Home based Human Factors evaluations

How can we best develop medical devices for use at home? For home use devices, including combination devices, over the counter (OTC) products, and many others, it is expected that users will engage with their devices in their homes and other non-clinical environments. Read 2 of our case studies on these types of results.

Combination Products

Combination products often pose unique design challenges and regulatory authorities have specific expectations regarding human factor submissions. Thus, HF engineering is a critical part of the product development lifecycle and market success.