A new framework for safely building open-source medical gear

FabCafe Bangkok’s donation of DIY PPE to local healthcare professionals.

During the COVID-19 lockdowns, makers globally responded to the scarcity of medical supplies by turning to open-source designs. In this context of decentralized, grassroots production, FabCafe Bangkok contributed by fabricating PPE to meet local needs in 2020. Similarly, FabCafe Taipei members later gained experience with open-source medical tools through first-aid training with the Glia tourniquet. These localized efforts signaled a broader, global shift toward community-driven healthware. Driven by these practical experiences, BioClub Tokyo recently joined an international study led by the Open Source Hardware Association (OSHWA) to better understand the rigorous assembly and provenance required for the Glia design.

Plan of a Mediaeval Manor, from William R. Shepherd, Historical Atlas (1923), p. 104. Public domain, via Wikimedia Commons.

It is useful to reflect on how these concepts stack upon one another, rooted in the ancient principle of the commons. Historically, this represented a collective resource such as grazing pastures or timber forests, managed and utilized by a community rather than a single entity.

The open-source movement reimagines this ancient philosophy for the digital age, treating foundational code as a communal asset that remains accessible for anyone to execute, refine, and distribute. By relocating the “recipe” from knowledge silos into the global commons, the community itself acts as the primary steward, detecting errors and driving collective innovation.

Open hardware extends this logic into the physical domain, replacing software code with 3D models, circuit schematics, and comprehensive bills of materials. This shift empowers anyone with the right tools to manufacture, personalize, and iterate upon physical objects. The Glia tourniquet project is a prime example of this hardware commons, providing its complete technical blueprints for public replication and assembly.

During the fabrication phase, BioClub Tokyo managed to get in contact with Jen Wilson, Glia’s Director of Manufacturing and Design. Wilson reiterated that while 3D-printed components provide the structure, the instrument’s mechanical integrity is primarily anchored in its non-printed elements. She clarified that the internal webbing must possess zero-stretch properties, as it must be capable of withstanding the extreme tensile forces. When navigating the complexities of regional supply chains, Glia has established protocols for material substitution to ensure safety. A notable instance of this localized adaptation occurred in Poland, where the project transitioned from the specified dual-component hook-and-loop system to Omni-tape, a consolidated alternative that was more readily accessible within their local market.

Seeking to understand the evolving landscape of healthware certification, we consulted with Joey Castillo, an Open Healthware Engineer at OSHWA, to explore the organization’s vision for this framework.

“It doesn’t affect the use of the device, but it does change the way it’s manufactured.”

Jen Wilson, on adapting the tourniquet’s hook-and-loop component to local supply chains

 

“OSHWA confirms the source is there. It is not a quality body. We don’t grade the documentation or validate anyone’s trials,” the organization explains.

Joey Castillo, Open Healthware Engineer at Open Source Hardware Association

For those intending to replicate this build, several critical observations emerged from this exercise:

• Rigid elements must be fabricated using 100% infill in ABS or PETG, ensuring no dimensional scaling or surface smoothing of the windlass is applied. Furthermore, strap selection must prioritize tensile strength and zero-stretch properties over aesthetic qualities, as any elasticity in the webbing directly compromises the instrument’s effectiveness.
• The assembly requires heavy-duty nylon thread rather than standard domestic varieties. For comprehensive guidance, Glia provides a specialized Design Intent document within the project’s GitHub repository.
• This tool is designed for point-of-injury care by trained personnel and is not intended to supersede certified medical instrumentation.

Regarding the complexities of regional adaptation and material substitution, OSHWA maintains a definitive position: the framework does not mandate a static bill of materials or curate a list of equivalents. Instead, it places the responsibility on the creator to document critical, non-negotiable components, such as capacitors with specific values or webbing possessing a minimum tensile threshold that are essential to the device’s integrity.

Documentation of this rigor benefits from collaborative review. BioClub Tokyo supports work in open-source hardware and healthware, and welcomes new contributions and ideas from the community. Sessions are held Tuesdays from 7 to 9pm on the second floor of FabCafe Tokyo.

We extend our gratitude to Joey Castillo, Open Healthware Engineer at the Open Source Hardware Association, and Jen Wilson, Director of Manufacturing and Design at Glia Equal Care, for sharing their expertise and insights.