Open Source Hardware, Exploring how Industry Regulation Affects Knowledge Commons Governance: An Exploratory Case Study

Abstract

Tools for clinical examination have not fundamentally evolved since the invention of the stethoscope by René Laennec in the nineteenth century. However, three decades ago, the medical community started to consider repurposing ultrasound scanners to improve physical examinations. A broad community of healthcare professionals trained in the new clinical examination paradigm could not be created due to the very high price of portable ultrasound scanners available on the market. In this paper, we study an Open-Source Hardware (OSH) community that aims to improve diagnosis in hospitals and medically underserved areas worldwide. They are designing an echo-stethoscope -a portable ultrasound scanner -that would be affordable in low and middle-income countries. The variety of expertise pooled to achieve this objective puts this knowledge common (KC) at the crossroads of open-source software (OSS), OSH, and medical communities. Unlike typical KC outcomes, an ultrasound probe is a physical object. Development and innovation in the physical world bring social dilemmas that the community has to overcome, restrictions in terms of openness, and in this case, unintended privatization. Our study uses the governing knowledge common framework (GKCF), a modified institutional analysis and development framework, to untangle the interactions between resources, participants, and governance structures.Our research describes why and how the creation of a physical object subject to industry regulation influences the evolution and governance of the KC. We provide evidence that temporary privatization of the KC can be used as a way to protect and sustain a common during the industrialization phase. We also demonstrate how a portfolio of projects is an effective and resilient way to help the common survive this privatization step.

Commoning Semantic Interoperability in Healthcare

“…Nevertheless, it may take some time for a common understanding and shared values to become clear to all. An example of such coexistence of open and closed commoning has also been observed in the case of open source hardware in healthcare (Carpentier, 2021). Furthermore, the involvement of a pharmaceutical company in the WG collaboration was not well received by some participants, as it would mean "bad publicity for the ROC project", given the lack of transparency in the business relationships between the pharmaceutical industry and healthcare providers in the past.…”

“…In this context, Hall and Schulman have explored incentives for patients to obtain interoperable EMRs (Hall & Schulman, 2010), which are a prerequisite for achieving EHRs as commons. During the coronavirus pandemic, opensource hardware gained prominence in healthcare which helped expand commons to include the creation of private companies to produce regulated medical devices and still achieve enough interest for the commoners to continue with their participation (Carpentier, 2021).…”

“…Dulong de Rosnay and Stalder define digital commons as "a subset of the commons, where the resources are data, information, culture and knowledge which are created and/ or maintained online" (Dulong de Rosnay & Stalder, 2020, p. 2). Due to the intangible nature of digital commons, they are not threatened by overuse and material exclusivity, but can be threatened by underuse, inadequate legal frameworks, pollution, poor quality or discoverability (Dulong de Rosnay & Stalder, 2020), which can cause digital commons projects to fail -something also referred to as the tragedy of the digital commons (Carpentier, 2021;Schweik & English, 2007) They also outline the four dimensions of digital commons: law and licencing, authorship, economics and modes of production, and governance. One of the emerging issues related to digital commons concerns data commons and personal data.…”

“…This pointed to another governance problem -that of the MoH not engaging with the obvious stakeholders of the ROC project. We can learn from the case of open-source hardware in healthcare (Carpentier, 2021) that a new approach to project portfolio management has been introduced in which the non-profits continue their work on the development of open-source hardware while a private company is established that will be responsible for manufacturing and selling the marketready products. The main reason for the need to create a new private company is the regulatory approvals that are required before anyone can sell medical devices on the market.…”

Key Enablers towards Mature Company-community Collaboration in Open Source Hardware

“…Important steps in the consolidation of the field of OSH have been the founding of progressive lighthouse projects such as Open Source Ecology for a global village construction set in 2003 (Macul, Rozenfeld, 2015) 3 ; Arduino for microcontrollers providing a low-cost OSH prototyping platform (Nayyar, Puri, 2016) 4 and RepRap for DIY 3D printers (Pearce, 2012) 5 , both in 2005. Other notable cases of OSPD projects that have been studied encompass EchOpen ultrasound imaging device (Carpentier, 2021), WikiHouse (Priavolou, Niaros, 2019), Zoybar electronic music instrument (Ilan, 2011), eNable making prosthetic hands (Smith, Mortati, 2017) robot (Mondada et al, 2017), OpenBionics prosthetic hand (Kostakis et al, 2018), Open Desk (Gasparotto, 2017), OSCar (Müller-Seitz, Reger, 2010), and many more. Scientific literature on OSPD projects is nonetheless still quite limited and more case studies are needed in future.…”