IV.D.2.1 Stakeholder Engagement and Co-Creation

Participate in co-creation sessions with representatives from the buyers group and supporting partners to fine tune the approach of the proposed solution to the challenge brief and to refine the innovation concept and validate user needs and care provider expectations to ensure alignment with systems specifications.

IV.D.2.2 Feasibility Study, Implementation Planning and Technical Specification Development

• Assess the technical feasibility of the proposed solution, including system architecture, data flow, key functionalities, and integration requirements as well as the clinical relevance and usability in the target healthcare setting.
• Conduct a preliminary regulatory assessment (e.g., CE marking requirements, GDPR compliance)
• Develop mitigation strategies around any technical, clinical, and operational risk identified.
• Draft a preliminary implementation plan for how the solution would be integrated in clinical workflows and IT systems including the identification of interoperability requirements (e.g., integration with EHRs, use of standards like Health Level Seven “HL7”  or Fast Healthcare Interoperability Resource “FHIR”).
• Consider scalability and deployment strategies for diverse healthcare environments.
• Assess logistical, training, and support needs from the end-user perspective.
• Define detailed functional and non-functional specifications for the proposed solution such as the technical architecture including hardware/software components, data flow, and interfaces.
• Ensure alignment with procurement specifications and quality/performance indicators
• Document cybersecurity, privacy, and data governance requirements.

IV.D.2.3 Development of Strategic Roadmap and Business Model Definition

• Define the R&D trajectory from concept to prototype to commercialization.
• Define Clinical and Health Economic evidence collection strategy to back up the value proposition of the health solution.
• Verify and any (ethics committee) approvals required during the PCP project – for the scientific demonstration of outcomes and to support regulatory approval as well as strategic market access and reimbursement goals, once commercially viable.
• Identify key development milestones and decision points for the next phases of PCP and allocate internal resources and collaboration with external partners (technical, clinical, regulatory).
• Conduct a market analysis to understand the competitive landscape, market access and reimbursement barriers, and opportunities as a basis for commercialization strategies, acceptable business models tailored to the healthcare market (e.g., public procurement, subscription, pay-per-use), pricing models, and reimbursement pathways.

IV.D.2.4. Deliverables Preparation

• Refine Phase I specifications based on evaluator feedback to align prototype features with procurer priorities, clinical requirements, and defined use cases.
• Compile all findings and plans into formal documentation required by the PCP process, including:

• • Feasibility Study Report
  • Roadmap and Implementation Plan
  • Business Model Canvas or equivalent
  • Technical Specification Document
• Present outcomes to the procurer consortium for evaluation and prior to moving on to the next phase.
• Record key recommendations and integrate them in the implementation plan as part of the procurer monitoring documentation.
• Prepare the bids for the second phase mini-tender based on the final deliverable and the feedback received from the monitoring team and apply if invited.