Bringing a new medical device or pharmaceutical to market can be costly and complicated. Manufacturers need to increase speed, quality, and results.
Modeling and simulation has the potential to revolutionize the medical field. The days of building a physical prototype to test each new idea are history. Today, medical device and pharma manufacturers can use computer modeling to eliminate poor designs before they leave development—and refine good ideas before they are implemented with patients. Tomorrow, virtual patient simulations may replace clinical trials.
This technology can accelerate product development and the regulatory submission process, increase patient safety and enhance performance. It balances the need for certainty in device and drug performance while limiting the delay in patient access by using modeling and simulation data and results as valid scientific evidence.
Developers can accurately design and test virtually under various scenarios. Verifying outcomes nearly eliminates the time and significant expense of physical experimentation, rework, and unforeseen failures.
“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.”
-- Scott Gottlieb, Former Commissioner, FDA
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