Stage 02 of 12
Product definition
Translate the opportunity into user needs, requirements, and claims.
Entry criteria
- The clinical need and intended users are understood
- Primary care settings and workflows are documented
- The team has agreed on the problem boundary
Required activities
- Prioritize user needs and use scenarios
- Define intended use, indications, and preliminary claims
- Create system-level requirements and acceptance criteria
- Identify interfaces, constraints, and product variants
Expected deliverables
- User-needs specification
- Product requirements document
- Preliminary claims matrix
- System context and use scenarios
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Unverifiable or conflicting requirements
- Claims that imply an unintended regulatory path
- Feature growth before core value is proven
Exit criteria
- User needs trace to measurable product requirements
- Claims and intended use are internally consistent
- Critical assumptions are assigned to feasibility work
Suggested next actions
- Select feasibility experiments
- Create a preliminary system architecture
- Start the product risk register
Find your next move
Build confidence in product definition.
Map your current evidence and gaps to the capabilities needed for this stage.