EPSRC-NIHR HTC Partnership Award 'Plus': Medical Devices and Vulnerable Skin: Intellegent sensing to promote self-management.

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

Abstract

Modern medicine has been transformed in recent decades, with advances leading to increased life expectancy and a significant number of individuals living with long term health conditions. This has, in part, been due to the development of advanced medical devices which provide a range of interventions, including respiratory support and mobility aids. Many of these devices have to interface with the body, which creates a mechanical force against the underlying skin and soft tissues. An individual ability to withstand these forces depends on the vulnerability of skin tissues, with factors such as age, vascularity and previous wounds contributing to their tolerance. Clinicians provide medical devices to match the patient needs at that time of fitting, ensuring the device is both functional and comfortable. Inevitably, circumstances and demands change with time for the individual, which can impair the effectiveness of the device and in some cases cause harm. Indeed, evidence has implicated medical devices in the development of over 30% of pressure ulcers acquired in hospitals. These pressure ulcers contribute to an NHS financial wound care burden of £4Bn/yr. Subsequently, many devices are discarded, thus compromising individual needs and costing the healthcare provider valuable resources.

Medical Devices and Vulnerable Skin NetworkPlus (MDVSNplus) will integrate research expertise and motivate clinicians and industrialists to provide intelligent strategies to maintain medical device longevity and patient comfort in a range of clinical settings. It brings together leaders in the fields of sensing, imaging and computer simulation to provide the necessary expertise to evaluate the impact of new and existing medical devices which attach to vulnerable skin. We aim to use these capabilities to develop a series of intelligent mechanisms, for example sensors, which can monitor the functionality and safety of devices over time. MDVSNplus will also target methods of detecting when a device is causing harm to vulnerable skin and create an early warning system for patients and carers.
MDVSNplus will encourage new research partners by offering funding for a series of feasibility projects which are aligned with our core aims. Each potential proposal will l be reviewed by an independent innovation panel and assessed based on the clinical need and feasibility to translate the research findings to practice. Funding to the MDVSNplus will also be used to host outreach events for clinicians and end users in order to provide evidence based guidance and education on the choice and application of medical devices. The MDVSNplus will also work closely with colleagues based in the healthcare sector, who specialise in medical devices and wound prevention, to bridge the gap between research findings and the application into clinical practice.

Through these funded projects the MDVSNplus will provide innovation to improve quality of life in individuals who depend on the use of medical devices. 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. It will also ensure that devices which are current being supplied can be optimised in terms of functionality and longevity, providing the best value for money. We also envisage that new medical devices and sensing technologies will attract interest from the healthcare industry to reinvest in novel medical device technologies. In order to sustain the impact of the research findings the applicants will lobby key agencies such as the MHRA (UK medical device regulator), to raise the awareness of medical device related injuries and inform legislation surrounding device design and application. Research output from the MDVSNplus will also contribute to clinical guidelines surrounding the application of medical devices and, where necessary, new standards of medical device testing.

Planned Impact

The MDVSNplus will acquire scientific knowledge and create innovative technological solutions to minimise the risk of medical device-related pressure ulcers (MDRPUs). These advances will result in novel device designs which can safely interface with individuals and meet their functional needs. The Network has been designed to maximise participation with new and existing partners through a series of funded feasibility studies. The global aim of the MDVSNplus is to bring disruptive technologies to the medical device market to promote sustainable evolution and long-term healthcare improvements. Successful impact will be provided through:

End Users and Clinicians
Research will improve QOL in individuals by providing them with safe medical devices for managing long-term medical conditions. Improved designs will reduce discomfort and lower the incidence of injuries, thus reducing the financial burden on healthcare providers (NHS wound care costs ~ £4Bn/yr). Safe medical devices will also be effective for prolonged periods, obviating the need for repeat interventions. Engagement with end-users, clinicians and managers will ensure devices are adopted, driven by the ultimate goal of self-management with appropriate safe medical devices.

Industry and the Economy
The UK has a strong medical devices industry base, employing ~ 50,000 mainly in SME's. Our research activities are designed to enable UK plc to create devices adopted worldwide and for patients to realise the benefit of these innovations. These devices using advanced manufacturing capabilities will lead to wealth generation leading to opportunities for the supply chain and the creation of skilled jobs.

Knowledge Transfer
MDVSNplus will disseminate the research outputs through scientific journals, conferences and lobbying activities. Knowledge transfer will be enhanced through studentships, mobilisation schemes and collaborative funding with academia. Knowledge Transfer Partnerships will be created with industrial collaborators to facilitate the translation of scientific advances to device manufacture. Continuous education on the potential risk of medical devices will remain a key target.

Regulation
MDVSNplus will support the process of device evaluation through participation on BHTA Standard Committees and by contributing to clinical guidelines e.g. NICE. Lobbying activities will target the Medicines and Healthcare products Regulatory Agency (MHRA) to advocate proportionate regulation, including approval of new technologies which ensure timely benefits to the patient. Consultations with industrialists, clinicians and academics will ensure full understanding of, and alignment with, ethical standards for device development. New devices with regulatory approval (CE marking) will be assessed through clinical trials, incorporating PPI, funded by appropriate agencies.

Communications and engagement
MDVSNplus will arrange innovation workshops, education days with key clinical user groups and training days with industry. These will provide evidence based guidelines on practical issues, such as attachment of devices, and strategies to manage vulnerable skin. Knowledge gained will also be available to existing local and UK events attended by clinicians such as ISPO, Tissue Viability Society. Where appropriate, proposed activities joint will be shared with other Networks, for example, the IMPRESS network whose focus on incontinence technologies has resonance with our activities.
MDVSNplus will expand the current website platform (www.soton.ac.uk/mdvsn ). A forum will be available for clinicians and end users who experience MDRPUs to conduct audits and record their findings. This data will be shared with MHRA, in an equivalent manner to that available in the US FDA website. Applicants are also in an ideal position to influence Guidelines in the US, Europe and the Pan-Pacific in the Prevention of MDRPUs.

