Choosing Between a Custom or Off-the-Shelf Pouch

When it comes to selecting a pouch for your medical device, should you use a custom pouch or an off-the-shelf stock pouch? The answer is often determined by how quickly you need to get your product to market, making lead time a determining factor. While there are benefits to each, choosing the right type of pouch is about finding the proper fit for your device and functionality to ensure your device stays safe and sterile until the point of use. In this article, we are going to break down some of the differences, benefits, and ideal use cases for each type.

Custom Pouches

Not all devices fit into standard formats. In many cases, forcing a device into a standard pouch can compromise sterile barrier integrity or usability. Which is why custom pouches are engineered specifically to a device’s specifications. Material combination, sizing, and opening style are chosen to accommodate the device's geometry, barrier needs, sterilization, and distribution environment. Custom pouches often require more time for design up front but are the preferred option for many devices.

Key Benefits

• Precise Fit and Protection: Reduces movement, abrasion, or puncture risk.
• Engineering Flexibility: Materials are uniquely chosen to accommodate the features and barrier needs of your device.
• Custom Printing and Usability Options: Branded printing, tear or thumb notches, hang holes, and other customizations make your pouch unique and appropriate for the end user.
• Economies of Scale: With high-volume orders, cost savings can occur with custom pouches.
• Included Validation and Technical Data: Often include validation of the material combination and a summary of Operational Qualification (OQ) and Performance Qualification (PQ) data to help with validation requirements.

Ideal Use Cases

• High-risk or high-value implants and instruments.
• Devices with sharp, delicate, or irregular geometries that require a unique size.
• Products requiring specialized materials to accommodate barrier properties (e.g., moisture or oxygen sensitivity) or sterilization methods.
• Large volume orders needed for market production.

Off-the-Shelf Stock Pouches

Stock pouches are ready-to-purchase pouches that use a standard size and material combination. They are used most often for development, prototyping, testing, validation, and to help cover low inventory levels. Stock pouches offer the greatest value when speed-to-market is the primary driver. By choosing an off-the-shelf option, you can avoid lead times associated with custom tooling and manufacturing, while still having a quality pouch produced on production equipment.

What is the difference between off-the-shelf stock pouches and pre-validated pouches? Pre-validated pouches are off-the-shelf pouches that often come with additional validation and technical data from the supplier. While this can help speed up validations and get to market more quickly, simulated transit testing and aging studies will still need to be conducted before going to market.

Key Benefits

• Fast Availability: No lead times or tooling requirements.

• Supplement Low Inventory: Ideal for small batches or short production runs.

• Useful for Packaging Validation: Can be incorporated into a full validation program.

• Included Validation and Technical Data: Stock pouches often include validation of the material combination and a summary of OQ and PQ data to help with validation requirements.
  

• Early prototyping and engineering builds.

• Low-risk or disposable medical products.
• Temporary solution before a custom pouch is finalized.
• Small volume needs.
  

WATCH OUT! When using stock pouches, it’s important to be aware of the following:

• Know who the supplier is and verify that the pouch you’re purchasing comes with proper documentation and traceability so that it’s compliant with ISO standards.

• Ensure the pouch is rightsized for your device. Incorrect sizing can lead to failed transit testing and risks damage to the device.

• Confirm your off-the-shelf option is compatible with the sterilization modality that your device will be using.

Each pouch, whether custom or off-the-shelf, serves a distinct purpose in the medical device supply chain. Custom pouches provide engineered protection for complex or high-value devices, while stock pouches offer speed and availability for early development products. By understanding the unique strengths of each option, you can choose packaging that aligns with your device’s protection needs, regulatory requirements, and speed-to-market goals. Regardless of what you choose, various tests still need to happen after you’ve selected a pouch to ensure the packaging and your device comply with all ISO validation requirements.