Abstract EHMA 2025: Advancing demand-driven innovation adoption in paediatrics through the theory of change: insights from the ADD4kids project working groups

EHMA 2025: Advancing demand-driven innovation adoption in paediatrics through the theory of change: insights from the ADD4kids project working groups Context: Demand-driven innovation (DDI) adoption is crucial for improving healthcare delivery, yet value-based procurement faces challenges such as regulatory barriers, lack of awareness, and risk aversion. Paediatrics encounters additional hurdles, including inadequate reimbursement, limited procurement strategies, and a restricted market. Despite various initiatives, a European consensus on paediatric DDI adoption is lacking. This abstract presents findings from nine working groups nested in the work package (WP) 2 of the ADD4kids project. The main objective of WP2 is to develop a framework to mainstream DDI instruments for paediatrics. ADD4kids aims to create a structured roadmap for mainstreaming paediatric DDI adoption. Methods: We applied the Theory of Change (ToC) to define the strategic vision of WP2, structured into Inputs, Activities, and Short, Mid, and Long-Term Outcomes. The Long-Term Outcome (2027) aligns with ADD4kids’ mission: enhancing paediatric healthcare. The Mid-Term Outcome (2026) is to identify, prioritize and address cross-border challenges through DDI adoption. Short-Term Outcomes (2025) include: (i) publishing a white paper on strategies to enhance DDI adoption in paediatrics and (ii) developing an EU action plan for sustainable paediatric innovation adoption. In 2024, WP2’s main Activities involved nine online working groups tackling key DDI adoption challenges, including internal alignment, upskilling, policy and funding, cross-border procurement, and health system interventions. Using collaborative tools, these groups conducted SWOT and root cause analyses, brainstorming sessions, and surveys, refining insights iteratively. Inputs (2024) included European Commission funding, along with a WP1-derived desk review on DDI and structured expert interviews. Results: The working groups' findings represent the Short-Term Outcomes identified through the ToC. Below, the summarized insights categorized into five key themes: Governance and Policy Alignment • Challenges: Lack of coordination, regulatory discrepancies, low policy prioritization. • Solutions: Establish an EU Paediatric Procurement Governance Hub, harmonize regulations, strengthen advocacy Funding and Sustainability• Challenges: Reliance on short-term funding, low private sector investment, insufficient hospital incentives. • Solutions: Implement long-term public-private funding, develop financial incentives, attract venture capital Data and Digital Health Integration• Challenges: Fragmented data, legal constraints, lack of AI integration. • Solutions: Standardize paediatric data, enable GDPR-compliant sharing, integrate AI-driven analytics. Procurement and Market Engagement• Challenges: Small market size, complex procurement, fragmented demand. • Solutions: Develop joint procurement alliances, simplify processes, enhance procurement training. Clinical and Patient-Centred Innovation • Challenges: Limited clinician participation, overlooked patient perspectives, institutional barriers. • Solutions: Institutionalize "Innovation Time," create patient advisory boards, foster risk-tolerance culture. Discussion: This study identified key challenges of paediatric DDI adoption and its potential solutions. Key takeaways include: • DDI efforts fragmentation hinders paediatric innovation highlighting the need for strong cross-border governance.• Financial sustainability remains a challenge due to reliance on short-term EU funding.• Data sharing and standardization play a crucial role in regulatory approval and adoption.• Stakeholder misalignment slows progress, requiring structured engagement strategies. • Procurement complexities hinder DDI adoption, necessitating targeted solutions. The ToC provides a structured framework to align activities with outcomes, laying the groundwork for a collaborativeand comprehensive EU action plan for paediatric DDI adoption.