Frequently Asked Questions
60 Minutes featured the astonishing work being done with MRI and focused ultrasound to treat both neuro-degenerative disease and severe addiction. Watch the video linked here: https://cbsnews.com/video/neurosurgeon-alzheimers-addiction-research-60-minutes-video-2024-01-14/
It's this work, +1M other papers in the field that drove the founding of Openwater and now our move to fully open-source our work at Openwater this month. We have low-cost focused ultrasound and blood/oxygen flow detection units coming on line now and could enable access for these procedures to all including the possibility of at-home treatments in the near-future.
Free as in Speech, Not Free as in Beer
At the JP Morgan Healthcare conference this week in San Francisco I got lots of questions from the investment community regarding our business model at Openwater and announced here on January 4. I took the initiative to compile these questions and share my responses below with everyone.
Our goal : A single device to treat, monitor and diagnose hundreds of diseases that can be made in the factories that make our consumer electronics like phones, laptops, monitors and projectors. Open sourced. Trusted. Innovating at the speed of Moore’s Law not multi-decade speed and multi-billion dollar investment typical for medical innovation. While our R&D is free and open to all - we make money selling our hardware and services. Our focus is not on making a million dollars per treatment (as is increasingly becoming the norm for healthcare) but on treating millions of people quickly. We make it up on volume. Charge a smaller amount of profit per unit, use the same unit with differentiated software to treat many diseases and save millions of lives faster.
The old adage for open source went “Free as in speech, not free as in beer”. In our analogy we make the recipe for the beer freely available but still sell the beer for those who prefer not to make it themselves. Additionally we guarantee the quality of the beer through our manufacturing process. By making it at scale at the research and development stage (prior to FDA approval) we can offer the beer to enable concurrent, cost-effective trials without the burden of expensive product development costs for our customers.
Trial costs may be substantially reduced by sharing safety data across all trials done using our platforms. Our customers fund the trials and take ownership of the regulatory approvals, not us, and may need fewer patients per trial (less cost) because of the shared safety data. We provide them with platform, hardware, software, and quality management support, among other services.
Even patient groups could fund trials. How? They can persuade their preferred doctors to enroll say 20 patients (including themselves at no cost), purchase our hardware, and raise funds to hire someone to shepherd it through IRB processes and oversee the trial with the doctor. This approach can be remarkably cost-effective, and for certain rare diseases, even with just 20 patients FDA approval has been achieved: link. The sharing of safety and adverse event data across trials - even for different diseases - reduces the number of required patients for each trial, significantly lowering trial costs initially and promising even greater reductions (10-100x) as safety data accumulates and becomes accessible to all.
Open source companies have generated billions of dollars while providing the trusted infrastructure for the internet, smart phones, web services, etc. We believe we can replicate this success in healthcare. By allowing everyone to scrutinize (and improve) the software, hardware designs, and data line by line, we can expedite progress and scale solutions across hundreds of diseases. As the volume of production increases, costs decrease exponentially—every 10x increase in production roughly corresponds to a 10x decrease in costs. Thus, a semiconductor-based platform with adaptable software for each disease and treatment could yield million-fold cost savings per treatment, spread across numerous diseases using the same hardware/software platform. Additionally, this platform introduces the potential for significant advancements in the treatment of common and rare diseases alike as shown already in our clinical feasibility results for treatment of diseases like Glioblastoma, Severe Depression and Large Vessel Occlusion Stroke.
Our approach is less risky than traditional business models for medical device development. It allows for numerous opportunities, utilizing the same hardware/software platform for treating multiple diseases and eliminating single points of failure that often thwart diagnostic or therapeutic development—either in the laboratory or during clinical trials. Many companies have faltered due to failed stage 3 trials, and countless others have perished prematurely because they couldn't amass the vast sums required for large-scale trials. Why not separate clinical trials from hardware/software platform development to reduce costs for a company and further reduce trial costs by extensively sharing adverse event and safety data across trials using our platform?
A silicon / software platform has the potential to disrupt healthcare, just as it has disrupted nearly every other industry over the past 30 years. An open-source platform can achieve this disruption both faster and cheaper. It's in reach to establish a multi-billion dollar business by selling the hardware systems and services, much like Red Hat has with its open-source business model. The concept of a healthcare R&D company focused on saving more lives more rapidly for less money should not be a novelty, yet regrettably, it is.
The journey from research to approval for medical devices often spans decades and frequently fails to achieve platform status, resulting in continued high costs upon regulatory approval for a narrow range of diseases.
Instead we are creating an open-source platform with the potential to treat all aggressive cancers. With a simple software change, we may be able treat any mental disease. Change the software once more for other potential applications like stem cell stimulation, senescent cell rejuvenation, high fidelity blood flow detection including oxy/deoxy, pathogen deactivation, immune priming, and more - all may be achieved non-invasively at a unit cost similar to that of a smartphone at scale where each unit can treat thousands of people.
Currently, we are collaborating with other companies by providing them with our Early Access Systems for their clinical studies and trials. These systems called Open-Lifu 2.0 and Open-Motion 3.0 can be ordered here for R&D efforts. (links here and here)
Please join us!
See founder’s letter: here
No. We believe our corporate structure makes that impossible. Our past, present, and future software is now AGPL licensed. Our hardware and other data are open via Creative Commons 4.0 Share-alike. All our patents are available via our Patent Pledge. These are enduring rights.
AI giants are creating confusion about open source. For some of them, having their models partially open is a gambit to help secure widespread support of their very expensive projects. That’s not at all what we’re trying to do.
In contrast we are working in healthcare where therapeutic development often takes 20 years and $2.6B to develop a new drug and the cost per person can be a few million dollars for treatment. Access to good healthcare remains only for the very rich. We can change that by creating a pan-disease therapeutic technology suite open to and available for all.
Because we can. It’s a shame that it is almost unheard of to do so. We are trying to do the right thing. Seeing FDA responses helps everyone get better at addressing concerns they raise and responses from the companies that raise concerns about the FDA. This will also be true for other regulatory bodies.
Although we use infrared light and ultrasound at known safe levels as shown on billions of people (link); we have not yet received marketing authorization from FDA or any other regulatory agency. We are not FDA- or regulatory-approved yet in any country. Our early access systems can be used by a research organization for clinical trials or other research.
The best way to do this now is to find a doctor/clinic interested in doing a clinical trial or feasibility study. They need to have an IRB which can review the plan for testing, and the safety of our devices, and the plan to assure patient privacy and security of data. We have worked with many IRBs to do this. Then patients need to be recruited, usually beyond just your loved one.
A single device to treat, monitor and diagnose hundreds of diseases that can be made in the factories that make our consumer electronics, with ISO 13485 quality. With shared safety data across clinical trials the number of patients required (and thus the cost of the trial) could also go down by 10x. This in contrast to drug development where it’s become typical for new drugs for a rare disease to cost over a million dollars a dose.
Even an aspirin can cause a safety issue from time to time. We want to know anything that can go wrong for humans with any disease using our devices. But yes, we are using low levels of infrared light and low strength ultrasound shown to be safe on billions of humans (link here). Still we need to assure safety, and the regulatory agencies require the data. Since we are collecting it anyway, why not pool it and make outcomes even safer, even faster?
Yes just email us at community@openwater.health
Check out our job ads. We are hiring. www.openwater.health/jobs
We haven’t done many internships but are considering it. We need people with certain skills to help us build the future. The best place to look is www.openwater.health/jobs
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.