Biomedical Engineering Expert Witnesses

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 extensive experience in the fields of cancer, biomedical research, pre-clinical animal research and ethics, and drug development, among others. After earning his BS from East Carolina University and his MS from The University of North Carolina at Greensboro, this expert completed his PhD in genetics and molecular biology at The University of North Carolina, Chapel Hill. He also went on to complete his MBA in biosciences management at North Carolina State University. This expert is an active member of the American Association of Immunologists, the Society for Leukocyte Biology, and the American Association for Cancer Research. In addition to being extensively published, he is the current associate editor of Frontiers in Immunology and Frontiers in Microbiology. Further, this expert has been engaged in a variety of university program development and research operations leadership roles throughout his career. Among his former roles, he has served as a research analyst with the Center for Human Genetics at Duke University Medical Center, a research associate for microbiology and immunology at The University of North Carolina Chapel Hill, and as an assistant professor of inflammatory diseases at Virginia-Maryland College of Veterinary Medicine. This expert currently maintains two assistant professorships at a public medical school in Virginia, in addition to his primary role as an associate professor of inflammatory diseases at a veterinary medicine education school.

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 highly-qualified expert has extensive experience in automated external defibrillator (AED) program design and compliance. He earned his BS in public affairs from the University of Oregon and his JD from the Lewis & Clark Northwestern School of Law. He is a member of the Oregon State Bar and an advisory board member of the Sudden Cardiac Arrest Foundation and the National Center for Early Defibrillation. He has been the founder of several firms, including Lazar Jensen Geobel, Fios, Inc., and AED Risk Insights, Inc. Currently, this expert is the founder and president of an AED program compliance company that develops and publishes national AED program design guidelines that describe industry standards for AED programs and the AED Law Center.

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.