Publications

10 25 50
 
Title Network Spidergram 
Description An illustration of the academic, clinical and industrial members within the Network and their involvement in our research projects. 
Type Of Art Artwork 
Year Produced 2014 
Impact Useful tool to quickly illustrate links between academic, clinical and industrial members within the Network 
URL http://www.southampton.ac.uk/mdvsn/about/network_partners.page
 
Description We have identified a series of robust biomarkers released from the skin, which indicate the potential for early skin damage following a period of wearing medical devices intended to manage acute and long-term medical conditions.

The translation of scanning technologies to define the shape of the residuum of amputation stumps for CAD/CAM purposes has attracted funding through the EPSRC Global Challenge Research Fund (GCRF) for adoption in Lower/Middle Income Countries e.g. Cambodia. The team has ensured that the bioengineering technologies are socially and culturally acceptable through the collaboration with local clinics e.g. Cambodian School of Prosthetics and Orthotics, including education to provide the relevant information for use in their practice.

Our objective to categorise tissue tolerance with respect to pressure ulcer risk was developed in an EPSRC CASE project designed to develop an algorithm which predicts the magnitude and frequency of movement from interface pressure data. This was achieved using novel Machine Learning techniques.
Exploitation Route The biomarker work is progressing in a 2019 awarded 4 year EU ITN grant "STINTS: Skin Tissue Integrity under Shear".

The Innovation Training Network is providing multi-disciplinary research training in understanding the complex biomechanical and biochemical pathways leading to loss of skin integrity, following the exposure to prolonged pressure, friction and shear forces. The project involves 3 ESRs based in Southampton, out of a total 13 ESR positions located around Europe, who will specifically focus on the assessment of biomarkers sampled from the skin surface, to identify the status of loaded skin and soft tissues. These biomarkers will include sampling sebum and sweat non-invasively from the skin before, during and after mechanical insults caused by the application of medical devices. The aim of this research is to identify the temporal profiles of robust biomarkers, which can provide an early detection of skin damage and indicate the period in which tissues need to fully recover following a range of mechanical-induced insults i.e. pressure, shear, friction. This will have important implications for a range of clinical scenarios where chronic wounds can develop from prolonged loading e.g. pressure ulcers, diabetic foot ulcers, device-related skin damage. The translation of scanning technologies project continues in both the EPSRC Global Challenge Research Fund (GCRF) for adoption in Lower/Middle Income Countries e.g. Cambodia and in the recent projects involving respiratory face masks.

Algorithm development is being evaluated against data from patients in the community, PROMISE, and those specifically with spinal cord injury.
Sectors Healthcare,Manufacturing, including Industrial Biotechology

URL https://www.southampton.ac.uk/mdvsn/projects/index.page
 
Description MDVSNPLUS involved a multidisciplinary consortium to evaluate and optimise cutting-edge technologies to improve the safety of interventional and therapeutic medical devices and minimise skin damage in vulnerable patients. Through international collaborations, the multidisciplinary network team has optimised the design of medical devices, providing benefits to patient safety while maintaining device functionality and delivering further commercial opportunities. It has led to the development of novel monitoring technologies, national policy changes and new international clinical guidelines, all of which have improved pressure ulcer prevention. As a direct result of the MDVSN funding the group has submitted an Impact Case Study entitled "Technologies to improve the safety of medical devices interfacing with vulnerable skin" to UoA3 REF 2021 Panel. Economic and Societal Impact The economic impact has been demonstrated through collaboration with industrial partners who have realised the research findings into successful commercial products, for example the Aerospacer Mattress (Medstrom Ltd, UK) and Microclimate Management (MCM) Mattress (HillRom, USA). These devices have been sold to international markets having been modified based on research findings to optimise performance. The network has also led to the development of new medical devices, for example a first-in-kind penile clamp for males post- prostatectomy with associated clinical guidelines (funded by Prostate Cancer UK). The commercial impact of MDVSNPLUS continues to be realised through a spin out company, Radii devices Ltd, which provides cutting-edge technology to support prosthetic and orthotic device designs. The company was recently successful in an Innovate UK grant (2022-2024) and has also developed a strong international collaboration with Philips Respironics (USA). Public, private or third/voluntary sectors Members of MDVSNPLUS network have been 'at the forefront of lobbying activities aimed at improving the reporting of device related pressure ulcers'. Based on insights accumulated through the body of underpinning research, NHS Improvement have changed reporting policy in England to include device-related damage, marking the first time that device-related pressure ulcers could be documented by clinicians. This reporting metric was implemented in April 2019 when it was incorporated into Pressure ulcers: revised definition and measurement framework. The network have also worked with NHS Improvement to co-create educational videos for clinicians to support best practice for medical device selection and application, which have been viewed ~24,000 times since their release in April 2020. MDVSNPLUS collaborated with the British Healthcare Trades Association (BHTA) and the International Organization for Standardisation (ISO) on the development of new standards for two sectors specialising in pressure ulcer prevention: seating and support surfaces. Disseminating their scientific evidence at support surface meetings and international symposiums in London and Las Vegas to educate manufacturers on the need to improve device design. This 'has resulted in the collation of extensive data to create a better understanding of the issues of support surfaces and their interactions with human skin. The Group has also provided underpinning knowledge to international definitions, published by ISO (ISO 21856 B.23: Forces on soft tissues of the human body, July 2019) to aid the design of a new standard, adopted within an ISO framework (ISO/TC 173/WG 11). Research output from MDVSNPLUS also contributed to international guidelines published by the National Injury Ulcer Advisory Panel (NPIAP), European Pressure Ulcer Advisory Panel (EPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA) in both 2014 (Schoonhoven) and 2019 (Worsley). The Prevention and Treatment of Pressure Ulcers/Injuries: Clinical Practice Guideline is available in 14 languages and represents the leading international consensus to standardise and improve pressure ulcer prevention. Papers from the network were cited in a number of key sections e.g. aetiology, support surfaces and medical devices. Impact to academia Our key research findings have included the characterisation of the skin response to representative clinical scenarios e.g. prolonged lying and the application of medical devices. The team have employed a range of sensing technologies to evaluate the interactions between an individual and a medical device, enabling monitoring of pressure ulcer risk. These technologies have involved pressure arrays, shear sensors and microclimate monitoring. The effects of these loads on skin health have been established using robust biophysical and biochemical markers (See Network citations). The team have worked with industrial collaborators to develop novel sensors, including an innovative flexible pressure and shear sensor that can be integrated within a prosthetic device for amputees (MRC Biomedical Catalyst grant with Blatchfords, UK, 2014-2016). This provides real-time patient feedback regarding the interface conditions, used to monitor risk of skin damage. Members of the team have also employed commercial sensing systems and advanced data processing to monitor individuals' posture and mobility in the acute and community clinical settings (Health Foundation supported QI study with Cornwall Foundation Trust, 2017-2020). Here novel algorithms based on machine learning are used to estimate key indicators which are clinically relevant for personalised patient care. These technologies are providing the platform to improve self-management and enable efficient care for vulnerable individuals. Partners within the network have also successfully employed artificial intelligence (AI) data processing, embedded within the monitoring platforms. This has created the basis for efficient use of the data and clinically relevant parameters to support self-management strategies for individuals using devices and personalised care for clinicians interacting with the technology. The MDVSNPLUS award has resulted in several ongoing legacy projects which have been funded by UKRI (e.g. 'BE-SAFE RPE' EP/V045563/1, 2020-2022) the National Institute for Health Research ( 'LOMIS' NIHR201315, 2021-2024), new industry partners (Care of Sweden, Linet), charities ('OASIS' project funded by Scleroderma UK, 2020-2022) and the EU ('STINTS' Marie Curie ITN 2019-2023). These projects cross different academic disciplines within healthcare technologies and involve partners around the world. The NetworkPlus grant acted as a catalyst for these projects and has long-standing impact beyond the completion of the award (2014-2019).
First Year Of Impact 2015
Sector Healthcare,Manufacturing, including Industrial Biotechology
Impact Types Economic,Policy & public services

