The aim of this place based impact acceleration account (PBIAA) is to support the translation of University research in medical technologies into new clinical products and services. There is a vibrant Medical Technology (MedTech) business cluster in the Yorkshire region, with over 200 companies employing more than 16,000 people, mostly in high value technical roles. The Universities of Leeds and Sheffield have strong track records in engineering and physical sciences research related to MedTech, particularly in areas that mirror the local business strengths (e.g. orthopaedics, dental, implantable devices and surgical technologies). While there is clear synergy between University research strengths and the business prominence in the region, there is currently a gap in the innovation funding pathway that is preventing technology innovations developed at the region's universities from being adopted by local companies. The aim of this PBIAA is to provide support to bridge this gap and build the connections between the academic, industrial and clinical assets in the region that will help grow the regional economy. It is particularly timely because the MedTech sector is transforming and there is increasing integration of new technologies into products and services. There are growing numbers of high-growth, high-innovation MedTech companies in the region with an absorptive capacity to benefit from this PBIAA, but we will also proactively engage with established companies that need to adopt new innovations to address the changing markets. We have worked with civic partners including the West Yorkshire Combined Authority and South Yorkshire Mayoral Combined Authority, NHS Trusts through the Leeds and Sheffield Biomedical Research Centres, local industry, investors and innovation support organisations to develop this proposal and shape the activities to most effectively enable impact to be realised from the region's engineering and physical sciences research base. Commercialisation of innovations in the MedTech sector is challenging due to the regulatory barriers for products intended for use in humans, with evidence from extensive pre-clinical testing required to demonstrate the safety and efficacy. The PBIAA will fund Impact Projects that aim to generate evidence to derisk a technology, both to prove the technical concept is effective and to demonstrate that it is a commercially attractive proposition. A stage-gated approach will be used to encourage higher risk in the early stages and fast failure. These projects will act as exemplars to encourage further business engagement and outcomes will form a portfolio of evidence to inform future activities. The PBIAA will also support activities to build the regional innovation environment. These include a suite of training activities and events that raise understanding of technical advances and translational processes in the MedTech sector, and act to bring together academic, clinical and industrial partners to help build a lasting innovation community. The PBIAA will support events to identify clinical needs, two-way secondments, as well as public and patient engagement activities that aim to improve understanding of needs across the diverse regional population. A dedicated collaboration fund will be used to support impact activities at universities across the region, nurturing the wider regional strengths in this sector, and draw on wider collaborations that utilise the full strengths of the UK research base. The PBIAA will provide regional industry with a vital connection to state-of-the-art research, enabling a sustainable regional research-derived product development pipeline. It will help drive regional economic growth, with new innovations being adopted by regional industry, creating high value jobs and unlocking private sector investment in R&D, supporting a £3bn/year industry beyond 2035.

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.

Biomedical Materials have advanced dramatically over the last 50 years. Historically, they were considered as materials that formed the basis of a simple device, e.g. a hip joint or a wound dressing with a predominant tissue interface. However, biomedical materials have grown to now include the development of smart and responsive materials. Accordingly, such materials provide feedback regarding their changing physiological environment and are able to respond and adapt accordingly, for a range of healthcare applications. Two major areas underpinning this rapid development are advances in biomedical materials manufacture and their characterisation. Medical products arising from novel biomedical materials and the strategies to develop them are of great importance to the UK and Ireland. It is widely recognised that we have a rapidly growing and ageing population, with demand for more effective but also cost effective healthcare interventions, as identified in recent government White Paper and Foresight reports. This links directly to evidence of the world biomaterials market, estimated to be USD 70 billion (2016) and expected to grow to USD 149 billion by 2021 at a CAGR of 16%. To meet this demand an increase of 63% in biomedical materials engineering careers over the next decade is predicted. There is therefore a national need for a CDT to train an interdisciplinary cohort of students and provide them with a comprehensive set of skills so that they can compete in this rapidly growing field. In addition to the training of a highly skilled workforce, clinically and industrially led research will be performed that focuses on developing and translating smart and responsive biomaterials with a particular focus on higher throughput, greater reproducibility of manufacture and characterisation. We therefore propose a CDT in Advanced Biomedical Materials to address the need across The Universities of Manchester, Sheffield and The Centre for Research in Medical Devices (CÚRAM), Republic of Ireland (ROI). Our combined strength and track record in biomaterials innovation, translation and industrial engagement aligns the UK and ROI need with resource, skills, industrial collaboration and cohort training. This is underpinned strategically by the Biomedical Materials axis of the UK's £235 million investment of the Henry Royce Institute, led by Manchester and partner Sheffield. To identify key thematic areas of need the applicants led national Royce scoping workshops with 200 stakeholders through 2016 and 2017. Representation was from clinicians, industry and academia and a national landscape strategy was defined. From this we have defined priority research areas in bioelectronics, fibre technology, additive manufacturing and improved pre- clinical characterisation. In addition the need for improved manufacturing scale up and reproducibility was highlighted. Therefore, this CDT will have a focus on these specific areas, and training will provide a strongly linked multidisciplinary cohort of biomedical materials engineers to address these needs. All projects will have clinical, regulatory and industry engagement which will allow easy translation through our well established clinical trials units and positions the research well to interface with opportunities arising from 'Devolution Manchester', as Greater Manchester now controls long-term health and social care spending, ready for the full devolution of a budget of around £6 billion in 2016/17 which will continue through the CDT lifespan.