Integrating IFU Development with 4 Key Elements of the HFE Process
Integrating IFU Development with 4 Key Elements of the HFE Process
Instructions for Use (IFUs) are often viewed as pesky regulatory requirements or convenient dumping grounds for risk mitigation. In reality, they are an important and integral part of the user interface. Their purpose is to guide users in the safe and effective use of medical devices or combination products. In many cases, the IFU is the only opportunity a company has to help users be successful and have a safe and positive experience with their product. That one opportunity will be lost if the IFU does not engage users or provide them with the information they need in a way that is easy and efficient to use.
For this reason, IFU usability should be prioritized along with the medical device or combination product it supports. AAMI TIR49:2013 provides rationale and guidelines for integrating medical device training and instructional materials into the Human Factors Engineering process for product development. In this article we will discuss 4 key elements of the Human Factors process and how they apply to the development of usable, engaging and effective IFUs.
User Profiles typically include such information as demographics (e.g., ages, gender, education levels) and the users’ occupations or roles in device use (e.g., surgeon, phlebotomist, lab technician, lay caregiver, patient). This information is just as useful in IFU design as it is in device design. In fact, providing IFU designers with even more robust User Profiles enables them to make targeted content and design decisions that optimize IFU engagement and usability. Here are a few examples of how user information can be applied in tailoring such IFU elements as content, writing style, font selection, illustration styling, layout and design to meet the needs of the user:
Prior experience of users with similar devices:
Users’ prior experience impacts their assumptions, knowledge and attitudes about a device or combination product. If potential risks associated with users’ prior experience cannot be removed through device design or safety measures, they must be mitigated by a thoughtfully crafted IFU (as well as packaging and perhaps other instructional solutions).
For example, users of a new autoinjector who have prior experience using automatic injectors will understand generally how autoinjectors operate and how the injections feel. However, they might experience use errors due to negative transfer issues (i.e., the interference of prior learning and experience with new learning or behaviors). This can be addressed in the IFU by drawing attention to the key differences.
Conversely, users with no prior experience using autoinjectors will be less knowledgeable and likely more fearful. Providing a simple, brief overview of the autoinjector and how it works will help orient them to the device. Using simple terminology (or at least defining terms that may be new) will help in building knowledge and confidence. To help alleviate fears, make the IFU look and feel friendly and easy to use (as opposed to a complicated, sterile medical document). For example, use an approachable (but still professional) writing style, format the IFU so that it seems familiar and easy to use, and consider using a relatable lifestyle cover photo or other artwork.
Physical and cognitive characteristics of users that might impact their ability to use an IFU:
Of course, patients experiencing severe impairments that prevent them from seeing, hearing, using their hands, or processing auditory or visual information would need help from a caregiver. But there are many less severe limitations that can influence IFU use. For example, arthritis patients might have trouble turning the pages of a booklet-style IFU or unfolding a map-style IFU, individuals with poor eyesight would have trouble seeing details in small illustrations or reading small text, those with hearing loss might have trouble hearing a video guide, and elderly patients might have trouble accessing or navigating IFUs provided online or through mobile apps. Be sure that the IFU is designed to accommodate any physical limitations prevalent within the user group(s).
When and how users typically engage with IFUs:
There is usually great variety in when and how users utilize an IFU. Some may read it thoroughly before using a device, others may only scan it for what looks important, others may use it as a guide while using the device, and still others may only refer to it when they’re not sure what to do. It is best to design the IFU to accommodate this range of uses. For example, make the IFU easy to navigate so users can find the information they want when they want it. Also, be sure that critical information stands out.
It is important for the IFU designer to know about any conditions in the use environment that pose challenges not just to device use, but also to use of the IFU. Ideally, this level of detail should be provided in the Environmental Profile. The following are some questions to explore about the use environment and examples of how the answers can apply to IFU design decisions:
What physical conditions might impact use of the IFU?
Some of the conditions that might impact the use of an IFU include lighting, space, noise, climate, activity, cleanliness, organization, and existing policies or processes. For example:
Poor lighting makes reading difficult. If there’s a possibility of poor lighting, the IFU should incorporate larger font sizes and illustrations.
If workspace is limited, it would be difficult to use a large, map-style IFU. It would be more appropriate to either provide access to the IFU digitally or use a layout style that doesn’t take up too much space.
If the environment is likely to be chaotic (as in emergency situations), users might be hurried and stressed. The IFU must be easily accessible and highly visible. It should also be simple and focused on only critical information.
How are IFUs stored? If the device will be used in a professional setting, how are IFUs typically made available to device users?
For home use, the question of IFU storage is only relevant if the IFU is for a reusable device. In such cases, consideration should be given both to where the IFU should be stored and where users might actually keep it. This may influence such decisions as IFU layout style and paper weight, as well as packaging design.
For clinical environments, information on how IFUs are typically stored and made available to device users helps in making decisions about the layout style for paper IFUs. It could also influence the decision about what delivery medium is most appropriate.
Is it likely users will have access to a computer or mobile device?
Simply put, before putting the time and expense into designing a digital IFU, make sure users will have the tools to use it!
