Human Factor Clinical Trials: Why Usability Matters in Medical Device Research

Human factor clinical trials evaluate not only whether a medical device functions correctly but also whether users can operate it safely and effectively. These studies are particularly important for devices that require direct interaction from patients or healthcare professionals. Human factor research typically consists of two phases: formative studies, which identify usability issues during device development, and summative (validation) studies, which confirm that the final device can be used safely by the intended population. Recruiting participants for these studies often requires highly targeted strategies, as participants typically need to already be using the medication administered by the device.