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Design and production system for carbon fibre ankle foot orthoses

Design and production system for carbon fibre ankle foot orthoses

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.

Partners:
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.

Obstetric airways trainer

The project aims to produce a prototype level anatomical training mannequin incorporating physical characteristics which are typical in obstetric patient.

Funded by Obstetric Anaesthetists’ Association

Partners: Sheffield Teaching Hospitals NHS Foundation Trust; Medipex Ltd Healthcare Innovation Hub

Project lead: Andy StantonP

General anaesthesia for obstetric surgery, including caesarean section, is often delivered in emergency situations where some of the specific physiological features relating to an individual patient that might affect oxygenation and airway management can be overlooked. 

Failure to intubate the trachea (insert a tube for ventilation) can have disastrous consequences for both the mother and unborn baby due the resulting lack of oxygen.  It is therefore important that anaesthetists are given appropriate training for this patient group.

However since general anaesthesia in obstetrics is relatively uncommon, training opportunities for anaesthetists are limited. The use of simulation and trainers for anaesthetists and their assistants is important in developing and maintaining their obstetric airway skills.

Current airway management trainers exist mainly for adult males, paediatric and neonatal models, including models for rare conditions. There are no obstetric specific airway management trainers for sale on the current market. 

Many of the physical changes which present themselves throughout pregnancy are not incorporated into the generic adult models and specific procedures in relation to obstetric patient positioning are not achievable.

By incorporating the specific functionality needed, we hope to produce a much more realistic obstetric patient training tool which will support learning in obstetric anaesthesia.

Andy Stanton, lead designer

Working with anaesthetists as representatives of Sheffield Teaching Hospitals, Lab4Living is developing a prototype obstetric airway management training tool which incorporates obstetric related functionality. This functionality includes:

  • Varying degrees of upper respiratory tract swelling depending on length of labour, conditions such as pre-eclampsia and use of oxytocin.
  • Enlarged breasts making insertion of the laryngoscope more difficult.
  • Longer hair and use of hair pieces leading to exaggerated neck flexion and suboptimal patient positioning.
  • The facilitation of a left lateral tilt of the operating table with potential incorrect application and direction of cricoid pressure with resulting vocal cord deformity.
  • Shorter neck with the growing prevalence of obesity in this population.

By incorporating interchangeable functionality to present differing emergence scenarios, the design team aims to produce a more realistic training tool to better inform clinical teams in the area of obstetric anaesthesia.

TacMap

This project concerns the development of an iconic tactile language for use in the production of tactile maps.

Project team:
Paul Chamberlain
Patricia Dieng

Signs and symbols can generally be described as pictographs, literal pictorial representations of the real world, and ideographs that are abstracted ideas of that world. While simple pictographs can relate to particular objects, the implications for meaning can become extremely complex when they become abstracted as ideographs or combined. Chamberlain, with RA Patricia Dieng, investigated whether pictographs, ideographs or abstract symbols used in tactile maps are more appropriate for blind people to conceptualise spatial and environmental concepts and relationships.

The study involved a series of user-workshops with Sheffield Royal Institute of the Blind. Important was how blind users interpreted the tactile qualities of the maps and how partially sighted people interpreted the visual qualities of the map. The aim was to create a communicative link between for people with vision and without vision.

The work has led to a spin out company TacMap which provide a design service utilising findings from the research and create tactile maps for a range of businesses and public services that include South Yorkshire Transport Executive and The Queen Elizabeth Olympic Park by the London legacy Corporation.

The Disability Discrimination Act (DDA) is placing demands of the public sector and industry to make buildings and facilities accessible, usable and safe for disabled people, and there is clearly a gap in a provision for the visually impaired. The research has involved the UK Universities Safety and Health Association (USHA) and considered how tactile symbols could support the Personal Escape and Evacuation Programme (PEEP).


‘This is wonderful, this illustrates so many things; plans are really useful, and it is great to be able to go in a room like for example here the toilets and to know where the basins, the WC and the hand dryers are’

The Starworks Network

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. 

Proof of Concept projects
From this, The Starworks Network has funded 10 proof of concept projects looking to address issues of comfort, fit, customisation and training.

