IV.B.2. PCP Phase II (Monitoring): Prototype development and conduct clinical validation

Estimated Execution Time

6-18 months (Aligned with the contractual duration of PCP Phase II and the Monitoring Team calendar defined in steps IV.A)

Objective

To assess the technical soundness, functionality, and usability of prototypes developed by contractors during Phase 2 according to the established verification protocol, verify alignment with the technical, functional, and operational requirements defined in the tender and recommendations/instructions from Phase 1, and ensure a fair, transparent, and traceable evaluation process that supports preparation for Phase 3 (pilot deployment).

Who is Involved

Hospital / Procurer Side (Internal)
- Monitoring Team: technical experts, procurement/legal advisors, and user or stakeholder representatives, particularly where usability or integration are critical.
Innovators / Providers (Internal)
- Contractors: suppliers developing prototypes, providing documentation, demonstrations, and participating in evaluations.
Healthcare Professionals / Operational Staff
- End-users: involved in usability validation, co-creation, and context-fit assessments.

Activities / Tasks

IV.B.2.1 Establish Phase II verification set up

Confirm the Phase II verification framework approved by the Monitoring Team, including scope, criteria, evidence requirements, decision rules, reporting formats, and documentation standards to ensure full traceability.
Define roles and responsibilities for verification activities, ensuring neutrality, equal treatment, and traceability.

IV.B.2.2 Execute prototype verification and validation activities

Coordinate and supervise prototype demonstrations and verification activities in line with the agreed protocol and schedule.
Involve Healthcare Professionals and end users in usability and operational fit validation under comparable conditions.
Collect and document objective evidence from demonstrations, tests, and validation activities using standardised templates.

IV.B.2.3 Consolidate results and prepare transition to Phase III

Assess prototype performance against predefined verification criteria, consolidating inputs from all reviewers.
Prepare structured monitoring outputs identifying results, risks, and improvement areas.
- Support contractors in the request of ethical approval for Phase III pilots, with the level and scope of support adapted to the requirements of the competent Ethics Committee and the applicable national framework.
Use Phase II findings to support decision making and prepare monitoring inputs for Phase III.

Tips / Common Pitfalls

✅ Allow technical clarification meetings. Enable contractors to explain key elements without compromising fairness.

✅ Apply multi-expert review for each prototype, ensuring all assessments are justified and documented.

✅ Ensure clinical team participation in co-creation. Even if overloaded, their input is critical to ensure prototypes meet real operational needs.

✅ Evaluate compliance with all requirements and monitoring recommendations. Confirm technical, functional, and operational alignment throughout the phase.

✅ Prepare ethical documentation early. Start drafting submissions to ethics committees or medical device authorities early during prototype development.

✅ Detect unfeasibility early. Prioritise key requirements over optional features within contractual limits.

❌ Introduce new criteria mid-process. Always use the scoring framework defined in the tender.

❌Apply superficial or inconsistent verification. Avoid overlooking operational needs or technological diversity.

❌ Fail to follow a consistent verification protocol. Apply the agreed procedure uniformly to all contractors.

Outcome / Deliverables

Comparative Evaluation Report summarising all prototype assessments, including individual scores, justifications, and compliance with defined requirements.
Lessons Learnt Document capturing evaluation insights, co-creation outcomes, and feedback from the Monitoring Team and stakeholders.
Recommendations Report for each contractor, outlining key observations and forward-looking guidance for transition to Phase 3 (Pilot Deployment).

Resources

Guidelines for Innovation Procurement (PCP/PPI)

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