Abstract
The medical device design process has a responsibility to define the characteristics of the object to ensure its correct interaction with users. This study presents a proposal to improve medical device design processes in order to increase user acceptance by considering two key factors: the user hierarchy and the relationship with the patient’s health status. The goal of this study is to address this research gap and to increase design factors with practical suggestions for the design of new medical devices. The results obtained here will help medical device designers make more informed decisions about the functions and features required in the final product during the development stage. In addition, we aim to help researchers with design process didactics that demonstrate the importance of the correct execution of the process and how the factors considered can have an impact on the final product. An experiment was conducted with 40 design engineering students who designed birthing beds via two design processes: the traditional product design process and the new design process based on hierarchies (proposed in this study). The results showed a significant increase in the user acceptance of the new birthing bed developed with the hierarchical-based design process.
Highlights
This study focuses on pointing out the importance of a new design processes for medical devices that can improve the characteristics of the product design and thereby increase user satisfaction
The main contribution of this new process focuses on showing medical device designers the importance of considering the hierarchy of users around a medical product and considering the fluctuation of the patient’s health status, since, depending on the progression of the disease, the patient needs the attention of various users
The results obtained here will help medical device designers and healthcare professionals understand the main trends in medical research and improve the design process
Summary
User-centered design in healthcare has been applied in different studies; research on this topic is limited. Best practices in the medical device industry increasingly seek informed innovation process developments. With the understanding of all stakeholders, industry leaders seek to maximize the effectiveness of their devices while reducing patient risk and the cost of execution to provide comprehensive solutions for both health and business [2]. Companies must be rigorous in their search for innovation, seeking the ultimate goal of developing new products more effectively and efficiently [3]. Profitable and systematic approaches are necessary for product development. They guarantee safe and effective devices for users, economic successes for manufacturers, and reliable and profitable investment for consumers [4]
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