Ensure market success by designing what clinicians and patients actually need
Our teams gather first-hand insights from ophthalmologists, surgical support staff, and patients to define the critical user needs that drive successful product design and development.
Build a durable competitive advantage in the crowded ophthalmology market
We deliver comprehensive market assessments, pricing analyses, and reimbursement strategies to create a clear, data-driven roadmap for commercial success and investor confidence.
Strategically navigate complex global regulatory landscapes
With a 96% FDA submission clearance rate, our regulatory experts develop the least-burdensome strategy for FDA and EU MDR approvals.
Custom anatomical testing models to de-risk development
Custom test models that simulate clinical condition ensures your device performs as intended with the correct evaluation to guide development or use for design verification.
Traceable, high-quality builds from prototype to human trial
We provide controlled manufacturing for your devices in our ISO Class 8 cleanrooms and BSL-2 biohazard lab spaces, ensuring they are ready for preclinical studies and clinical use.
Generate critical safety and performance data with studies designed for clinical relevance
Support with non-GLP, GLP, preclinical training, and histology services for your ophthalmic device. We collaborate directly with consulting ophthalmologists to ensure our preclinical study designs will deliver the most meaningful and translatable outcomes for your specific device.
Execute complex ophthalmic trials designed for successful submission and market adoption
Our global, device-focused CRO excels at managing the unique challenges of ophthalmology trials—from long-term patient follow-up to generating the health economic evidence required for reimbursement.
