IV.B.4. PPI (Monitoring): Co-deployment and new process / procedure validation

Estimated Execution Time

8-30 months (Ongoing throughout the PPI implementation period, aligned with the contractual timeline and the monitoring calendar defined in steps IV.A.)

Objective

To supervise the implementation of procured innovative solutions, ensuring full compliance with contractual specifications including performance, interoperability, and usability, monitor adaptation and phased deployment as planned in the procurement contract, co-create and validate final adjustments to address local needs and enable iterative improvement where contractually possible, evaluate real-world performance and usability focusing on outcomes relevant to users, patients, and citizens, and detect and resolve deviations early to ensure responsiveness, compliance, and continuity of delivery.

Who is Involved

Contracting Authority Representatives: oversees contractual compliance and delivery milestones.
Procurement Leads: coordinate supplier oversight and formal validation of deliverables.
Clinical and Operational Teams: validate usability, adoption, and operational performance.
IT Department: ensures integration, security, and technical compatibility.
Contractors: implement, customise, and support innovative solutions throughout execution.
End-user Representatives: key users validating solution usability and added value.
Evaluation and Testing Experts: perform technical validation, auditing, and performance verification.
External Certification Bodies (if applicable): confirm regulatory compliance (e.g. CE marking, ISO, cybersecurity, medical device).

Activities / Tasks

IV.B.4.1 Establish PPI monitoring and deployment governance

Validate implementation and deployment plans by agreement with contractor, starting from the documentation for initial batches or roll outs and including co-creation needs.
Define monitoring tools and procedures, including dashboards or remote tools, to track milestones, site readiness, and scaling up timelines.
Set up traceable documentation rules, including incident logs, corrective measures, and contractor follow up records.

IV.B.4.2 Execute monitoring, co deployment support, and compliance verification

Monitor technical and certification compliance, ensuring execution of conformance testing and delivery of official certifications including CE, ISO, GDPR where applicable.
Support IT integration and change management, coordinating system integration, training, communication, and onboarding of end users.
Facilitate co creation and feedback, enabling continuous collaboration for adaptation to workflows, UI UX, and operational constraints within contractual boundaries.

IV.B.4.3 Evaluate field performance and manage deviations

Collect and analyse field feedback, capturing satisfaction and usability data through structured surveys, logs, and performance indicators.
Evaluate operational impact through impact reviews covering efficiency, satisfaction, patient outcomes, and sustainability KPIs.
Document deviations and mitigation actions, maintaining traceable logs of incidents, corrective measures, and contractor follow up to detect and resolve issues early.

Tips / Common Pitfalls

✅ Engage IT and clinical teams early. Their involvement ensures smooth integration and alignment with hospital operations.

✅ Use a monitoring framework with clear KPIs. Include both process and value-based indicators (efficiency, satisfaction, sustainability).

✅ Maintain open feedback channels. Enable real-time issue reporting between contractors and end-users.

✅ Establish clear data governance rules. Define ownership, access rights, and permitted uses of operational and user data from the start.

✅ Request updated certification evidence. Ensure validity of tests, declarations, and compliance documentation throughout execution.

✅ Plan and communicate change management early. Include training, onboarding, and champions to foster adoption.

✅ Prepare for scaling up by monitoring flexibility, resource needs, support mechanisms and lessons learned.

❌ Rely solely on documentation. Always complement it with field verification or remote testing.

❌ Disregard user feedback once deployment starts. It’s essential for identifying hidden performance or usability issues.

❌ Underestimate integration complexity. Consider IT workload, interoperability constraints, and hospital infrastructure limits.

❌ Set unrealistic timelines. Account for regulatory audits, final certifications, and approval delays.

❌ Ignore early warning signals. Act immediately on underperformance, missed milestones, or deviations.

❌ Don’t be ready for a delay in certification approval or ethical committees’ approval, if necessary.

Outcome / Deliverables

Deployment Monitoring Reports documenting progress per batch, site, or wave, including incidents and performance data.
Certification and Testing Records confirming compliance and validity of conformance evidence.
User Feedback Reports summarising usability, satisfaction, and improvement suggestions.
Final Evaluation Report consolidating operational impact, lessons learnt, and recommendations for scale-up or replication.

Resources

Guidelines for Innovation Procurement (PCP/PPI) Presentation EC on PPI

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