went on to complete her PhD in biomedical engineering from Wayne State University. She is a member of various professional organizations, including the American Institute for Medical and Biological Engineering, the American Society of Mechanical Engineering, and the American Society of Engineering Education. She has published over 30 journal articles, three books, and has given nearly 60 presentations on topics in biomechanical and biomedical engineering. Formerly, she has held roles as an associate professor and full-time faculty member in biomedical engineering at Wayne State University. Additionally, she was a television producer for ESPN. Currently, this expert serves as a professor of biomechanics at a prominent CA medical school.

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.

This expert has over 30 years of experience in biomechanical engineering. He earned a BS and MS in engineering mechanics, as well as a PhD in applied mechanics in bioengineering, from the University of Wisconsin - Madison. He has published over 80 peer-reviewed journal articles, books and book chapters and holds privileges as a peer-reviewer for several biomechanical engineering journals. In addition, he is a member of numerous professional societies including the American Society of Biomechanics and the Biomedical Engineering Society. Previously, he served as an assistant professor of biomedical engineering at Worcester Polytechnic Institute and an associate professor of mechanical and materials engineering at Portland State University. Currently, he is a professor of biomaterials and biomechanics at a university in Oregon and is the owner and principal investigator at a bioengineering firm.

This highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and implementation, and over-the-counter and personal care product development. His former positions include research engineer for Eastman Kodak and GAF Corporation, project manager and laboratory supervisor for Biosearch Medical Products and Hydromer, and corporate manager of materials for Arrow International. Currently, this expert is the president of a medical device consulting company in Pennsylvania.

This highly qualified expert has over 15 years of experience in the field of bioengineering. He earned his BS in electrical engineering, two MS degrees - one in mechanical engineering and the other in electrical engineering - and his PhD in bioengineering from Georgia Institute of Technology. He is certified in deep learning with MATLAB and as a Level 1 chartered market technician and DTR international securities exchange trader. He is active in his field as a member of the IEEE Signal Processing Society, the IEEE Communications Society, and the Biomedical Engineering Society. He is also highly involved in research, having received multiple grants for his research and authored numerous publications. This expert currently holds 21 patents. He has held a number of distinguished positions throughout his career serving as the chief technology officer for 4-D Imaging, the chief risk officer of Carlyle Blue Wave Partners, and the chief science officer of Heart in Your Hand LLC and Endovantage LLC. Currently, this expert serves as an associate professor of engineering at a well-known university in Arizona, an associate professor of radiology at a medical university in Arizona, and the lead of camera software for a leading technology company.

This expert has over 30 years of experience in medical device development, specifically cardiovascular devices. He earned his BS in chemical engineering from Arizona State University and is a member of the International Society for Endovascular Specialists. This expert has a high level of clinical expertise for surgical, vascular and endovascular devices and procedures and is well versed in implantable device failure investigation and evaluation. He previously served as the president of Arizona Heart Innovative Technologies, LLC and as the vice president of research and development for Direct Flow Medical. He is currently the CEO of a medical device company in California that develops products to improve the quality of life for those with spinal cord injuries and disease.

This highly qualified expert has over 15 years of experience specializing in the electro-mechanical systems in medical devices. Specifically, this expert specializes in oxygen concentrators, oxygen conserving devices, breathe detection, power circuit design, instrumentation, and sensing. He earned his BS in electrical engineering from Northwestern and his MBA from Kellogg Graduate School of Management and has his six sigma black belt certification. He has held several roles including VP of engineering at Joslyn Hi-Voltage, director of electrical engineering at Baxter Healthcare and director of device risk management at Hospira. This expert also served as the director of global respiratory engineering in the home medical equipment division of Invacare. Currently, this expert owns a consultancy focused on the medical device product development in TX.

This product design and liability expert has over 50 years of experience in mechanical engineering. He has devoted his entire career to the design, development, and commercialization of medical devices and similar consumer products, developing 5 patents along the way. He received his BS in mechanical engineering from California State Polytechnic College before obtaining his MBA from California State College. Formerly, he served as an engineer and department manager at California Injection Molding Co., a senior project engineer and the manufacturing engineer manager at McGaw Laboratories, the director of engineering at Hudson Oxygen Therapy Sales Co., and the president at Fallbrook Engineering Inc. Currently, he serves as the president of a consulting engineering services firm in Washington.

