3 Key Tools To Mitigate ISO 11607 Package Design Failure

As a project leader for medical device manufacturing, there is one area in particular that I feel can really derail projects. When a project reaches me, often times the packaging has already been created and procured for the device(s) by the client. For an alarming ratio of these designs I am able to identify very high risk areas regarding the function of the packaging. Unfortunately at this point, due to the already incurred costs and project deadline pressures, a company is usually forced to accept the risk and go forward with building a lot and proceeding to testing. This means, control of the project has been lost, and with the long lead times of package testing, bringing their medical device to market could be in jeopardy.

In this article I identify three key activities to complete prior to designing terminally sterile packaging. Completing these steps can drastically mitigate the risk of a package failure for your medical device and bring control back to your project.

Defining Package Requirements
Defining the requirements up front for your package will allow you to focus on what is a possible final packaging configuration. This will keep you from wasting time on packaging solutions that do not meet your product’s needs. Make a checklist of questions and answers such as….

• Does the device need to be held together?
• How many devices to a package?
• Can the devices touch one another?
• How many sterile barriers are needed?
• Does the package need to be protected from the device?
• Can the package hold up through the chosen sterilization method?
• Will the package allow the sterilization method to be effective?

It is important to list every possible question you can think of. Take into account the device, sterilization method, and all stakeholders. When this is complete, the end function for your package will be defined. Any packaging configurations that meet all the requirements will be a possible final package design for your device.

Applying Triple Constraints
With the requirements defined, we move on to the constraints. Now the requirements might only allow for one possible type of package, but for most devices, there are many configurations that will fall within the guidelines determined in requirements. At this stage, the constraints of time, cost, and scope, better known as the “Triple Constraints,” will help to narrow down the remaining possible packaging options.

Time:
The constraint of time can determine if a device will be packaged in custom or off the shelf packaging. Custom packaging takes a lot longer often requiring design work and tooling. A project with a tight timeline might only be able to use generic packaging in order to stay on schedule.

Cost:
The constraint of cost falls along the same lines as the constraint of time. Any custom packaging will be more expensive than generic or off the shelf. The project budget will limit the types of packaging available to your device.

Scope:
The constraint of scope is the list of requirements above; however, it also concerns ‘wants’ as opposed to requirements. The marketing team might want graphics on the box to amp up the eye catching factor. The salesman might want the smallest possible package to carry around more of the product at one time. These wants will be product specific and will again limit the packaging options available.

Seeking Expert Judgment
Experience is an invaluable resource. Most companies have capable quality and engineering personnel, but they usually don’t have a vast knowledge of package testing nor have they seen hundreds of package types/designs being tested. Utilizing the experience of individuals who understand this process is probably the surest way of ensuring the success of your package design.

1. They can analyze the current requirements and constraints and help fill any gaps that were missed.
2. These individuals will know reliable vendors to design and source packaging materials whose lead times and cost might allow for packaging previously thought unavailable.
3. An expert will know the different risks associated with each package type and material, so you can decide on one that can hold up during conditioning, distribution, and aging.

On average, choosing your package design and building it can take anywhere from 4 to 12 weeks. Companies are always struggling to stay on schedule and often take a chance with their package design in order to save time or resources. But the cost of failure can be an additional 3-8 months in building and validating the package. So if a package design were to fail testing at the end of this process, the delay could even cause the project to go belly up.

Following these three simple steps (defining package requirements, applying triple constraints, and seeking expert judgment) can make a world of difference down the line. It’s a way of making sure to stay proactive instead of reactive in bringing your device to market.