In new product development process, human aspects are often overlooked in favor of a focus on the technical design of the system of interest (SoI). This paper demonstrates the value of including stakeholders/users as part of the SoI. As an illustrative case study, a Healthcare Professional (HCP) is selected as a representative human actor interacting with the SoI, an autoinjector, in a clinical environment. Conceptualized and encoded using Model-Based Systems Engineering and traced to the architectural decisions table, the approach highlights the benefits of Human-Systems Integration in sociotechnical systems. The study shows that the inclusion of the HCP within the SoI significantly influence architectural decisions in MedTech product development.
Menshenin et al. (Tue,) studied this question.