Project team: Heath Reed, Matt Willox, Naomi Rasyzk, Joe Langley, Julie Roe
Non-invasive ventilation (NIV) is the delivery of breathing support via a face-mask. It is used to treat individuals whose breathing is compromised. Evidence shows that when used long term it improves quality of life and life expectancy. Mass produced masks are available for adults but in children it is often difficult to find a mask that provides an adequate seal. Current options for children are to ventilate invasively via a breathing tube, to persevere with NIV through an inadequate mask or to abandon ventilation.
This research explores the application of 3D printing and scanning technologies within the NHS to enable the delivery of customised face mask for infants and children. Participatory research methods involving children and parents have helped specify techniques and processes that could be used to deliver novel mask-face interfaces in a way that suits the needs of individual patients.
To date, lab testing has demonstrated that the methodology and pre-production prototypes are more effective than standard mass produce masks that are currently available.
A critical part of the initial development and proposals was the active involvement of patients, their close families, and wider affected communities and organizations through specific focus group interactions. This includes, for example a parent who is now a member of the research programme team.
To further support the speed of future implementation and good concurrent practice, effective links with industries have been made. We have engaged with both a large global (Phillips Respironics) and a UK based manufacturer of NIV devices (B&D Electromedical), both of whom are enthusiastic in their support for the project. Materialise, who make 3D scanning systems and 3D printing technology, have joined the project team. Together these businesses can provide the relevant understanding of the practicalities of the ventilation business and of the materials, manufacturing and regulatory challenges involved in the project. As part of this concurrent phase of the research and development R&D we are also investigating potential business models appropriate for a national and international market.
Dynamic manufacturing provides a way to be responsive to the demands of the market and can help to create and accelerate production development. In this programme of research, Lab4Living researchers investigated new ways to design and produce carbon fibre ankle foot orthoses (AFOs).
Funded by Trulife.
Project Team: Design Lead – Nick Dulake
The enquiry gathered and analysed published anthropometric data. This was used to create the master CAD design file. The model was parametric, meaning that key dimensions could be changed whilst maintaining dynamic relationships. As a consequence, the master file could be used to create distinct new products that varied in scale or proportion. This meant that the foot orthosis could be customised to an individual. Prototypes were used in development testing with users.
The new system has been the catalyst for a leaner production process within Trulife’s factory in Sheffield, UK. At the end of the project, the new system was capable of producing over 270% of the output when compared to previous techniques whilst achieving higher quality and better consistency of product.
The Starworks Network is a young people’s prosthetics research collaboration. It has taken a co-design approach to bringing children and families together with experts from healthcare, academia and industry, to creatively explore and address the unmet needs in this area.
Funded by The UK Department of Health / National Institute for Health Research (NIHR)
Project led by NIHR Devices for Dignity MedTech Co-operative, Sheffield Teaching Hospitals.
The Lab4Living team was led by Joe Langley and Gemma Wheeler.
There are an estimated 2000 children in the UK living with a form of limb loss and many will use upper and/or lower limb prosthetics from an early age. However, product and service provision for these children is usually based on scaled-down versions of adult prosthetics, which often do not meet their unique functional, social and emotional needs.
In 2016, the Department of Health released £750,000 to build a network of clinicians, academics, industry experts, and crucially, children and families, to support research in this area. It aimed to ensure a balance between ‘clinical pull’ and ‘technical push’ in translating much-needed innovation in child prosthetics into everyday use.
Our regular collaborators, Devices for Dignity (Sheffield Teaching Hospitals) invited Lab4Living to bring a co-design approach to the building and maintenance of this network. We have played a key role in the design, facilitation and reporting of each stage of the project, ensuring that children’s voices were central throughout.
“The Child Prosthetics Research Collaboration led to inventions and optimizations that reflected what children and families need. The experts and academics who develop prosthetics would probably never have heard from families and children how a poor-fitting or unattractive limb can limit a child at home, in the classroom and in the playground.”
(Gary Hickey, INVOLVE)
Needs assessment We engaged children and families across the country through workshops, phone calls and postal activity packs tailored to a range of ages.
Sandpit events A series of four one-day workshops in Salford, Bristol, London and Sheffield, brought the key stakeholders together to creatively and collaboratively explore key challenge areas emerging from the initial needs assessment. We designed a set of bespoke tools to support activities in problem definition, inspiration, ideation, prioritisation, development, pitching and network-building.
We have continued to provide design support to these projects and the Network as a whole, and are pleased to announce that it has been awarded follow-on funding from the NIHR to continue supporting research and innovation in this important area. Starworks 2 has begun and will further engage with all stakeholders to bring new innovations and technologies to children with limb difficulties.
“This, to my knowledge […] is the first of its type in scale and content and hopefully will produce some exciting, useful and relevant developments […] for our paediatric clients, who have sadly, by nature of their relatively small numbers and even smaller voices, been largely ignored by industry and the profession. Empowering the client group that you are trying to help and allowing them a voice in what is being developed for them is surely the best way forward.”
Rose Morris, Clinician, in ‘Attracting innovation in child prosthetics’, The Clinical Services Journal, February 2018, p56-58.
