Defining what is RIH
To define the scope and specificities of our RIH framework, we applied an iterative approach wherein deductive and inductive analytical strategies alternated. Since one of our research team’s objectives was to develop a formal RIH assessment tool, we sought to build on key concepts from the literature, but we also explored whether these concepts meaningfully captured a range of empirical characteristics. Specifically, we generated a preliminary list of dimensions by drawing from the international health systems literature and bodies of knowledge that are particularly relevant to RIH. These included scholarships that are specific to health (e.g. HTA, ELSIs, determinants of health, health economics, health services research, etc.) and others that are specific to technology-based entrepreneurship (e.g. start-ups, incubators, business models, frugal or ‘bottom of the pyramid’ innovation, etc.).
Using a preliminary set of criteria such as innovativeness, health relevance and subsidiarity, we created an inventory of health innovations that could potentially qualify as responsible by performing a structured social media-based horizon scan supplemented with searches of specialised directories and websites. This exercise generated approximately 100 empirical examples that were extremely useful to circumscribe what RIH may entail in practice. Whilst results of this exercise are described in detail elsewhere (under review), we provide below a brief description of three innovations of our inventory to illustrate some of the principles and dimensions underscored by these examples.
The first innovation is a menstrual cup developed by a social enterprise and distributed free of charge to young women in developing countries through strategic partnerships with local organisations and a ‘buy one, give one’ model. Although its initial cost is higher than that of traditional alternatives, the menstrual cup can be used for up to 10 years, making it a much more affordable option in the long run (95% cheaper), as well as more ecological, since a woman uses up to 12,000 disposable sanitary products throughout her reproductive life. The second innovation refers to 3D-printed prostheses created and printed by a global community of volunteers for those in need of upper limb assistive devices (hands and arms). These prostheses are mechanical, customisable, easy to assemble, printed free of charge from anywhere in the world and delivered directly to the user. Their designs are open-source and shared on a website dedicated to the sharing of digital design files created by its users – more than 100 models are currently available at no cost. The third innovation is a portable nebuliser which is manually activated by a healthcare worker or caregiver and does not use batteries or any other external source of energy. It is easy to use, and its performance is equivalent to that of an electric-powered nebuliser. Although it is not yet available on the market, the projected price of the innovation is less than half of that of an electric nebuliser, whilst the cost of operation and maintenance is estimated to be low.
These examples allowed us to think about the value domains that resonate with different types of health innovations and to better understand the scope of dimensions that a RIH should have, such as the promotion of health equity, frugality and eco-responsibility. They also confirmed the importance of appraising the responsibility of a given innovation within the context where its users are located. For instance, the menstrual cup may favour social insertion of women who live in regions of the world where access to safe, effective sanitary products is a major challenge due to their cost or unavailability, which leads to social stigma and school/work absenteeism; 3D printable, open-source prostheses may benefit children who cannot afford traditional prostheses and need to perform simple tasks such as holding a ball, pressing buttons and turning pages; and the human powered nebuliser may be a proper solution for people who live in remote communities where respiratory health problems (e.g. tuberculosis, chronic obstructive pulmonary disease, asthma and lower respiratory tract infections) are prevalent and access to electricity is limited or non-existent.
In short, the inventory of potential examples of RIH enabled our team to gradually consolidate the framework that is presented below. It also contributed to the further development of the RIH Assessment Tool, which aims to identify whether an innovation may potentially qualify as a RIH and, if so, to assess its responsibility features. In order to evaluate and reach a consensus on the constructs of this Tool (screening criteria, assessment attributes and rating system), we conducted an international Delphi study in 2017 by consulting with experts with complementary perspectives on health innovation – RRI scholars, biomedical engineers, bioethicists and HTA experts. The findings of this study have been summarised and submitted for publication (under review) and were extremely helpful to revise and validate the value domains and dimensions of the framework.
