How Does Modeling Humans as System Elements Influence Architectural Trade-Off Decisions?

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.