Awaiting Public Project Summary

Awaiting Public Project Summary

World first automated design to delivery of custom 3D printed medical devices service

CBAS is proposing to develop a Prosthetic Interface Device (PID): Digital, an innovative, continuous, system that aids in collecting data remotely for patients with mobility impairments: patients with lower limb disorders and vulnerable elderly people. PID: Digital takes advantage of the CBAS machine-learning (ML) platform. This system is used to collect healthcare data from sensors worn by patients to enable remote assessment of their health. It provides clinicians with a true and complete picture of activity and mobility by representing patient conditions. This offers clinicians a clear tool to see that treatment is effective, progression of disease, and even clinical key performance indicators (treatment adherence/compliance measures). PID: Digital, can predict the need for in-house consultations with clinicians, potentially alleviating dependence on direct interaction between healthcare provider and patient, and supporting patient autonomy. The benefits include continuity of care, condition specific data, proactive intervention and reduced face-to-face assessment time via targeted patient engagement. This study will optimise existing ML algorithms for implementation in a cloud environment and build a system to scale these across multiple patients, clinicians and data types. These algorithms will provide clinically important information for identified patient groups, accessed via client end dashboards. All patients will be assessed in QMUL Gait Analysis Laboratory, providing gold standard validation. Clinical studies carried out by collaborators CUSH Health Ltd and Andiamo will trial PID: Digital alongside current best practise assessment methods. A regulatory and ethically compliant cloud environment and associated data storage will be designed and built with dashboards for identified for specified patients and associated user groups. The resulting system will be compliant to all medical device regulatory requirements to enable remote patient health assessment. On project completion, PID: Digital will have been trialled with two patient groups and be ready for regulatory submission as a class 1M medical device

Orthotics is a speciality involving the application of external devices to the body to support and improve posture, function and mobility, and manage pain and deformity. They include insoles, braces, splints, callipers, footwear, spinal jackets and helmets. In the UK, there are an estimated 2 million people requiring orthotic services and NHS spend is now over £207 million/year. Orthosis manufacturing processes have not changed in over 50 years and current waiting times for orthotics services are now up to 12 months. Manufacture of customised orthoses, such as ankle-foot orthoses, involves creating a plaster mould of the limb followed by manual and vacuum forming. Andiamo (http://andiamo.io/) is addressing the current limitations of orthotics services with a high-tech data driven approach and by taking design and manufacture outside of the acute setting. Our approach has attracted substantial media coverage and a number of awards. A short video about our work has been shared over 28,000 times and received over 2 million views to date (https://goo.gl/qNdJDn). Andiamo and Medway will work together to develop a joint offering to the NHS. Our overall aim is to develop a streamlined manufacturing process that optimises the design and delivery of superior customised orthoses in a fraction of the time of current manufacturing practices.

An estimated 2 million people use NHS orthotic services in the UK, with a total spend over £207 million/year. Orthoses are a high-value medical device, however, manufacturing processes have not changed in the last 50 years and as a result, current waiting times for orthotics services are now up to 12 months. Andiamo is the world leader in 3D printed orthotic services. We have the only clinically approved 3D printed ankle-foot orthoses being worn today anywhere in the world. We can deliver an orthosis within 1-week of consultation and are revolutionising orthotics services, however we are limited by current AM machines and a lack of integration and specialisation for medical device production. To solve this problem we have partnered with Medway Community Healthcare, an award winning healthcare provider with numerous NHS service contracts, and The Plastic Economy (TPE), an innovative early-stage company with novel platform technology and manufacturing knowhow. Based on the requirements set out by the BHTA, universal adoption of a service such as we propose, could save the NHS (by 2020) £1 billion every year and lead to an additional 300,000 patients under orthotic care. These patients will realise the benefits of orthotic care, such as improved mobility and quality of life. Post-project, TPE will adapt the platform technology for other medical devices and high-value industries.

Orthotics is a speciality involving the application of external devices to the body to provide support and manage pain and deformity. In the UK there are 2 million people requiring orthotic services costing the NHS £207 million/year. Current wait times for an orthotic are up to 12 months. Coupled with a shortage in qualified orthotists, orthotic provision services have failed to meet the market demand. The current approach to orthotics has not changed in over 50 years. Manual casting is a slow process taking up to 3 months and requires input from a range of health professionals, including technicians, physiotherapists, and orthotists. The whole process can take up to 12 months, by which time the patient’s condition may have deteriorated. This may mean the orthotic no longer fits, or in the case of a child they may have outgrown the orthotic. This results in ineffective treatment, skin irritations and repeat visits to the clinic—only to repeat the process. In turn leading to needless distress on the family and child Following our own personal experience of the orthotic provision service, we have proposed an innovative approach to manufacturing and providing orthotics. Our concept utilises state of the art 3D imaging and additive manufacturing with expert biomechanical analysis to design and manufacture customised orthotic devices. Our concept streamlines the orthotic provision service and meets the needs set out by the British Health Trades Association (BHTA) and NHS England. We believe we can deliver an effective orthotic within 1 week of consultation. The potential economic benefits to the taxpayer are enormous, with every £1 spent on orthotics services worth £4 to the NHS, such is the impact of orthotic care on overall health. Demand for orthotics is expected to grow with the ageing population and increasing prevalence of chronic disease, such as diabetes. Our rapid, streamlined service will be perfectly placed to meet this need. We now seek to prove our concept.

Andiamo was born from the experiences of its co-founders Samiya and Naveed’s with their disabled son Diamo. We are changing how orthotic services are delivered, to significantly improve the lives of disabled children and their families. Our experience has shown how much of an impact orthoses have on a child’s life. The orthotics service is responsible for the creation of orthosis such as back braces. An orthosis is designed to straighten a part of the body. Without this the quality of life for a child is severely impacted and they are at higher risk of requiring major surgery. The service uses processes that are highly stressful, time consuming and error prone. Whilst also taking up to 17 weeks to produce an often ill fitting orthosis. The techniques used to deliver the service haven’t fundamentally changed in a 100 years beyond new materials. The service aims to bring this down to 48 hours whilst increasing quality through the use of 3D scanning and printing. We believe that the lessons learnt during this project will lead to a pilot with the NHS to explore scaling a user centred orthotics service. By leveraging the inherent flexibility and decentralisation that 3D scanning and printing allows.