Drawing on the RRI core principles presented earlier and the iterative approach summarised above, we define RIH as follows:
RIH consists of a collaborative endeavour wherein stakeholders are committed to clarify and meet a set of ethical, economic, social and environmental principles, values and requirements when they design, finance, produce, distribute, use and discard sociotechnical solutions to address the needs and challenges of health systems in a sustainable way.
RIH is thus defined as an ambitious and sustained effort that requires collaboration among many diverse stakeholder groups (e.g. investors, technology developers, providers, managers and users of health services, regulators, policy-makers, etc.). Collaboration among these groups is certainly fraught with tensions because dominant settings of research, production and sale are not necessarily aligned with all of the many settings of adoption, adaptation and use of health innovations. Nevertheless, collaboration is essential not only from a normative procedural standpoint, but also because the development of innovations must tap into the complementary (and at times conflicting) expertise, know-how and experience these stakeholders possess as they handle different aspects of health innovations (e.g. financing, design, production, regulation, reimbursement, use, etc.).
The term ‘sociotechnical solutions’ emphasises the notion that the use of a technology, either as simple as a scalpel or as complex as a surgical suite, requires the combined action of an array of individuals and technical components. This term calls our attention to solutions that go beyond what is usually understood as health technologies (e.g. medical devices, drugs, vaccines, medical procedures or information systems) and that address the various factors that determine health across one’s life course (e.g. education, employment, physical environment, etc.).
The ‘principles, values and requirements’ of RIH are considered throughout an innovation’s ‘lifecycle’ (i.e. from the choice of materials to be used to end-of-life disposal), thereby encompassing its characteristics, the processes by which it is being produced, the organisation that develops it as well as the suppliers and distributors that are needed to produce and make it available to end users. As a result, RIH moves beyond a silo approach to more comprehensively support the governance of health innovations across multiple sectors and policy domains.
The value domains and dimensions of RIH
One important premise of our framework is that a given innovation would be deemed irresponsible – and thus excluded from further consideration – if it were not proven effective and safe and if the organisation bringing it to market were engaged in corporate social irresponsibility, which includes behaviours and corporate actions that are illegal, unsustainable or unethical, leading to negative consequences for individuals and ecosystems [
28]. As pointed out by Jones et al. [
29], some positions adopted by irresponsible organisations concerning corporate issues and the ways they relate to wider society include, but are not limited to, little precaution on environmental degradation and pollution, unfair treatment of suppliers and customers, and development and launch of new technologies regardless of the harm they may cause.
Table
2 presents the five value domains of the RIH framework which comprise of a total of nine dimensions. The first domain, ‘population health value’, suggests that, although innovation that provides individual health benefits is valuable, RIH should increase our ability to attend to collective needs whilst tackling health inequalities [
30]. The second domain, ‘health system value’, draws attention to the extent to which an innovation provides an appropriate response to contemporary challenges of health systems [
31]. Third, the ‘economic value’ domain, proposes that RIH must deliver both high-performing products as well as affordable ones in order to support equity and sustainability [
10,
32]. Fourth, the ‘organisational value’ domain underscores the business strategies through which an enterprise provides value to users, purchasers and society [
33]. Finally, the ‘environmental value’ domain highlights the need to reduce, as much as possible, the negative environmental impacts of health innovations throughout their entire lifecycle [
34,
35]. These value domains and dimensions provide health and innovation policy-makers with key elements that may foster the development of innovations responsive to system-level challenges and that support more equitable and sustainable health services. In the following paragraphs, we clarify the nature and importance of each dimension that integrates the RIH framework we propose.
