"The benefits outweigh the risk" is a frequently used justification by medical and combination device manufacturers to bring new devices to the market. However, is this justification good enough? Human Factors (HF) professionals, Beth Loring and Hollie Johnston, weigh in on the value of going above and beyond the minimum regulatory requirements to develop devices that are not just safe, but also successful and delightful to use.

Introduction With increasing awareness of the importance of gender inclusivity, the user research community should take time to reflect...

Think of the last time you interviewed someone, and they just responded with “yes” or “no.” We have all experienced an interviewee that...

We are developing the instructions for use (IFU) for an imaging device used by physicians. The client decided to conduct a small,...

The good news is that the FDA has published a report on the importance of observational research.

Last month at the 2017 International Symposium on Human Factors and Ergonomics in Health Care I organized a panel discussion to talk...