Chapter 8
Open Issues and a Proposal for Open-source Data Monitoring to Assure Quality, Reliability, and Safety in Health Care Devices Targeting Low- and Middle-income Countries Kate Michi Ettinger
Abstract Health care entrepreneurs who design medical devices and mobile health applications for emerging markets face difficulty when deciding how to demonstrate the safety of their products. Many middle and low-income countries have no uniform system to address safety. This paper presents findings from 40 interviews with stakeholders involved in device development. It illustrates multi-stakeholder perspectives on quality, reliability, and safety (QRS) issues for health care devices designed for low- and middle-income markets. The paper identifies key challenges for entrepreneurs in these markets. Then, it proposes an open-source technology approach to build a transnational QRS assurance system. Further research is needed to determine whether and how open-source technology could enable an easy-to-use, effective, and affordable QRS system for health care devices in emerging markets.
8.1 Introduction In 2010, at Unite for Sight’s Global Health and Innovation conference, I attended a session that introduced an award-winning neonatal incubator, NeoNurture (Zenios et al. 2012). As a product designer, I was in awe of the incubator’s brilliant design. Referred to as “appropriate technology,” these products meet the unique conditions of the low-income markets they serve at an appropriate price. Typically, in emerging markets, a neonatal incubator would be donated from a developed market. Parts would break due to frequent power fluctuations; with no access to spare parts for these foreign-made, expensive machines, the entire device would be discarded. NeoNurture was a low-cost neonatal incubator made entirely from used car parts. K.M. Ettinger (&) Center for Health Professions, UCSF and Mural Institute, San Francisco, USA e-mail:
[email protected] © Springer International Publishing Switzerland 2015 S. Hostettler et al. (eds.), Technologies for Development, DOI 10.1007/978-3-319-16247-8_8
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Thus, if a part broke, the machine could easily be repaired locally and could continue to be used to save the lives of newborn children. Bioethics is a discipline at the intersection of medicine, law, and ethics that addresses the implications of new technology on society and informs the way new technology is developed, particularly with regard to testing with human subjects. As a bioethicist, I wondered who assures the safety of appropriate technology devices in emerging markets? What kind of quality controls would be needed for a locally manufactured and repaired device? Who monitors the reliability of such a device over time? These questions returned in 2011 at Oxford’s Emerge Conference for Social Entrepreneurs. I heard Jane Chen, the co-founder of Embrace, speak about their experience developing a neonatal sleeping bag in rural India (WHO 2012). I learned that for many health care entrepreneurs in emerging markets, it is unclear how to assure quality and safety of medical devices. They face the challenging question of whose standards to follow: International Standards Organization (ISO), World Health Organization (WHO), United States Food and Drug Administration (FDA), Conformité Européene (CE) or none (if not required)? With a professional background as a bioethicist, product designer, and social entrepreneur, I initiated this preliminary study to identify the safety issues of medical devices designed for deployment in low- and middle-income markets. This paper presents findings from interviews with multiple stakeholders on quality, reliability, and safety (QRS) issues for medical devices in emerging markets. The paper begins with an overview of the traditional device development process, identifies changing market forces that impact device development and synthesizes multiple stakeholder perspectives on QRS issues. Then, it highlights opportunities to meet QRS challenges that product designers currently face. Finally, it proposes an open-source solution to assure QRS in emerging markets and identifies key issues to be addressed for an open-source QRS system.
8.2 Methods Forty interviews were conducted in person and via Skype with multiple stakeholders from India, Southern Africa, Europe/UK, and North America. Interview questions were open and qualitative. Questions were focused on barriers for low-cost devices to reach their intended customers, experiences assuring QRS for medical devices, and opinions about the idea of an open-source solution to assure QRS.
8.3 Results Interviews confirmed the absence of a uniform system to assure the QRS of health care devices in emerging markets. Perspectives on how to navigate this systems level gap varied widely. Interviews were not in sufficient quantity to yield
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statistically valid conclusions. Results are reported in a synthesized narrative that reflects the range of views encountered.
