HTA between theory and practice: Exploring boundary work in broadening HTA For MedTech governance

In this paper, we explore the social and political practices involved in broadening health technology assessment (HTA) for medical technology (MedTech) governance. We take as our case study the Dutch HTA Methodology 2021–2024 Program, which aimed to broaden HTA methodologies to the assessment of MedTech, and in so doing, broadened the stakeholders involved. Our research question is as follows: How do stakeholders involved in the program interpret HTA (methodologies) for MedTech, and how do they envision multi-stakeholder collaboration on HTA (methodologies)? We conducted 19 semi-structured interviews with program participants, including committee members and grant applicants. We also spent 120 hours observing program meetings as non-participants and conducted document analysis. Using boundary work as a sensitizing concept, we describe how broadening the actors involved both introduced and exposed different interpretations of HTA and HTA methodologies for MedTech. We describe three ways in which participants envisioned (potential) integration of these interpretations, which we term collaboration hybrids. Each collaboration hybrid encapsulates a way of navigating across boundaries. Our findings highlight that attempts to broaden HTA into a more prominent aspect of MedTech governance challenge the boundaries of what is understood as proper HTA. We argue that reflecting explicitly on these different interpretations, and the diverse ways to integrate them, increases the relevance of the HTA methodologies developed and the collaborations initiated in the governance of MedTech through HTA.