3D Systems announced that in collaboration with the University Hospital Basel in Switzerland, its unique point-of-care additive manufacturing solution has been used to design and produce the world’s first Medical Device Regulation (MDR)-compliant 3D-printed PEEK facial implant.
Professor Florian Thieringer and Dr. Neha Sharma, together with their team of biomedical engineers, successfully designed and manufactured a custom device to address a patient’s unique need using 3D Systems technology and product manufacturing expertise.
They used this implant as part of a successful surgery completed at the hospital on 18th March, 2025. Production of the first MDR-compliant facial implant was completed using VESTAKEEP i4 3DF PEEK by Evonik on 3D Systems’ EXT 220 MED. The cleanroom-based architecture of the 3D printer and simplified post-processing workflows allowed for the efficient production of patient-specific medical devices directly at the hospital.
“Our goal is always to provide the best possible care for our patients,” said Prof. Thieringer. “Being directly involved in both the design and manufacturing of patient-specific implants — right here in our hospital — allows us to tailor treatments precisely to individual needs, respond faster, and improve surgical outcomes. The ability to produce implants on demand represents a new era in personalised care.”
For more than a decade, surgeons have used VSP surgical planning solutions that combine best-in-class digital workflows with the industry’s broadest additive manufacturing portfolio of printers and materials to deliver comprehensive patient-matched solutions. Bringing together surgeons, engineers, and technology in the clinical setting allows for the immediate development of patient-specific treatments, overcoming the limitations of standard medical devices. Subsequently, healthcare providers are improving outcomes, increasing efficiency, and lowering the cost of care4
“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 utilised in more than 80 successful cranial implant surgeries at partner hospitals, demonstrating its swift integration and real-world effectiveness in delivering personalised patient care. The successful use of the EXT 220 MED for maxillofacial implants showcases our commitment to ongoing innovation that delivers personalised healthcare solutions for new applications.”
It is expected that the use of 3D-printed facial implants will accelerate based on the availability of advanced technologies. According to Market Research Future, the 3D-printed maxillofacial implant market size was estimated at more than $2 billion in 2024 and is anticipated to more than double to over $4 billion by the end of 2034.
Additive manufacturing is disrupting this sector by enabling a more cost-effective, efficient solution. 3D Systems has worked with surgeons for over a decade to plan more than 150,000 patient-specific cases and additively manufacture more than two million implants and instruments for 100+ CE-marked and FDA-cleared devices from its world-class, FDA-registered, ISO 13485-certified facilities in Littleton, Colorado, and Leuven, Belgium.
