Collaboration for clinical innovation: a nursing and engineering alliance for better patient care

Abstract

Background

There is significant need and enormous potential for innovation in clinical settings. However, for various reasons, this potential is rarely realised.

Aims

This paper aims to present a collaborative approach to innovation between clinicians and engineers, using two nursing case studies as examples. Suggestions are offered to improve facilitation of innovation in healthcare settings.

Methods

An engineering design process was applied to develop novel medical devices in response to unmet clinical needs identified by nurses. This process includes problem exploration, definition of project scope, concept generation, detailed design, manufacture, prototype evaluation and iterative design improvements.

Results

Two case studies are presented to showcase the results of this multidisciplinary approach to innovation. Both projects resulted in novel medical devices being put into clinical use safely and effectively.

Conclusions

Collaboration between nurses and engineers facilitates rapid iteration of novel solutions to unmet clinical needs. Both professions have similar approaches to problem-solving, complemented by specialist knowledge in their contrasting areas of expertise, making for a highly capable multidisciplinary team.

Introduction

The delivery of healthcare has been transformed over recent decades by new technologies; with continuing technological advances, the potential for innovation remains almost limitless. Historically, the NHS has been slow to adopt new technologies – the portable defibrillator was developed 25 years before it became a standard piece of ambulance equipment in the UK (DEFIBhub, 2019). Thankfully, the NHS is now recognising the critical importance of research, innovation and technology adoption (Accelerated Access Review, 2016), with clinicians involved at all stages (Department of Health, 2008). This is essential in order to drive improvement of future clinical outcomes and for the NHS’s survival as demand for finite health services grows (NHS, 2019). However, realisation of the health service’s high-level aspirations is often beyond the capacity of clinical staff due to staffing pressures and lack of technical support.

Clinicians are faced with problems every day, and they have no shortage of innovative ideas, although few see themselves as innovators (Weisberg et al., 2014). When they identify a problem, they typically search for existing solutions in either medical equipment suppliers’ catalogues or the medical literature. If a solution is not found, clinicians think laterally, considering whether solutions to similar problems could be translated from other areas. In the case of medical devices, this could mean using a device intended for a different purpose – so called off-label use. If the clinical need remains unmet after these avenues have been explored, there is a clear need for development of a new solution but no obvious route forward.

Clinical engineering (C.E.) departments exist in many hospitals to manage and repair medical equipment. Some C.E. departments include research and development (R&D) teams, which apply engineering methodologies to solve clinical problems, often resulting in novel medical devices. Clinicians’ input is essential to realise the full potential of these projects; however, because C.E. R&D teams are not commonplace, many clinicians are unaware of this valuable resource.

Here, we present two case studies of innovation projects initiated by nurses in a large UK hospital and realised by the in-house C.E. R&D team, which was formally established in 2014. By exploring commonalities between these and other projects, we suggest how barriers to clinical innovation can be overcome.

Methodology

The projects in this paper were initiated by nurses who identified unmet clinical needs and approached the in-house C.E. R&D team to develop novel solutions. The first stage of this process is exploring the problem together. A common engineering approach to problem definition is similar to the clinical approach to diagnosis: expanding thinking to discover the bigger picture, then converging on a definition of the key aspects of the problem. The solution phase follows, beginning with development of a range of potential solutions – analogous to the exploration of clinical treatment options – before the favoured solution is chosen and developed into the final product for the user. The design process can be visualised in several ways; a common presentation is the double diamond model (Figure 1).

Figure 1.

Double Diamond Model (adapted from Clarkson (2016) and Design Council (2019)).

Design projects are commonly iterative in nature, incorporating improvements based on feedback. The dotted arrows in Figure 1 illustrate iterative loops that inevitably occur during the design process (Design Council, 2019). The ‘design wheel’ (Figure 2) highlights the central role of iteration by presenting the design process as a perpetual cycle of exploration of needs, creation of concepts and evaluation of solution options, guided by project management (Clarkson et al., 2017).

Figure 2.

Design wheel (Engineering Design Centre, University of Cambridge, 2007).

