Scientific & Regulatory Diligence

Before you commit capital, get a clear-eyed technical read. We reconstruct the science, test the claims against the evidence, and map the regulatory path — so you enter the decision with your eyes open.

Technical diligence

Is the technical plan feasible, not just plausible? Assessed by a principal who can both evaluate the science and build the systems.

Claims-vs-evidence review

Trace the boldest claims back to the data; find the gap between what was shown and what is being claimed.

Regulatory pathway analysis

The actual route — 510(k), De Novo, PMA — and whether the predicate/comparison logic and evidence burden hold.

Founder & IP context

Background and landscape relevant to execution risk.

The deliverable

A decision-ready memo — what’s strong, what’s exposed, and the specific questions to ask next. (See our diligence framework in Insights.)