All Times EDT
Keywords: computational modeling, regulatory science
The science of medical devices is ever evolving with new technologies resulting in innovative products that may raise unique testing situations. Computational modeling can be used to address the needs of the progressing field of medical devices. For example, using simulation methods to test a device under various conditions to duplicate specific clinical or environmental conditions. Computational modeling, such as prediction models based on surrogate variables, Bayesian subgroup analysis, and sensitivity analysis for missing data, are a few methods of how computation modeling has been used for medical devices today. For example, in initial clinical studies for the artificial pancreas, models have been used in exchange for in vivo animal studies. In other studies, personalized simulation was used to indicate whether a patient was a candidate for a medical device or pharmaceutical by simulating dose effects or invasive clinical procedures to predict therapeutic outcomes. Yet, there are still many areas where these methods can impact medical device research. This roundtable discussion would focus on how computation modeling can serve a better role in medical device development.