P74: v-Patients: Using AI and Simulations to perform virtual clinical trials in the web-browser

Abstract

Background: Demand for new and more effective medical devices is increasing. At the same time, development costs are rising in terms of time to market and profitability. The introduction of technology-enabled device testing alternatives addresses these issues by refining and ultimately eliminating the need for animal and human testing, while making the process cost-effective, fast and safe. A transition strongly supported by the FDA. Methods: Virtonomy has created the first digital twin cloud-based technology v-Patients that enables medical device manufacturers to perform virtual testing in the web-browser by simulating the device in their target population based on real-world evidence data of humans and animals. Combining deep learning, statistical analytics, high-performance computing and simulation, this approach progressively replaces pre-clinical and clinical evidence with digital evidence throughout the whole development lifecycle, making it less expensive and more resource efficient. Results: v-Patients was already successfully applied during the design and approval process of novel ventricular assist devices, total artificial hearts, heart valve repair and replacement devices as well as a pacemaker. The virtual studies are used e.g. to verify design decisions, estimate worst-case scenarios of sizes and variants, identify suitable animal models, perform virtual tests on a large number of patients and to determine and justify anatomical and morphological eligibility criteria for sub-population selection. Conclusion: The virtual studies have proven to give results that may not have been possible with conventional approaches, reduce the risky and expensive trial-and-error process, and increase evaluation confidence to ensure product safety prior to clinical trials.

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