Where Physical Testing Alone Falls Short

Bringing an Intraocular Lens (IOL) to market depends on solid evidence that the design will perform safely and reliably under real world conditions. That evidence has traditionally come from physical testing and clinical studies, an approach that tends to be slow and expensive, and one that often reveals design flaws only late in the process, at the point where corrections are costliest. Regulatory bodies, including Notified Bodies and the FDA, are increasingly willing to accept computational modelling as legitimate supporting evidence, creating room for earlier insight and fewer physical test cycles, without compromising on safety or performance standards.

Webinar Scope

12Simulate examines how in-silico methods can support product development and submission dossiers for intraocular lens design in line with ISO 11979. Participants will see how these methods can shorten development timelines, where simulation-based evidence fits within a regulatory strategy, and how in-silico testing can lessen dependence on physical prototypes while reinforcing, rather than undermining, the strength of the overall evidence package.

Topics Covered

• Where physical testing alone limits the pace of IOL development

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

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

• Simulating the mechanical performance of an IOL

• Cutting physical test iterations while maintaining regulatory confidence

• Aligning simulation results with traditional test data under ISO 11979

• Practical aspects of model verification and validation

What In-silico Evidence Delivers

• Insight into design performance well before a physical prototype exists

• Confidence in simulation methods built up progressively as physical testing decreases

• Faster turnaround on design iterations during development

• A more robust and complete regulatory evidence package

Who Should Attend?

• R&D and design engineers developing intraocular lenses or comparable medical devices

• Regulatory affairs specialists shaping device submission strategies

• Teams aiming to lessen dependence on costly physical prototype testing

• Anyone interested in how in-silico evidence fits into medical device approval