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Short abstract:

We aim to increase understanding of (challenges in) the anticipatory governance of medical technologies, by describing and critically reflecting on the perspectives of industry actors, including the (dis)alignment of HTA as an anticipatory practice.

Long abstract:

The governance of medical technologies occurs in a network of actors, dispersed at regional, national, and supranational levels. Within this network, the companies that market medical technologies are an important stakeholder. Governance activities influence medical technology companies, by fostering certain technological innovations and not others. At the same time, the development of innovative medical technologies shapes the governance required. In this paper we explore this interaction between innovative medical technologies and attempts to govern them by investigating how medical technology industry actors navigate the (changing) governance landscape. Whereas more attempts have been made to understand governance practices, relatively little is known about the position and practices of industry actors themselves. We conduct in-depth, semi-structured interviews with (Dutch or European) industry actors, including actors from different strata of industry (ranging from start-ups to multinational companies), to gain a heterogenous perspective. Our analysis focuses on respondents’ experiences surrounding evidence generation, experiences with new regulations, and expectations of governing bodies like health technology assessment (HTA) agencies. Conceptually, our analysis builds on literature on anticipatory governance. This growing body of research theorizes the way in which actors involved in governing ‘the future’ conceptualize futures and actions in the present. We reflect on the legitimacy and adaptability of HTA (as an anticipatory practice) to the context of medical technologies, in terms of values, decision-making procedures, timelines, etc. In doing so, we aim to increase our understanding of challenges and formulate policy recommendations for the governance of medical technology.