Journal of Medical Engineering & Technology
ISSN: 0309-1902 (Print) 1464-522X (Online) Journal homepage: http://www.tandfonline.com/loi/ijmt20
Unmet needs: relevance to medical technology innovation? Avril D. McCarthy, Lise Sproson, Oliver Wells & Wendy Tindale To cite this article: Avril D. McCarthy, Lise Sproson, Oliver Wells & Wendy Tindale (2015) Unmet needs: relevance to medical technology innovation?, Journal of Medical Engineering & Technology, 39:7, 382-387, DOI: 10.3109/03091902.2015.1088093 To link to this article: http://dx.doi.org/10.3109/03091902.2015.1088093
Published online: 29 Sep 2015.
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Date: 03 December 2015, At: 01:34
http://informahealthcare.com/jmt ISSN: 0309-1902 (print), 1464-522X (electronic) J Med Eng Technol, 2015; 39(7): 382–387 ! 2015 Taylor & Francis. DOI: 10.3109/03091902.2015.1088093
INNOVATION
Unmet needs: relevance to medical technology innovation? Avril D. McCarthy*1,2,3, Lise Sproson2, Oliver Wells4, and Wendy Tindale1,2,3,4 Medical Physics and Clinical Engineering, 2NIHR Devices for Dignity Healthcare Technology Co-operative, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK, 3School of Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK, and 4Devices for Dignity Ltd, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK
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Abstract
Keywords
This paper describes and discusses the role of unmet needs in the innovation of new medical technologies using the National Institute for Health Research Devices for Dignity (D4D) Healthcare Technology Co-operative as a case study. It defines an unmet need, providing a spectrum of classification and discusses the benefits and the challenges of identifying unmet need and its influence on the innovation process. The process by which D4D has captured and utilized unmet needs to drive technology innovation is discussed and examples given. It concludes by arguing that, despite the challenges, defining and reviewing unmet need is a fundamental factor in the success of medical technology innovation.
Innovation, medical technology, unmet needs, user requirements
1. Introduction The remit of the National Institute for Health Research (NIHR) Healthcare Technology Co-operatives (HTC), as defined by the NIHR[20], is to: Focus on clinical areas and themes of high morbidity and unmet need for NHS patients and healthcare technology users, which have not benefitted from a high degree of innovation. The issue of high morbidity is relatively clear and statistics are generally available to evidence its extent, but the definition of ‘unmet need’ and how it is determined, assessed and prioritized, is less clear-cut. The purpose of this paper is to discuss the role of unmet needs in the medical technology innovation process using the experiences of one of the HTCs, namely Devices for Dignity (D4D). The Devices for Dignity Healthcare Technology Cooperative started with the premise that the functional needs of people need to be considered holistically rather than categorizing people by clinical condition. The D4D HTC highlighted dignity and independence as the key factors to drive technology innovation and set up three inter-related themes initially, namely: assistive technologies, continence management and renal technologies (with a focus on renal replacement therapies) as areas of focus and recently has added an additional dimension, rehabilitation technologies, to its assistive theme in response to unmet need demands. *Corresponding author. Email: [email protected]
History Received 8 May 2015 Accepted 26 May 2015
Each theme has a clinical and/or technical lead, with a national network of experts representing all stakeholders including users. The technology areas met the funders’ criteria of not benefitting from high degrees of innovation while having the potential to provide major patient benefits.
2. What is an unmet clinical need? Clinical ‘need’ can take many forms, but in a healthcare setting generally relates to some aspect of human functionality that is lacking or compromised (e.g. hand function, kidney function, mobility) and which requires assistance or a bodily function that is functioning normally but for choice or social reasons requires controlling (e.g. conception). An unmet clinical need is where the aid or control mechanism is unavailable or unsuitable for an individual or group of people. For medical technology innovation, identifying unmet need serves several roles: It is frequently the initiator and driver of innovation; It can start by identifying a problem with an existing technology or service or can highlight a completely new requirement; It demonstrates at the outset that there is likely to be a demand for the new technology and, thus, future adoption of the technology by users is more likely, although by no means guaranteed; and As an unmet need can be experienced by a single individual or a large group of people, it is important to determine the size and impact of meeting the need at the outset.
Unmet needs and medical technology
DOI: 10.3109/03091902.2015.1088093
Unrealised
Unmet NEEDS User Driven (Pull)
TechnologyDriven (Push)
Figure 1. Unmet needs model.
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3. Unmet vs unrealized needs Using the model shown in Figure 1, we can delineate between those needs of which the user is aware (and knows that their needs are unmet) and those needs where the user is as yet unaware and so the needs can be referred to as unrealized or latent. To illustrate the point with a non-medical example, one can use the contrast between instant film cameras and digital cameras. The advent of the digital camera still delivered an instant means of viewing a photograph, but also provided an unanticipated and disruptive element—by removing the need for film; thus, creating new markets for new accompanying digital technologies. A medical equivalent to the digital camera example is that of the introduction of the laparoscopic surgical technique, which offered a less invasive means of reaching a surgical site and thus reduced trauma, with commensurate faster recovery times. Various attempts had been made from the 18th century onwards to develop endoscopes to view inside the body. It was not until the complementary development of a video computer chip to enable magnification and projection of images onto television screens in 1986 that laparoscopic surgery became possible, with the first laparoscopic cholecystectomy performed in 1987 [1]. Its introduction was a breakthrough, but was also disruptive, as patient demand for the less invasive technique outstripped the availability of surgeons trained to use it. The digital camera and laparoscopic surgery are both examples of unrealized needs. In the latter, the underlying need is for gallbladder removal, the unrealized part of which is achieving it with reduced trauma. With such successful disruptive technologies, once they become available, customers (patients) then realize that there are new and unexpected ways of meeting a need or, in other words, there is a solution to a problem that they did not know they had. This aspect highlights where the technology itself can create a need or more accurately a customer-pull or ‘want’. It also identifies the risk that users may often define their need by what already exists and this can lead to incremental rather than step changes in technology innovation. To coin a phrase that Henry Ford is reputed anecdotally to have made referring to the Model T Ford car ‘If I had asked my customers what they wanted—they’d have said a faster horse’ [2,3].
