"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.

​ Rebecca Lee ​ At the 2024 HFES (International Human Factors Symposium), Laurie and Jan shared key study design considerations for testing

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,...

Discusses the meaning of "worst case scenarios" and provides guidance on selecting scenarios for usability testing of medical devi

This blog discusses the need for realism, types of stress, techniques for simulating stress, limitations of the techniques, and ethical cons