A robust Task and Use Error Analysis will include much of the information needed to develop the IFU’s content. As an input to IFU development, the Task and Use Error analysis should include the following elements:
A complete list of the use scenarios when interacting with the device:
This information serves as the basis for organizing the IFU into sections. For example, for an autoinjector the use scenarios might include storing the autoinjector, preparing to inject, injecting, disposing of the autoinjector. It makes sense then to organize the IFU into corresponding sections.
The tasks and steps necessary to successfully perform each use scenario:
This information forms the basis of the IFU’s step-by-step use instructions.
A list of user perceptions, cognition and actions (often called PCA analysis) required for successful completion of each task:
This provides a greater depth of insight into task performance and provides perspectives into knowledge tasks (what users must know), cues for necessary user actions and feedback for recognizing successful and unsuccessful performance. All of this information helps flesh out helpful details to be addressed in the IFU.
Possible use errors and causes:
This information is critical in identifying key warnings and safety information to include in the IFU and any added instructions needed to avoid use errors. The PCA analysis will aid in the identification of potential root causes of use error and corresponding risk controls.
Identification of critical tasks using severity of potential harms:
These ratings are used to identify how information should be prioritized in the IFU and where most emphasis should be given.
To learn more about how to conduct a Task Analysis and Use Error Analysis, see Mitigating Risk Starts With Assessing Risk: How to Write a Task Analysis and Task Analysis and Use Related Risk Analysis: When and How They Build Off Each Other.
It should be noted that, even with all this information, it is usually necessary for the IFU designer to use the device to better understand how to perform each task and to discern any difficulties or nuances that device experts might overlook. To gain the user’s perspective, it is most helpful if the IFU designer is not already experienced with the device.
Despite all efforts to create an effective, user-friendly IFU, usability testing with real device users will always uncover needed improvements. Testing the IFU on the intended user population will not only uncover IFU usability issues but will also facilitate a better understanding of real-world use of the IFU. For example:
IFU testing with intended users may reveal that the visuals do not complement the written instructions which may lead to confusion and potential use errors. Updating the IFU to align the visuals with written instructions would mitigate this usability issue.
IFU testing with intended users may also reveal that certain user groups do not actually interact with the device the way the manufacturer assumes. This would require a modification of the intended users group. Updates would first need to be made to the TA/UEA and the User Profile to drive appropriate IFU updates.
AAMI TIR49:2013 provides guidance to conduct “small, informal tests” of the IFU as it is being developed followed by a “formal pilot test” of the IFU (along with all other labeling and training materials, as applicable) before the validation study. As stated in AAMI TIR49:2013, “If the labeling and training materials are considered part of the risk mitigation strategy, then it becomes important to collect data that support the claim that the labeling and training are effective and do not in themselves induce use errors.” Testing and iterating the IFU early and often ensures that usability issues are addressed prior to validation testing.
IFU-specific usability testing should include:
Knowledge questions to assess whether users can find and comprehend information provided in the IFU.
IFU-optional simulated use scenarios to observe whether and how users choose to engage with the IFU and to explore the reasons for their choices.
IFU-guided simulated use scenarios to assess whether users can follow the IFU easily without use errors or difficulties.
Integrating IFU development with Human Factors processes is critical to the efficient development of engaging, user-friendly IFUs that are effective in mitigating risks. It also ensures that both the medical device (or combination product) and the IFU are developed from the same source of truth. Ideally, IFU development should be led by someone with expertise in performance-based instructional design. Practitioners of this type of instructional design are adept at performance-based task analysis, gathering target audience information and understanding the conditions under which tasks are performed. They know how to apply that information to design effective, outcome-oriented instruction and test it for efficacy.
If your organization does not have an experienced performance-based instructional designer, Agilis can help. We support companies by providing:
Heuristic IFU reviews to identify opportunities for improving usability.
Coaching and guidance on IFU design, development and testing strategies, and
Comprehensive IFU development and testing (such as IFU-specific formative studies).
References:
AAMI TIR49: 2013 - Technical Information Report - Design of training and instructional materials for medical devices used in non-clinical environments.
Jackson, James. “Use Related Risk Analysis (URRA).” Agilis Consulting Group, Agilis Consulting Group, 4 Feb. 2021, https://www.agilisconsulting.com/knowledge-center/blog/use-related-risk-analysis.
Smith, Clayton. “How to Conduct a Task Analysis.” Agilis Consulting Group, Agilis Consulting Group, 3 Nov. 2021, https://www.agilisconsulting.com/knowledge-center/blog/how-to-conduct-a-task-analysis.
About the Author:
Valerie Gernazian
Valerie brings to Agilis 35+ years of experience in Human Performance Technology and Instructional Design. In her role at Agilis by Kymanox, Valerie oversees the development of instructional solutions that support real users in the safe and effective use of medical devices and combination products. She expertly applies evidence-based instructional design principles, Human Factors data and regulatory guidances to help clients optimize their instructional materials. Internally, Valerie serves as our subject-matter expert on instructional design and evaluation.
About the Author:
Abhi Pandey
Abhi completed her M.S. in Human Factors Engineering at Texas A&M University. Abhi holds a B.S. in Biomedical Engineering from Texas A&M where she focused on device design control criteria and federal regulation/compliance. Abhi has participated in multiple medical and veterinary device design challenges where she has utilized innovative design criteria and incorporated hazard analysis and risk assessment methods in the device design and development process. Currently, she is interested in instructional design and leveraging human factors principles to reduce use-related device errors.