4. Spectrum of ‘unmet’ A technology need may fall into three categories of being unmet. (1) It may be fully unmet in that a technology or solution does not yet exist;
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(2) It may be partially met—a technology exists but it is lacking in functionality or excludes a proportion of potential users; and (3) It may be met fully by the technology but the user does not have access to the technology either by being unaware of it or by being unable to afford or procure it. The following section uses the experience of the ‘unmet needs’ proposed to the D4D HTC from 2008–2012, to expand on the three categories introduced above. Of the 190 ‘unmet needs’ submitted to D4D, the majority (50%) fell into category 2—of being partially met; of the remainder, 29% were fully unmet and 21% were not met for the individual proposing the need, but were not recognized by expert advisors as being unmet for a wider cohort. This latter group represented those individuals who were unaware of the existence of a technology or who were unable to access it or those who believed that they had an idea for a better technology. A substantial proportion of the partially met needs related to the user having complex needs frequently relating to co- and multiple morbidities. This demonstrates the importance of capturing user requirements fully to improve medical devices and to maximize user inclusion. The reader is directed to Martin et al. [4] for appropriateness of requirements capture methods used in ergonomic design, a wider discussion of the challenges of unmet needs described by Godfrey and Callaghan [5] and the commercial importance of designing for device inclusivity in Coleman et al. [6].
5. How do needs differ from ‘wants’ and does it matter? In the medical model, healthcare providers, especially publically funded ones, would argue that they have a duty to provide technology that is functional at the lowest possible cost. In the world of evermore constrained budgets and expanding demand this is a rational and reasonable stance to take, albeit one where the premise has two potential flaws: It disregards the perspective of the technology user; and It disregards evolving healthcare delivery models where the patient is increasingly expected to be cared for at home rather than in a secondary centre. There are many examples of healthcare technologies that pass the test of meeting an unmet need but fail fulfilling the ‘want’ or desirability test. A patient hoist is one such example. It may allow a person to be safely moved from one location to another without a carer needing to lift manually, but often the hoist is left unused. There are many potential reasons, but key ones are: (1) The perception of the user feeling undignified, uncomfortable or anxious while being hoisted or their informal carer perceiving the process to be undignified so avoiding its use. (2) The image of the technology—either that it does not look good and/or that it is perceived as conveying a message to others about its intended user’s lack of ability. Thus, by failing to consider or acknowledge the overall influence of the technology upon the user, a need may remain effectively unmet because the user chooses not to engage with the technology (despite its functionality), thereby negating its potential benefits simply because it has not addressed all of
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the needs and wants of the user. This issue is exacerbated because the procurer of the technology is often not the direct user of the technology and so the voice of the user is not typically heard or even asked to be heard.
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6. Contrast of healthcare product vs consumer product The consumer market demonstrates where a consumer demand can influence medical technology design positively. Spectacles provide an example of a medical device that has undergone a radical image overhaul. The days of the ugly NHS-prescribed round spectacles that children refused to wear have been transformed into being desirable fashion items that people now choose to wear with plain glass in the frames. This has been driven by the consumerization of the technology. However, en route the disruptive technology of contact lenses came into being, offering an alternative to wearing glasses for those requiring visual correction and, more recently, various forms of laser surgery have arisen, with variable success. In each case, the underlying root need is that of providing a visual correction to allow an individual to function, but it also demonstrates that there are multiple solutions that meet that need.
7. What are the challenges and how do you translate a need to a specification? One challenge is that people often feel that they have to provide a solution or to couch their need using the terminology of a solution. Of the 190 ‘need’ proposals that were submitted to D4D during its first 5 years, only 17% focused specifically on the root unmet need without any reference to a proposed solution to it, the remaining majority all proposed some form of solution and some omitted to elucidate the need at all. D4D has had to expend effort to persuade users to tell us about their unmet clinical needs (problems) with sufficient specificity to analyse whether technologies exist to provide a solution or whether new technologies are required. Essentially the unmet need is really only the start point for undertaking a full user requirements capture (URC) process and URC is a methodology that developers of safety critical products (e.g. aircraft) and ergonomists have been employing for many years. Martin et al. [4] provide a useful overview of the later stage of user requirements methods in medical device development. One further risk to innovators discussed by Christensen [7] is where solutions are perceived as being too radical and novel by potential customers; involving users early and throughout the design process can help to mitigate this risk.