 
Description British Health Trade Association
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact Adviser to Bed Section Mattress Standard Working Group from 2015, onwards. In October 2018, Professor Dan Bader chaired the BHTA annual Symposium, highlighting current thinking that will shape the future of pressure ulcer care.
URL https://www.southampton.ac.uk/mdvsn/news/events/2018/10/bhta2018.page?
 
Description Scientific Board Member
Geographic Reach Multiple continents/international 
Policy Influence Type Participation in a advisory committee
Impact Strategies to prevent breakdown of vulnerable skin.
 
Description Support Surface Group
Geographic Reach National 
Policy Influence Type Membership of a guideline committee
Impact ISO/TC 173/WG11 Committee Member - Support Surfaces When Lying Down
 
Description CASE award
Amount £93,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 09/2016 
End 09/2019
 
Description EPSRC CYCLOPS
Amount £47,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 04/2018 
End 06/2019
 
Description EPSRC IAA 2017 - Medical Device and Vulnerable Skin Network (MDVSN) Plus
Amount £21,000 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 07/2019 
End 03/2020
 
Description Enterprise Fellowship: Dr Joshua Steer
Amount £50,000 (GBP)
Organisation Royal Academy of Engineering 
Sector Charity/Non Profit
Country United Kingdom
Start 03/2019 
End 02/2020
 
Description European Pressure Ulcer Advisory Panel (EPUAP)
Amount € 5,000 (EUR)
Organisation European Pressure Ulcer Advisory Panel 
Sector Charity/Non Profit
Country Czech Republic
Start 02/2018 
End 03/2019
 
Description Global Challenges Research Fund (GCRF)
Amount £909,511 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 02/2018 
End 01/2021
 
Description LOad Monitoring and Intervention System (LOMIS) to prevent diabetic foot ulceration
Amount £965,000 (GBP)
Funding ID NIHR201315 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 01/2021 
End 12/2023
 
Description MICA: Integrated interfacial sensors for lower limb prosthetic applications
Amount £590,000 (GBP)
Funding ID MR/L013096/1 
Organisation Medical Research Council (MRC) 
Sector Public
Country United Kingdom
Start 04/2014 
End 02/2016
 
Description Marie Sklodowska-Curie Fellow ITN
Amount £3,000,000 (GBP)
Organisation European Commission 
Sector Public
Country European Union (EU)
Start 01/2019 
End 12/2022
 
Description NIHR Surgical MedTech Co-op
Amount £14,000 (GBP)
Organisation NIHR Diagnostic Evidence Co-operatve 
Sector Public
Country United Kingdom
Start 03/2019 
End 06/2020
 
Description NIHR128865 - Prevention and treatment of Incontinence-Associated Dermatitis (IAD) through optimising care: development and feasibility of the IAD Manual (PREVENT-IAD)
Amount £589,908 (GBP)
Funding ID NIHR128865 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 03/2020 
End 02/2022
 
Description NewMind NetworkPLUS
Amount £18,500 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 02/2018 
End 01/2019
 
Description PROMISE
Amount £497,191 (GBP)
Funding ID 509449 
Organisation The Health Foundation 
Sector Charity/Non Profit
Country United Kingdom
Start 11/2017 
End 10/2020
 
Description Paediatric Healthcare Technology Theme
Amount £143,000 (GBP)
Organisation National Institute for Health Research 
Department NIHR Biomedical Research Centre
Sector Public
Country United Kingdom
Start 09/2015 
End 12/2017
 
