Additive manufacture value chain to deliver bespoke orthotics within 48 hours with greatly improved health economics

Lead Research Organisation: University of Salford
Department Name: Sch of Health Sciences

Abstract

The NHS and health care sector provide orthotics (sometimes called "supports" or "braces") for people's feet and lower
limbs in order to help treat a wide range of problems associated with walking. People with diabetes and rheumatoid arthritis
sometimes experience excessive pressure under their feet and this can leads to devastating foot problems and even
amputation. Health professionals use orthotics to protect the feet. However, these orthotics need to be adjusted
(customised) for each individual patient and this is a complex, costly, and slow process prone to error.
The research in this project seeks to use innovative manufacturing techniques to combine foot shape with other data (e.g.
pressure under the foot) to design novel foot orthotics. The most innovative part of the project is that the orthotics will be
"printed" rather than using traditional hand-made techniques. The new "printing manufacture" method allows the shape of
the insoles and the properties materials used to be altered to exactly match the needs of the foot and patient, in an almost
infinite number of ways. It also reduces the risk of error and makes reproduction of exactly the same product possible. The
outcome of the project will be a new supply chain for foot orthotics into the NHS, using East Lancashire NHS Trust as a
beacon site for the technology and its implementation.
FDMDS are a 3D technology printing company and they will combine their additive manufacturing expertise with the foot
orthotics knowledge from Salfordinsole Healthcare, an existing supplier of foot orthotics to the NHS. The University of
Salford will research how different orthotic shape and materials used affect the foot. East Lancashire NHS Trust will be the
primary clinical site for orthotic testing and prescription.
The proposal will leave a legacy for FDMDS to use their printing technology for the orthotic sector beyond orthotics for feet.
FDMDS will work with the East Lancashire NHS Trust to develop a plan for how this new "printing" method might have
other advantages in health care. This may involve working with occupational therapists and prosthetists.

Planned Impact

The beneficiaries of the research will be:
1. FDMDS
2. Salfordinsole Healthcare (SIH)
3. East Lancashire NHS Trust (ELHT)
4. NHS Trusts and musculoskeletal services UK wide
5. Allied health professions related to orthotic practice (and the students in training).
6. Foot biomechanics researchers
7. International research and clinical partners of UoS
FDMDS and SIH will directly benefit from the expansion of orthotic product range (SIH) and introducing AM orthotics into
the marketplace (both). SIH has built a brand with greater emphasis on academic credibility than other orthotic companies.
This project enables SIH to maintain this identity. FDMDS requires orthotic, clinical and academic partners to enable it to
penetrate the market, and this project draws together these partnerships. This could prove essential for penetration of other
areas of the orthotic market, such as orthotics related to occupational therapy (Salford also has this discipline within the
School of Health Sciences).
ELHT will benefit directly in 3 ways. Firstly, the patients served by the Trust will get access to and benefit from increased
design freedoms developed in the project. Secondly, in adopting and developing the new end-to-end supply chain the Trust
and department are demonstrating their contribution towards an NHS led by innovation (as per Government policy). Finally,
for the staff concerned, the project will enable them to build new academic links and share biomechanics ideas and
concepts within the partnership (also design freedoms). This is expected to offer direct personal career advantages and
form part of their ongoing continued professional development (as per HCPC regulations).
These benefits are also relevant for staff and patients of other NHS organisations. As part of the exploitation plan and the
projected business development in the years post the project, circa 30 NHS Trusts are expected to be receiving AM
orthotics. This will be in the areas of diabetes but also musculoskeletal care, proving a total reach of AM orthotics in excess
of 50,000 patients within 5 years of the project. The benefits to patients are varied and complex but include improved foot
health, possible reduced anxiety, returning to work or other daily activities, greater confidence in their independent mobility,
and improved value they receive from the publically funded NHS. In the same timeframe over 100 clinicians will have
increased design freedoms because of this project.
For those involved in foot biomechanics research the application of this knowledge to real world problems is a common
aspiration. The project offers very high novelty in characterising the complex relationship between foot function and
external device (orthotic) structure, materials and function. In addition, this is being achieved in a way that is accessible to
clinicians at the point of contact with patients. This is arguably demonstrating a new paradigm and new standards for
orthotic practice worldwide. Whilst others have demonstrated printed orthotics (e.g. EU project FOOTPRINT) these remain
quite far from market and utility in the clinical setting.
UoS has international research and clinical training partners, and it would be an explicit objective to connect these partners
to the project and its outcomes. For example, the School has a memorandum of understanding and shared PhD projects
with the world largest Podiatry School at La Trobe University, Melbourne. It also has as established research relationship
with a leading orthopaedic specialist Hospital in Shanghai (Huashan) China. One of their interests is in orthotic practice and
avoidance of surgery for complex cases of diabetes and arthritis. INESCOP (Spain) are a sub contractor in the project and
with UoS have participated in multiple EU framework projects, and this project will enable them (with UoS, SIH and FDMDS) be more competitive in any future AM or orthotic technology project proposal.

Publications

10 25 50
 
Description 1. The project commissioned a new 3D printing facility allowing printing of polyjet materials to give varying physical and chemical material characteristics.
2. A series of polyjet 3D printing materials have been characterised individually and as mixtures with respect to their mechanical and Clinical Regulatory (MHRA) required safety toxicological profiles.
3. A series of orthotic templates and a toolkit of orthotic interventions has been developed using a combination of 3D printing and traditional orthotic materials.
4. The project has developed a process allowing a digital prescription for an orthotic to be transformed via CAD to a print-ready design.
5. Two trials have been performed on patients at risk of diabetic foot ulcer. The first trial compared, in a real world setting over 6 months, the current process for orthotic prescription to the new digital process in terms of health and economic benefits. The second trial investigated the relative efficacy of 3D printed orthotics compared with traditional orthotics in relieving pressure under the feet of these patients. Health economics data was also collected.
6. A change management roadmap was developed to facilitate roll of the digital suplpy chain in a NHS setting, which included a "user requirement specification".
7. A business case specific to the consortia was developed based on the "state of the art" for 3D printed orthotics in the marketplace and the technology readiness of products designed in the project.
Exploitation Route Further academic and commercial funding activities
Exploration of new design freedoms for footwear and orthotic sector
New projects on the adoption of digital technologies into health care
Sectors Digital/Communication/Information Technologies (including Software),Healthcare,Manufacturing, including Industrial Biotechology,Retail

 
Description To scope regional collaborations related to digital technologies in healthcare, with specific reference to regional growth strategies (e.g. Devo Manc) and post Brexit business to University collaborations New plans for commercial production facilities and business growth linked to the University have been informed by the project outcomes.
First Year Of Impact 2017
Sector Healthcare,Manufacturing, including Industrial Biotechology
Impact Types Economic

 
Title 3D printed orthotics 
Description New 3D printed multmaterial foot orthoses have been designed, produced and tested in laboratory and clinical settings. The work involved use of computer aided design processes to define geometries and material layers that were later printed using polyjet technology. These have passed non inferiority tests in terms of efficacy under controlled conditions. They require further development for use in real world situations. Additive manufacturing was connected into existing digital supply chain for orthoses design and production. The work will continue in a project extension currently in development. 
Type Therapeutic Intervention - Medical Devices
Current Stage Of Development Refinement. Clinical
Year Development Stage Completed 2017
Development Status On hold
Impact the work has provided stakeholders (e.g. the NHS) with some of the first data on the costs and efficiencies of the orthoses services they provide. This has allowed the costs of technology to be explored and stakeholder user requiements defined.