Open Healthware: Certification, Benefits, and Challenges

“Open healthware” refers to open source hardware created for healthcare applications. While not yet known by the term, open healthware dates back to projects like the Pandemic Ventilator and Open PCR.

In August 2024, the Open Source Hardware Association received a two-year grant from the U.S. National Science Foundation (NSF) to research the development and certification of open source health devices, launching the Open Healthware initiative.

At the Open Healthware Conference held from August 1 to 2, 2025, the initiative presented its year-one findings to a gathering of medical and open source professionals. Here is a summary of the findings:

Why is OSHWA interested in open healthware?

Alicia Seidle, executive director of OSHWA, started the conference by discussing why OSHWA began to explore open healthware certification. She attributed it to requests from community members and the increasing number of health devices submitted for certification. OSHWA has certified at least 79 health devices, even without a specific medical/health category.

They began to explore the possibility of an open healthware project category and the specific requirements of the category, e.g., regulatory data and sterilization plans.

Seidle made a case for open healthware, pointing out the importance of non-patented inventions: generic drugs, seatbelts, and insulin medication in Canada. She gave examples of organizations championing open healthware, like Field Ready, Glia, Open Source Medical Supplies, and Ubora.

She clarified that OSHWA would focus on certification and would not act as a regulatory body.

What has OSHWA learned about open healthware so far?

Policy Postdocs at OSHWA, Avinash Baskaran and Yves Nazon, presented a roadmap of OSHWA’s open healthware journey, starting from the 2020 pandemic when the idea of building improvised medical equipment via distributed manufacturing took off.

Before the pandemic, there was one certified open source health-related device in OSHWA’s database. 78 devices were certified during and after COVID. There was no unifying ecosystem for the open source medical devices being created. There was no body for open source medical device certification and no central directory for open healthware.

The OSHWA team conducted a series of virtual and in-person workshops and concluded that the future of open healthware would revolve around documentation, globality, marketing, and reproducibility. Open healthware technology would require better documentation, marketing, coverage, and replicability than open hardware.

What are the possible motivations for open healthware?

Joey Castillo, open healthware engineer at OSHWA and founder of Oddly Specific Objects, discussed various motivations for open healthware and their implications for shared documentation.

He spoke on the open hardware definition and a set of different “whys” (study, modify, distribute, make, and sell) that inform how open hardware is made and distributed.

Castillo gave his Open Book project as an example of a possible why (making open hardware that can be studied). The initial design had documentation printed on the silkscreen for anyone interested in studying the design. This approach changed when he started shipping Open Book kits, and he put assembly instructions on the silkscreen in service to another why (hardware you can make).

He gave further examples of Open Book releases that included pin definitions, Gerber files, bill of materials, and even business insights to illustrate the other whys.

He notes that the OSHWA certification “merely asks for design files, software (if any), and documentation,” but a certain why (under the open healthware umbrella, for example) might require documents and artifacts beyond the scope of the original definition.

Various open source organizations and projects were represented at the conference, such as the Ventilator Project, CareAgain, Ubora, Glia, Mindseye, FieldReady, Open Source Leg, Open Source Medical Supplies, and OpenNerve. Here are a few of them:

• Jen Wilson, Director of Manufacturing and Design at Glia, detailed the organization’s efforts to ensure access to medical devices around the world, especially in low-resource settings. Glia’s GitHub repository has free designs and assembly instructions for a 3D-printed stethoscope, tourniquet, face shield, and otoscope. She described the impact that is possible when healthcare resources are free, open, and easily accessible.
• Alex Baldwin talked about the unique challenges of creating and certifying an open source high-risk medical device like the OpenNerve implantable pulse generator (IPG). Implantables have a long list of requirements to meet before they are approved for human use. Development and testing are time-consuming and can be cost-prohibitive for open source projects. Despite these challenges, open source is needed to lower development costs, support abandoned devices, and help new entrants in the medical devices space.
• Dr. Jean Rintoul of Mindseye also spoke on the challenges of medical device innovation. In 2017, she created a portable, open source electrical impedance tomography (EIT) device called Spectra. It was crowdfunded in 2019, but she said formal safety requirements and available funding limited its impact. She described the current venture model as inefficient for medical devices and pinpointed the need for efficient paths for scaling medical innovation.

The Open Healthware Conference highlighted the usefulness, challenges, and realities facing open source health and medical technology.

OSHWA is still working on the open healthware certification, and they invite the community to shape the future of Open Healthware with them. You can watch the conference’s livestream replay on YouTube.