As the “Just-in-Time” mentality has become more pervasive within the medical device industry, it has also resulted in many more package validation testing projects being rushed and left to the last minute.
While the “Just-in-Time” mentality is here to stay, it is also important to realize that this “Just-in-Time” mentality can pose a significant risk of compromising the overall validation of your package testing. In some instances, for example, we are seeing MDMs with test projects that just can’t be done in the timeline being requested. Or the quantities of samples they produce are not adequate to meet any type of statistical significance.
With that being said, there are a few things that packaging engineers can do to help improve the testing process.
- Give yourself at least a month (ideally two) to plan for your testing validation needs. As this will give you enough time to properly prepare and assure a successful outcome. Taking the time to better understand your test process up front vs. doing everything at the last minute will help reduce costs and help you meet your timeline.
- Bring your testing supplier into the conversation as early as possible to head off any potential issues. This will also ensure that you have a successful validation and the level of accurate data needed for submission. As the old saying goes, “failing to plan is planning to fail.”
- Communication is still the key. To be successful with package testing, MDMs must figure out a way to better communicate and disseminate the wealth of information and knowledge within their own walls. One of our clients for instance holds weekly conference calls with all its package engineers to share information across the company.
- MDMs should also be willing to challenge their vendors and ask why they are recommending a certain test, or how they will verify the data is correct. At the same time, MDMs must also be open to looking at possible alternatives suggested by their vendor to meet their specific needs.
- It is also important for MDMs to request and receive adequate reports from their testing lab that are clear and concise and helps paint a picture of the type of testing that was executed.
The ultimate goal for both MDMs and testing labs should be the same: validating the package and/or product to bring safe and effective products to market.
Please don’t hesitate to contact us if you have a question on an upcoming test, or need a quote on a project.