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

Our approach is practical, collaborative, and focused on what matters most: helping medical device manufacturers develop medical devices that can be used safely and effectively by the people they are designed for.

Whether you are preparing for a formative usability study, human factors validation test, or regulatory submission, we can support your team with accessible and experienced human factors expertise. All our services are in 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.

When you work with Human Factors Insight, we don’t just work for you, we work with you. That is 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 every patient, caregiver, and healthcare professional.

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 discover our services in more detail.

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