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Article History

Received: 24 February 2026

Accepted: 18 May 2026

First Online: 1 July 2026

Competing interests

: O.F. has a leadership role and holds stock in WhalesDontFly GmbH, has had consulting relationships with Prova Health Ltd., and has a subcontractual consulting relationship with the Saudi FDA. MO declares a subcontractual consulting relationship with the Saudi FDA. S.G. is an advisory group member of the Ernst & Young-coordinated “Study on Regulatory Governance and Innovation in the field of Medical Devices” conducted on behalf of the Directorate-General for Health and Food Safety of the European Commission. S.G. has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd., Flo Ltd., Thymia Ltd., FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH, Saudi FDA, and Ada Health GmbH, and he holds share options in Ada Health GmbH. A.S.P. reports research funding and lecture fees from Johnson & Johnson, Bristol Myers Squibb (BMS), Novartis, and Curis, outside the submitted work. C.W. declares no competing interests.