Stage 01 of 12
Opportunity definition
Define the clinical need, users, market, and initial intended use.
Entry criteria
- A clinical or operational problem has been observed
- Potential users and care settings can be identified
- A team is prepared to test its assumptions
Required activities
- Interview clinicians, patients, operators, and economic buyers
- Map the current workflow and alternatives
- Draft the unmet need statement and initial intended use
- Estimate market size, adoption barriers, and stakeholder value
Expected deliverables
- Validated need statement
- Stakeholder and workflow map
- Initial intended-use statement
- Opportunity and market brief
Recommended capabilities
Look for providers with relevant device, market, and stage experience—not capability labels alone.
Common risks
- Solving a symptom rather than the root problem
- Confusing the user with the buyer
- Defining a need around a preferred technology
Exit criteria
- The need is supported by direct stakeholder evidence
- Users, use environment, and current alternatives are clear
- The opportunity supports further product definition
Suggested next actions
- Turn the need into measurable user needs
- Draft product claims without prescribing a design
- Identify the riskiest product assumptions
Find your next move
Build confidence in opportunity definition.
Map your current evidence and gaps to the capabilities needed for this stage.