Complex generic drug-device combination products are typically difficult to develop, which means that many of these products face less competition than non-complex products, and therefore can be more expensive and less accessible to patients. A generic drug-device combination product is expected to produce the same clinical effect and safety profile of the reference listed drug; however, it does not need to be identical in all respects, and in certain instances, differences in the design of the user interface for a generic combination product may exist.

• Recognize how FDA evaluates differences in UI for generic combination products
• Learn to identify factors that inform categorization of UI differences
• Discuss pre-ANDA interactions with FDA to enhance submission quality

Incorporating HFE into product development and compiling HFE documentation that meets the increasingly stringent requirements of regulators globally can be challenging and costly. This presentation describes considerations and approaches that can be taken to build robust HFE strategies that are efficient and cost effective, taking into account differing global requirements and ensuring product designs and documentation are acceptable to regulators.

One of the biggest pitfalls for device designers is starting HFE too late in their projects. Once the device is already designed, attempting to back-fill HFE files and run validation studies with the assumption that it will pass is a recipe for disaster, and one you need to take pains to avoid – every time.

• Clearly document the story of how HFE was involved in your design from start to finish
• Note the steps that made your device easier and/or safer to use
• Avoid drawing broad conclusions from a small or even unique data sample

It is actually possible to go too far in making user groups comfortable. Under normal use conditions, they may feel anxiety and fear about using the device – and your tests need to represent and capture this.

• Recognize that it is impossible to eliminate all stresses, distractions, and time pressures in real-use circumstances
• Acknowledge the testing risk of overly relaxed users, who don’t pay attention, listen to instructions, or try their best to use the product as intended
• Emphasize that the users themselves are not what the test measures

Should your IFU be written at an 8th grade reading level – or does that bring unnecessary risk of user confusion and stumbles? Understanding and asking questions about user literacy is time-consuming, but pays off when it comes time for summative testing.

• Closely analyze user literacy levels – including to outsourced specialty partners when necessary
• Correlate clinical studies with what goes into IFUs
• Build efficacy data back into HF studies

From specialized physicians to rare disease populations, certain device user groups can be very hard to contact or recruit in sufficient numbers. This rarity can also raise ethical concerns about the testing itself.

• Get clarity from FDA on acceptability of surrogates
• Weigh pros and cons of smaller sample sizes
• Track patterns in mixed responses and chart a new way forward
• Make sure you are not naïve about the expectations of physicians

How much detail is necessary for use cases and uFMEA reports? Does this change based on the simplicity or complexity of the device? It can be challenging to strike the appropriate balance on providing detail in uFMEAs and overall usability engineering reports so they remain manageable in size for external reviewers.

FDA focuses only on harm, not probability – but without it, can we really assess risk? Risk mitigation strategies often lean heavily on IFUs, which can make them overcomplicated and off-putting for users.

• Confront the trade-off on risk analysis
• Avoid the trap of accounting for every possible risk in a user-unfriendly IFU package
• Acknowledge the importance of probability and severity in honest risk assessment