Integration of human factors and ergonomics during medical device design and development: It's all about communication

• The aim was to understand the constraints under which medical device design and development take place.
• A thematic analysis was conducted based on 19 semi-structured interviews.
• Barriers to designing for safety and usability were identified. They included deficits in communication.
• The barriers to communication were both internal and external to the development process.
• We recommend the use of mediating representations such as personas and scenarios to address barriers to communication.

Manufacturers of interactive medical devices, such as infusion pumps, need to ensure that devices minimise the risk of unintended harm during use. However, development teams face challenges in incorporating Human Factors. The aim of the research reported here was to better understand the constraints under which medical device design and development take place. We report the results of a qualitative study based on 19 semi-structured interviews with professionals involved in the design, development and deployment of interactive medical devices. A thematic analysis was conducted. Multiple barriers to designing for safety and usability were identified. In particular, we identified barriers to communication both between the development organisation and the intended users and between different teams within the development organisation. We propose the use of mediating representations. Artefacts such as personas and scenarios, known to provide integration across multiple perspectives, are an essential component of designing for safety and usability.