Why Human Factors Matter Accuracy alone does not determine whether a physiological monitoring device performs well in real-world use. Human factors studies evaluate how users interact with a device during normal operation. They confirm that the device can be used correctly and repeatedly under the conditions reflected in its claims. For medical device manufacturers, this work strengthens the evidence package by showing that performance is achievable under realistic workflo

Wearable medical technology is reshaping diagnostics, monitoring, and chronic disease management. But clinical trials for wearables face unique challenges. At Parameters Research Lab , we help guide sponsors through the nuances of testing and validating wearable devices in the current regulatory landscape. 1. Accuracy Validation Across Skin Tones and Conditions From pulse oximeters to cuffless BP monitors, sensor accuracy must hold across diverse skin tones, body types, an