Devices for Dignity MedTech Co-Operative has announced the funding of 10 Proof of Concept projects, addressing a variety of needs for children using prosthetics.
Starworks has raised awareness of co-production methods through coverage in a Nature special issue on Co-production of research, published on 3rd October 2018 and in an upcoming guidance document by Involve (www.invo.org.uk).
A recent article in a clinical journal raises awareness and demonstrates recognition of the potential of the Starworks research collaboration. Raj Purewal, business development and partnerships director at NHS innovation specialist, Trustech, discusses how the project aims to increase progress in innovation in child prosthetics even further in an article for The Clinical Services Journal, February 2018, p56-58.
The Starworks project has supported the formation of collaborations between researchers across the country through Industry Forum events.
Related research on Sheffield Hallam University’s Research Archive
Radiotherapy treatment for breast cancer requires precision and accuracy. This research builds understanding and has developed a novel solution for safer breast radiotherapy through the creation of a support bra, enabling reproducible positioning of tissue during breast irradiation treatment and helping maintain modesty and promote dignity.
Funded by National Institute of Health Research.
Partners: Sheffield Hallam University: Faculty of Health & Wellbeing Sheffield Teaching Hospitals NHS Trust Panache Lingerie Ltd
Project Team: Design Lead – Heath Reed Prof Heidi Probst, Andy Stanton
Breast cancer symptoms affects a substantial proportion of the population and state-of-the-art radiotherapy approaches require increasing precision and accuracy to avoid long-term side effects.
There is evidence that immobilising the breast during radiotherapy following a diagnosis of breast cancer is problematic. Patients with larger breasts are particularly difficult to position. This decreases the accuracy of treatment and the process can increase levels of emotional distress and compromise dignity.
This bra has been designed specifically so that it doesn’t absorb too much of the radiation beam and therefore doesn’t increase the skin dose.
(Dr. Heidi Probst)
This research seeks to develop a novel solution for safer breast radiotherapy through the creation of a support bra. This will enable reproducible positioning of tissue during breast irradiation treatment, help maintain modesty and promote dignity.
A mixed methods approach has been adopted to build understanding of patient and staff requirements and develop insights into the materials that could potentially be used.
Very few centres will cover the patient during radiotherapy so this is unique – it allows the patient to be covered during the treatment.
(Dr. Heidi Probst)
The inquiry is ongoing. To date a number of prototypes have been created and are currently being tested. The research raises further avenues of investigation in relation to methodological approaches and ways of testing designs.
I’ve been clear 9 years now. Being able to wear a bra while you’re having radiotherapy treatment would be very helpful for women as they go through the treatment, make them feel much for comfortable at a time when you feel very vulnerable.
Motor Neurone Disease (MND) is a rapidly progressive neurodegenerative disease, with individuals developing weak neck muscles, leading to pain, restricted movement.
This research built understanding of optimal requirements for a supportive neck collar with flexibility to allow functional head movement. Through an iterative prototyping process the HeadUp Collar, a class one medical device, has been patented.
Funded by: National Institute of Health Research NIHR Devices for Dignity Motor Neurone Disease Association
Partners: University of Sheffield SITraN (Sheffield Institute for Translational Neuroscience) NIHR Devices for Dignity Motor Neurone Disease Association Sheffield Teaching Hospitals NHS Foundation Trust Barnsley NHS Foundation Trust TalarMade
Project team: Heath Reed – Team lead Joe Langley, Andy Stanton
Co-design workshops brought together people living with MND, carers, clinicians and designers. Participatory methods, including qualitative interviews, 2D visualisation and 3D mock-ups, helped build understanding.
The study is an example of collaborative, interdisciplinary research and new product development underpinned by participatory design. The NIHR i4i funding enabled the team to iteratively develop and detail the product over a 24-month programme.
“This is a product that can be completely customized to the patient’s needs and requirements – that’s the huge benefit and the beauty of the collar and its design.”
(Liz Pryde, Devices for Dignity)
The proof of the pudding for me was that they were coming to clinic wearing the collar, it wasn’t in the drawer with the other collars.
(Chris McDermott, Consultant Neurologist)
Following the iterative prototyping process the HeadUp collar, a class one medical device, was patented. It has undergone multi-centre clinical evaluation with results indicating that the product meets user requirements and showed an increase in the number of hours the collars are used, compared to existing neck orthoses.
It looks like clothing, really, rather than a medical device. Without the collar, I wouldn’t be able to drive and that makes a huge difference. With a rigid collar, you can look ahead but you can’t turn your head to see the traffic, but with this collar you can do that. It’s life-changing really.
(Philip, wearer of HeadUp Collar)
Over 1500 units sold in the first year
That’s 1500 people now able to get on with their lives with the support of this simple collar. Talarmade were shortlisted for the Partnership with Academia Award at the Medilink North of England Healthcare Business Awards 2019.
The collar, now known as HeadUp, is available to purchase from local manufacturing company TalarMade, who have more than 30 years’ experience in developing clinical innovations for use in rehabilitative and orthotic practice.
Related research on Sheffield Hallam University’s Research Archive