Medical device technologies (MDTs) include medical devices and assistive devices (Reference Shah and Robinson34), which have been defined elsewhere (36;38). There are a range of, often competing perspectives, concerning MDT such as regulators’ perspectives, manufacturers’ perspectives and users’ perspectives. All these perspectives are important to assess and synthesize, but users’ perspectives are particularly important for the success of a device. Users of MDTs are not homogeneous as they are often implicitly considered to be, but are constituted by different types and groups of people such as healthcare professionals, carers, and end users, for example, patients, people with disabilities and/or special needs, and elderly people, with different roles and interests (Reference Shah and Robinson34). Involvement of the users is essential because they expect that the medical device that is supplied to them, or that they buy and use, fulfills their personal needs and requirements, which may indeed vary from one user to another, especially in the case of end users. The most effective way of developing MDTs from users’ perspective, therefore, can be done by involving the healthcare professionals as well as the end users. For devices that are intended for the use by end users, views of and acceptance by end users is crucial to the device's role and longevity, no matter how well the device is manufactured, and how strongly it is recommended by healthcare professionals.
There is published evidence that end users’ involvement in the MDT development process (MDTDP) is associated with several substantial advantages for manufacturers. For example, the generation of ideas for new products and product innovation; access to users’ actual requirements and expectations; a reduction in development costs; an improvement in device design, usability, and safety; and the identification of potential problems at an early stage of the device development cycle, thus limiting costly device modifications and a reduction in device recalls (Reference Martin, Murphy and Crowe24;Reference Shah and Robinson33). Manufacturers, therefore, need to engage with the range of users of MDTs and involve them, as early as possible, in the development process (Reference Garmer, Liljegren, Osvalder and Dahlman12).
Up to now evidence on users’ involvement in the MDTDP is clearly focused on the views of healthcare professionals, particularly clinicians and nurses, while other types of MDT users, especially end users, such as patients, people with disabilities and/or special needs, elderly people, and carers, particularly lay carers, are less likely to be involved in the process (Reference Bridgelal Ram, Campling, Grocott and Weir4;Reference Ekelman11, p. 173; Reference Martin, Murphy and Crowe24;Reference Shah and Robinson32). The apparently minimal involvement of the end users (who we also call as nonhealthcare professional users), can be for various reasons including their personal characteristics and a need for supporting, preparing, and training them to enable their involvement in the MDTDP (Reference Shah and Robinson33).
According to Andre et al. (Reference Andre, Hartson, Belz and Mccreary2), user involvement depends and/or is facilitated by the availability of an appropriate framework. In relation to MDT, several frameworks have been used. For example, the technology transfer model (Reference Sheredos and Cupo35); the economic evaluation in health technology assessment (Reference Sculpher, Drummond and Buxton31); a framework for the development and evaluation of randomized controlled trials (Reference Campbell, Fitzpatrick and Haines8;25); a model of user engagement in medical device development (Reference Grocott, Weir and Ram14), and the integration of a Bayesian framework in the medical device development cycle (Reference Vallejo-Torres, Steuten and Buxton37). However, no universal and formal framework for the involvement of users, especially end users, in the process of MDT manufacturing from concept development through to the market deployment has been reported in the literature (Reference Bridgelal Ram, Campling, Grocott and Weir4;Reference Martin, Murphy and Crowe24;Reference Shah and Robinson32). In the absence of an acceptable and proper framework, a meaningful users’ involvement cannot occur systematically across the medical device sector, but it will take place haphazardly. This has had, and is likely to have, negative repercussions for both manufacturers and users of MDTs, for example the continuous abandonment of the devices by their users (Reference Batavia and Hammer3). There is, therefore, a need for an acceptable and generic framework for involving various types of users in the MDTDP. The authors, therefore, propose such a framework in this study. However, before presenting our conceptual framework, we briefly describe some key concepts, that is, stages of MDT development cycle, methods of involving users and types of MDT users, on which the framework is based.
