IV.D.2. PCP Phase II (Innovators): Prototype development and prepare the Pilots

Estimated Execution Time

Aligned with the contractual duration of PCP Phase II and the Monitoring Team calendar as referred to in phase IV.B.2 “PCP Phase II (Monitoring): Prototype development and conduct clinical validation”. Usually between 6 to 18 months.

Objective

To develop a functional prototype of the health innovation, transforming the validated design and plans from Phase I into a working solution. This phase focuses on building and integrating key system components to meet user and procurement requirements, while conducting early preclinical validation to test functionality, safety, and usability.

Who is Involved

Business Development / Innovation (Project Owner): Strategic oversight and cross-functional alignment
Operations / Project Management (Project Plan Owner): Maintains the implementation plan by integrating timelines, resources, regulatory milestones, risk management, and cross-functional coordination to ensure executable delivery.
Clinical / Scientific Affairs; Defines and executes the preclinical validation strategy, ensuring functionality, safety, usability, and clinical relevance are appropriately assessed
Product Development / R&D: Designs, builds, and integrates the core technical components of the functional prototype in line with system specifications and performance requirements.
IT Department: Develops and supports software architecture, system integration, cybersecurity, and interoperability functionalities required for prototype performance within healthcare environments.

Activities / Tasks

IV.D.2.1 Refine Prototype Design and Validation Framework. Develop and Integrate the Functional Prototype

Establish measurable performance indicators if not included in the tender documents; and define the verification objectives and methodology for data collection
Identify final compliance requirements (e.g., GDPR, MDR classification), and necessary approvals for preclinical testing: define clear guidelines and follow-up procedures for the development team on the requirements for the software/hardware approval.Create progressive mock-ups for UI/UX and validate with end-users, first internally and finally with the buyers’ representatives.
Design and build the core hardware and/or software components;
Integrate UI/UX elements aligned with clinical workflows and implement interoperability capabilities (e.g., HL7/FHIR interfaces) to ensure secure data flows and system interactions; and
Conduct internal stability and performance testing prior to external validation.

IV.D.2.2 Conduct the Verification of the Requirements and Iterative Refinement

Execute testing in simulated or controlled clinical environments to guarantee the accomplishment of all functional and non-functional requirements.
Engaging clinicians and end users for structured feedback on reliable enough prototypes.
Collect and analyze data on functionality, usability, and safety;
Address identified technical or usability gaps through iterative improvements; and ensure traceability of all modifications.

IV.D.2.3 Consolidate Documentation and Deliver Phase Outputs

Update technical architecture, system specifications, risk assessments, and quality documentation;
Refine implementation and business considerations based on validation findings; and
Compile validation of evidence, technical reports, and required deliverables for submission to the procurer consortium.
Prepare the bids for the mini tender of the next phase based on the feedback received on the final deliverable and the demonstrations, in invited.

Tips / Common Pitfalls

✅ Refine prototype scope and features early, incorporating clinician and procurer feedback and aligning with procurer and clinical priorities, usability, safety, and performance.

✅ Plan preclinical validation thoroughly, develop and test core components iteratively defining clear objectives, metrics, and ethical or regulatory approvals in advance.

✅ Pay attention to the payment scheme of Phase III when preparing the piloting approach and plan your financing needs.

❌ Prototype requirements were vague or misaligned, causing rework and unmet procurer expectations.

❌ Iteration changes were undocumented, reducing traceability and audit readiness.

❌ Validate with the buyers’ group (clinicians, patients, ..) without exhaustive previous internal validation. If the participants feel they are wasting time they will not be motivated to continue the collaboration.

Outcome / Deliverables

Functional Prototype and Validation Evidence Completed: A fully integrated prototype demonstrated and documented, accompanied by a preclinical validation report detailing test setup, methodologies, performance results, usability, safety findings, and summarized end-user and clinical feedback reflecting iterative improvements.
Updated Technical and Risk Documentation Finalized: Comprehensive technical documentation revised, including system architecture, data flow, interoperability and cybersecurity specifications, alongside an updated risk assessment and mitigation plan addressing development and validation insights.
Phase III bid completed: Final documentation to be presented for Phase III mini tender including feedback from the buyers.

Resources

Guidelines for Innovation Procurement (PCP/PPI) Regulatory Resources Repository

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