Clinical translation of 3D-printed patient-specific bone implants: a consensus statement

Extensive defects in long bones, resulting from trauma, disease, or other etiologies, impose significant morbidity on patients and may necessitate amputation, long-term disability, or premature mortality. While three-dimensional (3D)-printed, patient-specific implants offer promising regenerative solutions, their clinical implementation remains hindered by regulatory challenges, lack of standardized guidelines, and gaps in translational research. Addressing these barriers is critical to improving patient outcomes and optimizing healthcare resource utilization.

A multidisciplinary group of 29 experts - including clinicians (surgeons, anesthesiologists), biomaterial scientists, biomedical engineers, legal/regulatory professionals, health economists, meta-researchers, artificial intelligence experts, trialists, and biomaterial industry representatives - convened for the Consensus Meeting on 3D-printed patient-specific Bone Implants (CoMBI). Preceding the meeting, key questions were discussed in individual interviews and categorized into fundamental research, preclinical studies, and clinical trials and implementation (CoMBI themes). Experts presented on each theme, followed by structured discussions. Statements were synthesized, iteratively refined, and validated through open review.

The consensus meeting resulted in 20 key statements addressing the CoMBI themes, outlining a framework to advance regulatory compliance and facilitate the clinical adoption of 3D-printed implants. Key statements include the need for harmonized regulatory pathways, clear guidelines on preclinical validation, and innovative trial designs tailored to complex, patient-specific implants. Strengthening collaboration among policymakers, regulatory agencies, and clinicians is crucial to overcoming current implementation barriers and ensuring equitable patient access to these advanced technologies.

This Consensus Statement presents 20 key statements across fundamental research, preclinical studies, and clinical trials and implementation, offering a roadmap for accelerating the regulatory and clinical translation of 3D-printed patient-specific bone implants. The findings emphasize the critical role of interdisciplinary collaboration in overcoming challenges, such as standardizing implant development and navigating complex regulatory landscapes. By addressing these barriers and outlining practical strategies, the consensus highlights actionable steps to bridge the gap between innovation and clinical application.