## 1 Introduction
### Design Process
[PERSON] (1987) identifies the three categories of users as primary (those who frequently use the system), secondary (those who occasionally use the system), and tertiary (all users who are affected by the introduction of the system or influencing its purchase). Identifying all of the possible users allows designers to make reasonable decisions about their degree of involvement in a project to be successful. However, he/she does not specify that the hierarchies of the three groups can constantly change during the product's end-use, as is the case with a medical device [23]. According to the Federal Drug Administration, there is a definition for the design standards for medical devices. The current design process combines engineering disciplines, government regulatory agencies (national and international), independent certification, and compliance companies. The objective of these techniques is to ensure that a new product meets user expectations and that it is safe and effective in providing its stated benefits [24]. A 2020 study by [PERSON] et al. of Kwangwoon University in Seoul, Korea, analyzed 88 scientific sources related to the usability and UX of medical device design. The studies examined the concept of medical device usability from three points of view: patients, physicians/medical staff, and caregivers. The primary documents were up to international standards. The authors presented the principal UX analysis methodologies. The three main future challenges for human factors in medicine are user-product interaction, the technology and medical device design process, and aspects of clinical research. They concluded that usability can be considered a subset of UX. Second, assessments can be applied differently for medical devices and consumer goods. Third, usability can be evaluated differently, depending on the type of product. Fourth, there is a distinctive difference in the evaluation of the usability of medical devices compared to consumer goods [25]. A 2001 study by [PERSON] at the Research Institute at Loughborough University analyzed the importance of human-centered design systems and processes to achieve them. Adopting the framework of ISO 13407, each procedure was considered along with a set of usability methods to support it. Usability is now widely recognized as being critical to an interactive system or product [26]. An analysis of the literature shows that the main benefits of user participation in the design and engineering of a medical device include relevant information about the user perspectives, which improves the design of the user interface as well as the functionality, usability, and quality of medical devices [19]. The application of human factors, standards, and the practices of user centered design remains a priority in the industry for the development of safe, effective, and usable medical devices. Despite the challenges, the industry respects the rules and values user recommendations [8]. Figure 3: The user-centered design process. Participatory design aims to develop products with the participation of end users in order to capture information and user feedback at each stage of the design and development process. These participatory design approaches try to better understand real users. Designing easy to use products is essential [10]. Studies have shown that user research can be conducted in a rigorous way, and this type of research is necessary if we are to demonstrate the benefits of adopting user-centered principles for medical device developers. When developing any new medical device, the user requirements must be correctly specified. This will increase the likelihood of producing a device that is also easy and satisfying to use. These processes are a risk from a business point of view, as developing a new medical device is expensive. Therefore, it is essential that the correct device is developed and that this device is safe and meets the needs of users [27].