Technologies that have been designed for use in high -income countries often fail to deliver their full potential when transposed to Low and Middle -Income Contexts (LMICs) . The health sector is a case in point, as medical devices, whether donated or purchased, are generally short lived in those contexts. The mismatch between needs and available solutions originates from the inadequacy of both the technology and the business models. Essential medical t echnologies such as oxygen concentrators, neo natal incubators , anesthesia machines or diagnostic X -ray systems are classic examples. The case of d iagnostic X - ray imaging is particularly striking : 125 years after its invention, up to two thirds of the world population still does not have access to radiology services , according to the World Health Organisation . This is despite the fact that X -ray radiology is one of the cornerstone of healthcare and a crucial instrument for diagnosing a variety of health issues ranging from trauma to tuberculosis and other lung diseases. We are presenting an integrated methodological approach, to develop innovative solutions adapted to the context of LMICs . The approach relies on th ree crucial pillars: cooperation, interdisciplinarity and entrepreneurship with a long -term sustainab ility perspective . We propose a set of four complementary tools that increase the chances of successfully d eveloping and deploying the technologies at scale . The tools, while very practical, allow striking a balance between economic viability, environmental and social impact. We illustrate the use of these tools with the case of diagnostic X-ray imaging . We propose that u sing the approach and tools presented here could allow to rethink other complex technologies that have the potential to address social challenges , in the perspective of making them suitable for LMICs . We also believe that this approach to developing solutions addressing the nee ds of poorer communities, may lead to better products in industrialized contexts as well. INTRODUCTION The seventeen Sustainable Development Goals (SDGs) of the 2030 UN Agenda call for action by all countries to unite and promote social prosperity whi le protecting the planet. Technology impacts all the SDGs, as it serves a critical role in fulfilling basic human needs, such as food, health, shelter or education, as well as underpinning economic prosperity. For the purpose of this discussion, we define essential technologies as those technologies that can exped ite the achievement of the SDGs *. While most of these essential a Ecole Polytechnique Fédérale de Lausanne (EPFL), EssentialTech Centre, Switzerland. b Ecole Polytechnique Fédérale de Lausanne (EPFL) , Program EssentialTech, Switzerland. Now Pristem SA, Switzerland. c Faculty of Me dicine and Biomedical Sciences, and Department of Medical Imaging and Radiation Therapy , University of Yaoundé I, Cameroon . d EssentialMed Foundation, Switzerland, and University of Geneva, Global Health Institute, Switzerland. e Corresponding Author. * According to our analysis, t hey are specificall y to be found in the fields of information and communication, energy, agriculture, nutrition, medical devices, pharmaceut icals, water & sanitation, and transportation technologies . 2 technologies are widely available in industrialized countries, many of them have not been successfully deployed on a large scale in Low and Middle -Income Countries (LMICs). Of all the essential technologies, the medical devices sector lags considerably . According to the World Health Organization (WHO) : “Four fifths of global medical device sales revenue comes from sales in the Americas and Europe. Ten countries account for nearly 80% of world sales revenue, with the United States at the top of the list (41%), followed by Japan (10%), Germany (8%), and France (4%)”1. The imbalance in access between these industrialized countries and LMICs has been attributed primarily to high costs, technological complexity and also to a significant disregard of the unique constraints inherent to LMICs when developing these products . This disregard can lead to technology mismatches that engender high levels of premature device failure in LMIC contexts . Figure 1 Classic view of abandoned medical devices in the backyard of a hospital in Malawi. For the most part, these devices were acquired via donations. Note the presence of several neonatal incubators, in spite of the fact that they are sorely needed locally. ©Gradian Health, with permission Figure 1 illustrates this mismatch. I t shows medical devices abandoned in the backyard of a hospital in Africa. Sadly, such scenes are ubiquitous in many LMICs. Currently, most medical equipment used in low - resource settings is imported or donated from industrialised countries. Unfortunately, only 10 -30% of donated medical equipment becomes operational at the destin ation countries, according to WHO estimates1. This ultimately results in high but potentially preventable mortality rates, as illustrated by the following examples. Oxygen Concentrators : In paediatrics, hypoxaemia is the major fatal complication of pneumonia, the leading cause of death from infectious diseases in children under the age of five years worldwide, accounting for more childhood deaths than HIV/AIDS, malaria, and tuberculosis c ombined. Oxygen concentrators provide a sustainable and cost -effective source of medical oxygen (when compared with oxygen cylinders) for the treatment of hypoxaemic patients by providing concentrated oxygen (93% ± 3%) to stabilise their arterial oxygen sa turation levels. In high -income countries where suitable personnel and resources are available for maintenance, oxygen concentrators have a life expectancy of 7 years or more, depending on usage and frequency of maintenance. In contrast, concentrators used in LMICs have a much shorter lifetime due to 3 harsh operating environments (high heat, humidity and dust levels), poor quality power and a lack of basic maintenance tasks such as filter changes 2 3. A recent study in Lao People's Democratic Republic report ed 37% of recently procured concentrators experienced a fault requiring maintenance within a year of their installation 4 and a study in Nigeria5 found that of 57 ‘working’ concentrators tested, only 2 were fit for use (i.e. producing >85% oxygen and electr ically compatible ). Neonatal Incubators: An