Written by Wes Bush, Director, Packaging Engineering at Network Partners
As a result of the COVID-19 pandemic, natural disasters, severe weather, and a labor shortage to boot, many medical device manufacturers (MDMs) are struggling to meet demand due to availability of packaging materials. As a result, these unfortunate events have caused many packaging materials to be delayed or unavailable. When your company produces life saving and/or improving products for patients, not having the critical packaging materials to package and distribute your products is not a good spot to be in.
Unfortunately, there is no immediate solution, as strong-arming your supply base to magically have the materials available will only get you so far. This article intends to provide a path to minimize the risk of future packaging material shortages that may impact your business and the patients that urgently need your products.
If the packaging materials that are being used are not a proprietary construct, seek out additional suppliers that can offer the exact same packaging material and component that meets your specifications. A new supplier will need to be qualified and evidence provided that an equivalent packaging component meets specification can be produced, but this is likely the shortage lead time and reduced overall effort to get the needed packaging materials to your dock, assuming the new supplier can get the materials sooner.
Review the impacted packaging material(s) across your product portfolio to determine which products and/or packaging systems would be prime candidates to qualify a second packaging solution comprised of an alternative, similar performing, and more readily available material. Your supply base will be able to guide you to comparable packaging solutions that may fit what you’re looking for.
For a Packaging Engineer, requalifying a new material for an existing packaging solution is often very similar to starting over, as many industry standard tests will need to be repeated to maintain compliance and ensure patient safety. However, this path is likely faster than changing any designs due to the ability to rationalize and leverage design criteria from the previously qualified material and packaging solution.
To go through the effort of qualifying, verifying, and validating a new packaging solution is no small task. In fact, it’s a huge undertaking and drain on resources across many functional groups. Instead of only changing out a material for one that’s more readily available, take full advantage of this opportunity and bring legacy packaging systems up to current standards and best practices. Do you have corporate sustainability goals? Now’s the time to reassess your packaging solutions for greener alternatives. Just getting started on EU MDR? Now’s the time to change packaging solutions since you must already resubmit to your Notified Body. Have outdated legacy package designs? Now’s the time to incorporate current features for improved usability and clinical outcomes. Facing cost savings initiatives? Now’s the time to review your portfolio for packaging consolidations and component reductions. The list goes on. The general idea is if you’re going to make a packaging change, make sure you’re getting the most out of your capabilities, even if it takes a little longer than just swapping out a material to one that’s more readily available.
Unfortunately, there is not an obvious or quick solution for your current packaging material supply chain issues. However, when evaluating options to de-risk future potential packaging material shortages, consider multi-sourcing, multi-qualifying, and/or taking multi-advantages to help provide your products to the patients that need them.
The Network Partners team is equipped with the knowledge and skills necessary to help you navigate a packaging a material shortage and can provide the required Packaging Engineering resources to implement a more readily available material. Contact a Partner today.