Efficient design framework for developing and demonstrating auto injector reliability [White paper]
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Booth, D. and Bayford, R. 2023. Efficient design framework for developing and demonstrating auto injector reliability [White paper]. GovWhitePapers.
| Title | Efficient design framework for developing and demonstrating auto injector reliability [White paper] |
|---|---|
| Authors | Booth, D. and Bayford, R. |
| Abstract | The purpose of this paper is to provide an overview of the impact design frameworks and their associated methods have in developing products that are required to be highly reliable. Preliminary product development results are shown for two U.S.-based companies whose design teams are using the Improved Product Reliability Development Framework (IPRDF) to quickly design high levels of reliability into their emergency-use injectors. Both design teams achieved the FDA requirements for device reliability, reaching 99.9999% system-level reliability with a 95% confidence level after optimizing their designs. |
| Keywords | medical technology; quality assurance; system reliability; technology and manufacturing innovation |
| Sustainable Development Goals | 9 Industry, innovation and infrastructure |
| 3 Good health and well-being | |
| Middlesex University Theme | Health & Wellbeing |
| Publisher | GovWhitePapers |
| Publication dates | |
| 21 Dec 2023 | |
| Publication process dates | |
| Deposited | 03 Dec 2025 |
| Output status | Published |
| Web address (URL) | https://govwhitepapers.com/whitepapers/efficient-design-framework-for-developing-and-demonstrating-auto-injector-reliability |
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