Defining user needs for a novel medical device: Multi-iocus transcranial magnetic stimulation

Abstract

Transcranial magnetic stimulation (TMS) is a technical device adopted for various purposes in medical treatment and research. The next version of TMS that is under development worldwide, multi-locus transcranial magnetic stimulation(mTMS), allows fast digital control on the stimulation. However, studies of user-centered design of mTMS are scarce, implying potential ignorance on usability issues. This study fills this gap by exploring, understanding and defining user needs, which is reflected as design requirements that reflects user needs through prototyping and iteration.

Two user groups of mTMS are involved in the user research process: the research users and the subject users. The requirements and needs of users are explored by means of interviews and contextual inquiry. The research user interview data are analyzed in depth through the thematic analysis and the analysis results are reviewed and modified through triangulation. Potential problems for subject users summarized from the research user studies are verified and further developed through follow-up interviews with subject users. Contextual inquiry is conducted by observing the medical application of TMS. A user journey map and TMS interaction model are established by analyzing contextual inquiry data. The virtual prototypes are built and then evaluated by the users, which result in additional user needs and complete design requirements. Insights and findings from user research are summarized as the final design requirements for the mTMS system and its specific units.

The study draws three significant conclusions. First, user-centered design is valuable in mTMS development as it reveals important user needs that have not been assessed in previous development processes. Second, the triangulation of thematic analysis is essential in user research. Finally, it is critically important to include diverse user groups in user research in medical device development and design processes.