MedTech innovation across the life course – the importance of users and usability

This special edition of the Journal of Medical Engineering and Technology highlights technology innovations supported by two of the English national MedTech Co-operatives – NIHR Devices for Dignity and the NIHR Children and Young People MedTech Co-operatives. We particularly consider the need for, and impact of, users and usability in the innovation journey, brought to life through a number of case studies across the life course.

1. What are the NIHR MedTech & In-vitro diagnostic co-operatives?

There are eleven MedTech and In-vitro Diagnostic Co-operatives (MICs) established in England, which are funded by the National Institute for Health Research (NIHR) [1]. Each is hosted within the National Health Service (NHS) and acts as a catalyst for the development of new medical devices, healthcare technologies, and technology-dependent interventions; MICs also provide evidence on commercially-supplied in-vitro diagnostics. They work across healthcare, academia, industry and patient and family groups, to build multi-disciplinary teams that will work collaboratively to develop, evaluate and validate technologies, provide health economic evaluation, and generate the evidence required to support the adoption of medical devices, digital technologies or diagnostics. Being based within an NHS environment affords them the advantage of ready access to patients and users of innovative technologies, and MICs are the only UK organisations with a specific technology development focus which are hosted in healthcare delivery settings. This close integration with healthcare delivery provides significant benefits in terms of clinical collaboration, surfacing of unmet healthcare needs and user opinion and insights.

Devices for Dignity MedTech Co-operative (D4D) has a specific focus on technology innovations which can support people living with long-term conditions to maintain their dignity and independence, irrespective of age [2]. There are 10 million people in the UK with a long-term illness; D4D considers how these people are restricted by their conditions and the challenges that can arise from a combination of conditions, with a vision of preventing, reducing or addressing such limitations through technology developments informed by those who need and use them. It has a specific clinical focus on long-term neurological conditions, diabetes and renal disease, but with a particular emphasis on multi-morbidity.

The Children and Young People MedTech Co-operative (CYP MedTech) is the only MIC dedicated to child health and paediatrics [3]. It prioritises innovations that fit within seven themes: cancer, epilepsy, movement and muscle disorders, neonatal technologies, rare diseases, respiratory, sleep and ventilation, surgical technologies and transition. Developing technology that is sufficient to meet the specific healthcare needs of children and young people is paramount for the future sustainability of health and healthcare, and future national prosperity. The first two principles laid out in the UK 2010 Marmot review were to “give every child the best start in life” and “enable all children, young people and adults to maximise their capabilities and have control over their lives” [4].

2. Why users and usability?

The need for a focus on users and usability is driven by a number of factors. National policy and guidance highlight the importance of shared decision making in treatment and care in all healthcare settings [5] and there is evidence to indicate that active involvement of patients in their care can lead to improved outcomes and experience [6]. Indeed, the UK Government’s Five Year Forward View for healthcare services [7] outlined a need for a change in the relationship between patients and the NHS, with a shift in the power balance between doctor and patient. Equally, from a regulatory perspective it is now seen as an imperative for regulators overseeing medicines and medical devices to engage with patients and the public [8] which has been highlighted in a recent UK independent medicines and medical devices safety review [9]. Thirdly, but of no less importance, is the fact that sustained adoption of new healthcare technology is more likely to occur if users have co-created the solution, so involving users in iterative development and evaluation makes sense from a business and healthcare benefit perspective. This is underpinned by the publication by NIHR which emphasises the need to work with patients (and families in the child health setting) within priority setting partnerships to identify need and evidence gaps, implementing effective approaches such as co-production and community engagement, designing studies, the evaluation of research proposals, the conduct of research and the dissemination of results [10].

Assessment of the usability of new technology is crucial to the understanding of how it will be used (or not) in real world settings and patient/user feedback is essential to guide final design considerations. McCarthy et al., in this special edition, provide an example of usability engineering in practice, through the development of an electrical stimulation device for post-stroke therapy [11]. The theme of usability is further drawn out by Moody et al. who consider the barriers and enablers to the use of digital technology in older adults in three specific conditions [12]. In this special edition, Wheeler et al. [13] highlight the fundamental importance and value of involving children and young people in the development of new technologies, supported by the 1989 United Nations Convention on the Rights of the Child [14] stating that children and young people have the right to express their views freely in all matters that affect them, without discrimination and with the best interests of the child as the primary consideration. Given that children and young people make up nearly 25% of the UK population, and the impact of new health technologies on their future health is determined early in the life course, their involvement mitigates the risk of developmentally inappropriate or unacceptable technologies being developed leading to poor uptake and rejection.