Table 2
The value domains and dimensions of responsible innovation in health
Population health | Health relevance: Does the innovation address a relevant health problem? Ethical, legal and social issues: Was the innovation developed by seeking to mitigate its ethical, legal or social issues? Health equity: In what ways does the innovation promote health equity? |
Health system | Inclusiveness: Were the innovation development processes inclusive? Responsiveness: Does the innovation provide a dynamic solution to a health system need or challenge? Level of care: Is the level of care required by the innovation compatible with health system sustainability? |
Economic | Frugality: Does the innovation deliver greater value to more people using fewer resources? |
Organisational | Business model: Does the organisation that produces the innovation seek to provide more value to users, purchasers and society? |
Environmental | Eco-responsibility: Does the innovation limit its negative environmental impacts throughout its lifecycle as much possible? |
The population health value domain is comprised of three dimensions (Table
2). The ‘health relevance’ dimension seeks to ascertain the importance of the health needs addressed by an innovation within the overall burden of disease, considering the risk factors and causes of morbidity and mortality that are specific to the region where the intended users are located. For example, some types of cancer, such as bladder, kidney or prostate cancer, constitute an important burden of mortality and morbidity in high-income countries, whereas certain infectious diseases (e.g. HIV/AIDS, meningitis, tuberculosis) represent an important burden in developing nations [
36]. Since many new technologies tend to provide incremental benefits when compared to existing alternatives, one delicate issue when reflecting on the level of responsibility of an innovation consists of attributing value to its purpose. Because companies and investors are often reluctant to engage in research and development efforts when the putative markets are small or less affluent [
37], innovations that address life-threatening or chronically debilitating rare diseases as well as neglected tropical diseases may provide responsible actions to respond to health needs that would not otherwise be met. This first dimension is thus specific to RIH and brings to the fore a collective responsibility toward health needs.
Acknowledging that “
health care is a moral endeavour” and that “
the vast potential of technology poses complex moral challenges” [
38], the second dimension draws attention to the ELSIs that underlie the development, distribution and use of health technologies. Although such issues cannot be entirely identified in advance, RIH calls for a careful examination of mitigation strategies that are needed according to the context of use. For instance, an assistive device may exacerbate social stigma associated with disability in certain cultural groups or the default options of a monitoring device may not respect one’s individual right to privacy. The “
social shaping of technology” perspective suggests that the degree of responsibility of an innovation is influenced, implicitly and explicitly, by multiple values as the “
technologies and the actors that develop and implement them are inherently value-laden” [
39]. Accordingly, one would wish to define, at an early stage, the values embedded in innovations that, for instance, build on artificial intelligence such as wearable devices, robotics or mobile applications, in order to identify the mitigation means they require. This second dimension thus adheres to the RRI principle according to which ELSIs have to be reflexively anticipated, thereby extending the scope of the ethical analyses currently performed in HTA [
40].
The third dimension emphasises the importance of ‘health equity’, which is aligned with concerns about the varying “
capability to achieve good health” among different social groups and recognises that the achievement of health is embedded in “
broader issues of social justice and overall equity” [
41]. Current evidence indicates a strong correlation between healthcare disparities, measured in terms of accessibility, continuity and comprehensiveness of care, and vulnerability factors, such as poverty, ethnic minorities, incarceration, immigration status and underserved areas [
42]. In addition to these factors, vulnerability may also be generated or exacerbated by (1) health technologies that are used to legitimise discrimination and social inequalities, as illustrated by the built-in racial bias of the spirometer against black people [
43], (2) new forms of healthcare that are simultaneously innovative forms of clinical research (e.g. precision medicine), which increase the number of complex decisions that have to be made by patients and their healthcare providers [
44], and (3) healthcare delivery models in which access to services is based on ability to pay rather than equity, imposing financial barriers and contributing to significant and damaging financial loss [
45]. From this perspective, an innovation may be seen as responsible if it explicitly addresses the needs of groups who are considered vulnerable “
based on the ways in which they are marginalised, socially excluded, have limited opportunities and income, and suffer abuse, hardship, prejudice and discrimination” [
46]. Such vulnerable groups include, but are not limited to, subsistence farmers, long-term unemployed, informally employed and seasonal/daily workers; people living in deprived urban and rural areas, in poverty and homeless; people with disabilities and mental illnesses; ethnic minority groups, asylum seekers and refugees; single parents, older people and children [
46,
47]. The degree of responsibility of an innovation may thus be pondered by examining whether the ability to benefit from it varies according to one’s socioeconomic status, social position or capabilities. This dimension is thus grounded in the health literature and underscores that innovations seeking to benefit population health should also strive to promote health equity.
