Surgery (St Vincent's) - Theses

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    Tackling regulation “In situ”: A model for approaching regulation during a 3D bioprinting pre-clinical research translation program
    Mladenovska, Tajanka ( 2021)
    3D bioprinting uses the techniques of additive manufacturing, but includes living cells, with the goal of creating living 3D tissues for modelling disease or for patient implantation. This ongoing technological revolution presents a major challenge for regulators as the current regulatory frameworks are designed for mass manufactured, standardised devices, and as such are not suited to 3D bioprinted, individual-specific devices, often using the patient’s own cells. The aims of the project were to identify and highlight the challenges of regulating 3D bioprinting technologies, and to develop an approach and the relevant tools that researchers could use for integrating regulatory considerations into the development pipeline for a 3D bioprinting device during a research translation program. By using the Axcelda (formerly known as the Biopen) project example and associated publications, this research highlighted several areas of commonly missed opportunity to consider and integrate relevant regulatory requirements into the initial academic study design. These included both general and specific considerations such as the generation of technical and regulatory documentation to better outline the existing product and components, initial critical ingredient identification and safety profiling, risks and regulatory strategy, as well as to incorporate additional specific biocompatibility testing into early pre-clinical studies, among other considerations. Doing so demonstrated the potential of this process to lead to better designed, faster and more efficient studies (from a regulatory perspective), thus increasing the potential for successful translation into a commercial product.