TRLPhysical Sciences & EngrHealthcare (Pharmaceutical)Healthcare (Medtech)Healthcare (Diagnostics)Simplified
1Basic principles observedBasic principles observedBasic principles observedBasic principles observedProof-of-Concept
2Technology concept formulatedTechnology concept formulatedTechnology concept formulatedTechnology concept formulatedProof-of-Concept
3Experimental proof of conceptExperimental proof of concept in vitro and in vivo research modelsExperimental proof of concept in vitro and in vivo research modelsExperimental proof of concept in vitroProof-of-Concept
4Technology validated in labProof of concept demonstrated in defined laboratory/animal modelsProof of concept demonstrated in defined laboratory/animal modelsAnalytical validationPrototype in Lab
5Technology validated in relevant environmentNon-clinical and pre-clinical research studies, & initial demonstration of feasibility and efficacyProduct Development Plan
6Technology demonstrated in relevant environmentPhase I clinical trialsPhase I clinical trials
7System prototype demonstration in operational environmentPhase 2 clinical trialsClinical safety and effectiveness trials in operational environmentClinical validation in 1 sitePrototype in Live Environment
8System complete and qualifiedPhase 3 clinical trialsOverall risk-benefit Trials
9Actual system proven in operational environmentPharmaceutical can be distributed or marketedMedical device can be distributed or marketedClinical validation in multi-siteReady-to-Market