A practitioner-developed practical framework for assessing and communicating the readiness of a diagnostic development project across five dimensions, from biological hypothesis to systemic integration
Developed by Jose Pereira Leal, based on the conceptual framework introduced in José Pereira Leal, Precision Diagnostics: A Founder’s Journey (2025), ISBN 979-8267308892. Available on Amazon.
This page and the DRL materials are living documents and will evolve as the framework is tested and refined
Every diagnostics project will eventually confront three fundamental uncertainties. Most address them one at a time – first the science, then the clinical evidence, then the market. It feels logical, but it is everything but. By the time you discover that clinicians will not change their practice based on your evidence level, that the sample you need is never collected in routine care, or that the market you validated your test for does not reimburse the format you built, you have spent years and millions reaching a conclusion you could have tested in month six. The three uncertainties are not sequential stages. They are parallel threads that must be pulled simultaneously from the first day of development to the last. The DRL framework was built on that premise.
The Problem
Developing a new diagnostic test is one of the most complex undertakings in life sciences – technically demanding, clinically rigorous, commercially unforgiving, and politically underestimated. Yet the tools available to map, communicate, and evaluate that development journey remain surprisingly inadequate.
The Technology Readiness Level (TRL) scale, borrowed from aerospace and adapted for biotech, offers a useful linear shorthand but was never designed for the multi-dimensional reality of diagnostics. Biomarker-specific frameworks like BMK Tools improve on TRL for the scientific and regulatory dimensions, but still leave the commercial, strategic, and systemic dimensions largely unaddressed. The result is a persistent mismatch: developers who cannot communicate where they really are, investors who cannot assess what they are actually funding, and evaluators who apply the wrong criteria at the wrong stages.
The DRL framework was built to close that gap.
For developers and founders: The development journey rarely fails on the science. It fails on the coordination of five parallel tracks that must all advance simultaneously – technical, clinical, regulatory, commercial, and strategic – each with its own logic, its own timeline, and its own capital requirements. A project can be at TRL-7 technically while sitting at TRL-3 commercially, and that gap is invisible until it becomes a crisis. DRL makes it visible from day one.
For investors: Most diagnostic development companies present their progress as a single TRL number that conflates technical maturity with commercial readiness and regulatory status. A company at “TRL-7” may have strong clinical evidence but no regulatory strategy, no distribution model, and no health economics data. The investment required to bridge those gaps is orders of magnitude larger than the number implies. DRL gives investors a multi-dimensional profile that reveals not just where a project is, but where the bottlenecks are and what resolving them will cost.
For evaluators and TTOs: Grant panels and technology transfer offices must assess diagnostic projects using criteria designed for either basic research or pharmaceutical development. Neither fits. The result is that evaluators systematically overweight technical maturity and underweight commercial and strategic readiness – rewarding projects with strong science but no viable path to adoption. DRL provides a structured assessment grid that covers all five dimensions, with reproducible gate criteria rather than evaluator intuition.
The Framework
The DRL scale runs from DRL-1 to DRL-13, organised into four phases and five parallel streams. A project’s overall DRL is determined by its weakest stream – advancing the science while neglecting the commercial or strategic dimensions does not move the project forward.
The four phases:
- Phase 1 – Concept (DRL 1-2): Is the hypothesis sound and the landscape understood?
- Phase 2 – Development (DRL 3-7): Can the test be built, validated, and prepared for authorisation?
- Phase 3 – Market Entry (DRL 8-9): Can the test be authorised, sold, and used in routine care?
- Phase 4 – Systemic Integration (DRL 10-13): Can the test scale, sustain, and contribute to a diagnostics value chain?
The five streams:
- Scientific & Technical – from biological hypothesis through analytical validation to manufacturing and post-market surveillance
- Clinical – from clinical question through evidence generation to guideline inclusion
- Regulatory & Quality – from documentation discipline through pathway confirmation to multi-geography authorisation
- Commercial & Market – from use-case definition through business model lock to reimbursed multi-geography commercial operation
- Strategic & Systemic – from stakeholder mapping through investor narrative to sovereign procurement and policy influence
The last two streams have no equivalent in any existing diagnostic development framework. They are the dimensions that most commonly determine whether a scientifically and clinically validated product reaches patients at scale – or does not.
Why Existing Frameworks Fall Short
TRL was developed by NASA in the 1970s and adapted for EU research funding. It was never designed for regulated, evidence-based industries and has no concept of clinical evidence, regulatory pathway, business model, or reimbursement.
BMK Tools (Aviesan/EIT Health) is the most serious attempt to adapt TRL to biomarker development. It does well for the scientific and regulatory dimensions but does not address commercial development, reimbursement, or systemic integration.
ACCE(CDC) is the most rigorous clinical evidence evaluation framework for diagnostics. But it is an evaluation tool, not a development framework – it tells you how to assess evidence, not how to build it in parallel with everything else.
REASSURED (WHO/FIND) correctly identifies the design requirements for point-of-care diagnostics in resource-limited settings. But it is a product specification, not a readiness framework, and is limited to POC formats.
BRLa and P-IRL provide finer resolution at the early scientific stages or for specific platforms. Neither addresses commercial, strategic, or systemic dimensions.
The gap is consistent: none of these frameworks treats the commercial and strategic dimensions as first-class development tracks. DRL was built to fill that gap – by building on all of them, not replacing them.
Downloads
Three documents, each serving a different purpose.
DRL Whitepaper (PDF)
My argument: why TRL and existing frameworks are insufficient for diagnostics, how the DRL framework was constructed, and what each phase and stream requires. Designed for investors, funders, and anyone encountering DRL for the first time.
DRL Scoring Instrument (PDF / Excel)
The operational tool: 65 gates across 13 levels and 5 streams, each with a binary pass/fail question and a required evidence artefact. Designed for self-assessment by development teams, evaluation by TTOs and grant panels, and investment due diligence.
DRL Canvas (PDF / Excel)
The planning and strategy layer: inspired by the Business Model Canvas in its orientation – not a scoring exercise but a structured thinking tool that guides teams through the strategic questions each DRL stage requires before the artefacts need to exist.
Invitation to Collaborate
The DRL framework is a working proposal – grounded in practitioner experience and offered as a basis for community refinement. It has not yet been subject to formal empirical validation.
Groups with retrospective portfolios of diagnostic development programmes, incubators, technology transfer offices, accelerator programmes, and HTA bodies interested in stress-testing and calibrating DRL are explicitly invited to collaborate.
Developed by Jose Pereira Leal, based on the conceptual framework introduced in José Pereira Leal, Precision Diagnostics: A Founder’s Journey (2025), ISBN 979-8267308892. Available on Amazon.