WHY
Smart Medical Device manufacturers tend to invest more resources on the technological aspects while overlooking the usability of their devices. This is because usability tests are notoriously costly (due to the production of functional prototypes and the test themselves) and are considered less critical than ensuring the proper functioning of the product. However, literature shows that device usability issues are among the most frequent causes of market recalls of medical devices. This is particularly relevant in the field of Home Care, where users are frequently non-expert and impaired and devices integrate advanced functions that require appropriate levels of expertise and dexterity.

WHAT
The Potential Usability Module is a toolkit to conduct a pre-prototype usability assessment of a Smart Home-Use Medical Device at early stages of the R&D Process. As the name suggests, it evaluates the potential usability of a device, because it is to be used to assess wheter a product idea is viable enough to proceed with the realization of a functional, testable prototype. It is composed of three tools: the Context of Use Identikit, the Concept Criticalities Map, and the User-Device Interaction Table. However, the second version still presents room for improvements, and developing a third was left to future research.

HOW
The entire process that brought to the definition of The Potential Usability Module and its tools is based on the Design Thinking Framework. After investigating current medical devices R&D processes, the Home Care Context of Use (ISO 9241-11:2018), and the laws of User-Product Interaction, two versions of The Potential Usability Module were designed and evaluated (the first version through expert reviews and the second through a workshop).