While safety and efficacy is a predominate reason for using human factors tools in medical device design, a recent article in MDTmag written by Daniel Jenkins and Paul Draper, brings up the point that “Human Factors is not simply a tool for regulatory compliance” — fully integrating human factors tools and techniques into design and development brings a design to market that has a competitive advantage.

Jenkins and Draper suggest looking at the medical device as part of a system. By doing so, this guides the design development focusing on safety and effectiveness, while concurrently looking at the user interface, efficiency, usability, flexibility. When the user interface is examined, you may find those opportunities to build in features in the design like easy to read indicators, connections and guides to reduce the risk of error and adverse events in manufacturing and with the end user. Design teams taking this comprehensive approach will be best at bringing devices to market with new breakthrough features never before considered. To learn more, check out the Jenkins and Draper article here.

Need help with integrating human factors into your medical device development, or assistance in designing or executing a usability study? Contact our staff at Pearl for their expert advice.