On Thursday, January 29th, at 2pm ET, MDMA will
host an important Member-Only (no cost) webinar, "The Innovative World of 3D Printed Medical Devices, IP and FDA Considerations - What you Need to Know", hosted by Wiley Rein, LLP
MDMA Members can view the archived audio version of this webinar by clicking here.
3D printing technologies have opened up the capabilities for customization in a wide variety of applications in the medical field. 3D printing, also known as additive manufacturing, 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.
Additive manufacturing is just beginning to enter mainstream use in medical devices. This technology unlocks new avenues for creativity and innovation for medical device designers. FDA is working through some of the technical issues that this ever changing technology poses given this technology sometimes challenges the way the Agency has traditionally evaluated the safety and effectiveness of medical devices. FDA has begun to receive numerous submissions using additive manufacturing for both traditional and patient-matched devices and therefore as a result held a public workshop in order to discuss technical challenges and solutions of 3D printing. This webinar will discuss the current FDA regulatory landscape as well as other issues may be on the horizon as the FDA poses future an evaluation for future submissions.
3D printing also raises new issues in seeking intellectual property protection and policing intellectual property. 3D printed medical devices may be very similar to patented devices, and in fact could infringe existing patents depending on how the claims are worded. 3D printed products may also infringe on trade dress or trademark rights or copyright rights. This webinar will address the impact of 3D printing on forms of intellectual property and address strategies for protecting intellectual property.
The webinar will review these and other key topics and answer the following questions:
- How does 3D printing of medical devices impact different types of intellectual property?
- When determining which type of protection to seek, what factors related to 3D printing should IP counsel consider?
- What steps should counsel take to police and protect IP in light of 3D printing of medical devices?
- An overview of 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.