USA – HFE for over-the-counter medical devices and combination products: Nice to have or necessary?

If you work for one of the many companies developing an over-the-counter (OTC) medical device or combination product, you might be wondering: Do I need to conduct human factors/usability work? And if so, what activities should I perform? Through this blog post, we will help you answer these questions for your individual case.

Definition of over-the-counter (OTC) healthcare products

First, when is something considered an OTC product? An OTC product is available without a prescription, such that it can be sold directly to the general public without seeking treatment or consultation from a healthcare professional (HCP). The latter is especially important to take into account when designing the OTC product, as the lack of HCP involvement means that users must be able to self-diagnose, self-treat, and self-manage their condition. Example OTC products include nasal sprays, wart removal devices, self-tests (e.g., pregnancy tests), and laser hair removal devices…