8.3.1 Health Care Product Development Medical device development is a burgeoning industry. Globally, QRS assurance of devices varies by country. In established markets, government regulatory systems, such as the FDA, oversee and monitor medical device development. Although considered a “gold standard,” the FDA has been criticized for stifling innovation with prohibitively expensive processes and for failing its safety objective (Zuckerman et al. 2011). Some governments may expedite approval of medical devices previously approved by the FDA, or they may follow other guidelines, such as the WHO (Emergo Group n.d.). Finally, some health ministries that lack a systematic approach to address device safety may arbitrarily approve a device based on factors, such as financial compensation, rather than the results of safety evaluation. The lack of a standardized approach to safety evaluation across low- and middle-income markets creates economic uncertainty for entrepreneurs and funders as well as clinical uncertainty for clinicians and patients. Historically, most health technology was designed in developed markets where testing and manufacturing fall under regulatory oversight, such as the FDA. Following regulatory approval and deployment into the marketplace, these products would be donated to lower income markets funded by philanthropy, gifted as hospitals acquired newer technology, and/or purchased by the governments of these markets.
8.3.2 A Changing Landscape New Markets In recent years, there has been a shift to develop products within and for low- and middle-income markets. This shift arises from the recognition that the most significant global economic growth potential lies in the rising middle class of emerging markets and from the scale of four billion people who live on less than US$2 per day, often referred to as the Bottom of the Pyramid (BoP). The influx of capital targeting this market for impact investment has grown from US$8 billion in 2012 to a projected US$12.7 billion in 2014 (Saltuk et al. 2013). Staggering health care costs in established markets have prompted people to seek “frugal innovations” (low-cost inventions designed by and for low-income countries). In more established markets, these frugal innovations have the potential to serve as “affordable technology” solutions (Zeschky et al. 2011). Yet frugal innovations lack a trusted way to demonstrate their QRS other than through the FDA, which then raises their cost, making them unaffordable devices.
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New Sources of Capital Among those who fund health care products in low- and middle-income markets, new players have emerged. A growing trend away from traditional development that gives aid by donations has prompted more funding for empowerment-focused economic development. For example, social entrepreneurship encourages new businesses to solve local social impact issues with revenue generating business models (Yunus 2011). As a result, health care companies focused on the health needs within emerging markets are increasing. New types of funders include venture philanthropists (philanthropists who seed economic growth in an untested or emerging market by providing the initial investment in high-risk areas with no expectation for return on investment), patient capital (investors who seek to invest in social impact opportunities with the expectation of a lower return on investment after a longer time trajectory), and impact investors (capital investors who seek to have both social impact and timely financial return on investment). In addition, crowd-funding platforms enable direct funding for device development from non-traditional sources. These new types of funders may have varying degrees of awareness and concern about devices developed in environments without QRS oversight. New Approaches to Product Development A recent trend toward user/humancentered design has improved health care devices designed to meet the rugged and variable conditions of emerging markets (IDEO.org 2012). These new low-cost products often come from academic settings, where student projects identify appropriate technology solutions to solve health challenges. Though technically robust, these prototype solutions often struggle to reach intended markets due to barriers to financing, manufacturing, and distribution (Larson 2014; Prestero 2014). Radical innovation in the mechanisms and methods for design and manufacture are changing medical device development. Patient innovation spreads products designed by patients, while codesign recognizes patients/users as partners in an iterative approach to product design. Moreover, open hardware (Pearce and Mushtaq 2009) and open design (Balka et al. 2009) empower local manufacturing by providing design specifications for users to modify and adapt. The rise of 3D printing allows hyper local manufacturing of an object on demand (Wohlers 2008). These grassroots, iterative and open approaches do not fit into the traditional regulatory process that approves finished products.
