Personalized devices are here and, as we often see, the regulations are trailing the technology development. Global availability of additive manufacturing or 3D Printing has made customized devices much more readily available. In this session, industry experts will review the custom and personalized device space and how 3D printing is being utilized to make specialized devices tailored to a patient. The session will also cover the FDA's current thinking on the use of 3D printing for point of care manufacturing as well as the global framework being developed by IMDRF and how this will impact these devices.
Learning Objectives:
Provide an overview of custom and personalized devices currently available on the market
Provide an overview of FDA current thinking on 3D printing at POC
Gain an understanding of the outputs of the IMDRF working group on Personalized Medicine