Summary:
OSHWA is hosting a number of strategy and visioning sessions to collect community responses from open hardware health device creators and medical stakeholders. Participants of our initial sessions passionately agreed open hardware has a place in the healthcare field. To empower progress in open hardware health devices, or “open healthware”, the participants create the following goals:
A certification or framework to bolster open standards and guides for what it means in health hardware.
An open health community and stakeholders bridging silos and collaborating to create a common ground and maximize agency.
Standards that honor how are we the same, how are we different, so that we can create ubiquitous norms and practices inclusive of documentation, publication, production, certification, and governance structures.
Exploring values geographically in order to create a robust ecosystem.
OSHWA is driven to co-create in the ecosystem processes, to be part of our sessions, please fill out this brief survey.
Open Healthware Initial Strategy Sessions
OSHWA was awarded a 2-year National Science Foundation (NSF) POSE grant to foster an Open Healthware Ecosystem. The grant for the Open Healthware Ecosystem will include a framework at the intersections between health hardware and open source hardware principles, while building on many years of Open Source Hardware research . Empowering the open health hardware community to disseminate their open hardware and create standards is core to our work, and community perspectives are key to moving the medical industry towards an open hardware future.
OSHWA is hosting a number of strategy and visioning sessions and simultaneously collecting community responses through interviews, meetings and conferences from OSH creators and medical stakeholders. During each meeting notes are anonymized and respected for privacy but summaries will be posted for transparency and inclusion.
We were overjoyed with the response of our first virtual strategy sessions, we thank our participants immensely. The response was deeply gratifying, our meetings were filled beyond capacity in the first 24 hours. We appreciate each participant’s trust in and willingness to work with the OSHWA community to envision and plan for what a vibrant Healthware might be.
The following learnings and takeaways were co-generated with participants in our initial strategy sessions. We’ve summarized of our learnings and reflections after hosting the initial strategy sessions, speaking with a number of advisors and allies, and sorting through our collected notes. When we speak of ‘we’ below, we are talking about everyone who’s engaged with us in our conversations.
There is an Emerging Vision for Open Healthware
There was palpable excitement and passion for combining open hardware and health hardware in collaboration with a bright and motivated global community. The community was enthused to advance a co-created vision for open-source medical technologies by prioritizing access to source, affordability, and transparency. Through collaborative design and improved interoperability, we seek to streamline replicability, maintenance, and adoption. By reducing access barriers for students and non-medical staff, promoting shared tools and terminology, and eliminating proprietary restrictions, we can enhance education, innovation, and reproducibility. Freely available blueprints and infrastructure will support self-sufficiency in underserved areas, while advocacy for regulatory education around open source will help ensure options to traditional healthcare solutions.
Steps Toward a Broad Adoption of Open Healthware
We have work to do on the WHO, WHERE and HOW of standardizing open hardware within health hardware. Along with the health hardware community, OSHWA will champion the development and adoption of open health hardware, or “open healthware” by prioritizing accessibility, replicability, and transparency in open-source medical technologies. Our participants tasked OSHWA with fostering collaboration, interoperability, and usability while reducing barriers to education, innovation, and standardization. To support widespread adoption, participants agreed open hardware certification needed assistance from regulatory, technical, and institutional factors, demonstrating clinical validity through research, and engaging key institutions for support and credibility. By creating openly available resources, we will promote replicability, and access to healthcare solutions.
Creating Possibilities in Open Healthware Today and the Future
In a world with open healthware, medical devices could be easier to access, fix, and produce. OSHWA recognizes the critical limitations in the availability and adoption of open-source medical hardware, particularly in lack of awareness of open source, high costs of existing health regulations, import barriers, and proprietary systems which hinder access and innovation. To address these challenges, we are committed to advancing open healthware by promoting local production, transparency, and reproducibility standards. We will work to foster shared standards with our community around documentation, source files and data. Participants agreed a platform for collaboration, skill-sharing, and universal training is desired to extend device lifespans, improve responsiveness during emergencies, and empower healthcare systems to serve vulnerable populations in global health. Though this type of platform is outside of OSHWA’s current boundaries, we look forward to working with groups who have similar goals.
Building Collective Standards, Certification, and Guidelines
Hearing from a number of roles in health and medical hardware, there is a challenge in creating standards that can be ubiquitous for everyone, but also an opportunity to connect with the various threads of the healthcare fabric and understand how OSHWA can be most useful. Thoughtful standards and guidelines can make open healthware more understandable, replicable, and fair. There are differences in standardizations depending on the complexity of the hardware, the affiliation or institution of the inventors, or where on the globe the hardware is utilized.
