Public Funding for Additive Instruments Limited

The NHS performs 130,000 knee replacements annually. Demand is growing due to our ageing population and backlog caused by Covid-19\. Partial knee surgery is the fastest growing treatment, particularly in young patients for whom the risk of becoming less active, productive and socially connected is higher and has more severe long term consequences. Despite advances in orthopaedic implants, at present solid cobalt-chrome implants remain the gold-standard treatment for knee osteoarthritis. A major drawback of this material is that it diminishes bone health in the long term which can lead to bone loss and implant loosening. Existing partial knee tibial components show good patient outcomes, however, they disturb bone's natural dynamic remodelling because they are made from solid Cobalt Chrome. Additionally, 30% of them fail by loosening. Such implants under-load 70% of the bone area and inhibit bone growth, complicating revision surgery. Our 3D printed components integrate our unique porous structure which cadaveric and animal data indicates maintains bone loading and health better than conventional implants. Restoring physiological loading will stimulate long term bone growth around the implant and long-term biologic fixation via bone ingrowth into the porous implant. Our implant will be the first partial knee replacement with a polymer-on-polymer articulating surface, which removes the risk of allergenic response. We foresee this implant saving on lifetime costs for the NHS and more broadly, helping to keep young men and women active, productive, independent and socially connected as they age -- enjoying added years in work and a rewarding personal life. Employment opportunities are such that on average patients with arthritis earn less than those without. Furthermore, management of the disease has proven significantly more difficult for poorer patients, due to reduced opportunity to seek preventative treatment and longer public sector wait times. Partial knee replacements offer day surgery treatment and faster recovery than total knee replacement. They are also more cost effective at the point of care and over the long term. Our implants will improve this upon this by reducing risk of complication. In this way, our service will help to narrow the gap between the experience of the richest and poorest by ensuring affordable and timely treatment for all patients.

The NHS performs 100,000 hip replacements annually. Demand is growing due to our ageing population and backlog caused by Covid-19\. Despite advances in precision and robot assisted surgery, the hammer remains the state-of-the-art tool to insert hip replacement implants into the bone. This has two problems. (1) The hammer's weight and how hard the surgeon swings it are uncontrolled. In the worst case this can cause fracture of the bone. In many cases this causes poorly secured implants. (2) The repetitive impaction can cause injury, and particularly may curtail the career of our most experienced surgeons. The cost of losing highly trained surgeons to injury is significant. Our project will create a battery powered impaction device that replaces the hammer. It will allow repeatable surgery, with defined, consistent impact strikes. The impact force is pre-set for each patient (depending on their bone properties) thus reducing the risk of bone fracture. The device will also be able to tell the surgeon when the implant is properly seated, and prevent further risks associated with over impaction. The powered impaction device also makes the surgery less physically demanding, which will prolong the surgeon's career. Reducing the physical strength component may also encourage a wider demographic of people to choose orthopaedic surgery as a specialism, which is traditionally male dominated. The team of Imperial College London and Additive Instruments Ltd. brings together the skills of impaction technology and orthopaedic surgery and provides a clear pathway for the technology to reach clinical use. We have a strong advisory panel of surgeons and patients who helped put the proposal together and will be involved throughout the project as it unfolds.

The manufacturing industry is no stranger to revolutions, from the first industrial revolution in the late 18th century which saw the mechanisation of hand production, all the way to computerisation in the 20th century, manufacturing and production technology continues to evolve. The latest industrial revolution, Industry 4.0, which we find ourselves amidst, is driven by machines becoming "smart." Machines and systems are now augmented with sensors and artificial intelligence to make their own decisions. 3D printing or additive manufacturing (AM) is a key part in this revolution as it enables production of components not previously possible as well as more efficient designs, flexible production and less waste. As opposed to subtractive manufacturing which starts from a large block of material and removes material until it produces the desired shape, AM works by building (additively) an object layer-by-layer in a highly automated way. However, AM is still immature compared to many traditional manufacturing processes and requires further advancements before it can be considered "smart". When producing parts in metals, defects can occur. These defects may consist of cracks, internal pores or impurities, and these defects can significantly impact the performance of a manufactured component. The consequence of these defects can be premature, or even worse, unexpected, failure of the component. Manufacturing processes for metals such as welding, forging and casting are far more mature than AM, having been studied extensively for centuries. Consequently, there is a far better understanding of why these defects occur and how to optimise these processes to minimise them. Currently, AM is on the same journey of knowledge acquisition; a journey we believe can be accelerated by embracing a "smart" approach. This work will integrate innovative process monitoring equipment into AM machines to detect defects as they form during the build process, allowing us to fix them in-situ as well as enhancing our understanding of why they occur. This will help enable and accelerate the use of metal AM parts for structural end-use and high precision applications. This approach will give us confidence in the quality and safety of newly built AM components, reducing the need for slow and costly post-processing processes, and accelerate the adoption of AM as a manufacturing technology.

The COVID-19 pandemic has exposed the shortfalls of global supply chains. Demand for Personal Protective Equipment (PPE) has outstripped supply and the UK is struggling to provide front-line healthcare workers with the vital protection they need.This project aims to design and gain regulatory approval for a face mask that meets the standards for protection of healthcare workers against COVID-19 and can be manufactured at a rate of 2,500 masks per day. Our team will deliver a product in a highly compressed time scale by using innovative manufacturing techniques that remove the expensive and time consuming tooling stage necessary for mass production. UK based manufacturing will be used to ensure that the NHS is protected from the volatility of global markets and manufacturing streams.