5 tips to mitigate use-related risk for pre-filled syringes and other injection devices

October 30, 2020

With years of experience conducting human factors research with injection devices, we wanted to share some data-driven insights to those involved in the product development for these devices. We have pulled together five research and design tips to mitigate use-related risk for injection devices:

TIP #1: Design packaging and instructions for users

Users don’t look at instructions unless they are well-designed and easily found. When designing instructional materials, use pictures to illustrate critical information, use universal icons (e.g., stop sign) where possible, and use font styles sparingly to highlight critical phrases. The combination of simple text and visuals is an effective way to not only support different learning styles, but also help connect users to the physical device in front of them.

The design and physical arrangement of packaging can also be used as a mitigating control. Participants unintentionally discard or overlook important instructions For example, labeling that guides users to read instructions first, or physical barriers (e.g., a cardboard insert) that visually block items that should be accessed in an intended sequence. Keep in mind when designing the overall packaging that participants unintentionally discard or overlook important instructions.

Remember that a Quick Reference Guide (QRG) is helpful for many users as a visual reminder for critical steps but should not replace detailed instructions for use (IFU).

Instructional materials and packaging are important components in effectively communicating device functionality and mitigating use-related risk. Use best practices and iterative testing to inform layout, design, and language of packaging and instructions. Start conducting this testing early in the development process so changes are easier and less costly to make.

Tip #2: Design packaging to facilitate dose and drug differentiation

Packaging is important for dose and drug differentiation, particularly in the pharmacy where one manufacturer might have comparable products, but each with a different dose amount. One goal could be for pharmacists to be able to accurately pick the right medication carton off the shelf for the patient. With that in mind, visual and physical elements, such as the use of color, shape of the package, and text, should be tested to ensure that differentiation errors are minimized.

Any new packaging and labeling designs should be validated with respect to differentiation. Even minor changes can impact the potential for medication selection errors.

Tip #3: Simulate use environments during testing as realistically as possible

To encourage realistic behavior during testing, simulate use environments as realistically as possible. For example, when testing with clinicians, simulating a clinical setting might include using a manikin as a patient, and providing access to typical clinical supplies such as gloves and alcohol swabs. If testing with pharmacists, this may call for mocking up stocked shelves, and providing supplies such as pharmacy bags and prescription labels. For realistic simulated use with patients and caregivers, an injection pad can be placed on a participant or manikin’s body to evaluate device positioning.

Each user group may be operating a device in different use environments, requiring testing in several different simulated environments.

Tip #4: Most often, untrained users should be included in user testing

Another component of simulated use environments is to determine whether users will be trained on the device. Even if clinicians or patients are expected to receive training on a device, training might not be guaranteed, nor the training program well defined at the time of research, making it impossible to recreate. To account for these unknowns, we typically advise that research should be conducted with untrained users. While complete lack of training may not represent the highest-frequency use case, it represents the highest-risk use case — which is of most interest to the FDA. If it is determined that the potential risks are similar across untrained and trained user groups during formative testing, then you could consider making a case to reduce to one untrained user group.

If training is incorporated, it should also be included in the study evaluation and iterated upon throughout the development process based on user research results. When administering training, consider the format, consistency, length of typical time-lapse between training and first-time use (also known as “decay”), and any differences there may be between clinical and lay-person trainings.

Tip #5: Pay attention to logistical and design considerations

Thinking through logistics is key for successful research. In preparation for research execution, make sure to answer logistical questions such as:

    • Are you using a placebo or live drug?
    • Do you need refrigerated storage?
    • What type of injection pad should be used?
    • Does the research team have needle safety training?
    • Is there a first aid kit in the test room?

For device design, some common human factors considerations that can be evaluated during research include:

    • the injection site and angle
    • drug volume and viscosity
    • plunger or flange design
    • storage and packaging design
    • dose and drug differentiation
    • design of instructions for use

Attention to logistics, thoughtful product and research study design, and iterative user testing of designs can help mitigate user-related risk with pre-filled syringes and injection devices.

Contact us for more insight and to discuss how we can support your next project.