Presentation
Human factors activities in response to adverse events and customer complaints: Sharing experiences from post-market case studies
SessionAI/Risk (MDD6)
DescriptionWhile much focus is often placed on the design and development of new products and next releases, post-market activities are equally important, both from a regulatory perspective as well as to maintain a customer-first approach. Even the most comprehensive human factors plans and activities are unlikely to capture all potential use-related issues prior to a product’s market release, especially for complex systems. Additionally, some parts of the user interface might have been designed and developed prior to the implementation of a human factors program in accordance with the guidances and standards we adhere to today. The incorporation of human factors engineering into post-market activities can help ensure that use-related adverse events and customer complaints are properly addressed, and any modifications to the user interface are safe, effective, and aligned with user needs.
During this presentation, we will discuss a few case studies involving post-market activities that the usability team within Image Guided Therapy Systems at Philips Medical Systems has recently conducted. In these case studies, adverse events were reported from the field and, although risk assessments determined that the residual risk was acceptable, additional activities were conducted to see whether the risk could be reduced further. We will share the human factors activities conducted, special considerations given the limited scope of these post-market activities (compared to developing a complete new product), and lessons learned with considerations to how human factors can effectively collaborate with other stakeholders (e.g., system designers, clinical development, risk management).
Some case studies involve user interface components that are of unknown provenance and, therefore, had been originally designed without the application of human factors engineering. For these case studies, we will discuss our experiences of how we brought forward the value of post-market usability activities to other stakeholders, who (in some cases) might need some extra convincing to consider modifying system components that have already been in the field for many years. In one example, we applied our root cause analysis expertise to re-evaluate data collected during customer interviews to help educate development teams about how to get to the real underlying cause of adverse events in the field. In another example, we conducted interviews with customers (including some of whom had previously submitted related customer complaints) to re-evaluate user needs and organized a hands-on workshop with other stakeholders to help demonstrate and convince them of the issue at hand.
Other case studies involve design modifications made to the user interface in response to non-use-related issues (e.g., technical causes). For these case studies, we will discuss the unique considerations we took for these usability tests, given their limited scope. While the main goal of these evaluations was similar to that of a “standard” pre-market usability test – namely, demonstrating the safety and effectiveness of (new) risk control mitigations and the (modified) user interface – we also needed to consider how to design and conduct evaluations that focused on one specific component of a highly complex system and/or a particular worst-case scenario.
During this presentation, we will discuss a few case studies involving post-market activities that the usability team within Image Guided Therapy Systems at Philips Medical Systems has recently conducted. In these case studies, adverse events were reported from the field and, although risk assessments determined that the residual risk was acceptable, additional activities were conducted to see whether the risk could be reduced further. We will share the human factors activities conducted, special considerations given the limited scope of these post-market activities (compared to developing a complete new product), and lessons learned with considerations to how human factors can effectively collaborate with other stakeholders (e.g., system designers, clinical development, risk management).
Some case studies involve user interface components that are of unknown provenance and, therefore, had been originally designed without the application of human factors engineering. For these case studies, we will discuss our experiences of how we brought forward the value of post-market usability activities to other stakeholders, who (in some cases) might need some extra convincing to consider modifying system components that have already been in the field for many years. In one example, we applied our root cause analysis expertise to re-evaluate data collected during customer interviews to help educate development teams about how to get to the real underlying cause of adverse events in the field. In another example, we conducted interviews with customers (including some of whom had previously submitted related customer complaints) to re-evaluate user needs and organized a hands-on workshop with other stakeholders to help demonstrate and convince them of the issue at hand.
Other case studies involve design modifications made to the user interface in response to non-use-related issues (e.g., technical causes). For these case studies, we will discuss the unique considerations we took for these usability tests, given their limited scope. While the main goal of these evaluations was similar to that of a “standard” pre-market usability test – namely, demonstrating the safety and effectiveness of (new) risk control mitigations and the (modified) user interface – we also needed to consider how to design and conduct evaluations that focused on one specific component of a highly complex system and/or a particular worst-case scenario.
Event Type
Oral Presentations
TimeTuesday, March 262:35pm - 3:00pm CDT
LocationContinental Ballroom, Lobby Level
Medical and Drug Delivery Devices