The most commonly used scale to assess the development stage of an invention is the Technology Readiness Level (TRL), frequently included in funding applications by entities supporting R&D activities. Although the TRL scale is intended to be universal, it may pose challenges when applied to life science inventions.
Technology readiness can be described differently depending on the type of invention—whether it’s a drug/vaccine, tests/models, or diagnostic/medical devices. The example below presents an eight-level TRL scale specifically adapted for a group of inventions including medical devices and diagnostic tools/tests.
Technology Readiness Levels (TRLs) for Diagnostics and Medical Devices
TRL 1 – Review of Scientific Knowledge
Active monitoring of scientific literature to identify needs. Identification of basic research needs.
TRL 2 – Concept Development and Experimental Project Planning
Design of research plans to address specific questions and planning of experimental projects to resolve related scientific issues and assess feasibility. Focus on practical applications based on fundamental principles.
TRL 3 – Preliminary Candidate Characterization and Feasibility Demonstration
Initiation of R&D activities, collection and analysis of data to verify feasibility. Exploration of alternative concepts, identification and evaluation of critical technologies and components, and initial characterization of required specifications. Demonstration of potential diagnostic targets and high-risk components. Development of a business rationale for the proposed product.
TRL 4 – Optimization and Test System Preparation
Preparation for test system development. Finalization of diagnostic targets and detection or quantification methods. Development of detailed plans and definition of critical design requirements. Agreements with key external partners for development or implementation. Identification of production resources, supplier sourcing, and experimental design.
TRL 5 – Product Development – Reagents, Components, Subsystems, and Modules
Construction and testing of prototypes of components and subsystems at this stage without the need for GMP (Good Manufacturing Practice). Coding and unit testing of software. Initiation of pilot-scale production – prototyping. Development of testing protocols and integration testing. Launch of stability studies.
TRL 6 – System Integration and Testing
Integration and testing of instruments/devices, software, and tests; performance evaluation and specification updates. Implementation of design improvements to address defects identified during testing. Production of additional prototypes and evaluation of pilot batches. Advancement of software maturity. Preparation for clinical testing.
TRL 7 – Analytical Verification and Clinical Trial Preparation
Performance assessment of the integrated diagnostic system using engineered, retrospective human and animal samples. Preparation for clinical evaluation. Initiation of full-scale production planning for instruments and tests.
TRL 8 – Clinical Trials and/or Animal Studies, Regulatory Approval, and GMP Manufacturing Readiness
Execution of clinical trials and/or evaluation through animal studies. Obtaining necessary regulatory approvals and finalization of GMP-compliant manufacturing preparations.