Abstract
Technology has proliferated in medical devices recently, but user-friendliness has not kept pace. Human Factors and Usability(HF/U) gained more attention in the medical device industry much later than its counterparts. Medical devices developed without an emphasis on HF/U design could breed products that are not intuitive and difficult to learn and use. This eventually would give rise to errors leading to dire consequences. During the operation of a device, errors could hinder the effectiveness of treatments, monitoring, or diagnosis for a patient and, in some cases, contribute to death or permanent injury. Usability testing is critical to understanding the user interface of a device and mitigating product risks to the greatest extent possible. Due to the availability of various user groups, the environment of use, ethical approvals, and the costs involved, conducting multiple user trials in a healthcare setting is challenging. Clearly defined usability design guidelines with context in use help design better interfaces and identify usability problems early in the design process through frequent heuristic evaluations. To aid this process, we propose a framework for developing usability design guidelines from various sources within the medical device domain and other domains. Apart from literature, we gather insights from two key sources: 1) usability test reports through an industry case study and 2) adverse event reports from FDA’s online repository. Additionally, we explore the opportunity of incorporating usability in early design by introducing atypical scenarios based on clinical experiences. By doing so, it is possible to improve the tendency of medical device designers to emphasis usability in their designs much earlier in the design process. Furthermore, we consider popularly used guidelines and heuristics from Human-Computer Interaction domains to enable the positive transfer of designer’s knowledge with these popular guidelines. Finally, we present an initial set of usability design guidelines for medical device user interfaces developed based on the insights and the data collected. This thesis aims to lay the foundation for the future development of tailored usability design guidelines for specific medical device projects and platform needs.