Early Challenges in the Implementation of Automated CranialRebuild Freeware for Generation of Patient-Specific Cranial Implant Using Additive Manufacturing: A Pilot Project in Review

Traumatic Brain Injury (TBI) is a significant global health concern, particularly in low- and middle-income countries (LMICs) where access to medical resources is limited. Decompressive craniectomy (DHC) is a common procedure to alleviate elevated intracranial pressure (ICP) following TBI, but the cost of subsequent cranioplasty can be prohibitive, especially in resource-constrained settings. We describe challenges encountered during the beta-testing phase of CranialRebuild 1.0, an automated software program tasked with creating patient-specific cranial implants (PSCIs) from CT images. Two pilot clinical teams in the Philippines and Ukraine tested the software, providing feedback on its functionality and challenges encountered. The constructive feedback from the Philippine and Ukrainian teams highlighted challenges related to CT scan parameters, DICOM file arrays, software limitations, and the need for further software improvements. CranialRebuild 1.0 shows promise in addressing the need for affordable PSCIs in LMICs. Challenges and improvement suggestions identified throughout the beta-testing phase will shape the development of CranialRebuild 2.0, with the aim of enhancing its functionality and usability. Further research is needed to validate the software's efficacy in a clinical setting and assess its cost-effectiveness.