Bench to Production: Medical Devices

Prototype to Commercial Device

This evolution is in development. Curriculum details — items, duration, and hero materials — will be added as the class is finalized.

The founder's path from prototype to commercial device. Stage-gate development as a capital structure issue — breadboard to alpha to beta to V&V to pilot production. At each gate: what the gap analysis reveals, what it costs, and what that funding event does to the cap table. The design freeze decision, GMP transition planning, and the premature tooling trap that kills device companies at the finish line.