Chris Romeo

As regulatory expectations evolve for ophthalmic drug-device combinations, the role of human factors in device development has become increasingly important. Usability considerations are now directly impacting design decisions, clinical strategy, and the overall regulatory path for combination products.

• Examine how early human factors work is informing device design decisions in ophthalmology, particularly for user populations with varying levels of procedural experience
• Highlight ways in which drug product characteristics for intravitreal implants can drive delivery device development
• Discuss how development teams are using early-phase, simplified delivery systems to reduce complexity and de-risk initial trials while gathering user feedback
• Explore the rationale for transitioning to more advanced delivery platforms ahead of commercialization, balancing regulatory compliance with clinician ease of use

• Why does early recruitment remain a bottleneck, especially for injected therapies in conservative indications like glaucoma?
• How do we design devices and protocols for operators who aren’t traditionally trained in injection procedures? • How do we push back against unrealistic investor timelines and expectations for one-and-done cures?
• What happens when a formulation looks great in vitro but fails due to real-world hurdles like sterilization or inflammatory responses?