Evaluation of the Integration of Topological Optimisation in the Process Chain for Manufacturing Customised Orthopaedic Devices via Additive Manufacturing

Purpose: The effectiveness of the customised solutions compared to the conventional ones and the emergence of advanced production technologies, such as Additive Manufacturing (AM) techniques, strengthened the trend towards an enhanced individualization of the clinical treatments. In the present research, the value of topological optimisation (TO) in the manufacturing process of tailor-made orthopaedic appliance (upper-limb orthosis) was analysed. Methodology: From the morphology of a patient’s arm, orthotic models were developed. Nonparametric optimization (Simulia Tosca) was performed, based on the Finite Element Analysis (FEA) program (Abaqus), and contributed to the development of TO orthotic models with diverse levels of volume reduction fraction. The modelling and manufacturing framework for customising orthotic solutions was evaluated with a discussion on the feasibility of lightweight and high-performance products, encompassing production time and cost. Pilot products were produced with a Material Extrusion (MEX) printer. Findings: TO proved to be a practical and valuable approach for the advanced customisation of orthopaedic devices, offering lightweight solutions able to withstand stresses also during patient rehabilitation and remission. From the rapid prototyping perspective, specific strategies must be adopted to prevent the escalation of production costs and time. Originality: The research delves into the overall benefit of implementing an advanced modelling technique within the context of manufacturing highly customised orthoses, analysing how TO activity impacts the rapid prototyping process. Beyond product evaluation, the analysis explores broader implications, including the assessment of feasibility and the development of strategies for integrating the approach into clinical workflows and hospital settings.