Description SRUK-EPSRC sandpit call. Objective Assessment of Skin and Soft tissues (OASIS)
Amount £117,939 (GBP)
Organisation Engineering and Physical Sciences Research Council (EPSRC) 
Sector Public
Country United Kingdom
Start 03/2021 
End 02/2022
 
Description UKRI COVD Rapid Response call: A BioEngineering approach for the SAFE design and fitting of Respiratory Protective Equipment (BE-SAFE RPE)
Amount £440,985 (GBP)
Funding ID EP/V045563/1 
Organisation United Kingdom Research and Innovation 
Sector Public
Country United Kingdom
Start 12/2020 
End 06/2022
 
Title Early detection of changes in loaded human skin 
Description Biomarker release as the main outcome measure. MDVSNPlus has supported the development of techniques to assess the skin response to prolonged loading of medical devices. 
Type Of Material Model of mechanisms or symptoms - human 
Year Produced 2017 
Provided To Others? No  
Impact Using biomarker activity in sebum and sweat, our research has developed a methodology to estimate robust biomarkers, which reflect the status of loaded skin and the refractory period needed for skin recovery. (Worsley et al. 2016, Soutens et al. 2019 a and b). This will be further examined in the EU ITN "STINTS". 
 
Title Lymphatic function in human skin 
Description MDVSN has supported the development, for the first time, of minimally invasive techniques to assess lymphatic function in loaded human skin. In addition, the techniques have been adopted to examine the effectiveness of compression garments to manage lymphoedema 
Type Of Material Physiological assessment or outcome measure 
Year Produced 2017 
Provided To Others? No  
Impact Using ICG fluorescence imaging techniques, our research has developed an analytical methodology to estimate robust parameters which reflect the dynamic behaviour of transient lymphatic packets. This identified the role of lymphatic occlusion on the aetiology of skin breakdown (Gray et al. 2016). In addition, this approach has proved successful in monitoring the short-term effects of external compression garments on lymphatic function (Lopera et al. 2017). 
 
Title Changes in tissue composition and load response after transtibial amputation indicate biomechanical adaptation 
Description Dataset for article in "Annals of Biomedical Engineering" titled "Changes in Tissue Composition and Load Response After Transtibial Amputation Indicate Biomechanical Adaptation". 
Type Of Material Database/Collection of data 
Year Produced 2021 
Provided To Others? Yes  
URL https://eprints.soton.ac.uk/451001/
 
Title Finite Element Modelling 
Description MDVSN has supported the development of computer simulation (Finite Element Modelling) to predict soft tissue stresses and strain patterns resulting from the application of medical devices. The novel research has focused on two key medical devices; penile clamps and respiratory masks (Levy et al 2017; Verberne et al. 2020). The research has been collaborative in nature with named colleagues from the University of Tel Aviv (Levy and Gefen) and Eindhoven University of Technology (Oomens) 
Type Of Material Computer model/algorithm 
Year Produced 2015 
Provided To Others? Yes  
Impact Computer simulation provides the opportunity basis to conduct sensitivity analysis on both the design and material properties of devices to optimise the safety at the patient-device interface. It facilitates the reduction in the number of lab-based experiments and provides scientific evaluation of medical devices - in silico - thus establishing providing a design template for improved device features for use with patients with vulnerable skin. 
 
Description Apex 
Organisation Atacama Pathfinder Experiment
Country Chile 
Sector Charity/Non Profit 
PI Contribution Research into new support surface
Collaborator Contribution Manufacturer of specialist mattresses and funder of research project
Impact Performance indicator on existing and future products
Start Year 2016
 
Description Care of Sweden 
Organisation Care of Sweden
Country Sweden 
Sector Private 
PI Contribution Research project: Evaluating the performance of an immersion mattress in terms of tissue viability: effects of posture and immersion.
Collaborator Contribution Funding for project
Impact Ongoing project
Start Year 2018
 
Description Devices for Dignity HTC 
Organisation National Institute for Health Research
Department NIHR Devices for Dignity Healthcare Technology Co-Operative
Country United Kingdom 
Sector Public 
PI Contribution Joint networking events and research projects
Collaborator Contribution Joint networking events
Impact Facilitations of PPI activity
Start Year 2014
 
Description ESSITY (formerly SCA) of Sweden 
Organisation Essity
Country Sweden 
Sector Private 
PI Contribution Research into the benefits of prophylactic incontinence pads for use at the skin-support surface interface.
Collaborator Contribution Manufacturer of prophylactic pads for the loaded support surface and funder of research project
Impact Performance indicator on existing and future products
Start Year 2017
 
Description Edinburgh 
Organisation University of Edinburgh
Country United Kingdom 
Sector Academic/University 
PI Contribution Awarded funded for project: Conformable and wireless-interrogated pressure sensors for medical compression garments
Collaborator Contribution Working on project: Awarded funded for project: Conformable and wireless-interrogated pressure sensors for medical compression garments
Impact i) A successful EPSRC Impact Acceleration proposal: Optimum swimwear compression for British swimming athletes, which included industrial collaboration/contribution from both Pentland Group (i.e. Speedo) and Semefab. ii) A further additional responsive mode EPSRC proposal on turbine blade monitoring is currently on pause. iii) Dr. Hands presented at an invited talk "Smart compression garments for DVT, lymphoedema & dietetic ulcers at the EPoSS Annual Forum & MNBS meeting in Thessaloniki, in October 2018. After the above EPSRC Impact Acceleration project was successfully completed (March 2020), Semefab has now hired a new staff member who will be working on translating the technology to their fabrication facilities. They have thus demonstrated an ongoing commitment to continue their collaboration with us for development of our pressure sensors.
Start Year 2018
 