8. How do you prioritize one need over another? A key challenge for the D4D HTC is that it receives many technology proposals. The James Lind Alliance (JLA) focusses on identifying and prioritizing the unanswered research questions about the effects of treatments. Although its focus is not technology innovation, it too receives a large of number of proposals and faces a similar prioritization challenge. It states ‘it is therefore essential to adopt a systematic approach to managing and processing the survey submissions in order to create a list of uncertainties for
J Med Eng Technol, 2015; 39(7): 382–387
Table 1. Percentage breakdown of submitted ‘unmet needs’ that included a solution proposal per D4D theme. D4D Theme Assistive technologies and rehabilitation Urinary continence management Renal technologies Cross theme (41 D4D theme) None applicable (speculative submission)
Percentage (%) 55 14 8 5 18
prioritization’, which it scores and enters into a UK Database of Uncertainties about the Effects of Treatments (UK DUETs) [8,9]. Along with prioritization challenges faced by researchers (such as those who are part of the JLA), D4D and other medical technology innovation organizations can find that, within submitted technology proposals, many of which include unmet needs, a proportion are bounded by the proposer’s perceived solution to the need rather than being stated in a way that opens up a range of potential solutions. Expanding further on the 83% of proposals that included some form of suggestion or proposal for a solution, as one might predict from the diversity and extent of the theme, Table 1 shows that the majority (55%) of such applications to D4D related to assistive technologies; it is easy to see that as the nature of the technology is generally low-risk and lowtech it is amenable to a wide range of proposals for technology solutions. A significant percentage (18%) submitted were speculative, not fitting the D4D remit or any of its themes, the reasons for which are discussed later. The urinary continence management theme accounted for 14% of proposals while the more complex and higher risk area of renal technologies accounted for only 8%, with a further 5% being classified as crossing one or more themes.
9. D4D process overview Expanding the process outlined in Figure 2 further, the methods used are described in the following section. (1) Identifying unmet needs. (a) Advertising for direct interactions via D4D web site: www.devicesfordignity.org.uk. (b) Utilizing networks of clinical champions to look for needs. (2) Development of D4D strategic priorities in response to NHS and patient priorities (such as Commissioning for quality and innovation (CQUIN) guidelines and relevant charities). (3) Articulating the needs in a way that can be assessed. (a) During the first years of D4D, an iterative process was often required in order to articulate the need in a way that could be assessed and to separate out proposed solutions. (b) We now use a simple standardized form to capture needs which can be accessed via electronic media (D4D web site, email) or traditional (e.g. posted paper format) methods. (c) The form is followed up with telephone or video calls and meetings to ensure that the need has been captured and understood fully.
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Figure 2. Devices for Dignity unmet needs process overview.
(d) The information is used to develop an agreed statement of the unmet need applying SMARTER principles (Specific, Measurable, Agreed, Realistic, Time-phased, Exciting, Recorded) [10] suitable to initiate a user requirements specification. (e) Developing SMARTER needs provides a goal-orientated mechanism by which a subsequent technology developer can evaluate whether and to what extent they have met the need. (4) Validating that needs are unmet and assessing the extent to which they are unmet. (a) Gaining independent opinions through the networks of clinical theme and medical technology experts in the D4D consortium. (b) Gaining consensus through network discussions. (c) Feeding back to originator. (5) Prioritizing which needs will be developed further by D4D and which will be made available to other organizations. (a) Assessment against potential resource and effort required and D4D resource available and the potential impact of meeting the need. (b) Essentially it is about balancing a positive (clinical) impact of the technology against risk. (6) Translating prioritized needs into new solutions (a) Once a need has been prioritized by D4D, the most appropriate technology development approach is determined and development teams are established.
10. Process discussion During the early pilot phase (2008–2012) of D4D, despite clearly stating that its primary drivers were those of dignity and independence, a substantial proportion (18%) of cited needs were only loosely relevant or, in some cases, were not relevant to dignity and independence or the D4D themes. This likely reflected a pent-up demand for innovation assessment and development opportunities. The subsequent expansion of the NIHR HTC network at the start of 2009 from two to eight HTCs, covering a much broader remit, has assisted in
Table 2. Scoring matrix to inform unmet need prioritization process (MIRC). Market
Impact
Risk
Cost
Filter decision
Small (3) Low (3) High (3) High (3) No (12) Medium (2) Medium (2) Medium (2) Medium (2) Maybe (8) Large (1) High (1) Low (1) Low (1) Yes (4)
spreading the demand and enabling enquiries to be directed more appropriately. Articulation of need is not always easy, but it is well worth spending time on this initially as valuable development time and effort can be saved later. Time invested in understanding the unmet need fully can protect against missed opportunities and significant future time/resource demands correcting early prototypes, which may have been misdirected. This approach can be illustrated by a quote (anecdotally) mis-attributed to Einstein: ‘If I were given one hour to save the planet, I would spend 55 minutes defining the problem and five minutes solving it’ [11].
11. Balancing the D4D portfolio The operational model of D4D is unusual in that it considers technology users holistically. It is in support of this approach that D4D has several interconnected areas of focus. This adds a level of complexity in dealing with unmet needs, as D4D is often comparing highly variable unmet needs that then have to be prioritized across its focus areas. In medical research several helpful structured frameworks can be applied (e.g. PICO, PEO, SPICE) to help determine an answerable research question [12]. In the context of assessing unmet need to inform medical technology innovation, these research frameworks are not always suitable or appropriate. Given the large numbers of unmet needs that exist, not all of which can be taken forward, we propose the following matrix (Table 2) to help filter needs in the prioritization process: An illustration of the impact assessment filtering considerations is shown in Figure 2 and the product of the three factors gives an indication of potential impact. Direct
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Rang of potenal clinical benefit of use
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Product of frequency x duraon of use Rang of potenal user benefit of use
The product of the three factors gives an indicaon of overall technology impact
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Figure 3. D4D Filtering process for assessing potential technology impact.
