“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.
Además en el artículo se puede ver la MATRIZ de entregables para cada una de las etapas donde el ámbito de la Regulatoria ha sido adaptada a la regulatoria Europea.
CIMTI.cat has a network of international experts that integrate all the knowledge generated in the project in the form of strategies and recommendations in annual reports that are available to any agent of the healthcare system.