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

Area of Science:

• Biomaterials Engineering
• Regenerative Medicine
• Regulatory Science

Background:

• Extensive long bone defects cause significant patient morbidity, potentially leading to amputation or disability.
• 3D-printed patient-specific implants offer regenerative solutions but face regulatory and translational research hurdles.
• Optimizing healthcare resource utilization and patient outcomes necessitates addressing these implementation barriers.

Purpose of the Study:

• To establish a consensus framework for advancing the regulatory compliance and clinical adoption of 3D-printed patient-specific bone implants.
• To identify key challenges and propose actionable strategies for the translation of these advanced orthopedic technologies.
• To foster interdisciplinary collaboration among stakeholders involved in the development and implementation of 3D-printed bone implants.

Main Methods:

• A multidisciplinary group of 29 experts convened for the Consensus Meeting on 3D-printed patient-specific Bone Implants (CoMBI).
• Key questions were discussed in expert interviews and categorized into fundamental research, preclinical studies, and clinical trials & implementation.
• Statements were synthesized, iteratively refined, and validated through open review following expert presentations and structured discussions.

Main Results:

• The consensus meeting generated 20 key statements providing a roadmap for regulatory and clinical translation.
• Key statements highlight the need for harmonized regulatory pathways and clear preclinical validation guidelines.
• Innovative trial designs for patient-specific implants and strengthened collaboration are crucial for overcoming barriers.

Conclusions:

• This consensus statement offers 20 actionable steps to accelerate the clinical application of 3D-printed patient-specific bone implants.
• Interdisciplinary collaboration is critical for standardizing implant development and navigating regulatory landscapes.
• Addressing identified barriers will bridge the gap between innovation and clinical practice, improving patient access to advanced treatments.