Presentation
Finding the “Sweet Spot” for IFUs: Balancing Human Centered Design and Manufacturability at Scale
SessionPoster Session 2
DescriptionHuman factors (HF) practitioners have come a long way in helping to drive human centered design for medical products, including advancing improved designs for instructions for use (IFU), supported by robust human factors methodologies in the development process. These practitioners often have great skill in understanding how to determine the appropriate content and layout to meet design standards (such as from FDA guidance or ISO standards) and apply best practices for instructional design, as exemplified by recent HFES presentations and workshops (e.g. “Designing Simple Instructions for Medical Products” by Michael Wiklund and Erin Davis in 2024). However, there continues to be a gap between those designing the IFUs and those who have to commercialize it at scale in manufacturing. There is often a lack of understanding that adaptations to accommodate manufacturability at scale may adversely affect usability. Unfortunately, the IFU designers often don’t appreciate the manufacturability and commercialization considerations, which can frustrate graphic designers responsible for manufacturing who inherit the designs. Conversely, graphic designers responsible for manufacturing may lack sufficient HF and instructional design expertise to work independently on IFU development.
Many human factors groups in medical device or pharmaceutical manufacturing organizations, especially those that are small or newly established, rely heavily on HF consultancies to support IFU development, as they may not have the capability in-house. Even in larger, well-established and integrated HF organizations, gaps can still exist between development teams and those working in commercialization and manufacturing operations. These blind spots can lead to challenges downstream.
The intent of this panel discussion is to help build awareness and capability across HF practitioners in industry for these important considerations to bridge this gap, ensure that HF expertise can be incorporated early in the development process to avoid impacting safe and effective use of the product, and help bring IFU designs to users that can find the “sweet spot” between human centered design and manufacturability at scale. This will include discussing what these considerations are and how to navigate the necessary tradeoffs between competing needs from both consultancy and manufacturer perspectives in areas such as:
• Manufacturing capabilities and constraints: color limitations/processes, paper weight, multi-sided printing, folding patterns (vs packaging form factor and equipment capability), page weight to keep booklets opened without use of hands, glue mark positions, tear patterns/allowances, packaging height/space, potential for bundling with USPI
• Commercialization considerations: translations and regions with multiple languages, starting global while also accommodating localization for different cultures, local/regional regulatory requirements, brand identities, different printing capabilities by market, COGs cost-consciousness and patient access, accommodating promotional materials and marketing strategies
• Suggestions on how to stage and focus IFU development to ensure these considerations are incorporated: e.g. use a series of formative studies to focus separately on (1) content and layout, (2) visual communication, (3) commercialization
• The importance of Design Controls as a mechanism to understand not only the what but also the why behind the IFU design and ensure the appropriate design input, collaboration, and knowledge transfer starting early in and continuing throughout the IFU development process.
• Building relationships with commercial colleagues and demystifying the myths of what is and isn’t possible.
• How to collaborate effectively between manufacturers and consultancies
We also intend to use interactive elements, such as collecting feedback to help gauge interest and identify needs for a future workshop at the HFES HCS, where we can teach these concepts and show what their application looks like in practice, e.g. with an IFU co-creation exercise or case study.
Many human factors groups in medical device or pharmaceutical manufacturing organizations, especially those that are small or newly established, rely heavily on HF consultancies to support IFU development, as they may not have the capability in-house. Even in larger, well-established and integrated HF organizations, gaps can still exist between development teams and those working in commercialization and manufacturing operations. These blind spots can lead to challenges downstream.
The intent of this panel discussion is to help build awareness and capability across HF practitioners in industry for these important considerations to bridge this gap, ensure that HF expertise can be incorporated early in the development process to avoid impacting safe and effective use of the product, and help bring IFU designs to users that can find the “sweet spot” between human centered design and manufacturability at scale. This will include discussing what these considerations are and how to navigate the necessary tradeoffs between competing needs from both consultancy and manufacturer perspectives in areas such as:
• Manufacturing capabilities and constraints: color limitations/processes, paper weight, multi-sided printing, folding patterns (vs packaging form factor and equipment capability), page weight to keep booklets opened without use of hands, glue mark positions, tear patterns/allowances, packaging height/space, potential for bundling with USPI
• Commercialization considerations: translations and regions with multiple languages, starting global while also accommodating localization for different cultures, local/regional regulatory requirements, brand identities, different printing capabilities by market, COGs cost-consciousness and patient access, accommodating promotional materials and marketing strategies
• Suggestions on how to stage and focus IFU development to ensure these considerations are incorporated: e.g. use a series of formative studies to focus separately on (1) content and layout, (2) visual communication, (3) commercialization
• The importance of Design Controls as a mechanism to understand not only the what but also the why behind the IFU design and ensure the appropriate design input, collaboration, and knowledge transfer starting early in and continuing throughout the IFU development process.
• Building relationships with commercial colleagues and demystifying the myths of what is and isn’t possible.
• How to collaborate effectively between manufacturers and consultancies
We also intend to use interactive elements, such as collecting feedback to help gauge interest and identify needs for a future workshop at the HFES HCS, where we can teach these concepts and show what their application looks like in practice, e.g. with an IFU co-creation exercise or case study.
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices