TRL Physical Sciences & Engineering Healthcare (Pharmaceutical) Healthcare(Medtech) Healthcare(Diagnostics) Simplified
1 Basic principles observed Basic principles observed Basic principles observed Basic principles observed Proof-of-Concept
2 Technology concept formulated Technology concept formulated Technology concept formulated Technology concept formulated Proof-of-Concept
3 Experimental proof of concept Experimental proof of concept in vitro and in vivo research model Experimental proof of concept in vitro and in vivo research models Experimental proof of concept in vitro Proof-of-Concept
4 Technology validated in lab Proof of concept in vitro and in vivo research models Proof of concept in vitro and in vivo research models Proof of concept in vitro and in vivo research models Proof-of-Concept
5 Technology validated in relevant environment Non-clinical and pre-clinical research studies, & initial demonstration of feasibility and efficacy Product Development Plan    
5 Technology validated in relevant environment Technology validated in relevant environment Technology validated in relevant environment Technology validated in relevant environment Technology validated in relevant environment
6 Technology demonstrated in relevant environment Phase I clinical trials Phase I clinical trials    
7 System prototype demonstration in operational environment Phase 2 clinical trials Clinical safety and effectiveness trials in operational environment Clinical validation in 1 site Prototype in Live Environment
8 System complete and qualified Phase 3 clinical trials Overall risk-benefit Trials    
9 Actual system proven in operational environment Pharmaceutical can be distributed or marketed Medical device can be distributed or marketed Clinical validation in multi-site Ready-to-Market