| Summary: | 碩士 === 中原大學 === 工業工程研究所 === 96 === Since pen injectors have been marketed, it has been commonly used for insulin delivery. It provides people with diabetic convenient and safe injection at home comparing with traditional injection performed with syringes. Considering this, diabetics and their family are getting used to take and give insulin shots using pen injectors. As a result, more and more medical devices makers have recently focused on the development of new pen injectors offering a large variety of functions for the delivery of different medicines. Moreover, manufacturers advertise newer products such as auto-injectors. However, dose accuracy and dose precision remain the primary functions of the device.
This study consists of testing the dose accuracy and precision of a multi-dose and reusable pen injector through the discipline of Design of Experiments (DOE) and in accordance with the Measurement System Analysis (MSA) to identify the variations in linearity, bias, and precision. The purpose of this study is to verify the performance of the pen injector for dose accuracy and dose precision; to provide the R&D team with a rational method for evaluation and analysis; and finally to help the engineers to conduct the analysis for dose accuracy and dose precision on the pen injector during the R&D phase, in order to rapidly and accurately uncover potential failure modes, and decrease the time to product release and cost.
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