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David J Gilmore

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Usability engineering for a complex, medical device: a case study of an MR-Linac

David J Gilmore & Ashleigh Shier
Elekta, Sunnyvale, CA, USA & Healthcare Human Factors, Toronto, Canada
Proceedings of Contemporary Ergonomics and Human Factors 2019. Eds. Rebecca Charles and David Golightly. CIEHF

2019

Proceedings of Contemporary Ergonomics and Human Factors 2019. Eds. Rebecca Charles and David Golightly. CIEHF
This paper summarises the activities required and complexities encountered while undertaking the usability engineering process for a large, complex, and new-to-the-world medical device – namely Elekta Unity, the first high field Magnetic Resonance (MR)-Linac.
Elekta Unity is the world’s first high-field MR-Linac, enabling real-time viewing of diagnostic quality images during daily delivery of radiation therapy in cancer treatments. This means that changes in the tumor’s size or position can be more easily seen and treatments adapted to enable much greater precision in the delivery of the harmful radiation. As a potentially harmful medical device Elekta Unity requires a complete usability engineering process in order to acquire various regulatory approvals (e.g. 510K from the US government Food & Drug administration (FDA), CE Mark for Europe). Although we have previously presented the design work that lies behind Unity (Jenkins et al., 2017), in this case study we wish to share our experiences completing the usability validation. Our simple goal was to conduct an evaluation of the usability of all critical tasks (embedded in coherent, complete usage scenarios) for all relevant user groups on a production-equivalent system with production-ready training, thereby demonstrating that the product is safe and effective for use in clinical treatments. Most published accounts of this usability validation have tended to focus on relatively simple devices such as insulin pens and infusion pumps. To our knowledge there have not been (m)any accounts of usability validations for complex, multi-user medical devices.

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