Integrate Usability Evaluation into Clinical Investigation: Why, When and How?

There is an increased interest in real-world usability data, especially various global regulatory bodies for Medical Devices emphasize the importance of clinical evaluation of the usability of the devices. As promising as the combination of clinical investigations in a real-world setting and usability evaluation can be, it is challenging in practice to combine these two well-established methodologies. This paper presents an exploratory study which asked why, when and how to conduct this type of combined study.