Focused primarily on cardiovascular device technologies, this biomedical engineer brings more than 30 years of experience in product development, clinical evaluation, regulatory strategy, and commercialization of medical specialty products. This medical device development expert witness has more than 30 years of experience in the development, testing, evaluation, and commercialization of medical specialty products, with a primary focus on cardiovascular technologies. His career includes executive leadership roles such as President, Chief Executive Officer, Chief Technical Officer, and Vice President of Research and Development within start-up and publicly traded medical technology companies, where he managed product design and development, intellectual property strategy, pre-clinical and clinical study execution, manufacturing scale-up, and regulatory submission planning and interaction with the FDA and international regulatory bodies, including CE Mark processes. He currently serves as a consultant and expert to medical technology companies, investors, and legal counsel, providing technical analysis of underlying device technology, clinical and regulatory strategy, patent validity and infringement issues, commercialization practices, and matters involving reported patient injuries and associated company liability. His expertise encompasses cardiovascular and related medical technologies, including intravascular ultrasound systems, coronary and cerebrovascular catheters and guidewires, drug-eluting stents, implantable cardiac devices, cerebral protection systems, cardiopulmonary bypass and perfusion technologies, vascular access systems, and gas-enriched fluid delivery platforms. He has directed multi-phase bench, animal, and human clinical studies; overseen clean-room manufacturing of disposable and electromechanical systems; prepared and supervised pre-market regulatory documentation for FDA review; and led development of intellectual property portfolios as co-inventor on more than 16 U.S. and international patents.

He holds a PhD in Biomedical Engineering, a Master of Science in Aerospace Engineering, and a Bachelor of Science in Aerospace Engineering. In litigation settings, he has served as an expert witness in patent infringement disputes, regulatory-related matters, and cases involving implantable cardiac devices and alleged patient injuries. His experience includes preparation of detailed expert reports, deposition testimony, jury trial testimony, arbitration proceedings, and testimony before regulatory authorities regarding medical device performance and commercialization claims.