“Open healthware” refers to open supply {hardware} created for healthcare purposes. Whereas not but recognized by the time period, open healthware dates again to initiatives just like the Pandemic Ventilator and Open PCR.
In August 2024, the Open Supply {Hardware} Affiliation obtained a two-year grant from the U.S. Nationwide Science Basis (NSF) to analysis the event and certification of open supply well being gadgets, launching the Open Healthware initiative.
On the Open Healthware Convention held from August 1 to 2, 2025, the initiative offered its year-one findings to a gathering of medical and open supply professionals. Here’s a abstract of the findings:
Why is OSHWA interested by open healthware?
Alicia Seidle, government director of OSHWA, began the convention by discussing why OSHWA started to discover open healthware certification. She attributed it to requests from group members and the growing variety of well being gadgets submitted for certification. OSHWA has licensed not less than 79 well being gadgets, even and not using a particular medical/well being class.
They started to discover the potential of an open healthware undertaking class and the precise necessities of the class, e.g., regulatory information and sterilization plans.
Seidle made a case for open healthware, stating the significance of non-patented innovations: generic medication, seatbelts, and insulin treatment in Canada. She gave examples of organizations championing open healthware, like Discipline Prepared, Glia, Open Supply Medical Provides, and Ubora.
She clarified that OSHWA would give attention to certification and wouldn’t act as a regulatory physique.
What has OSHWA realized about open healthware to date?
Coverage Postdocs at OSHWA, Avinash Baskaran and Yves Nazon, offered a roadmap of OSHWA’s open healthware journey, ranging from the 2020 pandemic when the thought of constructing improvised medical tools through distributed manufacturing took off.
Open Lung by the Open Supply Ventilator Mission
Earlier than the pandemic, there was one licensed open supply health-related machine in OSHWA’s database. 78 gadgets have been licensed throughout and after COVID. There was no unifying ecosystem for the open supply medical gadgets being created. There was no physique for open supply medical machine certification and no central listing for open healthware.
The OSHWA crew performed a sequence of digital and in-person workshops and concluded that the way forward for open healthware would revolve round documentation, globality, advertising and marketing, and reproducibility. Open healthware expertise would require higher documentation, advertising and marketing, protection, and replicability than open {hardware}.
What are the attainable motivations for open healthware?
Joey Castillo, open healthware engineer at OSHWA and founding father of Oddly Particular Objects, mentioned varied motivations for open healthware and their implications for shared documentation.
He spoke on the open {hardware} definition and a set of various “whys” (research, modify, distribute, make, and promote) that inform how open {hardware} is made and distributed.
Joey Castillo’s Open Guide
Castillo gave his Open Guide undertaking for example of a attainable why (making open {hardware} that may be studied). The preliminary design had documentation printed on the silkscreen for anybody interested by learning the design. This method modified when he began delivery Open Guide kits, and he put meeting directions on the silkscreen in service to a different why ({hardware} you may make).
He gave additional examples of Open Guide releases that included pin definitions, Gerber information, invoice of supplies, and even enterprise insights as an instance the opposite whys.
He notes that the OSHWA certification “merely asks for design information, software program (if any), and documentation,” however a sure why (beneath the open healthware umbrella, for instance) may require paperwork and artifacts past the scope of the unique definition.
Varied open supply organizations and initiatives have been represented on the convention, such because the Ventilator Mission, CareAgain, Ubora, Glia, Mindseye, FieldReady, Open Supply Leg, Open Supply Medical Provides, and OpenNerve. Listed below are just a few of them:
- Jen Wilson, Director of Manufacturing and Design at Glia, detailed the group’s efforts to make sure entry to medical gadgets around the globe, particularly in low-resource settings. Glia’s GitHub repository has free designs and meeting directions for a 3D-printed stethoscope, tourniquet, face protect, and otoscope. She described the impression that’s attainable when healthcare sources are free, open, and simply accessible.
- Alex Baldwin talked concerning the distinctive challenges of making and certifying an open supply high-risk medical machine just like the OpenNerve implantable pulse generator (IPG). Implantables have an extended record of necessities to satisfy earlier than they’re accepted for human use. Growth and testing are time-consuming and may be cost-prohibitive for open supply initiatives. Regardless of these challenges, open supply is required to decrease growth prices, assist deserted gadgets, and assist new entrants within the medical gadgets house.
- Dr. Jean Rintoul of Mindseye additionally spoke on the challenges of medical machine innovation. In 2017, she created a transportable, open supply electrical impedance tomography (EIT) machine known as Spectra. It was crowdfunded in 2019, however she stated formal security necessities and accessible funding restricted its impression. She described the present enterprise mannequin as inefficient for medical gadgets and pinpointed the necessity for environment friendly paths for scaling medical innovation.
The Open Healthware Convention highlighted the usefulness, challenges, and realities dealing with open supply well being and medical expertise.
OSHWA continues to be engaged on the open healthware certification, and so they invite the group to form the way forward for Open Healthware with them. You may watch the convention’s livestream replay on YouTube.
