In 2014, Dassault Systems launched the 'Living Heart' project in collaboration with the Food and Drug Administration (FDA), bringing together cardiovascular researchers, medical device developers, and cardiologists to develop and validate precise digital models of the human heart. Today, this project takes a new step forward with the launch of a beta test for a new generation of virtual models, powered by generative AI, facilitating the development and approval of medical devices.
Until now, virtual twin models allowed the simulation of complex physiological scenarios. With the addition of AI, Dassault Systems pushes personalization even further: GenAI automatically adapts simulations to each patient or cohorts of patients, taking into account different variables such as tissue structure or physiological reactions to treatment.
This advancement builds on a decade of experience and accumulated data, which have generated thousands of virtual twins. These models serve as a training base for AI, allowing it to accurately predict the effects of treatments on different patient profiles without resorting to human or animal testing or compromising data confidentiality.
This beta test is part of the continuity of the 'ENRICHMENT Playbook', a collaboration between Dassault Systems and the FDA, which explores how virtual twins can transform clinical trials and reduce risks associated with experimental treatments. This guide aims to establish the credibility of in silico clinical trials in the medical sector and promote the adoption of this technology in regulatory processes.
The initiative does not stop at the heart but lays the groundwork for expanding virtual twins to other organs.
An Innovation Accelerator for Medical Devices
The major challenges in the development of medical devices are the time and cost of clinical trials as well as regulatory approval. By allowing various scenarios to be tested in reduced time and at lower cost, the new generation of virtual models will simplify and accelerate the development of medical devices, offering manufacturers increased reliability in validating their innovations while significantly improving patient outcomes.
Claire Biot, Vice President, Life Sciences and Healthcare Industry at Dassault Systems, comments:
"Ten years ago, the 'Living Heart' project marked a major milestone with the creation of the first virtual twin of a human heart. Today, we cross a new frontier with a fully parametric and customizable model. Thanks to our platform 3DEXPERIENCE, this advancement will enable medical device manufacturers to reduce development costs, accelerate regulatory approvals, and improve their ability to anticipate the integration of their devices into patients' anatomy, thus facilitating the rise of precision medicine on a large scale."