measures of impact are difficult to attain as they typically take several years to assess and data is not always easy to acquire. The risk rating relates to the product of EU medical device classification [13], technology complexity, required project team and anticipated funding required to develop a solution. The market size is self-explanatory, but should include an assessment of what market share could be anticipated and will be affected by whether the new technology is sustaining or disruptive (discussed under models of innovation). Cost includes the predicted cost of the device including development costs, whether it is considered a long-term investment (i.e. capital cost) or short-term recurrent cost (i.e. consumable), cost and time to getting it to market and likely costs of product adoption. This latter factor will be influenced strongly by who has budgetary control of the technology’s purchase. A score of 4 (4 1) would be a very strong indicator that the unmet need should be prioritized, whereas a score of 12 (4 3) would be unlikely to be prioritized. Clearly, the matrix shown in Table 2 is very simplistic and the full version would offer 81 (34) different combinations of scores. Nevertheless, the range of summated score values is more limited and anything in the range 4–8 would be considered, whereas in the range 9–12 would be less likely to be progressed. The reality is such that filters can be a useful tool, but do not replace the influence of the theme advisory experts and the human factor of intuitive ‘gut feel’ at times. What it does do effectively is prompt early consideration of the critical factors that might lead to subsequent project failure. By doing so, the process helps to aid and, thus, de-risk prioritization decisions. Starting with an unmet need (if validated and prioritized as being unmet) will also strengthen subsequent technology adoption by having responded to user ‘pull’ for technology to meet that need.
12. How do technology needs differ? Further complications can arise where there are multiple users of, and multiple stakeholders in, the decision to purchase the medical technology. An example is demonstrated by the former NIHR National Innovation Centre (NIC), ‘Wouldn’t It Be Good If’ programme (or WIBGI for short), which also collected unmet clinical needs generally expressed by healthcare professionals (the needs database is still available publically) [14]. D4D undertook the early stage of developing a new paediatric transport system for children with complex
medical needs on behalf of the NIC. Here the users are diverse and have very different priorities. The starting point was given as: A Paediatric Transport System is needed that promotes independence for children with profound and multiple disabilities and their carers who require continual access to a large amount of care and monitoring equipment. The amount of equipment and lack of storage space on current transport chairs restricts the freedom of children and parents to go out. Therefore, the system must enable integration of all the necessary equipment to allow excursions and also accommodate the changing size of the child so they do not require a complete different system every year. Although at first reading the unmet need appears detailed, the primary user is not stated and the scope and the metrics to measure the success of any solution are not defined. As an example a parent of a child might respond that they would like a lighter wheelchair that could be folded easily to place in a car boot. An engineer would wish to know: ‘lighter than what and what is the required compact size and time to fold up and deploy?’ Whereas a technology innovator might respond: ‘Why do you want a chair when you could have an alternative and more radical approach as a solution?’ The first challenge was to determine the scope of the challenge and to capture the requirements of the users. Returning to forming SMARTER statements of unmet need, the challenge relates to determining the specific and measurable elements of the need and agreeing what is realistic to achieve without constraining the potential solutions to the point where innovation becomes stifled [15]. Similarly, another challenge is: who is the customer? Is it the child, the parent, the healthcare professional or the person procuring the system or a combination thereof? Frequently with NHS prescribed and supplied devices such as assistive technology and continence devices, the technology user is not the purchaser of the technology. With such examples where the user is distanced from technology procurement, it can result in users becoming disenfranchized from the design process and as such there is a long-term risk that resulting devices are not ones that users would choose to use. Significant effort was expended in running focus groups involving each of the stakeholder groups, on-line surveys targeting each group and early conceptual design sessions with the range of likely users to prioritize the long list of potential technology requirements associated with the need. The process demonstrated clear and significantly differing priorities, but also that a consensus view can be reached by employing a collaborative approach at the outset of the technology specification and before design commences [16].
13. Models of technology innovation As introduced earlier, if unmet needs are stated relative to existing technology, then typically any technology development will be biased towards incremental changes of that technology (i.e. sustaining it), whereas if the need is stated in open terms there is a greater likelihood that a completely new
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DOI: 10.3109/03091902.2015.1088093
‘disruptive’ approach (like the digital camera or laparoscopic approach surgery) might also be discovered. In addition to whether the technology is sustaining or disruptive, the innovation approach taken may be ‘closed’ or ‘open’ [17]. 13.1. Closed innovation The closed model is one with which most large companies are comfortable. It assumes that the control of the development should be focused internally and provided by its own employees with any intellectual property arising from it belonging to the company.
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13.2. Open innovation In contrast, the open innovation approach takes a much more collaborative view—a kind of ‘the whole is greater than the sum of its parts approach’ if you will. In brief, it is where companies perform open innovation by essentially putting forth an innovation problem they are facing to the public (or, at least, a community of individuals outside of their own employees) and then inviting individuals to submit solutions to that problem. A fuller discussion is given by Christensen [18] of the Harvard Business School. An example of this approach taken within Devices for Dignity was its recent Innovate UK Small Business Research Initiative (SBRI) kidney care competition where a portfolio of unmet needs relating to renal technologies was collected, defined and then made available for innovators to respond with solutions [19]. According to Christensen [18], one of the main benefits of open innovation is that it allows companies to reach beyond their organizational boundaries and tap the outside expertise of a broader set of individuals than they could otherwise reach; this was the case with the SBRI competition where companies with particular skill and attributes, not always healthcare-related, were attracted into a new technology development challenge.
14. Conclusions The process of determining and validating unmet needs is not always easy and it can be tempting to overlook this critical aspect of medical technology innovation in the enthusiasm to rush to develop a solution. However, if the problem is not understood fully, how does one know that the right problem is being solved and, thus, that any solutions to it are appropriate, optimal or actually needed? Through the experience of D4D, we argue that defining and reviewing the unmet need is a fundamental aspect for ensuring project success. Developing a comprehensive understanding of the unmet need and why it is unmet, will not only inform the key requirements for any technology to be developed subsequently, but it will also strengthen any business case necessary to seek funding and to support subsequent product adoption.
