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

We apply our extensive knowledge of human factors research and design principles to help make medical devices safe, user-friendly, and regulatory-compliant. 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 companies, Sheldon has organized, managed, and conducted over a hundred formative and summative usability tests on a global level.

When you hire Human Factors Insight, we don’t just work for you — we work with you. That’s our core goal: 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. Because we believe safe, effective, and intuitive medical devices should be accessible to everyone.

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. Schedule a free consultation with our experts or request a quote to find out.

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