EPSRC - NIHR HTC Partnership Award: Medical devices and vulnerable skin: Optimising safety in design

Chronic wounds, as typified in the development of pressure ulcers (PUs) and diabetic foot ulcers, represent a huge problem for many patients, their families and the carers. Indeed, the management of such wounds can prove problematic and in some cases can be life threatening. Non-healing wounds continue to be a major issue in all health care systems, resulting in considerable distress to patients and carers and providing an estimated financial burden to the NHS of £4 billion pa. They are caused when parts of the body involving soft tissues, namely skin, muscle and fat, are exposed to prolonged mechanical loading. Although commonly involving immobile subjects who are bedridden or confined to chairs, these ulcers can arise in many other situations in which interventional medical devices introduce potentially damaging loads at the skin surface, afflicting patients of all ages. Indeed device-related ulcers represent a major healthcare problem, accounting for over 30% of hospital-acquired PUs. Current devices are based on designs employing traditional materials which are relatively stiff/rigid and do not match the compliance of fragile skin tissues. Accordingly the Network will provide a technological platform for novel designs of medical devices, incorporating suitable materials to make contact with fragile skin tissues, and manufacturing capability, which will protect them from device related injury.

The network is designed to integrate expertise from the NHS, healthcare industry, engineering consultancy and academia. It will provide cutting edge technologies and scientific understanding in order to ensure safety of vulnerable skin in situations arising from medical devices. As an example the Network will utilise imaging techniques and simple robust biomarkers to evaluate the health of loaded skin. The Network will also develop computer generated models to test device performance prior to evaluation on vulnerable patients. Materials developed in other engineering applications will be evaluated for their suitability in new and existing device designs.

Three proposed studies provide exemplars of devices attached to skin tissues; to provide breathing assistance for pre-term infants, protection for infants and adults with inherited disease and incontinence management for males. The network will engage with other partners and in particular our two supporting HTCs in Wound Prevention & Treatment and Devices for Dignity, who will prioritise subsequent activities based on identified clinical needs. These will inevitably involve engagement with other academic, clinical and industrial partners, which the Network will fully encourage.

Activity within the Network will provide benefits to patient-centric Quality of Life. Improving device design will reduce discomfort and lower the occurrence of lifelong scarring and disfigurement injuries. This will also offer the opportunity for the NHS to reduce costs associated with treatment of medical-device related skin damage and their potential recurrence. This, in turn, will attract interest from the healthcare industry to reinvest in a range of safe devices with novel materials and designs which can prevent damage to vulnerable tissues. The Network aims to extend the success of UK plc in the advanced wound dressing market, which currently embraces over 20% of the global market, into the wound prevention or avoidance market.
The wide dissemination strategy will attract other academics in the UK and Internationally to offer additional expertise to the innovation platform in the form of methodological or theoretical techniques and engage with the Network. In addition, activities from the Network will attract interest from additional Health Technology Cooperatives, thereby enhancing its scope and increasing its associations with the wider academic and clinical communities. The Network will also establish key links with organisations, such as the MHRA who regulate the medical device industry.

Technological advances in medicine has raised societal expectations in such a way that there is an increase in infants who survive childbirth and childhood and an increase in life expectancy of adults with long term conditions e.g. diabetes, cancer. In order to provide this advance there has been an expansion of medical devices which interface with patient's skin. However, some of these device-related interventions can cause trauma and soft tissue damage.

The network will expand knowledge and drive fundamental scientific advances by providing a forum for expansive multidisciplinary research. The aims of the proposed research will be governed by key pathways, namely; research to address known clinical problems, device designs are feasible for development by industry, each of which are underpinned by established research criteria. In order to achieve this expertise from bioengineering, health sciences, engineering design, medical physics (including imaging), computational methods and material science will be combined.

The proposed Network also aims to prevent hospital acquired wounds, which currently costs the NHS £4 billion pa. Economic Impact will be achieved through the development of novel designs and material features for medical devices which will lead to the generation of new product creating opportunities for the supply chain. The Network will provide a pathway to end-users (via the Cooksey model) by providing an accessible framework of clinical research. The Networks aims to extend the success of UK plc in the advanced wound dressing market, which currently embraces over 20% of the global market (worth $5 billion and set to triple in ten years) into the wound prevention market.

Establishing key links with policy making organisations such as the MHRA will increase the profile of medical device-related injury. Organising bodies which regulate safety and distribution of devices will play a pivotal role in providing institutional backing for changes in the design and manufacture of medical devices. The Network will also provide a pre-clinical platform for more rigorous testing of devices used in the healthcare setting, which will include pre-clinical simulation of new devices interacting with the skin. We will also look to inform clinical and technical guidelines provided by key national agencies such as NICE and BSI, in areas associated with "medical devices and wound prevention".

The Network output will affect Quality of Life in several aspects. For example, devices which safely interact with patients will be more comfortable to wear, thus improving their compliance and reducing the incidence of long-term injury. In addition, safe medical devices can be maintained in-situ for prolonged periods, stabilising the medical condition and reducing the need for repeat interventions.

The Network will have a number of Beneficiaries which will include academics, industrialists, clinicians and policy makers. Successful collaborations within and beyond the network will facilitate multidisciplinary research and provide a platform for novel, translational ideas. Partners will also be encouraged to develop a series of KTPs, and collaborate with established centres of excellence e.g. Strathclyde Institute of Medical Devices.

The network will actively communicate and engage with clinical, industrial, academic and organisational communities to raise the awareness of medical device-related injury. Clinical recognition will be promoted through the established clinical links proposed within the Network and developed through dissemination strategy. In addition the regularly updated website will include a comprehensive database of relevant research expertise within the HTC partnership and a search facility to enable initial contact between researchers, clinicians and industrialists. The website will also provide information relating to upcoming meetings and conferences of relevant to the multidisciplinary community.