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Medical Device Packaging: Considerations For Product Developers

 In an article on the MedicalDeviceonline.com website, Peggy Fasano of Boulder iQ gives her advice on packaging design for medical device designers. Below, we summarise the key points of this article.

Importance of Early Packaging Integration in Medical Device Development

Incorporating packaging considerations early in the medical device development process is crucial for ensuring a successful product launch. Treating packaging as an integral part of the device’s design can reduce stress, minimize risks, enhance product effectiveness, and avoid unexpected costs.

Impact of Packaging on Product Success

Design Considerations: Packaging affects not just the shipping and sterilisation of a medical device but also the overall user experience. Effective packaging must cater to both initial launch goals and long-term requirements, such as international shipping and compliance with regulatory standards like CE marking. Planning ahead ensures packaging materials and design do not become obstacles, thus maintaining timelines, controlling costs, and supporting sales.

Example of Implant Packaging Flaws: A company faced significant challenges with their initial packaging design for an implant. Their double-pouch system in a carton, meant to ensure sterility, was cumbersome for surgeons to use in the sterile field. This poor usability led to the need for redesign, additional testing, and a substantial delay and financial loss. This underscores the need to focus on usability and effectiveness of packaging right from the start.

Key Steps for Effective Packaging Design

  1. Define End Users and Their Needs:

Identify who will handle and use the device—be it administrative staff, nurses, doctors, or patients. Understanding their interaction with the device and packaging helps in creating a user-friendly product. Engaging stakeholders early in the development process can avoid costly redesigns later.

  1. Understand Device Usage Scenarios:

Evaluate how each user will use and store the device, considering aspects like shelf space, labelling visibility, and disposal of packaging. This comprehensive analysis helps in designing packaging that enhances user experience and adoption.

Logistics and Practical Considerations

Shipping and Storage: Packaging must protect the device during shipping and meet various logistical requirements. Early consideration of the shipping life cycle, international shipping needs, volume configurations, and storage conditions helps in designing packaging that is robust and compliant. For instance, planning for specific transport conditions and regulatory requirements prevents compliance issues and ensures smooth distribution.

Packaging Material and Cost Management

Material Choices:  Decisions on packaging materials should consider availability, cost, and functionality. Understanding end-user priorities, whether focused on appearance or function, guides material selection. Adjusting packaging elements based on stakeholder visibility can optimize development costs.

Sterilisation Requirements

Sterilisation Methods and Packaging Design:

Packaging must align with the chosen sterilisation method (e.g., ethylene oxide, gamma, or steam). Each method has unique requirements for packaging materials and configurations. Early collaboration with sterilisation vendors can optimize space and reduce costs. Properly sealed packaging is essential to prevent contamination post-sterilization, with packaging size directly impacting sterilisation efficiency and cost.

Conclusion

 Strategic Packaging Integration:  By integrating packaging design early in the medical device development process and treating it as a core component of the product, developers can save time and reduce costs. This approach ensures smoother market entry and better resource management, leading to a product that meets market needs effectively.

You can read the original article here.

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