Attachment I2-Technology Readiness Level (TRL) for diagnostics and devices (REFERENCE ONLY).pdf
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- Prototype development for Battlefield Wound Infection Prevention and Treatment (BWI P&T) Barrier Combination
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About this file
This document is a Technology Readiness Level (TRL) framework for medical countermeasure products, specifically diagnostics and medical devices, adapted from the harmonized Quantitative Technology Readiness Level (Q-TRL) standard. The framework establishes eight progressive levels that developers must complete sequentially to advance their products from concept to FDA approval.
The TRL progression begins at TRL 1 with review of scientific knowledge and identification of clinical pathological markers, advancing through TRL 2 (concept generation and experimental design development) and TRL 3 (characterization of preliminary candidates and feasibility demonstration). At TRL 4, developers optimize designs and prepare for assay and component development, followed by TRL 5 where product development occurs including reagent development, non-GLP prototype testing, and initiation of FDA Design History file and pre-IDE meeting. TRL 6 requires system integration and testing of alpha and beta instruments with completion of short-term stability testing. TRL 7 involves analytical verification through contrived and retrospective sample testing with preparation for clinical studies and full-scale production. The final stage, TRL 8, encompasses completion of clinical evaluations, FDA filing submission, and acquisition of FDA approval or clearance. A critical requirement noted throughout is that products must complete all activities at each specified level before advancing to the next TRL rating.
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TECHNOLOGY READINESS LEVELS (TRLs) FOR MEDICAL
COUNTERMEASURE PRODUCTS (DIAGNOSTICS AND MEDICAL DEVICES)
TRLs are adapted from the harmonized Quantitative Technology Readiness Level (Q-TRL) and are used when rating diagnostics and medical devices
Back to About TRLs
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).
TRL 1
Review of Scientific Knowledge.
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.
TRL 2
Concept Generation and Development of Experimental Designs.
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.
TRL 3
Characterization of Preliminary Candidates(s) and Feasibility Demonstration.
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.
TRL 4
Optimization and Preparation for Assay, Component, and Instrument Development.
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.
TRL 5
Product Development – Reagents, components, subsystems, and modules.
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.
Hold pre-IDE meeting with FDA. Initiate Design History file.
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TRL 6
System integration & testing.
Integrate and test alpha and beta instruments/devices, software and assays, evaluating performance and updating specifications.
Implement design improvements to address defects discovered during testing. Produce and evaluate pilot lots of reagents and beta (pilot) instruments. Increase the maturity of software. Prepare for clinical testing.
Complete short-term stability testing of reagents.
TRL 7
Analytical Verification and Preparation for Clinical Studies.
Evaluate assay and integrated diagnostic system performance utilizing contrived, retrospective human and animal samples. Make preparations for clinical evaluation. Begin preparation for full scale production of instruments and assays.
TRL 8
Clinical Studies and/or evaluation with Animal Studies, FDA Clearance or Approval, Finalize GMP manufacturing preparations.
Complete clinical evaluations. Prepare and submit FDA filing.
End of TRL 8: Acquire FDA approval, or clearance.
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