For each clinical innovation project, the initial exploration phase starts with a literature review and market search to identify any existing products that address the clinical need. If no suitable commercially available solution exists, a detailed stakeholder analysis is conducted, usually through an interactive workshop involving both clinicians and engineers. Engineers design the workshop questions to help them understand the user needs, clinical pathways and root cause of the problem. The goal is to define a set of solution-neutral user requirements that span the life cycle of the potential device, including function, safety, training, maintenance and disposal. After completing the exploration phase, the multidisciplinary team discusses whether the clinical need warrants development of a novel solution; if so, grant funding is sought for the project.

The creative phase starts with a concept generation workshop. Abstraction of the problem prevents focus on a single solution without consideration of other options. The result is a wide range of potential concept solutions, which the multidisciplinary team assesses against both the clinical-user requirements and the previously highlighted device life-cycle requirements. Rough prototypes of selected concepts are manufactured to help clinicians evaluate designs and provide feedback. The favoured concept is then designed for manufacture, tested and documented, and a manufacturing process is developed.

In both cases discussed below, the solution took the form of a new medical device, which is legally defined in Europe as ‘any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more … specific medical purposes’ (Council of the European Union, 2017).

The regulatory framework governing development and manufacture of new medical devices in Europe will change from the EU Medical Devices Directive (Council of the European Union, 1993) to the EU Medical Devices Regulation (Council of the European Union, 2017) in May 2020. These regulations set out the requirements for proving that a medical device is fit for purpose and worthy of a CE mark, which is legally required before a medical device can be placed on the market. Devices manufactured and used within the same hospital (‘in-house’) are exempt from CE marking; however, a robust development and testing process, underpinned by a quality framework such as ISO 13485 (The British Standards Institution, 2020), must be fully documented before the device can be put into service. The C.E. R&D team has the knowledge, processes and governance in place to develop and manufacture medical devices for in-house use. The team works to the standards required for commercialisation, thus ensuring safety and readiness for CE marking if the device shows commercial viability and potential for patient benefit beyond the Trust. The main advantage of the in-house exemption from CE marking is the compressed time frame for development of a clinically usable device.

In order to identify similar in-house innovation teams at other hospitals, the authors reached out to their professional networks and performed two independent searches using Google, Bing and PubMed. The searches focused on NHS hospitals in the UK, using terms including: NHS, healthcare, clinical engineering, R&D, innovation, medical device, development and in-house.

Case study 1: Innovation in paediatric anal dilator design

Design and production of a more user-friendly paediatric anal dilator, led by a paediatric nurse in collaboration with C.E. R&D.

Background

Anal dilatation is a common part of treatment for paediatric surgical patients following anoplasty surgery or after pull-through operations for Hirschsprung’s disease. The average incidence of anorectal malformation requiring surgical intervention is 1:2784 in Germany (Jenetzky, 2007), from which we can infer an annual incidence of approximately 1400 cases in Europe and 1800 in the United States (based on 2017 live birth figures; Statista, 2019). Clinicians, parents and carers use dilators to prevent or treat anal stenosis, both at home and in a clinical setting. Typically, regular anal dilatation is performed over 3–12 months with incremental dilator size increases.

Current commercially available dilators, shown in Figure 3, have significant drawbacks. Having observed parents’ emotive reactions to the aesthetics during teaching sessions, nurses started pre-warning parents to prepare them. Aesthetics aside, the cold metal induces the anus to contract, causing the patients upset, thus making an emotionally difficult task even harder for parents. Furthermore, dilators are sold as sets, though often only a few sizes are required; they are reusable between patients, therefore requiring de-contamination and risking loss, and they are expensive.

Figure 3.

Standard metal dilators alongside several iterations of the new dilators.

Method

After establishing that no commercially available dilators were suitable and there were no similar products that could be repurposed, a paediatric surgery clinical nurse specialist approached C.E. in 2002 to request their assistance in developing an improved dilator. C.E. designed and manufactured a new dilator that had significant advantages.

