NSF/FDA SiR: Development of a Regulatory Science Tool for Virtual Design of Novel Ventricular Pump Strategies

San Diego State University Foundation, San Diego CA

Investigators

Abstract

This NSF/FDA Scholars-in-Residence project is focused on ventricular assist devices (VADs), which are heart pumps used to support patients with severe heart failure. Many patients die each day while waiting for a heart transplant, and VADs can be a life-saving alternative. However, evaluating their safety and effectiveness is complex due to the dynamic interaction with each patient’s unique heart condition, posing significant challenges for the United States Food and Drug Administration (FDA). The goal of this project is to create a new computational model to predict the complex interactions of the VAD with the beating native heart. This model will simulate real-life conditions by integrating data from clinical studies, benchtop experiments, and computer simulations, offering a more precise method for predicting VAD performance. This model will enable the FDA to make better-informed regulatory decisions and support the development of safer, more effective VADs tailored to individual patient needs. This tool will drive improvements in VAD technology, ultimately enhancing patient outcomes and reducing deaths among those waiting for transplants. As part of the project, a graduate course on medical devices will be updated to include the use of computational models in regulatory science, and an FDA internship for an engineering student will be offered. These activities ensure that future engineers and regulators are equipped to advance VAD technology. This research has the potential to transform heart failure treatment by improving VAD performance and tailoring their performance to individual patient needs. It could reduce the number of deaths among those waiting for a heart transplant and lead to better patient outcomes. This research will result in a lumped parameter model (LPM) for predicting dynamic pressure and flow for a ventricular assist device (VAD) when coupled with the native human heart and circulation. The LPM will be a digital twin of an experimental mock circulatory loop (MCL) used for testing VAD safety and efficacy. A system of differential equations derived from an electrical circuit representation of the MCL are solved for a range of conditions representing heart failure patients and combined with the VAD performance curves to generate dynamic pressure and flow waveforms. These waveforms can be used to identify safety concerns such as pressure spikes and turbulent flow early in the design or review process. Verification, validation and uncertainty quantification of the LPM will be performed following FDA guidelines and published standards in preparation for use in VAD regulatory review and design. The LPM resulting from this project will aid industry and FDA via the science-based and transparent results and contribute to the integration of computational models into the regulatory review process. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.