Medical Device Prototype & Manufacture Unit

一百五十年前，英国人的预期寿命约为43岁。营养、医药和公共卫生的改善大大增加了这一点，今天出生的人可以预期寿命超过80岁。这150年的时间只是进化过程中的一眨眼，我们肌肉骨骼系统的进化还没有赶上预期寿命的增长。因此，毫不奇怪，肌肉骨骼疾病是NHS年度预算中最大的支出之一（约54亿英镑）。我们的愿景是终身肌肉骨骼健康。我们认为实现这一目标的唯一方法是在生命早期识别肌肉骨骼问题，然后在它们成为慢性病之前进行小干预以纠正它们。这种预防方法需要新的技术，我们将使用医疗器械原型和制造部门的设备创建新技术。我们寻求使用定制材料制造早期干预植入物，以通过控制所经历的骨应变使周围骨更坚固。我们希望制造智能仪器和植入物，可以测量滑液中的生物标志物，以提供关节健康的客观指标。我们希望部署新的生物材料，如纳米针，可以绕过细菌细胞膜，并在我们的植入式设备上提供抗感染涂层。我们将使用软组织“Velcro”固定结合功能化表面制造韧带、肌腱和关节囊修复补片，该功能化表面在一侧粘附到软组织，但在另一侧提供低摩擦滑动表面。我们还希望更好地了解骨质疏松症的衰老过程和双膦酸盐理论的影响。最后，我们希望对肌肉骨骼组织进行更高保真的实验室测试，以更好地了解病理学，以及组织对我们提出的治疗的反应。拟议的医疗器械原型和制造部门将使所有这些相互关联的研究主题取得突破。粉末床熔融增材制造（AM）机和双光子光刻AM机允许在我们需要的规模范围内制造多孔晶格材料，以创建具有150微米特征的刚度匹配植入物，直至用于我们的传感技术和纳米针的微流体通道。具有亚微米特征。纳米CT扫描仪具有比目前更高的分辨率（亚微米），3D显微镜配备了100纳米分辨率的共聚焦轮廓仪-这些成像仪器将允许病理组织的前所未有的表面和内部成像以及组织对我们干预的反应。我们的研究将在一个强烈鼓励翻译的环境中进行。原型和制造部门将建立所有监管批准和质量控制，使我们能够制造从第一批原型到小批量生产部件的早期临床安全性研究的器械。在一个高度重视翻译的环境中，这种先进的AM和成像设备的组合将使我们能够在所有研究主题中开辟新天地，并弥合激动人心的实验室测试和临床实践之间的差距。

One hundred and fifty ago, life expectancy in the UK was about 43 years. Improvements in nutrition, medicine and public health have dramatically increased this such that those born today can expect to live for over 80 years. This 150 year period is but the blink of an eye in evolution terms, and the evolution of our musculoskeletal system has not caught up with the increased life expectancy. It is therefore no surprise that musculoskeletal disorders are one of the biggest expenditures in the annual NHS budget (about £5.4bn). Our vision is for lifelong musculoskeletal health. We consider the only way to achieve this is to identify musculoskeletal problems early in life, then make small interventions to correct them before they become chronic. This preventative approach needs new technology which we will create using the equipment in the Medical Device Prototype & Manufacture Unit. We seek to manufacture early intervention implants using material that is tailored to make the surrounding bone stronger by controlling the bone strain experienced. We want to make smart instruments and implants that can measure biomarkers in synovial fluid to provide objective measures of joint health. We want to deploy new biomaterials like nanoneedles that can bypass the membrane of bacteria cells and provide anti-infection coatings on our implantable devices. We will manufacture ligament, tendon and capsule repair patches using a soft tissue 'velcro' fixation combined with functionalised surfaces that adhere to soft tissues on one side, yet provide a low friction sliding surface on the other side. We also want to better understand the ageing process of osteoporosis and the effects of bisphosphonate theory. Finally we want to perform higher fidelity laboratory testing of musculoskeletal tissues, both to understand better the pathology, but also the response of tissue to our proposed treatments.The proposed Medical Device Prototype & Manufacture Unit would enable breakthroughs in all these interrelated research themes. The powder bed fusion additive manufacture (AM) machine and 2-photon lithography AM machine allow manufacturing of porous lattice materials at the range of scales we need to create stiffness matched implants with 150 micron features down to microfluidic channels for our sensing technology and nanoneedles with sub-micron features. The nano CT scanner has a higher resolution (sub-micron) than currently available and the 3D microscope is equipped with confocal profiler with 100 nanometre resolution - these imaging instruments will allow unprecedented surface and internal imaging of pathological tissues and the response of tissues to our interventions. Our research will be conducted in an environment that will strongly encourage translation. The Prototype & Manufacture Unit will be set up with all the regulatory approval and quality control to enable us to manufacture devices from first off prototypes through to small batch production parts for early clinical safety studies. This combination of cutting edge AM and imaging equipment in an environment with strong emphasis on translation would enable us to break new ground in all our research themes and also bridge the gap between exciting laboratory testing and clinical practice.