This highly-qualified expert has extensive experience in the field of biomaterials and biomedical engineering. He earned an MS in mechanical engineering at the University of Palermo in Italy, an MS in biomedical engineering from Imperial College London, and his PhD in biomechanics and tissue engineering at the University of Pittsburgh. He also completed a post-doctoral fellowship in tissue engineering, biomechanics, and biomaterials at the University of Palermo. This expert is active in his field as a member of several organizations, including the Tissue Engineering & Regenerative Medicine International Society, the American Society for Mechanical Engineers, and the Society for Biomaterials. He is also highly involved in research, having authored numerous publications and spoken as an invited speaker at multiple conferences throughout his career. He also currently holds 13 patents. He has previously served as an R&D engineer in the biomedical robotics and EMC department at the University Campus Biomedico Rome, a biotechnology and bioengineering consultant for the Italian Ministry for Economic Development and Livanova, a post-doctoral researcher in tissue engineering and biomechanics at the University of Pittsburgh, and a research associate in tissue engineering at the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. Currently, this expert is a research assistant professor of surgery and bioengineering at a distinguished university in Pennsylvania, as well as a biotechnology and bioengineering consultant for a university-affiliated startup.

This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.

This highly-qualified expert has nearly 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma in nursing from Evanston Hospital School of Nursing before earning her BS in nursing and her MS in perinatal nursing from the University of Illinois at Chicago. She then went on to earn a post-masters certificate in midwifery from the State University of New York at Stony Brook and her PhD in perinatal epidemiology from the University of Maryland at Baltimore. This expert is a certified nurse-midwife and a licensed registered nurse. She is active in her field as a member of several organizations, including the American Nurses Association, the American College of Nurse-Midwives, and the American Academy of Nursing. She is also highly involved in research, having authored several peer-reviewed journal articles and book chapters and spoken at multiple scientific conferences throughout her career. For her work, she has been the recipient of numerous honors and awards. With over 15 years in academia, this expert has formerly served as an assistant professor of child, women and family health at the University of Maryland, and adjunct assistant professor in prevention and community health and an adjunct clinical associate professor of clinical management and leadership at George Washington University, and, most recently, as an adjunct associate professor at the Uniformed Services University of the Health Sciences. Clinically, she has served as an maternal child health epidemiologist and a health sciences administrator for the United States Department of Health and Human Services and the CDC and has worked extensively with the FDA as an epidemiologist and branch chief for the FDA's Center for Devices and Radiological Health. Additionally, she served as the director of women's health, medical ethics and patient advocacy for the Office of the Assistant Secretary of Defense. Currently, this expert is the owner and CEO of an epidemiology consulting group based in Maryland.

This Washington-based expert has over 20 years of experience in chemistry and medical device research, specializing in polymer synthesis, polymer characterization, analytical chemistry, medical device design and intellectual property management. He received his BES in chemistry and photographic sciences from St. Cloud State University before earning his PhD in polymer chemistry from the University of Southern California. He is active in his field as a member of the American Chemical Society, is a highly-published author on the topics of polymer chemistry and medical devices, and holds 65 patents that have enhanced the field of polymer chemistry. Previously, he has served as a polymer chemist and then a senior polymer chemist at Medtronic, an adjunct professor of polymer chemistry at the University of St. Thomas, and a senior scientist at DexCom Inc. He also formerly served as an associate professor and then a professor of chemistry, as well the assistant dean of the college of science and technology and the interim assistant vice president and dean of graduate studies at Bloomsburg University. Currently, he serves as the vice president of intellectual property at a technology research lab in WA.

This expert in material sciences and electrochemistry received his BA in bio-engineering from the University of Pittsburgh before studying medical device fabrication science and then obtaining his PhD in physics at the University of Melbourne. He has experience with medical devices such as neural stimulators, neural recorders, and chemical sensors. This expert has two approved patents and two pending patents relating to materials used for medical devices and has published 27 articles in his field. Formerly, he served as a Fulbright research fellow at the Center for Eye Research Australia, a medical devices scientist at the University of Melbourne, and an NIH postdoctoral research fellow at the University of Pennsylvania. Currently, this expert is a senior scientist at a medical device company in California. He is also a co-founder and the CTO of a medical device company that specializes in developing bio-stable materials for neuro-interface devices.

This expert has over 30 years of experience in the medical device industry, with broad expertise in cardiovascular and endovascular fields with a focus on percutaneous catheters, heart assist devices, brain and aortic aneurysm treatment, and vascular closure products. He earned his MS in mechanical engineering at Moscow State Technical University and worked as the lead engineer at the Scientific Institute for Transplantology and Artificial Organs before moving to the United States. He is a registered patent agent through the US Patent and Trademark Office and is a member of the Association of University Technology Managers, the International Society for Rotary Blood Pumps, and the American Society for Artificial Internal Organs. He formerly served as the scientific director and vice president of technology at Datascope Corp. before he served as the CTO of Cerus Endovascular. This expert is currently the principal of a patent consulting company, the founder of a medical technology development company, and the vice president of product development for a medical device start-up in New Jersey.

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 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 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.