In February 2021, the NHS Accelerated Access Collaborative (AAC) and the UK Care Quality Commission (CQC) published a set of six evidence-based principles (“Developing a shared view: Enabling innovation and adoption in health and social care”) [15] that are crucial for health and care providers to be effective at adopting innovation. The principles, which clearly emphasise the important role of users, are:

• Develop and deploy innovation with the people that will use them.

• Develop a culture where innovation can happen.

• Supporting people.

• Adopt the best ideas and share leaning.

• Focus on outcomes and impact.

• Be flexible when managing change.

The essence of user involvement and participatory design has formed from the principle “Nihil de nobis, sine nobis” or “nothing about us without us”, now embodied in the statement “no research for us without us”. In the last decade, research involvement has shifted from the traditional didactic approach of research being “performed on” participants to adopting an inclusive approach that serves to build interpersonal trust through open, honest, and collaborative relationships with users, and institutional trust by organisations creating long-term partnerships with the communities they serve, through which there is shared ownership in all research decisions among researchers and community members. Ensuring the breadth of user involvement in medtech development requires consideration of cultural and socio-economic factors. It is important to address diversity and inclusion in user groups, as exemplified by Sproson et al. in this edition, who describe their experiences of user involvement with a local Somali community in a project focussing on the development of technology for assessment of cognitive impairment [16]. Some health technologies risk widening the health inequalities gap and marginalise communities [17] and feedback from a highly diverse range of potential users, at an early stage of the innovation process, can help to highlight this and offer opportunity for appropriate mitigation.

3. Impact of a pandemic

The Covid−19 pandemic has necessitated a re-think of patient and public involvement (PPI) in medtech development. The inability to have face to face interactions with users and the need for infection protection and control meant that traditional methods of undertaking PPI in research and innovation were upturned. As the world familiarised itself with video-conferencing and digital approaches to interactions were developed, creative approaches to support user involvement in health technology innovation came to the fore. There is no doubt that some of these methods will be sustained post-pandemic, as innovators have discovered some of the longer-term benefits and begun to address the initial limitations. We are likely to see a hybrid approach to PPI in the future, with a combination of virtual and face to face methods and a variety of different media in use. In particular, a mixed and creative approach needs to be considered with underserved communities, and inclusive of those who would be considered as digitally excluded or marginalised, to ensure that innovative and technological approaches to facilitate user-engagement and involvement don’t serve to further exclude communities that are most in need. This edition highlights a number of experiences of user involvement during the pandemic, with examples citing adaptive practices and new methodologies [16], the use of 3D printing [11] and considerations of digital exclusion [13].

A further consequence of the pandemic has been the limited access to clinical teams for researchers and innovators, both at the height of the pandemic as they were called to provide frontline medical care, and subsequently, as backlogs for clinical care require their absolute focus. Ringfenced clinical time is essential if medtech innovation is to flourish, and again this has required creative approaches. Despite these challenges, there has probably never been a better time to innovate in healthcare, as the pandemic has demonstrated how fast we can change and the impact that the introduction of digital technologies can have on our lives and the delivery of healthcare. This has been needs-led innovation at its most intense and the time is right to build on this wave of creativity.

4. Collaboration and networks

Collaboration is a key element of the MIC approach, across all eleven national organisations and with external stakeholders. Relationship building and management is key to successful collaboration, and in this edition, Olubajo et al. discuss the contribution of inter-personal relationships to inter-organisational collaborations for the development of medtech [18]. They examine the complexities, challenges and opportunities within multi-party collaborations and ways to drive these forwards, with a particular consideration of the three-way approaches – industry, academia and healthcare – that form the basis of the MICs.