Description Essity 2020 
Organisation Essity
Country Sweden 
Sector Private 
PI Contribution Project to investigate the role of pH in Incontinence Associated Dermatitis when using absorbing products
Collaborator Contribution Joint collaboration on project
Impact N/A - project ongoing
Start Year 2020
 
Description Footfalls and Heartbeats Ltd 
Organisation Footfalls and Heartbeats
Country United Kingdom 
Sector Private 
PI Contribution Funded to work on a research project with Nottingham University.
Collaborator Contribution Working on a research project involving "Optical fibre sensing at the interface between tissue and orthosis or prosthesis".
Impact ongoing project
Start Year 2017
 
Description Hill-Rom 
Organisation Hill-Rom
Country Global 
Sector Private 
PI Contribution Performance evaluation of a range of mattresses designed to control microclimate and periodically redistribute pressures
Collaborator Contribution Manufacture of range of specialist mattresses and project funding
Impact Performance indicator on existing and future products. Co-developed ClinActiv+ MCM™ (Microclimate Management) latest advanced therapy surface system from Hill-Rom.
Start Year 2014
 
Description Imperial 
Organisation Imperial College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Imperial Confidence in Concept (ICiC) - 2019 - Project: A device to prevent pressure ulcers using novel pressure equalisation technology
Collaborator Contribution Funding for the above project
Impact Ongoing project
Start Year 2019
 
Description Impress Network 
Organisation University of Leeds
Country United Kingdom 
Sector Academic/University 
PI Contribution MDVSN funded partner project 'Breaking Barriers in Skin Sensing Assessment'
Collaborator Contribution Impress working on 'Breaking Barriers in Skin Sensing Assessment project within our Vulnerable Skin and Incontinence area of interest.
Impact Ongoing project. The results of the 12 month project was shared with MDVSNPlus.
Start Year 2016
 
Description Industrial KTP for smart prosthetic liners 
Organisation Blatchford Clinical Services
Country United Kingdom 
Sector Private 
PI Contribution Provided academic expertise and mentoring
Collaborator Contribution Commerical developement of soft liners
Impact Ongoing research project
Start Year 2018
 
Description Kings College London (Plus) 
Organisation King's College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Named Co-I on MDVSNPlus award - awarded funding for project
Collaborator Contribution Named Co-I on MDVSNPlus award and worked on project: Imaging the mechanical properties of the vulnerable skin
Impact Working on project: Imaging the mechanical properties of the vulnerable skin
Start Year 2016
 
Description Linet 2021 
Organisation Linet
Country Czech Republic 
Sector Private 
PI Contribution Funded research projects on alternating pressure modes, microclimate and movement monitoring and employment of 12 month research assistant.
Collaborator Contribution Funding of £90k
Impact Not applicable as yet
Start Year 2021
 
Description Linkoping University 
Organisation Linkoping University
Country Sweden 
Sector Academic/University 
PI Contribution Research into the identification of biomarkers and optical indicators for early detection and prevention of pressure ulcer formation in vulnerable patient populations.
Collaborator Contribution Working jointly on projects and applications
Impact Ongoing projects
Start Year 2018
 
Description Medstrom (PLUS) 
Organisation medstrom healthcare ltd
Country United Kingdom 
Sector Private 
PI Contribution Research into the pressure relief characteristics and microclimate control of new support surfaces
Collaborator Contribution Manufacturer of specialist mattresses and funder of research project
Impact Co-development of new AeroSpacer revolutionary therapeutic mattress evidenced to reduce temperature, moisture and humidity, reduce shear strain, provide effective pressure redistribution to assist in the prevention and treatment of moisture lesions and pressure ulcers. https://www.medstrom.com/products/aerospacer-range/ Publication of paper Worsley PR et al (2016). An evaluation of fluid immersion therapy for the prevention of pressure ulcers in Clinical Biomechanics, 40, pp 27-32.
Start Year 2016
 
Description NIHR WoundTec HTC 
Organisation NIHR WoundTec HTC
Country United Kingdom 
Sector Public 
PI Contribution Professor Bader was Co-I of original application and has supported successful continuation of funding from NIHR. He contributed to its final report (submitted April 2018)
Collaborator Contribution Joint networking events
Impact Support provided for successful NIHR paediatric call
Start Year 2014
 
Description Nottingham 
Organisation University of Nottingham
Country United Kingdom 
Sector Academic/University 
PI Contribution MDVSN funded partner project 'Development of a prototype optical fibre CO2 skin gas sensor'
Collaborator Contribution University of Nottingham worked on 'Development of a prototype optical fibre CO2 skin gas sensor' project.
Impact Ongoing project. The results of the 12 month project was shared with the MDVSNPlus.
Start Year 2016
 
Description Nottingham (Plus) 
Organisation University of Nottingham
Country United Kingdom 
Sector Academic/University 
PI Contribution Named CO-I on MDVSNPlus Award. Awarded funding for project.
Collaborator Contribution Named CO-I on MDVSNPlus Award and worked on funded project: Optical fibre sensing at the interface between tissue and orthosis or prosthesis
Impact MDVSN funded partner project on 'Optical fibre sensing at the interface between tissue and orthosis or prosthesis' Publication of papers: "Fibre-optic biosensors in healthcare applications", Liang liang Liu, University of Nottingham. Symposium on Fibre Optic and Photonic Sensor for Industrial and Healthcare Applications: New Challenges and Opportunities, Rank Foundation. Held at Grasmere, Cumbria in October 2018 Submitted to Sensing and Bio-sensing Research Journal: Manuscript title: A reflection-mode fibre-optic sensor for breath carbon dioxide measurement in healthcare Another paper acknowledging MDVSN was https://www.spiedigitallibrary.org /conference-proceedings-of-spie/10340/103400X/Optical-fibre-sensin g-at-the-interface-between-tissue-and-medical/10.1 117/12.2269811.short?SSO=1
Start Year 2016
 
