Human Factors Insight is a human factors and usability engineering consultancy specialized in medical device development.

We apply our knowledge of human factors research and design principles to help make medical devices safer and user-friendly. We have extensive experience ensuring regulatory compliance with international usability standards and notified bodies including ANSI / AAMI / IEC 62366, ISO 14971, FDA’s final guidance on Human Factors Engineering, MDR, and NMPA.

The team is led by Sheldon Pijpers, a leading human factors engineer in the field of medical device human factors and usability engineering. As part of his senior roles at previous HFE consultancies, Sheldon has organized, managed, and conducted numerous formative and summative usability tests on a global level. When you hire us, we don’t just work for you — we work with you. Senior human factors expertise, dedicated from project start to finish.

Our mission

We understand developing a medical device is costly and rigorous process. Therefore, our mission is to make usability and human factors engineering more accessible to medical device and pharmaceutical companies of any size. This mission is carried out by providing accessible and transparent usability and human factors consultancy services — all with the goal of developing safe, effective, and user-friendly products for the medical industry.

"Our mission is to make human factors and usability services accessible for medical device companies of any size"