Introduction Healthcare systems are increasingly integrating advanced technologies into daily practice, leading to a growing emphasis on the adoption of innovative high-tech medical devices. Unlike conventional device replacements, these innovations introduce new technologies that can significantly impact clinical workflows, patient outcomes, and organizational structures. However, the complexity and uncertainty surrounding their adoption present major decision-making challenges for hospitals. Despite the critical nature of these decisions, most hospitals lack a structured approach to guide them. This thesis addresses this gap by developing a decision-making framework to support hospitals in the acquisition of innovative high-tech medical devices.

Methodology This study employed a three-phase approach: analyzing the current decision-making process for acquiring innovative high-tech medical devices, developing a decision-making framework, and evaluating the framework. Semi-structured interviews with stakeholders from two hospitals were conducted to map current practices and identify challenges. Insights from the interviews and a successful case study informed the development of the framework, designed using principles from the Cynefin framework to address the complexity of innovation adoption. The framework was refined based on expert feedback and evaluated through a semi-structured questionnaire focusing on its structure, usability, and expected effectiveness.

Results The results of this study revealed several challenges in the current decision-making processes for acquiring innovative high-tech medical devices including limited exploration of broader organizational needs, premature formation of project groups and unclear early-stage leadership. The interviews and the case study highlighted the importance of iterative decision-making, early project leadership by a technically skilled project leader, and flexibility in adapting project structures as new insights emerge. Based on these findings, a decision-making framework was developed that addresses these challenges by promoting adaptive, stakeholder-driven, and strategically aligned acquisition processes. Both respondents of the evaluation questionnaire agreed that the framework is clearly structured, adds value to the hospital’s decision-making process, and supports a well-informed investment decision. Nevertheless, some limitations were identified.

Discussion The developed decision-making framework approaches the acquisition of innovative high-tech medical devices as a complex, iterative process aimed at uncovering broader organizational needs behind device requests. It emphasizes early stakeholder involvement, flexible project structures, and delayed formalization of business cases to better navigate uncertainty. While the framework offers hospitals a structured but adaptable tool to professionalize decision-making and foster innovation, its development was based on interviews at only two hospitals and has not yet been tested in real-world applications. Future research should focus on validating the framework through longitudinal case studies and further refining its usability with detailed guidance and practical examples.