Start with the observed problem
A useful need statement describes who experiences the problem, where it occurs, what happens today, and which outcome should improve. It should remain true even if the product concept changes.
- Name a specific patient, clinician, operator, or care-system population
- Define the setting and workflow
- Describe the measurable problem and desired outcome
- Keep technology and product features out of the statement
Test the statement with stakeholders
Interview users, decision makers, and economic buyers separately. A frequently observed problem is not automatically important enough to change behavior or justify purchasing.
- Ask for recent examples rather than opinions
- Map clinical, operational, and economic consequences
- Record contradictory evidence
- Revise the boundary before defining requirements