Open-Source Medical Device Platform Aims to Accelerate Time to Market

By Bio-IT World Staff

August 14, 2025 | San Francisco biotech Openwater is pioneering a multi-purpose platform approach to medical device development, combining infrared light and low-intensity focused ultrasound technologies to create what CEO Aaron Timm describes as the "smartphone" of medical devices. 

Nearly a decade in development, Openwater's platform centers on two foundational devices: Open-Motion for blood monitoring and diagnosis, and Open-LIFU for therapeutic applications using low-energy sound waves. Neither device has FDA approval yet, but both are showing promising results across multiple therapeutic areas including oncology, stroke care, mental health, and long COVID treatment. 

Platform Strategy Disrupts Traditional Development 

The company's open-source approach represents a significant departure from traditional medical device development. By licensing intellectual property under Affero General Public License and hardware under Creative Commons, Openwater enables researchers and companies to build upon existing safety data and validated technology frameworks rather than starting from scratch. 

This platform model offers several advantages: investigators gain access to shared safety datasets that accelerate research validation, investors face reduced risk with faster returns, and regulators benefit from real-time data transparency. The approach also enables parallel data collection across multiple trials, addressing the FDA's primary concern of patient safety. 

Early results demonstrate the platform's versatility. Open-LIFU has successfully broken up glioblastoma tumors in preclinical mouse studies and showed significant efficacy in treating treatment-resistant depression in clinical trials. Recent research has explored its potential for breaking up amyloid microclots linked to long COVID. 

Open-Motion has proven particularly effective in stroke diagnosis, using infrared light to detect large vessel occlusions that cause acute ischemic stroke. Clinical trials show superior precision and accuracy compared to traditional diagnostic methods, with FDA approval potentially just a couple of years away for this application. 

Manufacturing Innovation Drives Down Costs 

Openwater has dramatically miniaturized its technology, evolving from room-sized equipment to portable console-and-wearable systems comparable to gaming devices. The company leverages consumer electronics manufacturing processes to drive down costs, targeting a sub-$1,000 price point within several years. 

Academic collaborators including University of Arizona, University of Pennsylvania, Brown University, University of Birmingham, and MIT are currently testing the latest portable, modular versions in basic research and clinical trials. The company envisions creating a "Silicon Hospital"—a future where hospital-grade medical care becomes non-invasively available globally through its platform technology. 

For the complete story on Openwater's platform technology and its potential to transform medical device development, read the full article at Diagnostics World News.