Digital Evidence is Already Being Used at FDA to Support Regulatory Submissions
By: Daniel R. Matlis, President
FDA is leading the way in the use of simulation and modeling in the medical device industry. “Simulation is digital evidence, not made up stuff,” said Tina Morrison Ph.D., Deputy Director, Division of Applied Mechanics, OSEL, CDRH, U.S. FDA, during her keynote address on Day 2 of the Siemens PLM Industry event, hosted by Medtronic at their operational HQ in Minneapolis, MN.
For details on Day 1 of the event see At 21, Computer System Validation Comes of Age.
Day 2 also included presentations from Medtronic, Atrium Health, Siemens Healthineers, and Agilent Technologies on their use of simulation and modeling across the product lifecycle and the environment of care.
“Access to safe and effective medical device technology calls for Regulatory Grade computer models & simulations,” said Morrison.
“Many companies aim for the Digital Twin and end up getting a Digital Mutant” commented Brent Roberts, Vice President of Medical Supply Chain Strategy at WL Gore. “I think one of the keys to ensuring you don’t end up with a digital mutant is to stick with partners who understand the journey and rely on them helping you translate your internal view to a rest of the world outlook,” Roberts added.
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We also welcome you to Register for FDA Grand Rounds “Advancing Regulatory Science with Modeling and Simulation at FDA” on August 9, 2018 from 12 – 1pm EST.