Is User Experience a suitable goal in the development of medical devices?

Abstract

Product development in medical technology is largely governed by Regulatory Affairs. In contrast, for consumer products Human-Centred Design (HCD) is the guiding principle. Both approaches are laid down in international standards and overlap many aspects such as procedure, applied methodologies and development activities. For medical devices patient safety and therefore risk management is the guiding development goal. In HCD the focus lies on User Experience (UX), a positive experience throughout the entire product life cycle. The question arises whether UX could play a more important role in medical device development, particularly considering the similarities of the two development processes

Keywords

• human-centred design
• hcd
• iso 9241-210
• iec 62366-1
• mdr
• user experience
• usability
• product development
• risk management