Design Thinking as a Complement to Human Factors Engineering for Enhancing Medical Device Usability

ABSTRACT Medical devices are indispensable in the diagnosis, treatment and management of disease. To enhance the usability of medical devices, human factors engineering (HFE) has been widely applied. While it takes into account human capabilities and limitations, the use of HFE in the design of medical devices has challenges that render its implementation incomplete, resulting in its potential not being fully exploited. This study examines the literature on HFE to identify gaps and review recommendations with regard to its application in the design of medical devices. The literature reveals that HFE tends to place emphasis on the reduction of errors at the expense of medical device usability, that it has challenges in drawing on multiple perspectives, that it provides limited space for creativity and innovation, that it does not give adequate attention to contextual factors, and that communication barriers interfere with its implementation. The literature suggests that the shortcomings of HFE are methodological. To fill the gap, we propose the use of design thinking in HFE, not as a substitute but as a complementary approach, for enhancing usability. Design thinking, by virtue of being a human-centered approach, has the potential to add value to HFE by incorporating the subjective components of usability.