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The purpose of this webinar is to pull back the curtain and share how manufacturers can leverage lessons we learned on the journey to securing the world’s first FDA-clearance for a 3D-printed, patient-specific PEEK cranial plate solution. More importantly, the presentation will focus on how the clearance paves the regulatory pathway for other innovative additively manufactured PEEK implants. Register to hear insights directly from the innovator behind 3D Systems’ extrusion 3D printing technology for healthcare and the team’s director of regulatory affairs who is integral to establishing master files for devices (MAFs).  
 
Key topics include: 

  • Why the team doubled down on the EXT 220 MED and its ability to 3D print high quality implants in PEEK. 
  • How the team overcame multiple challenges to ultimately secure the first FDA clearance and what does the cleared process mean for future submissions. 
  • What experience and documentation can help manufacturers integrate AM and/or expand portfolios with PEEK and other high-performance polymers. 
  • What orthopaedic and spine applications can be 3D printed and how do modified PEEK materials, such as carbon fiber-reinforced PEEK or calcium phosphate/HA-enhanced PEEK help expand opportunities  

Register now to attend. During the webinar, we welcome you to submit your questions about the new 3D printing platform, materials, processes and applications as well as about navigating regulatory waters to accelerate your next innovation.  

Meet the Speakers...

  • Stefan Leonhardt

    Stefan Leonhardt, PhD | Director, Medical Devices, 3D Systems

    Stefan Leonhardt is Director, Medical Devices for 3D Systems. In this role, he leads the Company’s efforts focused on 3D printing with medical high-performance polymers. Stefan joined 3D Systems in 2022 through the acquisition of Kumovis, a company he co-founded with four colleagues in 2017. While at Kumovis, he and his colleagues developed the first 3D printing platform specifically designed for medical device production, now known as 3D Systems’ EXT 200 MED.

    Stefan studied medical engineering at the Technical University of Munich. He holds an MBA with a focus on digital transformation and new business models. Stefan also earned a Ph.D. for his work on material development for resin-based 3D-printing technologies for the development of bioreactors.

  • Ashley Dawson

    Ashley Dawson, PhD | Director, Regulatory, 3D Systems

    Ashley Dawson is the Director of Regulatory Affairs at 3D Systems, where she leads a global regulatory team and provides regulatory strategy for new and sustaining products. Ashley has 19 years of medical device experience in Regulatory and Clinical Affairs. She has been at 3D Systems for two years.

    Dawson received her PhD in Molecular Biology from the University of Texas at Arlington in 2003. Previous companies include Smith+Nephew and Alcon.