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Six key questions to ask when sourcing flexible medical device packaging

The time to begin thinking about medical device packaging is when an application for FDA approval is being prepared for submission, says LPS Industries, a diversified manufacturer in the flexible packaging industry. Since package development takes time and is required for FDA approval, considering packaging late in development will only further delay time to market. LPS shared with PlasticsToday six important questions medical device OEMs should ask to determine the most appropriate and least expensive package for a given product.

What is your product? Does it have sharp edges? Does it need to be kept wet or dry? What is the end use and who is the end user? Answering these fundamental questions will help define the parameters of package development.

What protection does the product need? Will it require protection from physical damage (impact, abrasion, compression), environmental conditions (heat, cold, humidity), or atmospheric elements (light, oxygen, water vapor)? Answering these questions will help in the material selection process: a monolayer film, such as polyethylene or polyester, may be sufficient or a multilayer laminate with different barrier properties may be required.

Does the package need protection from the product? Could sharp edges or protrusions puncture the film? Could the film stretch or tear because of the weight of the product? Answering these questions may also involve economic considerations, such as choosing between a heavier gauge of a less expensive film or a lighter gauge of a stronger but more expensive material.

How long should the protection last? Considering the length of time that protection needs to be at its optimal level is when the shelf-life discussion occurs. In fact, shelf life is a bit of a misnomer, because the key consideration should be a conservative estimate of the amount of time a packaged product spends in various stages of its lifecycle. The shelf-life clock starts ticking when the product is packaged in the manufacturing facility. Estimated time spent in inventory, time in transit, time at the distributors, and time and turnover frequency with the end users must also be taken into account. Note on the last item: Don't think about averages; think about when the last package will be opened in its customary end user location.

What other features may be required? While containment is the primary goal of packaging, numerous other features may be desirable, required, or used to distinguish a product from a marketing or regulatory perspective. Examples include:
•  reclosability
•  tamper-resistance construction
•  tamper-evident design
•  puncture resistance
•  how and where the package will be opened
•  shape
•  user information
•  utility

Now that you know what kind of package you need, what attributes should you look for in a package supplier? Accreditation by a recognized independent organization is a good place to start, according to LPS Industries.

A supplier not only should have a range of packaging options but also the knowledge and experience to determine how best to meet specific product and packaging requirements. It is also advisable to review a list of the potential supplier's current customers, notes LPS. If a number of companies with similar packaging requirements have chosen a particular manufacturer, there's usually a good reason for that.

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