Identifying the Challenges of the Processes of Introducing and Commercializing Domestic Medical Equipment to the Market

Background: Given the rapid growth of medical technologies and the increasing demand for high-quality medical equipment, the optimizing process for these devices is of paramount importance. This study aimed to explain and identify the processes for entering the market of domestically manufactured medical equipment in Iran and to examine the challenges and obstacles in obtaining medical equipment licenses. Methods: This study was conducted in 2024. The method used in this research was qualitative and with a qualitative content analysis approach. The data are obtained from in-depth semi-structured interviews with people who were selected purposefully (with maximum diversity of managers, government officials and technologists).The number of participants is 18, which was determined by reaching the saturation stage. The data were analyzed using MaxQDA software 2020. Results: Findings from interviews, coding, and concept extraction are presented in the form of causal conditions that create defective processes (8 factors), interfering conditions (4 factors), exit strategies (24 strategies), and consequences of the defective process (5 consequences). Conclusion: The research results showed that the process faces major challenges such as complexity of implementation steps, time-consuming nature, high costs, lack of transparency, and lack of coordination between regulatory agencies. These problems, while reducing productivity, have increased dependence on imported medical equipment and reduced the motivation of domestic manufacturers. In order to address these problems, solutions to overcome defective processes were proposed, which includes steps such as needs analysis, process simplification, strengthening technological infrastructure, and improving coordination between organizations, which could lead to significant improvements in the efficiency, transparency, and speed of licensing processes.