Declaration of interest The work was funded through the NIHR Devices for Dignity Healthcare Technology Co-operative at Sheffield Teaching Hospitals NHS Foundation Trust. The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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Unmet needs: relevance to medical technology innovation? Avril D. McCarthy, Lise Sproson, Oliver Wells & Wendy Tindale To cite this article: Avril D. McCarthy, Lise Sproson, Oliver Wells & Wendy Tindale (2015) Unmet needs: relevance to medical technology innovation?, Journal of Medical Engineering & Technology, 39:7, 382-387, DOI: 10.3109/03091902.2015.1088093 To link to this article: http://dx.doi.org/10.3109/03091902.2015.1088093
Published online: 29 Sep 2015.
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Date: 03 December 2015, At: 01:34
http://informahealthcare.com/jmt ISSN: 0309-1902 (print), 1464-522X (electronic) J Med Eng Technol, 2015; 39(7): 382–387 ! 2015 Taylor & Francis. DOI: 10.3109/03091902.2015.1088093
INNOVATION
Unmet needs: relevance to medical technology innovation? Avril D. McCarthy*1,2,3, Lise Sproson2, Oliver Wells4, and Wendy Tindale1,2,3,4 Medical Physics and Clinical Engineering, 2NIHR Devices for Dignity Healthcare Technology Co-operative, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK, 3School of Health and Related Research (ScHARR), University of Sheffield, Regent Court, 30 Regent Street, Sheffield S1 4DA, UK, and 4Devices for Dignity Ltd, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK
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1
Abstract
Keywords
This paper describes and discusses the role of unmet needs in the innovation of new medical technologies using the National Institute for Health Research Devices for Dignity (D4D) Healthcare Technology Co-operative as a case study. It defines an unmet need, providing a spectrum of classification and discusses the benefits and the challenges of identifying unmet need and its influence on the innovation process. The process by which D4D has captured and utilized unmet needs to drive technology innovation is discussed and examples given. It concludes by arguing that, despite the challenges, defining and reviewing unmet need is a fundamental factor in the success of medical technology innovation.
Innovation, medical technology, unmet needs, user requirements
1. Introduction The remit of the National Institute for Health Research (NIHR) Healthcare Technology Co-operatives (HTC), as defined by the NIHR[20], is to: Focus on clinical areas and themes of high morbidity and unmet need for NHS patients and healthcare technology users, which have not benefitted from a high degree of innovation. The issue of high morbidity is relatively clear and statistics are generally available to evidence its extent, but the definition of ‘unmet need’ and how it is determined, assessed and prioritized, is less clear-cut. The purpose of this paper is to discuss the role of unmet needs in the medical technology innovation process using the experiences of one of the HTCs, namely Devices for Dignity (D4D). The Devices for Dignity Healthcare Technology Cooperative started with the premise that the functional needs of people need to be considered holistically rather than categorizing people by clinical condition. The D4D HTC highlighted dignity and independence as the key factors to drive technology innovation and set up three inter-related themes initially, namely: assistive technologies, continence management and renal technologies (with a focus on renal replacement therapies) as areas of focus and recently has added an additional dimension, rehabilitation technologies, to its assistive theme in response to unmet need demands. *Corresponding author. Email: [email protected]
History Received 8 May 2015 Accepted 26 May 2015
Each theme has a clinical and/or technical lead, with a national network of experts representing all stakeholders including users. The technology areas met the funders’ criteria of not benefitting from high degrees of innovation while having the potential to provide major patient benefits.
2. What is an unmet clinical need? Clinical ‘need’ can take many forms, but in a healthcare setting generally relates to some aspect of human functionality that is lacking or compromised (e.g. hand function, kidney function, mobility) and which requires assistance or a bodily function that is functioning normally but for choice or social reasons requires controlling (e.g. conception). An unmet clinical need is where the aid or control mechanism is unavailable or unsuitable for an individual or group of people. For medical technology innovation, identifying unmet need serves several roles: It is frequently the initiator and driver of innovation; It can start by identifying a problem with an existing technology or service or can highlight a completely new requirement; It demonstrates at the outset that there is likely to be a demand for the new technology and, thus, future adoption of the technology by users is more likely, although by no means guaranteed; and As an unmet need can be experienced by a single individual or a large group of people, it is important to determine the size and impact of meeting the need at the outset.
Unmet needs and medical technology
DOI: 10.3109/03091902.2015.1088093
Unrealised
Unmet NEEDS User Driven (Pull)
TechnologyDriven (Push)
Figure 1. Unmet needs model.
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3. Unmet vs unrealized needs Using the model shown in Figure 1, we can delineate between those needs of which the user is aware (and knows that their needs are unmet) and those needs where the user is as yet unaware and so the needs can be referred to as unrealized or latent. To illustrate the point with a non-medical example, one can use the contrast between instant film cameras and digital cameras. The advent of the digital camera still delivered an instant means of viewing a photograph, but also provided an unanticipated and disruptive element—by removing the need for film; thus, creating new markets for new accompanying digital technologies. A medical equivalent to the digital camera example is that of the introduction of the laparoscopic surgical technique, which offered a less invasive means of reaching a surgical site and thus reduced trauma, with commensurate faster recovery times. Various attempts had been made from the 18th century onwards to develop endoscopes to view inside the body. It was not until the complementary development of a video computer chip to enable magnification and projection of images onto television screens in 1986 that laparoscopic surgery became possible, with the first laparoscopic cholecystectomy performed in 1987 [1]. Its introduction was a breakthrough, but was also disruptive, as patient demand for the less invasive technique outstripped the availability of surgeons trained to use it. The digital camera and laparoscopic surgery are both examples of unrealized needs. In the latter, the underlying need is for gallbladder removal, the unrealized part of which is achieving it with reduced trauma. With such successful disruptive technologies, once they become available, customers (patients) then realize that there are new and unexpected ways of meeting a need or, in other words, there is a solution to a problem that they did not know they had. This aspect highlights where the technology itself can create a need or more accurately a customer-pull or ‘want’. It also identifies the risk that users may often define their need by what already exists and this can lead to incremental rather than step changes in technology innovation. To coin a phrase that Henry Ford is reputed anecdotally to have made referring to the Model T Ford car ‘If I had asked my customers what they wanted—they’d have said a faster horse’ [2,3].
