DEF CON 32 - 3DU Homo ex Machina - Lacey Harbour

The future of healthcare is precise, personalized, and involves point of care with a wide variety of applications. Each application has its own unique set of challenges that change based on risk and the stakeholders’ perspective. Foreseeing these challenges, in 2021 FDA issued the discussion paper 3D Printing Medical Devices at the Point of Care to expound upon pertinent challenges and request stakeholder feedback. Within this paper, the concept of the 3D Printing medical device production system (MDPS) as a medical device was presented. In this session, we will investigate the concept of the MDPS from the perspective of different stakeholders, the necessity of AI to make this in-hospital MDPS POC solution a reality, and the unique relationship the MDM and HDO must have to support the MDPS.