STAGES IN MDT LIFECYCLE RELEVANT FOR INVOLVING USERS
The lifecycle of a medical device can be divided into several stages, over which there is some debate. Cooper and Kleinschmidt (Reference Cooper and Kleinschmidt9) described thirteen stages in the lifecycle of a medical device, which were modified to twelve stages by Rochford and Rudelius (Reference Rochford and Rudelius30). Elsewhere, seven stages of the medical device lifecycle have been mentioned (38). Shah and Robinson (Reference Shah and Robinson32) reviewed the different stages of medical device lifecycle reported in a wide range of analyses and determined that the various stages of the medical device lifecycle can be placed into five key phases as follows.
Stages of the Medical Device Lifecycle
The lifecycle stages are as follows: Concept stage (idea generation and concept development), Design stage (device (re-)design and prototype development), Testing and trials stage (prototype testing in-house and trials in the real field), Production stage (device production based on business and commercial rational), and Deployment stage (device use in the market and postdeployment user feedback).
The literature shows that users can be involved at four stages, that is, concept, design, testing and trials, and deployment stages, of the above-mentioned five stages (Reference Shah and Robinson32). We, therefore, suggest these four stages can best be used to develop our theoretical framework for involving users in MDTDP (Supplementary Figure 1, which can be viewed online at www.journals.cambridge.org/thc).
Methods for Involving Users
Recent published work suggests several methods that have been used for involving different types of users in the MDTDP (Reference Bridgelal Ram, Campling, Grocott and Weir4;Reference Martin, Murphy and Crowe24;Reference Shah and Robinson32). For example, interviews, focus groups, usability tests, customer feedback, cognitive walkthrough, cognitive task analysis, users and producers seminars, and field observation methods used for involving the end users, such as patients, people with disabilities and/or special needs, and lay carers, and the professional users, for example, physicians, general practitioners, surgeons, nurses, cardiologists, radiologists, MRI professionals, and physicists) in the development process of different types of MDTs. For instance, an inhaler (Reference Anderson, Dalby, Byron, Peart and Farr1), assistive devices such as robotic aids, wheel chairs, wheeled mobility devices (Reference Batavia and Hammer3;Reference Buhler6;Reference Buhler, Hoelper, Hoyer and Humann7;Reference Kittel, Marco and Stewart19;Reference Mulholland, Packer and Laschinger27, ventilators (Reference Garmer, Ylven and MariAnne Karlsson13), teleradiology system (Reference Handels, Rinast and Busch15), neuromagnetometer (Reference Hasu16;Reference Miettinen and Hasu26), intraventicular blood pump (Reference Hummel, van Rossum and Omta17), telemedicine system (Reference Kaufman, Patel and Hilliman18), patient monitoring system (Reference Liljegren and Osvalder21), patient-controlled analgesia pump (Reference Lin, Isla and Doniz22), and infusion pumps (Reference Garmer, Liljegren, Osvalder and Dahlman12;Reference Obradovich and Woods28;Reference Zhang, Johnson and Patel39).
In our theoretical framework, we will be suggesting that many of the methods mentioned above can be successfully and directly deployed in relation to the involvement of the professional users and the end users at four different stages of the MDT lifecycle (Supplementary Figure 1).
Users of Medical Device Technologies
Primary users of medical devices can be divided, based on their professional and personal traits, into different groups, such as healthcare professionals, patients, people with disabilities and/or special needs, elderly people, and carers, that is, professional and lay carers (Reference Shah and Robinson34). In addition, Shah and Robinson (Reference Shah and Robinson34) are of the opinion that professional people use the devices for the benefit of patients, people with disabilities and/or special needs and elderly people—whom they describe collectively as “end users.”
To clarify further the term “user” here, which often in practice has led to confusion in studies as to whom exactly is referred to by the term, we think medical device users can be classified into two major categories, that is, end users (nonprofessional users) and professional users. The former category may include patients, people with disabilities, and/or special needs, elderly people and lay carers, essentially those nonhealthcare professionals directly using devices, whereas the professional users may include a wide range of healthcare professionals and professional carers. This further classification is based on a factual assumption that end users generally have no or less formal qualifications and training, whereas the professional users are fully and properly qualified and skilled to use specific MDTs. In addition, they differ from each other in several other ways. In describing our framework, we will, therefore, use only two terms, that is, “end users” and “professional users” for those who use MDTs (Supplementary Figure 1).
