Risk-sharing agreements for medical devices: a stakeholder-based qualitative study in Czechia.

Abstract

The rising costs and uncertain clinical value of innovative health technologies have spurred growing interest in alternative reimbursement models, particularly outcome-based risk-sharing agreements. While such models are increasingly discussed and applied in the pharmaceutical sector, their use in the context of medical devices remains limited and underexplored, despite similar challenges regarding evidence generation and financial risk. This qualitative study examines stakeholders' perspectives