Concept for Process Mining for smart Medical Device Development

Ongoing digitalization affects not only products themselves, but also the process of their development. Software tools and digital workflows generate a large number of events that are recorded in so-called event logs. Process mining uses these events and, among other things, allows conclusions to be drawn about the sequences of events during the development process. In this way, the process and the associated process model can be cross-checked and optimized. Especially in regulated areas such as medical devices, great importance is given to the traceability of the inputs made. In addition, there are further criteria to adapt process models individually, which can be of great benefit in the heterogeneous world of medical devices. This regulatory requirement cooperates well in context of process mining and the recording of event logs. In this paper, a concept for the application of process mining to optimize a customized process model for the development of smart medical devices is presented and evaluated by a case study. Furthermore, aspects could be uncovered that will be used to optimize and extend the concept in future research.