Assuming that the present list of OSH solutions for PPE and ventilators is a sufficiently comprehensive one, results clearly show that there is great variance regarding the aspects of adherence to open-source best practices and also of development level, both across technologies and also across specific criteria. For instance, regarding openness, while virtually all entries in both ventilators and PPE lists have readily downloadable production files from their websites, none whatsoever has a certification from OSWHA. Similarly, development level varied a lot: while a few ventilators have been cleared by government agencies, others do not even have presented a functional prototype. There was also variation regarding the repository and language. Finally, variation could be clearly seen in the level of elaboration of documents. For instance, while some assembly instructions consisted of mere exploded views, other projects contained detailed step-by-step explanations including photographs and even videos. In the same vein, some ventilators have been extensively tested and calibrated in very controlled laboratorial conditions, while others have been simply put into motion. If all criteria listed in the tables are considered to have equivalent importance to the aspects of OSH adherence and development status, one can conclude that efforts on these designs are half the way there: mean percentages for Tables 1 plus 2 (adherence to OSH standards), and 3 (development status) are 52.1% and 49.2% for ventilators, respectively; mean percentages for Tables 4 plus 5 and 6 are 67.8% and 40% for PPE, respectively. These observations can be paired with the one showing that technologies listed in the tables better abide by criteria representing early steps in making a solution open source (e.g., upload of production files) in contrast to late ones (e.g., OSHWA certification). Under this perspective, it can be found that, while it is considerably easy to find OSH alternatives to PPE and ventilators online, manufacturing and making them properly work may represent a more significant challenge. This line of reasoning can be analogously applied to the results regarding development status, leading to the understanding that functional and open access technology may exist in good numbers, but only a few may be qualified as scientific or medical-grade apparatus. These considerations corroborate those of previous studies. In his review of ventilators for COVID-19, Pearce (2020a) concluded that available systems lacked complete documentation and are still poorly tested and in their early stages of design. Following work from the same author brought forth a complementary conclusion that among the equipment needed to face COVID-19 pandemic, as requested by the Government of India, although most have open-source designs available, only 15% of them fully adhere to the OSH format, which includes usage of open tools and components. This led the author to propose five associated core lines of research for investigation capable of mitigating present and future health crises (Pearce 2020b).
The present depiction of the OSH alternative to fight the COVID-19 scenario may be mistaken as a harsh critic of the model and maybe even a reason for abandoning it. The authors of the present study, in agreement with previously mentioned experts, believe in quite the opposite idea. Even though few designs abide more completely by OSH best practices and, at the same time, are well developed to the point of owning official medical clearance, these exceptions may be of immense value, bearing the potential to turn the table around on the shortage issue. Some good examples of this are the fabrication of the recently made-open Medtronic’s ventilator design (https://www.medtronic.com/us-en/e/open-files.html) by a Brazilian medical equipment producer (https://www.saevo.com.br/ventilador-pulmonar-br1/) and the starting of fabrication of the INSPIRE-OpenLung design from the University of São Paulo (USP), authorized by ANVISA. Furthermore, the other less-developed solutions with obscure documentation are possibly on the track to become medical-grade equipment as their authors can better organize and share their intellectual property, given that they receive the appropriate support. In this particular, it is symptomatic that the best performing solutions in our study are those from large and well-established research teams. Finally, some OSH designs, even if developed at a suboptimal level, can more quickly be transferred to the medical service, if the application is less demanding in terms of performance and safety, such as the case with some PPE.
In line with previous suggestions, we also understand that the strategy to work around the limitations of the OSH paradigm is to do it more and better. Particularly, while some inventors and ingenious scientists may see the process of obtaining a certification from OSHWA as mere paperwork and/or a vanity corroboration of their research, we take it as an avenue for excellence, which is the fastest track to legal authorization, widespread dissemination, and even to profitable business (Cota et al. 2020; Ferreira 2008; Pearce 2017). By abiding to the OSH best practices, authors maximize integrity, visibility, and high-fidelity reproductions of their solutions. By their turn, these factors attract well-informed feedback that induces improvement, even greater visibility and dissemination, in a closed virtuous circle that culminates in excellence (Gibb 2014). Although such seal of adherence to OSH standards is not a warrant of quality and efficacy of any given technology, it is certainly an excellent starting point, once it means handing the intellectual product to widespread scrutiny and review. Additionally, for the interested third part, the certification is an important indicator that his/her efforts to reproduce the hardware have greater potential of success and, thus, it is a major factor to attract audience to contribute to the virtuous circle previously described. Finally, the case for OSWHA certification, in particular, is made here only because it is, to the extent of our knowledge, the only open association that is fully committed to investigate the OSH model and to propose an objective system to evaluate documentation and grant a peer-reviewed validation. Furthermore, it is arguably the most mature technical/scientific association in the world that deals with the topic of OSH. It has been active for almost a decade, it is open to external membership, and it has a rotation of board members and leaders, which are chosen among associates. Additionally, it gathers researchers that are productive in the many unfolding fields of science related to open source hardware.
To further illustrate the importance of fully abiding by the best practices, we proceed to briefly explore a real case of local third part manufacturing of OSH solutions to face the COVID-19 pandemic. Right after the classification of the disease as epidemic by the World Health Organization on January, 30th, a group of scholars, students, makers, and local entrepreneurs from the city of São João Del-Rei, in the country-side of the State of Minas Gerais, Brazil, organized themselves to start production of face shields to be handed as donations to medical services in the region, anticipating the probable shortage of PPE. After deciding for the Prusa face-protector design with small adaptations for improved productivity, a successful crowdsourcing campaign raised funds for the production of three-hundred 3D-printed face shields (Fig. 2a and Fig. 2b) and almost two-thousand acetate foil-only alternatives. As hobbyists and enthusiasts only, the group faced a multitude of difficulties in this initiative, including a steep learning curve of logistics supporting purchase and delivery of consumables, planning of product manufacturing and distribution, “client” management, and other daily challenges of the industry environment. Although the endeavor was quite successful, the group faced major obstacles, jeopardizing a more significant contribution, related mostly to concerns regarding access to information, legal aspects, and design performance. For instance, production of face shields could be considerably larger if commercial usage were granted by the license, once it would not be limited to the amount covered by funds raised. Unfortunately, this is not in the case of the Prusa model, which has a license CC-BY-NC 4.0. In fact, the NC part of the CC license forbids reproduction of licensed material for commercial proposes. For this reason, best practices clearly state that OSH licenses must not do so and a process of certification would certainly have pointed that out. In the same vein, the group seriously considered starting manufacturing OSH versions of ventilators and even assembled a first functional unit (Fig. 2c). However, concerns regarding legal and medical aspects, and also regarding viability of acquiring the needed consumables were major factors for abandoning the idea. Again, better adherence to OSH best practices and certification would be helpful in fostering the initiative.