Medical Devices Expert Witnesses in New York

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 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 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 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 expert earned his BS at Duke University, and his PhD in Biomedical Engineering at the University of Virginia. He has received $268,003 in funded support, and has been involved in the writing of 10 grant proposals for research in his field. He has authored 12 publications, and serves as a reviewer for several scientific journals, including the Journal of Biomechanical Engineering. He is an active member of both the Orthopaedic Research Society, as well as the American Society for Engineering Educators. He currently serves as an assistant professor of biomedical engineering at a university in New Jersey.

This expert specializes in infection control. He earned his PhD in Bioengineering from the University of Pennsylvania and pursued a fellowship focused on diagnostic imaging at the Temple University School of Medicine. For two decades, he worked for a firm manufacturing automated endoscope reprocessors, serving as the Director of R&D and the Chief of Infection Control. He currently owns a consultancy focused on healthcare quality and safety; he is also a prolific writer on these issues.

This qualified expert earned his BS in physics from University of Washington and his MS in mathematics from University of Oregeon. He also completed a MS in applied physics from the Oregon Graduate Institute of Science and Technology and his PhD in electrical engineering at Oregon Health and Science University. He subsequently entered an NIH-funded postgraduate fellowship in dermatology at the Oregon Health & Science University. After serving for a number of years as an associate professor in bioengineering and dermatology at the University of Missouri, he now directors the department of biomedical engineering at a private university in Pennsylvania.

This qualified expert has over 35 years of experience in biomedical engineering. He earned his BA in physics and mathematics from DePauw University and received his PhD in physics from Yale University. He is a member of multiple associations, including the American Association for Clinical Chemistry and the American Physical Society. He currently has 10 patents and has 19 patent applications. He served as an assistant professor and research associate in physics for the University of Virginia for 3 years. He was then a physicist for Lawrence Livermore National Laboratory and a staff physicist for Measurex Corporation. He was also the vice president of engineering and advanced technology for Cytometrics and the technology innovation leader of R&D for Becton Dickinson. He has authored several scientific articles over the course of his career and received the Cytometrics Founders' Award for his work. Currently, this expert is the founder and principal consultant for an innovative business consultancy based in Pennsylvania.

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 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 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.