8.3.3 Stakeholder Perspectives on the Current State of QRS Affairs Perspectives: Product Developers and Entrepreneurs Health care product designers and entrepreneurs recognized this gap in oversight for their products. For US-based entrepreneurs, many expressed concerns related to cost pressures and the belief that any efforts to address quality and safety would take scarce resources from
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constrained product development budgets. Perspectives included: “we’re under so much pressure to demonstrate that we have an idea that can work in order to secure more funding before we even think about assuring quality and safety”; “we are all too underfunded in this market to do anything like the regulatory approach”; “we’ll put the products on the market and show that they work”; “it’s better than what they have now, which is nothing”; “I never considered on whom the prototypes would be tested. We leave it up to the local doctors; they know their patients”; “open design allows for people to adapt the device to their needs; we can’t monitor quality, reliability or safety once it’s released”; “in these markets, consent is dubious; if you ask people, they will always say yes; they have no other options”; and “this is highly problematic and distressing; we don’t know whose standards to follow.” Entrepreneurs have adopted varying strategies from doing nothing to pursuing a hybrid approach that sought FDA approval for a high-cost model in established markets in order to subsidize a low-cost model. Health care product designers from the United Kingdom, Canada and Europe consistently viewed the QRS gap as a problem. Interestingly, health care entrepreneurs based in emerging markets were the most concerned; many expressed a moral obligation to society and product users to do more than required. Some entrepreneurs chose to follow FDA guidelines, even though it did not serve their economic interests. Emerging market-based entrepreneurs expressed a need for context-appropriate, effective, and affordable solutions to assure QRS. Perspectives: Funders and Impact Investors Interviews with impact investors and philanthropic funders yielded a range of perspectives. One health care portfolio manager from an impact investment fund was unaware of the QRS gap. Another device portfolio manager from an impact investment fund reported that it provides funding for its portfolio companies in emerging markets to fulfill FDA requirements regardless of whether the products are intended for US markets. Some funders felt that, when nothing was required, additional efforts to assure safety would be unnecessary and that money would be better spent on direct outcomes. Additionally, there was concern that unless a system was acceptable across several countries, it would not be a worthwhile use of funds. Both a funder and an entrepreneur expressed the fear that, if no one else takes these extra steps, then the time and cost put into safety assurance could put the enterprise at a competitive disadvantage. While there was interest to see an alternative approach to QRS for emerging markets, they wanted to see a pilot with adoption across multiple markets before they would financially support their portfolio companies to participate. Perspectives: Ecosystem Stakeholders Interviews with ecosystem stakeholders included corporate device product managers, device regulatory consultants, and incubators that support new enterprises. Multiple interviewees noted that low-cost devices struggle to gain market access because they have small margins. Thus, there is little economic incentive for government interests that facilitate market entry to allow them access. Furthermore, requirements may be altered to increase money spent in the process of securing market access. Frequently expressed was the
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concern that products are being tested in low-income communities under conditions that may not comply with established market standards. Perspectives: Clinicians Interviews with clinicians provided the insight that, while new experimental products may be available, unless there is research that demonstrates clinical efficacy, it is unlikely that a new product will be used. For widespread adoption of new technology, such as devices and mHealth apps, clinical effectiveness research and integration into clinical training environments will remain necessary. However, lower level care workers, such as community health care workers (CHCW) who often provide front-line care in rural emerging markets, were eager for new technology, such as mHealth apps, to support their care efforts. Interviews with CHCWs in rural South Africa revealed preference for and deference toward new technology; namely, an mHealth app that would enhance their diagnostic abilities (Karlen and Ettinger 2013). CHCWs trusted that, if given a device for use in the field, their employer would evaluate and assure the QRS of new technology prior to issuing it to them. Perspectives: Patients Interviews with patients in emerging markets revealed that people have a traditionally deferential relationship to care providers. Access to care is difficult. People only go to a health professional because they are very sick. In this vulnerable state, patients do not question the recommendations of providers. Further, in many low- and middle-income countries, patients do not have access to legal systems that protect consumer rights by holding faulty device makers accountable. Given these conditions, putting the burden on patients to question whether a device is experimental or safe is unreasonable.
8.3.4 Synthesis: Stakeholders in the Emerging Markets Devices designed for deployment in emerging markets face many challenges from design through distribution (Larson 2014). From these stakeholder perspectives, the absence of a consistent system for safety assurance is clearly a pain point. In emerging markets, device funders may not be externally obligated to follow standard approaches to assure safety for their device portfolios, and only some may elect to fund their portfolios to assure device safety. To show that products work by putting them on the market without rigorously monitoring for safety outcomes is problematic. This approach turns all consumers into human research subjects and runs the risk that only successes will be identified and failures may be ignored. History reveals that the protection of human subjects in testing new products is imperative (Coleman et al. 2005). While the opportunity to deliver advances in medicine to those without access to care is compelling, something is only better than nothing when that something is delivered in a way that respects human dignity.
