Technology readiness level (TRL) scale was originally defined by NASA as “a type of measurement system used to assess the maturity level of a particular technology. TRL scale uses the parameter that evaluates the maturity of a technology according to a series of indicators that go from 1 (the basic principles are documented) to 9 (the technology is released, and industrial production is started”.
The TRL scale was introduced in EU funded projects in 2012 and is currently the point of reference for determining the development or maturity of a research and its readiness for the market uptake and potential investments.
TRL is useful to indicate the research project result’s TRL level and define what steps should be taken in order to bring the research result to the market.
How to define your TRL
Example from pharmaceutical industries
It is important to emphasize that the TRL scale is self-declared and it may differ from sector to sector. Find the pharma sectorial application of TRL scale applied to drug discovery process.
It spans the whole innovation process, from basic research activities and preclinical studies (TRL1-4), over investigational new drug application (TRL5), to clinical trials (TRL6-8) and product launch (TRL9).
The main focus is on the problem itself and on generating research ideas, Hypothesis are formed and preliminary studies are set to define parameters and to identify candidate concepts and/or therapeutic drugs.
First preclinical studies, using animal models, to identify and assess the potential safety and toxicity problems, adverse events and side effects. Demonstrating proof-of-concept and safety of candidate drug formulations.
Pilot lots drug candidate are produced for further development, GLP safety and toxicity studies in animal model systems are used and clinical protocols for Phase 1 clinical testing.
Pre-IND meeting is held with the European Medicines Agency (EMA) and/or the US Food and Drug Administration (FDS-CDER). Phase 1 clinical trials are conducted to demonstrate the safety of candidate in a small number of humans.
Phase 2 clinical trials are conducted to demonstrate initial efficacy (preliminary evidence). Updated IND application, amended with a new clinical protocol to support phase 3 clinical trials or surrogate test plan I submitted.
Safety and effectiveness of the candidate drug are tested in Phase 3 clinical trials or surrogate tests. New drug application (NDA) is prepared and submitted to EMA/FDA.
The new pharmaceutical drug, now can be distributed and marketed. Phase 4 studies such as safety surveillance studies to support use in special populations, and clinical trials are performed.
Example from hardware and system technologies
In hardware and system technologies, research activities (TRL1-4) aim to deliver basic technological components that work together in a low fidelity environment. Development activities/prototyping (TRL5-7) facilitate transition towards expected behavior of the future product in realistic environment. Finally, innovation activities (TRL8-9) combine production configurations with desired fully-functional product.
The resulted applications are mainly speculative, with no proof pf concepts to support assumptions. At this level, technology is limited to analytical studies.
Active R&D activities, including analytical and laboratory studies to physically validate the previous analytical predictions and assumptions. the first proof of concept.
The resulting system integrates basic technological components that work together in a low fidelity compared with the eventual system. This “ugly prototype” or “pre-prototype” includes integration of ad hoc hardware in the laboratory environment
Integration of components with reasonable and realistic supporting elements for testing in a simulated environment. High fidelity is achieved in laboratory.
The technology is tested in a relevant environment. It starts to be considered as a representative prototype to be tested in a high-fidelity laboratory environment or in a simulated operational environment
Technology is proven to work in its final form and under expected operational conditions. Tests and evaluation of the system are made in its intended or pre-production configuration. Design specifications, including quality and safety conditions along with operational suitability are evaluated. At this stage pre-serial manufacturing is intended to overcome any future mass production issues.
Technology is shaped in its actual application, meeting production configuration and under real conditions such as those identified during operational tests and evaluation.
