Presentation
“How was I supposed to know?” Designing injection device instructions for use for injection-naïve users
Event Type
Oral Presentations
TimeWednesday, June 8th4:00pm - 4:30pm EDT
Location
DescriptionFor medical device manufacturers, the optimal approach to risk mitigation is to make products inherently safe by design. However, when designing an injection device that is relatively low in complexity and is intended for use by laypeople with a wide variety of experience and mental models, the product’s design is only one way to guide safe and correct use. As such, IFUs are a key component of the product’s user interface—especially for injection-naïve users who have limited knowledge of injection device use. Additionally, with the Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) frequently requesting data from injection-naïve users during HF validation testing, ensuring that products are designed for injection-naïve users is crucial.
When evaluating injection devices with injection-experienced users, we see predicable trends in performance and root causes: did not check expiration date because of habit, did not hold the device against the skin as instructed due to negative transfer, etc. Experienced researchers could easily generate a list of anticipated findings and associated root causes for a usability test of an injection device with injection-experienced users. In many cases, these injection-experienced users are comfortable using a new injection device and, consequently, might not even refer to the instructions.
Injection-naïve users, however, are a bit less predictable. Because they have no hands-on experience using injection devices, their initial assumptions about the product and expectations for using it can vary immensely—and these variations can lead to a wide variety of use errors with any number of root causes. Some users might have never seen a sharps container before; some users might not understand the concept of a multi-dose pen-injector; some users’ expectations might be influenced by experiences at their doctor’s office or from watching TV. Many naïve users will recognize the gaps in their knowledge and turn to the IFU—making this document critical in guiding the safe and effective use of an injection device for use by injection-naïve individuals. As such, creating clear, comprehensive IFUs is imperative for injection devices for use by injection-naïve laypeople
Many combination product manufacturers cite the product’s IFU as a mitigation in their risk documentation, but when the IFU is evaluated with intended users, the IFU performs relatively poorly. This is because manufacturers often only ensure that all relevant content is included in the IFU, but they do not dedicate the time and resources to the content structure and presentation to facilitate comprehension. Though the FDA released its guidance on combination product labeling in 2019 (Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry), the guidance shares only high-level expectations for instructional documentation, relying on manufacturers to determine the optimal design of the IFU’s content and format.
Based on the presenters’ extensive experience conducting usability tests of injection devices and designing injection device IFUs, this presentation will uncover the common use errors committed by injection-naïve users throughout injection device use, the common associated root causes, and proposed IFU-design-based mitigations. Such use errors might include, but are not limited to, the following:
• Not identifying the IFU
• Not inspecting the device for damage or expiration
• Selecting an unacceptable injection site
• Misidentifying the device’s needle end
• Not removing the device’s cap
• Holding device against skin for an insufficient amount of time
• Disposing device in a household trash can
• Incorrectly determining when to take the next dose
When designing an IFU for injection-naïve users, manufacturers must consider more than simply what content to include in the IFU. For example, should introductory content be provided to help shape users’ mental model of the device before use, or would that be overwhelming? How can the IFU effectively communicate unique interactions, such as the need to administer two injections for a complete dose? How can the IFU be comprehensive, yet simultaneously seem approachable and not too dense with information?
From this presentation, attendees will gain a better understanding of injection-naïve users’ behaviors with injection devices and the optimal mitigations via IFU design. This presentation will include IFU design recommendations, as well as provide examples of effective and ineffective IFU design approaches and explain why certain design choices are favorable compared to others.
When evaluating injection devices with injection-experienced users, we see predicable trends in performance and root causes: did not check expiration date because of habit, did not hold the device against the skin as instructed due to negative transfer, etc. Experienced researchers could easily generate a list of anticipated findings and associated root causes for a usability test of an injection device with injection-experienced users. In many cases, these injection-experienced users are comfortable using a new injection device and, consequently, might not even refer to the instructions.
Injection-naïve users, however, are a bit less predictable. Because they have no hands-on experience using injection devices, their initial assumptions about the product and expectations for using it can vary immensely—and these variations can lead to a wide variety of use errors with any number of root causes. Some users might have never seen a sharps container before; some users might not understand the concept of a multi-dose pen-injector; some users’ expectations might be influenced by experiences at their doctor’s office or from watching TV. Many naïve users will recognize the gaps in their knowledge and turn to the IFU—making this document critical in guiding the safe and effective use of an injection device for use by injection-naïve individuals. As such, creating clear, comprehensive IFUs is imperative for injection devices for use by injection-naïve laypeople
Many combination product manufacturers cite the product’s IFU as a mitigation in their risk documentation, but when the IFU is evaluated with intended users, the IFU performs relatively poorly. This is because manufacturers often only ensure that all relevant content is included in the IFU, but they do not dedicate the time and resources to the content structure and presentation to facilitate comprehension. Though the FDA released its guidance on combination product labeling in 2019 (Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products — Content and Format Guidance for Industry), the guidance shares only high-level expectations for instructional documentation, relying on manufacturers to determine the optimal design of the IFU’s content and format.
Based on the presenters’ extensive experience conducting usability tests of injection devices and designing injection device IFUs, this presentation will uncover the common use errors committed by injection-naïve users throughout injection device use, the common associated root causes, and proposed IFU-design-based mitigations. Such use errors might include, but are not limited to, the following:
• Not identifying the IFU
• Not inspecting the device for damage or expiration
• Selecting an unacceptable injection site
• Misidentifying the device’s needle end
• Not removing the device’s cap
• Holding device against skin for an insufficient amount of time
• Disposing device in a household trash can
• Incorrectly determining when to take the next dose
When designing an IFU for injection-naïve users, manufacturers must consider more than simply what content to include in the IFU. For example, should introductory content be provided to help shape users’ mental model of the device before use, or would that be overwhelming? How can the IFU effectively communicate unique interactions, such as the need to administer two injections for a complete dose? How can the IFU be comprehensive, yet simultaneously seem approachable and not too dense with information?
From this presentation, attendees will gain a better understanding of injection-naïve users’ behaviors with injection devices and the optimal mitigations via IFU design. This presentation will include IFU design recommendations, as well as provide examples of effective and ineffective IFU design approaches and explain why certain design choices are favorable compared to others.