• Gain a clearer assessment of regulatory requirements
• Gauge the impact of risk assessment on device submission and clearance or approval
• Anticipate common review pitfalls
• Review schematic diagram of Use Risk Assessment techniques and their applications

The regulatory requirements for applying human factors to medical devices and combination products are constantly evolving, but have become progressively well-understood over the past decade. Increasing expectations for application of human factors to standalone drugs and similar products indicate that companies must be prepared to apply human factors in unique ways that may not follow the standard processes for devices. Additionally, human factors science can provide immense value when applied outside of the typical regulatory applications.

• Learn from cases of applying human factors to development of drug products
• Identifying when and how human factors expertise should be included in development
• Applying human factors science more broadly across organizations

Usability testing for pediatric users is especially difficult: patients can’t talk, can’t swallow certain formulations, and are more impacted by certain textures. When the actual device users are more likely to be caregivers, parents, and hospital staff, what are the extra complications you must bear in mind?

• Differentiate between use errors by caregivers and those by children
• Analyze a large-scale study evaluating pediatric challenges
• Gain clarity on what HCPs and caregivers prefer when working with this patient pool

Preclinical human factors validation studies have rapidly proliferated – but if a clinical trial is a truly controlled environment, will the manner of device use be proper for evaluating usability? Is it the right thing to do to hold a human factors study before Phase III – and if so, how should you proceed without clear guidelines?

• Evaluate whether you can use commercial IFUs for clinical studies or need to create separate ones
• Map the steps necessary for testing devices meant for home use
• Visualize the differences that regulators may expect from clinical to commercial stages

You don’t need to go through an IRB for every single study you do – but for those where it is necessary, it is a relationship you cannot afford to have go sour. Especially with tests involving pediatric users or their caregivers, novel devices will need special approval, and you will have to maintain a positive working relationship all throughout the process.

• Start with a clear vision of whether your device and/or user groups will require IRB approval
• Stay on the same page with your vendors regarding their IRB relationships and involvement thresholds
• Track the level of IRB involvement across different patient age cohorts or investigational drug vs placebo

The design of the user interface is everything, and when done poorly it is the antagonist in all human factors dossier regulatory submissions. In 1996, a CDRH working group published “Do it by Design: An Introduction to Human Factors in Medical Devices,” which promoted the concept of user-centered design and served as a primer for the impact of design upon safe and effective use of medical devices. This session provides a historical view to present revisions of human factors design standards while providing best practices for optimizing the design of any user interface.

• Review ergonomic design principles – where to find them and how to use them
• Grasp why simply reporting use errors is not enough to make meaningful changes in the design of the user interface
• Recap where we have been and what’s to come next in the revised ANSI/AAMI HE 75

The risk level of each task is determined in the original hazard analysis from the quality team, and then trickles down into other levels of analysis. By keeping your hazard analysis and risk assessment based on every step, you can determine what risks users truly face.

• Quantify the severity of harm to users if tasks are done inaccurately
• Ensure your team explores every task regardless of severity
• Follow the most recent regulatory guidelines

• Review new and historic regulatory guidelines
• Compare and contrast to U.S. and other markets
• Fine-tune your approach for Chinese regulatory authorities

On top of desk-based activities like task and risk analysis, formative usability studies are a helpful tool to uncover potential use errors associated with product use. How these use errors are analyzed and added to use-related risk documentation requires careful consideration of what was observed and associated root causes.

• Recognize different ways in which non-SME R&D team members might respond to formative study learnings that are more familiar to HF SMEs
• Appropriately define acceptance criteria during testing to ensure your formative usability studies are generating meaningful results
• Differentiate between participant feedback that is based on the participant's experience rather than speculation