estimated 15 million babies are born too early every year, where almost 1 million children die each year due to complications of preterm birth . In low -income settings, half of the babies born at or below 32 wee ks (2 months early) die due to a lack of feasible, cost- effective care, whereas in high - income countries, almost all of these babies survive (source WHO fact sheets 6). It has been reported that prevention and management of hypothermia could avoid up to 40 % of neonatal deaths in developing countries7. However, due to lack of functional neonatal incubators, health care facilities in developing countries are often unable to properly manage hypothermia in newborns , especially in cases where skin -to-skin warming w ith a parent (aka ‘kangaroo care ’) are not applicable or indicated (e.g. when the child is sick and needs medical attention). Although several initiatives attempted to tackle this need for infant incubators and other neonatal care devices8 9 as we ll as countless local designs in the frame of student projects, none has been successful in reaching any scale . Anaesthesia Machines : The Lancet Commission on Global Surgery estimates some 5 Billion people have inadequate access to safe surgery due to failure modes in the complex perioperative ecosystem10. In the operating theatre a single malfunctioning device may preclude surgery, requiring referral to distant hospitals or, in emergency cases, cause significant morbidity and mortality. A survey of hospitals in Malawi found that 50 % did not have a functioning anaesthesia machine, including donated equipment with no product training from the donor or service support from the original manufacturer11. Furthermore, most anaesthesi a machines require compressed oxygen and mains power, which, in many underfunded facilities, is frequently unavailable. One non -profit company has addressed this through a combination of technical design12, expanded simulation -based product training conduc ted by local physician anaesthesiologists re- creating real- life conditions, and investment in local bioengineering capacity to ensure equipment can be maintained in operating condition and urgent service provided in a timely manner. This model, which has hybrid for -profit and not -for-profit characteristics, has been deployed successfully in over 700 LMIC hospitals , and been used to train hundreds of clinical providers. However, it relies on significant philanthropic funding and has yet to provide a model as a scalable, self- sustaining and entirely market - based solution. Diagnostic X-ray imaging: According to the WHO, between two-thirds and three -fourths of the world’s population do not have proper access to radiology services13. X-ray radiology is a crucial instrument in healthcare for diagnosing a variety of health cases. It is essential for the diagnosis and management of pulmonary diseases, such as tuberculosis and pneumonia, which still represent a high burden in LMICs. For trauma, it is vital for cases such a road traffic accidents, of which 90% occur in LMICs 14, precisely where this device is lacking. The poor access to essential medical device s above arises from failures to adapt the conception and deployment strategies of these devices to the contexts of LMICs15. However, i nnovations that are adapted to such contexts are sorely needed , in order to enable access to the essential benefits they con fer. On the other hand, they could also represent new commercial opportunities and markets for medical equipment manufacturers . This article is intended for researchers, engineers, as well as budding entrepreneurs primarily in academic and research instit utions, who are interested in accelerating universal access to essential technologies, notably medical devices, in developing and emerging countries. 4 We propose and discuss a holistic methodology, which advocates going beyond the traditional practices emp loyed in academic research settings for medical device innovation. This multi -dimensional approach has also been inspired by established industrial, entrepreneurial and social science perspectives, where one of the main goals is to reduce risks associated with the innovation and facilitate its subsequent commercial viability and deployment for large -scale social impact. We illustrate this proposed approach via a technically complex example, diagnostic X -ray imaging, in order to examine how it could be rende red more accessible globally in a sustainable manner by completely re - thinking its conception. We expect that it should be possible to extend the applicability of this methodology to other medical devices, including the examples mentioned earlier. Approach Since the goal is to simultaneously accomplish commercial viability and large -scale health and social impact, it is important to develop a holistic understanding of the context where the product will be used, as opposed to primarily or exclusively concentrating on the technological aspects. The main challenge is to develop sustainable solutions –from a technological, ecological and an economic perspective - that are affordable, adapted to local needs and constraints, as well as scalable. Due consid eration has to be given as to how the innovative technology will be deployed and sustained through out the product life cycle , including its proper decommissioning. It is necessary to develop strategies that achieve both social impact and commercial success, in a mutually reinforcing manner : numerous models exist that allow a blend of varying degrees of social impact and financial return. As Prahalad elegantly argued16, LMICs represent major untapped opportunities and should not be considered as mere philant hropic beneficiaries. While conventional marketing approaches remain relevant, it also necessary to give due consideration to certain critical differences between High- Income Countries (HICs ) and LMICs. The importance and the need to rethink approaches to engineering devices that can succeed in LMICs has been discussed in the past17. Here we aim to complement these efforts by intro ducing a more holistic approach, including practical tools that are based on widely used entrepreneurship, social impact and sust ainability principles. In the ensuing sections , we introduce four strategic tools to help structure the technology innovation process destined for LMICs, which we have framed in the following questions: 1. What: What is the current social situation (unmet need) and how do we draft a roadmap in o rder to achieve relevant social impact ? This question is ideally answered using the I mpact Canvas tool. 2. Where : Contextual factors may affect the performance and access to the essential technology under consi deration . For this , we proposed a Context Analysis canvas . 