Bringing Medical products to market safely with Emily Gorcenski

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 report
• FDA Medical Device databases
• FDA Guidance on 3D printed medical devices
• Elon Musk on Ventilators
• Dyson on Ventilators
• FDA Guidance document for N95 respirators designed for general public use
• Chinese masks recalled
• FDA guidance on biohacking
• USDS call for volunteers