3D Systems announced its point-of-care additive manufacturing (AM) solution was used to design and produce the world’s first Medical Device Regulation (MDR)-compliant, 3D-printed PEEK facial implant. This was done in collaboration with the University Hospital Basel in Switzerland.

Prof. Florian Thieringer and Dr. Neha Sharma, together with their team of biomedical engineers, designed and manufactured a custom device to address a patient’s unique need using 3D Systems technology and product manufacturing expertise. Production of the first MDR-compliant facial implant was completed using Vestakeep i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED.

The printer’s cleanroom-based architecture and simplified post-processing workflows allow efficient production of patient-specific medical devices right at the hospital.

According to Market Research Future, the 3D-printed maxillofacial implant market size was estimated at over $2 billion in 2024 and is expected to more than double to over $4 billion by the end of 2034.

“The rapid adoption of the EXT 220 MED by leading healthcare institutions combined with our expanding applications pipeline, underscores the transformative power of 3D printing in clinical settings,” said Stefan Leonhardt, Ph.D., director, medical devices, 3D Systems. “We are proud to collaborate with the pioneering clinicians at University Hospital Basel and other leading hospitals worldwide to expand the applications that can be addressed with additive manufacturing. Since its launch in August 2023, our innovative solution has already been utilized in more than 80 successful cranial implant surgeries at partner hospitals, demonstrating its swift integration and real-world effectiveness in delivering personalized patient care. The successful use of the EXT 220 MED for maxillofacial implants showcases our commitment to ongoing innovation that delivers personalized healthcare solutions for new applications.”

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