Human Factors Validation for an Upgraded LED Phototherapy Device
5 September 2024
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.
Discover more
Consequences of Excluding Human Factors Engineering from Medical Device Development
Problem Statement: During the development of the Near Infrared Spectroscopy (NIRS)–based diagnostic device - a spinal implant sensor system for tissue oxygen monitoring, the team...
Ensuring Cost-Effective Large Animal Testing for a Spinal Cord Implant
Introduction: Class III products are considered to have the highest risk. They are typically invasive, connecting directly with the central circulatory or nervous system, or...