Why Physical Testing Alone Is Becoming a Bottleneck
Bringing  a heart valve device to market requires robust evidence that the design  performs safely and reliably under physiological conditions.  Traditionally, that evidence has come from physical bench testing,  preclinical studies, and clinical investigations—an approach that is  time-consuming, costly, and often leads to the late discovery of design  issues, when changes are most expensive to implement. Regulatory  agencies, including Notified Bodies and the FDA, increasingly recognize  computational modelling as valuable supporting evidence, creating opportunities to gain earlier  design insights, reduce physical testing iterations, and accelerate  development without compromising safety or performance.

Webinar Scope
In this webinar,  4RealSim will explore how in-silico methods can support the development  and regulatory submission of heart valve devices while aligning with  applicable standards such as ISO 5840. Participants will learn how  computational modelling can accelerate product development, strengthen regulatory submissions,  and reduce dependence on physical prototypes by complementing  traditional testing with simulation-based evidence.

Topics Covered

• Why physical and clinical testing alone slows down heart valve device development

• How the EU and FDA view in-silico evidence in regulatory submissions

• Building a credible in-silico evidence package for heart valve devices

• Simulating performance and safety of heart valve devices under physiological loading conditions

• Reducing physical test iterations while maintaining regulatory confidence

• Positioning simulation results alongside traditional bench and preclinical test data

• Practical considerations for model verification and validation

What In-silico Evidence Delivers

• Earlier insight into device performance and safety before physical prototypes

• Increased confidence in simulation-driven development while reducing reliance on physical testing

• Faster design iterations and optimization throughout the development process

• A stronger, more comprehensive regulatory evidence package

Who Should Attend?

• R&D and design engineers developing surgical or transcatheter heart valve devices

• Regulatory affairs professionals responsible for medical device submissions

• Teams seeking to reduce the cost and time associated with extensive physical prototype testing

• Anyone interested in integrating in-silico evidence into the development and regulatory approval process for heart valve devices