by Aya Caldwell, Anna Young, Jose Gomez-Marquez, and Kristian R. Olson
As published in IEEE Pulse August 2011
As global health development assistance has tripled in the last decade, policymakers are recognizing the need for accessible health technologies aimed at low and middle income countries (LMICs) [1, 2]. Developing these technologies is not simple . It requires a delicate departure from top-down, sophisticated engineering towards user-enabled designs that are elegant, simple, and field tested and tailored. In this scenario, the stakes are higher, technologies must succeed with a unique set of design challenges and address a higher burden of global illness. To ensure these technologies aligned with ususer’s needs, co-development with innovators in LMICs and multiple iterations with their feedback are needed for ultimate translation to practical use.
Boston has emerged as a cluster of biomedical innovation for global health. The area’s leading academic institutions in medicine and engineering have coupled their collaborations across the globe, to create design and invention spaces for impact-driven research in global health. In this rich environment, now is the time for Global Health Technology 2.0. We define Global Health Technology 2.0 as the practical applications of science that are effective and sustainable in their intended care delivery settings. Here, technology stands as an independent determinant of global health rather than an aspect of policy that gets folded in as systems mature. In our work towards this new model of technologies in health, we outline a new way of doing research and development. The practice of Global Health Technology 2.0 equally balances attributes of Collaborative Research, Co-creation, and User-driven insight to drive the invention of innovative projects.
The Center for Integration of Medicine and Innovative Technology’s (CIMIT), the Center for Global Health at Massachusetts General Hospital (MGH) and Innovations in International Health at the Massachusetts Institute of Technology (IIH@MIT) have formed a collaboration that puts our research and development model – Global Health Technology 2.0 – to work and advances a growing global health portfolio. Using device examples, we highlight a series of design innovation practices. Using device examples, we highlight a series of design innovation practices.
CIMIT GHI, the Center for Global Health at MGH and IIH@MIT – A Collaborative Approach Based on Co-Creation
CIMIT GHI and the Center for Global Health at MGH are a multi-institutional collaborative effort focused on LMIC health care provider training and supports using medical technologies and trainings. These two groups work in Indonesia, Cambodia, and Ethiopia. For example, they helped design a network of more than 500 midwives in rural Aceh province. The 2005 Asian Tsunami and the preceding civil conflict greatly disrupted the health care system and midwives had received no continuing medical education. This training is aimed at maternal and newborn care and included implementation of a novel resuscitation device at delivery. From this experience, they have begun helping with the training network of new birth attendants in Ethiopia. In addition, CIMIT GHI and the Center for Global Health at MGH continue to use their field positions to co-develop medical devices, such as the “Car-Part” incubator and CoolComply . All of the training and technologies are aimed at enhancing providers where human resources are critically lacking.
Across the Charles River, IIH@MIT works with CIMIT and the Center for Global Health at MGH to invent and fabricate low-cost medical devices by bringing together multidisciplinary teams in a Skunkworks environment, where collaborative relationships augment traditional lab resources. Through this model of lean, interdisciplinary teams, IIH accelerates medical technology design for LMICs. IIH uses rapid prototyping technology and the latest advances in applied engineering techniques to create early-stage prototypes of even the most high-risk medical device ideas. The core innovation strategy of IIH relies on a network of on-the-ground collaborators in LMICs willing to give early feedback on the device prototypes, answering design and functionality questions that could never be solved from the lab in Cambridge. In fact, the IIH portfolio includes a research project called Medical Education Design and Invention Kits (MEDIKit) focused specifically on enabling physicians and nurses in LMICs to create rapid prototypes of their own ideas for device solutions to global health challenges.
The interdisciplinary and communal network creates an environment that encourages investing time in high-risk, early stage technologies, knowing that funding is just a prototype away and believing that this is the quickest strategy to develop a solution that will patient lives. This approach has a growing portfolio of inventions that are at different stages of deployment. These include an inhalable vaccine delivery technology, behavioral diagnostics for medication adherence promotion, paper microfluidic diagnostics for remote populations, and low-cost incubators for rapid tuberculosis detection. With a presence in more than 15 countries, we are well poised to accelerate medical technology transfers, create models for scale and in turn, focus on high impact technologies.
IIH, CGH and CIMIT GHI are committed to the belief of co-creation and the advancement of Global Health Technology 2.0.
In Figure 1 we explore the evolution of appropriate technology, popularized by E.F. Schumacher in the 1970s with his book Small is Beautiful . Appropriate technology has many connotations across various field of development. For our purposes, we define appropriate technology as health technologies that take the user needs and context into consideration. Appropriate technology changed the paradigm of design development to focus on the needs of the community; however, innovators in LMICs had limited involvement throughout the product development value chain. To compensate for this, participatory design focused on bringing innovators into the product development phase, but failed to create a truly iterative process that engages the innovators in the field in every stage of product development.
