December 1, 2022

Packaging Validation Planning Insights

Valuable packaging planning insights from your medical device packaging partner

Launching a new medical device is exciting. Opportunity is in the air to improve patient health, and every manufacturer is on the lookout for increased revenue and growth. With that excitement comes looming anxiety. A common problem that many start-up medical device manufacturers face is not understanding the full scoop of medical device packaging requirements before they get too far down the road. They make assumptions about what kind of shipper and packaging can be used along with the kinds of sealers that are acceptable. Then they find out their product launch is held up because lead times for packaging and sealing equipment and timelines for packaging projects take longer and are more complicated than expected.

The excitement fizzles out, and you’re left feeling overwhelmed, disappointed, and wondering what steps you need to take to get your launch back on track.

PCL’s co-founder and Vice President of Packaging Engineering Ryan Erickson completely understands that packaging validation requirements are often misunderstood by leadership teams of small companies. “In my experience, if the leadership team isn’t aware of the requirements for validating sterile packaging, they’re oftentimes surprised at what an undertaking it is,” he says. “I wish I would have educated the leadership team that the package can’t just go into any pouch, and we can’t use just any sealer. There are FDA regulations and ISO 11607 standards to navigate, and I discovered that the earlier you can start, the fewer surprises you’ll encounter.”

PCL’s Packaging Planning Checklist is a useful tool to help you anticipate the requirements for your sterile packaging to achieve a smooth product launch. Whether you work with the PCL team to ensure compliance with ISO 11607 for validating sterilized medical device packaging or are interested in PCM’s contract packaging services, our packaging checklist will help you meet your product launch goals.


Start Packaging Planning Early

No matter the device size or estimated quantity for a new product launch, PCL’s team of packaging professionals will guide you through your project launch so you’re aware of factors that will affect your launch schedule and budget.

First, the packaging cost is not insignificant nor is a quick turnaround. The total cost for funding the packaging process includes design to meet engineering protocols, manufacturing, and validation. Elements include FDA and ISO 11607 compliance requirements, tooling & dies, packaging materials, pre-validated or custom packaging alternatives, and printing for boxes.


Factors to Consider

  • Does the initial idea for your package make sense? Many factors help determine what kind of packaging makes the most sense for device: annual volumes, budget, device features/environmental sensitivities, etc.
  • Do you want a custom packaging solution? Some pre-validated packs and trays are perfect for some devices, and others need more customization. It’s important to weigh alternatives to keep your launch on track.
  • What medical device packaging experience does your in-house team have? If you rely on your in-house staff and resources, you may run into problems with sophisticated packaging equipment operations, and maintenance and dialing-in process settings can be complicated.
  • What information is needed to help management understand packaging process requirements as part of the product launch plan? Executives want to quickly know the facts that will impact the bottom line. Showing your packaging launch plan in an easy-to-understand spreadsheet will help them understand complete costs, tooling fees, lead times, material comparisons, volume tiers, etc.

Download our Checklist Here

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