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Regulatory Focus™ > News Articles > 2019 > 8 > CDRH Seeks Computational Model of Human Heart to Speed Device Development

CDRH Seeks Computational Model of Human Heart to Speed Device Development

Posted 06 August 2019 | By Ana Mulero 

CDRH Seeks Computational Model of Human Heart to Speed Device Development

The US Food and Drug Administration (FDA) is seeking to determine whether data generated from computational whole human heart modeling can accelerate medical device review times.
FDA’s Center for Devices and Radiological Health (CDRH) issued a request for information (RFI) last Thursday for vendors of computational modeling software capable of performing clinically relevant simulations of the human heart. The Division of Applied Mechanisms (DAM) within CDRH’s Office of Science and Engineering Laboratories will integrate the selected solution into an ongoing project—an in silico clinical trial with a virtual patient (VP) population.
With funding from the agency’s Critical Path program, the selected solution will be integrated into the ENRICHMENT in silico clinical trial project. The project is as an expansion of a research collaboration agreement between the agency and Dassault Systèmes, first established in 2014.
The project aims to harness the potential of VPs by demonstrating the value proposition of computational modeling and simulation for expediting evaluation and approval processes. The graphic below depicts the cost and time savings vision, from the design phase to patient access.

“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study and assess product safety,” said DAM Deputy Director Tina Morrison. Morison, who serves as a principal investigator, adds that “in silico clinical trials have already been shown to produce similar results as human clinical trials.”
The focus of the project expansion is two-fold. The project will examine ways to reduce the size and duration of prospective clinical trials as well as the cost and risk associated with human data collection during real clinical trials. It is further intended for demonstrating whether a “collaborative product lifecycle management (‘PLM’) platform” can create efficiencies in reviews.
The project brief specifies that work will examine how the PLM platform approach “can significantly improve the robustness, response time and transparency of the medical device review process by enabling regulators with full digital access to all relevant information,” such as simulation results and “people required to make science-based, informed regulatory decisions.”
The RFI is to identify potential vendors capable of performing whole human heart computations with a virtually implanted generic heart failure device that will be created for the project. “We will need a physics-based computational model of a whole human heart, one that includes all critical functionality of the heart: electrophysiology, solid mechanics, and fluid dynamics, including all relevant anatomical features (such as ventricals, atria and vessels).” A mock investigational device exemption application will be reviewed as part of the project. 
The project coincides with a measure of success CDRH established in 2018 to have more than 50% of manufacturers of novel devices come to the US first or in parallel with other major markets. It looks to build on work CDRH completed in collaboration with the Medical Device Innovation Consortium, resulting in Bayesian tools for using digital evidence in the form of VPs.

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