Chapter 8Open Issues and a Proposalfor Open-source Data Monitoringto Assure Quality, Reliability, and Safetyin Health Care Devices TargetingLow- and Middle-income Countries

Kate Michi Ettinger

Abstract Health care entrepreneurs who design medical devices and mobile healthapplications for emerging markets face difficulty when deciding how to demonstratethe safety of their products. Many middle and low-income countries have no uni-form system to address safety. This paper presents findings from 40 interviews withstakeholders involved in device development. It illustrates multi-stakeholder per-spectives on quality, reliability, and safety (QRS) issues for health care devicesdesigned for low- and middle-income markets. The paper identifies key challengesfor entrepreneurs in these markets. Then, it proposes an open-source technologyapproach to build a transnational QRS assurance system. Further research is neededto 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 asession that introduced an award-winning neonatal incubator, NeoNurture (Zenioset 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 conditionsof the low-income markets they serve at an appropriate price. Typically, inemerging markets, a neonatal incubator would be donated from a developed market.Parts would break due to frequent power fluctuations; with no access to spare partsfor 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, USAe-mail: kme@muralinstitute.com

© Springer International Publishing Switzerland 2015S. 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 couldcontinue to be used to save the lives of newborn children.

Bioethics is a discipline at the intersection of medicine, law, and ethics thataddresses the implications of new technology on society and informs the way newtechnology is developed, particularly with regard to testing with human subjects.As a bioethicist, I wondered who assures the safety of appropriate technologydevices in emerging markets? What kind of quality controls would be needed for alocally manufactured and repaired device? Who monitors the reliability of such adevice over time?

These questions returned in 2011 at Oxford’s Emerge Conference for SocialEntrepreneurs. I heard Jane Chen, the co-founder of Embrace, speak about theirexperience developing a neonatal sleeping bag in rural India (WHO 2012). I learnedthat for many health care entrepreneurs in emerging markets, it is unclear how toassure quality and safety of medical devices. They face the challenging question ofwhose standards to follow: International Standards Organization (ISO), WorldHealth 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 socialentrepreneur, I initiated this preliminary study to identify the safety issues ofmedical devices designed for deployment in low- and middle-income markets. Thispaper presents findings from interviews with multiple stakeholders on quality,reliability, and safety (QRS) issues for medical devices in emerging markets. Thepaper begins with an overview of the traditional device development process,identifies changing market forces that impact device development and synthesizesmultiple stakeholder perspectives on QRS issues. Then, it highlights opportunitiesto meet QRS challenges that product designers currently face. Finally, it proposesan open-source solution to assure QRS in emerging markets and identifies keyissues to be addressed for an open-source QRS system.

8.2 Methods

Forty interviews were conducted in person and via Skype with multiple stakeholdersfrom India, Southern Africa, Europe/UK, and North America. Interview questionswere open and qualitative. Questions were focused on barriers for low-cost devicesto 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 healthcare devices in emerging markets. Perspectives on how to navigate this systemslevel 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 thatreflects the range of views encountered.

8.3.1 Health Care Product Development

Medical device development is a burgeoning industry. Globally, QRS assurance ofdevices varies by country. In established markets, government regulatory systems,such as the FDA, oversee and monitor medical device development. Althoughconsidered a “gold standard,” the FDA has been criticized for stifling innovationwith prohibitively expensive processes and for failing its safety objective(Zuckerman et al. 2011). Some governments may expedite approval of medicaldevices previously approved by the FDA, or they may follow other guidelines, suchas the WHO (Emergo Group n.d.). Finally, some health ministries that lack asystematic approach to address device safety may arbitrarily approve a device basedon factors, such as financial compensation, rather than the results of safety evalu-ation. The lack of a standardized approach to safety evaluation across low- andmiddle-income markets creates economic uncertainty for entrepreneurs and fundersas well as clinical uncertainty for clinicians and patients.

Historically, most health technology was designed in developed markets wheretesting and manufacturing fall under regulatory oversight, such as the FDA.Following regulatory approval and deployment into the marketplace, these productswould be donated to lower income markets funded by philanthropy, gifted ashospitals acquired newer technology, and/or purchased by the governments of thesemarkets.

8.3.2 A Changing Landscape

New Markets In recent years, there has been a shift to develop products within andfor low- and middle-income markets. This shift arises from the recognition that themost significant global economic growth potential lies in the rising middle class ofemerging markets and from the scale of four billion people who live on less thanUS$2 per day, often referred to as the Bottom of the Pyramid (BoP). The influx ofcapital targeting this market for impact investment has grown from US$8 billion in2012 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 coun-tries). In more established markets, these frugal innovations have the potential toserve as “affordable technology” solutions (Zeschky et al. 2011). Yet frugalinnovations lack a trusted way to demonstrate their QRS other than through theFDA, 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- andmiddle-income markets, new players have emerged. A growing trend away fromtraditional development that gives aid by donations has prompted more funding forempowerment-focused economic development. For example, social entrepreneur-ship encourages new businesses to solve local social impact issues with revenuegenerating business models (Yunus 2011). As a result, health care companiesfocused on the health needs within emerging markets are increasing.