4. Spectrum of ‘unmet’ A technology need may fall into three categories of being unmet. (1) It may be fully unmet in that a technology or solution does not yet exist;
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(2) It may be partially met—a technology exists but it is lacking in functionality or excludes a proportion of potential users; and (3) It may be met fully by the technology but the user does not have access to the technology either by being unaware of it or by being unable to afford or procure it. The following section uses the experience of the ‘unmet needs’ proposed to the D4D HTC from 2008–2012, to expand on the three categories introduced above. Of the 190 ‘unmet needs’ submitted to D4D, the majority (50%) fell into category 2—of being partially met; of the remainder, 29% were fully unmet and 21% were not met for the individual proposing the need, but were not recognized by expert advisors as being unmet for a wider cohort. This latter group represented those individuals who were unaware of the existence of a technology or who were unable to access it or those who believed that they had an idea for a better technology. A substantial proportion of the partially met needs related to the user having complex needs frequently relating to co- and multiple morbidities. This demonstrates the importance of capturing user requirements fully to improve medical devices and to maximize user inclusion. The reader is directed to Martin et al. [4] for appropriateness of requirements capture methods used in ergonomic design, a wider discussion of the challenges of unmet needs described by Godfrey and Callaghan [5] and the commercial importance of designing for device inclusivity in Coleman et al. [6].
5. How do needs differ from ‘wants’ and does it matter? In the medical model, healthcare providers, especially publically funded ones, would argue that they have a duty to provide technology that is functional at the lowest possible cost. In the world of evermore constrained budgets and expanding demand this is a rational and reasonable stance to take, albeit one where the premise has two potential flaws: It disregards the perspective of the technology user; and It disregards evolving healthcare delivery models where the patient is increasingly expected to be cared for at home rather than in a secondary centre. There are many examples of healthcare technologies that pass the test of meeting an unmet need but fail fulfilling the ‘want’ or desirability test. A patient hoist is one such example. It may allow a person to be safely moved from one location to another without a carer needing to lift manually, but often the hoist is left unused. There are many potential reasons, but key ones are: (1) The perception of the user feeling undignified, uncomfortable or anxious while being hoisted or their informal carer perceiving the process to be undignified so avoiding its use. (2) The image of the technology—either that it does not look good and/or that it is perceived as conveying a message to others about its intended user’s lack of ability. Thus, by failing to consider or acknowledge the overall influence of the technology upon the user, a need may remain effectively unmet because the user chooses not to engage with the technology (despite its functionality), thereby negating its potential benefits simply because it has not addressed all of
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the needs and wants of the user. This issue is exacerbated because the procurer of the technology is often not the direct user of the technology and so the voice of the user is not typically heard or even asked to be heard.
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6. Contrast of healthcare product vs consumer product The consumer market demonstrates where a consumer demand can influence medical technology design positively. Spectacles provide an example of a medical device that has undergone a radical image overhaul. The days of the ugly NHS-prescribed round spectacles that children refused to wear have been transformed into being desirable fashion items that people now choose to wear with plain glass in the frames. This has been driven by the consumerization of the technology. However, en route the disruptive technology of contact lenses came into being, offering an alternative to wearing glasses for those requiring visual correction and, more recently, various forms of laser surgery have arisen, with variable success. In each case, the underlying root need is that of providing a visual correction to allow an individual to function, but it also demonstrates that there are multiple solutions that meet that need.
7. What are the challenges and how do you translate a need to a specification? One challenge is that people often feel that they have to provide a solution or to couch their need using the terminology of a solution. Of the 190 ‘need’ proposals that were submitted to D4D during its first 5 years, only 17% focused specifically on the root unmet need without any reference to a proposed solution to it, the remaining majority all proposed some form of solution and some omitted to elucidate the need at all. D4D has had to expend effort to persuade users to tell us about their unmet clinical needs (problems) with sufficient specificity to analyse whether technologies exist to provide a solution or whether new technologies are required. Essentially the unmet need is really only the start point for undertaking a full user requirements capture (URC) process and URC is a methodology that developers of safety critical products (e.g. aircraft) and ergonomists have been employing for many years. Martin et al. [4] provide a useful overview of the later stage of user requirements methods in medical device development. One further risk to innovators discussed by Christensen [7] is where solutions are perceived as being too radical and novel by potential customers; involving users early and throughout the design process can help to mitigate this risk.
