Seeking a common human factors language for the development and testing of injection devices
Injection devices include drug–device combination products incorporating a needle for subcutaneous medication delivery. Often utilized by patients and caregivers, it is important for injection device user interface (UI) design to be intuitive to use outside of a traditional healthcare setting. To en...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2025-12-01
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| Series: | Drug Delivery |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/10717544.2025.2541660 |
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| _version_ | 1850042792618754048 |
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| author | Megan O. Conrad Molly E. Laird Mary Beth Privitera Melissa R. Lemke Molly Follette Story |
| author_facet | Megan O. Conrad Molly E. Laird Mary Beth Privitera Melissa R. Lemke Molly Follette Story |
| author_sort | Megan O. Conrad |
| collection | DOAJ |
| description | Injection devices include drug–device combination products incorporating a needle for subcutaneous medication delivery. Often utilized by patients and caregivers, it is important for injection device user interface (UI) design to be intuitive to use outside of a traditional healthcare setting. To ensure safety and efficacy, the FDA requires a human factors (HFs) assessment as part of a new drug application (NDA) for new drug products and through the abbreviated new drug application (ANDA) pathway for generic drug approval. Despite the importance of defining injection device features as part of the HFs assessment, no comprehensive list of related definitions has previously been established. This paper compiles such definitions creating a common language for use in HFs assessments. Specifically, injection device classifications and characteristics are defined and then related to UI features and common tasks required for successful devices use. Information presented can be applied during device development and testing creating a common language for engineers, designers, and regulators. The definitions may be especially impactful for the approval of generic injection devices as the ANDA pathway for generic drugs requires a UI comparison of the proposed generic device to that of the existing reference listed drug. |
| format | Article |
| id | doaj-art-9977599490ef443dbbecdf54a1987c70 |
| institution | DOAJ |
| issn | 1071-7544 1521-0464 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Drug Delivery |
| spelling | doaj-art-9977599490ef443dbbecdf54a1987c702025-08-20T02:55:27ZengTaylor & Francis GroupDrug Delivery1071-75441521-04642025-12-0132110.1080/10717544.2025.2541660Seeking a common human factors language for the development and testing of injection devicesMegan O. Conrad0Molly E. Laird1Mary Beth Privitera2Melissa R. Lemke3Molly Follette Story4Mechanical Engineering, University of Detroit Mercy, Detroit, MI, USAHS Design, Morristown, NJ, USABiomedical Engineering, University of Cincinnati, Cincinnati, OH, USAHuman Ability Designs, Detroit, MI, USAHuman Spectrum Design, LLC, San Carlos, CA, USAInjection devices include drug–device combination products incorporating a needle for subcutaneous medication delivery. Often utilized by patients and caregivers, it is important for injection device user interface (UI) design to be intuitive to use outside of a traditional healthcare setting. To ensure safety and efficacy, the FDA requires a human factors (HFs) assessment as part of a new drug application (NDA) for new drug products and through the abbreviated new drug application (ANDA) pathway for generic drug approval. Despite the importance of defining injection device features as part of the HFs assessment, no comprehensive list of related definitions has previously been established. This paper compiles such definitions creating a common language for use in HFs assessments. Specifically, injection device classifications and characteristics are defined and then related to UI features and common tasks required for successful devices use. Information presented can be applied during device development and testing creating a common language for engineers, designers, and regulators. The definitions may be especially impactful for the approval of generic injection devices as the ANDA pathway for generic drugs requires a UI comparison of the proposed generic device to that of the existing reference listed drug.https://www.tandfonline.com/doi/10.1080/10717544.2025.2541660Pen injectorsautoinjectorspre-filled syringetask analysisuser interfaceDDCP |
| spellingShingle | Megan O. Conrad Molly E. Laird Mary Beth Privitera Melissa R. Lemke Molly Follette Story Seeking a common human factors language for the development and testing of injection devices Drug Delivery Pen injectors autoinjectors pre-filled syringe task analysis user interface DDCP |
| title | Seeking a common human factors language for the development and testing of injection devices |
| title_full | Seeking a common human factors language for the development and testing of injection devices |
| title_fullStr | Seeking a common human factors language for the development and testing of injection devices |
| title_full_unstemmed | Seeking a common human factors language for the development and testing of injection devices |
| title_short | Seeking a common human factors language for the development and testing of injection devices |
| title_sort | seeking a common human factors language for the development and testing of injection devices |
| topic | Pen injectors autoinjectors pre-filled syringe task analysis user interface DDCP |
| url | https://www.tandfonline.com/doi/10.1080/10717544.2025.2541660 |
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