Medical Devices: Computer-Aided Clinical Trials


Clinical trials of medical devices cost $10-$20MM, take 4-6 years and suffer from a +30% failure rate. In response, we have developed in-silico pre-clinical trials starting from 100s of real patient signals, mapping them to our heart models, perturbing the models to generate 10,000's of heart models across a range of conditions and then feeding them for closed-loop evaluation with medical devices. Such computational modeling of medical devices in the closed-loop physiological context can provide regulatory-grade evidence and insights prior to an expensive clinical trial.

This project is part of the $4.2MM NSF CPS CyberCardia Frontiers project on Medical CPS.