Institutional Mechanisms and Systemic Bottlenecks in the Implementation of Innovative Medical Devices: A Case Study of Shanghai

Objective This study aims to systematically examine the application mechanisms, key obstacles, and countermeasures for the landing and promotion of innovative medical devices in Shanghai. Methods Utilizing expert consultation and qualitative research methods, in-depth interviews were conducted with 16 experts from hospital equipment, asset, and logistics management fields. This was combined with an analysis of internal hospital policy documents, and data were systematically organized and thematically refined using Colaizzi's seven-step phenomenological analysis method. Results T he findings indicate that the hospital admission of innovative medical devices faces multi-dimensional systematic obstacles. These primarily include: the preemptive constraints of platform listing rules (such as the complexity of the "first listing" process and the impact of the "first excess" rule on pricing strategy), lengthy and rigid internal approval processes, insufficient clinical awareness and acceptance, as well as economic pressures and market overlap issues. To address these barriers, hospitals have implemented a classified management and collaborative promotion mechanism. Specific measures include: simplifying processes and establishing fast-track channels, strengthening cross-departmental collaboration and forward planning, and implementing policy tilts and centralized procurement volume guarantees. Conclusion The landing and promotion of innovative medical devices is a systematic project requiring coordinated process optimization, departmental collaboration, clinical education, and policy support. Although the current mechanisms have improved admission efficiency, it is still necessary to continuously address deeper challenges such as the lag in changing clinical behaviors and balancing economic feasibility with policy compliance. Furthermore, efforts should be intensified to strengthen in-hospital promotion, improve higher-level support policies, and optimize equipment introduction models to foster the sustainable application of innovative technologies.