EPSRC Centre for Innovative Manufacturing in Medical Devices

EPSRC医疗器械创新制造中心将研究和开发功能分层设计和近患者制造的先进方法，以实现器械功能与患者需求和手术环境的成本效益匹配。这将提供“正确的产品，通过正确的过程，在正确的时间给正确的病人”，以提高可靠性和性能的标准。该中心将研究和开发：1）功能分层设计系统，最初将应用于现有的器械制造工艺，随后应用于支架制造，开发新型临床前模拟方法，使植入物设计与患者功能相匹配，提供具有成本效益的增强可靠性分层方法（SAFER）2）创新的近患者制造工艺，通过对患者需求的分层和个性化定义，为个性化器械提供更具成本效益的方法。这两项旗舰挑战将与整个中心的关键平台功能相结合，首次产生医疗器械的闭环设计和制造框架，以提供增强的性能和可靠性。这些创新设计和制造的进步将首先集中在用于肌肉骨骼疾病的3类医疗器械上，这些医疗器械的故障成本和对整个寿命可靠性的需求很高。国家中心将开发、领导和整合由工业家、学者、临床医生和监管机构代表组成的国际网络，以支持肌肉骨骼医疗器械制造业应对创新设计和制造挑战，并将成果应用于全球高度监管市场的制造实践。该中心将创建研究基础设施，工具和方法，专业知识和适当的合格人员，以支持英国医疗器械制造业的持续创新和发展。为此，该中心将在EPSRC优先研究领域“制造未来”和“迈向下一代医疗保健”开展工作，利用现有的卓越中心的能力并与之合作。该中心将提供一个基础创新设备制造研究的平台，并通过外联和翻译活动促进工业界对其的迅速利用，以及一个向其他技术多样化的通用平台。它将提高英国在医疗器械制造研究方面的研究能力，以支持下一代医疗器械的开发和高质量制造工艺的开发，以提供具有成本效益，可靠和有效的器械。它将用于增强现有器械的制造，如关节置换和支持新产品和生物材料支架的制造。该中心将在外地五个主要的学术英才中心开展工作。该中心将由利兹大学（费舍尔、威廉姆斯、英厄姆、威尔考克斯、詹宁斯和雷德蒙）牵头，并将得到纽卡斯尔（达尔加诺和麦卡斯基）、诺丁汉（格兰特、艾哈迈德和勇士）、谢菲尔德（哈顿）和布拉德福德（科茨）的合作支持。该中心将与主要制造商和用户密切合作，包括亲眼目睹患者和手术变异挑战的外科医生。该中心将为发展基础医疗器械制造科学提供一个平台，并促进行业的快速开发。

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.