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

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.

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.