Advancements in modeling and simulation technologies are transforming healthcare by allowing medical professionals to virtually explore, model, and test treatments, to understand and model the human body, and engineer safer and more effective device designs and procedures. The FDA has recognized the significance of virtual modeling and simulation and potential impact on patient outcomes. Since signing a 5-year agreement with the FDA in 2014, and with more recent milestones for its Living Heart Project, Dassault Systèmes continues to align with the FDA on the use of simulation and modeling to digitally transform patient care.
In July 2017, FDA Commissioner Dr. Scott Gottlieb publicly outlined the FDA plan to help consumers capitalize on advances in science, stating, “Modeling and simulation play a critical role in organizing diverse data sets and exploring alternate study designs. This enables safe and effective new therapeutics to advance more efficiently through the different stages of clinical trials.” More recently, Tina Morrison, Ph.D, Deputy Director, Division of Applied Mechanics and Chair of FDA’s Modeling and Simulation Working Group spoke at the recent Science in the Age of Experience conference in Boston in June, in a session entitled, “Advancing In Silico Medicine at FDA; Perspectives on Simulation in Medical Devices.” Watch her keynote below:
Dassault Systèmes plays an important role in advancing scientific progress by working closely with the FDA and acting as an innovation partner and hub in the local Boston area. Taking advantage of significant technological advances can reduce the distance between the virtual world and the real world, a topic that was 
explored in a workshop hosted by Dassault Systèmes at its Waltham, Massachusetts campus in July, attended by over 100 Life Sciences professionals.
Under the theme “Accelerating Patient-Centric Innovation for Competitive Advantage’, the half-day session featured technology experts and industry leaders representing BioPharma and Medical Device companies from around North America including Biomodex, Medtronic, Novartis, Accenture and Sanofi, top-level scientific researchers from MIT, Tufts University, and Massachusetts General Hospital, and representatives from MassMEDIC and Massachusetts Biotechnology Council , Boston-area organizations designed to connect and foster relationships between local life sciences networks.
During the workshop, Steven Levine, Sr. Director SIMULIA Strategic Initiatives, spoke about the Living Heart Project and the power of Virtual Human Modeling. John Halmen, Pr. Engineer, and other representatives from Medtronic spoke about how the company is using simulation to engineer safer medical devices. Carolyn DeVasto, Global VP of Commercialization at Biomodex, spoke about the applications of simulation for interventional radiology. Finally, Karl D’Souza, Sr. Solution Consultant, Virtual Human Modeling, spoke about how simulation can optimize combination product development, for treatments or devices composed of two or more different types of medical products (i.e., a combination of a drug,device, and/or biological product with one another) for faster time to market.
Key themes emerging from the day included:
- Multi-scale modeling and simulation are impacting the life sciences industry from the molecule to the organ to the whole human and more
- Combination devices are bridging the space between traditional Biopharma and Medical Device companies
- Additive manufacturing is increasing in its importance – supporting innovation in clinical environments
- Personalized health is being driven by Virtual Human Modeling
To learn more, watch the Life Sciences Innovation Day Panel Discussion here:
For more information on The Living Heart Project: https://www.3ds.com/heart
