Human factors study: surgical ocular delivery

Supporting an FDA submission through a human factors engineering programme

Our client was developing a surgical ocular delivery device and needed a partner to support their human factors engineering programme, in order to make a submission to the FDA. To help them evaluate the usability, safety and effectiveness of their device, we began by conducting an extensive analysis of the intended users, uses and use environments. We then carried out multiple simulated use studies with specialist vitreoretinal surgeons and surgical staff, using these insights to identify key design improvements for the system.

Following these studies, our human factors experts evaluated and improved the client’s whole system including packaging, labelling and the instructions for use, culminating in a successful submission to the FDA.

Drug delivery | Surgical | Human factors | User studies

Understanding different use environments

To help our client write the appropriate documentation for their FDA submission, we needed to build an in-depth understanding of their users and use environments across different target markets.

This involved travelling to multiple sites across the United States to perform human factors studies with a range of intended users.

Designing a human factors study in a surgical setting

To keep the study cost-effective, we simulated a surgical and clinical environment in a market research facility, using ophthalmic microscopes, setting up sterile fields and employing aseptic techniques to meet the required standards. Using a market research facility allowed us to monitor and record each surgeon’s interactions more effectively than would be possible in an operating room.

In the majority of cases, we can confidently simulate a surgical ophthalmic setting in a market research facility, to the standard required by the FDA. This can save significant costs compared to an actual use study, while providing the same quality of usability evaluation.
Thomas Grant, Senior Human Factors Consultant, Team Consulting

Man watching surgical procedure on monitor

Bringing real surgeons into the user study

We needed to ensure we had the right user groups in the study, to guarantee it met the FDA’s requirements. This involved a careful recruitment process, targeting specialist vitreoretinal surgeons, with relevant experience, who would be typical users of the ocular delivery device. It also required recruiting an appropriate surgical team to support the opening and preparation of the ocular device.

Simulating ocular drug delivery procedures

By designing a study that accurately simulates the conditions of ocular surgery, including representative tissue for precise incisions and suturing, we were able to evaluate the full procedure of use in the appropriate context. This led to effective participant engagement as well as high quality research and findings.

User-centered IFU design

We partnered with the client to design and develop effective, regulatory compliant IFUs and user manuals to support the use of their device. This involved carrying out extensive user research on clinical and surgical procedures, to identify opportunities to optimise usability and improve product safety through the design of the instructional material.

Representative training for surgeons

For all ocular surgical instruments, users are typically provided with an introduction to the device, or in some cases are supported prior to or during their first procedure. To replicate this training, we worked with the client and their surgical training experts to provide participants with training that was repeatable and representative of actual use.

Outcome

We performed multiple human factors studies, evaluating the whole system including all intended users involved in the device preparation, handling and use. The result was a comprehensive and collaborative HFE programme, as well as an optimised IFU, which supported our client in their FDA submission.