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.
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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.
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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
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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:
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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.
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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.
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Note: this is a hypothesis based on the above data we seek feedback from all to refine and improve our estimates.