Karen Krygier, PhD, MBA

I am a healthcare technology executive, strategist, and scientist with nearly 25 years of leadership experience spanning medical devices, digital health, AI-enabled healthcare platforms, and commercialization. I have led product strategy, clinical and regulatory affairs, quality systems, market access, business development, and enterprise growth for both established healthcare organizations and emerging technology companies.
I have successfully guided products from concept through commercialization, leading multidisciplinary teams responsible for clinical evidence generation, regulatory approvals, reimbursement strategy, product launch, and market expansion. My work has contributed to multiple FDA PMA approvals, 510(k) clearances, CE Mark/MDR certifications, payer adoption, and peer-reviewed scientific publications across cardiovascular, peripheral vascular, neurology, movement disorders, and digital therapeutics.