No abstract

Medical device development involves user safety, and it is governed by specific regulations. The failure of medical device developers to consider the influence of users, the environment, and related organizations on product development during the design and development process can result in added risks to the use of medical technologies. Although many studies have examined the medical device development process, there has been no systematic and comprehensive assessment of the key factors affecting medical device development. This research synthesized the value of medical device industry stakeholders’ experiences through a literature review and interviews with industry experts. Then, it establishes an FIA-NRM model to identify the key factors affecting medical device development and suggests appropriate pathways for improvement. Results indicate that the development of medical devices should begin with stabilizing organizational characteristics, followed by strengthening technical capability and use environment, and finally, consideration should be given to the user action of medical devices. The results provide medical device developers with optimal development pathways and resource allocation recommendations to support developers in developing medical device development strategies as well as ensuring the safety and effectiveness of the products for end users.