ISO 13485:2016
DEVICE DEVELOPMENT

Pacemaker
Packaging & Labelling

The project focused on the development of packaging and labeling solutions for a range of medical devices manufactured by St. Jude Medical, including the Tendril SDX, Atlas + HF, and Identity ADx XL DR. These devices are critical components of St. Jude Medical’s product portfolio and required meticulously designed packaging and labeling to ensure regulatory compliance, convey essential product information clearly, and differentiate them effectively in the market.

Background and Challenges

Developing packaging and labeling for medical devices like the Tendril SDX, Atlas + HF, and Identity ADx XL DR poses multifaceted challenges. Ensuring regulatory compliance with stringent FDA standards, alongside conveying essential product information clearly and concisely, presents a significant hurdle. Moreover, differentiating products in a competitive market while adhering to branding guidelines requires careful consideration.
Logistical complexities in the supply chain and the need to accommodate multilingual requirements further complicate the process. Addressing these challenges demands close collaboration between St. Jude Medical and Nectar, necessitating a deep understanding of regulatory requirements, industry standards, and effective packaging and labeling design practices for medical devices.

Achieving Results with Nectar

Packaging Design
Nectar’s packaging design expertise ensured that the packaging for these medical devices not only provided adequate protection during transit but also enhanced the overall presentation and brand perception. They crafted packaging solutions that were not only functional but also visually appealing and consistent with St. Jude Medical’s branding guidelines.
Labeling Design
Nectar meticulously designed the labels for the Tendril SDX, Atlas + HF, and Identity ADx XL DR devices, ensuring compliance with regulatory requirements and industry standards. They incorporated essential information such as product specifications, usage instructions, and safety warnings in a clear and concise manner, facilitating user understanding and compliance.
Usability Testing
Nectar conducted usability testing to evaluate the functionality and user-friendliness of the pacemaker packaging. This involved gathering feedback from healthcare professionals to identify areas for improvement and ensure that the packaging met their needs in clinical settings.
Regulatory Compliance
Nectar played a crucial role in ensuring that the packaging and labeling designs adhered to regulatory requirements and standards specific to the medical device industry. This involved thorough knowledge of applicable regulations and standards, as well as meticulous attention to detail to ensure all necessary information was included and accurately presented.

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