Abstract

This work presents an interdisciplinary engineering framework and a collaborative digital platform supporting the design, optimization, and proof-of-concept validation of patient-specific surgical devices for maxillofacial applications. The proposed methodology starts from computed tomography images and integrates three-dimensional anatomical reconstruction, hybrid CAD modelling, material characterization, finite element analysis, topology optimization, and additive manufacturing within a unified collaborative environment involving surgeons and engineering specialists. The proposed workflow was validated through a proof-of-concept study performed on patient-specific additively manufactured anatomical replicas. A comparative evaluation between the conventional wafer-based workflow and the proposed device-based approach demonstrated the technical feasibility of the methodology, achieving sub-millimetric positioning accuracy together with an estimated reduction in operative time under identical simulated surgical conditions. Although these results do not represent clinically validated outcomes, they provide representative preclinical estimates supporting the effectiveness of the proposed engineering approach and establish a solid basis for future in vivo investigations. The principal contribution of this work lies in the methodological integration of clinical planning, engineering design, numerical validation, additive manufacturing, and multidisciplinary collaboration within a single digital framework. In addition, a novel patient-specific device for orthognathic surgery is presented as a representative case study demonstrating the applicability of the proposed methodology to the development of customized surgical solutions.

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