Ti6Al4V mandibular devices by additive manufacturing: Assessment of as-built quality

Additive manufacturing (AM) represents a promising healthcare innovation. Clinicians need ready-to-use devices in short time, which means high as-built quality and low uncertainty. Medical devices need to respect stringent quality requirements ensuring safety and effectiveness. The medical practitioners often outsource the manufacturing to hub services. This study aims to assess the as-built quality of AM mandibular plate prototypes manufactured by direct metal laser sintering technology using Ti6Al4V alloy and highlights several challenges that emerge from using the commercial printing services where user does not have control over the actual manufacturing process. Verification of dimensions, morphology, surface finish and mechanical properties is conducted. Finite element analysis on computer-aided design (CAD) models was performed for stress analysis. Non-destructive analysis by micro-computed tomography (micro-CT) allowed measurement of the dimensions, ascertaining the dimensional accuracy in reference to the CAD models, and the presence of pores and internal defects, while destructive analysis allowed determination of the mechanical properties. Although no large internal defects were detected, some regions of micro-porosity and incomplete fusion of feed particles were observed. Accurate production of fine details was also a concern in the printed parts. The proposed framework establishes a structured assessment scheme, which could be useful for other AM medical designs and for stakeholders involved in AM for biomedical applications.