## 1 Introduction
### Design Process
Models are continually changing, yet the foundation of the design process is constant. There are two well-known models: one proposed by [PERSON] and [PERSON] and the other developed by [PERSON]. Both are configured around engineering design, as they are used for the development of medical devices. Both posit that medical devices are products that have to be manufactured because at the end of the day, they are needed and have a more technical vision. [PERSON] and [PERSON]'s model allows the designer to become fully aware of the needs and environments within which they operate; it also gives the designer time to discuss their design with the end-users before the conceptual design phase. [PERSON]'s model fundamentally assumes that the process begins at one end and progresses straight to the final result; [PERSON] incorporates manufacturing into the design process. While these models are essential, they focus on visualizing the process but not the activities [16]. Since 1990, designers have explored design thinking and practice. The pioneers of this were the IDEO design studio at the Stanford University School of Design; they tried to map the process in different ways: rounds, cycles, double diamond, etc. However, there are two fundamental values or principles that they could not avoid: design thinking must primarily be human centered, beginning with the user's needs and then proceeding to the creative stage [17]. The design process has been described as a problem-solving activity [18]. This is typical of the first generation of design methods. The idea of human needs and the subdivision of the process were the natural way to approach a design problem, as described in Figure 1.  
Today, the traditional design scheme is implemented in product design [19]. This method is a linear process consisting of researching the design requirements, defining concepts, developing the design of the product itself, manufacturing it, and launching it on the market, as shown in Figure 2. However, such a scheme has notable shortcomings, notably the lack of definitions for prototypes based on adaptation to the requirements and needs of its end user and the lack of an evaluating stage for the usability of the product itself. For [PERSON] [20], the traditional design process, also understood as form-oriented design, has the creation of mass-produced functional objects based mainly on quantitative data as its main objective. On the other hand, the user-centered design process presents an alternative path where, beyond defining design requirements, designers seek to understand and explain the actual users of the products to be designed and their needs and context of use. Once these variables are established, user testing allows the design to be redefined based on the end-user requirements and prototypes produced before manufacturing, as shown in Figure 3.  
User-centered design focuses on generating practical and attractive proposals for its users and on creating aesthetically pleasing and functional objects. Its main objective is to provide a great user experience, basing its indicators on quantitative data and in-depth ethnographic studies of the profiles of users who interact with the product under development and the understanding of the requirements that may be needed [21]. Figure 1: Design as a process to solve human needs. Figure 2: Design as a linear process. Based on the above, we can conclude that user-centered design seeks to generate products that improve the quality of life of the user by exploring their ethnographic diversity. Thus, the user-centered process aims to drive innovation and tends towards smaller consumption niches [22]. This method of implementing the design process provides humanistic aspects, commercial objectives, and a renewed vision of the execution process for designers. Traditional design processes mainly address the typification of users in three groups.