CONCEPTUAL FRAMEWORK FOR USERS’ INVOLVEMENT
It is noteworthy that the MDTDP is an iterative process starting from idea generation and concept development through to device design and prototype development and testing, and device deployment in the market (Reference Bridgelal Ram, Grocott and Weir5). We believe that the involvement of users can be through an iterative process that can take place at different points in the MDT lifecycle (Supplementary Figure 1). We also believe that in developing a MDT there can be three possibilities as under.
MDT Development Scenarios
Scenario A: Device New to the Market. In the case of development of a device new to the market, a lengthy and detailed iteration from the stage of concept development through to the stage of device deployment in the market will be required (Supplementary Figure 2, which can be viewed online at www.journals.cambridge.org/thc). This type of device can be developed using either an existing technology or a new technology (Reference Dixon, Brown, Meenam and Eatock10).
Scenario B: Major Upgrade of an Existing Device. A major upgrade of an existing device will involve an iterative process between the design and prototype development stage, prototype testing and trials stage and deployment stage (Supplementary Figure 3, which can be viewed online at www.journals.cambridge.org/thc).
Scenario C: Redesigning of a Device Prototype. The redesigning of a device prototype will involve an iterative process mainly between the design and prototype development stage and prototype testing and trials stage (Supplementary Figure 4, which can be viewed online at www.journals.cambridge.org/thc). For prototype redesigning, users’ ideas can be helpful that can be solicited through their involvement by means of the idea generation and concept development stage.
Bearing in mind these possible scenarios and the iterative process of developing MDTs, we propose a conceptual framework (Supplementary Figure 1), which suggests two routes by which involvement of particular types of users may be exercised and various methods can be applied for involving users in various ways at four different stages of the device lifecycle, as follows.
User Involvement Streams
In this framework (Supplementary Figure 1), we suggest two routes, that is, end users’ stream and professional users’ stream for involving users in the MDTDP. Each of the streams covers four stages starting from the idea generation and concept development, device design and prototype development, prototype testing, and trialing through to the market deployment of the device. These four stages of users’ involvement are proposed for the development of a device that is new to the market (Scenario A) (Supplementary Figure 2). However, as we have noted, major upgrading of an existing device (Scenario B) will generally involve three stages, that is, designing, testing and trialing, and deploying of the device in the market (Supplementary Figure 3), on the other hand redesigning of a prototype (Scenario C) will require iterative user involvement primarily between two stages, that is, the design and prototype development stage and the testing and trials stage; however, soliciting users’ opinions by means of the concept (idea generation) stage can be helpful in this scenario (Supplementary Figure 4, which can be viewed online at www.journals.cambridge.org/thc). The operation of the streams is described below.
End Users’ Stream
We suggest that the end users’ (EU) stream (Supplementary Figure 1) is deployed for the involvement of end users, that is, patients, persons with disabilities and/or special needs and elderly people, in addition to lay carers. In general, this stream would be used by MDT developers for MDTs that will be used only by the end users themselves, and/or their carers as proxies for them, generally outside clinical settings and usually at their homes. We believe that devices used by the end users can be relatively simple and less complex as well as more complex and/or innovative. We, therefore, put forward two device exemplars for the application of this stream.
Exemplar 1. A medical device that will be used by the end user(s) and the device will not be very complex. For example, an inhaler device.
In the case of this type of MDT, the developers can use the EU stream, and involve end users in the iterative process between various stages of the device development cycle (Supplementary Figure 1); however, depending on, and as mentioned, in the MDT development scenarios described above. In developing this type of devices, manufacturers can involve professional users, particularly healthcare professionals, such as clinicians, through professional users’ (PU) stream for obtaining their opinions and suggestions regarding the device (Supplementary Figure 1).
Exemplar 2. A medical device that will be used by the end user(s) and the device will be more complex and/or innovative. For example, assistive devices such as a robotic aid.
Developing this type of MDT, there can also be three scenarios mentioned earlier. In the case of developing this type of device new to the market (Scenario A), it is possible that the concept can come from the end user(s), the professional user(s), or the manufacturer. If the concept was developed by the end user(s) then s/he/they should be involved iteratively as described in the MDT development scenario A (Supplementary Figure 2) and using the EU stream (Supplementary Figure 1). However, if the concept was developed by the professional user(s) or the manufacturer, then a model may be more appropriate as that in scenario 4 mentioned under the PU stream, which is described below.