3. Who : Who are the key stakeholders (global and local) that we need to involve in our project to assure successful deployment, uptake and long- term effective use of the technology? Here we propose a Value -Chain canvas . 4. How : How can we make the impact sustainable and economically viable in the long term? How can our venture be self - sustained while achieving the social goal? This requires the use of the Sustainable Business Model canvas . These quest ions represent four different lenses through which we can look at the problem our technology innovation aims to solve and how to best structure the solution . We briefly present these tools in the following paragraphs , using the example of the medical X -ray technology , and Cameroon as a pilot country, to illustrate how they could be applied . All the tools presented here are intended to be used in workshops where participants are knowledgeable in the specific domains treated. It is particularly important for the stakeholders from LMICs to participate in such discussions. In the case of our X-ray example, this would include the participation of radiologists, radiographers, medical doctors, engineers, patients, etc. They provide invaluable inputs without which the 5 tools may not deliver their full potential. It is important to point out that t he exercise of using the tools will in itself help to reveal and identify the stakeholders. The tools are intended to be used iteratively th roughout the technology development process, as the information and strategies are most certainly likely to evolve during the project. They also need to be used in parallel as they are all interconnected: outputs from one of them will be inputs for another one. Finally, in general such brainstorming sessions work best when they are fun and informal, e.g. using a large printed poster version of the tool with posted notes, refreshments and a good deal of humor. WHAT? Roadmap to impact In order to ensure tha t an innovative venture provides positive social benefit s, it is necessary t o define the desired long- term goals at the very onset of our activities. The pathway to the desired impact involves clearly understanding the current situation and then determining all the steps and resources required to generate the effects that ultimately lead to the impact. It is advisable to start by accurately ident ifying the unmet need to be addressed , we call this the situation . The next step is then to determin e the inputs (resources, skills , people , infrastructure, etc.) required , as well as gaining a sound understanding of the context . Activities are a set of actions or tasks that the organiz ation needs to perform with the inputs , in order to help realize and support the impact objectives. As a consequence, o utputs will be generated, which can be defined as the tangible products and services that result from the activities undertaken. These outputs will then cause changes or e ffect s on individuals or the environment , which are the outcomes that you expect to result from the delivery of products and services. Finally , the outcomes can lead to the much desired impact , which is defined as the e ffects and/or changes in s ociety or the environment that follow from the o utcomes that have been achieved. One of the most commonly used methods to describe and map out the pathway to impact is the “Theory of Change”18. It generates what we term , for the purposes of this article , an Impact Plan , which enables a clear identif ication and distin ction between expected outputs , outcomes, and impact . It also enables the identif ication of critical steps and required resources, as well as the anticipat ion of alternative plans if the present plan is inade quate or not suitable . As an illustration, in the case of the X-ray, a simplified example of the impact plan is shown in T able 1 below . Situation: Inputs: Activities: Outputs: Outcomes: Impact: Low access to radiology resulting in high morbidity /mortality. Context Information Medico- technical expertise, Purchasing power . Infrastructure challenges . R&D . Development of training modules for machine operation & maintenance. Industrialization. Development of appropriate marketing and servicing strategies . Robust, affordable X -ray machines, Training modules available. Industrial strategy to market and support technology, digital services (cloud -based image storage and remote diagnosis). Reduction in operating costs and clear economic mod el for acquisition Increased access & precise diagnosis; skilled personnel; proper, safe and sustained operation. Reduction in morbidity & mortality due to trauma, tuberculosis and other medical conditions requiring medical imaging. Table 1: i mpact canvas tool, filled- in with specific data for the X -ray example The tool clearly indicates that the mere design and subsequent production of a cost -effective robust digital imaging system (which is an output ), do es not automatically imply a long -term reduction in the morbidity and mortality relating to orthopedic traumas and pulmonary diseases , which is the i mpact which would be hoped for . There needs to be some intermedia ry outcome s, meaning that the technology needs to be accessible in h ospitals, along with suitably trained staff, as well as continued support in terms of maintenance , repairs and quality of care . The Impact Plan can help uncover alternative paths and provide important insights about the quickest and most efficient strateg y to reach impact and scale. For instance, in one can envisage creating a start -up 6 company or, a lternatively, it could be more relevant to transfer or licen se out the innovation to an existing company with compatible interests . Finally , the Impact Plan al so involves the selection of methods to measure and track progress towards outputs, outcomes and impact via the use of carefully chosen indicators /metrics, which can sometimes be challenging, notably for impact . WHERE? The Context Analysis tool. The context in which technologies are