Stories and lessons: What works (and doesn’t) in collaboration between your Human Factors team and key team stakeholders?
TimeFriday, April 1611:00am - 12:00pm EDT
LocationMedical and Drug Delivery Devices
DescriptionThe role of human factors (HF) activities in the medical device and combination product industry has grown substantially over the past decade. Accordingly, companies functioning in these industries are steadily developing robust HF programs and increasing the size of their internal teams to address product development needs and meet the regulatory expectations. professionals conduct a variety of activities that have become standard expectations for any regulated medical product based on the evolving requirements of the FDA guidance, international regulations, and other industry standards. Though these HF activities can be executed by with relative autonomy, conducting HF work under a silo mode rarely achieves the goal of optimizing device design if collaboration with other key stakeholders is limited or delayed. Additionally, HF data can often be used by other functions to drive decision-making during development. Cultivating these relationships is mutually beneficial and can ultimately result not only in better products, but in teams that more deeply understand the how HF can be used outside the bounds of meeting the regulatory standards. This presentation aims to shine a spotlight on the interface of HF to other key stakeholders throughout the total product life cycle.
Medium to large companies often employ multidisciplinary teams to address product needs and work towards successful market approval. Though collaboration is always desirable, factors like short timelines, high workload, and lack of awareness can lead to siloed work. Some common roles in medical products companies and possible collaboration opportunities are outlined below. This presentation will highlight data gathered via survey from employees of medical device and combination product developers. We will explore pain points and areas for improved collaboration.
The presentation will explore the expectations and perceptions of the interface points between HF and:
• Incorporating HF activities into the overall design control process; for example: design inputs, outputs, design reviews, verification, and validation.
• Collaborating with HF team on developing user interface evaluation methodology.
• Developing risk assessment methods that accommodate different needs (e.g., process, design, or use-related risk)
• How to consider use-related risk in the overall product risk profile
• Difficulties translating general hazards to more specific use errors
• Reconciling how HF concerns may differ from other risk programs (e.g., focus on severity of harm, difficulty in estimating occurrence ratings accurately)
• Incorporation of HF work into the entire submission package
• Learnings from previous submissions and trends in regulatory thinking
• Instances in which projects may need to deviate from the standard HF expectations
• Understanding how HF data translates to determining product safety and effectiveness
• Using traditional market research activities to collect data relevant to HF
• Reconciling differences between marketing materials and the regulated elements of the user interface (e.g., instructions for use)
• Consolidating resources to achieve multiple goals with fewer research activities
Research & Development
• How HF study results are incorporated into product requirements
• Presenting data in a way that resonates with both parties
• Reconciling new product features with user needs
• Incorporating information to drive design changes