In the case of major upgrade of this type of an existing device or redesigning of a prototype, end users can be involved as described in the MDT development scenario B (Supplementary Figure 3) or scenario C (Supplementary Figure 4), respectively, and through the EU stream (Supplementary Figure 1). In all the three cases, manufacturers can involve healthcare professionals particularly clinicians at later stages, that is, testing and trials stage and deployment stage through the professional users’ stream for obtaining their opinion and suggestions regarding the device (Supplementary Figure 1).
Professional Users’ Stream
We suggest the professional users’ (PU) stream for the involvement of professional users of MDTs (Supplementary Figure 1). We propose that this stream should be used by MDT developers for creating medical devices that will be used only by the professional users, that is, healthcare professionals and/or professional carers for treating and/or caring for an end user or inserting/implanting the device in to the body of an end user by a healthcare professional.
In this stream, professional users can be involved iteratively between various stages of the device lifecycle depending on and as mentioned in the MDT development scenarios A, B and C described above. In addition, there will be a need to involve the end users, at the testing and trials stage and the deployment stage through the EU stream, to check the device performance. To make the application of the PU stream more plausible, we put forward two device exemplars.
Exemplar 3. A medical device will be used only by healthcare professional(s) for the treatment / diagnosis and/or care of the end user(s). For example, a neuromagnetometer.
To develop this type of device, there can be three scenarios, that is A, B, and C as mentioned earlier. For developing this type of device new to market (Scenario A), there can be two possibilities. First, if professional user(s), such as surgeon(s), developed the device concept then we suggest that s/he/they should be involved from the concept development stage, through to device design and prototype development, testing and trials and the deployment stages of the device using the PU stream (Supplementary Figures 1 and 2). Second, if the manufacturer developed the concept, then the professional users may not be involved at the concept development stage but at the latter stages. However, we suggest that they should be involved at this stage to avoid any unforeseen and potential limitations. For developing MDTs as mentioned in Scenario B or Scenario C, manufacturer can involve professional users through the PU stream and at the stages and in the manner described in the respective scenarios (Supplementary Figures 3 and 4). Irrespective of the scenarios, there will, however, be a need for end users’ involvement at the testing and trials and the deployment stages through the EU stream to evaluate the device performance (Supplementary Figure 1).
Exemplar 4. A device will be used by the end user(s) but a healthcare professional will insert/place it in to the body of the end user. The device is more complex and/or innovative. For example, an implantable medical device.
There can be three scenarios, that is, A, B, and C, as mentioned earlier, to develop this type of device. In scenario A, if the concept was developed by the healthcare professional(s) then s/he/they can be involved at all four stages described in MDT development scenario A and using the PU stream (Supplementary Figures 1 and 2). However, if the concept for developing this type of device came from the manufacturer, then the manufacturer may not involve healthcare professionals at the concept stage but at the device design and prototype development stage through to the testing and trials and deployment stages through the PU stream (Supplementary Figures 1 and 2). We, however, suggest that the manufacture involves healthcare professional at the concept stage to discuss the device concept to thrush out any potential limitations. In the case of developing MDT as mentioned in scenarios B and C, manufacturers should involve the professional users as described in the respective scenario (Supplementary Figures 3 and 4). Irrespective of the scenarios, there will, however, be a need to involve the end users at the testing and trials stage, and deployment stage through the EU stream to assess the device performance (Supplementary Figure 1).
User Involvement Methods
We suggest various methods (Supplementary Figure 1) for involving both the end users and the professional users, using the EU stream and the PU stream respectively, in the MDTDP. The most common methods that we suggest for both types of the users and the streams include interviews, focus groups, brainstorming sessions, and users-producers seminars at the concept stage; interviews, usability tests, and users’ feedback at the design stage; usability tests, interviews, and discussion at testing and trials stage; ethnography, interviews, and surveys for (post-) deployment stage of the device (Supplementary Figure 1).
