Navigating Healthcare Innovation Cycle  is an article from CIMIT in Boston where they explain the methodology used to follow-up a health-tech project during its development. CIMIT has adapted the TRLs (Technological Readiness Levels) adding the TRL10 to the “Healthcare Innovation Cycle” (picture). In every step, a series of milestones must be fulfilled from four different fields (clinical, business, regulatory and technology) to optimize the project development.

You can see the HealthTech Deliverables MATRIX in which CIMTI has adapted the American regulation into the European one.