Attachment I2-Technology Readiness Level for diagnostics and devices (REFERENCE ONLY)

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TRLs are adapted from the harmonized Quantitative Technology Readiness Level (Q-TRL) and are used when rating diagnostics and medical devices

SMARGORP ADRAB

TECHNOLOGY READINESS LEVELS (TRLs) FOR MEDICAL

COUNTERMEASURE PRODUCTS (DIAGNOSTICS AND MEDICAL DEVICES)

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Back to About TRLs

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These TRLs are adapted from the harmonized Quantitative Technology Readiness Level (Q-TRL) and are used when rating diagnostics and medical devices.

NOTE: When using these criteria, a medical countermeasure product should be rated at a particular level only after the developer has completed all activities listed at that level (e.g., a product is rated at TRL 4 once it completes all of the activities listed in TRL 4). Review of Scientific Knowledge.
TRL 1

Active monitoring of scientific knowledge base to identify clinical pathological markers for diagnostic countermeasure candidates. Scientific findings are reviewed and assessed as a foundation for characterizing approaches to intervene in disease. Basic research needs identified.

Concept Generation and Development of Experimental Designs. TRL 2

Develop research plans to answer specific questions and experimental designs for addressing the related scientific issues and to establish feasibility. Focus on practical applications based on basic principles.

Characterization of Preliminary Candidates(s) and Feasibility Demonstration. TRL 3

Begin research and development (R&D), data collection, and analysis in order to verify feasibility. Explore alternative concepts, identify and evaluate critical technologies and components, and begin characterizing specifications required. Demonstrate the performance of candidate diagnostic targets and high-risk components. Develop a business case for the proposed product.

Optimization and Preparation for Assay, Component, and Instrument Development. TRL 4

Prepare for test system development. Down-select diagnostic target(s) and finalize methods for detecting or quantitating target(s). Develop detailed plans and finalize critical design requirements. Identify key external development partners. Identify manufacturing resources, vendor sourcing, and experimental designs.

Product Development – Reagents, components, subsystems, and modules. TRL 5

Develop reagents and buffers. Build and test non-GLP prototypes of components and subsystems. Code and unit test software. Begin pilot scale manufacturing preparations. Develop protocols for assay and integration testing. Initiate reagent stability testing.