So, you’re working on a new medical device or combination product.
You may need human factors testing to bring this product to market. You’ll find yourself in one of two groups:
- My product will require human factors validations (HFV) testing; or
- I can justify not performing HFV testing.
Which path do I pursue?
So how do you know which path to pursue? Historically this was largely based on your regulatory path. For example, if pursuing an ANDA, you likely were not too concerned about performing HFV testing.
However, the current guidance from the FDA is that this will come down to the risk associated with your specific product. HFV will be determined based on your product’s use risk and whatever equivalency claims can you justify to a comparable product. For those who may be unfamiliar with the human factors process, use risk is the risk your product poses to its users as a result of them interacting with its interface. The FDA details their preference for how to analyze use risk in their guidance Purpose and content of use-related risk analyses for drugs, biological product, and combination products.
Use Related Risk Analysis (URRA)
If you need more assistance on how to draft a URRA, I recommend reviewing Greenlight Guru’s free webinar Use related risk analysis & how it applies to medical device development. In this webinar my colleague and I provide a detailed overview of both the theory behind a URRA and its construction.
So let’s assume you have completed your URRA; what now? The results of the URRA will have identified that your product either:
- Bears sufficiently low enough risk that there will be no critical tasks directly related to the product, or
- Does not bear sufficiently low enough risk, and there are critical tasks directly related to the product.
If your product is low risk, you may be able to use the URRA results to justify why a full HFV study isn’t required. However, if your product includes critical tasks, you must demonstrate that it is safe and effective for use. Typically, this involves following Path 1 and conducting HFV testing. Alternatively, the FDA permits a comparative analysis approach, showing that your product is sufficiently similar to an existing market product.
Comparative Analysis
The purpose of the comparative analysis is to demonstrate that any use related differences between the product in development and the commercial product are considered “no more than minor.” Meaning if you were to pull the existing product out of the user’s hand and replace it with your own, they would be able to safely and effectively complete their tasks without needing to take the time to familiarize themselves or be trained to the new product. To perform a comparative analysis effectively, you will need to:
- Compare all product labeling (including instructions for use)
- Complete a comparative task analysis (The FDA prefers this to be done via the PCA [perception, cognition, action] method)
- Perform a physical comparison of all components within each system
Depending on the results of the comparative analysis you will either have sufficient justification to claim the “generic” product does not create any new use risk and omit performing Human Factors Validation; or a clear indication that you will need it.
About the Author
With 8 years in the medical device industry, David Orenstein specializes in human factors engineering, conducting user studies, risk analysis, and reporting for medical devices and combination products. As a Senior Human Factors Engineer at Sanner, he leverages his expertise to ensure devices are designed with patients and users in mind.