Biomedical Expert Witnesses

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. 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 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 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 certified Regulatory Affairs Professional has more than 20 years of experience ensuring compliance with the FDA. Throughout his career, he has managed 510(k) submissions, reviews, appeals, and clinical trials for a multitude of devices with applications ranging from dentistry to cardiology and neurology. Prior to launching his current consultancy, he served as a Director of Regulatory Affairs at medical device firms that manufacture class II and class III products. Have experience with: Catheters/Stents: IV administration sets, peripheral perfusion/infusion catheters, coronary perfusion/infusion catheters, thoracic catheters, chest drains and blood bags, embolectomy catheters, thrombus aspiration catheters, PTA, PTCA, CVC, ECMO, retrograde and antegrade hemodialysis catheters, urethral and ureteral catheters/stents, insulin administration, Closed System drug Transfer Devices (CSTD), non-roller cardiopulmonary bypass pumps and catheters, coronary and peripheral BMS, peripheral covered stents, aortic covered stents, DES, ureteral stents, urological stents, esophageal stents, intracranial aneurysm stents, pericardium covered stents, vascular grafts and vascular grafts with helix or nitinol reinforcement, and vascular patches. Biomaterials: bone void fillers, resorbable implants, hydroxyl appetite, hyaluronic acid, dental impression materials, PEEK, calcium carbonate, Beta TCP, imaging contrast agents, hydrogel dressings, lubricious coatings, artificial saliva, contact lenses and contact lens solutions, antimicrobial coatings, antithrombotic coatings, IIb/IIIa inhibitors, mTOR inhibitors, and omega3 coatings, injectors and pens, antimicrobial wound cleanser and bandages. Orthopedic/Dental: ACL/PCL screws, suture anchors, tacks, staples, spinal cages, trauma plates and screws, CMF, approximation pins and rods, dentures, veneers, dental implants/abutments, impression material, autoclave equipment, dental units, limb lengthening systems, and intra-oral x-ray equipment. Accessories: tunnelers, suture wings, convenience kits, stylets, peel away dilators, cannulas, scalpels, suture, guidewires, sheathes, extension sets, repair kits, luer valves, needle/syringes, blood vacuum tubes, needle safe devices, O2 regulators, radiation therapy patient positioning systems, radiation range compensators, sterilization biological and chemical indicators, and fiber wire docking stations. Hardware/Software: neonatal clinical trial software, firmware, RIS software, image repository software, ECG analyses software, TENS, MIRS, MMA, MDDS, EMC therapy, PACS, stereotactic tracking system, stereotactic software, patient monitors, ventilators, lift beds, TMS (transcranial magnetic stimulator), active tinnitus implants, Holter monitors, phototherapy devices, data fusion software, hyperbaric chambers, autoclave sterilizers, powered muscle stimulators, cryosurgical units, MDM workflow software, Doppler and GPS ultrasound scanners, GPS needle sensors, vascular access needles, RF, nerve block needles, fiber optical lasers, neuron stimulators, and therapeutic massagers, MIMS, viewing monitors, body contouring devices. Reusables: nasopharyngoscope, colonoscope, colposcope, neurological endoscope, sinuscope, arthroscope, and laparoscopes, instruments, tunneler rods, irrigation systems, therapeutic mattresses, OB/GYN scopes, patient cables and electrodes, scooters, vein graft tunneling systems, confocal optical imaging devices, and cannulae, 3DHD endoscopes, IR fluorescence and Indocyanine green endoscopes, measuring microscopes. General Surgery: surgical film, pressure mattresses, cryo-biopsy needle, surgical mesh, plugs, anal fissure drug suppository and delivery plunger, anorectic Nifedipine CTD, red light therapy dermatology lasers, surgical lasers, and Continuous Low Irradiance Photodynamic Therapy (CLIPT) for phototherapy drug activation, collection and transport media, disinfecting swabs and wipes, gastrostomy tubes.

This qualified electric shock expert obtained his BS and MS in Bioengineering and Engineering Science from Stanford University and his PhD in Biomedical Engineering from Duke University. He is a Certified Professional Engineer and is a member of multiple engineering and bioengineering associations. The expert has published 75+ articles on electric shock and medical devices. He is an Emeritus Professor of Biomedical Engineering at a top university in the South and remains active as a consultant.

This highly qualified engineer earned his BS and MS in mechanical engineering from California Polytechnic State University. He went on to earn his PhD in mechanical engineering from the University of California, Berkeley. He has over 10 years of experience conducting failure analysis for various products including biomedical devices. He formerly served as Principal Mechanical Engineer at COR Innovations, Inc., a biomedical device start-up. In this role, he was responsible for designing multiple functioning prototypes and designing and fabricating numerous electromechanical bench top apparatus' for materials testing and validation. He went on to serve as Senior Staff R&D Engineer at Abbott Vascular Structural Heart, where his primary role was serving as technical lead for improvements in their MitraClip device. He currently serves as Chief Technology Officer and co-founder of a medical device company that is focused on treating vaginal atrophy in breast cancer survivors and post-menopausal women through a novel and hormone-free, energy based therapy.

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 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 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 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 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 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 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.