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
$658M
Avg. capitalized cost to FDA approval of a novel therapeutic medical device is $658M and more than 13 years
DOI: 10.1001/jamanetworkopen.2022.31609
85%
of cost is in device development
$10M
Estimated FDA in-all De Novo approval costs w/ our Open-source Safety-data-shared devices in sub-3 years. (see below for logic on this hypothesis)
Advancing Healthcare through Open-source and Safety Data Sharing in Medical Device Development
Openwater is enabling collaboration via open source development and sharing of safety data to reduce cost and speed rapid development and regulatory approval of new technologies. We have made all of our research, patents, architectures, design and software open-source.
Why we’re doing this: The landscape of medical device development is a tough one: each developer has to create their own hardware and software and manufacturing supply chain and then this typically goes to just one medical indication.
We see a different approach: manufacturers, developers, and researchers stand to gain substantial benefits from the proactive sharing of architectures and safety data, while achieving higher production volume with our approach should enable us to make high quality semiconductor components for use by all. This collaborative approach both fosters a culture of transparency and innovation and points toward advantages in regulatory compliance, cost savings, and the ability to leverage safety data across multiple clinical trials.
How: Our business model may speeds regulatory approvals in addition to consumer electronics pricing at speed. Today's average novel therapeutic device capitalized cost is 13 years and $658M in 2024 dollars. This from a comprehensive study of all novel therapeutic devices to achieve FDA approval over the last 30 years detailed in the table below. 85% of that $658M is in the device development labeled "Non-clinical: device development" in this table
The remaining 15% of the average capitalized cost of an FDA approved novel therapeutic medical devices is in acquisition of safety and efficacy data. On average 607 patients are needed for trials that that span 8.6 years. We may have a major opportunity to massively reduce the number of patients and the elapsed time needed:
1) The average number of patients estimated for therapeutic ultrasound clinical approval is 50-150 patients this reduces cost for trials not just in numbers of patients needed, but also in the elapsed time and their associated capitalized costs . For example:
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Trials leading to the FDA approval of treatment of essential tremor in 2016 involved 76 patients
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Sonoblate's FDA approval for prostrate cancer treatment was based on clinical data from 117 patients in a multicenter trials. Further discussion here
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ExAblate acheived FDA approved for the non-invasive treatment of uterine fibroids. The approval was supported by a pivotal study involving 109 patients, and later FDA approval for the palliation of pain in patients with bone metastases via a pivotal trials of 148 patients
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Exogen achieved FDA approval for the treatment of non-union bone fractures in clinical trials involving 74 patients.
2) Shared safety data pan-disease (like pan-cancer or pan-mental disease): the literature suggests a further 30-40% reduction in needed patients and the equivalent reduction in elapsed time required (and thus in capitalized costs). Several studies make these estimates. As exampled we cite 4 below.
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FDA Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry (2019)
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Berry, S.M., Carlin, B.P., Lee, J.J., & Muller, P. (2010) – Bayesian Adaptive Methods for Clinical Trials
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Clin Cancer Res (2020) 26 (17): 4511–4520 "A Pan-cancer Clinical Study of Personalized Neoantigen Vaccine Monotherapy in Treating Patients with Various Types of Advanced Solid Tumors" by C Yong Fang et. al
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Cancer Discov. 2021 Apr; 11(4): 822–837. "The Future of Clinical Trial Design in Oncology"
Conservative summary of these estimates below:
Our open-source and reconfigurability is fundamental to our business model. Our highly reconfigurable platform has life-saving potential to deliver therapies for cancers, mental diseases, cardiovascular diseases and much more sharing across a sub-field of diseases to accelerate approvals - via the same Openwater open-source platform.
This approach may massively lower the cost and time of development for each therapy. Our goal: save more lives more quickly - regulatory approvals with sub-$10M spending and sub-3 year timelines by our customers using our platform.
Note: this is a hypothesis based on the above data we seek feedback from all to refine and improve our estimates.
Key Advantages
The benefits of open-source and collaborative safety data sharing in medical component 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. 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 to much to develop new medical devices from scratch. The highest costs in new medical device development are in novel therapeutics.
Our platform approach cuts costs for all; minimizing redundancies in component and system design, manufacturing oversight, safety testing, and data collection.
The outcome: important savings in research, development and deployment, modifications and even recalls. The broader our platform’s adoption, the better 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 components.
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, medical components intended exclusively for research purposes. Openwater acknowledges that, as of January, 2024 the device has not undergone review and clearance or approval by the U.S. Food and Drug Administration (FDA) for commercial distribution and use.
Important Safety Information
Research-Only Purpose
The components discussed on this site are exclusively intended for research purposes and are not cleared or approved by the FDA for clinical use or commercial distribution. It is solely available to researchers and research institutions.
Lack of FDA Review
The safety and effectiveness of these components have not been establishedthrough the FDA's formal review process. Researchers should be aware that the component has not undergone the regulatory scrutiny required for general medical use.
Risk Awareness
The potential risks associated with these components are not fully known.Researchers and research institutions are advised to exercise caution and fully inform allinvolved parties about the investigational nature of the component and the uncertaintiessurrounding its safety and efficacy.
Informed Consent
Researchers using these components 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 components 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 components.
Restricted Use
These components 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 component. 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 acknowledges that, as of January, 2024 the device has not undergone review and clearance or approval by the U.S. Food and Drug Administration (FDA) for commercial distribution and use.