Accelerating Clinical Innovation With Open-Source Medical Platforms

By Aaron Timm, CEO, Openwater

Healthcare has long relied on a closed model of innovation. Companies spend years developing a single drug or device, guarded by patents and advanced through siloed pipelines. Breakthroughs happen, but slowly, and access is limited to those with the resources to fund them.

Open source flipped that model in technology, with projects like Linux, Android, and Kubernetes. That same shift is beginning in healthcare. A growing set of innovators is publishing hardware designs and software openly, giving researchers and developers the freedom to adapt and extend medical technology for new clinical challenges.

For healthcare, open source can reduce the cost of technology and extend its reach to more hospitals, researchers, and patients. Devices that once required multimillion-dollar machines can now be built at a fraction of the cost and size, opening the door for broader participation in trials, faster iteration, and a more collaborative path to discovery.

What Open Source Means In Medtech

Open source in medical technology means that all essential design documents, such as blueprints, schematics, code, build instructions, and supporting documentation, are publicly available. Anyone can use, modify, improve, and distribute these resources, provided future adaptations maintain the same open license. This is a significant shift from the traditional approach, where companies protect their intellectual property and patents.

The open-source ecosystem now spans both software and hardware in healthcare. Hospitals, universities, and startups are able to build, adapt, and deploy devices without the limits or costs found in vendor-controlled systems. When technical designs are shared publicly, clinicians and researchers worldwide can more easily solve problems, suggest improvements, and report how they use these devices in real-world settings.

This approach means updates, bug fixes, and entirely new features can be contributed by a global network rather than a single supplier. As a result, medical technology evolves more quickly, better fits local needs, and becomes more accessible to a broader set of users.

Evidence From Other Industries

Open source has already shown its power in global technology markets. Research shows that nearly 70 percent of European organizations believe that open source adoption improves their competitive position and drives innovation, while 75 percent see quality gains. Well-known projects, such as Linux, Android, and Kubernetes, began as small collaborations and now serve as the foundations of computing and internet infrastructure worldwide.

Open-source methods are now coming to medicine, bringing global participation and broad access. By publishing not only software code but also device designs and operational workflows, these efforts allow more clinics and care teams to create, adapt, and deploy new health tools. This helps address local health challenges, saves time, and reduces costs.

The Value In Medicine

The value of open source in medicine is increasingly clear. A growing body of evidence, including a 2022 review, shows open hardware can expand access to lifesaving care, especially for respiratory diseases, which remain leading causes of death worldwide. Many patients in low- and middle-income settings cannot afford commercial devices for diagnosis or treatment, but open-source tools like flow meters, noninvasive ventilators, and infant CPAP machines are available at a fraction of commercial prices.

Analyses of 10 open source device projects, ranging from pulse oximeters and infusion pumps to prosthetic arms, reveal open-source models consistently lower costs, speed up development, and enable wider access, sometimes reducing price tags by 80 percent to 95 percent. For instance, a recent study showed that researchers openly sharing MRI system designs allowed smaller hospitals and universities to deploy working units for far less than the multimillion-dollar cost of traditional equipment.

In real-world clinical use, open-source platforms such as myoelectric prosthetics, syringe pumps, e-Health sensor kits, and OpenBCI have achieved global adoption. These devices put highly functional tools in the hands of clinics and labs for a fraction of the historic cost, supporting both resource-limited and advanced research settings.

Yet open-source device innovators must also navigate strict regulatory demands and address liability and reliability concerns. Community collaboration now extends to shared testing protocols, open validation data, and transparent documentation, making regulatory approval and safe clinical adoption more attainable.

In recent years, the Open Source Hardware Association (OSHWA) has expanded its mission to healthcare by launching the open healthware initiative, supported by the National Science Foundation. This program develops open certification standards for medical hardware and brings together engineers, clinicians, and regulators at forums like the 2025 Open Healthware Conference. OSHWA certifies devices for community transparency and technical documentation, leaving regulatory oversight to official authorities. Global groups like Glia and Field Ready participate, and dozens of devices have already earned certification. Through these efforts, OSHWA and open healthware are making medical innovation more accessible, collaborative, and standards-driven for creators and patients.

By combining dramatic cost savings, flexible designs, and open collaboration, open-source medical platforms are accelerating the pace of innovation and expanding access to advanced healthcare solutions across the world.

Open Source And Clinical Trials

Regulators are testing the model, too. The FDA released its MyStudies platform as open source, giving researchers code they can adapt to build secure mobile apps for collecting real-world clinical trial data. Instead of writing software from scratch, institutions can customize the platform, cutting development time and improving data quality.

Researchers are using open tools to widen access to trials. In low-resource settings, researchers piloted a modular mobile platform that showed it was feasible to collect clinical trial data where traditional infrastructure was lacking. In Europe, the SIMCor project built an open-source web application to validate virtual patient cohorts and run computer-simulated trials.

Several medical hardware projects already publish their designs. Glia shares open schematics for stethoscopes and pulse oximeters. The OpenFlexure project has released a 3D-printed microscope that labs can build and adapt. E-NABLE distributes blueprints for prosthetic hands that volunteers can print and deliver.

Openwater has published its hardware and software designs on GitHub, where researchers are using the technology in trials on depression, stroke, and other neurological conditions. Making those designs public opens the door for other teams to explore new therapeutic targets or adapt the systems for their own studies.

What Tech Leaders Should Take Away

The real advantage for tech leaders is recognizing open source as a strategy to expand influence and move entire industries forward. In healthcare, it lowers costs, expands access, and accelerates discovery in ways that closed models cannot match. This model has been used to great effect by the Allen Institute, by bringing open-source access to neuroscience research.

The same dynamics that reshaped computing and basic research are now beginning to reshape medicine. Those who contribute to open platforms can set standards and build ecosystems where progress doesn’t depend on a single company.

About The Author:

Aaron Timm, CEO of Openwater, has held executive leadership roles at digital health, medical device, and medical imaging companies. He has led all aspects of commercial strategy, corporate development, and business operations to scale start-ups into high-growth, multinational companies. Aaron has experience navigating regulatory compliance, patent law and product-scale supply chain. In addition to chief executive roles at Synarc and WorldCare Clinical, Aaron has served as general counsel of both private and publicly traded companies. Aaron earned degrees from Georgetown University and Harvard Law School and is a member of the State Bar of California.