Design for Usability of Complex Medical Devices: Leading a Technology-Push Innovation Towards User Acceptance

This study explores the applicability of usability design processes in the development of a complex medical device in order to enhance the marketability and user acceptance of such.

In healthcare, risk mitigation and prevention of potential use errors are the prevailing topics that need to be addressed throughout the development processes of medical devices. However, it is also acknowledged that medical device manufacturers ought to go beyond the mere functional and safety-related aspects of the device-to-be since potential customers also consult usability testing results before purchasing such systems. Yet, it remains unclear how and at what development stage manufacturers include the user perspective in their design iterations in order to enhance the system’s usability.

Through action research, this study investigates the approach towards product usability applied throughout the development process of a medical device manufacturer. Interdisciplinary usability workshops were conducted, involving designers and application specialists from within the company that represent future users of the device. These so-called user proxies are able to provide the input from a user perspective at several stages of the design process. It was found that device usability is considered as a crucial topic in order to detect and mitigate use errors as early as possible. Including user proxies in the development process is beneficial to receive feedback from internal professionals that come closest to future users of the system. However, it is challenging to translate user proxies’ insights directly into the development process due to the system’s complexity and technical constraints.

The study presents an outline of how to make the usability aspects fit into current development processes in order to increase user acceptance. It contributes to academia and practice alike as a starting point to further investigate how to integrate and standardize usability design processes throughout the development of medical devices.