About
Principal and Founder. A former Fortune 500 R&D leader, now a strategic and technical advisory practice for healthcare, life-sciences, and biotech organizations.
Stratagem Healthworks was founded by Dr. Donald G. Munroe, a healthcare executive with a proven record in In Vitro Diagnostics, life sciences, and AI-enabled clinical workflows. He has led the design, development, and global commercialization of FDA-regulated IVD and AI-powered diagnostics across immunoassay, microarray, tissue diagnostics, and multiomics platforms.
He has directed R&D organizations of up to 600 people and $200M budgets across the US, Canada, UK, Europe, and India, and has presented to CMS, the FDA, and payers to improve the cost, quality, and accessibility of care. His work spans oncology, women's health, and transplant diagnostics, from early technology roadmaps to evidence generation, reimbursement, and clinical-guideline strategy.
By the Numbers
Signature Contributions
Inventions that opened new regulatory and clinical ground.
Co-invented the second-generation OVA1 ovarian-cancer test, the first traditional 510(k) clearance for a multivariate diagnostic algorithm (FDA, 2016). Secured a Category I CPT code and an $897 Medicare payment, a fourfold reimbursement increase, backed by a 27-site, 500-patient clinical study.
Launched DynaChip, the world's first FDA-cleared automated protein-microarray system for HLA antibody analysis, predicting transplant-rejection risk, paired with high-throughput HLA typing and lab automation for major global accounts.
Executive Competencies
Track Record
Senior R&D, scientific, and commercial leadership across Fortune 500 diagnostics and high-growth ventures.
Strategic advisory practice for diagnostics, AI-enabled clinical workflow, and life-sciences companies: fractional executive leadership, board advisory, executive coaching, and innovation strategy.
Led the R&D integration of a $3.6B business unit with 600+ associates across the US, Canada, UK, EU, and India and a ~$200M budget, spanning Specimen Management, Microbiology & Infectious Disease, Molecular Diagnostics, and Point of Care.
Led 85 innovators. Set a 10-year vision and 5-year strategy using design thinking and agile, delivering multiplexing chemistry, AI-enabled imaging, and multiomics, and executing IVDR readiness.
Co-invented the FDA-cleared 2nd-gen OVA1 test. Secured a Category I CPT code and $897 CMS payment, co-led a $31M capital raise, and won a $7.5M CPRIT grant, with collaborations at UC Irvine, the DoD, Moffitt Cancer Center, and Kaiser Permanente.
Launched immunoassay menu additions (PHI, AMH, SHBG, and more). Prevented $15M in stock-outs, safeguarding $200M in annual revenue, and led the R&D response to four FDA warning letters.
Launched DynaChip. Oversaw an $80M R&D portfolio across 15 businesses, 500+ staff, and 14 sites, driving a 43% increase in program releases and 36% growth in new-product revenue.
R&D and technology-commercialization leadership in microarrays and pharmaceutical discovery. Contributed to Gattex (approved 2014), earned 8 U.S. patents, and published widely in peer-reviewed journals.
Credentials
Volunteer & Advisory Roles
Advisory Board. Boutique global executive search in healthcare, life-sciences, tech, and industrial.
Commercialization Team Partner. University of Arizona IP, licensing, and startups.
Entrepreneurship Project Team. Advancing Arizona's Bioscience Roadmap.
Circle of Advisors. No-cost health-tech accelerator at the Phoenix Bioscience Core.
A 30-minute conversation. No pitch, just a bearing.