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.
Funding announced

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.

Raising Awareness

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).

Raising Awareness

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.

Supporting Collaborations

The Starworks project has supported the formation of collaborations between researchers across the country through Industry Forum events.

Resources

Related research on Sheffield Hallam University’s Research Archive

Toilet Talk

This project used creative methods to engage children with continence issues, alongside their parents and/or siblings, in discussing the challenges they face in daily living and in ideating potential solutions. 

Project funded through Engineering and Physical Sciences Research Council (EPSRC). Both groups are National Institute for Health Research Healthcare Technology Co-operatives (NIHR-HTC).

Partners:
Devices for Dignity (Royal Hallamshire Hospital, Sheffield); 
IMPRESS (Incontinence Management & PRevention through Engineering and ScienceS)

Project Team:
Project lead – Dr Joe Langley

Researchers:
Dr Gemma Wheeler (Lab4Living); Nathaniel Mills (Devices for Dignity); Sarah King and Dr Peter Culmer (IMPRESS, Leeds); Chris Redford (Freelance Illustrator).  

Approximately 900 000 children and young adults are affected by incontinence in the UK (BBC 2015), whether as a result of medical problems or issues with toilet training. Although children represent a smaller percentage of the population with continence issues, the impact upon them should not be underestimated. The effect on a child’s wellbeing at school (risk of bullying, potential lack of confidence in participating in social or sporting activities) may have lasting implications for the rest of their lives. Despite this, the effects of incontinence are not well understood and require further research.

To respond to this challenge, a partnership between Devices for Dignity and IMPRESS (Incontinence Management & PRevention through Engineering and ScienceS; funded through the EPSRC) was formed. Lab4Living researchers Joe Langley and Gemma Wheeler were invited to join the team to help design and facilitate a bespoke Family Day event, using creative methods to learn about the lived experiences and unmet needs of children living with incontinence, and their families. The aim of this workshop was to inform future innovation of relevant medical technologies in this area, to better support these families in their day to day lives.

The stakeholders were children with continence issues, their parents and siblings, healthcare professionals, engineers and researchers looking into incontinence and its effects.

Impact

A conference paper, Child-led, Creative Exploration of Paediatric Incontinence, has explored the methods and impact of this project.

A range of bespoke tools was developed in collaboration with an illustrator to creatively and collaboratively explore the challenges faced by children with incontinence issues. These tools aimed to place the young people as the experts in the rooms, reflecting on their wider life (i.e. their hobbies, friends, family) and took an asset-based approach to highlight the skills and resources they already leverage to address their personal challenges. Later, ideation activities were used to empower the families as inventors to highlight and address any unmet health needs.

“What can I say, but ‘what a team!’ I was really overwhelmed by the response from the families – the kids were fantastic and the parents engaged and obviously committed to supporting this in the long term.”

(Dr Peter Culmer, project partner at IMPRESS)

During the workshop, the illustrator visualised emerging findings on a live mural in order to demonstrate progress made through the session and to highlight the value placed on the participants’ input. Central to each of the activities was the aim to reframe a traditionally ‘taboo’ topic as something that is safe, and even fun, to explore through creative means.

A range of ‘blue sky’ ideas generated at the workshop, in response to the challenges identified, was incorporated into a comic (available at: https://tinyurl.com/ToiletTalkComic). Based on this input, two further workshops have been organised by the project partners (including Lab4Living) with children and families to develop a smart watch app to help children develop regular toileting behaviours. Early feedback has been extremely positive; we are currently seeking an industry partner to take this forward.

Impact

The IMPRESS network has shared findings from the workshop, including the comic on its website: The http://impress-network.com/wp-content/uploads/2017/11/KidsToiletTalk_COMIC.pdf http://impress-network.com/wp-content/uploads/2017/12/KTTreport4web.pdf

This first phase of funding drew to a close at the end of 2018 but the work of IMPRESS continues via the Surgical Medtech Cooperative under their Colorectal Theme.

Support4All

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.

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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.

(Rachel, test volunteer)

Head-Up

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.