MediGate Framework
A MedTech product innovation development process, from university research to commercialization
MediGate divides development into six stages, from Stage 0 Innovation Ideation to Stage 5 Full Launch / Scale Up, with a gate between stages where the project is judged against set criteria before moving on.
Stage 0
Innovation Ideation
Decide which academic MedTech research has the potential to be exploited.
Self-assessment
Which stage is your innovation in?
Self-assess against each gate's criteria and see what's missing before moving on.
Discover → Develop → Validate → Navigate → Scale is the easy-to-follow support journey showing how CMICe helps at each point, while MediGate is a stage-gate framework for developing MedTech products, from the research of Kruachottikul et al. (2024). The two are divided differently and do not map one-to-one.
Six stages, five gates
At each gate the project is judged against set criteria. The decision is one of four: approved, approved with conditions, on hold, or terminated.
- S0
Stage 0
Innovation Ideation
Decide which academic MedTech research has the potential to be exploited.
- Gate 1 · Project Definition Acceptance
- S1
Stage 1
Build Business Case
Build the business case from the core deep-tech research, customer needs and technical requirements.
- Gate 2 · Initial Design Acceptance
- S2
Stage 2
Design & Development / Early Validation
Develop the product design, a workable prototype and the manufacturing process, with early verification and validation.
- Gate 3 · Final Design Acceptance
- S3
Stage 3
Test and Validation
Final validation of the product and preparation for its introduction.
- Gate 4 · Early Product Launch Acceptance
- S4
Stage 4
Launch
Early market introduction, improving both the business and the product from market feedback.
- Gate 5 · Product Launch Acceptance
- S5
Stage 5
Full Launch / Scale Up / Post-Launch Review
Full market introduction, collecting and analyzing feedback from the market.
Build → Measure → Learnruns as a loop across Stages 2–4, and every stage can iterate (iterations & spirals).
Every stage sets out activities across several areas — see all 10 functional groups
- Management
- Business Development
- Financial Management & Funding
- Revenue Model & Reimbursement
- Technology Development
- Legal & Tech Transfer
- Regulatory
- Clinical
- Manufacturing & Operations
- Quality
Published research (open access)Kruachottikul et al. (2024). Journal of Innovation and Entrepreneurship, 13:71
Read the MediGate paperFive gates along the way
Before moving from one stage to the next, a project passes a gate judged on criteria, deliverables and recommended readiness levels. The decision is approved, approved with conditions, on hold, or terminated.
- Gate 1
Project Definition Acceptance
Recommended readinessIRL ≥ 1 · TRL ≥ 3 · CRL ≥ 1
S0 Innovation Ideation to S1 Build Business Case
- Gate 2
Initial Design Acceptance
Recommended readinessIRL ≥ 3 · TRL ≥ 3 · CRL ≥ 3
S1 Build Business Case to S2 Design & Development / Early Validation
- Gate 3
Final Design Acceptance
Recommended readinessIRL ≥ 5 · TRL ≥ 5 · CRL ≥ 5
S2 Design & Development / Early Validation to S3 Test and Validation
- Gate 4
Early Product Launch Acceptance
Recommended readinessIRL ≥ 7 · TRL ≥ 8 · CRL ≥ 8
S3 Test and Validation to S4 Launch
- Gate 5
Product Launch Acceptance
Recommended readinessIRL ≥ 8 · TRL ≥ 8 · CRL ≥ 8
S4 Launch to S5 Full Launch / Scale Up / Post-Launch Review
IRL = investment readiness level · TRL = technology readiness level · CRL = clinical readiness level (from Fig. 1 of the MediGate paper)
Want to move your innovation forward systematically?
Tell CMICe what you’re developing and where you are now, and the team will help plan the right next step.