Design Strategies for Safe Combination Medical Products

Combination products, such as injection devices, inhalers, nebulizers, and drug patches, are increasingly being used by laypeople for self-administration at home. Regulators such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) want to ensure that all users – and laypeople in particular – can administer the correct dose at the right time to the right part of their body. Manufacturers have a responsibility to predict likely use errors and, wherever possible, to “design out” the error such that the user automatically uses the product as intended. Designing the user interface such that use error is impossible, or unlikely, is the preferred and most effective approach to reducing use-related harm. The weaker alternative is to rely on instructions and training to avoid use errors; labeling and training are also valuable risk mitigations but should not be the primary ones.

In this white paper, we'll review some of the most common combination products use errors and how to approach combination product design to help ensure safe use.