Medical Devices Expert Witnesses in Pennsylvania

Biomedical Engineering, Intellectual Property - Medical devices, commercially reasonable efforts, patent, intellectual property, product liability, corporate governance, licensing, strategy, inter partes review, misappropriation of trade secrets, ITC, IPR, ITC, fiduciary duty, pacemaker, defibrillator, neurostimulator, biomedical engineering

Peter Crosby is a biomedical engineer with over 45 years experience in the medical device industry, and has served as CEO of six medical device companies, public and private, in 4 countries. He has served as a member of the Board of 13 companies, and is currently serving as a member of the Board of three companies. He has brought many medical devices from concept to market release, through R&D, clinical trials, regulatory approval (FDA and CE Mark) and market launch. He is an inventor of over 50 issued US patents and applications and foreign equivalents. He has served as an expert in multiple patent cases - infringement, ownership, validity, IPR and ITC. His clinical domain and specialty experience includes otolaryngology, cardiology, cardiac surgery, anesthesia, pain management, radiology and diagnostic imaging, in vitro diagnostic devices, orthopedic surgery devices, and oncology. His product experience includes cochlear implants, diagnostic ultrasound, mammography, implantable...

Media, Pennsylvania

Medical Devices, Biomedical Engineering - Mechanical Engineering, R&D, Product Development, Clinical diagnostics, Blood collection, Biospecimens, Point of care testing, Microfluidics, Spectroscopy, Cell therapy, Intellectual Property, Microscopy, Physics, Biomedical sensing, Optics, Imaging, Mathematics, Laboratories & Testing, Lasers

Dr. Fletcher is Founder and Principal Consultant at RnDDx Solutions LLC, a consulting firm focused on industrial biomedical and mechanical engineering, and research and product development, in medical devices, diagnostics, optical devices, point-of-care blood sample testing, and on expert witness patent litigation, including subject matter expertise in medical device mechanical engineering, and subject matter expertise in medical devices for blood collection and blood sample processing for diagnostics and therapeutics. He has particular expertise in mechanical engineering design and development of non-invasive and minimally invasive biomedical diagnostics systems, blood collection and stabilization, blood separation, and blood and cell preparation for both diagnostic and therapeutic applications, including the development of sample collection devices, needles, and lancets. He is co-inventor on 23 patents for devices and methods in blood collection and processing. Yale educated Ph...

Landenberg, Pennsylvania

Statistics, Medical Devices - biostatistics, FDA, Pharmaceutical Statistics, Sanofi, Edwards, Gilead, AI/ML expert, machine learning, clinical trial, Medical Device, Vaccine, Group Sequential Design, Bayesian Adaptive Design, Statistical Review of Evidence, Oncology, Epidemiological, Regulatory Submissions, Survival Analysis, Statistical Expert Witness, RWE

Lei Li, PhD, is a biostatistician and former FDA CDRH statistical reviewer with extensive experience in regulatory statistics, Real-World Evidence (RWE), medical device submissions, and pharmaceutical development. At FDA, Dr. Li evaluated statistical components of 510(k) and PMA submissions, assessed safety and effectiveness evidence for medical devices, reviewed RWE and post-market studies, and advised on complex statistical issues for regulatory decision-making. His FDA work included evaluation of study design adequacy, endpoint justification, sample-size rationale, bias and confounding, missing data robustness, and interpretation of clinical performance metrics under regulatory standards. In industry, Dr. Li served as Statistical Project Leader at Sanofi and Principal Biostatistician at Edwards Lifesciences, supporting global clinical and regulatory programs across multiple therapeutic areas, including rare diseases, inflammatory diseases, vaccines, oncology, and cardiovascular ...

Mars, Pennsylvania

Medical Devices, Spine Surgery & Spine Care - Neurosurgery, Orthopaedic Surgery, Biomechanics, Intellectual property, Engineering, Biomedical, Firearms and Ballistics, Trauma

Rank of Full Professor at Drexel University College of Medicine, and Adjunct Full Professor at Carnegie Mellon University.