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<h2 class="hd hd-2 unit-title">Introduction</h2>
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<h4>Introduction</h4>
<p>Even in the 21st century, the developing world still suffers from a myriad of preventable and controllable diseases, most of them absent from the developed world by following proper diagnosis and well-known interventions. Medical technology can help bridge the health chasm that faces many poor nations. If medical devices have clinical benefit and are designed for the local providers and patients, there can be an improvement of standard of care for many diseases. Fortunately, global health development assistance has tripled this century, and medical technology is becoming a priority in low and middle-income countries (LMIC’s).</p>
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<h2 class="hd hd-2 unit-title">Traditional Medical Device Development in LMIC’s</h2>
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<h4>Traditional Medical Device Development in LMICs</h4>
<p>Over the past several decades there has been significant focus on medical innovation for the developed world. Traditionally, medical technological transfer has been a hand-me-down approach from developed to developing countries. Unfortunately, many of these health solutions created for developed nations are not adequate for the majority of the population of developing nations. Thus, there remains a large gap in the appropriate number of medical devices to serve the tremendous unmet need that exists in emerging markets. Needs and treatment paradigms that are extremely different in emerging markets – from the screening and diagnosis process, to physician-patient interaction, to the accepted gold standard of care, to the motivations and expectations of the local patients and cultural barriers, to the price points that can be paid and reimbursement process (both from private and public sector), to the different environmental elements that the medical technology needs to face. </p>
<p>Until recently, approximately 95% of medical devices in LMIC’s were donated and about 70-80% of these devices were non functional within five years. It is estimated that 38% of the pieces of equipment were out of service. In attempt to solve this problem, many organizations try to take technology from the developed world, strip the “bells and whistles”, and provide a cheaper, less feature-rich solution for the emerging market. However, due to the dramatic patient demographic and treatment paradigm difference, these approaches are rarely successful in the developing world.</p>
<p>Reducing the complexity and cost, usually removing non-essential features, is known as frugal innovation, a term that has been generally coined for technology development in LMIC’s. In our case, these frugal innovations are more grassroots innovations born out of direct needs, fueled by educating the lowest strata of the society. </p>
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<p>Timothy Prestero<br />CEO, Design that Matters</p>
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<h3 class="hd hd-2">Medical Waste in the Developing World</h3>
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Unit Exercise
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<legend id="948ad30727ec47608021d6819550a027_2_1-legend" class="response-fieldset-legend field-group-hd">What is the approximate dollar amount wasted on medical equipment that is unused?</legend>
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<h2 class="hd hd-2 unit-title">New Approaches to Medical Device Development</h2>
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<h4>New Approaches to Medical Device Development</h4>
<p>Devices in the developing world are currently not adapted to be rugged in harsh conditions and easily repairable. This is one of the reasons for shifting to an approach that uses bottom-up design principles, which has become a trend in recent years. </p>
<p>An effective approach is to conduct localized development, where one designs a medical device from scratch with the local population and medical personnel as the target for which to build the product profile around. Such an approach has shown success, but requires transitioning from a focus on sophisticated engineering solutions to a user-enabled design.</p>
<p>There has been an evolution from developing “Appropriate Technology” where the users needs are taken into consideration, to “Participatory Design” where innovators on the ground in developing world are brought in for the product design process, to now “Co-creation” where those on the ground exchange ideas through an entire iterative development process to create a true collaborative design.</p>
<p>Tim Prestero leads the organization Design that Matters, which focuses on rapid prototyping and human centered design. They understand that the cost of change is greater as the development process progresses and their techniques encourage inexpensive failures and allow them to quickly test assumptions. Prototyping allows them to communicate ideas and obtain feedback from end users early. Their focus is to create devices that are hard to use incorrectly. They have developed many successful devices, such as Firefly, a newborn phototherapy device used to treat jaundice (also known as icterus, caused by high levels of bilirubin in the blood) in developing countries. </p>
<p>Some large corporations such as Medtronic are collaborating with healthcare professionals, policy makers, government agencies, patient advocacy groups, non-governmental organizations, and other corporations to pursue innovative strategies that improve awareness, availability, and affordability of effective treatments.</p>
<p>The Consortium of Affordable Medical Technologies (CAMTech) emphasizes on this co-creation approach by focusing on “People, Processes, and Products”. CAMTech’s methodology is to identify clinical challenges through Clinical Summits, source promising innovations through Hackathons and Innovation Awards, and develop breakthrough medical technologies through its Accelerator and physical co-creation labs in developing countries. Recently they launched the CAMTech Online Innovation Platform, an online and global network to connect innovators to experts, investors, clinical opportunities, partners, and resources.</p>
<p>The Little Devices Lab at MIT directed by Jose Gomez, is extending this philosophy by having workers within the walls of hospitals and health facilities, which design and maintain their own medical technology. The Lab has designed a Do-It-Yourself (DIY) methodology and toolkit called the Medical Education Design and Innovation Kit (MEDIKit), which enables physicians, nurses, and other healthcare workers in LMIC’s to create rapid prototypes of medical devices using toys and Lego like construction blocks. </p>
