Role: Product architecture & regulatory strategy
Problem
Superficial radiotherapy demands sub-millimeter precision in beam placement. Achieving that repeatability with a robotic steering mechanism, while satisfying a complete Design History File, 21 CFR Part 820 design controls, and the relevant IEC 60601 safety standards, requires coordinating mechanical, software, and regulatory work streams simultaneously.
Role
Product architecture and regulatory strategy lead, overseeing the full development lifecycle: requirements generation, design verification and validation planning, risk management per ISO 14971, and regulatory submission strategy. The program maintained a compliant Design History File throughout, positioning it for a clean FDA pathway.
Outcome
The underlying technology was sold as an asset for $15MM. Direct work and development to get the system operational was critical to reaching that milestone: proving the technical approach worked, and pairing it with the regulatory groundwork that made the asset defensible to acquirers.