placed and used in LMICs presents considerable challenge s18. We noted that these challenges can be broadly and rationally grouped into five categories ( Fig. 2). We present each of these categories and illustrate the learnings which can be drawn from the use of the tool in the example of diagnostic X -ray imaging . i) Lack of F inancial resources . LMICs are, by definition, countries where financial resources are scarce (according to the World Bank, Cameroon’s health expenditure per capita for 2016 in international dollars was 169 at purchasing power parity, compared to 4’178 for the UK and 9’870 for the United States) . This affects not only their ability to purchase the technology in the first place but also to pay for services and consumables related to the technology. When finan cial resources are scarce and operational budgets unpredictable , we propose that it makes better economic sense to consider the Total Cost of Ownership (TCO) of the device , rather than the initial purchase cost alone . This is because most of these devices t ypically have recurring costs for them to continue functioning (e.g. maintenance contracts, cons umables), and thus periodic budgetary deficits can be a crippling factor for sustainable social impact . TCO calculation involves adding up all the costs incurred by the owner of a product, including the initial purchase price , taxes, tra nsport, commissioning, training , operational costs and consumables, maintenance, repairs and disposal, during the complete life cycle of the product. Unfortunately, many buyers of medical equipment in LMICs especially still focus on acquisition cost s and fail to e valuate product life cycle expenses, including consumables and maintenance . If they did, they would either plan accordingly for those costs (if they have the means) or choose an entirely different product . Currently, digital X -ray solutions have struggled to take hold in LMICs due to their high TCO and/or have not shown to work sustainably due to their fragility with respect to the context (e.g. Computed Radiography). The most prevalent X -ray technology in LMICs is still the analogue system that requires film plates to obtain the image. At first glance, this looks to be an affordable option, if you only focus on the initial purchase price. However, a closer look reveals non -negligible recurring costs from consumable s (X-ray film plates and chemicals) and maintenance costs, where the annual maintenance contracts are typically 8% of the purchase price or higher in LMICs . We have carried out a simplified TCO calculation for a diagnostic X -ray that considers a lifecycle of 10 year s (Table 2). Taking into acc ount the purchase price, con sumables and maintenance costs the calculation yields a TCO of US$544’000, of which 84% are consumables . More extensive models would typically include additional dimensions such as training costs, energy consumption, floor space etc. Furthermore , the problem of w eak supply chains in LMICs result s in shortages of key consumables, such as film and developing supplies, which effectively blocks such film-based machines from providing access to the essential service. Based on this analysis, one can see that one of the key strategies to improve access X -ray radiology is to propose a machine that eliminates or reduces consumables to a minimum, such as a digital X -ray machine. However, digital X -ray machines do exist, bu t come at premium acquisition costs well beyond the scope of many LMIC budgets. Figure 2 Context analysis canvas 7 USD Comments Purchase 35’000 Analog machine Consumables 5d/week 455’000 $3.5/film incl. chemicals , 50 films /day, 10 years Uninterruptible power supply 10’000 one- time purchase (maintenance costs are neglected here for simplicity) Maintenance 10yr 28’000 Typically 8% of initial purchase price/year Repairs 16’000 1 tube, 1 cassette, Labour Total Cost of Ownership (TCO) Estimate for 10Years 544’000 Not included: radiation protection equipment, automatic film processor, staff training, electricity and water supply, radiographic room infrastructure etc. Table 2: Total cost estimate for an analogue X -ray system Therefore, the challenge is to optimize costs for the complete lifecycle, not just the initial purchase price . If the device can be designed intelligently such that it is robust and requires very little maintenance over its lifetime and no consumables, then if a TCO approach is adop ted it would likely represent a more affordable and sustainable approach towards improving access to X -ray radiology in many LMICs, even if the initial purchase price is higher than the film -based machines. Thus , the technology’s lifetime is a key parameter and it seems reasonable to aim for a lifetime of 10 years for such a piece of capital equipment . ii) Lack of Quality Infrastructure . Lack of quality infrastructure in key areas such as electricity supply, roads, water supply and buildings poses a majo r challenge. Poor electricity ranks as the highest infrastructural challenge for medical devices in LMICs: frequent power outages reduce equipment availability , while electrical perturbations (spikes and sags) are highly deleterious and a ccount for about 3 0% of medical equipment damage19 20. In order to confront these challenge s, it is necessary to rethink the design of power supply circuits , which are the main unit in direct contact with electricity grid. In the case of the X-ray machine, it should be protected against grid inst abilities (e.g. electrical surges ). Given the poor quality of electrical installations in small hospitals in LMICs , it would be advisable to design the power supply to accept simple AC (110/220) power sources rather th an three- phase supply that are more difficult to install. The incoming power from the grid should go through a stage or device that is immune from power surges and can accept and store away all the power delivered (e.g. super- capacitors) . The power supply should also include a low - maintenance battery with a long lifetime that is capable of assuring continuous function for at least one hour in the event of a power failure; this would eliminat e the need for expensive and maintenance -intensive external uninter ruptible power supplies (UPS). One hour would generally be sufficient time to allow the hospital personnel to bring up a back -up generator, in the event of an extended power