When Physical Testing Alone Can't Keep Up With Device Timelines

Bringing a heart valve device to market depends on robust evidence that the design performs safely and reliably under physiological conditions. That evidence has traditionally come from physical bench testing, preclinical studies, and clinical investigations, an approach that costs time and money, and one that often surfaces design flaws only late in the process, at the point where fixing them is most expensive. Regulatory agencies, including Notified Bodies and the FDA, are increasingly open to computational modelling as valuable supporting evidence, which creates room for earlier design insight, fewer physical test iterations, and faster development, without giving up ground on safety or performance.

Webinar Scope

This webinar looks at how in-silico methods can support the development and regulatory submission of heart valve devices while staying aligned with standards such as ISO 5840. Participants will see how computational modelling can speed up product development, strengthen regulatory submissions, and reduce dependence on physical prototypes by pairing traditional testing with simulation-based evidence.

Topics Covered

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

• How EU and FDA regulators currently view in-silico evidence in submissions

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

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

• Cutting physical test iterations while keeping regulatory confidence intact

• Positioning simulation results alongside traditional bench and preclinical test data

• Practical aspects of model verification and validation

What In-silico Evidence Delivers

• Insight into device performance and safety well before a physical prototype exists

• Growing confidence in simulation-driven development as physical testing decreases

• Faster design iteration and optimization throughout development

• 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 looking to reduce the cost and time tied to extensive physical prototype testing

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