Human factors in-clinic studies

In contrast to user studies, human factors assessments are qualitative. The question is not “how many people make an error?” but “why do they make an error – and is it linked to the user interface?” We enjoy working with clinical trial teams to create a bridge between clinical and human factors objectives and balance the needs of clinical study practice with the requirements of a usability study.

Our team understands the benefits of working closely with study monitors, medical science liaisons and study site staff. This enables us to plan in careful detail, before running studies in hospitals and clinics with the care and rigour we would bring to any validation study.

We have worked on several human factors in-clinic or actual-use studies, all of which have resulted in successful submissions or resolutions of a post-market requirement.

We work on studies where the users are sometimes healthcare professionals, sometimes patients. Our human factors experts attend investigator meetings and train nurses to be study observers. Most of all, we really enjoy the opportunity to work with the study participants and learn more about the real-world use of medical devices.