The maturity of a technology under development is frequently evaluated using a Technology Readiness Level (TRL) scale. TRLs are ordered according to the characteristics of the demonstration or testing environment under which a given technology was tested at defined points in time. The scale consists of nine levels, each one requiring the technology to be demonstrated in incrementally higher levels of fidelity in terms of its form, the level of integration with other parts of the system, and its operating environment than the previous, until at the final level the technology is described in terms of actual system performance in an operational environment. The primary purpose of using TRLs in the DoD is to help management in making decisions concerning the development ant transitioning of technology. TRLs provide a common understanding of technology status and facilitate risk management.
Medical related products require TRL definitions and descriptions that are appropriate to the technologies upon which they are based and that account for the statues and regulations that govern their development and use. Biomedical TRLs are further categorized into TRLs for drugs, vaccines, devices, or combined drug-devices.
Medical countermeasures (MCMs) are developed to prepare and protect against both natural and man-made public health threats. TRLs are defined for MCM products, such as a drug or vaccine, and for Product Development Tools (PDTs), such as assays, models, and reagents.
Some Federal agencies have defined their own set of TRLs to better meet their specific mission requirements. Agency-specific TRLs have been defined for the Biomedical Advanced Research & Development Authority (BARDA), Department of Defense (DoD), Department of Energy (DoE), National Aeronautics and Space Administration (NASA), and National Institutes of Health (NIH).