The Head-Up project produced an innovative head support to help improve posture, relieve pain and aid communication for people with motor neurone disease. The case study illustrates collaborative, interdisciplinary research and new product development underpinned by participatory design processes.
The study was initiated by a two-day stakeholder workshop followed by early proof-of-concept modelling, market analysis and patient need evidence building. The work subsequently led to a successful NIHR i4i application funding a 24-month iterative design process, patenting, CE marking and clinical evaluation by end users.
The evaluation has informed minor amendments to the proposed design we refer to here as the Sheffield Support Snood (SSS). The outcome positively demonstrates use and performance improvements over current neck orthosis provision and, we argue, the process of multidisciplinary and user engagement created a sense of ownership by MND participants, who have since acted as advocates for the product.
Motor Neurone Disease (MND) is a rapidly progressive neurodegenerative disease with a relentless progression, a profile of complex disabilities and fatal consequences, to which there is currently no cure. It predominantly affects the motor neurones, the cells that control muscle activity including speaking, walking, breathing, swallowing and general movement of the body. As the disease is incurable, the efforts to support patients are heavily focused on sustaining a maximum quality of life.
The adult human head weighs approximately 5kg and is supported by a complex system of relatively small muscle groups that co-ordinate to support and control head movements. In very simplistic terms, the weight of the head is supported by muscles fibres that tie into back of the base of the skull at one end and attach to the back and sides of the lower neck. For people with MND, as these muscles begin to waste away, the head droops or flops, usually forwards and/or sideways in ways that can vary greatly depending on the individual.
‘Head drop’ exacerbates problems with swallowing, breathing, eating, communication and drinking. Ideally a neck collar should help alleviate these problems. However, during workshops conducted with MND patients and carers in the pre-proposal stages of this project, participants confirmed that currently available collars are of limited use for people with MND and are often rejected.
The participants in early workshops clearly expressed the unmet need as: “a neck and head support system for MND patients, and potentially those with other neck weakness conditions that provide sufficient support whilst allowing freedom for head movements, is comfortable to wear and is non-stigmatising in its cosmetic appearance”.
Devices 4 Dignity (D4D) and Knowledge Transfer – Extending Quality of Life of older and disabled people (KT-EQUAL) organised an innovation workshop, hosted by Lab4Living (a Design and Health collaboration initiative) at Sheffield Hallam University (SHU). This brought together people living with MND, teams of designers, engineers, MND clinicians and researchers, and people living with MND to explore unmet patient needs, validated by the user perspectives.
The event resulted in a range of early concepts in response, and followed by a health economics analysis articulating the current ‘cost’ in terms of quality of life and the potential gains from a product that met the user needs outlined above.
The project took 28 months. It had management and commercialisation work-packages running concurrently throughout the duration. The research and three dimensional design development followed a 12-month iterative and participatory design process involving repeated cycles of prototyping supported by experiential design components, a comfort assessment of existing collar designs and engineering virtual simulations.
In the background to these workshops, throughout the process, the design team was also producing a series of tools to assist them in the technical specification of the neck support. One such example of this is the development of ‘Edwood’.
Edwood was a life-size wooden mannequin designed to simulate the human head, neck and torso. Its head could be filled with a variety of weights to bring it up to average human head weight, of between 0 to 6 kg. Edwood’s neck had been made out of a column of flexible polymer, simulating the top of the spine, and was the only connection between the head and the torso. Edwood’s structure was such that it could not independently support the weight of its head, to the extent that the head would drop forward and to the side to contact the torso; either ear to shoulder or chin to chest.
Following this design process, the final output was patented, CE marked and subjected to a clinical evaluation with a sample population of 20 participants drawn from a population of people living with MND, different from those who had participated in the design process.
Discussion & Conclusion
The benefits of this participatory process included the emancipation of the patient users. A comment by the clinical lead, a specialist Neurologist but with only limited knowledge of new product development or participatory design process, clearly articulated this. His perception was that he hadn’t realized how involved the patients and other project members would be in the design phase. He also commented on how it could have be possible to simply pay lip service to the suggestions from the patient and clinical users and pursue one’s own design agenda. However, responsive action was the strongest possible affirmation that someone was being listened to. Prototypes being made that responded to suggestions from the patient users, clearly demonstrated that this was more than lip service and he said that, when some sacrificial concept prototypes were tabled in a workshop and the patients could see how they connected to comments they had made, there was immediately a much stronger sense of engagement.
The challenges posed by such an extensive piece of Participatory Design were not insignificant – the use of domain-specific language by the different professionals presented a significant initial barrier to the collaborative design process. Other challenges included negotiating Intellectual Property rights; negotiating the sheer volume of work involved in developing a project from inception through to commercial viability within a single research funding programme; time constraints arising from a participatory approach rather than a ‘traditional’ design / product development process; and finally the sheer complexity in commercialising a product concept.
The process can be described as an exemplar of a user involved design and innovation process with genuine user participation in the design. This has helped ensure that the novel head and neck support meets the needs of many of the target user group as well as functional requirements identified at project outset and those that emerged during the course of the enquiry. In the context of medical device development, there were direct benefits to participation, in particular, in regard to developing deep, qualitative understandings of the context of use, that enabled the team to mitigate. Although the neck support has only been evaluated by a relatively small sample, the results indicate a very positive response that validates the innovation model applied in this project, the user and clinician involvement and the design output.
Head-Up (2015). [online]. Last accessed 19th June 2015 at: http://www.lab4living.org.uk/head-up