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Jason Krzeszak

Jason Krzeszak, BS, MS, MBA

Director of Global Product Development Strategy

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Jason has accumulated 15 years’ experience in the medical device industry through multiple roles at Medtronic, two start-up device manufacturers and roles at NAMSA. Joining NAMSA in 2018, Jason now manages the Global Product Development Strategy Team, which is comprised of cross-functional strategic consultants. Mr. Krzeszak 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.

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 study 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