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8.4 Key Issues to Address in the Current Context The stakeholder interviews revealed these needs in the current market: • Flexible yet standardized, transnational approach to assure the reliability and safety of devices manufactured for/in emerging markets. • Flexible yet credible systems that provide quality assurance for open hardware, open design, 3D printing, and locally manufactured products. • Easy-to-use, affordable, and efficient methods to guide responsible testing for prototype, pilot, and small-scale studies. • Easy-to-use, affordable, and efficient methods to protect privacy and to assure consent for health data in the context of open data initiatives. • Credible, affordable systems for frugal innovations, patient innovations, and makers to demonstrate safety to gain access to regulated markets.
8.5 The Timing for a New, Open Approach to QRS Recent shifts in market forces suggest that the time may be ripe for a new approach to assuring QRS for medical devices. An open-source approach based on transparency and participatory governance could enable pooling limited resources to build a robust, transnational QRS assurance system that would leapfrog current legacy approaches and bridge the competing interests of innovation and regulation. An Open-source Solution Open source means that the source code, the foundational structure of how something works, is openly available without proprietary conditions for use and without any restrictions on subsequent use (Open Source Initiative 2005). Defined by the type of open-source license selected, open-source projects empower people to collaborate on the development of a shared resource, enable people to improve the resource, and create a resource that is freely and openly available for use, modification, and repurposing. The transparency of opensource methods enables systems to be readily able and/or adapted to work with other systems (interoperability). The World Wide Web is enabled by W3C, a global consortium of technology stakeholders who understand the shared value in building a digital highway for information and commerce and who collaborate to develop standardized protocols for interoperable technologies (specifications, guidelines, software, tools). Similarly, collaboration by diverse device stakeholders in emerging markets to build an open-source QRS system would realize their shared interest to develop an effective and affordable way to assure QRS. An open-source QRS system could be a highway for health care innovations on the journey from research through deployment to gain access to markets while assuring safety. Open-source Tools for Data Capture An open-source approach would mean that the basic building blocks for the QRS data monitoring system would be accessible
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to everyone. Developing the tools (specifications, hardware, software, and methods) needed to capture QRS data from diverse devices through open-source collaboration could enable affordable, flexible ways to capture and monitor QRS data. These open-source tools could be updated, modified, and expanded in a dynamic, participatory, and responsive manner. These open-source tools would send data directly to an open-source QRS data monitoring system. Private Data Monitoring with an Opt-in Open Data Option There remains a high degree of sensitivity around product data and concern about showing failures. While the software system for data monitoring would be open-source to enhance interoperability, the data collected could remain private. An opt-in open data system could operate like GitHub, which is a storage company for software code. For GitHub users, one can store the code for open-source projects for free, while one pays for storage of private data (i.e., proprietary code). Thus, an opt-in open data monitoring system would give product makers a choice whether to make their QRS data open to the public. Even if an enterprise would choose to keep its data private, the data would be in a standardized format that could be evaluated and certified by independent auditors. Real-time Data Capacity Building For this kind of open-source QRS system to be effective, it will require the capacity to monitor and analyze data in (near) real time. This approach could shift oversight from closed government systems to public–private partnerships; for example, higher educational institutions could provide real-time data monitoring services to subsidize education costs while training a new generation to develop open data skills. Thus, participation in an open-source QRS system could be a catalyst to foster technical capacity building in emerging markets. Issues to be Addressed To realize this vision, the following questions need to be addressed: 1. What are the technically feasible ways to enable device makers to efficiently capture QRS data? 2. What are the financially viable ways to build an open data monitoring system that could serve as a global resource for QRS assurance? 3. How could a system leverage open-source tools to make it easy-to-use, effective and affordable to capture QRS data? 4. How could this approach build local skills and capacity to maintain and evaluate QRS data? 5. What type of incentive structure is needed to build this resource? 6. Will governments collaborate on a global strategy to assure QRS for health care devices in emerging markets?
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8.6 Conclusion There are critical systemic gaps in assuring the QRS of health care devices designed for deployment in low- and middle-income countries. Changing conditions necessitate developing new approaches to assure QRS for medical devices in emerging markets. There is an opportunity for further research to determine how an open technology approach to address QRS could enable an easy-to-use, effective, and affordable pathway for the responsible deployment of health care devices in emerging markets.
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