The process of developing a medical device has become increasingly complex, not least because of the Medical Device Regulation. Some of the associated changes affect in particular the software development companies. One of the challenges to provide safe software products is the usability engineering process. Adequate methods must be identified to find severe usability issues effectively and efficiently.
The aim of this study was a comparison of normative recommended formative evaluation methods.
Two expert-based methods and two user-based methods were compared regarding effectiveness in finding issues, the level of detail and the temporal effort.
The heuristics and the isometrics, both showed a significant advantage regarding the effectiveness and similarity in level of detail and temporal effort.
Based on this paper, the heuristics and the isometrics, both can be recommended, but further studies are necessary to consolidate this statement. Also, further methods should be considered, and more test persons must be involved to give an overall comparison of formative evaluation methods in the usability process of medical apps.
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