Biorealistic synthetic model of the foot and ankle

Scholl footcare and their owners "RB" (Reckitt Benckiser) invest significantly in R&D processes to conceive, design, test and validate their new products against well defined consumer needs. This involves interactions between many different professionals, from marketing, design, innovation, regulatory and business delivery. Processes are iterative, often run against very tight schedules, and necessarily involve risk of escalating costs, failure to meet time tables, and sub optimal product performance.
RB therefore wishes to speed up, make more efficient and reduce risk within R&D activities wherever possible. One key area is the avoidance of clinical and laboratory studies that involve human participants. These are slow, costly, can be difficult to predict, and can have variable outcomes. Furthermore, due to these issues, product conception and development prior to testing can be influenced by the knowledge that downstream clinical or laboratory studies carry risk.
To address these issues it is proposed that a foot simulator model is developed and deployed within ongoing RB Scholl innovation and product development activities. The research is intended to have impact the following commercial areas:
1. Faster screening of product concepts and designs through physical testing
2. Faster time to prototype and reduced iterations of prototypes
3. Improved product design and effectiveness due to greater control, time and flexibility in the innovation process that current processes allow.
4. Scientific data underpinning product conception, design and evaluation
5. Improved internal technical file data and thereafter regulatory requirements.
6. Product claims and marketing
7. Patent on foot simulator device
The aim of the PhD is to design loading mechanisms and a phantom foot that enables the mechanical and physiological behaviour of the human foot to be mimicked under realistic conditions. The purpose of this is to enable Scholl product concepts tested in sufficiently realistic in vivo setting that innovation is sped up, risk reduced and new products conceived. The loading mechanism and foot should be modular/adaptable in order to enable variations in foot type (i.e. consumer type), physical activity and footwear, and thus ensure a close fit between consumer market and in vitro testing conditions.

The CDT students will help create solutions for amputees and people with debilitating conditions such as stroke and diabetes, reducing mortality and enabling them to live more satisfying, productive and fulfilling lives. These solutions, co-created with industry and people living with disabilities, will have direct economic and societal benefits. The principal beneficiaries are industry, P&O service delivery, people who need P&O devices, and society in general.
Industry
The novel methods, devices and processes co-created with users and industry will have a direct economic value to our industry partners (by the creation of IP, new products, and improved industry and academic links). Our CDT graduates will be the natural potential employees of our industry partners and for companies in the wider healthcare technology sector. This will help address the identified critical skills need and shortage leading to improvement in the UK's competitiveness in this rapidly developing and growing global market. The CDT outcomes will help UK businesses spread risk (because new developments are well founded) and more confidently enter new markets with highly skilled employees (CDT graduates).

P&O service delivery
Doctoral engineering graduates with clinical knowledge are needed to improve the deployment of advanced technologies in practice. Our main UK industry partner, Blatchford, stated: "As technology develops it will become easier for the end-user (the patient), but the providers (the clinicians) are going to need to have a higher level of engineering training, ideally to PhD level". The British Association of Prosthetists and Orthotists estimates that no more than ten practising P&O clinicians have a PhD in the UK. Long-term P&O clinical academic leadership will be substantially improved by the CDT supporting a select number of clinically qualified P&O professionals to gain doctorates.

Users
The innovation of devices, use of device and patient monitoring, and innovation approaches in LMIC should not only lead to improved care but also lower healthcare costs. Diabetes UK estimates that the total healthcare expenditure related to foot ulceration and amputation in diabetes was £1billion (2014-15), with 2/3 of this related to foot ulceration. Small innovations could lead to large cost savings if targeted at the right aspects of care (e.g. earlier adoption, and reducing device abandonment).
An ability to work is fundamental to a person's place in society and their sense of purpose and has a significant societal impact in all territories. This is perhaps greatest in LMIC where attitudes towards disability may still be maturing, and appropriate social care infrastructure is not always in place. In these cases, an ability to work is essential for survival.
Improved design approaches will impact on all users regardless of context, since the device solutions will better match local and individual user needs. Addressing issues related to prosthetic/orthotic device abandonment (e.g. cosmesis) and improved adherence should also lead to greater social participation. Improved device solutions will shift focus from what users "cannot do" to what they now "can do", and help progress attitudes towards acceptance of disability.
Societal
The majority of the global P&O users are of working age, and a key economic impact will be keeping users in work. The average age at amputation due to diabetes is just 52 in the USA but much younger in countries with less well-developed health care and trauma services (e.g. 38 in Iran). Diabetes UK reports that 35-50% of people are of working age at diagnosis and that there are around 70,000 foot ulcers in the UK, precursors to amputation. There is a similar concern for stroke survivors around a quarter of whom are of working age and are 2-3 times more likely to be out of work after eight years.