Thrilled to share this chapter: Open Issues and a Proposal for Open-source Technologies to Assure Quality, Reliability, and Safety in Health Care Devices Targeting Low- and Middle-income Countries From the book: Technologies for Development, edited by Sylvia Hostettler et al. S. Hostettler et al. (eds.), Technologies for Development, DOI 10.1007/978-3-319-16247-8_8 © Springer International Publishing Switzerland 2015

1. 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 uni-
form system to address safety. This paper presents findings from 40 interviews with
stakeholders involved in device development. It illustrates multi-stakeholder per-
spectives 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: kme@muralinstitute.com
© Springer International Publishing Switzerland 2015
S. Hostettler et al. (eds.), Technologies for Development,
DOI 10.1007/978-3-319-16247-8_8
81

2. 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
82 K.M. Ettinger

3. 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 evalu-
ation. 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 coun-
tries). 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.
8 Open Issues and a Proposal for Open-source Data Monitoring … 83

4. 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 entrepreneur-
ship 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/human-
centered 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 reg-
ulatory 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
84 K.M. Ettinger

5. 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 entre-
preneurs 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 entre-
preneur 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 disad-
vantage. 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
8 Open Issues and a Proposal for Open-source Data Monitoring … 85

6. 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 dem-
onstrates 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 prob-
lematic. 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.
86 K.M. Ettinger

7. 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 trans-
parency 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 founda-
tional 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 open-
source 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 emerg-
ing 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
8 Open Issues and a Proposal for Open-source Data Monitoring … 87

8. 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. These
open-source tools could be updated, modified, and expanded in a dynamic, par-
ticipatory, 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?
88 K.M. Ettinger

9. 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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