The FDA’s new focus on Modeling and Simulation

The Commissioner of the Food and Drug Administration, Dr. Scott Gottlieb recently published a blog post about the FDA’s plans to improve the use of computational modeling and simulation in the regulatory process.

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From a medical device company’s standpoint, computational modeling and simulation have had clear advantages over bench and pre-clinical testing alone.  Now with the FDA being on board with in silico data included in submissions, there is even more reason to include finite element analysis in every stage of product development.

From the article:

Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials. FDA’s efforts in modeling and simulation are enabled through multiple collaborations with external parties that provide additional expertise and infrastructure to advance the development of these state-of-the-art technologies.

At System Insight Engineering we have experience developing sophisticated tissue behavior models that help provide insight and clarity to questions around medical device functions.  These simulations help define the edge cases for new devices and provide an ideal environment to highlight worst-case scenarios.  Our experience presenting to the FDA and communicating the work that goes into the models has resulted in lower pre-clinical requirements and clearer paths forward.

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