Human Factors Validation for an Upgraded LED Phototherapy Device

Introduction: 

In the rapidly evolving field of medical device technology, even minor updates can significantly impact user interaction and safety. A medical device company sought our Human Factors expertise for their LED phototherapy device, which had undergone a substantial upgrade, including a new light engine, power supply, and controller. Although the updated design preserved the core user interface with only minor modifications to the Instructions for Use (IFU), the need for a comprehensive Human Factors (HF) validation study was initially overlooked.