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Technology Readiness Level Reference

The document outlines 9 technology readiness levels (TRLs) for physical sciences and engineering technologies as they relate to different areas of healthcare. TRLs progress from basic principles observed at level 1 to an actual proven system at level 9. At lower levels, proof of concepts are established through laboratory research and modeling. Higher levels involve clinical trials and demonstrations in real-world environments to prove safety, efficacy, and readiness for distribution/marketing.

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132 views1 page

Technology Readiness Level Reference

The document outlines 9 technology readiness levels (TRLs) for physical sciences and engineering technologies as they relate to different areas of healthcare. TRLs progress from basic principles observed at level 1 to an actual proven system at level 9. At lower levels, proof of concepts are established through laboratory research and modeling. Higher levels involve clinical trials and demonstrations in real-world environments to prove safety, efficacy, and readiness for distribution/marketing.

Uploaded by

Mandea
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Physical

Healthcare Healthcare Healthcare


TRL Sciences & Simplified
(Pharmaceutical) (Medtech) (Diagnostics)
Engr

Basic Basic
Basic principles Basic principles Proof-of-
1 principles principles
observed observed Concept
observed observed

Technology Technology Technology Technology


Proof-of-
2 concept concept concept concept
Concept
formulated formulated formulated formulated

Experimental Experimental
Experimental
Experimental proof of concept proof of concept
proof of Proof-of-
3 proof of in vitro and in in vitro and in
concept in Concept
concept vivo research vivo research
vitro
models models

Proof of concept Proof of concept


Technology demonstrated in demonstrated in
Analytical Prototype in
4 validated in defined defined
validation Lab
lab laboratory/animal laboratory/animal
models models

Non-clinical and
pre-clinical
Technology
research studies, Product
validated in
5 & initial Development
relevant
demonstration of Plan
environment
feasibility and
efficacy

Technology
demonstrated Phase 1 clinical Phase 1 clinical
6
in relevant trials trials
environment

System Clinical safety


prototype and effectiveness Clinical Prototype in
Phase 2 clinical
7 demonstration trials in validation in Live
trials
in operational operational 1 site Environment
environment environment

System
Phase 3 clinical Overall risk-
8 complete and
trials benefit Trials
qualified

Actual system
Pharmaceutical Medical device Clinical
proven in Ready-to-
9 can be distributed can be distributed validation in
operational Market
or marketed or marketed multi-site
environment

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