When the government can effectively use technology to do its job more efficiently, it typically means great things for the broader population. And in the case of medical device testing and trials conducted by the FDA, it can mean the difference between life and death for patients. Dassault Systèmes recently announced a 5-year extension of its collaboration with the FDA in using its 3DExperience tech platform to build digital tools that will enable more efficient regulatory review of medical devices including cardiovascular devices.
The extension represents the second phase of the collaboration under the 21st Century Cures Act. What’s novel about the course of activity between the two is the use of virtual patients to test out the likelihood of device errors or mishaps in the pre-clinical phase of testing. So far, the virtual patients have shown to produce very similar results to human tests. There is promise in being able to speed up the cost and time to get to the actual clinical trials.
“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and assess product safety. In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials,” commented Tina Morrison, Ph.D., Deputy Director in the Division of Applied Mechanics, Office of Science and Engineering Labs, Center for Devices and Radiological Health, FDA. “The FDA continues to encourage research to facilitate the introduction of safe and effective therapeutic solutions.”
Claire Biot, vice president, Life Sciences Industry, Dassault Systèmes is optimistic about the partnership approach. “Our collaboration with the FDA underscores the relevance and sustainability of digital twin experiences created with the 3DExperience platform to test devices and drugs in scientific and medical innovation,” Claire states. “Enriching technology already well established in regulated industries such as aerospace and automotive, virtual patients support the complex development of therapies for the heart, brain and more by eliminating traditional cost and time bottlenecks. With this new review process, Dassault Systèmes and the FDA can be partners in the transformative impact of the virtual world on industrial innovation, new treatments and the patient experience."