If you’ve gone through the development process, you know custom designs are costly and take time. Pre-validated packaging solutions eliminate some of these pain points. Not only is the design ready-to-go, but initial steps of the sealing validation are also done (i.e., OQ and DOE). Generally, an aging study has also been performed. The convenience of pre-validated packaging is often a gamechanger for start-ups and smaller medical device manufacturers (MDMs). We sat down with Sean Coast, Staff Engineer at PCL, to discuss everything you need to know to determine if your project is a good fit for pre-validated packaging.
Is Your Medical Device Suited for Pre-Validated Packaging?
Pre-validated packaging has become increasingly common in the industry and is readily available. Yet there will always be some medical devices and products that require custom packaging solutions. Customers with “drop-and-seal” medical devices are ideal candidates for pre-validated solutions. Drop-and-seal healthcare products typically feature simple geometry. They don’t need extra protection, design iterations, or custom backers—they can be dropped into the package and sealed. For a multi-SKU family of medical devices, a fit check gives an initial analysis on whether the system is appropriate given the SKU variation.
Multi-SKU products are generally similar in geometry, mass, etc. Some variances can be found but ideally won’t require alterations in how it is packaged if a pre-validated system is desired. Say you have 30 SKUs in a family and 20 of them can be packaged the same way. The remaining 10 SKUs have a feature that needs additional TPU protection. Now, they can’t all be packaged the same and it is more complex. The more outliers present, the more closely the benefits of pre-validated packaging should be weighed against the challenges.
Why Choose Pre-Validated Packaging?
The unknowns of getting to market evolve into stressful hurdles. Custom packaging solutions can generate cost-creep and unforeseeable delays. The advantages of pre-validated packaging can mitigate surprises in favor of:
- Ensuring an easier, faster route to market
- Delivering more cost control, with fewer product-specific determinations
- Providing resources and quality assurance for start-ups newer to the market
- Leveraging existing vendor relationships, eliminating material searches and design development
- Checking off validations that are already completed
- A variety of sizes for different sized devices
With Pre-validated Packaging, What Remains to Be Done?
Pre-validated packaging is designed to provide a ready-made solution for a wide range of clients. However, device-specific validations still need to be completed, an aging study, for example. The pre-validated packaging system would have been subjected to an aging test to provide data for the packaging itself. That data speaks to how the packaging performs over time, but not the packaged, sealed medical device. If the client requires device-specific testing for an FDA submittal, those tests will include a Performance Qualification (PQ), Design Verification (DV), and any device-specific aging tests.
Sometimes, a product will align with a pre-validated packaging solution but encounter a failure along the way. Let’s say a pre-validated tray system fits your device; the data has been validated for DOE, OQ and accelerated aging, but when your medical device is sealed in the packaging and undergoes transit testing, a failure occurs. Even with best practices and sound data, these failures can still happen and must be identified and corrected. Still, the necessary requirements to fix it are likely to be less intensive than fully custom packaging.
Is Pre-validated Packaging Cost Effective?
Pre-validated packaging systems are generally less expensive than a custom design. They are seen as a “one-size-fits-most” solution. It is more accurate to consider what unknowns and costs are removed from the overall fee. A big benefit of pre-validated packaging is the removal of some of the line items that start to add up, in addition to the value saved in time by the faster track to market.
What are the Downsides of Pre-validated Packaging?
Fortunately, the upsides of pre-validated packaging far outweigh the downsides. One possible downside is that a sterile barrier breach or transit failure can happen. That said, it is a controlled downside in the sense that many other factors have already been validated, so the odds are highly in your favor.
Another con could be that, because of the broad appeal that a pre-validated packaging system has to have, it may not have the specific aesthetic you imagined. Looking at the big picture for many medical devices, when patient safety is one of the utmost concerns, aesthetics tend to be less critical. Especially when it’s an MDMs first product launch, getting it to market is paramount; specific aesthetics are expendable.
Key Takeaways
When truncated timelines and smaller budgets seem like an insurmountable roadblock, pre-validated packaging could be the answer. The convenience of pre-validated packaging has pushed companies to produce more options, making it easier for MDMs to find a packaging solution that will work for their device.