8. How do you prioritize one need over another? A key challenge for the D4D HTC is that it receives many technology proposals. The James Lind Alliance (JLA) focusses on identifying and prioritizing the unanswered research questions about the effects of treatments. Although its focus is not technology innovation, it too receives a large of number of proposals and faces a similar prioritization challenge. It states ‘it is therefore essential to adopt a systematic approach to managing and processing the survey submissions in order to create a list of uncertainties for
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Table 1. Percentage breakdown of submitted ‘unmet needs’ that included a solution proposal per D4D theme. D4D Theme Assistive technologies and rehabilitation Urinary continence management Renal technologies Cross theme (41 D4D theme) None applicable (speculative submission)
Percentage (%) 55 14 8 5 18
prioritization’, which it scores and enters into a UK Database of Uncertainties about the Effects of Treatments (UK DUETs) [8,9]. Along with prioritization challenges faced by researchers (such as those who are part of the JLA), D4D and other medical technology innovation organizations can find that, within submitted technology proposals, many of which include unmet needs, a proportion are bounded by the proposer’s perceived solution to the need rather than being stated in a way that opens up a range of potential solutions. Expanding further on the 83% of proposals that included some form of suggestion or proposal for a solution, as one might predict from the diversity and extent of the theme, Table 1 shows that the majority (55%) of such applications to D4D related to assistive technologies; it is easy to see that as the nature of the technology is generally low-risk and lowtech it is amenable to a wide range of proposals for technology solutions. A significant percentage (18%) submitted were speculative, not fitting the D4D remit or any of its themes, the reasons for which are discussed later. The urinary continence management theme accounted for 14% of proposals while the more complex and higher risk area of renal technologies accounted for only 8%, with a further 5% being classified as crossing one or more themes.
9. D4D process overview Expanding the process outlined in Figure 2 further, the methods used are described in the following section. (1) Identifying unmet needs. (a) Advertising for direct interactions via D4D web site: www.devicesfordignity.org.uk. (b) Utilizing networks of clinical champions to look for needs. (2) Development of D4D strategic priorities in response to NHS and patient priorities (such as Commissioning for quality and innovation (CQUIN) guidelines and relevant charities). (3) Articulating the needs in a way that can be assessed. (a) During the first years of D4D, an iterative process was often required in order to articulate the need in a way that could be assessed and to separate out proposed solutions. (b) We now use a simple standardized form to capture needs which can be accessed via electronic media (D4D web site, email) or traditional (e.g. posted paper format) methods. (c) The form is followed up with telephone or video calls and meetings to ensure that the need has been captured and understood fully.
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Figure 2. Devices for Dignity unmet needs process overview.
(d) The information is used to develop an agreed statement of the unmet need applying SMARTER principles (Specific, Measurable, Agreed, Realistic, Time-phased, Exciting, Recorded) [10] suitable to initiate a user requirements specification. (e) Developing SMARTER needs provides a goal-orientated mechanism by which a subsequent technology developer can evaluate whether and to what extent they have met the need. (4) Validating that needs are unmet and assessing the extent to which they are unmet. (a) Gaining independent opinions through the networks of clinical theme and medical technology experts in the D4D consortium. (b) Gaining consensus through network discussions. (c) Feeding back to originator. (5) Prioritizing which needs will be developed further by D4D and which will be made available to other organizations. (a) Assessment against potential resource and effort required and D4D resource available and the potential impact of meeting the need. (b) Essentially it is about balancing a positive (clinical) impact of the technology against risk. (6) Translating prioritized needs into new solutions (a) Once a need has been prioritized by D4D, the most appropriate technology development approach is determined and development teams are established.
10. Process discussion During the early pilot phase (2008–2012) of D4D, despite clearly stating that its primary drivers were those of dignity and independence, a substantial proportion (18%) of cited needs were only loosely relevant or, in some cases, were not relevant to dignity and independence or the D4D themes. This likely reflected a pent-up demand for innovation assessment and development opportunities. The subsequent expansion of the NIHR HTC network at the start of 2009 from two to eight HTCs, covering a much broader remit, has assisted in
Table 2. Scoring matrix to inform unmet need prioritization process (MIRC). Market
Impact
Risk
Cost
Filter decision
Small (3) Low (3) High (3) High (3) No (12) Medium (2) Medium (2) Medium (2) Medium (2) Maybe (8) Large (1) High (1) Low (1) Low (1) Yes (4)
spreading the demand and enabling enquiries to be directed more appropriately. Articulation of need is not always easy, but it is well worth spending time on this initially as valuable development time and effort can be saved later. Time invested in understanding the unmet need fully can protect against missed opportunities and significant future time/resource demands correcting early prototypes, which may have been misdirected. This approach can be illustrated by a quote (anecdotally) mis-attributed to Einstein: ‘If I were given one hour to save the planet, I would spend 55 minutes defining the problem and five minutes solving it’ [11].
11. Balancing the D4D portfolio The operational model of D4D is unusual in that it considers technology users holistically. It is in support of this approach that D4D has several interconnected areas of focus. This adds a level of complexity in dealing with unmet needs, as D4D is often comparing highly variable unmet needs that then have to be prioritized across its focus areas. In medical research several helpful structured frameworks can be applied (e.g. PICO, PEO, SPICE) to help determine an answerable research question [12]. In the context of assessing unmet need to inform medical technology innovation, these research frameworks are not always suitable or appropriate. Given the large numbers of unmet needs that exist, not all of which can be taken forward, we propose the following matrix (Table 2) to help filter needs in the prioritization process: An illustration of the impact assessment filtering considerations is shown in Figure 2 and the product of the three factors gives an indication of potential impact. Direct
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Rang of potenal clinical benefit of use
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Product of frequency x duraon of use Rang of potenal user benefit of use
The product of the three factors gives an indicaon of overall technology impact
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Figure 3. D4D Filtering process for assessing potential technology impact.
