"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.

Read about Beth Loring's and Elizabeth Johansen's work on applying human factors engineering methods to design for under-resourced settings.

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

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