Medical Device Prototype & Manufacture Unit

Lead Research Organisation: Imperial College London
Department Name: Dept of Mechanical Engineering

Abstract

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 al 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.

Planned Impact

If the research enabled by the equipment is successful, we will have created new medical devices for early intervention in musculoskeletal disease, thus enabling prevention rather than treating end stage disease. Our preventative approach means we will be treating healthier patients. Thus the impact of our research will lower the risk and improve the benefit of prophylactic musculoskeletal treatment.

Specific examples of this impact (reduced risk and improved benefit) are:

(1) Improved post-operative patient function. This will be achieved by the soft tissue repair patches that self-fix to tissue to repair at the end of the surgical procedure.
(2) Reduced infection and technology to help treat superbugs like MRSA that have become resistant to antibiotics. This will be achieved through nanoneedle surface features to prevent biofilm formation on our implants.
(3) Far better patient stratification for appropriate treatment. This will be achieved using smart instruments which will be capable of monitoring biomarkers that objectively indicate cartilage health.
(4) New treatments for young patients. Partial joint replacement that increases the strength of surrounding bone will increase practice of early intervention, because the better bone makes revision easier.

Our early intervention strategy will prolong the healthy life of natural joints and delay the need for joint replacement. This preventative strategy will involve smaller, less expensive interventions than joint replacement. Maintaining the native joint will provide better functional outcome and reduce the rehabilitation burden. Thus the impact would be healthier patients, at less cost to the taxpayer. This is essential because the NHS annual spend on musculoskeletal disorders is £5.4 billion and growing. The unsustainable rising cost of musculoskeletal disorders is a similar problem in other developed countries, indicating the impact would be wider than just the UK.

The medical devices we will create wit the proposed equipment could be of strong economic value to the UK. Our pathways to impact describe how the equipment will enable us to generate human safety clinical data far quicker than is currently possible. Having these data will enable us to fully realise the true economic value of the above technologies. The medical device industry is extremely risk averse, and adopting a new technology, either through licensing or acquisition, is far more likely if clinical data exists to validate the lab and animal data. Any such licensing/acquisition of tech by one of the 'big-4' large orthopaedic companies would generate impact in two ways. First, it would generate revenue for the UK, but more importantly it would enable the technology to be distributed through global supply networks, ensuring global impact.

Publications

10 25 50
 
Description We have used the equipment to manufacture implants that regenerate bone, this work is still in progress and not yet published.
Exploitation Route the outcomes will be used by two Imperial College spin out companies to create a new orthopaedic implant design that replaces the joint and regenerates bone around the implant.
Sectors Healthcare

 
Description We have used the equipment in this award to set up an ISO 13485 quality management system, and operate the equipment as such. This was a goal of the proposal, and has led to the formation of a spin out company Additive Instruments Ltd.
Sector Healthcare
Impact Types Economic

 
Title Load limiting device for orthopaedic surgery 
Description Load limiting device for orthopaedic surgery 
IP Reference 1903271.3 
Protection Patent application published
Year Protection Granted 2019
Licensed Yes
Impact None yet
 
Company Name Additive Instruments Limited 
Description The company was set up to commercialise the IP that was generated during the EPSRC research. It uses additive manufacture to make instruments for orthopaedic surgery. 
Year Established 2019 
Impact None yet.
Website https://www.additiveinstruments.com/