Comparing Perceptions of Human Factors - Priorities of Cardiologists and Biomedical Engineers in the Design of Cardiovascular Devices

Abstract: This study aimed to understand perceptions of Human Factors (HF) within the Product Development Process (PDP) of catheter-based cardiovascular therapies. Attitudes of biomedical engineers were compared to those of the clinicians who use these devices. The main objectives were to:1.Determine how Engineers and Cardiologists perceive HF impact on user experience.2.Gain an understanding of how various design factors affect the user experience. 3.Identify Engineers’ familiarity with HF resources and understand what HF data they seek during the PDP.By identifying and later filling data gaps and barriers to optimise design, these findings can improve how HF is implemented during the PDP, leading to improved user experience and better patient outcomes.MethodsData were gathered from 57 Biomedical R&D Engineers and 20 Interventional Cardiologists via questionnaires and semi-structured interviews. An online form was distributed at an internal medical device company Global Catheter Summit during November 2023 targeting engineers with experience developing catheter-based devices. Data from Cardiologists were gathered across two in person events between February and April 2024. Parameters to gauge specialty and experience were gathered from both cohorts (Engineers & Interventional Cardiologists). Quantitative data were gathered in Excel and statistically analysed using SPSS. Qualitative data was thematically analysed using NVivo. DiscussionThe results highlighted that the Engineers’ priorities in the PDP differ from the prioritised needs of the Cardiologists, but both groups identified grasps/manipulations as important factors influencing user experience. Engineers focused on the factors specific to the device itself – they believe the device is what the user cares most about, however, the Cardiologists ranked the impact of having multiple operators and what surgical access site is being used highly, pointing to the importance of considering use scenario and environment. 75% of Engineers strongly agreed with the statement “I feel user centred design is important when developing a new product”, indicating that project teams place value on HF activities but there are several challenges in implementing these. Engineers often struggle to find the data and expertise they need to implement HF activities in a meaningful and impactful way, without compromising on timeline, budget, and other product development activities. Of those who identified themselves as R&D or Design Engineers 69% (N=33) struggled to find the data they wanted. User specific and context specific data, torque strength and dynamic force data were highlighted as key gaps in user data. Differences in priorities further underlines the need for user centred design, and implementation of an iterative design approach which engages the end user from design conception, to design implementation, and beyond.ConclusionOverall, both Engineers and Cardiologists respect the impact of HF on the optimisation of user interaction. They agreed on the need for further innovation to improve user experience for CBCD. Priorities of Biomedical Engineers during the design process differed from the prioritised needs of Cardiologists when using devices, however both cohorts felt manipulations required to operate devices is an important factor to consider during design. The Engineers reported a paucity of specific user related data regarding handle interaction in this field. There is a need for easily accessible literature reporting upon user force data for dynamic motion (i.e. torque, push and pull); force data for female users, and general human body measurements that are applicable to device design. This data can serve as an indicator of where academia and industry should focus their research efforts to improve the implementation of HF, and ultimately optimise the user experience.

Keywords: Human Factors in Healthcare, Interventional Cardiology, Product Development, User-Centred Design

DOI: 10.54941/ahfe1005076

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