outage. Furthermore, it may require 30 -50 kW for a split of a second to take an X -ray radiograph , which is often equivalent or even above to the total power available to a small hospital in LMICs . Thus, it would better to design the machine such that its overall consumption is considerably less t han that , e.g. 1 kW or less . It could achieve this by avoiding to draw power from the grid directly , but rather from a storage device within the power supply (e.g. via super -capacitors) . iii) Hars h Environment . In m any LMICs , the environment within the hospitals is typically hot, humid and dusty, which can be highly damaging to medical technology products and will reduce their longevity. The climate in some LMICs is characteris ed by temperatures in excess of 40 °C and close to 100% humidity, which fall outside the product specifications of most medical device s. For the X -ray, a case in point is the positioning mechanism of the source -detector gantry with respect to the patient. It must not only be simple and user -friendly , but also highly rugged and durable and able to last for at least ten years , despite rough handling and exposure to the harsh environmental conditions. For example, failure -prone electronically controlled motors and components could be replaced with an entirely mechanical positioning system, based on a structure of pulleys and counterweights that enables easy and 8 accurate manipulation of the X -ray arm for all the required positions. The syst em could also integrate mechanical solutions to limit the range of motio n, to avoid impact and shock s, instead of traditional electronically -based sensors. The ergonomic characteristics of this mechanical system must of course be suitable to the needs . Finally, as water leakages may occur in small district hospitals located in tropical climates , the user interface could be based on a robust , tactile screen technology (such as the one used for automated teller machines), thus dispensing with fragile components like the keyboard and computer mouse. iv) Lack of Skilled personnel . Even if a robust and well- adapted technology product were available, the lack of suitably qualified personnel can lead to improper use and product breakdown . Creative ways need to be proposed to facilitate the use of the technology even by peop le who lack complete and recent training. For example, the use of pictograms and images can i mprove ease of use, while at the same time removing language and cultural barriers. In the case of X -ray imaging , a user -friendly electronic guide could be integrated into the device, that may be regularly updated , e.g. through a standard GSM phone connection , in order to appropriately guide and upskill the operator according to their current level of expertise. Finally, the huge lack of trained radiologist s in LMIC s could seriously hinder the impact produced by deploying X - ray systems. In addition to training doctors to interpret X -ray images , a solution with the capability to run computer -aided diagnosis (CAD) , i.e. software tools based on Artificial Intelligence and deep learning techniques that offer guidance in the X -ray interpretation could be very valuable . It seems feasible to send X-ray images to remote sites via the GSM network, which could enable their interpretation by remote ly located radiologists (tele- radiology) . v) Poor Governance . Major medical equipment needs to be correctly managed to guarantee continued effective results. In LMICs, issues with mismanagement can be frequent and affect all aspects, from the initial purchase of the technology, through to maintenance and repair, all the way to the final decommissioning and disposal. Especially problematic is the current practice in the industry of selling maintenance contracts , which have an annual fee. Often the funds lack at a later stage , and maintenance contracts are not renewed , which results in the maintenance being stopped . For large equipment , like imaging devices , this is especially problematic and represents a serious impediment to product sustainability . The problem r equire s a bold solution. One idea could be to do away with recurring maintenance contracts, but instead include several years of maintenance in the one -off initial purchase price (e.g. six years with an optional four -year renewal ). Such an approach might h elp towards addressing the common challenge of poor financial planning in the management of major medical equipment. It is appears preferable to offer real additional digital services for a fee, than forcing the customer to “pay for uptime”. This should be all the more feasible if the technology has been designed for robustness and durability. In addition to this, it is now also technically possible to monitor each machine remotely from a centralized location. This could be useful to predict and prevent potential breakdown s beforehand , via preventive maintenance planning, or to provide remote assistance . All five factors discussed are interrelated and interdependent. Each one may significantly increase the risk of failure of a technology product. Of course, there is one more component, which is the cultural specificity of every region or country. Differences can be quite important, and these elements cannot be emphasized enough . As an example, the look and feel of a product is hi ghly important and adequate attention devoted to this aspect can drastically improve the chances of product uptake, as in any market in the world. In the case of diagnostic X-ray imaging , the user interface (touch screen) should be tested in several hospi tals in LMICs and redesigned in an iterative manner, in order to ensure that the workflow and the graphi cs of the interface are appropriate for radiographers of diverse languages, cultures and skills . However, the overall system should also tested with radiographers in high -income countries , as it can be anticipated that it will also fill an unmet need in industrialized countries where healthcare costs are exploding. Being able to market the product in industrializ ed countries as well, not only represents an 9 interesting potential market, but contributes also to brand credibility for customers in LMICs (who don’t want a product “designed for the poor”). WHO? The Product Value Chain for a holistic perspective . LMIC markets are characte rised by uncertainty, variations in available resources