Background
Di is the subject matter expert for usability engineering. She specializes in FDA interactions and usability testing strategies, development of usability engineering file(UEF), risk analysis, medical and regulatory writing, review and analysis of pre-clinical and clinical data, usability engineering process, design of usability study as well as usability study as part of a clinical study, regulatory and engineering review of labeling materials. Di advises and designs usability studies for medical devices and combination products across all therapeutic areas. Di also specializes in regulatory submission, digital health regulatory affairs, and software documentation review.
Di is fluent in Mandarin Chinese and German. She is capable of working with our international clients and review technical documents directly in these two languages, which largely improves efficiency and reduces chance of errors from translations.
Education
Di received a Master of Science in Engineering degree from the Johns Hopkins University in Bioengineering. Her graduate research focused on medical devices development in spine and neurosurgery space. She received her Bachelor of Science degree from the University of Virginia, with double major in Mechanical Engineering and Philosophy, and a minor in material Science. Di is currently pursuing a part time law degree from the Northwestern Pritzker School of Law.
Experience
Di is an engineer by training, with 4 years of experience in medical device usability engineering and 6 years of experience in technology law and regulations.
Prior to joining MCRA in 2022, Di worked in international patent prosecution, strategy, and innovation management consulting, where she gained profound experience in legal and regulatory strategies. She has medical device innovation and development experience from working in R&D team at the Center of Bioengineering Innovation and Design at Johns Hopkins University, where she had more than 300 hours of surgical shadowing experience and participated in usability study designs in different stages of medical device development cycle. Her projects have won 1st prize in the Johns Hopkins Healthcare design Competition among more than 120 submission worldwide, and 2nd place in the Hopstart Venture Challenge.
Currently, Di also serves as a part time lecturer at Johns Hopkins Center of Bioengineering Innovation and Design (CBID). She designs and teaches lectures and workshops on medical device regulations, usability engineering, and intellectual property for the graduate degree program in Bioengineering.
Overview
At MCRA, Di leads the Human Factors and Usability Engineering service. Her work spans the full spectrum of Human Factors and Usability Engineering support from early-stage concept development to regulatory clearance or approval across all therapeutic areas.