Human factors insights in ocular drug delivery development

24 Mar 2026 5min read

Ocular drug delivery is a focus area for innovation in both pharmaceutical development and medical device design. Limitations of traditional methods and the increasing prevalence of chronic eye diseases have prompted significant research and development in novel ocular drug delivery systems. Key areas of development include implants and drug-eluting contact lenses, which provide sustained drug delivery over months or years, and cell encapsulation devices which are bio-engineered cells, often genetically modified to produce specific therapeutic proteins. These cells are encapsulated within semi-permeable membranes and implanted into the eye, continuously releasing therapeutic proteins to offer a sustained and controllable drug delivery system for chronic conditions.

This article explores key insights gained from working in human factors for ophthalmic drug delivery and highlights critical considerations when applying a user-centred design methodology during development.

How has Team Consulting supported ophthalmic drug delivery?

Team Consulting has supported pharmaceutical clients in ophthalmic drug delivery for over 15 years. Our experience spans various areas of ocular drug delivery, including sprays, vial kits, pre-filled syringes, implants, and transvitreal subretinal delivery, as well as digital health solutions like digital therapeutics and mobile applications. We’ve conducted over 800 ophthalmic human factors research sessions with participants, with over 650 of those sessions being with clinicians working in ophthalmology.

Drawing on these insights, we’ve identified five key considerations for human factors research in ocular drug delivery.

1. Recruiting retinal specialists presents distinct challenges that require a tailored approach

Recruiting retinal specialists can be challenging as their demanding clinic schedules often limit availability and engagement levels can be low, particularly when research involves procedures they consider routine such as intravitreal injections. To tackle these challenges, we have developed a recruitment strategy that considers their specific expectations around incentives and provides flexibility with the schedule. Demonstrating the novel aspects of the research has proven effective, as retinal surgeons tend to be receptive to innovation and advancements in their field.

2. Using representative equipment and tissue enhances participant engagement during usability research

To ensure participants take usability sessions seriously, especially with unfamiliar devices, it’s important to simulate realistic procedural environments. Intravitreal injections carry strong existing mental models and participants may assume they know what to do, risking disengagement. During usability research, we address this by using representative equipment and porcine tissue, asking participants to “scrub in”, providing assistants and clearly marking sterile zones. For complex procedures, we simulate the full surgical workflow, including preparatory steps like placing vitrectomy ports, to help participants familiarise themselves with the eye and equipment. These elements enhance engagement and reduce study artifacts.

3. Understanding the use context is essential in identifying user tasks, especially for cell and gene therapies

Clinical practices and task delegation vary widely between sites and individuals. For instance, retinal specialists differ in their reliance on assistants for intravitreal injections, ranging from no support to delegating tasks like unpackaging, priming or dose setting. Additionally, there are significant differences between Europe and the US, with trained nurses in the UK more likely to provide injections. However, for cell and gene therapies, clinicians tend to perform many more steps themselves due to the complexity and cost of the therapy. These differences must be accounted for in design and testing.

4. Involving Human Factors teams to provide unique insights during the development of the IFU, packaging and training

Involving Human Factors teams during the development of the IFU, packaging and training can help shape these materials by contributing user-centred insights. By conducting formative evaluations, the team can iteratively test and refine instructional content for optimal usability. Retinal specialists and assistants rarely consult instructions during use and rely on existing mental models. For example, most clinicians may be approaching a device with a mental model of “clean technique” regarding handling and if a device requires aseptic handling additional mitigations may be required.

5. Building strong relationships with clinical teams and sites is essential for successful actual use studies

Actual use studies for ocular delivery devices have been required in recent years by the FDA where a drug/device combination has not been assessed in a clinical study. These studies involve observing device use in real-world clinics. They are an interesting study hybrid, where an HF assessment takes place alongside a clinical study focused on safety outcomes each governed by its own protocol. Communication is key to successful planning and implementation of the study:

Discussing requirements and roles early on with the clinical team will help set expectations, so they understand how the visiting HF team will need to work with the chosen study sites. Regular communication helps both sides to navigate the differences in expectations, procedures and vocabulary.
Establishing relationships in advance with the study site staff helps enormously when the HF team is on site. Clinics are usually working on packed schedules and the HF team will need to be considerate and flexible while ensuring that they can meet their study objectives.

Optimising human factors studies for ocular therapy development

Insights gained from 800 ophthalmic human factors research sessions, many with ophthalmology specialists, highlight the importance of contextual understanding, realistic simulation, and early collaboration with clinical teams during device development. These practices not only enhance usability and safety but also support regulatory success and patient outcomes. As ocular therapies continue to evolve, integrating human factors from the outset will remain essential to delivering effective, intuitive and clinically viable solutions.

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