ACS Biomater Sci Eng. 2023 Nov 20.
The field of craniomaxillofacial (CMF) surgery is rich in pathological diversity and broad in the ages that it treats. Moreover, the CMF skeleton is a complex confluence of sensory organs and hard and soft tissue with load-bearing demands that can change within millimeters. Computer-aided design (CAD) and additive manufacturing (AM) create extraordinary opportunities to repair the infinite array of craniomaxillofacial defects that exist because of the aforementioned circumstances. 3D printed scaffolds have the potential to serve as a comparable if not superior alternative to the "gold standard" autologous graft. In vitro and in vivo studies continue to investigate the optimal 3D printed scaffold design and composition to foster bone regeneration that is suited to the unique biological and mechanical environment of each CMF defect. Furthermore, 3D printed fixation devices serve as a patient-specific alternative to those that are available off-the-shelf with an opportunity to reduce operative time and optimize fit. Similar benefits have been found to apply to 3D printed anatomical models and surgical guides for preoperative or intraoperative use. Creation and implementation of these devices requires extensive preclinical and clinical research, novel manufacturing capabilities, and strict regulatory oversight. Researchers, manufacturers, CMF surgeons, and the United States Food and Drug Administration (FDA) are working in tandem to further the development of such technology within their respective domains, all with a mutual goal to deliver safe, effective, cost-efficient, and patient-specific CMF care. This manuscript reviews FDA regulatory status, 3D printing techniques, biomaterials, and sterilization procedures suitable for 3D printed devices of the craniomaxillofacial skeleton. It also seeks to discuss recent clinical applications, economic feasibility, and future directions of this novel technology. By reviewing the current state of 3D printing in CMF surgery, we hope to gain a better understanding of its impact and in turn identify opportunities to further the development of patient-specific surgical care.
Keywords: 3D printed medical devices; FDA regulation; additive manufacturing; biomaterials; bone regeneration; craniomaxillofacial surgery