Dan Nathan-Roberts, an associate professor in the Industrial and Systems Engineering department, has spearheaded a unique industry-academic partnership to advance medical device safety assessment. This collaborative effort is between Dr. Nathan-Roberts’ Human Factors and Engineering (HFE) research laboratory and Userwise, Inc., a Silicon Valley-based company that conducts usability validation testing for medical products and consults manufacturers on receiving Food and Drug Administration (FDA) approval. Together, the two have recently been granted a $401,000 grant from the FDA to improve and streamline this process.
The FDA requires high-fidelity simulated use of a medical device by its intended users prior to its release to the market. To make simulation as representative of real life as possible, participants are trained to use a device, dismissed for a certain period of time, and asked to return to complete usability validation. This waiting period, which can range from days to weeks, is built into the study to take into account “training decay,” a hotly debated aspect of the study amongst usability practitioners. Currently, though, there is a lack of concrete methodology for identifying an appropriate and suitable training decay period and evidence for any theory is insufficient.
Nathan-Roberts, along with Userwise and graduate student Kelli Sum (BS, MS), intends to address this gap by conducting a usability study that reveals generalized training decay curves and standardized methods for medical device testing. Userwise has even assembled a consortium of volunteer industry advisors (Pfizer, Abbott, J&J) that will provide feedback and serve as a channel for sharing findings of the study to industry.
Nathan-Roberts previously worked as an ORISE fellow in the FDA’s Center for Devices and Radiological Health and was one of the founding members of the home healthcare standards committee. His research group focuses on patient-centered healthcare and design primarily for the home environment. Kelli Sum, a College of Engineering alum and former Davidson Scholar, returned from working in industry to earn her Master’s and do research with Nathan-Roberts. With the grant, they hope to ultimately improve user error identification in medical devices while avoiding an undue toll on manufacturers and delays in getting life-improving innovative products to patients.