Due to COVID-19, the majority of routine surgical procedures have been suspended. Lifting restrictions and returning to surgery, however, places a significant burden on the NHS. Further, demand for elective joint replacement surgery for osteoarthritis is set to double by 2030. Consequently, surgeons and patients need to interact in new ways to enable procedures to be delivered without compromising NHS workers, quicker operational delivery reducing waiting lists and in-patient time. Consequently, the need for innovative, enabling technologies has accelerated dramatically. 3D Metal Printing (3DMP) is a UK micro-SME specialising in the design and manufacture precision-engineered leading edge medical devices using additive manufacturing technology (3D Printing) supported by digital planning, training and visualisation tools. Our mission is to restore outstanding patient quality of life through cost effective, personalised surgical treatment. Our vision is to become a leading Med-Tech company providing an innovative, integrated range of additively manufactured products, 3D surgical planning and digital applications. We have developed TOKA(r)--- a novel 3D printed orthopaedic implant providing a personalised solution to knee arthritis for younger patients unsuitable for knee-replacement. Established in 2014, we have grown to 11 staff including biomechanical engineers and software developers with an advisory board consisting of leading orthopaedic surgeons. The proposed project will enable us to undertake 4 critical tasks significantly accelerating our business plan projections and revenue (1) sterilisation / packaging processes to deliver ready-to-use TOKA kits to healthcare providers; (2) scale up manufacturing processes (3) Patient app; complete and integrate our digital product suite (4) achieve FDA/MDSAP compliance for US market entry. Successful project delivery will accelerate our timeline to a commercially viable, differentiated product that will increase our competitive advantage over competitor technologies and open global commercial opportunities for 3DMP. This will support TOKA in delivering positive impact for the NHS (enabling remote consultations minimising infection risk; reducing hospital stays and associated financial savings) and patients (better clinical outcomes; reduced inpatient time; return to active lifestyles with health and wellbeing benefits e.g. preventing the onset of obesity or diabetes).

3D Metal Printing (3D-MP) develop solutions for public health improvements by continually innovating and improving our product range to deliver superior patient outcomes. We additively manufacture a range of custom-made medical devices and digital applications for 3D surgical planning. Additive manufacturing is an innovative technology that works by fusing together very fine layers of metal powder using a laser beam. This process can produce complex geometries which might not have been possible using conventional techniques; the 'unsintered' or loose material is recycled for future use, making it both economical and environmentally friendly. 3DMP are developing a 3D printed orthopaedic implant (TOKA) as a precision engineered personalised solution to knee pain, particularly designed for young patients suffering from knee arthritis but not yet suitable for partial or total Knee-Replacement. High-Tibial-Osteotomy (HTO) is a surgical treatment option for those patients, preserving the native joint by re-aligning the tibia and the weight / forces distribution, often the cause of major pain. Current market solutions are very challenging, present several complications and cause patients' soft tissue irritation due to the generic nature of the plate. TOKA removes those complexities providing surgeons with an intuitive 3D planning environment to achieve precise intervention, optimum knee alignment with minimal risks for patients and personalised prosthesis for superior comfort and fast recovery. Due to COVID-19, the majority of routine surgical procedures have been suspended. Lifting restrictions and returning to surgery, however, places a significant burden on the NHS and risks an increase in COVID infections. Demand for elective joint replacement surgery for osteoarthritis is set to double by 2030\. In the UK there are currently \>130,000 knee surgeries annually. Surgeons and patients need to interact in new ways to enable procedures to be delivered without compromising NHS workers and wider societal immunity. Consequently, the need for innovative, enabling digital technologies has accelerated dramatically. Our project will integrate TOKA's existing digital products (Surgical Simulator, VR training and Patient App) and surgical hardware to create an interactive platform supporting TOKA adoption in the NHS. TOKA Portal will provide surgeons, patients and NHS procurement teams a single point of interaction enabling communication, collaborative design, procurement, scheduling and post-operative monitoring. This will have significant positive impacts for the NHS in sustainably recovering from COVID-19, (enabling remote consultations minimising infection risk; reducing hospital stays; supporting the NHS digital transformation; £40M. annual savings in delivering HTO operations), patients (better clinical outcomes; reduced inpatient time; return to active lifestyles with health and wellbeing benefits e.g. preventing the onset of obesity or diabetes) and the environment (reduced transport emissions through remote consultations; reductions in energy and waste by reducing overnight hospital stays). The project is core to 3DMP's mission to restore patients' wellbeing in an efficient healthcare system and will initially create 3 new jobs building on previously funded public research supporting NHS delivery of HTO operations, more cost effectively and sustainably, enabling early stage knee osteoarthritis sufferers to return to work and life more active lifestyles.

