Why Physical Testing Alone Is Becoming a Bottleneck

Bringing  a stent 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 stent devices while aligning with  applicable standards such as ISO 25539 and relevant ASTM standards,  including ASTM F2477 and F3067. 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 stent device development

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

• Building a credible in-silico evidence package for stent devices

• Using computational modelling to support compliance with ISO 25539 and relevant ASTM standards

• Simulating  stent deployment, expansion, radial strength, fatigue performance, and  vessel interaction 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, deployment behaviour, fatigue resistance, 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 supporting regulatory submissions

Who Should Attend?

• R&D and design engineers developing coronary, peripheral, or neurovascular stent devices

• Simulation, verification, and validation engineers supporting medical device development

• 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 stent devices

Relevant Standards Discussed

• ISO 25539 – Cardiovascular implants and endovascular devices

• ASTM F2477 – Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents

• ASTM F3067 – Standard Test Method for Radial Loading Characteristics of Balloon Expandable and Self-Expanding Vascular Stents