From the outset of the project, we have held virtual and in-person workshops with a global crowd of people who work at the intersection of Open Source Hardware and medical fields to understand what Open Healthware is and what is required for building an ecosystem.
Across the events, there was an apparent need for educational and supportive materials to be offered for the general public, professionals in Open Healthware, and everyone in between.
Our first step in creating these support materials was to create a centralized document that gives a brief overview of what Open Healthware is and how OSHWA is facilitating interactions surrounding it.
Goals of this guide:
Provide a general understanding of OSHWA and Open Source Healthware that both novices and long term community members can benefit from
Create a centralized document that answers questions, shares common languages, and lists examples.
Create a compiled centralized resource.
Document what we have learned and are working on.
Why This Guide?
This guide was made from data collected during multiple working sessions that included designers, health educators, and Open Source Healthware community members as well as with feedback from OSHWA’s Open Healthware ecosystem survey.
When asked what resources were needed, community members shared education material requests for resource tools such as a FAQs page, common language, how-to guides, best practices, reading lists, community outreach, and more.
While some resource items will live apart from this guide, we are trying to create a starting point so that anyone, no matter their Healthware background can gain a general understanding of what Open Healthware is while still providing resources that Healthware experts can use to answer questions when they’re stuck, to educate others, and find solutions they might have missed.
Community Revisions and Updates
This guide is made with the input of OSHWA’s Open Healthware Community members and continues to seek feedback, input, and revision requests from our Healthware community.
As much as we’d like to capture all education materials in this documents, we know that this guide will need consistent updating to keep up with the growing needs of
Open Healthware. OSHWA is US based but has community members in all parts of the world with vastly different educational needs and we would like to reflect that in this guide.
If you feel we are missing much needed educational tools, would like to add revisions, request updates, or simply give feedback, Email OpenHealthware[at]OSHWA.org
Year One Reflections On Open Healthware
Before the pandemic, OSHWA’s involvement with medical devices was limited to a few projects in our certification directory related to health applications. However the urgency of the COVID-19 crisis shifted everything. During COVID-19, we saw distributed manufacturing blossom with the need for rapid and adaptable solutions to keep pace with the impact covid was having on communities around the world. Some examples of this in action include when the University of Wisconsin designed an open source face mask that Ford scaled into millions of units, and when Medtronic open-sourced their ventilator designs to meet urgent global demand.
After COVID-19, our community’s request began to shift, with two major desires making themselves known:
A medical-specific certification pathway that answered the question what does it mean to be both open source and a medical device?
A directory to connect the many groups already working in the space such as Field Ready, Ubora, Glia, and more.
In response to this shift in community needs, we began building what we now call the Open Healthware ecosystem. To unify the field, we coined the term, healthware, to be a bridge between medical-grade devices (like pacemakers) and health-related devices (like step trackers).
An NSF POSE grant helped us formalize this work, and we launched over 100 interviews with researchers, makers, regulators, and industry stakeholders. From those conversations, a few key themes stood out:
Flexibility is essential. Certification must adapt to different geographies, regulations, and user needs.
Transparency matters. People want to know what their devices are doing, and they want equitable access to healthcare tools.
Liability is a concern. Many want to contribute but fear legal consequences if something goes wrong.
Standards bodies must be included. Collaborating with organizations like ISO and the FDA will be critical to long-term adoption.
Listening to the Community: Workshops & Takeaways
Our interviews fed directly into a series of four workshops—two virtual, two in-person.
The message from the community was clear: they want a Healthware certification. Participants identified key stakeholders (makers, researchers, manufacturers, regulators, clinicians) and outlined what success might look like: alignment with local regulatory boards, strong documentation, replicability, and transparent governance.
Importantly, participants emphasized that OSHWA’s role is not to guarantee safety, that’s for regulators, but to ensure openness, documentation, and community connection.
