Systems thinking and designerly tools for medical device design in engineering curricula.

Background: In this paper we focus on medical device development (MDD) in Industrial Design Engineering (IDE) academia. We want to find which methods our MDD-students currently use, where our guidance has shortcomings and where it brings added value.

Methods: We have analysed 19 master and 3 doctoral MDD-theses in our IDE curriculum. The evaluation focusses around four main themes: 1) regulatory 2) testing 3) patient-centricity and 4) systemic design.

Results: Regulatory aspects and medical testing procedures seem to be disregarded frequently. We assume this is because of a lack of MDD experience and the small thesis timeframe. Furthermore, many students applied medical-oriented systemic tools, which enhances multiperspectivism. However, we found an important lack in the translation to the List of Specifications and to business models of these medical devices. Finally, students introduced various participatory techniques, but seem to struggle with implementing this in the setting of evidence-based medicine.