3D Printing and Innovative Medical Devices: Clarifying FDA Regulations & Identifying Strategies For Success
3D printing technologies have opened up the capabilities for customization in a wide variety of applications in the medical field. 3D printing turns traditional manufacturing on its head, moving from mass production to individual production and mass customization as some believe it is the perfect model for personalized medicine. Using bio-compatible and drug-contact materials, medical devices can be produced that are perfectly suited for a particular individual giving rise to many regulatory challenges for the FDA. The FDA is working through some of the technical issues that 3-D printing poses and has begun to receive numerous submissions using 3-D printing for both traditional and patient-matched devices. This presentation will discuss the current FDA regulatory landscape as well as the impact of 3D printing on forms of intellectual property and address strategies for protecting intellectual property.
• Identifying factors related to 3D printing that IP counsel should consider when developing a IP protection strategy
• Reviewing the current regulatory landscape for 3D printed medical devices and what challenges lie ahead for those seeking FDA clearance/ approval of these innovative devices?
• Understanding key takeaway messages and questions still posed from the recent FDA stakeholder meeting regarding 3D printing of medical devices.