Trust, risk, and safety management emerged as recurring themes. People want OSHWA to steward this work in the near term, while leaving space for a potential international body in the future. Above all, clarity about what certification does and does not mean is essential.
When we synthesized all of the workshop discussions, four themes consistently surfaced:
Documentation and Transparency – Seen as an essential ingredient for building safety, trust, and community in the Open Healthware ecosystem. Things such as verification and validation (V&V) records, 3rd party testing, and culturally adaptable documentation were all referenced as examples of desired documentation from the community.
People also associated documentation with transparency and wanted to create a new norm of thorough documentation for the healthware community while it is still in its infancy.
Globality – Globality refers to the certification’s ability to reflect and be applicable to diverse global needs. Regulatory frameworks differ by country, cultural barriers affect adoption, and localized production hubs are critical. Ensuring that the certification process isn’t exclusively based on Western models of technological development to encourage global participation is essential.
Education and Outreach – The open hardware movement at large needs people to be more educated about how it functions, and healthware is no different. Participants made it known that healthware needs more advocates, educational programming, and branding. Dispelling the myth of low cost equals low quality is paramount. Positive marketing successes for certification can encourage people to believe that healthware certification is a professional mark that communicates credibility and inspires trust.
Reproducibility – The ability to replicate designs, supported by robust documentation and testing, is a cornerstone of belief in healthware. Access to resources for verifying reproducibility and standardized methods for recreation are central to this goal.
Data Driven Insights & Challenges
At our workshops, participants shared their thoughts and reflections in real-time through collaborative documents, responding directly to prompts we provided.
Afterward, our team carefully reviewed every contribution and scored them using a consensus-based approach called the Likert method. We focused on the four core themes – Documentation, Globality, Marketing, and Reproducibility – and looked at participant responses through three lenses: constraints, stakeholders, and vision.
We also explored sub-themes such as Clarity, Transparency, Regulatory Compliance, Standardization, Validation, Interoperability, and Liability through these lenses as well.
From our analysis, five unique insights emerged:
Regulatory & validation documentation is non-negotiable. It’s the strongest mechanism for building trust across geographies.
Liability fears are widespread. Contributors need clarity on responsibility and legal risk.
Interoperability is a tension point. Stakeholders value it, but it often emerges unevenly across contexts.
Marketing gaps are real. Open source remains poorly understood, requiring more education and awareness.
Reproducibility drives consensus. Standardization, clarity, and shared resources are seen as key to success.
Common Language & Phrases of Open Healthware
Emergency Response - Effective emergency response means life-saving health interventions are implemented to ensure that affected populations have timely access to quality health services. This reduces the health impact of the emergency, ensures public safety, meets peoples’ subsistence needs and eventually saves lives.
Distributed manufacturing -According to Wikipedia, “Distributed manufacturing, also known as distributed production, cloud producing, distributed digital manufacturing, and local manufacturing, is a form of decentralized manufacturing practiced by enterprises using a network of geographically dispersed manufacturing facilities that are coordinated using information technology. It can also refer to local manufacture via the historic cottage industry model, or manufacturing that takes place in the homes of consumers.”
Democratizing Innovation - Democratizing Innovation is a term coined by Dr. Eric von Hipple, to describe a “user-centered design process that is aided by improvements in computer and communications technology, increasingly, and can develop their own new products and services”:
Creator - A creator is a Fabricator/Maker/Designer, these are self-identified terms often used in the open hardware industry to define the role of someone at one or more steps of the process of creating open hardware.
Replicator - This is a self-identified terms often used in the Open Hardware industry to define someone who replicating someone else’s design.
Git - Git is a free and open source distributed version control system, many repositories leverage Git in their name such as GitHub or GitLab. Users of the open hardware community often leverage third-party repositories to assist with design and source version control.
Repository - In this context repositories are a digital space that holds source files and build information, Wikipedia lists and defines specific types of repositories, including software
Patent/expired patent/patent search - Patents are a type of intellectual property that vary from country to country. An expired patent is a patent that has expired with the governmental organization who granted it. A patent search is the act of searching a database for a patent. Open Hardware is an alternative to the intellectual property landscape.
