Evolutionary game analysis on the regulation of medical devices used in health services delivery.

Medical devices (MDs) play a critical role in healthcare delivery while also bringing potential medical risks and unintended harms to patients. Although government regulation is well recognized as a critical and essential function for ensuring the safety of MDs in many countries, the supplementary role that hospitals play is often neglected. This paper constructs a tripartite evolutionary game model involving the government, hospitals, and MDs enterprises to explore their strategic behaviors of MDs regulation in healthcare delivery. We performed theoretical analysis and numerical simulations to examine the stability of stakeholders' strategy selections. Our results reveal that: (1) Evolutionarily stable strategy (ESS) can be reached under specific revenue conditions for the government, hospitals, and MDs enterprises. (2) Penalty intensities largely affect the convergence rates of hospital strict management and enterprise quality improvement strategies. (3) Whistleblowing is an efficient factor to influence strategy selections of the hospital and MDs enterprise. Based on these findings, we propose policy recommendations to enhance MDs regulation effectiveness, including encouraging hospitals' engagement in regulation, promoting whistleblowing with more public participation, balancing penalty systems, and strengthening multi-party cooperation.