DISCUSSION
Practice has been very varied in involving users in the MDTDP and sometimes user involvement, particularly end user involvement, is very modest. Low or limited user involvement could be due to several factors such as a lack of funds and time available to manufacturers who are operating in a very competitive market (Reference Shah and Robinson33). It may also occur through the personal limitations of users (through cognitive, physical, or informational problems) to meaningfully participate in the MDTDP (Reference Shah and Robinson33). Despite above-mentioned constraints, there is often a willingness among manufacturers to use feedback from users’ in the development of MDTs. Nevertheless, there is then the poverty of effective frameworks to incorporate users’ feedback in the MDTDP. It is the need for such a framework that we have addressed in this study.
We have proposed a generic theoretical framework for directly involving both the end users (nonprofessional users) and the professional users in the MDTDP (Supplementary Figure 1). We recognize that medical devices differ from each other depending on the nature and complexity of the technology involved, type of the intended user, the environment and context of the use and the type of medical condition for which the device(s) is/are used. The nature of medical devices and the type of the intended users are, however, the most critical issues in involving users in the MDTDP. In this framework, we have, therefore, suggested two routes, that is, EU stream and PU stream through which needs of the intended users can be incorporated in the MDTDP (Supplementary Figure 1).
In our framework, we have proposed that if the medical device being developed is a simple device that will be used by the end users then the EU stream will be the first choice to develop such device. This is because end users know their needs better than anyone else. In addition, we assume, end users, and their lay carers, might already have used a similar device at some point in time; therefore, they may have experience and knowledge of the limitations of using such a device. End users, therefore, can be helpful in (re)designing and/or upgrading of existing devices as well as developing a new device that can be used for a similar purpose. It is also possible that healthcare professionals, and professional carers, can convey some of the needs and requirements of the end users, which they have come to know often through early contact with some of the end users. Manufacturers can, therefore, also involve professional users through the PU stream to get their perspectives about the device. An example is the development of an inhaler by Anderson et al. (Reference Anderson, Dalby, Byron, Peart and Farr1), who involved both the end users, that is, asthma patients and their lay carers, and professional users, that is, physicians, general practitioners, and asthma nurses from the concept and design development stages through to the testing and trials stages and their perspectives were obtained by various methods, such as interviews, focus groups, usability tests, and user feedback.
Our framework suggests that if the MDT being developed is both complex and/or innovative, which is to be used by either the end user or the professional user, and a healthcare professional, a professional carer, and/or a manufacturer suggested the concept, then the PU stream should be the first choice to develop such device. Nevertheless, the involvement of end users will be required at the later stages in particular during testing and trialing stage and at the stage of device deployment in the market to assess and evaluate the device performance. For example, involvement of both healthcare professionals and end users in the development process of a neuromagnetometer—a complex device that is used by healthcare professionals for the analysis of the human cortex (brain) activity in patients with certain medical conditions, such as epilepsy and brain tumors (Reference Hasu16;Reference Miettinen and Hasu26). There is a further example of such a deployment in relation to a complex and innovative device developed through users’ involvement, which is the Gynecare TVT Secure System device for female stress urinary incontinence. This device was primarily developed by involving mainly professionals staff such as uro-gynecologists and urologists, a primary route similar to the PU stream suggested in our framework, while end users (female patients with stress urinary incontinence) were used at the testing and trialing stage and deployment stage, a secondary route similar to that proposed in the EU stream mentioned in our framework (Personal email communication from Peter A. Meier, Principal Scientist, Research & Development, ETHICON GmbH, Germany). It is important to bear in mind that end users may not possess sufficient technical knowledge and understanding about such complex products to be able to fully give incisive assessments about them. Manufacturers, therefore, should not expect end users to solve major technical problems, therefore, their involvement should be mainly for the purpose of identifying and clarifying their requirements and the vital features of the devices for them (Reference Lichter, Schneider-Hufschmidt and Zullighoven20). Nevertheless, for innovative devices such as in relation to emerging medical technologies, end users can still be extensively involved at the testing stage of the device prototype (Reference Buhler6).