New types of funders include venture philanthropists (philanthropists who seedeconomic growth in an untested or emerging market by providing the initialinvestment in high-risk areas with no expectation for return on investment), patientcapital (investors who seek to invest in social impact opportunities with theexpectation of a lower return on investment after a longer time trajectory), andimpact investors (capital investors who seek to have both social impact and timelyfinancial return on investment). In addition, crowd-funding platforms enable directfunding for device development from non-traditional sources. These new types offunders may have varying degrees of awareness and concern about devicesdeveloped in environments without QRS oversight.

New Approaches to Product Development A recent trend toward user/human-centered design has improved health care devices designed to meet the rugged andvariable conditions of emerging markets (IDEO.org 2012). These new low-costproducts often come from academic settings, where student projects identifyappropriate technology solutions to solve health challenges. Though technicallyrobust, these prototype solutions often struggle to reach intended markets due tobarriers to financing, manufacturing, and distribution (Larson 2014; Prestero 2014).

Radical innovation in the mechanisms and methods for design and manufactureare changing medical device development. Patient innovation spreads productsdesigned by patients, while codesign recognizes patients/users as partners in aniterative approach to product design. Moreover, open hardware (Pearce andMushtaq 2009) and open design (Balka et al. 2009) empower local manufacturingby providing design specifications for users to modify and adapt. The rise of 3Dprinting allows hyper local manufacturing of an object on demand (Wohlers 2008).These grassroots, iterative and open approaches do not fit into the traditional reg-ulatory process that approves finished products.

8.3.3 Stakeholder Perspectives on the Current State of QRSAffairs

Perspectives: Product Developers and Entrepreneurs Health care productdesigners and entrepreneurs recognized this gap in oversight for their products. ForUS-based entrepreneurs, many expressed concerns related to cost pressures and thebelief 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 somuch pressure to demonstrate that we have an idea that can work in order to securemore funding before we even think about assuring quality and safety”; “we are alltoo underfunded in this market to do anything like the regulatory approach”; “we’llput the products on the market and show that they work”; “it’s better than what theyhave now, which is nothing”; “I never considered on whom the prototypes wouldbe tested. We leave it up to the local doctors; they know their patients”; “opendesign allows for people to adapt the device to their needs; we can’t monitorquality, reliability or safety once it’s released”; “in these markets, consent isdubious; 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 tofollow.” Entrepreneurs have adopted varying strategies from doing nothing topursuing a hybrid approach that sought FDA approval for a high-cost model inestablished markets in order to subsidize a low-cost model.

Health care product designers from the United Kingdom, Canada and Europeconsistently viewed the QRS gap as a problem. Interestingly, health care entre-preneurs based in emerging markets were the most concerned; many expressed amoral obligation to society and product users to do more than required. Someentrepreneurs chose to follow FDA guidelines, even though it did not serve theireconomic interests. Emerging market-based entrepreneurs expressed a need forcontext-appropriate, effective, and affordable solutions to assure QRS.

Perspectives: Funders and Impact Investors Interviews with impact investorsand philanthropic funders yielded a range of perspectives. One health care portfoliomanager from an impact investment fund was unaware of the QRS gap. Anotherdevice portfolio manager from an impact investment fund reported that it providesfunding for its portfolio companies in emerging markets to fulfill FDA requirementsregardless of whether the products are intended for US markets. Some funders feltthat, when nothing was required, additional efforts to assure safety would beunnecessary and that money would be better spent on direct outcomes.Additionally, there was concern that unless a system was acceptable across severalcountries, it would not be a worthwhile use of funds. Both a funder and an entre-preneur expressed the fear that, if no one else takes these extra steps, then the timeand cost put into safety assurance could put the enterprise at a competitive disad-vantage. While there was interest to see an alternative approach to QRS foremerging markets, they wanted to see a pilot with adoption across multiple marketsbefore they would financially support their portfolio companies to participate.

Perspectives: Ecosystem Stakeholders Interviews with ecosystem stakeholdersincluded corporate device product managers, device regulatory consultants, andincubators that support new enterprises. Multiple interviewees noted that low-costdevices struggle to gain market access because they have small margins. Thus, thereis little economic incentive for government interests that facilitate market entry toallow them access. Furthermore, requirements may be altered to increase moneyspent 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 conditionsthat may not comply with established market standards.

Perspectives: Clinicians Interviews with clinicians provided the insight that, whilenew experimental products may be available, unless there is research that dem-onstrates clinical efficacy, it is unlikely that a new product will be used. Forwidespread adoption of new technology, such as devices and mHealth apps, clinicaleffectiveness research and integration into clinical training environments willremain necessary.

