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

Estimated Execution Time

Ongoing throughout the PPI implementation period, aligned with the contractual timeline and the monitoring calendar defined in Phase IV.A. It may be from 8 to 30 months.

Objective

To co-deploy and validate the health innovation in real-world healthcare settings, adapting it to each procurer’s context and evaluating its performance, usability, cost-effectiveness, and impact on care quality, building evidence for sustainable adoption and wider market uptake.

Who is Involved

Business Development / Innovation (Project Owner): Strategic Lead for Co-Deployment and Adoption
Operations / Project Management (Project Plan Owner): Execution Lead for Real-World Implementation, translates the co-deployment strategy into a detailed, site-specific implementation plan integrating timelines, resources, regulatory milestones, risk mitigation, and validation checkpoints
Clinical / Scientific Affairs; Clinical validation and evidence generation lead, defines and executes the real-world validation protocol, including clinical endpoints, usability measures, safety monitoring, and process performance indicators.
Product Development / R&D: technical adaptation and optimization lead, refines and adapts the solution to meet site-specific infrastructure, workflow, and user interface requirements identified during co-deployment.
IT Department: integration, interoperability, and cybersecurity lead, ensures seamless integration with hospital IT ecosystems (EHRs, PACS, middleware, etc.), respecting interoperability standards.
Market Access / Health Economics: value demonstration and adoption strategy lead, collects and analyzes real-world resource utilization, workflow efficiency, and cost data during co-deployment.

Activities / Tasks

IV.D.4.1 Site Adaptation and Deployment Preparation

Conduct structured site assessments (clinical, technical, organizational, and data governance) to define local adaptation requirements and ensure alignment with procurement specifications.
Customize workflows, system configurations, interfaces, and integration components to each procurer’s infrastructure while preserving scalability and regulatory compliance.
Develop and execute site-specific deployment plans, including timelines, milestones, resource allocation, risk mitigation measures, and logistics (hardware, software, data integration).
Establish local governance structures, communication channels, and support mechanisms to ensure coordinated implementation.

IV.D.4.2 Implementation, Training, and Operational Integration

Deliver tailored training programs and user-support materials (manuals, e-learning modules, quick-reference tools) for clinical, technical, and administrative staff.
Deploy the solution into live clinical workflows in a phased and controlled manner, ensuring safe and seamless operational integration.
Provide on-site or remote support during early use phases to ensure user confidence, rapid issue resolution, and structured feedback collection.
Ensure IT integration and change management, coordinating system integration, training, communication, and onboarding of end users.
Monitor early adoption and operational performance, addressing usability, technical, or interoperability challenges in real time.

IV.D.4.3 Evaluation, Optimization, and Evidence Generation

Ensure that the comprehensive evaluation framework, covering clinical, technical, organizational, usability, and economic KPIs, is aligned with what has already been specified in the value-based tender documentation. Where necessary, negotiate and formally agree with stakeholders on the detailed measurement procedures and assessment methodology.
Conduct real-world validation of safety, effectiveness, workflow impact, and cost-effectiveness, ensuring technical and certification compliance execution of conformance testing and delivery of official approvals and certifications including ethics approval, regulatory approval, ISO, GDPR where applicable
Collect and analyze quantitative and qualitative data (clinical outcomes, resource utilization, process efficiency, user satisfaction, patient acceptability).
Implement iterative improvements based on evaluation findings, documenting refinements, version updates, and lessons learned across sites.
Compile site-specific and cross-site validation results into structured reports, supporting joint publications, procurement decision-making, and post-project scaling strategies.
Connect with procures for co creation and feedback sessions, enabling continuous collaboration for adaptation to workflows, UI UX, and operational constraints within contractual boundaries.

Tips / Common Pitfalls

✅ Engage and co-design early: Involve each site from the start through needs assessments, co-design sessions, and alignment on workflows and validation metrics.

✅ Deploy iteratively and collaboratively: Plan phased rollouts with clear milestones, continuous feedback loops, and flexibility to adapt to real-world challenges.

✅ Monitor and document impact: Track KPIs, data and feedback, collect and validate data systematically, and share evidence and lessons learned to support scaling and sustainability.

❌ Avoid Insufficient site adaptation that risks leading to workflow mismatches and resistance from users.

❌ Avoid limiting user training or engagement as this reduces confidence, performance, and overall acceptance.

Outcome / Deliverables

Site-specific deployment and adaptation reports completed, documenting implementation activities and outcomes
Final evaluation, implementation and dissemination reports submitted, covering clinical, economic, and organizational performance with KPI analysis including consolidated cross-site results and project contributions

Resources

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

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