Why Physical Testing Alone Is Becoming a Bottleneck
Bringing an Intraocular Lens  (IOL) to market requires solid evidence that the design performs safely  and reliably under real world conditions. Traditionally, that evidence  has come from physical testing and clinical studies, an  approach that is slow, costly, and often means late discovery of design  issues, right when changes are most expensive to make. Regulatory agencies, such as Notified Bodies or the FDA,  increasingly recognize computational modelling as valid supporting  evidence, opening a path to earlier insight and fewer physical test  iterations without lowering the bar on safety or performance.

Webinar Scope
In this webinar, 4RealSim will explore how in-silico methods can support product development and device submissions for intraocular lens design while being compliant with ISO 11979. Participants will learn how they can accelerate the development process and how simulation-based evidence fits into their regulatory strategy, and how in-silico testing can reduce reliance on physical prototypes while strengthening, not weakening, the overall evidence package.

Topics Covered

• Why physical testing alone slows down IOL development

• How the EU/FDA views in-silico evidence in regulatory submissions

• Building a credible in-silico evidence package for IOL design

• Simulating mechanical performance of IOL

• Reducing physical test iterations without reducing regulatory confidence

• Positioning simulation results alongside traditional test data according to ISO 11979

• Practical considerations for model verification and validation

What In-silico Evidence Delivers

• Earlier insight into design performance, well before physical prototypes exist

• Stepwise trust into simulation approaches while reducing physical testing

• Faster iterations in design changes during development

• A stronger, more complete regulatory evidence package

Who Should Attend?

• R&D and design engineers working on intraocular lenses or similar medical devices

• Regulatory affairs professionals building device submission strategies

• Teams looking to reduce reliance on costly physical prototype testing

• Anyone exploring how in-silico evidence fits into a medical device approval process