Summary
We had a meeting with members of our community in Boulder, CO. The meeting was located at Sparkfun headquarters and had members who span multiple aspects of the open healthware community. While the roles held by our participants were quite varied, we do want to acknowledge the heavy US influence during this meeting, noting that all of our participants currently operate within the United States. We had two days of intensive workshopping that delved into a multitude of topics such as:
Open source healthware business practices
Community building methods and avenues
Continued conversations about what is required in the the full source of healthware
Funding mechanisms for open source endeavors
Balancing product risk and maker contribution
There were multiple takeaways from this workshop. One major finding was that good business practices translate across the closed and open spectrum. This was found to be beneficial because there are currently existing materials people can utilize to aid their open business endeavors. Another was that people wanted to build community and have very different ways of achieving those goals. We explored participant’s personal methods for effective community building and received great input about how OSHWA could incorporate these methods into its future practices. Lastly, even within the pro open source community, we found that there are further conversations to be had about balancing business interests with the openness of a technology. During the waning portion of the workshop, an activity where participants charted what success and failure would look like for the open source healthware community in the future was conducted. The workshop ended with a group discussion summarizing the workshop, and even though people felt like a lot was accomplished, much like the work, it was recognized that there is still more to do.
Replication and Documentation as Cornerstones of Open Source Healthware
A central theme across the sessions was the critical importance of replicability for open source healthware (OSHW). Participants emphasized that successful replication depends on detailed documentation—covering everything from material selection (e.g., aluminum vs. steel) to design intent and safe usage instructions. Special attention was given to biotech and pharmaceutical protocols, where even small documentation gaps can jeopardize replicability. Some groups advocated for tutorials to inform others the proper way to replicate a device. A “minimum viable standard” for documentation was suggested, accompanied by metadata that states risks, testing or QMS, IRB history, design rationale, and more. This would enabling transparency while supporting end-user understanding and safety.
Certification, Risk, and the Need for Nuanced Standards
Participants explored the evolving structure of certification for open healthware, identifying the tension between self-certification and formal third-party validation. There was broad consensus that medical devices require more rigorous review when compared to health devices due to their risk profiles. Participants suggested certification processes should reflect stages of development, from prototype to clinical use, and define what it means for a device to "work" in both functional and contextual terms. The community stressed that certification should serve as a meaningful mechanism to signal trust, safety, and reproducibility.
Governance, Transparency, and Partial Openness
Spirited discussion emerged about "open-washing," where projects claim openness without fully disclosing design files, source code, or usage constraints. These discussions centered around what openness means in differing contexts (e.g. business, personal use, etc.) It was determined that the definitions of transparency may be different depending on context but it must include enough information to enable replication and safety assessment. Participants questioned the role of OSHWA in screening and endorsing external organizations, highlighting the need for robust governance processes that evaluate replicability, documentation quality, and community contribution. Governance must also address peer review models and the qualifications of reviewers.
Community Engagement and Education as Movement Drivers
Participants highlighted the vital role of community building, both within core developers and broader stakeholder networks (patients, clinicians, engineers, educators). Education emerged as a powerful tool to grow awareness and uptake, especially when tailored to different audiences using accessible language and cultural sensitivity. The idea of community “ambassadors” was raised as a scalable model for trust-building and outreach. Participants stressed the need to define why open healthware matters to the public; linking it to values like health equity, affordability, and access. They also voiced a desire for resources to aid them in creating community. Intersectionality between technical, clinical, and advocacy communities was framed as a strength to be leveraged.