As Table
2 indicates, the ‘health system value’ domain is comprised of three dimensions, starting with a dimension that examines the degree to which innovation processes and outcomes are ‘inclusive’. For Klaassen et al. [
17], opening up science and innovation practices to multiple societal actors is important for “
democratic reasons and also to broaden and diversify the sources of expertise and perspectives”. To achieve inclusiveness in RIH, one must firstly clarify the particular set of individuals and institutions that should contribute to the design, development and pilot stages of an innovation (e.g. health and social care practitioners and managers, patients and informal caregivers, community and civil society representatives, etc.). Secondly, it is important to define what modalities of engagement should be deployed to capture their expectations, needs and interests, to assess the value and importance of these claims and to handle them in an open way. In other words, RIH should rely on the engagement of a well justified set of stakeholders and the ways in which their inputs will or will not be integrated into the innovation should be clear and explicit. Therefore, this dimension is both process- and product-oriented and draws on a RRI principle which stipulates that, even though stakeholder engagement may differ from one type of innovation to another, the processes and outcomes should be held accountable [
12].
Responsiveness, an important RRI principle, recognises that unforeseen consequences may result from innovations and that the context in which they are disseminated may shift in unexpected ways. This principle requires the ability “
to develop an answer [response]
and react [respond]
to external developments caused either by other actors or the natural environment” [
48]. Within the RIH health system value domain, the ‘responsiveness’ dimension brings to the fore the value of providing flexible and opportune solutions to existing and emerging system-level challenges. According to a scoping review of the international peer-reviewed literature on health systems, approximately two-thirds of the challenges documented by scholars were related to health service delivery (e.g. access, vertical integration, referral systems), human resources (e.g. staff availability, competency and distribution), and leadership and governance (e.g. strategic policies, horizontal coordination) [
31]. This suggests that, although the nature and importance of health system challenges vary across countries, responsible innovations should carefully consider their contribution to, and impact on service delivery, human resources and governance. This dimension thus adapts a RRI principle to the systemic context in which health innovations are deployed, keeping in mind the importance of addressing health system needs and challenges in a sustainable way.
The ‘level of care’ dimension seeks to ascertain the extent to which the innovation is compatible with health system equity and sustainability. As MacDonnell and Darzi [
49] suggest, innovations that reduce the labour intensity of care should be encouraged to better manage health spending growth. Following the principle of subsidiarity, the most decentralised unit in the health system (e.g. primary care, non-clinical settings) should be mobilised to provide care when it is possible to do so effectively and safely. By increasing the capacity of general practitioners and community health and social care providers to locally attend to their patients’ needs, responsible innovations may reduce geographical access barriers that are characteristic of rural and remote areas. Similarly, innovations that are aligned with patients’ capacity for self-care may offer responsible solutions if high-quality outcomes are achieved. This dimension is thus anchored in health services research and invites a careful consideration of the requirements in terms of infrastructure and specialisation of new technologies.
Within the economic value domain, the ‘frugality’ dimension emphasises the importance of providing more value to more people using fewer resources [
50]. According to Tran and Ravaud [
51], frugal innovations in health may result from (1) simplification of existing techniques or technologies (e.g. low-cost bubble continuous positive airway pressure, portable electrocardiogram machine); (2) use of modern technologies to tackle ‘old problems’ (e.g. SMS to improve adherence to antiretroviral therapy, 3D printed prostheses); (3) diversion of existing tools for completely different purposes (e.g. solar-powered autoclave, paper clips in surgery); and (4) use of low-tech approaches to solve local unmet needs (e.g. Kangaroo care for preterm infants, solar disinfection of water). Whilst frugal innovation is considered to be the outcome of low-resource settings, where traditional solutions are too expensive, not available or impossible to use with existing resources, the concept of frugality may also be applied to design and develop low-cost, high-quality technologies. Examples of such technologies are provided by Williams [
52], who studied how a non-profit ophthalmic consumables and equipment manufacturing company in India was able to successfully design and develop intraocular lenses and ophthalmic drugs to treat non-communicable eye diseases (cataract, glaucoma, age-related macular degeneration, diabetic retinopathy) for marginalised people. In fact, frugality may address RIH process, product and organisational concerns in conjunction by seeking to substantially reduce the cost of an innovation through focusing on the core functionalities its users require and optimising its performance level (i.e. quality, robustness, accuracy, durability) in view of the intended purpose and context of use [
53]. Frugality may thus support RIH by increasing affordability because of optimised innovation production processes and/or lower maintenance needs; usability, which enables reaching out to patients who would not otherwise benefit from the innovation, including remote or resource-poor settings; and fit between the innovation’s performance and its context of use. This dimension is informed by the health economics literature on the pressures new technologies exert on the growth of health expenditures [
32,
54], but it goes beyond the provision of affordable health interventions.
