Optimizing Ophthalmic Device Testing For Enhanced Performance And Compliance

By Rick Camp & Katie Grayson, Eurofins Medical Device Services

Ensuring the safety and effectiveness of ophthalmic medical devices is a process that must span from the initial design stage through to post-market surveillance. Early validation testing is critical to rigorously assess performance and preempt costly, time-consuming delays later in development. Robust data gathered from a strategic testing plan strengthens regulatory submissions, helping devices avoid extended review cycles, failed submissions, and accelerate market readiness.

Strategic testing provides key benefits like improved device performance, faster time to market, and competitive differentiation. Key early-stage tests include biocompatibility, extractable and leachable testing, and stress testing. For specialized devices like intraocular lenses, testing must cover optical performance and material stability. For complex combination products, integrated strategies must address both the drug and device components, requiring specialized protocols for drug-device interaction and stability. Prioritizing tests and running parallel testing streams can compress timelines and build an efficient, resilient development process.