III.B.3.1. Define Functional requirements

• Identify the main functional domains required to address the healthcare challenge. Respond to “what the system must do” statements.
• Focus on functions that directly address unmet needs and user workflows. Express functions in outcome-oriented and technology-agnostic terms.

III.B.3.2. Define Non-functional requirements

• Define cross-cutting requirements such as performance, scalability, interoperability, usability, security, reliability, maintenance and accessibility requirements.
• Ensure requirements are verifiable and suitable for innovation procurement. All requirements are SMART (Specific, Measurable, Achievable, Relevant, Time-bound).
• Ensure consistency across sites and alignment with organisational constraints.

III.B.3.3. Validate and structure the requirements

• To identify and define the core functional, technical, and strategic components (“building blocks”) that will form the foundation of the tender documents and the solutions to be procured.
• Each building block must align with the identified needs, expected outcomes, and the procurement structure defined for the PCP or PPI process.
• The creation of building blocks or parts of the solution, can help to structure the tender, create lots and envision the integration of them.
• Review requirements for clarity, coherence, and non-ambiguity.
• Categorize requirements as mandatory, preferred, or optional to guide evaluation weighting.
• Include relevant legal, ethical, and environmental considerations (e.g., GDPR, eco-design).
• Cross-check consistency with SOTA and Market analysis outcomes.
• Consolidate requirements into a structured format ready for tender drafting.
• Confirm endorsement from all procurers before finalizing the list.