Donald G. Munroe, Ph.D., specializes in translating transformative diagnostic and AI-enabled patient care innovations into scalable, FDA-cleared, and reimbursed clinical platforms. He has led global R&D organizations of more than 600 professionals and PMO functions at Roche, Becton Dickinson, and Beckman Coulter, delivering next-generation IVD systems across molecular diagnostics, women’s health, immunoassays, digital pathology, and AI-enabled clinical decision support.

His track record includes the first traditional 510(k) clearance for a multivariate ML-enabled proteomic diagnostic and securing a Category I CPT code with $897 CMS reimbursement for the OVA1 ovarian cancer test. As Founder of Stratagem Healthworks, he advises private equity and venture-backed companies, startups, and university innovation programs on regulatory sequencing, evidence-first commercialization, AI validation architecture, and capital-efficient R&D execution to de-risk and scale advanced diagnostics platforms.

Dr. Munroe holds a Ph.D. in Cancer Genetics from the University of Toronto.