and major income disparities within the same country. Therefore, it is vital to gain as wide a perspective as possible about the targeted markets. In order to assure a systematic approach, we propose an expanded version of the value chain concept originally defined by Michael Porte r21. According to Porter, the value chain refers to the organization of a company or a business unit as a whole; each group of activity in the company, such as operations, logistics or marketing, are a segment of the chain. Each segment consumes resources and adds value to the final output of the company. Our concept of value chain focuses on the product itself and not on the internal organization of a company . Thus, we refer to it as the Product Value Chain (PVC) , where each segment of the chain is an activity that adds value to the final solution . A generic version of our proposed Product Value Chain tool is shown in Figure 3. Analy sing this value chain is vital as there is a tight relation ship between each segment and the final product , as well as between the segments themselves . In order for the chain to be sustainable , each contributing segment needs to reliably provid e value to the chain as well as retriev e value for itself, i.e. it must be suitably incentivi sed. For example , one segment is the transport of the product. The transporter brings value to the product by making it locally available , but also needs to earn a suitable margin for this task. Each segment of the chain must be broken down to identify key suppliers, partners and other stakeholders who need to contribute to the sustainable availability and operation of the product . It also helps to identify potential challenges, which should be a ddressed as the technology is developed through the inputs of the key stakeholders . The information deriv ed from the PVC analysis can thus be used to verify that all the specifications of the product are correct. For the X -ray example , a simplified but specific Product Value Chain is shown in F igure 4. This exercise allows the identification of the key stakeholders who could be the key enablers in the various chain segments . For Cameroon , conducting the analysis reveals that the National Radioprotection Agency i s critical, because their approval is indispensable for the medical us age and proper commissioning of the technology. The same is true about the local radiographer organizations wh o are also vital players . Finally, this exercise also helps to bring out the importance of having continued and self -sustaining personnel training solutions, due to the high p ersonnel turnover that is often found in LMICs . Figu re 3: Generic Value Chain Canvas. This generic version should be expanded into a more detailed and technology -specific chain. 10 Figure 4 The specific value chain as defined in the case of the X -ray example One of the important add roles of this tool is to help establish tradeoffs across the value chain . For example, developing an ultra -robust solution might reduce need for maintenance and repairs, but could increase the cost of the techno logy and make it harder to sell; or spending time to designing a simpler man -machine interface may reduce the need for tra ining and so forth. HOW? The Sustainable Business Model canvas . We also belong to the school of thought that believes that entrepreneurship is the best approach to deploy a technology -based product in sustainable manner at scale. One of the crucial comp onents of entrepreneurship is the identification and elaboration of a suitable business for your product. Thus, i t is important to understand revenue generation processes for any prospective product in LMIC markets, in order to ensure sustainable commercial viability. Most technology innovations require significant financial investments to convert them from a prototype and industrialise into a marketable product. Thus, a robust business model is also paramount for convinc ing and obtaining investors . We adopted the widely used business model canvas for traditional businesse s originally described by Osterwalder and Pigneur 22. This tool provides a systematic method to determine the mechanism(s) by which a new venture will generate income, as well as assis t in developing the value proposition to contribute to sales and marketing activities. However, s ince we also aim to achieve social impact with the innovation, we modified this canvas to reflect impact and sustainability aspect over and above financial performance , giving rise to what we refer to as the Sustainable Business Model Canvas (Fig. 5). 11 Figure 5 Sustainable Business Model Canvas. Modified from the Business mo del canvas by Osterwalder et al22. In the case of the x -Ray example, the content could be the following: Values and Mission: The company will be making profit and it will be striving for sustainable glob al access to Xray imaging. It will strive to reach “zero downtime” in any contexts, and deploy at least 60% of its products in LMICs Targeted Impact: Reduce mortality/morbidity due to trauma and pulmonary disease. Beneficiary Needs: Access to affordable and good quality X -ray diagnosis Customer Segments: Ministry of Health; private hospitals; international organizations; NGOs; development agencies. Value Proposition: Reduced TCO; Robustness and durability; six -year warranty; digital and enabled for telemedicine and Computer Assisted Diagnosis. Customer relationship: Local subsidiary and/or distributors (depending on customer segement) . Benefits: Financial – revenue from sale of machines and radiology services; Environmental – As the machine is digita l, there is no chemical waste as in film -based machines; no lead; Social – contribution to universal health coverage by sustainable radiology access. Key Activities: Engineering; Certification; Marketing; Shipping; Commissioning and Training; Maintenance. Key Resources: Engineers; Technicians; Radiology teachers; Sales force; Facilities; IP and Context knowledge. Partner Network: Contract Manufacturer; Freight Forwarder; Radiographers Associations; Medical School. Costs: Financial - Salaries, goods, ship, r ent; Environmental – risk of no proper recycling of the battery; Social – risk of X -ray overexposure, due to the ease of retaking a digital image. We propose adding what we term the “Strategy ” layer at the top of the canvas for representing the vision and strategy of