A B S T R A C TFor over ten years, metallic skeletal endoprostheses have been produced in select cases by additive manufacturing (AM) and increasing awareness is driving demand for wider access to the technology. This review brings together key stakeholder perspectives on the translation of AM research; clinical application, ongoing research in the field of powder bed fusion, and the current regulatory framework. The current clinical use of AM is assessed, both on a mass-manufactured scale and bespoke application for patient specific implants. To illuminate the benefits to clinicians, a case study on the provision of custom cranioplasty is provided based on prosthetist testimony. Current progress in research is discussed, with immediate gains to be made through increased design freedom described at both meso-and macro-scale, as well as long-term goals in alloy development including bioactive materials. In all cases, focus is given to specific clinical challenges such as stress shielding and osseointegration. Outstanding challenges in industrialisation of AM are openly raised, with possible solutions assessed. Finally, overarching context is given with a review of the regulatory framework involved in translating AM implants, with particular emphasis placed on customisation within an orthopaedic remit. A viable future for AM of metal implants is presented, and it is suggested that continuing collaboration between all stakeholders will enable acceleration of the translation process. fection or surgical complications [11][12][13].Currently, the majority of skeletal endoprostheses are produced from titanium (Ti) or cobalt chromium (CoCr) based alloys, which meet the criteria of durability, strength, corrosion resistance and a low immune response [14,15]. These characteristics however come at the cost of the high stiffness of these alloys in comparison to bone. Mismatch between the mechanical properties of bone and orthopaedic materials

The 3D printing process offers several advantages to the medical industry by producing complex and bespoke devices that accurately reproduce customized patient geometries. Despite the recent developments that strongly enhanced the dominance of additive manufacturing (AM) techniques over conventional methods, processes need to be continually optimized and controlled to obtain implants that can fulfill all the requirements of the surgical procedure and the anatomical district of interest. The best outcomes of an implant derive from optimal compromise and balance between a good interaction with the surrounding tissue through cell attachment and reduced inflammatory response mainly caused by a weak interface with the native tissue or bacteria colonization of the implant surface. For these reasons, the chemical, morphological, and mechanical properties of a device need to be designed in order to assure the best performances considering the in vivo environment components. In particular, complex 3D geometries can be produced with high dimensional accuracy but inadequate surface properties due to the layer manufacturing process that always entails the use of post-processing techniques to improve the surface quality, increasing the lead times of the whole process despite the reduction of the supply chain. The goal of this work was to provide a comparison between Ti6Al4V samples fabricated by selective laser melting (SLM) and electron beam melting (EBM) with different building directions in relation to the building plate. The results highlighted the influence of the process technique on osteoblast attachment and mineralization compared with the building orientation that showed a limited effect in promoting a proper osseointegration over a long-term period.

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The increasing demand for a wider access to additive manufacturing technologies is driving the production of metal lattice structure with powder bed fusion techniques, especially laser-based powder bed fusion. Lattice structures are porous structures formed by a controlled repetition in space of a designed base unit cell. The tailored porosity, the low weight, and the tunable mechanical properties make the lattice structures suitable for applications in fields like aerospace, automotive, and biomedicine. Due to their wide-spectrum applications, the mechanical characterization of lattice structures is mostly carried out under compression tests, but recently, tensile, bending, and fatigue tests have been carried out demonstrating the increasing interest in these structures developed by academy and industry. Although their physical and mechanical properties have been extensively studied in recent years, there still are no specific standards for their characterization. In the absence of definite standards, this work aims to collect the parameters used by recent researches for the mechanical characterization of metal lattice structures. By doing so, it provides a comparison guide within tests already carried out, allowing the choice of optimal parameters to researchers before testing lattice samples. For every mechanical test, a detailed review of the process design, test parameters, and output is given, suggesting that a specific standard would enhance the collaboration between all the stakeholders and enable an acceleration of the translation process.

Nanofibrous structures have morphological similarities to extracellular matrix and have been considered as candidate scaffolds in tissue engineering. Scaffolds made from electrospun fibers have potential in cell adhesion, proliferation and cell function. In this study, different percentages of graphene have been dispersed in a polycaprolactone-cyclopentanone solution to produce electrospun fibers. The microstructure and morphology of the fibers and the mechanical behavior of the electrospun systems were evaluated to analyze the influence of graphene content on the performances of the fibers. A significant dimensional difference between the fibers diameters of was obtained due to the graphene percentage. Accordingly, the mechanical properties of the fibrous systems are found to be influenced by the presence of the graphene. Rat stem cells were cultured on the fibrous scaffolds to evaluate the effect of the arrangement of the fibers on the morphology of the cells and differentiation into neurons. In particular, a higher population of dopaminergic neurons has been identified on the fibers with a higher percentage of graphene.

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