AI-Enabled Diagnostics
Integrating AI into digital pathology, imaging, and multiomics workflows, from concept to clinical impact.
Insights
Insights and perspectives
Thinking from Dr. Donald Munroe on AI-enabled diagnostics, IVD strategy, regulation, reimbursement, and R&D leadership, plus white papers, talks, and where to find us.
Perspectives
What we write and advise on
Evergreen themes at the intersection of diagnostics, AI, regulation, and R&D leadership.
IVD Regulatory Strategy
FDA and IVDR pathways, with design-for-reliability and manufacturability built in upstream of development.
The Future of LDTs
Navigating the shifting US regulatory landscape for laboratory-developed tests.
R&D Operating Models
The operating models shaping diagnostics innovation, and how to choose among them.
Evidence & Reimbursement
Clinical utility, health economics, CPT coding, CMS decisions, and payer advocacy.
Lean-Agile R&D
Portfolio governance and agile operating systems that sustain predictable execution.
White Papers & Resources
Harnessing Artificial Intelligence to Elevate Lean Six Sigma Principles
Where AI raises the ceiling on Lean Six Sigma in R&D and operations.
7 Hard Startup Lessons from a Panel at Anchor Ventures
Field-tested lessons for founders and operators in health tech.
Dr. Donald Munroe Appointed to Edgewater Talent Advisory Board
Advisory Board appointment at Edgewater Talent.
The Future of LDTs in the USA
A perspective on laboratory-developed tests and the shifting regulatory landscape.
In the Field
Speaking & events
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2025
BIO Boston 2025
Five critical R&D operating models shaping diagnostics innovation. Read the recap.
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Feb 2025
Anchor Ventures Founder Panel
Seven hard startup lessons for health-tech founders and operators.
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Ongoing
CMS, FDA & payer presentations
Advancing coverage, coding, and clinical-guideline decisions for novel diagnostics to improve cost, quality, and access.
From LinkedIn
Latest thinking
During BIO Boston 2025: five critical R&D operating models
Five operating models shaping innovation, explored during BIO Boston 2025.
Andrew Van Ella joins the Edgewater Talent leadership team
Welcoming Andrew Van Ella to the Edgewater Talent leadership team.