Often, when designing or considering the manufacturing process for a medical device, there’s one element that often gets left until the last minute: the medical device packaging. There are so many other steps to worry about, figuring out the packaging can get lost. However, the right packaging used can reduce costs, potentially optimize the sterilization processes, and aid in the manufacturing process. Not considering the packaging early on can lead to production delays, increased costs to both manufacturers and patients, and other issues.
Let’s look at medical device packaging and see when it should be considered, and why. With Flexan, our Flexacution method considers this part early on, and you can learn more about our process here.
The medical device packaging decision process
At Flexan, we believe the decisions you make about medical device packaging need to happen at the very early planning stage. With our Flexacution method, we look at the entire process from start to finish, and that may include exploring and determining the packaging.
Why is this step so important to think about at the start? Well, there are a few reasons why packaging has to be part of the earliest stages, so let’s consider each in turn.
It can help determine the best manufacturing process
Are you looking at fully automated? Semi-automated? Entirely manual? What types of machinery will be needed to create the device, and will it have sharp edges? What shape will the finished product be? What size will the device or component be? What type of sterilization method will be used for the device?
These are just some questions which must be asked when determining the packaging and in developing all the manufacturing steps. These steps will in turn help decide if the packaging should be a tray, a pouch, or which type of packaging will work best.
Packaging affects cost
When designing, developing, and delivering a new medical device, cost is always an issue. The method of manufacturing, including the device packaging, affects this significantly. The question is, how can you create a package that will safely store, allow for ease of use for caregivers, and allow for transport of the device without making it cost-prohibitive?
Specific to sterilization, Ethylene Oxide “gas” requires permeability vs. gamma sterilization, a low penetration barrier. This component needs to be settled upon near the start of the development process to ensure problems and cost overruns can be met and mitigated.
Not planning for packaging at the start can delay product launch
One thing you want to avoid when you are trying to innovate in the medical device industry is product delays. When you don’t plan ahead, including the packaging, product delays are almost destined to happen. Product problems cause cost increases and then lost time to market.
This lost time can make the product you’re developing cost prohibitive. It can also leave an opening for a competitor to step right into the void and beat you to market.
The product packaging must match FDA sterility requirements
There are several requirements for medical device packaging by the FDA and they include:
- A manufacturer must be able to consistently form and seal a package, meeting requirements for the strength and seal of the bond after heat-sealing, the seal’s visual aesthetics and the ability to open the package.
- The package design must be sufficiently robust to withstand shipping through all types of climates and a variety of physical hazards.
- A package must be able to maintain its integrity over time. For a sterile, disposable device package, that’s usually two years, for example.
ISO 13495 standards
ISO 13485 is the regulatory standard the rest of the world uses with medical devices. To bring a new device to the market, you must comply with regulatory standards. ISO standards must be taken into consideration
- Known and traceable materials
- Non-toxic, non-leaching and odorless
- Making sure package is Free of holes, cracks, tears, creases, and localized thinning
- Intended use for the device
- Providing physical protection
Some other considerations for medical device packaging
If you thought that was enough to think about just on the packaging element alone, well, you haven’t even gotten close to the end yet. None of these details are too small to think about, and considerations about all of them should be made early so they can adapt if problems arise. Here are some additional elements to factor in and to achieve proper packaging and bring a device to market:
- A package should be neither be too small nor too large.
- Labeling on the packaging must be easily understood and well-placed.
- Raw materials used in sterile medical device packaging must be traceable, safe, and effective in creating a microbial barrier.
- Package manufacturing machinery must be set up and maintained in a validated state and produce a result that can be measured and monitored over time for performance to specification.
- The resulting packages must pass a variety of quality assurance checks.
- How will the device instructions for use be incorporated into the packaging?
Packaging testing and process validation
Once you’ve finally determined what type of packaging you want, the final processes necessary to bring your device to the rest of the world can be put into place. Now comes the testing and validation process to find out if the package manufacturing is robust. Testing medical device packaging is more than just testing that the pouch seals meet a minimum peel strength requirement, you also need to test that the device will not get damaged in the pouch and that the pouch isn’t going to get punctured by the device. These two tests need to be done even if you are reusing packaging you have used before.
- Package Integrity Testing. This determines the sterility and the shelf life of a medical device or product.
- Package Strength Testing. This test shows the force required to separate the two components of the sterile barrier system.
With these standards met and the testing finalized and validated, you finally have medical device packing ready to transport your device to market.
Flexan’s method smooths out the packaging process
As you can see, the packaging component is as vital and important as any of the other parts in a medical device’s design and development. Fortunately, you don’t have to do this all alone. Flexan has been providing the steps necessary to bring medical devices to market for decades. Our Flexacution process takes all of it into consideration and we partner with you to find the right way to bring your device to markets all over the world.
If you’d like to learn more about what Flexan can do, visit our website, then contact us for a deeper discussion about your needs and how we can help.