<p>There are different types of MEDIKits that are designed to develop various potential devices. A modular design language helps users see the underlying logic and parts, which physical stops keep components within safe ranges of operation. Local users are able to hack and extend the modules of the kits and change functionality to create new innovations. The Little Devices Lab takes advantage of the toy and consumer electronics supply chains that are must faster and efficient than traditional healthcare supply chains. </p>
<p>The Lab makes use of makerspaces, which are open spaces where anyone can make anything and are on the rise in hospitals in developing countries. These spaces invite new people to explore new opportunities to attempt to create devices. Such an environment encourages an experimental workflow that leads to innovative breakthroughs.</p>
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<h2 class="hd hd-2 unit-title">Challenges in Medical Device Development</h2>
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<p>Many challenges to development are present in LMIC’s. A higher burden of disease introduces unique challenges. Lack of resources, minimal technical support and more harsh conditions of the hospitals and health facilities in LMIC’s require devices to be rugged and easily repairable in the field. Connectivity still remains an issue and design must assume that not everyone is online in the developing world. Regulatory roadblocks, cultural barriers, and lack of trust of local developments often make it more difficult for new players to enter the market. A recent discussion at GHDonline touched on specific challenges for each of the chain of events between initial design and eventual implementation of global diagnostics, and finally agreed that a systems-wide approach is necessary to strengthening the delivery system for diagnostics. </p>
<p>A one-size-fit-all approach is too often used but it is a custom design that is often required for success in LMIC’s. This one-size-fit-all particularly fails patients with unique diseases and presentations of illness. This is another argument for the DIY approach and encouraging curiosity towards what’s inside and how and why devices are designed in a specific disease to determine how it can be modified. An example of a device trying to overcome the one-size-fit-all drawback is Diapneu, a neonatal apnea monitor developed by one of the authors and his team in Colombia. This device integrates clinical and physiological information from the patient in a personalized algorithm, and its hardware is designed specifically for the neonatal population. Although the device showed to be a promising innovation, it has encountered many barriers, especially financial and cultural, highlighting the importance of building trust among local collaborators and the medical community.</p>
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<p>Timothy Prestero<br />CEO, Design that Matters</p>
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<h3 class="hd hd-2">Challenges in Medical Device Development</h3>
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<legend id="eea447a2d16343f2999d818f15745c0b_2_1-legend" class="response-fieldset-legend field-group-hd">It is important for designers to consider logistics of maintanance and repair for medical devices as LMICs often suffer from lack of resources, minimal technical support and more harsh conditions in the hospitals and health facilities.</legend>
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<h2 class="hd hd-2 unit-title">Examples of Success</h2>
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<p>Fortunately there are a growing number of successful examples of devices in LMIC’s to point to. 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 have been developed through CAMTech.</p>
<p>GlobalDiagnostiX was designed as the first medical radiography device specifically designed for harsh tropical climatic conditions and unstable electricity networks in developing countries. It is only composed of mechanical, solid and stainless parts. It has a radiographic image sensor to withstand shocks and high temperatures. The total cost of ownership is also 10 times cheaper than the current equipment. It has an energy storage system that allows the entire system to operate for several hours without an external energy supply.</p>
<p>Rich Fletcher, based at the MIT D-Lab and the Tata Center for Technology and Design, has been developing medical devices for global health, with a particular focus on mobile diagnostic tools. One of his recent developments was a stethoscope, which connected to a mobile application, is able to predict the probability of a patient to having specific pulmonary diseases. </p>
<p>We also illustrate a successful example in depth in Chapter 38 in the text book with a case study of Embrace, a warmer that was designed for hypothermic infants in developing countries. Also the reader is referred to the WHO Compendium of New and Emerging Health Technologies, and The Lancet Commission on Technologies for Global Health, a good review that includes medical devices but reinforces the idea that technology alone is not enough, and should be accompanied with other innovations to support effective adoption and implementation.</p>
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<h2 class="hd hd-2 unit-title">Conclusion</h2>
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<p>Given the unique challenges of the developing world and failures of past approaches, new approaches focused on designing innovations through an iterative, collaborative, bottom-up approach is becoming the standard model for medical device development. </p>
<p>In fact, innovations from the developing world are beginning to trickle up to the developed world. For example, GE’s Vscan Ultrasound system was originally created for the developing world but now has become commonplace in many hospitals in North America.</p>
<p>One must remember that creating a solution specifically designed for both high-income markets in the developed world and low-income markets in the developing world often fail. Therefore it is important to promote and trust the innovative spirit currently percolating in LMIC’s, while continuing to foster process innovations for effective implementation and scaling up.</p>
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