Certification came up as a way of capturing the standards a device adheres to and showing validation of the source specific to open healthware that is more complex than OSHWA’s current certification model. A preference bubbled up for an international governance group to verify the certification so that the certification was beholden to no one government, while also being flexible enough to fit within various government structures and their own standards for medical devices. OSHWA is prepared to take on the role of certification for the source of open healthware, and utilize an international governance group with the help of community experts for standard verification and validation.
Modeling the Adoption of Open Medical Hardware
Many participants agreed that lagging adoption in health and medical hardware creates an education opportunity about open source as a vital part of the ecosystem. OSHWA is are committed to building replicability testing documentation, legal frameworks for licensing hardware and liability guidelines and potentially regulatory templates for open healthware to ensure continuous usability and credibility. By advocating for industry-wide standards and post-market surveillance, our community believes we can enhance public confidence. We will also work to counter biased narratives by highlighting the current hardware and it’s proven reliability, security, and effectiveness of open healthware. This effort requires a global culture shift, one that embraces transparency, accountability, and collaboration to realize the full potential of open-source innovation in healthcare. To scale the adoption of open healthware, together, we can address key regulatory, legal, and sustainability challenges that hinder trust and long-term impact.
Including our Key Stakeholders
OSHWA can’t do this work without our community. Key stakeholders include creators and users of open hardware in the medical space. Participants identified makers, DIYbio groups, academics, researchers, and medical staff already aware of open hardware as subgroups of stakeholders to build standards for a larger ecosystem. Participants discussed the adoption and impact of open healthware which requires active engagement with a wide range of stakeholders who hold influence across regulatory, institutional, and commercial domains. These include international and regional regulatory bodies (such as ISO), national agencies (like the FDA or Health Canada), and local oversight organizations that shape compliance and standards.
Healthcare practitioners and institutions including clinicians, hospitals, and patient associations play a critical role in validating and implementing open healthware in practice. Additionally, it was noted, industry players such as pharmaceutical companies, medical device manufacturers, and tech corporations hold considerable power over market dynamics and technological development. Fostering cross-sector collaboration with these groups to ensure that open healthware is not only developed responsibly but also widely accepted, integrated, and scaled across healthcare systems is paramount.
Communal Success indicators of open healthware
There was heartfelt and eager discussions around driving the success of open healthware, and how to measure success. People thought OSHWA should focus on key indicators such as the adoption and integration of open-source medical devices first into research and emergency use, and in the future into healthcare systems, including clinical and use, including open hardware with FDA approval, to show open intellectual property can achieve regulatory rigor.
We aim to leverage the growth of credible open healthware companies producing quality-tested, reliable devices that enhance usability across diverse contexts and push them to use our certification system. Success will also be reflected through the publication of impactful, peer-reviewed research utilizing open-source health technologies.
A major milestone will be the establishment of improved standards and certification pathways, widely recognized by standardization bodies, regulatory agencies, and governments, and a certification platform would give our community a metric for open hardware designs. Thoughtful responses were gathered on increasing acceptability of open healthware, participants mulled that it will unlock greater funding opportunities and build a vibrant expert community to further advance, validate, and refine open healthware solutions.
Plans to create a road map for open healthware
There was broad acknowledgement for the usefulness of a roadmap for growing open healthware. OSHWA is committed to creating a clear and actionable roadmap for reproducibility tests, standards and certification of the source. This includes clarifying pathways by defining a healthware certification, risk classifications and outlining design documentation, risk analysis of open healthware, and how quality management systems relate in the context of open source. Understanding how a certification process fits into FDA equivalency (510K) for existing devices, will further accelerate adoption. An interesting idea to ensure sustained progress by supporting the formation of public organizational structures gained momentum. It was thought a dedicated public nonprofit could guide open healthware through commercialization.
We’re addressing and overcoming barriers and threats to open medical hardware
One of the biggest threats echoed by members of our community related to replication, a key benefit of open hardware. Addressing issues of replicability, validation, and verification is thought to be a mechanism key to gaining trust in open healthware. Local cultural acceptance came to light, particularly in regions where fraud and counterfeiting are prevalent and will be a key barrier to overcome and important partnerships to grow for our ecosystem. Validation will be strengthened through dedicated funding for replication and testing, the development of local third-party certification networks, and the implementation of replicability guidelines. Participants brain stormed ways a trust-scoring system could further ensure the reliability and quality of open-source devices.
Developing an engagement strategy for medical hardware ecosystem stakeholders
As a final priority, participants wanted assurance that open healthware is not only innovative and accessible, but also trusted, validated, and replicable across diverse contexts. By supporting our community’s intention to share, a transparent validation processes, and international oversight, we aim to build a resilient ecosystem that mitigates risks of open hardware meaning different things in different places, and leverages common goals for transparency, completeness of source, and wide reproduction of devices. These efforts will help foster long-term adoption, especially in regions where trust, infrastructure, and regulatory reliability may be limited.
