Presentation
Designing for Real-World Use: Human Factors Lessons from Post-Market Support
SessionPoster Session 2
DescriptionBackground: Post-market support is a critical stage in the medical device and combination product lifecycle, and the role of human factors in this phase is often underestimated despite its substantial impact on device safety, usability, and long-term performance. Complaint investigations were conducted for two products: a complex medication kit and a prefilled-syringe vaccine. Both products used off the shelf components.
Methods: Human factors studies were performed to understand how the complaints occurred and to identify possible mitigations.
Results: The Instruction for Use (IFU) for both products was complete and technically correct. Some study participants read the IFU but then performed tasks based on intuition, producing behaviors consistent with reported complaint scenarios. These behaviors largely reflected mismatches between the product designs and users’ mental models. Searching for alternate off the shelf components revealed trade-offs: replacing one component often eliminated a single failure mode but introduced others. Supplier selection also introduced non usability constraints such as compatibility, quality system, and regulatory status.
Discussion: Four practical lessons emerged:
1. A design that is “safe and effective” does not guarantee a complaint free launch.
2. Pre-launch training and targeted user education at initial rollout are critical to bridge the gap between device functionality and users’ mental models.
3. Relying on the IFU alone is insufficient to mitigate usability risk; selecting components or formulations that align with user expectations is a preferred approach.
4. Product teams should adopt a comprehensive mitigation strategy that combines human factors testing, evaluation of alternative components, and enhanced complaint intake mechanisms to detect and categorize failure modes early.
Conclusion: Although the IFUs were complete and correct, both products failed to meet users’ expectations in practice, leading to recurring problems that instructions alone could not resolve. Replacing current off-the-shelf component with other off the shelf components resolved some issues but created new ones (for example, device compatibility, supplier and regulatory challenges). To reduce post market complaints, it is recommended:
• Fix design issues (device/formulation) when feasible rather than relying solely on instructions.
• Provide clear, focused training at product launch.
• Choose components or formulations that balance intuitive ease of use with supply and regulatory considerations.
• Improve complaint collection and process so new problems are identified and remediated quickly.
Methods: Human factors studies were performed to understand how the complaints occurred and to identify possible mitigations.
Results: The Instruction for Use (IFU) for both products was complete and technically correct. Some study participants read the IFU but then performed tasks based on intuition, producing behaviors consistent with reported complaint scenarios. These behaviors largely reflected mismatches between the product designs and users’ mental models. Searching for alternate off the shelf components revealed trade-offs: replacing one component often eliminated a single failure mode but introduced others. Supplier selection also introduced non usability constraints such as compatibility, quality system, and regulatory status.
Discussion: Four practical lessons emerged:
1. A design that is “safe and effective” does not guarantee a complaint free launch.
2. Pre-launch training and targeted user education at initial rollout are critical to bridge the gap between device functionality and users’ mental models.
3. Relying on the IFU alone is insufficient to mitigate usability risk; selecting components or formulations that align with user expectations is a preferred approach.
4. Product teams should adopt a comprehensive mitigation strategy that combines human factors testing, evaluation of alternative components, and enhanced complaint intake mechanisms to detect and categorize failure modes early.
Conclusion: Although the IFUs were complete and correct, both products failed to meet users’ expectations in practice, leading to recurring problems that instructions alone could not resolve. Replacing current off-the-shelf component with other off the shelf components resolved some issues but created new ones (for example, device compatibility, supplier and regulatory challenges). To reduce post market complaints, it is recommended:
• Fix design issues (device/formulation) when feasible rather than relying solely on instructions.
• Provide clear, focused training at product launch.
• Choose components or formulations that balance intuitive ease of use with supply and regulatory considerations.
• Improve complaint collection and process so new problems are identified and remediated quickly.
Event Type
Poster Presentation
TimeTuesday, March 244:45pm - 6:15pm EDT
LocationRhinelander Gallery