Jason has accumulated 20 years of experience in the medical device industry through multiple roles at Medtronic, two start-up device manufacturers and roles at NAMSA. He has developed clinical and regulatory strategies across a breadth of therapies and has depth within cardiovascular, organ transplant, wound care, urology and spinal devices. Jason has deep-rooted experience in clinical trial design, pre-market/post-market regulatory strategy, clinical operations and product development experience from early preclinical feasibility research through commercial approval in international markets.

Having joined NAMSA in 2018, Jason now manages the Global Strategy Services business, which is comprised of a large team of cross-functional strategic consultants. Jason has earned a Bachelor’s of Materials Science (BSE) & a Master’s of Biomedical Engineering (MSE) degrees at the University of Michigan, as well as a business degree focused on consulting (MBA) at Cornell University.

CORE COMPETENCIES

• Strategic development, management and execution of clinical studies for medical devices from first in human through feasibility, confirmatory/pivotal and post-market studies
• Authoring Clinical Evaluation Reports (CERs) for CE-mark certification and FDA clinical study annual and final reports
• Study management, oversight and leadership of study management teams, including project managers, clinical research specialists, coordinators, clinical quality associates and contract CRAs
• Clinical Affairs department leadership, including process improvement, mentoring and performance management
• Development of Design Evaluation Strategies (DES) to assess design for clinically applicable data (preclinical) and clinical studies required for clinical validation
• Development of benefit risk assessments and pre-submission structures for de novo 510k submissions
• Preclinical study director experience for over 75 feasibility animal studies, including protocol development, animal model selection, study execution and data collection/interpretation and reporting
• Key presenter for pre-market clinical study proposals and pre-approval proposals, including primary endpoint, indication and study design justifications—resulting in gained acceptance from FDA, Notified Bodies (TUV-SUD, BSi), Competent Authorities and PMDA (Japan)
• Collaborated with the U.S. Food and Drug Administration (FDA), Vascular Surgery Society and competitor manufacturers to develop a society-led registry to meet post-approval conditions for aortic stent grafts

RECENT PROJECTS 

• Devised a clinical evidence strategy for an organ preservation system; led the device manufacturer through first engagement with the FDA through the pre-submission and IDE application process to achieve an IDE approval for a pivotal clinical study
• Led a start-up manufacturer through country selection, protocol development and clinical study execution of a first in human, confirmatory, multi-center study of a novel wound healing therapy device
• Provided a full product development plan for a start-up manufacturer at the prototype stage to achieve a de novo 510k approval of a novel drug sensing system