Medical device packaging design is an integral part of delivering your device to market safely and securely, with the sterile barrier intact. Yet this critical process is often given little attention in the overall product development process. Most single-use sterile medical devices can be opened with a high degree of confidence that the product has maintained sterility throughout the product lifecycle, yet getting to this point can prove troublesome. Here are three steps to consider when designing your ideal medical device packaging system.
1. Start packaging design early in the product development process.
Thoroughly defining the requirements of a packaging system early in the product development process sets the stage for long-term success. Prequalifying those requirements prior to full package system validation will save time and money in the long-run. Preliminary evaluation of product-package compatibility allows for early detection of design or manufacturing problems and affords time for revisions prior to full validation. Identifying possible packaging system failures and addressing them proactively during early design phases greatly increases the chance of successful validation and patient safety. When this step is skipped or left to the final hour, short-cuts often utilized to save time and money can increase the risk of noncompliance with regulations. Instead, during this process different sterile barrier systems can be evaluated and manufacturing methods evaluated to best meet the needs and characteristics of a particular device.
Test failures are not an uncommon occurrence and must be taken into account during the development process. Failure to plan is planning to fail. By starting this process early in product development, these contingencies can be addressed early, and unwelcomed delays and added costs can be avoided.