Licensing - Licensing is to issue a license to or to permit or authorize especially by formal license.
Sublicensing - A subordinate license granted to another by one already having a license.
Additive manufacturing - 3d printing as a method that ‘adds’ material.
CAD - Computer-aided design, often used to design mechanical files.
STL/ STEP Files (Hardware) - File formats common in 3D printing
BOM (Bill of materials) - A list of all the materials that go into a specific build of hardware.
Supply Chain Issues - Meriam Webster defines supply chain as: “the chain of processes, businesses, etc. by which a commodity is produced and distributed” Common issues are disruptions, delays or challenges in any step of that process.
Fork - A fork is a form of branching, but generally involves storing the forked files separately from the original; not in the repository.
Branch - A "branch" is a line of development. The most recent commit on a branch is referred to as the tip of that branch. The tip of the branch is referenced by a branch head, which moves forward as additional development is done on the branch. A single Git repository can track an arbitrary number of branches, but your working tree is associated with just one of them (the "current" or "checked out" branch), and HEAD points to that branch.
Pull - Pulling a branch means to fetch it and merge it.
Hackerspace/Makerspace- “A hackerspace (also referred to as ahacklab, hackspace, or makerspace) is a community-operated, often "not for profit", workspace where people with common interests, such as computers, machining, technology, science, digital art, or electronic art, can meet, socialize, and collaborate.”
Reproducer - this is a self-identified terms often used in the open hardware industry to define someone who reproducing someone else’s design.
IOT - Acronym for Internet of Things. It refers to a network of physical devices, vehicles, appliances, and other physical objects that are embedded with sensors, software, and network connectivity, allowing them to collect and share data.
Design Freeze - A design freeze is similar to a stable version or release; modifications, derivatives, and updates result in a new version with separate documentation needs. This concept is similar to how the US FDA addresses new or “substantially equivalent” designs that build on prior approved devices. These still have unique reporting requirements for approval to market and distribute for human use.
Open Source (OS) - OSHWA follows the open source definition as stewarded by OSI
Open Source Hardware - Per the Open Hardware definition, “Open Source Hardware is hardware whose design is made publicly available so that anyone can study, modify, distribute, make, and sell the design or hardware based on that design.
Open Source Healthware - Healthware is an OSHWA-defined term describing hardware designed for health and medical applications. This definition is a work in progress. Currently, OSHWA is working with Open Healthware community members to best define “Open Healthware”
Medical Device - According to the World Health Organization, “A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.”
Regulatory agencies - As defined by Britannica: “regulatory agency, independent governmental body established by legislative act in order to set standards in a specific field of activity, or operations, in the private sector of the economy and then to enforce those standards.” Regulatory bodies in open healthware may include your region's medical device regulation agency or board, such as CE, FDA, MDEL, etc.
ISO - Refers to ISO standards. Standards are internationally agreed by experts. It could be about making a product, managing a process, delivering a service or supplying materials – standards cover a huge range of activities. Open source appears as an ISO standard in the open chain project.
DIN - DIN Standards are the results of work at national, European and/or international level. There is a DIN spec for open source hardware:
Open Know-How Open Know-Where - Open Know-How is an open data model for sharing hardware designs and documentation online, to know how something can be made.
Avoiding U.S Centric language USA centric phrases like: FDA, or CLASS 1, 2, 3. Instead we try to broadened to include more country’s codes or say regulatory body instead of choosing just one.
Intro to OSHWA
Who?
Open Source Hardware association (OSHWA) is a non profit that seeks to connect members of the Open Source Hardware and Open Healthware field to each other and the world! Much of our work also includes general education around Open Source Hardware and Healthware . We also maintain the Open Hardware certification and database. Through 2025- 2026 we’re working on building out an Open Healthware ecosystem.