One major design decision related to the choice of material. Dilators on the market were manufactured from surgical stainless steel – a functional, practical and durable choice for a reusable device in a hospital. However, these dilators are used by parents of infant patients in the home. The cold metal and intimidating appearance of the instrument were found to be detrimental to the experience of both patients and users. The team selected a plastic material that was safe, warm to the touch and formable into the required shape. The combination of the clinical experience of the nurses and the design and manufacturing knowledge of the engineers was key to making the right design decisions such as material choice.

The first-generation plastic dilator was well received by nurses and carers, which resulted in gradual order quantity increases. In addition, other Trusts began to hear about the device and wanted to purchase them. It became difficult to meet the manufacturing demand as each dilator was handmade and the product could not be provided to other hospitals without the CE mark. Therefore, the newly established C.E. R&D team submitted a successful application to the Trust’s charity for an Innovation Fund Award in 2014. This facilitated redesign for larger quantity manufacture and subsequent CE marking under C.E.’s quality system, to allow for external sales.

C.E. R&D and the paediatric surgery nursing team used the design wheel approach (Figure 2) to iterate the dilator design. Elements such as material remained the same, but assembly and manufacture processes were outsourced, reducing both manufacturing cost and time. C.E. R&D created the additional technical file documentation required for CE marking and registered the fourth-generation dilator with the Medicines and Healthcare products Regulatory Agency in 2018 as a Class I medical device under the Medical Device Directive.

Results and discussion

C.E. is the legal manufacturer of paediatric plastic anal dilators. The fourth iteration of the product, which is manufactured under the C.E. Quality Management System and carries a CE mark under the Medical Device Directive, was launched in 2018. To date, several hundred units have been provided to patients across the Trust.

Conclusion

Nurses, patients and parents reported a high level of satisfaction with the new dilators. Through several design iterations and optimisation of manufacturing techniques, the project team reduced the unit cost and made the device single patient use, eliminating decontamination costs.

Case study 2: Improving accessibility of patient-controlled analgesia

Development of a new assistive handset for patient-controlled analgesia, led by a nurse from the Trust’s Pain Service in collaboration with C.E. R&D.

Background

Severe acute pain, when local techniques are not available, is best treated with intermittent intravenous doses of opioids for rapid pain relief. Patient-controlled analgesia (PCA) pumps allow patients to self-administer smaller and more regular doses of analgesia in comparison to traditional nurse-administered doses (Craft, 2010). PCA is the current gold standard for intravenous pain relief on wards, giving patients more autonomy, which results in an improved psychological state and higher patient satisfaction scores (Garimella and Cellini, 2013; Lehmann, 2005; Nemati, 2015). A Cochrane Systematic Review in 2015 demonstrated evidence to support that, in addition to increased patient satisfaction, PCA provided slightly better pain control compared with non-patient controlled methods (McNicol et al., 2015). It is also safer and more effective than intramuscular or intermittent intravenous administration.

The patient's decision to press the PCA button remains paramount to successful use of PCA; however, it was estimated by the Pain Service that 20% of patients lack the physical ability to activate the handset button. This figure was calculated by retrospective analysis of patients prescribed PCA systems over 48 h in conjunction with theatre recovery staff, along with the approximate ratio of patients who had used alternative PCA demand methods with the Trust’s former fleet of pumps (Graseby 3300).

Nurses in the Pain Service identified a need for an assistive PCA switch for patients with limited strength, movement or dexterity. Previous versions of PCA had allowed the use of a ‘sip/puff’ system, which inspired nurses to look for a design solution to this challenge. They approached the in-house C.E. department in 2012 with a proposal for a PCA assistive handset device (PCA+) to increase patient benefit.

Method

The PCA+ was developed collaboratively by Pain Service nurses and C.E. R&D, utilising the design wheel shown in Figure 2. Device development and initial functional prototype manufacture were funded by an Innovation Award from the Institute of Physics and Engineering in Medicine in 2012.

