"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.

At the beginning of September 2020 I attended the online forum “Digital Health and COVID-19: How COVID is Accelerating Home Use Devices”...

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