Why?
The Open Source Hardware and Healthware world is growing quickly. We think it’s important to connect people working on Open Source Hardware to each other to create community, build community standards, and progress open source around the globe.
Where?
Oshwa works with the global Open Source Hardware world! Check out our Open Hardware certification map to see where certifications have come from.
How?
OSHWA connects community members through our Open Hardwares Summit, Open Healthware Conference, Open Hardware Month, and through social media! Our current Open Healthware ecosystem initiative has been funded by NSF which has allowed us to flesh out building a healthware department.
What We Do:
Open Hardware Summit (OHS):
The Open Hardware summit is an annual event where OSHWA invites members of the open hardware community to gather. The event is two days of speakers, workshops, panels, and networking. It’s one of our community’s most beloved events.
Open Healthware Conference (OHC):
A conference Similar to the Open Hardware Summit but more specific to the healthware field. We focus on groups and people working on Open Source medical and health related devices and projects. 2025 was our first OHC in early august bringing people together from across the health and medical spheres. a quote from one of our attendees “I’ve finally found the people I’ve been searching for my entire career.”
Certification:
Don’t forget about our OSHWA certification! The Certification provides an easy and straightforward way for producers to indicate that their Open Hardware products meet a uniform and well-defined standard for open-source hardware compliance.
Fellowships:
To check out our current fellowships and up to date programs go to oshwa.org/programs
Community Building:
OSHWA Loves connecting people. Whether in person or online. Here’s where you can find us online! Mastodon Bluesky Hackster LinkedIN Instagram
Intro to Open Healthware
Open Source Healthware is Open Source Hardware that falls under the umbrella of medical and health related devices. This can range from personal protective equipment (PPE), implantables, prosthetics, assistive devices, diagnostic equipment, and more.
The story of Healthware really begins with the emergence of autonomous, small scale manufacturing capability via additive manufacturing, particularly 3D printing. This manufacturing sea change soon began to affect the most humanitarian of goals- how to increase access to quality medical care in places traditionally restricted.
In 2014, Glia was founded in London, Ontario, Canada and soon published the world’s first peer reviewed open source stethoscope, which was made from 3D printed parts and inexpensive office supplies. The idea that someone could self-manufacture a medical device that was affordable, actually functioned, safe to use, and made to quality standards for extended use- was a novel and soon popular idea. Additive manufacturing inspired the development of many distributed manufacturing sites in rural, crisis, and low-resource areas, specifically for the production of Healthware at a locally-affordable price point.
During the Covid-19 pandemic response in 2020, there was a surge of interest for medical and health related open source hardware as a stopgap to global supply chain disruption. Since then, there has been a growing demand for resources to support the growing Healthware community. In 2025, OSHWA began developing an ecosystem to meet those needs.
Open Source Healthware Device from Glia Aka: The Glia Stethoscope!
3DP Indirect Ophthalmoscope Shield from OSMS
Angelo Amplifies Emotion: Assistive hearing device
Angelo Amplifies Emotion: Assistive hearing device from Angelo
Rebelia Robotic Hand
Rebelia Robotic Hand from Robot Garage
OpenNerve An implantable Pulse Generator
OpenNerve An implantable Pulse Generator from OpenNerve
Uses of Open Healthware
Humanitarian Aid
Because Open Healthware designs can be accessed online from anywhere in the world, many devices can be manufactured within conflict zones or rural, low-resource settings without traditional access to medical care.