However, lower level care workers, such as community health care workers(CHCW) who often provide front-line care in rural emerging markets, were eagerfor new technology, such as mHealth apps, to support their care efforts. Interviewswith CHCWs in rural South Africa revealed preference for and deference towardnew technology; namely, an mHealth app that would enhance their diagnosticabilities (Karlen and Ettinger 2013). CHCWs trusted that, if given a device for usein the field, their employer would evaluate and assure the QRS of new technologyprior to issuing it to them.

Perspectives: Patients Interviews with patients in emerging markets revealed thatpeople have a traditionally deferential relationship to care providers. Access to careis difficult. People only go to a health professional because they are very sick. Inthis vulnerable state, patients do not question the recommendations of providers.Further, in many low- and middle-income countries, patients do not have access tolegal systems that protect consumer rights by holding faulty device makersaccountable. Given these conditions, putting the burden on patients to questionwhether 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 fromdesign through distribution (Larson 2014). From these stakeholder perspectives, theabsence of a consistent system for safety assurance is clearly a pain point. Inemerging markets, device funders may not be externally obligated to follow standardapproaches to assure safety for their device portfolios, and only some may elect tofund their portfolios to assure device safety. To show that products work by puttingthem on the market without rigorously monitoring for safety outcomes is prob-lematic. This approach turns all consumers into human research subjects and runs therisk that only successes will be identified and failures may be ignored. Historyreveals that the protection of human subjects in testing new products is imperative(Coleman et al. 2005). While the opportunity to deliver advances in medicine tothose without access to care is compelling, something is only better than nothingwhen 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 andsafety 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 forprototype, pilot, and small-scale studies.

• Easy-to-use, affordable, and efficient methods to protect privacy and to assureconsent for health data in the context of open data initiatives.

• Credible, affordable systems for frugal innovations, patient innovations, andmakers 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 approachto assuring QRS for medical devices. An open-source approach based on trans-parency and participatory governance could enable pooling limited resources tobuild a robust, transnational QRS assurance system that would leapfrog currentlegacy approaches and bridge the competing interests of innovation and regulation.

An Open-source Solution Open source means that the source code, the founda-tional structure of how something works, is openly available without proprietaryconditions for use and without any restrictions on subsequent use (Open SourceInitiative 2005). Defined by the type of open-source license selected, open-sourceprojects empower people to collaborate on the development of a shared resource,enable people to improve the resource, and create a resource that is freely andopenly available for use, modification, and repurposing. The transparency of open-source methods enables systems to be readily able and/or adapted to work withother systems (interoperability). The World Wide Web is enabled by W3C, a globalconsortium of technology stakeholders who understand the shared value in buildinga digital highway for information and commerce and who collaborate to developstandardized protocols for interoperable technologies (specifications, guidelines,software, tools). Similarly, collaboration by diverse device stakeholders in emerg-ing markets to build an open-source QRS system would realize their shared interestto develop an effective and affordable way to assure QRS. An open-source QRSsystem could be a highway for health care innovations on the journey from researchthrough deployment to gain access to markets while assuring safety.

Open-source Tools for Data Capture An open-source approach would mean thatthe 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 collabora-tion could enable affordable, flexible ways to capture and monitor QRS data. Theseopen-source tools could be updated, modified, and expanded in a dynamic, par-ticipatory, and responsive manner. These open-source tools would send datadirectly to an open-source QRS data monitoring system.

Private Data Monitoring with an Opt-in Open Data Option There remains ahigh degree of sensitivity around product data and concern about showing failures.While the software system for data monitoring would be open-source to enhanceinteroperability, the data collected could remain private. An opt-in open data systemcould operate like GitHub, which is a storage company for software code. ForGitHub users, one can store the code for open-source projects for free, while onepays for storage of private data (i.e., proprietary code). Thus, an opt-in open datamonitoring system would give product makers a choice whether to make their QRSdata 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 byindependent auditors.

Real-time Data Capacity Building For this kind of open-source QRS system tobe effective, it will require the capacity to monitor and analyze data in (near) realtime. This approach could shift oversight from closed government systems topublic–private partnerships; for example, higher educational institutions couldprovide real-time data monitoring services to subsidize education costs whiletraining a new generation to develop open data skills. Thus, participation in anopen-source QRS system could be a catalyst to foster technical capacity building inemerging markets.

Issues to be Addressed To realize this vision, the following questions need to beaddressed:

1. What are the technically feasible ways to enable device makers to efficientlycapture QRS data?

2. What are the financially viable ways to build an open data monitoring systemthat could serve as a global resource for QRS assurance?

3. How could a system leverage open-source tools to make it easy-to-use, effectiveand affordable to capture QRS data?

4. How could this approach build local skills and capacity to maintain and evaluateQRS 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 designedfor deployment in low- and middle-income countries. Changing conditionsnecessitate developing new approaches to assure QRS for medical devices inemerging markets. There is an opportunity for further research to determine how anopen technology approach to address QRS could enable an easy-to-use, effective,and affordable pathway for the responsible deployment of health care devices inemerging markets.

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