Intravitreal Implant Delivery Device for Retinal Conditions

Adult patients may suffer from retinal conditions such as age-related macular degeneration or diabetic macular edema. To treat these conditions, trained Retina Specialists may perform intravitreal injections to deliver medication to the vitreous cavity at the back of the eye. This product consisted of an injector device, which delivered a drug implant into the vitreous cavity with the touch of a button. 

This research study sought to gather participant feedback on an early-stage design of the intravitreal implant delivery device. Areas of interest were:

• Do users have issues using the device to perform an intravitreal injection on a mock patient?

• What initial impressions do users have about the design of the injector (e.g., length, grip, colors)?

• What initial impressions do users have about the instructions for use (IFU) and packaging of the injector?

• What type of training would users expect for this product?

To collect data, we ran a usability study. Participants were asked to use the think-aloud method, where they shared their thoughts as they performed an intravitreal injection on a mock patient with macular degeneration. If any difficulty or issues were observed, study personnel (myself and another colleague) asked probing questions to determine what caused the issues. We also interviewed participants using open-ended questions and Likert Scales to gather their thoughts on ease of using the device, the current design (e.g., color, grip, length of needle), and initial impressions on packaging and labeling.

Based on observations and participant feedback, some findings included:

• Participants were able to easily perform the intravitreal injection because the device is very similar to what is available on the market.

• Many participants found that the "window" indicating whether or not the implant had left the injector was too small. Suggestions included making the "window" larger and emphasizing relevant information in the instructions for use. Notably, the "window" is a redundant feature, as participants were able to visibly see the implant enter the eye and could feel/hear the click of the button used to inject the implant.

• Many participants felt that the paper carton holding the injector inside of the sterile packaging was extraneous, as it did not appear to provide extra protection or otherwise serve any purpose. Suggestions included to remove the carton packaging.

• Many participants did not know what injection technique to use, and therefore recommended that the instructions for use specify what technique to follow, if important for patient safety.

• Most participants found the injector ergonomic, as holding it felt similar to holding a pen. Additionally, they noted that the grooves reduce slipperiness by providing a grip area.