AbstractThis paper presents a case study by the Biomedical‐Healthcare Model‐Based Systems Engineering (MBSE) Challenge Team in response to inputs received during workshops held at the 2015 and 2016 INCOSE International Workshops. At IW2015 and IW2016, the Challenge Team held workshops, including clinicians and systems engineers, to assess potential contributions of systems engineering, and MBSE, to clinical operations. At these workshops it was claimed that clinical operations were too complex to be modeled with existing MBSE tools from defense and aerospace. It was further claimed that there would be very limited value to MBSE products. Based on these claims, the MBSE Challenge team undertook several case studies to evaluate the ability of MBSE tools to represent clinical operations and to address problems relevant to healthcare. This paper describes the outcomes of applying one MBSE tool, the DoD Architecture Framework, to characterize clinical operations as the intended use environment for medical devices.
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