The SmILE project applies a structured co-creation approach to define user requirements for a health platform supporting musculoskeletal conditions. By combining evidence analysis with input from patients and healthcare professionals, the project examines needs, acceptance, concerns and digital capabilities. SmILE supports the development of usable, inclusive, trustworthy and user-centred digital and implant-enabled solutions.

The SmILE approach combines evidence review, stakeholder engagement and qualitative and quantitative research methods. The following sections detail each step of the co-creation process and its outcomes.

Defining needs beyond technology assumptions

The co-creation approach begins with a comprehensive state-of-the-art analysis to avoid technology-driven assumptions. Stakeholder mapping identifies patients, healthcare professionals and other relevant groups involved across musculoskeletal care pathways. Patient journey mapping is used to examine every day experiences before, during and after treatment, highlighting where monitoring, feedback or support is currently missing or fragmented.

Consolidating evidence and measurable outcomes

A broad literature review analysed more than fifty relevant publications and digital resources to identify established evidence, gaps and actionable insights. Existing digital health platforms are reviewed to assess their features, limitations and relevance for older users and healthcare professionals. Patient-reported outcome measures (PROMs), which capture patients’ assessments of their health status and functional outcomes, and patient-reported experience measures (PREMs), which reflect patients’ experiences of care and service delivery, are systematically collected and characterised. This analysis results in an initial, evidence-based list of user needs and system requirements.

Capturing patient perspectives in detail

Based on these findings, a patient-focused survey and in-depth interview are developed to explore health status, daily functioning, experience with musculoskeletal conditions and familiarity with digital tools. These instruments examine what types of health information patients consider meaningful to track over time, such as pain, mobility, physical function, and more. They also explore expectations towards smart implants and mobile applications, preferred features, information formats and perceived benefits. Particular attention is given to concerns around data access, privacy, autonomy, usability and technical reliability.

Understanding clinical requirements and constraints

In parallel, a dedicated survey and interview for healthcare professionals captures clinical needs, workflows and decision-making requirements. Questions address the usefulness of implant-generated data, remote patient-reported measures and automated insights for monitoring recovery, detecting complications and supporting treatment decisions. These instruments also explore preferences for data presentation, integration with existing systems, and perceived barriers such as data overload, trust in automated systems and regulatory considerations.

Enabling pan-European participation

To support inclusive participation across different countries, healthcare systems and social contexts, the study combines quantitative surveys with qualitative interviews, with all instruments made available in multiple European languages. Recruitment is supported through digital communication, direct outreach and in-person engagement, enabling consistent data collection while accommodating diverse participant preferences.

From co-creation to validated requirements

The collected input supports the analysis of user requirements covering functionality, usability, data governance and acceptance. These results contribute to a key project milestone, providing a structured basis for system validation, regulatory alignment and further development activities. By grounding design decisions in documented user input from both patients and healthcare professionals, SmILE establishes requirements that are measurable, transparent and aligned with real-world needs.

Links

https://horizon-smile.eu/

https://www.linkedin.com/showcase/smile-smart-implants-for-life-enrichment/

Keywords

co-creation, user requirements, musculoskeletal health, digital health platform, usability, user centred design