Results and discussion

The overall result of this collaboration was the design and manufacture of three PCA+ devices for in-house use. These fourth-generation devices were introduced in 2016 and are kept in the medical equipment library, alongside a stock of 126 PCA pumps for loan to inpatients when required.

Four generations of the handset design are shown in Figure 4, illustrating the iterative prototyping process. The final device, including GorillaPod legs, is shown in Figure 5.

Figure 4.

Prototype development of PCA+ assistive handset.

Figure 5.

Final design of PCA+ assistive handset with 3D printed cradle and GorillaPod legs.

The final concept encapsulates the original handset; therefore, it does not interfere with the internal electronics of the PCA pump. This facilitated rapid development and reduced the risks associated with introduction of the new device. Several of the key user requirements and the associated design features are shown in Table 1.

Table 1.

Sample extract from requirements specification, including associated design features.

Requirement	Stakeholder	Measures of success	Design feature
Functional interface with Carefusion P5000 PCA pump	Patient	100% of patient requests for pain relief are registered by PCA pump. No damage to PCA handset resulting from use of PCA+ device	Close-fitting cradle allows handset to be reliably and accurately positioned
Interface with/attach to bed, chair or other structure to enable patient to reach switch	Patient	Compatible with existing beds and chairs in the Trust. Does not damage or hamper the use of the structure to which it is attached	Flexible legs can interface with any bed rail or similar without causing damage
PCA+ can be installed on the bed quickly without tools	Nurse	Installation in <1 min without reference to instructions or prior experience of the system	Flexible legs allow for rapid, precise and varied positioning
PCA+ can be accurately located by the patient	Nurse	One person can locate the PCA+ within an accuracy of <1 cm in <1 min
PCA+ can be activated by different body parts, e.g. hand, elbow, foot or head	Patient	The patient can activate the switch within 5 s on 95% of attempts	Lever design reduces activation force. Large contact area reduces requirement for patient dexterity or precise movement, making it suitable for activation by any limb or the head. Lever shape guides patient to press at the correct location
PCA+ should be cleanable daily to Trust infection control standards, typically using a wipe	Infection control team, healthcare assistant or nurse	All areas that could pose a risk are accessible with a standard wipe	Cradle designed without small indentations to prevent trapping of dirt
PCA+ should be suitable for standard end-of-use clean with cleaning fluid	Medical equipment library technician	All components must be suitable for 12-h soak in cleaning fluid	Material selection
Production manufacture <∼£250 each	Trust	Production cost <£250	Simple design. Use of commercially available mount reduces cost

Verification testing investigated how reliably PCA+ button presses were registered by the pump; the results confirmed that the PCA+ does not prevent normal operation of the PCA pump. The consequences of incorrect user assembly were also investigated.

Following successful verification, risk assessment and documentation, the device was put into clinical use within the hospital. The PCA+ was also incorporated into local PCA training sessions by the Pain Service. As the legal manufacturer, C.E. R&D is responsible for regular post-market surveillance, which involves reviewing device usage, dealing with complaints and collecting feedback from clinicians. Although the device has received positive feedback from clinicians regarding its design, the most notable finding has been significantly lower utilisation compared with initial estimates (<1% of patients using PCA pumps). This could be attributed to several factors, including lack of awareness amongst current staff who have not undertaken the revised training. Crucially, many of the recorded device loans spanned several weeks, suggesting that the devices were likely to have been used on multiple patients within one loan period, although this was not documented. A detailed analysis of the process for usage and ordering of these devices is being conducted to establish whether the system can be adapted to better meet the needs of users in order to increase device utilisation.

Future design iterations could include features to facilitate easier cleaning, improve visibility of the handset light (indicating availability of pain relief) and design for compatibility with handsets from different manufacturers.

Conclusion

This design project exemplifies a successful collaboration between nurses and engineers at all stages: from identification of a problem to device development and implementation in clinical practice. It demonstrates the benefits of a multidisciplinary team for generating a specification and reaching an effective design. However, it also highlights the importance of fully understanding the care pathways and environment. Methods must be established to facilitate accurate assessment of the true success of the innovation in order to evaluate its clinical benefit. In the next stage of this project, research is required to improve understanding of the clinical usage of the devices currently in service, before focusing on design improvements and expanding the market. PCA pump manufacturers are supportive of the project and have indicated that, following CE marking, the PCA+ would be listed as an accessory in their catalogues.

