3D Systems announced that in collaboration with the University Hospital Basel (Switzerland) the Company’s 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. Prof. 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 March 18, 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 printer and simplified post-processing workflows enable 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 personalized 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. As a result, healthcare providers are improving outcomes[1],[2], increasing efficiency[3], and lowering the cost of care[4].
“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.”
It is anticipated that the use of 3D-printed facial implants will accelerate based on the availability of advanced technologies. According to Market Research Future[5], 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. As a pioneer in personalized healthcare solutions, 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.
[1]Ballard DH, Trace AP, Ali S, et al. Clinical Applications of 3D Printing: Primer for Radiologists. Acad Radiol 2018;25(1):52–65.
[2] Chepelev L, Wake N, Ryan J, et al. Radiological Society of North America (RSNA) 3D printing Special Interest Group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios. 3D Print Med 2018;4(1):11.
[3] Morgan C, Khatri C, Hanna SA, Ashrafian H, Sarraf KM. Use of three-dimensional printing in preoperative planning in orthopaedic trauma surgery: A systematic review and meta-analysis. World J Orthop 2020;11(1):57– 67.
[4] Ballard DH, Mills P, Duszak R Jr, Weisman JA, Rybicki FJ, Woodard PK. Medical 3D Printing Cost-Savings in Orthopedic and Maxillofacial Surgery: Cost Analysis of Operating Room Time Saved with 3D Printed Anatomic Models and Surgical Guides. Acad Radiol. 2020 Aug;27(8):1103-1113.
[5] Market Research Future, 3D Printed Maxillofacial Implant Market Research Report By Application (Craniomaxillofacial Reconstruction, Dental Implants, Orthognathic Surgery, Trauma Reconstruction), By Material (Titanium, POM, Polyether Ether Ketone, Glass Ceramics), By Technology (Stereolithography, Selective Laser Sintering, Fused Deposition Modeling, Computer-Aided Design), By End Use (Hospitals, Dental Clinics, Ambulatory Surgical Centers) and By Regional (North America, Europe, South America, Asia-Pacific, Middle East and Africa) - Forecast to 2034 (March 2025).
