Medical Device Expert - Dartmouth - Design & FDA
Contact this Expert Witness
- Company: Quantify Engineering, LLC
- Phone: (603) 727-9750
- Cell: (603) 727-9750
- Website: www.quantifyengineering.com
Specialties & Experience of this Expert Witness
General Specialties:
Medical Devices and Biomedical EngineeringKeywords/Search Terms:
Failure Analysis, Design History File (DHF), FDA Regulatory, Orthopedic Implants, Hip Implants, Knee Implants, Cardiovascular, Neurological Devices, Urological, Surgical Tools, Surgical Mesh, Warming Systems, EEG, Biosensors, Biomaterials, Polymers, Metals, ISO Standards, Patent Litigation, Rehab DevicesEducation:
PhD, University of Rhode Island; MSc, Dartmouth College; BSc, University of FloridaYears in Practice:
18Additional Information
Dr. Jay Vincelli, PhD, PE, is a licensed Professional Engineer (PE) in mechanical engineering and a PhD-level biomedical engineer specializing in the forensic analysis and development of medical devices for manufacturers, product liability, and patent litigation matters. Litigation Support & Forensic Leadership Dr. Vincelli has directed the technical investigation and forensic strategy for over 110 medical device matters. As a former Laboratory Director, he managed the protocol development and testing for complex litigation involving orthopedic implants, surgical mesh, IVC filters, forced-air warming systems, and many other devices. He combines this high-volume experience with deep technical rigor, notably conducting a large-scale retrieval study at Dartmouth College involving the failure analysis of over 500 metal-on-metal hip implants. Dr. Vincelli has served as the designated expert witness in multiple depositions, including the Christiansen v. Wright bellwether trial. Regulatory & Industry Expertise Beyond litigation, Dr. Vincelli maintains an active industry practice supporting FDA regulatory submissions and device development. His "real-world" engineering experience includes: Design Verification: Performing degradation experiments for the OrthoSpace rotator cuff balloon (Class III). Regulatory Clearance: Advising CREmedical on FDA clearance strategies for advanced EEG systems. Innovation: Inventor of a patented cardiopulmonary bypass circuit (U.S. Patent #9,561,315) and designer of an explantation tool for hip implants. Quality Systems: Developing ISO 17025-compliant quality manuals and maintaining training in ISO 10993 (Biological Evaluation) and as an ISO 9001 Lead Auditor. Cross-Disciplinary Foundation Dr. Vincelli’s forensic approach is grounded in "hard science" applications outside of medicine. He previously served as a Failure Analysis Engineer for the U.S. Naval Air Warfare Center, performing metallurgical and fracture analysis on aviation components (e.g., engine blades, gearboxes) and certifying Navy welders. He also possesses significant automotive industry experience, having managed product launches and Six Sigma investigations for Freudenberg-NOK.