Results and discussion

In these case studies, nurses identified unmet clinical needs and expanded the multidisciplinary team to include engineers in order to develop effective solutions. Utilising the expertise of specialised staff groups maximises the success of such projects. Basing a team of design engineers within the hospital and making clinicians aware of their services provides clinicians and engineers with easy access to each other’s expertise and enables clinicians and patients to evaluate iterations of a device in a clinical environment and provide rapid feedback to the design team.

The authors identified innovation teams whose remit included medical device development embedded in 9 of the 152 acute hospitals in England (NHS Confederation, 2017). Notable examples include Devices for Dignity (hosted at Sheffield Teaching Hospitals NHS Foundation Trust) (National Institute for Health Research, 2019) and the Centre for Healthcare Equipment & Technology Adoption (CHEATA) (CHEATA, 2020) which is part of C.E. at Nottingham University Hospitals NHS Trust. The size, composition and remit of these teams vary considerably: each has a different mixture of professions and balance of consultancy versus in-house device development. Very few published articles on these teams’ work were found; most information was garnered from professional connections and teams’ own websites. Several PubMed search results focused on adoption of technological innovations rather than proof of concept and design iteration work. Although our searches were not exhaustive, our sparse results suggest that in-house hospital innovation teams are rare, and many of them are poorly publicised.

It should be noted that models for bringing healthcare staff together with designers, engineers and developers to initiate and contribute to healthcare innovation projects also exist outside of the NHS; several academic institutions host healthcare innovation teams. The UCL Institute of Healthcare Engineering has links to eight partner hospitals (University College London, 2020). The Helix Centre was launched as a joint venture between Imperial College London and the Royal College of Art, consisting of an interdisciplinary team working on healthcare innovation projects (Helix Centre, 2018). Anglia Ruskin MedTech Campus facilitates the commercialisation of new technologies across the UK MedTech sector, working with industry partners to combine academic research with commercial exploitation (Anglia Ruskin University, 2020b). Their Medical Device and Technology Research Centre has close research and clinical partnerships with Essex Partnership University NHS Foundation Trust and works across multidisciplinary areas, bringing together a multidisciplinary team from across the NHS, academia and industry (Anglia Ruskin University, 2020a). The Maxwell Centre in Cambridge also provides an interface for industrial engagement with University of Cambridge researchers across the physical sciences and engineering, with a focus on the translation of science and technology to medicine and health (University of Cambridge, 2020).

Innovation centres can also be found embedded in the private healthcare system in the United States, the largest of these being Kaiser Permanente’s Garfield Innovation Center (Garfield Innovation Center, 2020). The Mayo Clinic’s Center for Innovation, also in the United States, is a not-for-profit organisation with the aim of transforming the experience and delivery of healthcare through the application of design thinking (Mayo Foundation for Medical Education and Research, 2017).

Conference presentations we have given on our work and our innovation model have been well received across the UK. Delegates and speakers have shown great interest and support for our approach, giving the impression that they are not aware of similar teams elsewhere; this correlates with the findings of our searches.

One of the primary challenges facing clinicians in the context of clinical innovation seems to be the lack of a clear pathway (Weisberg et al., 2014). An additional barrier is staff shortages, which restrict clinicians’ opportunities to meet with colleagues outside of their department. Furthermore, clinicians are required to follow guidelines and protocols to deliver evidence-based treatment, which limits their agency but protects patient safety.