Research
While many of our community members create Healthware for humanitarian access to medical care, others use Open Healthware to advance pre-existing research or explore new areas of medical and health innovation. Because documentation is open, community engagement can result in research scaling at an incredibly rapid rate, reducing development time between the first prototype and final product.[Example: LibreRecorder]
Sales
While Open Healthware is an emerging commercial market, openness and transparency are core values for brands developing and marketing Healthware. [Example: Glia and Varro Life Sciences]
Repair
Because all Healthware documentation must be open, including user manuals and repair guides, a Healthware user that has purchased a device has the ability to learn whether it can be repaired, modified, or customized safely by the user. In some instances, devices like prosthetics can be personalized and adapted for individual needs. Occasionally, Healthware can be created by actual repair needs, such as designing a 3D-printed replacement knob for medical equipment. [Example: MSF Oxygen Concentrator Knob]
Standardization
Community-built Open Healthware standards ensure that everyone applying for a Healthware certification is required to meet the same documentation and openness standards that commonly apply to non health-related open hardware.
Creates Prior Art
Open documentation helps establish prior art. This prior art will make it harder for the invention to be patented by someone else, and easier to challenge that patent if it is granted.
Open Licensing and Reproducibility
Open licensing allows resale, modification, redistribution. Because of open licensing, Open Healthware devices and designs can be a quickly-deployed solution during supply chain disruptions. With open licensing, derivatives or forks support robust customization and diversification. Hardware can be modified and personalized depending on a specific population. Upgrades and changes can be improved with community feedback. [Example: Open Flexure Microscope]
Transparency
By accessing open source files, the public can explore and innovate Healthware for themselves. In some cases, devices can be made in hackerlabs, in-home maker spaces, or small biomed labs because the files are open source. Because Healthware has a culture of transparent documentation, adverse event reporting can be more robust through data sharing, process improvement tracking, and quality assurance metrics attached to a Healthware device.
Advantages of Open Healthware
Open Healthware Community
The Open Healthware Community tends to attract humanitarian-centered designers and fabricators who seek to create more accessible, thoughtful, and equitable medical devices by helping people who have limited access to medical care.
Accessibility
Communities with limited access to medical devices can work with Open Healthware advocates to design, manufacture, or procure Healthware that fit their unique needs. [Example: Standing Wheelchair]
Customization and Innovation
Mass produced, closed source medical devices may not have the same level of customization options that Open Healthware does and if they do, will often come with a higher cost. Open sourcing the design process for prosthetics allows patient customization and adaption, especially important for pediatric users who need prosthetics that fit as their bodies grow. [Example: Team Unlimbited]
Challenges of Open Healthware
Separating Safety from Open-ness
The OSHWA Open Healthware certification only guarantees that a device is open source, not that the device is safe. Devices needing approval from a regulatory body (such as the United States FDA) will still need to go through those regulatory bodies for safety verification.
Building the Ecosystem
Users who would most benefit from Open Healthware have not been educated about Open Hardware or Healthware. OSHWA is working through 2026 to build the community and ecosystem.
Limited Regulatory Pathways
Some of the most impactful humanitarian Healthware designs can be made by one or two people via additive manufacturing in a non-industry setting. However, regulatory bodies currently have no pathway for validating distributed manufacturing by micro teams, especially for low-resource settings that may have no local regulatory authority to enforce international quality standards. Also, the financial cost for regulatory compliance is often prohibitive for community-based teams in low-resource settings, where the compliance requirements are often based on standards from well-resourced countries and not designed for low and middle-income countries.
Open Healthware FAQS
Q. What does an OSHWA certification guarantee?
A. Only that it’s open source and has the proper licensing to enable the source files to adhere to the Open Hardware definition.
Q. Isn’t there a good reason we have factories producing healthcare items?
A. Yes, and you should use ISO standard manufacturing facilities when the files state ISO is required. The intellectual property should not be a reason you don’t use standards and specifications when you should.
Q. Is this anti-regulatory or does it go against well established medical practices?
A. No! If you need a regulatory process, such as CE, MDEL or FDA, you should use that regulatory process, the intellectual property should not be a reason you don’t go through a regulatory body when you should. If the project was made in an ISO standard facility, you should use ISO standard manufacturing facilities when the files state ISO is required. The intellectual property should not be a reason you don’t use standards and specifications when you should.