Our approach, Co-Creation, takes participatory design one step further and is integral to the Global Health Technology 2.0. Co-Creation allows for true collaborations where innovators across the globe continuously exchange ideas throughout the entire product development process. We envision innovators as any individual that is motivated to develop a solution to a problem. Consequently, this innovator could be anyone from a doctor at a prestigious hospital in Boston to a car mechanic in a repair shop in rural Indonesia. This methodology empowers end-users of the technology to graduate from being the recipients of solutions into technological innovators. Through Co-Creation the relationship changes from designer-client into one-to-one collaboration. Each project in Massachusetts General Hospital GHI and IIH portfolio is measured for success based on its level of cocreation.
Challenges in Medical Device Development
There are currently 6.9 billion people in the world and almost half, live on less than $2.50 per day . Within these statistics, the disparity between access to health care is glaring. For example, the location of where one is born – developed or not – drastically alters chances of survival for both the newborn and the mother. Mothers in developing countries are 300 times more likely to die and newborns are ten times more likely to die than mothers and newborns in developed countries . Even more alarming is that many of these deaths are preventable with simple solutions and interventions. Technological innovations are part of that solution.
Unfortunately, the current state of medical technological transfer is one of hand-me-down devices from developed countries to developing countries. Without designs that are aimed at operating within the rigors of developing countries’ medicine, these transfers often fail. Estimates cite 95 percent of medical equipment in LMICs is donated and 70-80 percent is non-functional within five years in clinics in resource limited settings  . Estimates of the dysfunction in these settings vary; recent analysis found 38.3% pieces of equipment out of service . In an effort to rectify this gap in access, many global manufacturers retrofit or strip-down their products to make simplified, cheaper versions. This can only take you so far. When you encounter challenges that have no analog in the developed markets the model fails. A fundamental requirement is to use bottom-up design principles and take advantage of indigenous technology innovations.
Appropriate technology can often lead to trickle-up innovations. These can be unintended spin-offs from a developing world application into a developed world application. Examples of this include GE’s Vscan Ultrasound® systems originally designed for LMICs and later commercialized as low-cost alternatives for emergency medical technicians and emergency rooms in industrialized countries [9, 10]. It is critically important to recognize that trickle-up innovations occur when a designer can focus and adapt the parameters for design towards LMICs. The temptation is often to assume one can create a dual use solution for low and high income markets. While this may be possible, our experience has shown this approach leads to tougher demands from the high income market. This in turn rapidly dilutes the design parameters that make the same technology shine in LMICs. In essence, it renders dual-use approach into a game of chances. Good design can improve on this. One of the values of Global Health Technology 2.0 is shifting established design paradigms to solve problems in the face of elegantly identified design challenges. This process is expected to impact health in LMICs and in the developed countries alike.
Global Health Technology 2.0
Using a few examples, we outline key insights into creating a center of excellence with our evolving model of collaborative research and development.
Using devices as a hallmark of professionalism can catalyze the uptake of new protocols and continuing medical education for personnel. In Aceh, Indonesia after the 2004 Tsunami, CIMIT GHI and MGH helped design a novel community-based midwife training program focused on peri-birth emergencies as one of the first steps in rehabilitating the primary care services. The training was concise, on-site, and women were distributed an Indonesian-manufactured newborn resuscitation device. Unexpectedly, the midwives began to hold up these tube-and-mask devices and say, “I’ve been trained”. This became a symbol of medical sophistication and a driver both for untrained midwives to seek training and for expectant mothers to seek the care of trained midwives.
In parallel, IIH created a series of prototyping kits called MEDIKit aimed and health care workers eager to create their own solutions. MEDIKits are platform technology for device construction. Modular components allow medical professionals to design their own appropriate solutions. For implementation, the kits are coupled with an eight-week training course, taught by IIH researchers. Given the appropriate tools and the right context set by the course, MEDIKit participants are immediately empowered to innovate in their work environment, addressing the challenges in health care that hinder development.
Experiencing a solution through a prototype offers a substantially different experience than a concept on paper. By forming rapid design and prototyping teams, IIH creates affordable prototypes for user testing in a matter of days, and deploys them into the field soon after. Boston University Professor Catherine Klapperich created the SNAP Portable DNA Isolation system. Dr. Klapperich visited the IIH labs with a challenge to turn her desktop version of a microfluidic manifold for isolating DNA into a portable machine aimed at developing countries. Employing a combination of energetic students, knowledgeable design directors and armed with automated rapid prototyping technologies, Dr. Klapperich received a final prototyping in a few weeks. The SNAP system introduces a self-contained microfluidic system capable of extracting nucleic acids from a blood sample at the point of care, without the need for electricity, cold chain, or specialized training. With a device, she was able to continue her research, attract grant funding from CIMIT’s annual innovation grants, and produce field data that is driving the device closer to a product.
Lean, Collaborative R&D Structures
In response to a constrained funding environment for health technologies, we have instilled a model of collaborative resource sharing. Going beyond the bilateral partnerships formed between co-principal investigators’ once funding materializes, we have formed an ecosystem where our resources are pooled in to a “commons” available to members of the network. Each researcher is subscribed to a model of paying it forward to advance an agenda of invention and prototyping among colleagues.