Funding and Sustainability Beyond Grants
Several discussions referencing the persistent challenge of funding open source healthware, precipitated an additional set of conversations around funding. While public funding (e.g., NSF, NIH) remains a potential resource, public funding agencies have historically favored software and it was recognized that a diversity of funding sources would improve the sustainability of Open Healthware. Participants explored diversifying funding through crowdfunding, private donors (including tech philanthropists), and open-friendly foundations. There was a strong push for OSHWA certified projects to clarify their unique value to funders—particularly around supply chain transparency, community legitimacy, and impact measurement. Business models emphasizing service, support, or subscription, rather than one-time sales, were viewed by participants as more sustainable and ethically aligned with the open source ethos. These conversations were quite thought provoking and will help set the stage for future OSHWA endeavors that can more directly focus on the intricacies of this issue.
Policy, Standards, and Regulatory Interfaces
The regulatory landscape was viewed as both a barrier and an opportunity. Open healthware might aid regulatory compliance by enabling derivative approvals or reuse of validated documentation. Participants advocated for engaging with policy and standards bodies to ensure open practices are codified in regulation. Open-source hardware was framed as a potential driver of faster, safer innovation—potentially outpacing traditional models in adaptability and resilience. Standardizing formats for documentation, metadata, and open IRB processes was seen as a pathway to more stable and trusted regulatory integration.
Strategic Ecosystem Mapping and Role Clarity
An ecosystem mapping exercise revealed the diversity of stakeholders working in or adjacent to open healthware—from academic labs and legal firms to grassroots initiatives like Open Insulin. However, many participants noted a lack of shared vision or coordination. Providing a unified strategic framing was proposed to help align diverse efforts and clarify long-term goals. Furthermore, understanding who contributes what—whether it's scientific expertise, manufacturing, education, or policy work—can guide the community toward more cohesive and impactful collaborations. Transparency in each actor’s role, intent, and contribution is crucial for collective success.
Business Models, Global Perspectives, and Systemic Change
Participants critiqued the current proprietary medical device ecosystem for incentivizing obsolescence and profit over patient care. It was further stated that current business models focus on treatment over curing, because treatment provides recurring revenue streams where curing puts a company out of business once all the patients are cured. Open source was positioned as a viable alternative—ethically aligned and globally relevant. Discussions highlighted open sourced business models (like Red Hat) and its ability to drive innovation and resilience in ways closed systems often cannot. These conversations also highlighted that most good closed source business practices also apply to both open hardware and open healthware businesses. This was seen as encouraging by the group because of the plethora of resources that already exist on how to run a successful business.
The Role of OSHWA: Convener, Validator, but Not Regulator
OSHWA’s role was seen as central, but not authoritarian, to the open healthware community. Many felt OSHWA should act as a convening body and “trusted curator,” providing frameworks, standards, and community spaces rather than enforcing strict rules. Participants valued the idea of OSHWA helping others navigate the open healthware landscape—highlighting good practices, supporting community review, and possibly maintaining a directory based on openness and replicability. Crucially, they did not want OSHWA to become a replacement for the FDA or risk creating a gatekeeping structure that limits innovation, which aligns with previous participant input and OSHWA’s own desires.
Opening the Certification Process to Community Input
Another recurring theme was the call for community involvement in the certification process. Participants wanted the process itself to be transparent, and open to feedback, with opportunities for community review and co-creation. There was conversation about making this process an iterative one, but ultimately the conversations led to the prevailing thought that the certification process shouldn’t be continually iterated on, in order to create standardization. Some proposed lightweight badges or labels that indicate different levels of openness, replicability, or readiness while others suggested a model where developers or community members can “vouch” for a project, share success stories of replication, or flag concerns. Many of these ideas were reflections of things or topics brought up in past workshops.
Avoiding Harm While Embracing Access and Innovation
Finally, ethical considerations about safety and risk were present throughout. While participants agreed that OSHWA should not become a health regulator, they acknowledged the dangers of misuse, especially in clinical or high-risk contexts. Many advocated for clear messaging around intended use, potential hazards, and known failures which was a sentiment echoed from the previous New York workshop. The community clearly wants to balance access and innovation with accountability—allowing for experimentation and iteration without creating false impressions of reliability. Transparent staging, honest limitations, and clear documentation were seen as essential to this balance.
