The design of a medical package requires balance. As a device developer/engineer, it's easy to get tunnel vision for the product itself, but there’s an important factor that can't be forgotten: the end user.
Truly great medical device packaging is a dance between what’s best for the device and what’s best for the consumer.
This “Goldilocks Zone” is totally achievable; below are some guidelines for getting your packaging “just right.”
Maintain Absolute Sterility
Sterility is an omnipotent concept that is top of mind for every engineer who designs medical devices, so it goes without saying that your packaging must support your devices' sterilization requirements.
Sterilization cannot be compromised. A contaminated device isn’t worth the material it’s made from. So however your device is being sterilized - "moist heat (steam), dry heat, radiation, ethylene oxide gas, vaporized hydrogen peroxide, or other sterilization methods (for example, chlorine dioxide gas, vaporized peracetic acid, and nitrogen dioxide)" - you need a package design and material that can withstand it.
Oxidation is a risk for just about any custom package design that needs to sustain a long shelf life. So your packaging needs to account for when the product will be used. Polymer-based packaging solutions tend to be the gold standard for minimizing oxidation. In addition, some devices contain oxygen absorbers to suck up any straggling molecules.
If you try to ride a rusty bicycle, its gears will grind to dust. The same principle applies to medical devices that have succumbed to oxidation. The only difference being that you probably wouldn’t use a rusty hemostat to add flair to your patio decor.
Clearly Communicate all Instructions and Warnings
The balance between product and user in custom packaging design must maintain equilibrium, because no one wants to suffer the consequences of getting it wrong.
Getting it right involves stimulating the psyche of the user, while also following device labeling standards. Text and symbols can easily be placed on just about any material, and great graphic design can effectively instruct a user how to properly use your product.
In fact, there are many cases in which ER visits related to the misuse of a device have declined in direct correlation with the design and communication improvements of a package.
So whether you are incorporating your instructions into the material of your packaging, or simply designing space on your package to place these instructions, it's something you need to plan for in your medical packaging. Pro-packaging engineers will be able to guide you through incorporating instructions that enhance your package and the users' experience with your device.
Lead to Proper Use
Your end user must immediately understand how to open the package while keeping both themselves, and the device, intact.
In this instance, a user-centered package is what’s going to take your design to the next level. Think of how your user will open your package - as well as the environment in which this will be done. Operating Room? Emergency Room? Ambulance? Doctor's Office? As you can imagine, each of these instances is very different and could affect how your product is unpackaged.
Laura Bix, PhD, Assistant Dean for Teaching, Learning and Academic Analytics for the College of Agriculture and Natural Resources and a Professor at the School of Packaging at Michigan State University shared in a recent presentation, about a survey and study she conducted specific to paramedics and their interactions with packaging. You can view her full presentation here, but, the short story is that in this environment parademics indicated some difficulty identifying and opening devices. And in her simulation exercise, a couple paramedics even used their teeth to open packages to execute the task at hand within this less controlled environment (in comparison to an O.R.).
"To be really, really excellent in terms of design, we also need to bring equal voice to the users' needs. And, the users' functional capabilities and the expectations for what they need to do with the product also need to drive the [packaging] design decisions."
- Laura Bix
Cater to Your User
Who is your user? Maybe it's a nurse or a surgeon. Maybe it's a patient. Maybe it's a patient with limited mobility or other restrictions. How can your device be packaged to ensure safety, device protection, and usability.
It's a tricky, but extremely important puzzle to solve. We've all heard the stories and statistics about packaging that isn't safe enough; i.e. Each year, 200,000 children (17 years old or younger) are taken to the emergency room for adverse drug events.
But, on the other end of the design spectrum, easy-to-open packaging might instead be needed for senior citizens with low grip strength or people with disabilities. For an incredible, real-life experience that perfectly illustrates the importance of this consideration, please check out Michael Fisher's story (starting at 27:25 in the video) here.
The balance comes from considering what the product has to do vs. what the user has to do with the product.
Finding a Balance
Your product is a proprietary endeavor, so only you know which factors ultimately matter most. Still, I hope this article provided some clarity that you’ll take back to the design lab.
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