Presentation
After the PDF IFU: Investigating Digital Transformation of the IFU Experience
DescriptionTraditional paper IFUs can fail to engage users, especially in pediatric contexts notorious for user distractions, where errors can be critical. Paper IFUs are often digitized into PDFs as a first step in the electronic IFU (eIFU) process – going beyond this, embedding HF throughout the entire development lifecycle has allowed us to investigate a digital transformation to the user experience of IFUs – improving engagement and user experience. Through our process-driven collaboration, Bayer and Crux uncovered not only usability improvements but also the opportunity to design a fit for purpose digital platform that drives real performance benefits and meets evolving user needs.
This presentation explores our novel, user-centred approach to developing eIFUs for pediatric oral suspension medication, and the resulting impact on task completion and user experience. Over five iterative phases, the team conducted (1) eIFU brainstorming and ideation, (2) interface prototyping, (3) an exploratory sprint study comparing three different concepts for an eIFU to understand features, effectiveness, and participant preferences, (4) development to build a complete eIFU, and (5) formative simulated-use testing with 17 lay caregivers to evaluate usability, comprehension, and performance of the eIFU design.
The application of human factors principles and usability considerations throughout the development lifecycle proved critical to empowering user-centric evolution of the eIFU. Users were engaged early and often, informing everything from content hierarchy to interface behaviour. The final eIFU prototype featured interactive video and text guidance, step-by-step navigation, and adaptive feedback. This resulted in a small uplift in correct use (to 93% correct-use), and crucially for repeat and engaged use - high subjective ratings for clarity and helpfulness – including among users with low digital health literacy. IFUs serve a purpose in the learning stages of a new device, and engagement is an important element of information absorption for learning.
The background for this work stems from Bayer’s commitment to advancing digital health tools that are truly usable by diverse populations. Digital tools offer opportunities to go beyond paper-based IFUs, with improved capabilities for personalised and engaging content, and so opportunities to further support safe and effective use, particularly for caregivers with limited health literacy or digital experience. The current concept of an eIFU typically encompasses digitization of an existing document into an online accessible PDF version. Recognizing that companies can go further, Bayer initiated a development program to explore how digital formats could better serve end users- focussing on paediatric contexts where dosing, preparation, and administration tasks are complex and can be error-prone.
Crux collaborated with Bayer to translate this vision into a tangible, testable solution for an eIFU. eIFUs require multidisciplinary expertise; this included Crux’s human factors engineering, industrial design, digital UX, and clinical insight, that complimented Bayers human factors and development engineering, and clinical expertise. This enabled a seamless integration of technical feasibility with user empathy. The team’s approach was grounded in iterative design and evidence-based decision-making, with each phase of research feeding directly into interface refinements and content adjustments.
This project underscores the value of multidisciplinary collaboration in medical device development. By bridging the gap between design, engineering, and clinical practice, the process began the development of a solution that is not only technically sound but also deeply attuned to user needs.
This presentation explores our novel, user-centred approach to developing eIFUs for pediatric oral suspension medication, and the resulting impact on task completion and user experience. Over five iterative phases, the team conducted (1) eIFU brainstorming and ideation, (2) interface prototyping, (3) an exploratory sprint study comparing three different concepts for an eIFU to understand features, effectiveness, and participant preferences, (4) development to build a complete eIFU, and (5) formative simulated-use testing with 17 lay caregivers to evaluate usability, comprehension, and performance of the eIFU design.
The application of human factors principles and usability considerations throughout the development lifecycle proved critical to empowering user-centric evolution of the eIFU. Users were engaged early and often, informing everything from content hierarchy to interface behaviour. The final eIFU prototype featured interactive video and text guidance, step-by-step navigation, and adaptive feedback. This resulted in a small uplift in correct use (to 93% correct-use), and crucially for repeat and engaged use - high subjective ratings for clarity and helpfulness – including among users with low digital health literacy. IFUs serve a purpose in the learning stages of a new device, and engagement is an important element of information absorption for learning.
The background for this work stems from Bayer’s commitment to advancing digital health tools that are truly usable by diverse populations. Digital tools offer opportunities to go beyond paper-based IFUs, with improved capabilities for personalised and engaging content, and so opportunities to further support safe and effective use, particularly for caregivers with limited health literacy or digital experience. The current concept of an eIFU typically encompasses digitization of an existing document into an online accessible PDF version. Recognizing that companies can go further, Bayer initiated a development program to explore how digital formats could better serve end users- focussing on paediatric contexts where dosing, preparation, and administration tasks are complex and can be error-prone.
Crux collaborated with Bayer to translate this vision into a tangible, testable solution for an eIFU. eIFUs require multidisciplinary expertise; this included Crux’s human factors engineering, industrial design, digital UX, and clinical insight, that complimented Bayers human factors and development engineering, and clinical expertise. This enabled a seamless integration of technical feasibility with user empathy. The team’s approach was grounded in iterative design and evidence-based decision-making, with each phase of research feeding directly into interface refinements and content adjustments.
This project underscores the value of multidisciplinary collaboration in medical device development. By bridging the gap between design, engineering, and clinical practice, the process began the development of a solution that is not only technically sound but also deeply attuned to user needs.
Authors
Event Type
Oral Presentations
TimeWednesday, March 2510:30am - 10:52am EDT
LocationNassau
Digital Health