RFID Needle Shield Assembly for Injection Device Traceability
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Solution Overview
Problem
Existing medical injection devices lack a comprehensive tracking system that allows for data recording and retrieval throughout their life cycle, making it difficult to trace the history, quality control, and identify root causes of device issues.
Innovation Solution
Incorporating an RFID tag into the needle shield assembly of an injection device, which functions as a read-write device to store and transmit data from manufacturing to end use, ensuring traceability and quality control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of information
If an RFID tag is incorporated into the needle shield assembly, then traceability and data recording capability are improved, but device complexity increases
Solution Approach 1:
The RFID tag is integrated into the needle shield assembly, merging the tracking function with an existing structural component. This allows the needle shield to serve dual purposes: protecting the needle and storing product lifecycle data, thereby improving traceability without adding a completely separate system
Solution Approach 2:
The needle shield assembly is transformed into a multi-functional component that provides both mechanical protection and data storage/communication capabilities. The RFID tag enables the same component to participate in both physical safety and information tracking functions
2Loss of information
If an RFID tag is incorporated into the needle shield assembly, then product lifecycle tracking is improved, but manufacturing complexity increases
Solution Approach 1:
The RFID tag is attached to or integrated with the needle shield assembly during the shield's manufacturing process, before the shield is assembled with the syringe and other components. This preliminary integration ensures the tracking capability is established early in the product lifecycle and simplifies subsequent assembly operations
Solution Approach 2:
The RFID tag integration is combined with the needle shield manufacturing process itself, rather than being a separate post-assembly step. This merging of operations reduces the total number of manufacturing steps and simplifies the overall production workflow
Data Source
AI summary
The present invention relates to an RDID tag enabled shield assembly that provides a sterile enclosure of a medicament delivery port of a medicament container. The container can be a needleless pre-filled syringe, a vial, a cartridge, or a collapsible bag or pouch. The RFID tag is fixedly attached to one or more components of the shield assembly through co-molding or another form of permanent or removable attachment. The present invention also relates to a method of tracking the life cycle of a medicament container or a medicament injection device where the RFID tag enabled shield assembly attached to the medicament container. Data is written to or read from the RFID tag during the entire life cycle of the medicament container or injection device, including assembly, packaging, storing, distribution and use.