Dassault Systèmes and FDA expand cooperation in the cardiological medical equipment

2019: Carrying out clinical trials by in silico method

On August 5, 2019 the Dassault Systèmes company announced prolongation for five years of the cooperation with Management on control of products and medicines of the USA (FDA). Platform 3DExperience will be used in development of a digital instrument for increase in efficiency of regulatory testing of cardiovascular medical devices. Researchers hope that this the process first in own way will allow to expand innovations in the industry and will open for patients access to safe and effective methods of treatment of diseases of heart – the leading reason of death rate in the world.

This second stage of the current cooperation supports implementation of the Act of methods of treatment of the 21st century (21st Century Cures Act). The "virtual patients" created using methods of computing modeling and simulation will be applied to increase in efficiency of clinical trials of developments of medical devices. The Living Heart project in which the heart 3D model is involved, will study possibilities of modeling as source of electronic data for approval of the invented cardiovascular medical products. Computer simulation of clinical trial (in silico) which will allow to reduce testing for animals belongs to it and to lower required number of examinees of patients when preserving the high level of security and efficiency of the studied device. It is expected that digital process will become more effective and less costly in comparison with the existing valuation methods. For August, 2019 temporary restrictions and high cost of assessment of similar products can interfere with access for patients to similar therapy. At the same time this approach will allow to save confidence in accuracy, security and efficiency of the device.

FDA publicly recognized those advantages which are offered by modeling for health care and also estimated the high potential of clinical trials of in silico for safe and effective promotion of medical products from a stage of preclinical researches before clinical trials and an output to the market.

Modeling and simulation can help at creation of clinical trials. They are capable to provide data on efficiency, to select the most suitable patients for a research and to help with assessment of security of a product. In certain cases clinical trials of in silico already showed the results similar on quality to clinical trials in public. FDA continues to encourage the researches directed to implementation of safe and effective therapeutic solutions speaks Tina Morrison, the leading researcher, the associate director of Department of applied mechanics, Bureau of scientific and engineering laboratories at the Center for control over the equipment and radiation safety, FDA

Our cooperation with FDA demonstrates relevance and reliability of technologies of digital doubles on platform 3DEXPERIENCE for testing of devices and medicines and also development of scientific and medical innovations. The concept of virtual patients supplements the technologies which proved in the regulated industries, for example, space and automobile. Such approach promotes complex development of methods of treatment for diseases of heart, brain and many other pathologies at minimization of traditional costs and temporary restrictions. Thanks to the provided process of assessment of Dassault Systèmes and FDA can participate jointly in positive changes which virtual environment brings in industry innovations, methods of treatment and experience of patients, notes Claire Biot, the vice president for solutions for the medicobiological industry in Dassault Systèmes