Participatory Regulatory Science for Patient-Centred Digital Health and Policy Uptake

Who we are and what we bring

We are a research and innovation group specialised in participatory and value-based methodologies applied to regulatory science, digital health innovation and public policy translation. Our added value lies in our ability to connect users, regulators and public authorities and translate participatory evidence into regulatory- and policy-relevant outputs that support real-world uptake.

Key expertise

• Participatory design & value-design thinking
  Structured co-creation processes involving patients, healthcare professionals, regulators, industry and public administrations, ensuring that innovation is aligned with real needs and public value.

• Iterative piloting of acceptance and usability
  Multi-iteration assessment of usability, trust and acceptability of evolving digital health solutions, integrating stakeholder feedback to inform design choices, human factors considerations and regulatory-relevant aspects.

• Participatory regulatory science
  Embedding patient-centred and stakeholder-driven evidence into methodologies supporting the evaluation of innovative and hybrid health technologies (medical devices, AI-enabled solutions, digital tools).

• Policy dialogue & Green Paper processes
  Design and facilitation of policy roundtables with local and regional policymakers, and management of Green Paper–type consultation processes to translate project results into actionable policy and regulatory options.

• Public and innovation procurement
  Experience in procurement-related projects, supporting the translation of project outcomes into operational adoption frameworks and public policies.

Track record

• Participation as coordinator and partner in Horizon 2020 and Horizon Europe projects.

• WP leadership in stakeholder engagement, methodology development, policy translation and impact.

• Strong, long-standing collaboration with local and regional public administrations and health authorities.

Why partner with us

• We strengthen impact, policy uptake and sustainability of Horizon projects.

• We reduce implementation risk through proven EU project experience.

• We offer a credible bridge between innovation, regulation and health system implementation, fully aligned with patient-centred approaches.