Guiding stakeholder involvement in health technology assessment for medical devices: A novel approach for clarifying stakeholders’ roles and contributions

• HTA must adopt a structured, replicable approach to stakeholder inclusion. • The implemented framework is adaptable to global HTA systems for MD evaluations. • Direct patient participation is needed to ensure their values shape MD evaluations. • Providers, payers, and industry act as experts and decision-makers in MD evaluations. • HTA agencies need better tools and time to fairly assess stakeholder contributions. Stakeholder involvement is recognized as essential in Health Technology Assessment (HTA), yet engagement remains insufficient, particularly in medical device (MD) evaluations. However, literature on how to systematically identify and integrate stakeholders remains scarce. This study proposes a reflective framework to support HTA practitioners think about stakeholder inclusion and applies it to explore perspectives within the medical device context in Portugal. We adapted Ulrich’s Critical Systems Heuristics (CSH) as a conceptual lens to structure reflection on stakeholder roles and contributions in MD HTA. The framework is organized around four sources of influence (motivation, control, knowledge, and legitimacy) and was operationalized through 26 semi-structured interviews with experts from Portugal’s HTA agency, hospitals, patient associations, and industry. Interview data were analysed using directed content analysis and the Framework Method, allowing to contrast current ('is') and ideal ('ought') views within each source of influence. The common themes were then used to construct interpretive narratives that captured rationales for stakeholder inclusion. The application of the framework revealed context-specific insights into stakeholder engagement in MD evaluation. Findings show stakeholder roles in MD evaluations extend beyond traditional classifications. For each CSH source of influence, rationales and conditions for stakeholder engagement were identified. Under motivation, stakeholders identified diverse purposes and measures of success, ranging from improved patient access to innovation to system-wide resource optimization. Under control, providers, purchasers, and payers were seen as central decision-makers, yet ideal processes included multidisciplinary governance and clearer procedural support. Under knowledge, multiple actors (including patients) were valued as contributors of contextual expertise, but gaps were highlighted in methodological tools. Under legitimacy, patients and the public were underrepresented and called for stronger mechanisms for direct involvement and broader societal alignment. Across all sources of influence, significant gaps were found between current practices and stakeholder expectations to highlight areas for development. Rather than prescribing fixed engagement procedures, the proposed reflective framework offers a structured lens to support HTA practitioners in reasoning through stakeholder roles, values, and contributions in MD evaluations. The framework is transferable to other decision-making contexts and fosters more transparent and inclusive deliberation.