measures of impact are difficult to attain as they typically take several years to assess and data is not always easy to acquire. The risk rating relates to the product of EU medical device classification [13], technology complexity, required project team and anticipated funding required to develop a solution. The market size is self-explanatory, but should include an assessment of what market share could be anticipated and will be affected by whether the new technology is sustaining or disruptive (discussed under models of innovation). Cost includes the predicted cost of the device including development costs, whether it is considered a long-term investment (i.e. capital cost) or short-term recurrent cost (i.e. consumable), cost and time to getting it to market and likely costs of product adoption. This latter factor will be influenced strongly by who has budgetary control of the technology’s purchase. A score of 4 (4 1) would be a very strong indicator that the unmet need should be prioritized, whereas a score of 12 (4 3) would be unlikely to be prioritized. Clearly, the matrix shown in Table 2 is very simplistic and the full version would offer 81 (34) different combinations of scores. Nevertheless, the range of summated score values is more limited and anything in the range 4–8 would be considered, whereas in the range 9–12 would be less likely to be progressed. The reality is such that filters can be a useful tool, but do not replace the influence of the theme advisory experts and the human factor of intuitive ‘gut feel’ at times. What it does do effectively is prompt early consideration of the critical factors that might lead to subsequent project failure. By doing so, the process helps to aid and, thus, de-risk prioritization decisions. Starting with an unmet need (if validated and prioritized as being unmet) will also strengthen subsequent technology adoption by having responded to user ‘pull’ for technology to meet that need.
12. How do technology needs differ? Further complications can arise where there are multiple users of, and multiple stakeholders in, the decision to purchase the medical technology. An example is demonstrated by the former NIHR National Innovation Centre (NIC), ‘Wouldn’t It Be Good If’ programme (or WIBGI for short), which also collected unmet clinical needs generally expressed by healthcare professionals (the needs database is still available publically) [14]. D4D undertook the early stage of developing a new paediatric transport system for children with complex
medical needs on behalf of the NIC. Here the users are diverse and have very different priorities. The starting point was given as: A Paediatric Transport System is needed that promotes independence for children with profound and multiple disabilities and their carers who require continual access to a large amount of care and monitoring equipment. The amount of equipment and lack of storage space on current transport chairs restricts the freedom of children and parents to go out. Therefore, the system must enable integration of all the necessary equipment to allow excursions and also accommodate the changing size of the child so they do not require a complete different system every year. Although at first reading the unmet need appears detailed, the primary user is not stated and the scope and the metrics to measure the success of any solution are not defined. As an example a parent of a child might respond that they would like a lighter wheelchair that could be folded easily to place in a car boot. An engineer would wish to know: ‘lighter than what and what is the required compact size and time to fold up and deploy?’ Whereas a technology innovator might respond: ‘Why do you want a chair when you could have an alternative and more radical approach as a solution?’ The first challenge was to determine the scope of the challenge and to capture the requirements of the users. Returning to forming SMARTER statements of unmet need, the challenge relates to determining the specific and measurable elements of the need and agreeing what is realistic to achieve without constraining the potential solutions to the point where innovation becomes stifled [15]. Similarly, another challenge is: who is the customer? Is it the child, the parent, the healthcare professional or the person procuring the system or a combination thereof? Frequently with NHS prescribed and supplied devices such as assistive technology and continence devices, the technology user is not the purchaser of the technology. With such examples where the user is distanced from technology procurement, it can result in users becoming disenfranchized from the design process and as such there is a long-term risk that resulting devices are not ones that users would choose to use. Significant effort was expended in running focus groups involving each of the stakeholder groups, on-line surveys targeting each group and early conceptual design sessions with the range of likely users to prioritize the long list of potential technology requirements associated with the need. The process demonstrated clear and significantly differing priorities, but also that a consensus view can be reached by employing a collaborative approach at the outset of the technology specification and before design commences [16].
13. Models of technology innovation As introduced earlier, if unmet needs are stated relative to existing technology, then typically any technology development will be biased towards incremental changes of that technology (i.e. sustaining it), whereas if the need is stated in open terms there is a greater likelihood that a completely new
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DOI: 10.3109/03091902.2015.1088093
‘disruptive’ approach (like the digital camera or laparoscopic approach surgery) might also be discovered. In addition to whether the technology is sustaining or disruptive, the innovation approach taken may be ‘closed’ or ‘open’ [17]. 13.1. Closed innovation The closed model is one with which most large companies are comfortable. It assumes that the control of the development should be focused internally and provided by its own employees with any intellectual property arising from it belonging to the company.
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13.2. Open innovation In contrast, the open innovation approach takes a much more collaborative view—a kind of ‘the whole is greater than the sum of its parts approach’ if you will. In brief, it is where companies perform open innovation by essentially putting forth an innovation problem they are facing to the public (or, at least, a community of individuals outside of their own employees) and then inviting individuals to submit solutions to that problem. A fuller discussion is given by Christensen [18] of the Harvard Business School. An example of this approach taken within Devices for Dignity was its recent Innovate UK Small Business Research Initiative (SBRI) kidney care competition where a portfolio of unmet needs relating to renal technologies was collected, defined and then made available for innovators to respond with solutions [19]. According to Christensen [18], one of the main benefits of open innovation is that it allows companies to reach beyond their organizational boundaries and tap the outside expertise of a broader set of individuals than they could otherwise reach; this was the case with the SBRI competition where companies with particular skill and attributes, not always healthcare-related, were attracted into a new technology development challenge.
14. Conclusions The process of determining and validating unmet needs is not always easy and it can be tempting to overlook this critical aspect of medical technology innovation in the enthusiasm to rush to develop a solution. However, if the problem is not understood fully, how does one know that the right problem is being solved and, thus, that any solutions to it are appropriate, optimal or actually needed? Through the experience of D4D, we argue that defining and reviewing the unmet need is a fundamental aspect for ensuring project success. Developing a comprehensive understanding of the unmet need and why it is unmet, will not only inform the key requirements for any technology to be developed subsequently, but it will also strengthen any business case necessary to seek funding and to support subsequent product adoption.
Declaration of interest The work was funded through the NIHR Devices for Dignity Healthcare Technology Co-operative at Sheffield Teaching Hospitals NHS Foundation Trust. The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper.
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