Clinical maturity of 3D printing and bioprinting technologies: A systematic analysis of clinical trials across medical applications
3D printing and bioprinting technologies are increasingly being integrated into clinical research and healthcare, enabling the development of patient-specific medical devices, anatomical models, and bioengineered constructs. This study analyzes registered clinical trials in ClinicalTrials.gov to characterize the current clinical landscape and relative degree of clinical maturity of medical 3D printing and bioprinting technologies across different application domains. Search terms included 3D printing, bioprinting, additive manufacturing, patient-specific devices, surgical guides, scaffolds, and biofabrication. Eligible studies involved human subjects and clinical applications related to diagnosis, treatment, surgical planning, or rehabilitation. The identified trials (ca. 700) were categorized into four main domains: patient-specific anatomical models, disease models, orthoses and assistive devices, and implantable prostheses and regenerative scaffolds. Anatomical models represent the most extensively translated application, with widespread use in surgical planning, procedural simulation, and patient communication across multiple specialties. Orthoses and assistive devices also account for a substantial proportion of studies, reflecting the growing adoption of digital workflows for personalized rehabilitation solutions. Implantable prostheses and scaffolds constitute a rapidly expanding area, particularly in orthopedics and maxillofacial surgery, where customization improves anatomical fit and functional outcomes. In contrast, bioprinting-based disease models and regenerative constructs remain limited to early-stage clinical investigations. Overall, the distribution and design of clinical trials reveal a gradient of translational development, with mechanically driven applications showing broader clinical adoption than biologically complex systems. Continued advances in materials, manufacturing processes, and regulatory frameworks will be critical to support large-scale clinical validation and broader implementation of these technologies in personalized and regenerative medicine.