3D Metal Printing Ltd. is a MedTech engineering company based at the University of Bath Innovation Centre. Our mission is to restore outstanding patient quality of life using custom-made treatments. We develop solutions for public health improvements by continually innovating and improving our product range to deliver superior patient outcomes. We additively manufacture a range of custom-made medical devices and digital applications for 3D surgical planning. Our proposed TOKA VR Surgery Training will enable surgeons and clinical staff to remotely train to treat patients suffering from knee osteoarthritis. The introduction of virtual training would allow faster TOKA HTO package adoption by the NHS, rapidly upskilling surgeons and supporting the pandemic transition to increased remote engagement with patients. The VR surgery model would also benefit medical schools where students could access high quality training remotely to continue their studies, supporting academic institutions to deliver new remote teaching methods. Longer term, the approach could be applied to other orthopaedic surgical procedures. The scope of the project is to deliver: Specialist surgical training - VR training of more surgeons in specialised early intervention procedures like HTO – High Tibial Osteotomy - thus reducing demand for joint replacement. Immersive remote learning - VR with haptic feedback providing the sensation of the drilling, sawing etc. gives the surgeon a realistic immersive experience. Personalised medicine - Using pre-operative imaging (CT-scan and x-rays) to plan and simulate surgery de-risks many aspects of the procedure and allows for the manufacture of 3D-printed personalised implants and surgical guides utilising the existing NHS resources. The introduction of virtual training and planning would allow faster NHS adoption of the TOKA HTO procedure through rapid upskilling of surgeons and supporting a transition to greater remote engagement with elective patients. The TOKA VR technology will provide benefits to healthcare providers in terms of social distancing and reduced risk of infection through: - Reducing the number of physical interactions between patients and surgeons through remote consultations; - A virtual learning environment reducing travel time to and physical laboratory time in practising procedures - Reducing surgery times - Reducing staff numbers in theatres due to the simplified TOKA procedure - Integration with the overall TOKA surgical platform could save the NHS up to £40M. annually based on treating 3,000 HTO and 11,000 UKR cases in the UK annually (Health Enterprise East, 2019).

The lifetime risk of knee osteoarthiritis is estimated to be as high as 45% (most common muscoloskeletal disease in the world). The current main standard of care for end-stage knee OA is joint replacement, effective for older patients but incurs a high cost to the healthcare system. For younger patients (40 to 65 yrs.) the risk of knee replacement failure is significantly higher than for older patients. By comparison High Tibial Osteotomy (HTO) can be considered as ideal in a younger demographic, particularly those individuals with greater activity demand. The technique preserves the native joint by re-aligning the tibia using a stabilising plate; potentially allowing more intense use in athletics or high impact activities (Smith 2015). However, current market solutions present several complications related to the generic nature of the plate and concerns of orthopaedic surgeons regarding the reproducibility of the surgery and costs. Our procedure ToKa® overcomes these problems by providing a patient specific plate which significantly reduces potential soft tissue damage, overall surgical times and is more cost effective. The project seeks to validate the approach and build an evidence pack in collaboration with the Royal Devon and Exeter Hospital, the NHS SW Innovation Trust and leading surgeons to demonstrate the safety and efficacy of ToKa enabling a full scale clinical trial to be undertaken. This will bring the product into market more quickly allowing patients to enhance wellbeing and quality of life. By reducing the procedure complexity the societal financial benefit could significantly impact NHS budgets.