A surgeon implants a hip replacement that was designed and manufactured specifically for that patient’s bone structure and activity level, using a process that takes place near the hospital rather than in a distant factory. This matters because current medical devices—especially joint replacements and other implants for musculoskeletal disease—are mass-produced to fit an average patient. Surgical variation and individual anatomy mean many devices perform poorly or fail early, and revision surgeries are costly and painful. The centre aims to replace that one-size-fits-all model with a closed-loop design-and-manufacturing framework that matches device function to each patient’s needs and the surgical environment. If successful, the approach could reduce device failure rates, lower the lifetime cost of implants, and speed up access to personalised devices. It would also strengthen the UK’s medical device manufacturing sector by creating new design tools, near-patient production methods, and a trained workforce. The research focuses on class 3 medical devices for musculoskeletal disease, but the underlying framework is intended to be adaptable to other implant technologies.
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The EPSRC Centre in Innovative Manufacturing in Medical Devices will research and develop advanced methods for functionally stratified design and near patient manufacturing, to enable cost effective matching of device function to the patient needs and surgical environment. This will deliver "the right product, by the right process to the right patient at the right time" to an enhanced standard of reliability and performance. The centre will research and develop: 1) Functionally stratified design systems, which will be initially applied to existing device manufacturing processes and subsequently to the manufacture of scaffolds, developing novel pre-clinical simulation methods, which match implant design to patient function, delivering a cost effective Stratified Approach for Enhanced Reliability (SAFER) 2) Innovative near patient manufacturing processes, enabled by stratified and individualised definitions of patient need, to provide a more cost effective approach to personalised devices. The two flagship challenges will be integrated with the key platform capabilities, across the centre to generate, for the first time, a closed loop design and manufacturing framework for medical devices to deliver enhanced performance and reliability. These innovative design and manufacturing advances will focus in the first instance on class 3 medical devices for musculoskeletal disease, where the cost of device failure and need for throughout life reliability are high. The National Centre will develop, lead and integrate an international network of industrialists, academics, clinicians and regulatory body representatives in order to support the musculoskeletal medical device manufacturing industry to deliver the innovative design and manufacturing challenges and implement the outcomes into manufacturing practice in a global highly regulated market. The Centre will create the research infrastructure, tools and methods, expertise and suitably qualified personnel to support continued innovation and growth of the medical device manufacturing sector in the UK. To do so, the Centre will work across the EPSRC priority research areas "Manufacturing the Future" and "Towards next generation healthcare," drawing upon capabilities and collaborating with existing centres of excellence. The Centre will provide a platform for fundamental innovative device manufacturing research and promote its rapid exploitation by industry through outreach and translation activities and a generic platform for diversification into other technologies. It will grow the UK's research capability in medical device manufacturing research to underpin the development of next generation medical devices and the development of high quality manufacturing processes to provide cost effective, reliable and effective devices. It will be applied to enhanced manufacturing of existing devices such as joint replacements and support manufacture of new products and biomaterial scaffolds. The Centre will operate across five leading academic centres of excellence in the field. The Centre will be led by Leeds University (Fisher, Williams, Ingham, Wilcox, Jennings and Redmond) and will be supported by collaboration from Newcastle (Dalgarno and McKaskie), Nottingham (Grant, Ahmed and Warrior), Sheffield (Hatton) and Bradford (Coates). The Centre will work closely with major manufacturers and users including surgeons who see at first hand the challenges of patient and surgical variation. The Centre will provide a platform for developing fundamental medical device manufacturing science and promote its rapid exploitation by industry.
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