We do not prescribe specific method(s) for involving the users at any point in the MDTDP, because we believe that the selection of those particular method(s) depends upon the resources, both money and time, and expertise available to the MDT developer. Developers should, therefore, decide themselves whether to use any particular method, taking into account costs and resources available, together with the type of data required and the quality of information obtainable through the method. There is no doubt that the involvement of users in developing MDT is a protracted process; nevertheless, its impact on the device development is very great (Reference Buhler6). “The manufacturers, therefore, need to build-in time and resource for such activities into the development plan and ensure end-user as well as professional-user value is captured in the product's value proposition” (Personal email communication by Michael Borroff, Director of Strategic Health Outcomes, DePuy International).
Limitations. The authors recognize limitations of this framework such as the need for its validation, which will be undertaken in collaboration with our industrial partners, and the generality in its description. The latter is, however, done purposely to provide a generic framework and for ensuring involvement of different types of MDT users and to present it as an easily understood approach for managers in the medical device manufacturing industry.
POLICY IMPLICATIONS
According to Marshall et al. (Reference Marshall, Case and Oliver23), a “designing for all” approach is required in product development to meet the needs of users particularly the needs of specific groups of end users. The PU stream is the most widely used route of users’ involvement by the majority of device manufacturers. This practice has led medical research to be biased in favor of professional users, essentially only doctors/clinicians (Reference Rhodes, Nocon, Wright and Harrison29). We, therefore, would like to draw attention to a few important issues in this regard. First, manufacturers must involve potential users, be they patients, healthcare professionals, or carers who are actually going to use the device. Second, members of research and development (R&D) staff within manufacturing companies must not be assumed to predict accurately actual users’ needs. Hence, it is unwise they should be involved as a total proxy on behalf of the real users of the device. Nevertheless, there are exceptions, for example, if a particular member of R&D who has ever used a device in his/her capacity either as a healthcare professional, caregiver, or patient then he/she might be suitable to be involved in the development of such device and represent users’ needs. Our framework (Supplementary Figure 1), therefore, ensures the involvement of different types of the medical device users to meet their specific and often hitherto unmet needs and requirements. Development of this conceptual work will support MDT manufacturers, particularly small and medium manufacturers (SMMs), who may have limited expertise with regard to engagement with users, especially end users, in developing decision-making protocols regarding users’ involvement in the MDTDP.
CONCLUSION
The development and evaluation of medical devices from users’ perspectives requires not only the involvement of healthcare professionals but also that of the ultimate end users, that is, patients, people with disabilities and/or special needs, and their lay caregivers. This is because the needs of various types of the users vary widely from each other. The evidence shows that such end users quickly discard devices that do not fulfill their personal expectations, even though both manufacturers and healthcare professionals may consider those end users’ requirements met. MDT developers and manufacturers need to recognize this potent potential discrepancy between the parties involved, and involve end users as well as professional healthcare staff directly in the MDTDP. Nevertheless, the engagement of some types of medical device users, particularly end users may not always be possible for various reasons such as a lack of formally defined user involvement process; hence, more formal approaches and a generic framework for involving end users needs to be developed and refined. The availability of a user involvement framework such as that proposed in this study will help medical device manufacturers, particularly SMMs, in planning and developing strategies for involving end users and professional users in the MDTDP.
SUPPLEMENTARY MATERIALS
Supplementary Figure 1: www.journals.cambridge.org/thc
Supplementary Figure 2: www.journals.cambridge.org/thc
Supplementary Figure 3: www.journals.cambridge.org/thc
Supplementary Figure 4: http://www.journals.cambridge.org/thc
CONTACT INFORMATION
Syed Ghulam Sarwar Shah, MBBS, MSc (Sarwar.Shah@brunel.ac.uk), Research Fellow, Multidisciplinary Assessment of Technology Centre for Health Care, Ian Robinson, PhD (Ian.Robinson@brunel.ac.uk), Professor Emeritus, Centre for the Study of Health and Illness, School of Social Sciences & Multidisciplinary Assessment of Technology Centre for Healthcare, Sarmad AlShawi, PhD (Sarmad.AlShawi@brunel.ac.uk), Lecturer, Brunel Business School & Multidisciplinary Assessment of Technology Centre for Healthcare, Brunel University, Kingston Lane, Uxbridge, Middlesex UB8 3PH, UK
