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Combination Products: Common Use Errors and Design Considerations

Combination products, such as injection devices, inhalers, nebulisers, and drug patches, are increasingly being used by laypeople for self-administration at home. Regulators such as the FDA and the 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; labelling and training are also valuable risk mitigations but should not be the primary ones.

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Richard Featherstone leads Emergo by UL’s Human Factors Research and Design (HFR&D) team based in Europe. He is an experienced human factors and usability practitioner and the founder of Medical Device Usability. Richard helps clients develop their human factors/usability engineering strategy and identify activities needed to ensure usability work complies with the MDR, as well as other regulatory imperatives for applying human factors engineering during product development.

Linda Giesselink is a Managing Human Factors Specialist and has been with the HFR&D team since 2015. She has experience delivering HFE services to the medical device and pharmaceutical industries. Linda leads and oversees research and design activities such as conducting usability tests and design of user interfaces and user documentation.
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Richard Featherstone
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Linda Giesselink
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