Description Peacocks 
Organisation Peacocks Medical Group Ltd
Country United Kingdom 
Sector Private 
PI Contribution Working on a joint research project related to lower limb orthoses
Collaborator Contribution Working on a joint research project
Impact On-going development
Start Year 2016
 
Description Philips Consumer Lifestyle 
Organisation Philips Healthcare
Country Netherlands 
Sector Private 
PI Contribution Identification of the response of sensitive skin to repetitive use of personal healthcare products e.g. electrical shavers
Collaborator Contribution Working on joint project
Impact Ongoing project
Start Year 2019
 
Description Philips Respironics (Enterprise) 2020 
Organisation Philips Research
Country United States 
Sector Private 
PI Contribution Development of the fundamental 3D face-mask model and multi-individual model using mesh morphing approaches
Collaborator Contribution N/A
Impact Ongoing project
Start Year 2020
 
Description Philips Respironics Research (2020) 
Organisation Philips Research
Country United States 
Sector Private 
PI Contribution An evaluation of Adhesives materials for respiratory mask designs to safely interface with the skin
Collaborator Contribution N/A
Impact Project ongoing
Start Year 2020
 
Description Queen Mary University of London 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution MDVSN funded partner project 'Design and in vitro testing of soft, biodegradable electrochemical sensors for O2 and glucose monitoring at wound sites'
Collaborator Contribution Queen Mary University of London worked on a project focused on the 'Design and in vitro testing of soft, biodegradable electrochemical sensors for O2 and glucose monitoring at wound sites' in alignment with the core aims of the MDVSNPlus.
Impact Paper currently in progress.
Start Year 2016
 
Description Queen Mary University of London (Plus) 
Organisation Queen Mary University of London
Country United Kingdom 
Sector Academic/University 
PI Contribution Awarded funding for project: Early Detection of Pressure Injury Using Novel Wireless Epidermal Textile Sensors in Wheelchair users Living with Spinal Cord Injury
Collaborator Contribution Worked on project: Early Detection of Pressure Injury Using Novel Wireless Epidermal Textile Sensors in Wheelchair users Living with Spinal Cord Injury
Impact Based on preliminary results, the research team hope to extend the project to apply the device on a cohort of healthy volunteers and people with Spinal Cord injury.
Start Year 2016
 
Description ScarletRed 
Organisation Scarletred
Country Austria 
Sector Private 
PI Contribution Employed in a number of research projects
Collaborator Contribution Objective assessment and monitoring of the erythema index on prolonged use of medical devices.
Impact Objective assessment and monitoring of the erythema index and its relationship with other indicator of mechanical induced damage (e.g. cytokine release in sebum and TEWL). Examination of the effects of pressure in the presence and absence of shear. Research articles are being prepared.
Start Year 2016
 
Description Sumed International 
Organisation Sumed International (UK) Ltd
Country United Kingdom 
Sector Private 
PI Contribution Two research projects: "Bioengineering technologies to monitor movements in supported postures: a potential strategy to prevent pressure ulcers" and an evaluation of pressure monitoring technologies to create an "Individualized Pressure Ulcer Prevention Plan" for patients with Spinal Cord Injury.
Collaborator Contribution Funding of research project and partner on EPSRC CASE Studentship Award
Impact Joint research projects, Joint clinical workshops and PhD CASE Award. Papers Caggiari et al. (2019 and 2020)
Start Year 2016
 
Description Sumitomo Riko 
Organisation Sumitomo Corporation
Country Japan 
Sector Private 
PI Contribution Research project:SR Soft Vision Test Plan for Usability and Validity
Collaborator Contribution Funded project
Impact Report supported the successful CE marking of the product.
Start Year 2017
 
Description TMIC-IMAG Lab, University of Grenoble 
Organisation University of Grenoble
Country France 
Sector Academic/University 
PI Contribution Worked on joint projects involving Machine Learning
Collaborator Contribution Provided Machine Learning expertise and support
Impact Provided Machine Learning expertise and support for PhD project. Journal paper is currently under review.
Start Year 2018
 
Description Texisense 
Organisation Texisense
Country France 
Sector Private 
PI Contribution Worked on joint project with Machine Learning input
Collaborator Contribution Provided Machine Learning expertise and support
Impact Provided Machine Learning expertise and support
Start Year 2018
 
Description UCL 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Awarding of funding for project: Developing bespoke flexible sensors for prosthetic and orthotic liners
Collaborator Contribution Working on project: Developing bespoke flexible sensors for prosthetic and orthotic liners
Impact Paper drafted for submission: "A deep learning approach to non-linearity in wearable stretch sensors"
Start Year 2018
 
Description University of Sheffield 
Organisation University of Sheffield
Country United Kingdom 
Sector Academic/University 
PI Contribution Awarded funding for research project:Towards a synthetic test-bed to predict damage done during vulnerable skin-textile interactions in aggressive environments as used in incontinence solutions
Collaborator Contribution Awarding of funding.
Impact Ongoing project
Start Year 2018
 
Description University of Southampton 
Organisation University of Southampton
Department School of Electronics and Computer Science Southampton
Country United Kingdom 
Sector Academic/University 
PI Contribution Funded research project: Battery free smart bandage
Collaborator Contribution Research project: Battery free smart bandage
Impact Ongoing project
Start Year 2018
 
Description Wessex AHSN 
Organisation Wessex Academic Health Science Network
Country United Kingdom 
Sector Private 
PI Contribution Funding opportunities
Collaborator Contribution Support with promotion of events and research projects
Impact Support with promotion of events and research projects
Start Year 2016
 