Differences in hospital structures inhibit the adoption of a universal NHS procedure for innovation; however, the Academic Health Science Network (AHSN) and the Accelerated Access Collaborative exist to increase the development and uptake of innovations in the NHS. The recently published guide for MedTech innovators targeting the NHS England market (The AHSN Network, 2019) will be a useful resource, although the tone implies a focus on commercial potential rather than patient benefit, and it offers minimal advice on the initial translation of an idea into a prototype. Thus, lack of access to engineering expertise remains a key barrier to clinical innovation. By working closely with the local AHSN branch, the C.E. R&D team involved in the case studies presented above has been able to collaborate with small to medium-sized enterprises to offer an exceptional consultancy service in this region. C.E. R&D teams will also be key in helping to deliver the NHS Long Term Plan (NHS, 2019) through consideration of unmet needs across both primary and secondary care settings and collaboration with the Sustainability and Transformation Partnerships in England.

The success of the projects described here makes the case for employing more engineers within healthcare organisations in order to improve quality of care whilst making financial savings, either directly through reduced equipment costs or indirectly through improved efficiency. Publicising the work of C.E. R&D teams is of key importance to raise awareness amongst clinicians, managers and the wider healthcare workforce.

Conclusions

In their respective fields, clinicians and engineers utilise similar problem-solving approaches, coupled with specialist knowledge and expertise. Together, these professionals become a uniquely skilled multidisciplinary team, ideally placed for developing novel solutions to clinical problems. However, in-house C.E. R&D teams are a rarity, and few of the existing teams are adequately publicised. The case studies presented here demonstrate the valuable contribution of engineers to patient care through the multidisciplinary team applying a problem-solving approach. Wider adoption and publicity of this approach could add value by facilitating cost savings, improving efficiency of resource use and improving patient care through innovation.

Key points for policy, practice and/or research

• Problem-solving is central to the roles of both clinicians and engineers, and their approaches to problems are remarkably similar.

• Engineers employed in healthcare settings are uniquely placed to collaborate with clinicians to rapidly develop and implement solutions to unmet clinical needs.

• Despite clear benefits, most healthcare organisations have no obvious route for clinicians to initiate collaborations with engineers.

• Owing to their broad skill set and problem-solving ability, engineers have the potential to make valuable contributions to health and social care policy.

• Future research could explore the role engineers embedded within hospitals could play in introducing new technologies through collaboration with industry as well as clinicians.

Biography

Rachael Andrews is a clinical scientist and design and innovation engineer. Her research interests include systems engineering, lifestyle medicine, non-communicable diseases and the translation of research findings into clinical practice.

Sarah Greasley is a clinical scientist and design and innovation engineer. She holds a PhD in Biomaterials from Imperial College London. Her interests include engineering design and research for patient benefit.

Sarah Knight is a design and innovation engineer and chartered engineer. She worked in engineering consultancy before focusing her broad skills and experience on medical device innovation in the NHS.

Sonya Sireau is a clinical scientist, chartered engineer and head of Clinical Engineering Innovation, which she co-founded with Dr Thomas Stone to identify and design solutions to unmet clinical needs in the NHS.

Andrea Jordan is lead clinical nurse specialist for paediatric surgery. She holds an MSc and has led the nurse specialist team through many changes and innovations to improve patient experience.

Andrew Bell is a registered general nurse with an MSc in Clinical Management of Pain. Over the last 15 years, he has witnessed many changes in the Pain Service at Cambridge University Hospitals.

Paul White is a consultant clinical scientist and head of Clinical Engineering at Cambridge University Hospitals NHS Foundation Trust. He holds a visiting professorship at Anglia Ruskin University’s Postgraduate Medical Institute.

Declaration of conflicting interest

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Ethics

These projects were not part of a clinical research study, therefore ethical permissions were not required. Since the products were developed within the hospital in which they are used, they fall under the in-house exemption of the Medical Devices Directive. They were developed and implemented under the Trust’s governance framework for medical devices.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The paediatric anal dilator project was funded by a grant from Addenbrooke’s Charitable Trust (grant number 9137). The PCA+ project was funded by a Research and Innovation Award from the Institute of Physics and Engineering in Medicine (in 2012).

ORCID iDs

Rachael Andrews https://orcid.org/0000-0003-4702-6737

Sarah Greasley https://orcid.org/0000-0003-3798-224X

Sarah Knight https://orcid.org/0000-0002-9471-7365