the team . This will help the team to determine a common vision about issues such as the ir principle on profit: do they maximize profit or impact? If profit is made, will it be reinvested or will it be distributed to the shareholders and what proportion ? The Strategy layer also allows the definition of the impact we are seeking with the new innovation, as well as the identification of the potential beneficiaries. The beneficiary (e.g. pat ient) of a technology may not be the same as the customer (the one who pays for it) e.g. health ministry, private health care organization or 12 health insurance. Th e proposed S ustainable Business Model Canvas makes this distinction clearly discernible . The second “ Operations ” layer below is the traditional business model canvas22. This is where we define operational activities as well as customer strategy and segments. On the left hand side, the purpose is to define who will do what in ge nerating the value proposition, which is the product itself a long with other services sold to a specific custome r segment. The right hand side defines the relations with the customer segments, i.e. how they are reached , and what kind of interaction is planned with them (aftersales services etc.) . This is the revenue generating part. Finally the “ Performance ” layer displays a triple bottom line involving financial, environmental and social dimensions. This layer prompts us to consider striking the right balance between economic viability and impact, between profitability and affordability, between potential social co sts (i.e. collateral negative side - effects of the technology on society ) and benefits, between potentially generating environmental damage and improving life of the poorest. This exercise also forces us to reflect and clearly express our underlying drivers for the project . It is thus a very important and useful task to wards creat ing clarity and alignment in the team concerning individual aspirations and personal philosophies. With respect to our X -ray example, this tool allows us to address many questions relevant to the development of a complete business plan. O ne crucial question is who can and will pay for the acquisition of the technology? From the exercise of filling in the canvas five potential customer segments can be identified : i) Ministry of Health in the target countries; ii) P rivate hospitals (e.g. operated by faith -based organizations); iii) NGOs; iv) State development agencies (e.g. SDC in Switzerland, USAID in the US A, GIZ in Germany ), v) international organizations such as UNICEF or the international Committee of the Red Cross (ICRC). The canvas also requires that we assign a specific value proposition for each of these “customer segments”. In some cases, the product alone ma y be sufficient , whereas in others it might require the inclu sion of ancillary services, such as on-site training of radiographers , maintenance by the company or even telemedicine to offset lack of requisite skills locally . The use of this tool allows us to unveil and assess the global market potential of such a techn ology originally designed for LMICs . In the end it may turn out that a robust low -total -cost-of-ownership X-ray digital imaging solution may also be attractive even to the markets in high -income countries. It is well known that the challenges to contain and reduce healthcare is global concern. For example , many physicians in high -income countries may wish to provide more services , such as radiology, to their patients but are unable to afford major equipment , as larger healthcare entities can . In principle, t his market segment would also be able to accommodate a sligh tly higher price than in LMICs . This could permit a two -tier pricing structure and thereby increas e the overall commercial attractiveness of the product and business plan for investors . Furthermore , such a dual market opportunity would also lend credibility to the product and potentially boost brand reputation in LMIC markets, since people in those regions are also sensitive to international brand s. Discussion As mentioned before, the tools discussed above should be used in an iterative way. The process is summarized in figure 6. Most importantly, these tools should guide the development of the technology before it is transferred for implementation to the private sector . They are very powerful tools to de -risk the technology and try to maximize chances that the solution can be implemented and scaled. The whole process rests on three pillars: Cooperation, Interdisciplinarity and Entrepreneurship. 13 Figure 6 The overall process from concept to implementation, showing the three pillars of a successful approach: Cooperation, Interdisciplinarity and Entrepreneurship. Cooperation: We cannot overemphasize the importance of a clo se collaboration with the local stakeholders in LMICs , which as expected, follows the well -known business mantra of “know your customer”. However we also wish to stress the importance of international academic and research collaborations when developing so lutions for LMICs . Consultations with key international organizations , such as the WHO and the ICRC , can offer invaluable input s during the product development process. Altogether, these multi - stakeholder collaborations can provide a crucial contribution in understanding the need s, then defining and co-creating the solution . Interdisciplinarity is key a nd becomes immediately evident when applying the tools: engineers or scientists alone cannot address the multiple facets of these complex challenges. The tools we propose can help “bring everyone to the same page” and identify creative solutions. Medical doctors, engineers, physicists, anthropologists, designers, logisticians and a wide variety of experts in other fields need to come together and co -develop solutions in order to maximize the chances of success. Entrepreneurship is the cement that holds everything together. A sustainable impact can only be achieved if the project rests on a sound and economically viable value chain and business model. It is extremely important that researchers and academics recognise the need to be confronted with such aspects , which would help find solutions and trade -offs than can balance costs and stringent requirements . In our opinion, simply considering that this should be done by “the private sector…later” may