The creation of domain-specific stakeholder networks provides a useful vehicle to support new collaborations and sustain and enrich existing partnerships. Also, in this edition, Needham et al. share their learning from the creation of the Starworks network – a multi-stakeholder network which has been developed to stimulate new research and innovation in child prosthetics [19]. This has children and their families at the heart of the network, working as equal partners in shaping future development priorities, aligning with the principles of participatory and co-design described by Wheeler et al. [13]. The Starworks network is an example of how a niche area, perceived as unattractive to industry due to a low volume market and limited profitability, can be stimulated to engage new innovators and promote new collaborations, through the involvement and leadership of end users. It has succeeded in addressing child-specific issues in prosthetics through fostering impactful innovation and creating a sustainable and engaging network, with wide stakeholder involvement. It builds upon the success of the UK national paediatric technology network, Technology Innovation Transforming Child Health (TITCH) [20] which was established in 2014 with a mission to address the fragmented approach to developing and evaluating child health technology across the UK. Its ethos is to ensure that health technology for children and young people is developed collaboratively with children and young people, such that it is developmentally appropriate and incorporates the versatility required to adapt to changes in anatomy, physiology and social maturity. It has identified over 100 unmet needs through networked events and other mechanisms and now comprises over forty members with expertise in a broad range of professions including paediatric specialties, community medicine and general practice, allied health professions, design, engineering and education, together with small and medium sized enterprises, large corporations and patient/parent/carer representation.

5. Evaluation, implementation and training

The innovation journey from unmet need to adoption is described by a number of authors in this edition. That journey is not necessarily smooth and often requires organisations such as the MICs to act as a catalyst in order to remove barriers to progress. Robust evaluation of new health technologies, with appropriate outcome measures and metrics of success, are key to providing evidence of the value of an innovation. Knox et al. describe their approach to this through a case study of the implementation of telehealth in long-term neurological conditions, and provide recommendations for the future, with emphasis on the importance of taking a person-centred approach [21]. Technology implementation requires broad considerations of service changes/reconfigurations and training for sustainable results. There is innovation potential in the training itself and Soreny et al. describe their approach to co-design of digital learning resources for care workers through their NeuroCare KnowHow project [22]. This is an online learning platform for care workers supporting people with neurological conditions, informed by patients, families, care workers and healthcare managers, which will give confidence to care workers “on the go” and at the point of need.

6. User attitudes

Both Hampshire et al. [23] and Lanfranchi et al. [24] focus on user attitudes and views on specific technologies, gathered at the pre-development/early development phase, to elicit user perspectives on future innovations, noting that extending the diversity of user groups consulted can help to reduce the likelihood of intervention-generated inequalities [17] and improve the likelihood of more widespread and sustained adoption. It can also widen the opportunity for new applications of the technology to be discovered, and hence improve business potential and healthcare benefits. Lanfranchi et al. looked at user attitudes towards virtual home assessment technologies, to be used to support occupational therapy assessments for patient discharge; user involvement identified the added potential application for use in an ambulance setting, which had previously not been considered [24]. In their case study describing the development of a “toolbox” to support children and young people with juvenile idiopathic arthritis, Wheeler et al. describe the value of multi-stakeholder engagement involving children, young people, their parents and professionals [13]. Using participatory design supports a deeper level of understanding about lived experience, diversity of opinion and allows a safe space for competing priorities from each stakeholder group to be considered, resulting in an outcome that has the potential to benefit all those taking part.

The importance of service provider involvement in health technology development, should also be considered within the sphere of user attitudes as highlighted by Mills et al. [25], as some of the technologies will be operated within clinical care pathways. Most importantly, equality, diversity and inclusion should be at the heart of health technology development, and in particular should not exclude children and young people, or those of advancing age, simply because their views may not be considered at an appropriate level of maturity or may be perceived in some sense, to be less relevant. Several papers within this special edition highlight different approaches that can be adopted to harness the diverse views of children, young people and adults, and recognise the need for input from a variety of socio-economic and ethnic groups.