Company Name RADII DEVICES LTD 
Description Radii Devices is a spinout using software to improve prosthetic limb design. The business is founded by Dr Joshua Steer, who is building upon his postgraduate research at the University of Southampton. He is now working as a Royal Academy of Engineering Enterprise Fellow to commercialise his research applying state-of-the-art modelling techniques to the design of sockets for prosthetics limbs, increasing quality of life for people with amputation and saving healthcare providers valuable time and cost. The scope of the company's medical device R&D consultancy has since increased, with a large collaborative project to develop a modelling platform for the design and evaluation of non-invasive respiratory masks. 
Year Established 2019 
Impact Postgraduate student Joshua Steer has built upon an undergraduate project in prosthetics to forge a research pathway and resultant spinout company that will provide life-changing benefits for people with limb loss. His business, Radii Devices, is applying state-of-the-art biomechanical modelling to give clinicians real-time prediction of fit during the socket design process. Diabetes is a leading cause of amputation around the globe and is forecast by the International Diabetes Foundation to have increased by 55% in 2035. In the US alone, the number of people with amputations is projected to double to four million by 2050. Radii Devices' technology will enable healthcare providers to achieve necessary time and cost savings in this context of increased demand. The company now employs 5 members of staff and has attracted substantive hedge funding (£150k, 2020).
Website https://futureworlds.com/radii-devices-improving-prosthetic-limb-design/
 
Description Annual Sandpit/Workshop (MDVSNPLUS) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact The sandpit event of May 2017 was used as a platform to summarise the achievements of MDVSN and outline the future objectives within MDVSNPlus, with details of outcome of three feasibility studies each with the core aim of intelligent sensing to promote self-management.
Year(s) Of Engagement Activity 2016,2017,2018
URL http://www.southampton.ac.uk/mdvsn/news/2016/10/mdvsn-third-sandpit-2016.page?
 
Description EPUAP 2020 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Prof Bader and Dr Worsley chaired and presented at medical devices session
Year(s) Of Engagement Activity 2020
 
Description EWMA 2020 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Prof Bader and Dr Worsley presented on medical device-related pressure ulcers
Year(s) Of Engagement Activity 2020
 
Description Final Annual Report for 2018-2019 for the Medical Device and Vulnerable Skin NetworkPLUS 
Form Of Engagement Activity A magazine, newsletter or online publication
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Final report to summarise key activities such as attracting over 20 new collaborative industrial partners from the U, Japan, Sweden, Austria and France, facilitated by organisations, such as the NIHR Office for Clinical Research Infrastructure (NOCRI), to improve medical device design.

Over the NetworkPLUS period, we have funded 14 external projects (~£280k), partnering with colleagues from over 30 academic, industrial and clinical disciplines to improve device design. This has involved a range of applications involving respiratory masks, support surfaces, prosthetic sockets for amputees and penile clamps for incontinent men.

Our research findings have been used by industrial partners to evaluate and develop new medical devices which safely interface with skin and research findings have influenced the 2019 guidelines produced by the European, US and Pan-Pacific Panels (EPUAP/NPUAP/PPPIA). The document includes explicit recommendations and guidelines for pressure ulcer prevention and treatment that are intended for use worldwide.

The MDVSNPlus has also targeted policy for support surface testing. This includes representation at the British Healthcare Trades Association (BHTA) meeting for support surface manufacturers (Bader and Worsley) and participation (Worsley) on ISO committees for the standardised testing of support surfaces (ISO/TC 173/WG 11).
Year(s) Of Engagement Activity 2019
 
Description GCRF Visit to Cambodia 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Patients, carers and/or patient groups
Results and Impact Conducting research studies, to develop tools to improve P&O service access, train clinicians and improve efficiency of service funding use in a LMI country.
Year(s) Of Engagement Activity 2019
 
Description Infection Prevention Conference, Liverpool 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Infection Prevention Conference with focus on prevention of pressure ulcers
Year(s) Of Engagement Activity 2019
 
Description Key note speaker (MDVSNPlus: 2018-2019) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Key note speaking slots introducing MDVSNPlus at a number of International conferences, events, workshops in the period 2018-2019 including:

TVS (Tissue Viability Society Conference) 2018 - 25-26 April, Newcastle: at this event, we organised a dedicated Device-Related Pressure Injuries Session with invited speakers.
EPUAP Focus Meeting 21-23 May, Turku, Finland
Annual Meeting of the EPUAP - 12 -14 September 2018, Rome
8th World Congress of Biomechanics, Dublin 8-12 July 2018
ISPO-UK conference 12th & 13th October, 2018, Southampton.
Advanced Treatments and Technologies in Wound Care (ATTWC2018), London, 15th & 16th October 2018
BSI ISO Committee - 22-24th October 2018
BHTA Symposium, London - 25th October 2018.
Surgical MedTech Cooperative National Meeting, Leeds, 7th November 2018
Newton Bhabha Researcher Links Workshop, Advances Biomaterials and Biosensors, India 13-15th November 2018
Fourth Annual FortisNet Meeting - Thursday 24th January 2019, University of Southampton Science Park.
CYCLOPS, Nottingham 16th Jan 2019
INSPIRE Pressure Ulcer Seminar (INPRuS) - 17 Jan 2019, London
NewMind event - 30th Jan 2019 Manchester
Annual Meeting of EPUAP, Lyon, 19-20 September 2019
Year(s) Of Engagement Activity 2017,2018,2019
 
Description Keynote speaker (MDVSNPlus: 2016-2017) 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Key note speaking slots introducing MDVSNPlus at a number of International conferences, events, workshops in the period 2016-2017, including:

EPUAP Focus Meeting Germany, TVS Meeting UK, European Seating Symposium Ireland. , Skin Integrity Conference UK, Sumed International Workshop UK, Posture and Mobility Group UK, Institute of Mechanical Engineering Scientific Conference UK, Royal College of Surgeons UK, EPUAP/WUWHS Italy, Rehabilitation Congress UK, NPUPA Shear Conference US, Wounds UK, Dutch Pressure Ulcer 2016, The Netherlands, Portuguese Wound Management, Portugal, IRC Anniversary Conference UK, Leeds Innovation UK, BHTA UK, International Seating Symposium US.
Year(s) Of Engagement Activity 2014,2015,2016,2017
URL http://www.southampton.ac.uk/mdvsn/news/events/archive.page
 
