7 Costly Medical Packaging Mistakes and How to Avoid Them

Amazing medical devices let down by bad medical packaging? Unfortunately, it happens way more than it should in the medical industry.

We’ve met so many medical teams who came to us after experiencing the fallout from below-par packaging - devices damaged in transit, shipments stuck at customs, or sterile barriers compromised. It’s tough to see good work undone by poor packaging.

At SmartShield, custom packaging is our passion. It’s what we do every day: designing custom crates, cutting foam, and working shoulder-to-shoulder with healthcare teams to make sure life-saving equipment arrives safely and ready to use.

We get it. When you’re racing to develop or ship a critical device, packaging can feel like the least important detail. But a packaging slip-up can mean a recall, a customs headache, or even put patient safety on the line.

From our years of hands-on experience, here are the seven mistakes we see most often - and how you can steer clear of them.

1. Skipping the Regulatory Stuff

Nobody loves paperwork. But medical packaging is heavily regulated, and skipping key steps is like skipping your device’s safety testing.
 
In Canada, Health Canada expects compliance with ISO 11607 and other relevant standards, and if you’re shipping to the U.S. or EU you also have to meet FDA or MDR requirements.

SmartShield tip: Bring your packaging team into the process early. We build compliance into our designs right from the start, so you’re not scrambling at the end.

2. Forgetting About Sterile Integrity

It’s tough watching perfectly good devices get scrapped because the sterile barrier got compromised.  Even a tiny pinhole, a weak seal, or an unnoticed tear in the packaging can allow contaminants in and invalidate your product.

Then, once sterility is lost, the device isn’t just unusable, it becomes a potential liability. You’re looking at wasted product, regulatory headaches, and a knock to your reputation.

SmartShield tip:  Choose robust barrier materials and test those seals! We work with certified testing facilities where we can have your packaging tested and certified so you can be confident in the packaging’s performance before it leaves your facility.

3. Ignoring Temperature, Humidity and Dust

Electronics, diagnostics, medical liquids, even some implantables are temperature-sensitive. Add humidity or dust and you’ve got a recipe for failure.

SmartShield tip: Pair shock protection with insulated liners, cold or hot packs, and desiccants. We always simulate worst-case transit conditions before finalizing a design.

4. Transit Testing

This one’s huge. If you’re shipping MRI components or transplant equipment, one rough bump can cost thousands.

SmartShield tip: Do the drop tests. We build shock absorption and stabilizers into both our small and large shipments, then run them through comprehensive testing so there are no surprises in transit.

5. Defaulting to Single-Use When Reusables Make Sense

We know everyone wants to reduce waste and keep costs down. But we’re still seeing disposable boxes or packaging being used over and over for repeat shipments.

On paper it feels easier, but in reality, single-use packages add up quickly in expenses and environmental impact.

We’ve worked with customers who were shocked to see how much money they were throwing away on packaging that got binned after one trip. In some cases, the packaging itself became a bigger line item than the shipping.

SmartShield tip: Look for reusable. Heavy-duty crates with modular foam inserts are designed to last through multiple shipments without compromising protection. They usually pay for themselves after just a few uses and dramatically cut down on waste. We’ve helped clients switch to reusables and watch their costs and landfill contributions drop. Another happy side effect is their customers noticing the upgrade too.

6. Forgetting the People Who Open the Package

If healthcare staff are wrestling with your packaging or can’t find handling instructions, you risk damage and frustration.

SmartShield tip: We design with the end user in mind. Easy-open trays, ramps that double as lids, clear tamper-evident labels - all of it helps the device arrive safely and be ready to use.

7. Treating Packaging as an Afterthought

We’ve lost count of the times a team has reached out to us at the last minute. We completely understand, deadlines are tight and packaging often gets pushed to the end. But packaging is never just a box, it’s part of your device’s safety system. Building it in early makes everything smoother and safer.

SmartShield tip: Loop in your packaging designer early. Share your CAD files. We’ll prototype and test while your device is still in development, saving you time, stress, and money.

Ready to make your medical packaging one less thing to worry about?

We know how many moving parts go into launching or shipping a medical device, and packaging can feel like one more stress. That’s why our team at SmartShield is here to help.

From quick advice to full custom medical packaging solutions, we’ll work alongside you to design packaging that protects your devices, keeps you compliant, and makes life easier for your team. No jargon, no judgement, just our experience and passion for getting it right.

Let’s chat about how we can support your next project.