Dr. Christina Higgins has worked in the medical device industry for more than 10 years, primarily in the in vitro diagnostic device field. She currently serves as the Interim Executive Director for the Critical Path (C-Path) for Sickle Cell Disease consortium, supporting the consortium’s mission to accelerate medical product development for sickle cell disease. Dr. Higgins was previously Vice President of Clinical Diagnostics at OPKO Diagnostics. Dr. Higgins has been an author of several types of regulatory submissions for reference lab assays, point of care devices, and laboratory developed tests, including 510k, De Novo, Premarket Approval, and applications to support compliance with state laboratory standards and CLIA regulations.
Professor Higgins co-teaches LAW 577A Development & Innovation in Biologics, Devices, & Diagnostics during the Spring term.
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