Within the organisational value domain, the ‘business model’ dimension, which focuses on “
the rationale of how an organisation creates, delivers, and captures value” [
55], acknowledges the tension between value capture (i.e. economic returns) and value creation (i.e. provision of a high-quality product). This tension increases when the performance of the organisation is measured exclusively in economic terms. Research shows that the business models currently established in the medical device industry, coupled with the rapid growth and high return logic of venture capital, tend to generate technologies that health systems can no longer afford and whose added value may remain marginal from a clinical or population health standpoint [
33]. Whilst philanthropic organisations may be able to contribute to RIH, their economic sustainability remains challenging [
56]. This is why hybrid organisations such as social purpose businesses, cooperatives and enterprising non-profits that rely on alternative, economically viable business models may better support RIH. For Haigh and Hoffman [
57], hybrid organisations differ from traditional businesses in that they adopt explicit goals to foster social and/or environmental change, maintain sustainable and mutually beneficial relationships with suppliers, employees and customers, and interact with competitors and other institutions with the goal of benefitting society as a whole. Whilst traditional commercial enterprises may contribute to economic development and offer valuable innovations, organisations that adopt alternative business models are in a position to provide more value to consumers, users and society. The Aravind Eye Hospital, an ophthalmic institution that provides a large proportion of its services (diagnostic examination, ophthalmic surgery and postoperative care) to low-income people in southern India, is a well-known example of a healthcare organisation that adopts an alternative, economically viable business model to deliver high-quality, low cost ophthalmological care to those who have little or no access to major eye care facilities due to geographical and financial barriers [
58,
59]. Hence, this dimension draws on the social entrepreneurship scholarship and bridges a gap in the RRI literature.
Finally, within the environmental value domain, the ‘eco-responsibility’ dimension acknowledges the importance of healthcare’s carbon footprint and emphasises the environmental impacts of health innovations throughout their lifecycle [
35]. Activities inside and around hospitals tend to consume a lot of energy and raw resources and to produce a range of hazardous materials that may be dangerous, infectious, toxic or radioactive. For instance, activities that have negative environmental impacts include discarded materials and equipment, expired or unused pharmaceutical products, drugs and vaccines, and chemicals generated through disinfecting procedures or cleaning processes. The negative impacts on human health of hazardous material (10–25% of healthcare waste) are numerous, including infectious diseases due to exposure to contaminated waste, intoxication, injuries and poisoning caused by chemical and pharmaceutical waste, and health problems attributable to genotoxic and radioactive waste [
60]. Efforts to reduce current negative environmental impacts of health-related activities may thus prove responsible as would the development of ‘green’ technologies [
61]. For instance, a new product may be designed so as to be free of substances such as latex, heavy metals or chemicals that are of major public health concern or harmful and toxic to ecosystems. It can be made of recycled or renewable content materials and be designed to be easily recycled, reused, remanufactured, composted or biologically degraded when it reaches its end of life. Compliance with environmental regulations and green certifications as well as efficient energy consumption during its production and/or utilisation may also reflect environmental responsibility. Hence, this dimension draws on a RRI principle and is aligned with a planetary health research priority [
62].