Call it a Golden Age of healthcare innovation.

Scientifically accurate, personalized simulation of medical procedures before they happen. In silico clinical trials. New, AI-enhanced drug development and patient-centric experiences. The pace of progress is thrilling. And Dassault Systemes is emerging as a leader in the field, thanks to virtual twins that have proved their value in other industries and are now driving exciting advances in life sciences and healthcare. 

Fast Company, an American business magazine, has named The Living Heart Project and Enrichment Playbook among its “World Changing Ideas” for 2025, a recognition highlighting groundbreaking initiatives redefining healthcare innovation through virtual twin experiences and in-silico clinical trials.

Adapted from Fast Company:

In 2014, a coalition of doctors, engineers and government officials came together to create the world’s first 3D, lifelike digital replica of a human heart—also known as a virtual twin. Within two years, the Living Heart Virtual Twin was openly available to help medical experts improve testing, treatment and patient care. Last October, the coalition published with the FDA, the world’s first “in-silico clinical trial (ISCT)” guide based on the official FDA guidance and the ASTM V&V40 standard, on how to use virtual twins to improve clinical trials, the result of a five-year collaboration. This “ISCT Playbook paves the way for using virtual twins for the entire human body; projects are already in progress for the liver, lungs and brain, among others.

Dassault Systèmes Senior Director of the Virtual Human Modelling program Steve Levine, who founded the Living Heart Project and served as co-principal investigator with the FDA on the ENRICHMENT Project, was pleased with the recognition.

“When we launched the Living Heart Project, a true virtual twin of a human organ was considered an impossible dream, that is, until we did it,” Levine said. “The Enrichment Playbook demonstrates that together, we’ve gone far beyond just dreaming. We’ve built a pathway for digital evidence to stand shoulder-to-shoulder with animal studies and human trials, enabling a faster, safer and more inclusive future for medicine.”

Recognizing World Changing Ideas

Each year, Fast Company acknowledges innovations that address global challenges across industries. The magazine explains its World Changing Ideas Awards recognize initiatives based on their impact, design, scalability and ingenuity. Projects selected demonstrate the potential to create substantive, positive change in society. The recognition of Dassault Systèmes’ Living Heart Project and Enrichment initiatives is a testament to our visionary approach and tangible contributions to healthcare innovation.

What is the Living Heart Project?

A decade ago, Dassault Systèmes launched the Living Heart Project, believing that working together, we could create the world’s first lifelike, fully functional virtual twin of the human heart. It succeeded, enabling researchers, medical device developers and healthcare practitioners to improve treatment techniques, test devices and understanding complex cardiovascular conditions.

In clinical practice, the virtual twin can be customized for a patient’s specific physiology, allowing surgeons to test and validate treatment plans before operating. Not only does the virtual twin increase the chance of success, the medical care team, patients and families are all better able to understand surgical interventions, increasing everyone’s confidence.

“It was mind blowing for us to see the possibilities, not only to have more ownership as part of the care team as parents, but to see this technology at work in the hospitals,” Allison Seed, who’s had experience with The Living Heart Project as the parent of a daughter born with congenital heart defects and was successfully treated at Boston Children’s Hospital (BCH), said at a symposium in 2023. “It filled us with so much hope for our daughter.”

More recently, early adopters have begun scaling the use of modeling and simulation in surgeries. The team at Boston Children’s who cared for Seed’s daughter, hired a team of more than 12 engineers to run modeling and simulation as part of care plans. As of fall 2024, around nine centers in the United States had begun working with BCH on their challenging cases, and importantly are now able to be reimbursed for the medical value delivered through modeling and simulation services.

“On a national level, we’ve submitted CPT Level Three codes to achieve durable billing for these processes,” said Dr. David Hoganson, who leads the BCH team. “It’s quite expensive, as you can imagine. I think this is going to be a super important aspect to make this care available to everybody.”

Fast forward to today: the Living Heart Project is entering a transformational phase enhanced by AI-powered virtual twins. The newest iteration of the heart simulation is fully customizable and parametric, allowing medical device companies to design, test and validate innovative solutions with unprecedented speed and precision.

“A decade ago, the Living Heart Project made history by introducing the first virtual twin of a human heart,” Claire Biot, vice president, Life Sciences & Healthcare Industry at Dassault Systèmes, said in a press release earlier this year. “Today, we make another giant leap forward with the next generation – a fully parametric, customizable whole-heart simulation, enabling medical device companies to design, test and validate innovations faster and with greater confidence. Powered by our 3DEXPERIENCE platform, this breakthrough will help our customers reduce development costs, accelerate regulatory approval and transform their ability to predict how devices will integrate with real-world patient anatomy, empowering precision medicine at scale.”

How the Enrichment Playbook advances healthcare

The Enrichment Playbook, a result of Dassault Systèmes’ five-year collaboration with the U.S. Food and Drug Administration (FDA), guides the medical industry on how to use in silico clinical trials for regulatory success. These trials use virtual twins to simulate the effects of medical devices, drugs or treatments on virtual patient populations.

By using virtual twins and generative AI to simulate trial outcomes, in silico trials reduce reliance on human and animal testing, allowing for faster, safer and more inclusive clinical trials, ultimately accelerating the delivery of life-saving treatments.

Key achievements of the Enrichment Playbook include:

• Development of a comprehensive framework for in silico clinical trials
• Validation methodology of these trials’ regulatory credibility through collaboration with FDA advisors
• Application of artificial intelligence trained with computational models to expand the population of virtual patients, creating a test environment that can go beyond what is practical in a physical trial.

This playbook paves the way for virtual twins to address more than cardiovascular conditions. Applications for other organs, including the liver, lungs, and brain, are already underway. In fact, Levine believes human testing designed to validate the in silico trial results will overtake traditional clinical trials within the next few decades.

Dassault Systèmes leading Healthcare innovation

Recognition in Fast Company’s World Changing Ideas reinforces our reputation as the global leader in virtual twin technology for healthcare. These innovations not only modernize medical device development but also foster collaboration between industry leaders, regulators and academia to set new industry standards.

The healthcare innovation goes beyond the Living Heart Project and ENRICHMENT Playbook. During the COVID-19 pandemic, virtualizing clinical trials with Medidata helped develop vaccines in record time. The 3DEXPERIENCE platform and virtual twin experiences support sustainable manufacturing in MedTech. And virtual twins as a services (VTaaS) is poised to revolutionize BioPharma manufacturing.

From testing prosthetics to mimicking surgical procedures and enhancing drug development, Dassault Systèmes is advancing a future where digital innovation directly translates to longer, healthier lives.

Learn More about Virtual Twins for Life Sciences and Healthcare

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