Description MDVSNPlus conference: Celebrating our Collaborations 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact In May 2019, we hosted a MDVSNPlus conference: Celebrating our Collaborations with academics, clinicians, funders and industrial partners who have supported our aims to improve medical device design. We discussed progress to date and future plans to improve device design and match this critical healthcare challenge.
Year(s) Of Engagement Activity 2019
 
Description Open day presentation 
Form Of Engagement Activity Participation in an open day or visit at my research institution
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact The activity of MDVSN and MDVSNPlus has been introduced at a separate University of Southampton Network - Institute for Life Sciences
Year(s) Of Engagement Activity 2016,2017,2018
URL http://www.southampton.ac.uk/ifls/news/2016/01/21-fortisnet-launch.page
 
Description Partner Tour 
Form Of Engagement Activity A formal working group, expert panel or dialogue
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact During May/June 2017 we visited a number of MDVSNPlus Industrial and academic partners across the UK including:
i) Brightwake, Kirkby-in-Ashfield, Nottinghamshire, with a tour of their R&D & Production facilities and discussions over a proposed nasal bridge project and next steps
ii) Faculty of Engineering, University of Nottingham to discuss joint projects and funding opportunities.
iii) Sumed International, Glossop, Derbyshire, discussions on current pressure ulcer mapping projects.
iv) Devices for Dignity HTC and TITCH, Royal Hallamshire Hospital, Glossop Road, Sheffield to discuss joint NIV mask project and plans for joint events.
Year(s) Of Engagement Activity 2017
 
Description Pressure Ulcer event: Monitoring, Reporting and Improvement, London 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presentation at National Pressure Ulcer event: Monitoring, Reporting and Improvement
Year(s) Of Engagement Activity 2019
 
Description Promise Scaling Up Day 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Scaling up Day, Health Foundation, Exeter
Year(s) Of Engagement Activity 2019
 
Description STINTS Public Engagement Event 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Public/other audiences
Results and Impact On 22nd November 2019, we held a Public Engagement Event in Southampton for the STINTS Network of early stage researchers and invited members of the public to talk about objectives of STINTS project.
Year(s) Of Engagement Activity 2019
 
Description Social Media 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact MDVSN's and MDVSNPlus' twitter account has in excess of 480 followers, increasing by the year and is used to disseminate news, funding calls and updates on our activity.

The Network also has a dedicated LinkedIn group - Medical Devices and Vulnerable Skin Network - and is used to share information with stakeholders and peers.
Year(s) Of Engagement Activity 2015,2016,2017,2018,2019
URL https://twitter.com/mdvsnetwork
 
Description Social Media Platforms 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Social media platforms have been established via Twitter and a dedicated group - Medical Devices and Vulnerable Skin Network - on professional networking site LinkedIn to reach new audiences with an interest in medical devices and their impact on vulnerable skin.

Outcomes have included collaboration approaches from new industrial partners.
Year(s) Of Engagement Activity 2014,2015,2016,2017
URL https://twitter.com/mdvsnetwork
 
Description Stop The Pressure: Device-related Pressure Ulcer Videos 
Form Of Engagement Activity A broadcast e.g. TV/radio/film/podcast (other than news/press)
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Dr Peter Worsley produced a number of instructional and educational videos on how to prevent device-related pressure ulcers on behalf of the NHS England and NHS Improvement Stop the Pressure Programme.
Year(s) Of Engagement Activity 2019
URL https://www.youtube.com/watch?v=-enA2xlEKmk&t=2s
 
Description TITCH (Technology Innovation Transforming Child Health) 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact On 26th September 2017, we held a joint TITCH (Technology Innovation Transforming Child Health) and MDVSNPLUS (Medical Devices and Vulnerable Skin Network) Event: "Innovation in Medical Devices for Children Workshop".

At the event, clinicians and academics attended a number of presentations covering medical device innovation in respiratory masks, prosthetics and orthotics, and extracorporeal devices for paediatrics.

These presentations included:
i) Technology Innovation Transforming Child Health (TITCH)
ii) Starworks Innovation Project: Innovations in Prosthetics for Young People
iii) The impact of respiratory masks on skin health
iv) Skin breakdown in premature neonates
v) Chronological Evaluation of the Functional Changes in Neonatal Skin

In the afternoon, delegates worked in groups with academics, clinicians and industrial partners to develop ideas and proposals for research funding.
Year(s) Of Engagement Activity 2017
URL https://www.southampton.ac.uk/mdvsn/news/2017/10/titch-children-workshop.page?
 
Description Website (MDVSNPlus) 
Form Of Engagement Activity Engagement focused website, blog or social media channel
Part Of Official Scheme? No
Geographic Reach International
Primary Audience Professional Practitioners
Results and Impact Our website has been used to disseminate the Network's project activities and information related to upcoming meetings, conferences and sandpits of relevance to the multidisciplinary community.

The website also offers a forum for feedback of medical devices from clinicians and provide key links to the new NHS England-MHRA National Reporting and Learning System, which will act as an integrated reporting route for medical device incidents.

The website orginally developed with MDVSN has been updated to reflect the 2016-2019 activity of MDVSNPlus.
Year(s) Of Engagement Activity 2016,2017,2018,2019
URL http://www.southampton.ac.uk/mdvsn/index.page?
 
Description Wounds UK 
Form Of Engagement Activity Participation in an activity, workshop or similar
Part Of Official Scheme? No
Geographic Reach National
Primary Audience Professional Practitioners
Results and Impact Presenting at annual Wounds UK Conference to update delegates on current research
Year(s) Of Engagement Activity 2019