be a missed opportunity to better tailor the innovation for its task and this may strongly undermine the chances of success for the technology. We believe that t he tools discussed here may assist academics in adopting and assimilating entrepreneurial approaches in their innovation process, which may enable them to better understand the challenges in LMICS and be able to contribute effective solutions to them. For completeness, there are two topics worth mentioning that both tie up well with the discussion before and often a source of misconception when it comes to innovations for LMICs. The first issue concerns intellectual property: to patent or not to patent. We believe that patents can be very useful , essentially for three reasons. Firstly, to protect the innovation against competition especially in the markets of industrialised countries . Secondly, since the industrialization of such an innovation require s appreciable private capital, a solid patent portfolio is helpful in negotiations with investors and contributes to the overall valuation of the enterprise . Third ly, as academic inventors we may want to assure that the intended impact will be reached with our innovation s, 14 and patents can be an effective tools for policing this purpose . For example, a royalty -free sublicense could be given to a company along with a condition that it sells a certain pre -agreed proportion of the ir products in LMICs . This can potentially protect against “mission creep” , e.g. when the licensee is confronted with lucrative opportunities that have higher margin s in high -income markets , which could tempt them to focus their sales away from LMICs towards the more lucrative opportun ities. The second issue relates to regulatory aspects , as many LMICs do not have functional regulatory frameworks for medical products . Thus, it may be tempting to overlook norms and regulations, justifying it as a way to reduce costs and time -to-market for much needed product s. Industrial norms and regulations define rules for safety and effectiveness and explain how medical devices should be developed and industrialized, as well as some aspects of how they are to be marketed. I n our X -ray example, ther e are more than a doze n industry standards that apply and for HICs, e.g. EU or USA, and compliance to the Medical Devices Regulation (CE marking ) or FDA requirements is mandatory . Compliance to those norms and regulations is essential, as for any products destined for high -income countries , regardless of the existence of local requirements in LMICs . An x -ray solution has effectively been developed in line with the approach described in this article. Thanks to this methodology, we believe it may be on track towards solving the longstanding and reputedly difficult issue of global access to X -ray radiology, something that was highlighted by the WHO already in the 1970s23. A start -up company has been formed which is currently industrializing the technology , with support from both European and African private investors . Of course it would be premature to claim success until the company has deployed a significant number of the devices in LMICs. Conclusions The primary mandate of academia and other public research cent res is to extend the boundaries of knowledge and science , which of course is of crucial importance . On top of that, we argue that it is equally important to spare no efforts to make the benefits of these discoveries available to all hum ankind , including those at the bottom of the pyramid . We believe that more effort and priority is required to ensur e that vital technologies are also accessib le to those with limited means . For example, it is stunning that over 120 years after the discovery of the X -ray technology by Röntgen we still have two thirds of humanity with no access to this essential technology. In our view, academia can and need s to do more to promote scientific research and innovation that is destined at unmet needs in LMICs in essential technologies such as medical devices, or in the field of water and sanitation or nutrition . In entrepreneurship, unmet need equals opportunity. Tackling multi- dimensional problems involving a combination of stringent constrains relate d to costs, climate, infrastructure, usability etc., creates scientifically interesting challenges, which can lead to patentable innovations and novel interesting entrepreneurial opportunities . Finally , the technology example we discussed is complex , as X-ray devices involve hardware, software and mechanical components , as well as high voltage (up to 150’000 Volts) and ionizing radiation technology . In addition, these devices are generally expensive and require complex and long sales cycles that involv e several stakeholders , such as financial institutions, hospital management, radiologists, national radioprotection agencies, training institutions and commissioning sub -contractors. We thus hold a strong conviction that innovation for LMICs should not be confined solely to simple basic devices such as solar lanterns and cook stoves , but should also venture into more complex technologies if they are indeed needed and essential . We hope that the methodology we shared in this article can inspire research ers on how to approach technology innovation projects and improve their chances of success . We also hope that we have been able to transmit our views that we should embrace challenges that also involve complex technology so lutions and not dwell exclusively on (over -) simplified solutions, sometimes referred to as “ low-tech ”. Instead, we should strive to develop what could be termed “ smart -tech”, i.e. smart ly conceived technologies designed to suit the most demanding and limited -resource conditions, but ulti mately having a universal appeal and relevance . 15 AKNOWLEDGEMENTS Would like to express our special thanks to the University of Applied Sciences and Arts Western Switzerland (HES -SO), The Paul Scherrer Institute, The University Hospital of Canton de Vaud (CHUV), The Swiss Tropical and Public Health Institute (SwissTPH), the University Hospital Center and the CURES at the Ecole Nationale Supérieure Polytechnique in Yaoundé . The authors wish to thank Dr Gérard Escher, Fiona Fossati and Gene Saxon (EPFL) , Steve Rudy (Gradian He alth Systems) , and Blaise Mentha (Privegest) for their help and advice with the manuscript.