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1,560
2024-03-01 to 2024-08-31
Collaborative R&D
Additive Manufacturing (commonly referred to as 3D-printing) is widely considered to be a key future enabling technology for customised healthcare devices and personalised medicine due to its increased design freedom and cost effectiveness for manufacturing small quantities, including one-off designs. However, the translation of research and innovation in this field into clinical use has been very slow. Key reasons for this include the lack of clinical evidence, comprehensive material-processing data and standardisation, which are essential in healthcare. The proposed network will support regulatory guidelines and decisions concerning Additively Manufactured healthcare solutions. This will include standard mass-produced and custom-made medical devices, as well as combinatory devices that include medicinal or biologic components (e.g. drug eluting devices). Both in-house (e.g. in hospitals) and external manufacturing will be considered. The increasing accessibility of Additive Manufacturing (e.g. through low cost, desktop printers), and the move towards decentralised production (e.g. in clinical settings) has enabled more healthcare professionals (and in some cases, patients) to participate in the design and manufacture of devices. An increasing number of companies are entering the market who have enabling technologies but no previous experience in healthcare applications and regulation. With more manufacturing vendors and varied operator backgrounds, it is increasingly challenging to ensure adequate adherence to quality standards and good manufacturing practices that are still evolving for these emergent techniques. Furthermore, since Additive Manufacturing offers greater potential for personalisation of devices (patient-matched and custom-made), then the relative liabilities for device safety and effectiveness become less clear between healthcare professionals specifying devices and the manufacturers designing and producing them. Given this increased multi-stakeholder complexity in responsibilities for quality and regulatory conformance, this network unites the varying expertise to collaboratively support the establishment of informed regulatory procedures that will accelerate the introduction of innovative, evidence based Additive Manufacturing solutions. The network will also identify requirements for training and knowledge exchange, building on expertise within the core network team.