Emily Gorcenski is an American data scientist who has run trials for medical device software. We are living in an interesting time and facing a medical device shortage. Emily talks to Scott about how medical device regulation works as well the barriers and challenges. What kinds of medical devices exist and how are they categorized? How can we as technologists help in the current crisis?THERAC-25 reportFDA Medical Device databasesFDA Guidance on 3D printed medical devicesElon Musk on VentilatorsDyson on VentilatorsFDA Guidance document for N95 respirators designed for general public useChinese masks recalledFDA guidance on biohackingUSDS call for volunteers