7. Responsible innovation

Responsible innovation needs to consider the social and ethical aspects of innovation and within that, the environmental and economic pillars of sustainability. Whilst this edition of the journal does not explicitly include papers with this focus, it is inevitable that future health technologies will need to embrace this agenda if they are to be consistent with the Sustainable Development Goals set up by the United National General Assembly [26] and meet user expectations with respect to climate change considerations. Economic considerations are also very much part of responsible innovation and will be a key factor in any technology evaluation by the National Institute for Health and Care Excellence (NICE) [27]. This will have relevance for future adoption and, in particular, for any future mandated take-up in England’s NHS though the recently introduced MedTech Funding Mandate [28].

8. Investing in children makes sense

In this special edition Mills et al. describe the value of investing early in the life of the end user [25]. Children and young people are the productive workers of the next forty years and the parents of the following generation. What happens in early life leads to irreversible changes in adulthood, whether positive or negative, so investing early reaps social and financial benefits. By way of example, approximately 20% of children (27% in most deprived areas) are obese at age 10–11 years [29]; the annual cost of obesity to the NHS is £4.2 billion, with wider costs are estimated at £27 billion. Autism (affecting 1–2% of children) alone is estimated to cost £2.9 billion annually and the lifetime costs per child with autism is estimated at £2.06 million [30]. Much of what we observe in adulthood has its origins in childhood including major healthcare issues such as cardiovascular disease, stroke, hypertension, type 2 diabetes mellitus, dementia and cancer. The title of the UK Chief Medical Officer’s report in 2012 “Our children deserve better; prevention pays” challenges us to move from a reactive position of treating late onset disease to a responsive mode of healthcare prevention [31]; innovative solutions to old problems will be key in the delivery of sustainable future health and healthcare.

9. Parity of Esteem

Parity of esteem is about giving equal priority to mental and physical health. It was enshrined in UK law in the Health and Social Care Act in 2012 [32] but despite this, there is still a considerable way to go to make this a reality. Funding for research into mental health lags behind that for physical health and we know that there are significant differences in quality of care, despite the well-known interdependencies between physical and mental health [33]. The numbers are stark – serious mental health issues affect 10% of 11 year-old children [34] with increasing numbers admitted to specialist inpatient units [35] at an estimated national cost £2.1 billion per year group. Similarly, one in four adults experiences at least one diagnosable mental health problem in any given year. Mental health problems represent the largest single cause of disability in the UK and in 2016 the cost to the economy was estimated at £105 billion a year – roughly the cost of the entire NHS at that time [33].

There is no doubt that developers of medical technology need to consider parity of esteem as part of needs capture with users. Without this, the impact of mental health issues on technology usage will be overlooked, leading to a potentially negative effect on uptake, and a reduction in the opportunity for population health improvement. This is not an easy area for co-development and it is essential that the approaches employed with users are age and context appropriate [12,13,16].

10. Across the life course

We are all potential users of medical technology at different stages of our lives. As we move towards greater personalisation in medicine, we need to consider what we can do to better ensure our health technology innovations are genuinely fit for purpose – not on a generic basis but recognising how they fit with our many different lifestyles, personal challenges, ages and abilities. As quoted by Sproson et al. in this edition, “Life doesn’t move in straight lines, it has peaks and troughs” [36]. Technology across the life course is not a “one size fits all” from cradle to grave. It requires a more sophisticated approach which considers our differences. Developing technology for children and young people requires a versatile and flexible approach, recognising that children may initially benefit from technology-supported healthcare delivered by parents and caregivers, and as they progress to a sufficient level of cognition and developmental maturity they will use technology independently. As children and young people with established physical and mental health problems live well into adulthood, health technology solutions need to ensure continued engagement whilst supporting a sustainable impact on health and healthcare. This adaptive approach to technology development fits equally well in the development of health technology in the adult healthcare setting as we move towards a more personalised approach to healthcare.

The papers in this special edition recognise the multiple challenges and opportunities of medtech development with users right across the life course. In many cases they offer guidelines and recommendations which it is hoped will be useful to developers and multidisciplinary teams in this exciting field.

Acknowledgements

The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

The authors would like to acknowledge the help of Dr Clare Bartlett in the preparation of this editorial. We would also like to thank all the patients, members of the public and other stakeholders who have contributed to the work presented in this special edition of the journal; without them the value of our organisations would be so much less.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Additional information

Funding

The special edition papers were supported by NIHR D4D and NIHR CYP MedTech.