Dassault Systèmes and FDA Extend Partnership for Five More Years

Dassault Systèmes announced that its collaboration with the FDA (U.S. Food and Drug Administration) has been extended for an additional five years. The 3DEXPERIENCE platform will be used to develop a new digital tool that enables the regulatory authority to review cardiovascular and medical devices more effectively. Researchers aim for this process to increase innovation in the industry and open the way for patients to access safe and effective new treatments against heart disease, a leading cause of death worldwide. The second phase of the collaboration supports the U.S. 21st Century Cures Act by using virtual patients based on computer modeling and simulation to enhance the impact of clinical trials for new device designs. In this groundbreaking project featuring the Living Heart simulated 3D heart model, the use of cardiac simulation as a digital source of evidence in the approval of new cardiovascular devices will be examined. This involves a computational clinical trial aimed at ensuring device safety and efficacy while reducing animal testing or the required number of patients. The new digital process is intended to be more efficient and cost-effective than current procedures that can impede patient access to new treatments due to delays and costs, without compromising the importance attributed to device safety and efficacy or creating any loss of confidence.

Tina Morrison, Deputy Director of the Office of Applied Mechanics, Science and Engineering Laboratories, Center for Devices and Radiological Health at the FDA: "Modeling and simulation can help strengthen clinical trial designs, support efficacy evidence, identify the most suitable patients for the study, and evaluate product safety. In some cases, computational clinical trials have already been shown to produce results similar to clinical trials conducted on humans. The FDA will continue to encourage research to accelerate the development of safe and effective treatment solutions."

Claire Biot, Vice President of Life Sciences Industry at Dassault Systèmes:

"Our collaboration with the FDA indicates that digital twin experiences created on the 3DEXPERIENCE platform to test scientific and medical innovation devices and drugs are valid and sustainable. As a result of enriching technology already used in regulated industries such as aerospace and automotive, virtual patients support comprehensive development of necessary treatments for the heart, brain and other organs by eliminating traditional cost and time bottlenecks. Through this new review process, Dassault Systèmes and the FDA are collaborating to demonstrate the transformative impact of the virtual world on industrial innovation, new treatments and patient experience."