
Open-source medical devices for low- and middle-income countries

WHY and HOW
This is an edited excerpt from “Open-Source Hardware May Address the Shortage in Medical Devices for Patients with Low-Income and Chronic Respiratory Diseases in Low-Resource Countries” by Farre et al., J Pers Med. 2022;12(9):1498. Specific references and additional details can be found in that original publication.
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The problem
Some limited solutions
The open-source approach
Open-source hardware opportunities
3D printing
Simple electronic platforms
Other market novelties
Open-source medical devices for LMICs
No competition with the conventional market
How to implement it
Cautionary note
Safety issues
Reference approach
Another possible approach
Conclusions
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The problem
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Intense engineering and clinical research in the last decades have made it possible first to invent and subsequently develop very sophisticated and effective medical devices. This excellent progress comes, however, with the drawback that, in practice, such advanced devices are not available to most of the populations in low- and middle-income countries (LMICs). Indeed, most medical devices are produced and commercialized by companies in developed countries, with production costs, markup, and, thus, product prices that make the devices unaffordable to most individual patients and healthcare systems in LMICs.
As a result, whereas almost all patients in developed countries and a small wealthy minority in LMICs have access to commercialized medical devices, billions of inhabitants in low-resource regions have scarce or no access to life-saving medical equipment. Such widespread inequity in access to life-saving solutions prompts a uniquely important question aimed at addressing and resolving this global problem. In other words,
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what potential steps can be undertaken to eliminate or at least reduce this access inequality problem besides passively waiting under the wishful thinking that economic differences among countries will progressively disappear?
Some limited solutions
Several solution strategies have been considered and implemented over the years. For example, philanthropic donations of commercially available medical devices can be a helpful solution for specific sites and needs. Unfortunately, philanthropy cannot be a universal solution owing to the very high costs involved (thus, inefficient use of donations), and also because the functioning time of donated medical devices to LMICs is short due to the lack of maintenance and repair capabilities.
Another solution that may help reduce inequalities in the access to medical devices is to promote their production and commercialization by local companies in LMICs. Building so-called “frugal” medical devices can also help lower prices. In frugal devices, the concept is to produce devices providing the most basic and necessary functions, thus, avoiding the costs corresponding to more complex or sophisticated functionalities that may be helpful for slightly improving the treatment, increasing profitability for the for-profit medical center, or for patient comfort, but are beyond the fundamental medical aim of the device.
The alternative of fabricating less expensive devices by reducing non-fundamental functions or producing them in LMICs is very promising and should be actively promoted. However, the costs incurred in any conventional industrial process and implementation, even in the case of not-for-profit companies in LMICs, may result in product prices still not sufficiently low to be affordable for many patients in low-resource regions. Indeed, a disproportionately large share of medical device companies’ revenues is slated toward expenses beyond those needed to manufacture their products.
The Open-Source approach
Interestingly, a relatively new option, the open-source approach, may contribute to facilitate the provision of affordable medical devices for patients in LMICs. Open source is defined as a way to design and distribute the technical information required for building devices such that anybody can freely and unrestrictedly use the know-how to replicate the device or modify the design for improvement or adaptation to different applications.
The free open-source concept was born several decades ago in the software industry as an alternative to proprietary software. The free and open-source software idea is that contributing engineers write and freely distribute routine codes, platforms, or applications so that other developers can eventually modify and incorporate them into their applications (e.g., Linux, Android). Open source creates a gift economy that encourages rapid innovation. Free and open-source software development is now mature and well documented to be a successful technical development method.
Open-source hardware opportunities
3D printing
The concept of free open-source was subsequently expanded to hardware products, mainly thanks to the extension of two new technological developments. One of them was the commercialization and widespread access to low-cost 3D printers. Thus, open-source hardware developers contribute by building and freely distributing the files containing driving codes readable by conventional 3D printers. Then, any individual can fabricate pieces made of different materials, which otherwise would require an expensive traditional process of design and fabrication by classical methods. Low-cost desktop 3D printers are now widely used not just for prototyping but to fabricate consumer goods at prices that are beneath those available in the conventional market.
Simple electronic platforms
The other technological development that has expanded the open-source approach is the creation of standardized and simple electronic platforms allowing to read signals from sensors; carry out signal processing, including feedback control algorithms; and drive actuators in real-time (e.g., the Arduino electronic prototyping platform). These low-cost platforms do not necessarily have the highest performance offered by the most-novel, high-price options provided by the industry, but allow an enormous range of applications and are more than adequate for a vast array of scientific and medical applications. Similarly, they also drive substantial cost savings.
Other marked novelties
Two relatively recent commercial novelties have made this all possible. First, the progressive cost reduction of electronic components, sensors, and actuators as a result of the globalization process in industrial chains. Second, the worldwide extension of e-commerce distribution channels (e.g., Amazon, eBay, Alibaba) eases the retail purchase of components.
