Abstract
Medical device success is based on good design which enables it to fulfil its intended use specification effectively and safely. Human factors guidance provides recommendations for evaluation efforts to meet safety, efficacy, and user experience requirements. The heterogeneity of medical devices leads to varied and subjective interpretations of these guidelines. This creates a variability in selection of usability and user experience evaluation methods leading to a knowledge-practice gap. This thesis pragmatically examines the design process of medical devices with a focus on factors that influence effective design evaluation practices.By leveraging a mixed methods approach, the studies were designed to explore the human factors guidance, stakeholders’ perceptions and the popular usability and user experience evaluation methods to provide an insight into the application of these methods and what they measure. This was achieved through a series of survey studies, secondary data analysis of a user satisfaction survey and an exploratory usability testing study of a medical device prototype in a high-fidelity environment.
The findings indicate a preference for usability over user experience, a predominantly user centred approach in design practices and the end users’ willingness to take part in evaluation activities. Additionally, they reiterate the importance of human factors and context which determine appropriate methods and aspects measured. Standardized and custom questionnaires are efficient in capturing self-reported metrics on experiential perceptions and usability testing represents a recommended evaluation methodology due to its adaptability in assessing both usability and user experience.
The critical nature of medical device use necessitates user involvement in design processes to evaluate both objective usability performance and subjective user experience measures, ensuring device safety and effectiveness. Conclusions from this project confirm the invariable complexity of medical device human factors evaluation. However, designing usability evaluation strategies, which combine complimentary methods, facilitate a holistic view of both device performance and user perceptions on device use leading to efficient, usable and fail-safe medical devices.
| Date of Award | Sept 2025 |
|---|---|
| Original language | English |
| Supervisor | Raymond Bond (Supervisor), Justin Magee (Supervisor) & Kyle Boyd (Supervisor) |
Keywords
- medical device design research
- human-centred design
- useability testing
- patient safety
- human factors evaluation