Q. Is OSHWA making any claims about the safety of Open Healthware?
A. No, we are only ensuring the things we certify are open source with accessible source and proper licensing.
Q. If I want to help but am not a designer/maker, how can I get involved?
A. Join discord(s), slacks, LinkedIn discussions, or email us OpenHealthware@oshwa.org, we’d love to hear from you! Q. Does this mean anyone can change it and mess it up?
A. Yes! It also means that people could improve and make your project better. If you don’t want your project to change or don’t want to give your baby to someone else, you may not want to do Open Source Hardware.
Q. How do Open Source business models work?
A. When it comes to open hardware, business models are the same as closed source. There is an IP strategy to be used with open source, but you run your business the same way based on other business models such as service, C2C, B2B, etc
Q. How do I find Open Healthware projects?
A. Check out our certification list!
You can also find more projects under UBORA’s device list
or check out Field Ready’s Accessibility Retrofitting Kit
or look at Open Source Medical Supply’s repository
Q. How can I get people to hear about my device?
A. OSHWA’s Discord, Open Hardware Summit, Open Healthware Conference, Open Hardware Month Show and Tells, or Certification Round ups
Q. Why would someone share their hard work?
A. This changes depending on who you are and what you’re working on. A few benefits of Open Source include innovation, collaborating, and personalization. Designers have a variety of reasons from altruism to funding opportunities. Here’s a great video from our resident engineer Joey Castillo, he provides a wonderful presentation as to “why we do Open Source”
Q. What can be changed, what shouldn't be changed, where can I add value?
A. OSHWA is working on a contributor guide. Stay tuned!
Q. How does liability change if it’ s Open Healthware?
A. Making a product opens you up to various liabilities no matter if it’s open source or closed source. In the US, that we know of, distributing files in itself does not trigger strict product liability laws.
Q. Where can I find a job in Open Source Hardware?
A. Check out our discord channel!
Q. How do I get involved with other people’ s projects?
A. Typically you would go directly to the project page (not OSHWA) to get involved. However, OSHWA’s discord channels can help people find each other in our community.
Want to Explore More?
NIH’ s Good Samaritan Law interpretation
Liability of Good Samaritans in Medical Emergencies
Makers Unite Face Shield Resources
Open Source Medical Supplies FB Community
Open Source Community in Africa
Open Know-How / Open Know-Where
Open Healthware Best Practices Reproducing, Best Practices for Designing Coming Soon!
OSHWA’ s Guide to How T o Contribute to an Existing Project Coming Soon!
Open Hardware Ecosystem NGOs and Non-Profits
Academic Journals in Open Source Hardware
HardwareX Journal of Open Hardware Journal of Open Engineering
Documentation Repositories
Materiom Kitspace.org NIH 3D Print Exchange Open Know-How
Funding Organizations
Alfred P . Sloan Foundation Gordon and Betty Moore Foundation NSF POSE
Community Organizations
BeagleBoard.org e-NABLE Open Hardware Makers Open Research Institute OpenAir Collective Open Ecology Open Compute Project RepRap.org Wildlabs.net
Bio, Medical, and Emergency Response
Field Ready Global Community Bio Summit Open Source Medical Supplies Safecast
Standards Organizations
DIN IEEE SA OpenForum Europe
Think Tanks and Research Centers
Engelberg Center on Innovation Law & Policy, NYU Law Public Knowledge Federation of American Scientists
Open Hardware in Science
AfricaOSH CERN GOSH reGOSH Open Ephys Public Lab
Citations
Chris’ s OSHWA Media Style Guide
Open Source Hardware Definition
World Health Organization - Medical Devices
Merriam Webster Repository Definition
Wikipedia Repository Definition
Wikipedia Distributed Manufacturing Definition
MIT Press Direct, Democratizing Innovation
Britannica Regulatory Agency Definition
Merriam Webster License Definition
World Health Organization Definition for Emergency Response
The Glia Stethoscope Project Introduction