Consequently, it is currently possible for individuals or small professional groups to fabricate complex devices in a way that was not possible historically or even a few years ago. The fields of application of the open-source approach, which is considered a strategic and production-change paradigm, are ample in the current technology-based world, including industry, research, and medical devices.
Open source medical devices for LMICs
Combining 3D printing, Arduino-like platforms and easily available electronic components can drastically increase the savings for free and open-source tools over commercial equivalents. The combination of free open-source software and hardware approaches makes it possible for either expert engineers or individuals with basic technical knowledge to take advantage of the know-how provided by a vast community of developers worldwide. The approach allows for a democratization of the production of high-value products not seen before.
No competition with the conventional market
The open-source approach for fabricating medical devices in LMICs is a path clearly different from the conventional proprietary-based system of products mainly commercialized by companies in developed countries. The aim is not necessarily trying to establish a commercial competence simply because, in practice and for financial reasons, the commercial market is not operating in LMICs (with the exception of providing products for a small minority of wealthy patients).
This situation is not expected to change in the upcoming decades given the huge gap between costs and prices in developed countries and financial capabilities in LMICs. In this context, the open-source approach appears as a possible route enabling access to medical devices for use by a significant proportion of patients in low-resource regions, and this approach is already seeing results in closing the gap between the haves and have-nots in scientific instrumentation.
How to implement it
There is room to define what could be the best model to implement the open-source approach. Among different possible ways, a promising possible model to start developing the production is such that the low-cost medical devices are built by small technical teams linked to hospitals or to associated engineering schools, which could work independently or be coordinated at the regional or national levels. It is important to also involve LMICs professionals to ensure that the project is suitable for implementation under local conditions, specifically, to facilitate “personalizing” the project to the characteristics of on-site healthcare staff and patients.
Ideally, medical experts should be involved in the design and the evaluation of the devices, first on the bench and subsequently in patients. This is a common limitation found in most open-source medical devices projects published particularly in technological journals and environments.
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It is worth noting that the technical complexity required to assemble the low-cost open-source devices is at the level of a simple academic exercise for engineering/electronics students. In this regard, a possible option for clinicians potentially interested in using the device on their patients is to contact teaching staff in the technical schools in their region and foster collaboration. For such engineering professionals, helping to construct the device would be a straightforward and simple set of steps that could, for instance, be part of an example of practical work to be realized by students. Such collaboration may be synergistic for both sides since electronics/engineering partners would produce useful devices applicable in the real world, and the clinicians would have access to therapeutic tools that otherwise would be unavailable. Regardless of the construction approach, as the device can be assembled locally, the only costs incurred would be low since they involve purchasing general-purpose components (e.g., by e-commerce) and the relatively low labor costs in LMICs. Of note, the open-source approach may not only allow for adequate availability of medical devices to patients but may also help develop the local industry network in LMICs.
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Cautionary note
An important cautionary note regarding the ease of obtaining the information to build open-source devices is that well-meaning people without adequate technical/biomedical training may dangerously misuse it. It is fundamental to discourage such practice while further including cautionary statements that inform a priori the dangers associated with such misinformed initiatives.
Safety issues
Reference approach
A fundamental issue to be addressed regarding the local fabrication of medical devices is their safety and patient protection. The normal rule in developed countries is that any medical device to be used on patients should have been approved by the corresponding regulatory body (e.g., FDA, CE mark). This process has the advantage of ensuring, at a national or international level, that a device complies with minimal quality and safety standards and conditions. Unfortunately, the complexity and cost of obtaining regulatory approval has morphed into a time-consuming and expensive barrier against innovation and competition from new companies entering the medical technology market. Obviously, this model for medical device safety control is conceptually and practically not applicable for devices locally fabricated by the open-source approach.
Establishing the concept that, to be used in LMICs, medical devices must have an FDA or CE mark is in practice equivalent to prohibiting most inhabitants from having access to potentially life-saving treatments and makes extremely difficult the development of a local industry of medical devices.
Another approach
Although it may appear in developed countries that control by national regulatory agencies is the only possible procedure for ensuring safety and patient protection, it is not and was not the only possibility. Indeed, decades ago in developed countries, when most innovations on medical devices were invented and developed by building them locally before being industrialized, patient safety was ensured by inspection and approval by hospital ethical boards, which in fact is the way for currently approving clinical trials.
This local model was in the past, and continues nowadays, to be useful for protecting patient safety when subjected to new medical procedures. Therefore, this process could be equally applied to approving devices built locally, provided that the ethics committees are supported by technical professionals, either by including them in the ethical boards or by establishing procedures for external consultation with technical experts prior to ethical board approval.
Conclusion
As summarized in Table 1, the relatively novel, free open-source approach for design and distribution may be a uniquely useful and valuable tool for facilitating affordable medical devices for patients in LMICs who otherwise would not have access to the instruments and devices that, in some cases, enable life-saving diagnosis and treatment.
