DRLDRLDiagnostics Readiness Levels

The framework

One journey, seen from five directions.

DRL describes diagnostic development as a coordinated profile. It asks not only what has been achieved, but which evidence artefacts exist and which stream currently constrains the whole programme.

DRL v1.0 · 13 levels · 5 streams · 65 evidence gates

The readiness rule

The weakest stream is the binding constraint.

A diagnostic project does not become deployment-ready because one dimension is advanced.

Each stream is assessed consecutively. A level is passed only when its defined evidence artefact exists. The overall DRL is the lowest completed level across the five streams, while the full profile preserves the important differences between them.

The headline number is a communication device, not a substitute for the five-stream profile or professional judgement.

Four phases

From concept to integration

  1. 01
    DRL 1–2

    Concept

    Is the hypothesis credible, the clinical question clear and the surrounding landscape understood?

  2. 02
    DRL 3–7

    Development

    Can the diagnostic be designed, verified, validated and prepared for authorisation and delivery?

  3. 03
    DRL 8–9

    Market entry

    Can it be authorised, introduced, purchased and used in routine care?

  4. 04
    DRL 10–13

    Systemic integration

    Can it scale, remain effective and contribute to a resilient diagnostics value chain?

Five streams

Development as a profile

  1. 01

    Scientific & Technical

    Biological rationale, prototype, analytical performance, manufacturing, scale-up and surveillance.

  2. 02

    Clinical

    Clinical question, study design, validity, utility, workflow change and guideline adoption.

  3. 03

    Regulatory & Quality

    Quality system, intended use, classification, pathway, submission, authorisation and lifecycle.

  4. 04

    Commercial & Market

    Use case, customer discovery, value proposition, business model, reimbursement, distribution and growth.

  5. 05

    Strategic & Systemic

    Stakeholders, intellectual property, capital, partnerships, procurement, policy and system integration.

Level architecture

Thirteen levels across four phases

Each cell in the operational instrument corresponds to a gate with a required evidence artefact.

Diagnostics Readiness Levels mapped across concept, development, market entry and systemic integration
Figure: DRL v1.0 level mapping.

Relationship to other methods

Built alongside, not in place of, established frameworks.

TRL, KTH Innovation Readiness Levels, BMK Tools, ACCE, REASSURED, BRLa and P-IRL each illuminate important parts of innovation or diagnostic development. DRL draws on that landscape while focusing specifically on how five diagnostic-development streams remain coordinated through market entry and system adoption.

It is intended as an organising layer: specialist clinical, regulatory, quality, health-economic and product-development methods remain necessary within it.

Read the v1.0 white paper →