Toward a Standard User-Centered Design Framework for Medical Applications of Brain-Computer Interfaces

The brain-computer interface (BCI) field has been growing rapidly, resulting in a wide variety of systems that use different technologies and paradigms to allow interaction between a person and the external world using brain signal responses. The complexity and diversity of BCI-based systems make it difficult to address their usability in a standardized fashion, therefore it is often difficult to correctly identify use-related errors, in order to elaborate robust metrics for improving the system design and to compare it with others. In addition, when a BCI system's final intended use is a medical application, it must comply with regulatory requirements governing the design process, risk management, and usability assessment in order to be validated and commercialized. Most early-stage BCI designs do not take such requirements into account, which leads to failure in translating functional prototypes into commercial medical devices for further clinical evaluation in advanced stages of the design. This paper proposes a unified framework for usability assessment of BCI design throughout the research and development (R&D) process using a user-centered approach. It focuses on providing a general guideline for BCI for medical applications, considering the risk management process mandatory for medical devices, in which usability is a key aspect for ensuring safety and performance.