Stage 03 of 12
Feasibility
Retire the highest technical, clinical, and commercial uncertainties.
Entry criteria
- Critical requirements and assumptions are identified
- Candidate technical approaches can be compared
- Success and failure criteria are defined
Required activities
- Prototype the highest-risk functions
- Run bench experiments and architecture trade studies
- Assess biological, electrical, software, and use-related risks
- Estimate cost, schedule, and supply-chain constraints
Expected deliverables
- Feasibility evidence package
- Architecture decision record
- Preliminary risk analysis
- Development estimate and recommendation
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Testing easy functions instead of critical uncertainties
- Mistaking a demonstration for repeatable performance
- Ignoring production constraints during architecture selection
Exit criteria
- Critical feasibility questions have objective evidence
- A preferred architecture is selected with documented tradeoffs
- Residual uncertainties are acceptable for formal development
Suggested next actions
- Create the integrated development plan
- Confirm regulatory classification and strategy
- Establish design controls and project governance
Find your next move
Build confidence in feasibility.
Map your current evidence and gaps to the capabilities needed for this stage.