Field Innovation Network
The ability to take a device from the lab to a field site 4,000 miles away within 48 hours allows innovation teams to get real-time valuable feedback. At the onset, our institutions affiliated a network of international laboratory sites, health care facilities, and research centers in Central and South America, Southeast Asia, East Africa, Pakistan, and Europe. Each site has the ability to produce high quality user and field testing within days of receiving a device. Conventionally, designs are incubated in labs for months, deployed many months after and then a design team regroups to analyze user feedback. In contrast, after fourteen days of prototyping, an affiliate, Dr. Jonathan Spector, a neonatologist at the Massachusetts General Hospital, saw his design for a Neonatal Rescue Cot (NRC) shipped to three different sites in Nicaragua. User adoption studies were conducted for the NRC and then sent back to Boston for continued iteration a week later.
Another example is CoolComply seen in Figure 4. CoolComply addresses two fundamental problems with M ulti-Drug Resistant Tuberculosis (MDR-TB) – the difficulty of monitoring patient adherence at the home given the long treatment time (18-24 months) and maintaining adequate temperatures (15 degrees Celsius) for the medication . In 2009, CIMIT GHI visited two novel treatment sites of the Global Health Committee/Cambodian Health Committee (GHC/CHC) in Cambodia and Ethiopia and noted the superior performance of home-based care approaches to MDR TB . However, despite a successful model for adherence, GHC/CHC highlighted the rate limiting factor of home-based cool-chain equipment, and the consequent hindrance on scalability of this model in both countries. CIMIT GHI brought this challenge back to Boston and began working with IIH and the Center for Global Health at MGH to create an intelligent network of devices that can propel MDR-TB home-based care. Throughout the process, the team has worked with the GHC/CHC in Ethiopia, patients, and providers on design modifications, process, and implementation.
Having ongoing clinical care-research relationships in a number of LMIC settings is another strength of academic inclusion in the Global Health Technology 2.0 process. Institutional Review Board (IRB) review is the ethical assessment of the merits of performing any investigation on a given population of patients. It is imperative that IRB committees in resource-constrained settings have the capacity and opportunity to evaluate the risks and benefits of studies affecting their community. Though the initial connection with or de novo creation of local IRB committees may take time, pre-evaluation of subsequent evaluations are streamlined. This process has served both to establish ethical merits and engage the local scientific communities in Indonesia, Pakistan, Ethiopia, and Nicaragua.
Our model goes beyond multidisciplinary teams and into discipline shifting. Co-creation discourages participants from being pigeonholed and specialized. The best ideas may come from individuals that have limited background in the subject area, but willing to explore ideas and prototyping. Our own process experience has repeatedly demonstrated the value of role-flexing. A team may include a client, anthropologist, economist, physician, designer, and an engineer. Traditional role “pigeonholing” leads to division of process along these disciplinary lines. However, in a generative process of co-creation, we see the client become not only a user, but a designer; the physician a policy advisory; and an anthropologist, a designer. Role-flexing has already yielded novel approaches and solutions in unforeseen ways- precisely what is needed to avoid pitfalls of decades past. This is the inception of co-creation.
Invention Still Matters
Finally, Global Health Technology 2.0 is not only about delivery. Through appropriate, tailored, affordable design, clinics around the world gain access to devices not possible ten or even five years ago. Barriers to care may become innovation opportunities and long-identified “stuck-points” to providing necessary care surmounted. However, a creation space, including academia and partners, must be nurtured for this process to flourish in the realm of the new global health. Global Health Technology 2.0 positions adoption of effective health technologies as an independent determinant of health. Co-Creation is essential as a source of these technologies. Herein, collaborations across the globe, disciplines, and cultures continuously exchange ideas throughout the entire product development process.
Team diversity, established clinical care and research platforms, rapid and iterative prototyping, and training the next generation of innovators are essential ingredients. Shifting established design paradigms to solve problems in the face of previously insurmountable innovation challenges stands to impact health and health care delivery in LMICs and in the developed world alike.
Technological innovations have the potential to change the lives of millions of individuals living in resource limited settings; yet many of these technologies are unused, broken, and providers are disempowered . The high failure rate is, in part, a result of devices not being designed for these settings. Technology product development should be based on Co-creation with specific end-user adoptability and feedback. These should be incorporated to modify designs so that effectiveness and durability in the intended clinical setting is optimized. There is a sizable need for technologies that are simple to use, meet required performance metrics, and are ruggedized to operate.
Collaborations and Co-creation with end-users allows a unique group of individuals from various disciplines, institutions, and sectors to innovate around the challenges currently faced in global health and technology development. These in turn act as an impetus to develop specific solutions for the intended user to successfully translate their research. The successful implementation of technologies in the context of global health has the potential to augment health care provider’s impact and catalyze the improvement of patient care and outcomes not only in LMICs, but this can also reduce the burgeoning health care costs in industrialized nations as these concepts are relevant globally. This process of extending the novel languages of innovation is just beginning of Global Health Technology 2.0.
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