Open Source, Always
Growing a movement: We’re here to save lives. It’s why we’re open source: the more people that have access to this technology, the more partners who join with us, the faster we can innovate, and the more lives we’ll save.
By Open Source we mean specifically:
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AGPL licenses for all our software: github link
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Creative Commons - ShareAlike 4.0 for all of our hardware always: github link
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Our Patent Pledge includes unfettered complete use of our 68 current patents and any and all future ones
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Plus - open access to a trove of design decisions, lab recipes, FDA + clinical data, safety data from our devices and more. github link
This openness empowers researchers, academics, and innovators with the tools and information needed to advance medical science and help the regulators to massively lower the cost and time to regulatory approvals and for treatment costs.
Fast & Low Cost Clinical Approvals in Reach
Our Founder, Dr. Mary Lou Jepsen explains the huge opportunity for open source business models in healthcare on a January 2025 broadcast from Modern Healthspan.
$658M
Avg. capitalized cost to FDA approval of a PMA novel therapeutic medical device is $658M and more than 13 years
DOI: 10.1001/jamanetworkopen.2022.31609
85%
of cost is in device development, additional savings in pan-disease trials
$5M
Hypothesized FDA in-all PMA approval costs w/ our Open-source Safety-data-shared devices in 2.5 years.
(our hypothesis here)
Key Advantages
The benefits of open-source and collaborative safety data sharing in medical platform development extend far beyond individual companies or researchers. By fostering an environment of openness, transparency, and shared learning, stakeholders collectively contribute to advancing healthcare, ensuring patient safety, and driving innovation in the dynamic field of medical device development exponentially faster and cheaper. Our devices for sale now for R&D use are already 10-100x lower in cost than anything comparable. Join us in leading innovation. For more information contact community@openwater.cc
Enhanced Regulatory Compliance
The problem of getting complex new systems through regulatory acceptance is severe.
Our approach: sharing architectures, designs and safety data facilitates for all a more thorough understanding of the safety basis of many medical devices being developed.
The outcome: regulators get consistent data for many platforms; developers’ work is eased; interactions between developers and regulators become more collaborative; approvals become faster; devices get to market.
Cost Savings and Resource Optimization
The problem: it costs too much to develop new platforms which may become medical devices from scratch.
Our platform approach cuts costs for all; minimizing redundancies in component and system design, manufacturing oversight, safety testing, and data collection.
The outcome: Potential important savings in research, development and deployment, modifications and even recalls. The broader our platform’s adoption, the better potential the cost and size reductions for all in trials and use.
Accelerated Innovation and Time-to-Market
The problem - device development is slow and expensive and hard to achieve market ROI when each device addresses one narrow set of indications.
Our approach: each new generation of our platform will have more powerful components and software, enabling more uses. Just like a smartphone.
The outcome: This means new indications can be added without the cost and time of platform design - rather like a phone app. Faster to invent and faster to prove and faster to deploy.
Improved Patient Safety
The Problem: not enough safety data, not shared
Our approach: Collaboration in safety data sharing promotes a proactive approach to identifying and mitigating potential risks associated with medical platforms.
The outcome: By collectively addressing safety concerns, developers contribute to a safer healthcare ecosystem, ensuring that patients receive the most reliable and effective medical technologies available. Thus driving cost out of healthcare.
Optimized Clinical Trial Design
The problem - device trials using different designs, that migrate in uncoordinated ways.
Our approach means a broadly-used platform has system quality manufacture data made open, rigorous and widely understood.
The outcome: Safety and efficacy results from one trial can be easily and rapidly shared and compared with those of other trials. Methodologies will accelerate as researchers see the basic platform technology as a solved problem.
Facilitation of Post-Market Surveillance
The problem is inconsistent data between uses, regions, indications, devices, and so on.
Our approach: explicitly open-source, enabling open data collaboration and data-sharing.
The outcome: This benefits regulators with faster and more specific actions; it enables researchers and clinicians whose confidence in the breadth of safety and efficacy information is essential, and benefits patients.
How to Participate in Safety Sharing
Safety Disclosure
This notification serves as a safety disclosure for the our Open-LIFU and Open-Motion, platforms intended exclusively for research purposes. Openwater's platform has not received FDA clearance or approval for commercial distribution.
Important Safety Information
Research-Only Purpose
The platform discussed on this site is exclusively intended for research purposes and is not cleared or approved by the FDA for clinical use or commercial distribution. It is solely available to researchers and research institutions who are able to customize to address the specific disease state they wish to study.
Lack of FDA Review
The safety and effectiveness of this platform has not been established through the FDA's formal review process. Researchers should be aware that the platform has not undergone the regulatory scrutiny required for general medical use.
Risk Awareness
The potential risks associated with this platform are not fully known. Researchers and research institutions are advised to exercise caution and fully inform all involved parties about the investigational nature of the platform and the uncertainties surrounding its safety and efficacy.
Informed Consent
Researchers using these platforms are responsible for obtaining informed consent from participants, clearly communicating the experimental nature of the device and any potential risks associated with its use.
Monitoring and Reporting
Researchers are urged to closely monitor the use of these platforms during research activities and promptly report any adverse events or unexpected side effects to Openwater safety@openwater.cc. This information is crucial for ongoing evaluation and refinement of these platformss.
Restricted Use
These platforms should be confined to research settings and not used in clinical practice or commercial applications. Their use should be limited to researchers and research
institutions with the expertise to manage and monitor the investigational nature of the platform. For inquiries or additional information, please contact safety@openwater.cc
This notification serves as a safety disclosure for our Open-LIFU and Open-Motion systems intended exclusively for research purposes. Openwater's platform has not received FDA clearance or approval for commercial distribution.