Which Is a Better Choice, Custom or Stock Medical Device Flexible Packaging?

By March 24, 2014 No Comments

The answer is, it all depends. When using film or a film/foil construction as the primary packaging, two of the most important considerations are cost and timing. Protective qualities of material combinations vary widely. When selecting material constructions to package a new test or device, both cost and timing must be carefully balanced against the ability of the packaging to deliver the required protection.

With new medical tests and devices, which by their very nature tend to be unique, the first instinct of many brand owners is to consider custom constructions specifically designed to meet the unique needs of the new application. Development of completely new packaging is invariably expensive and may require funding by a budget otherwise intended for marketing the new device. This requires considerable time, which can significantly delay time-to-market.

Before reaching any decision regarding custom versus stock constructions, it is necessary to determine exactly what will be required of it. There are a number of variables to be considered. One important consideration is the sensitivity of the medical device to environmental influences such as oxygen and water vapor transmission, light, pressure and the general environment to which it will be shipped and stored. Another is the ability of the packaging to resist puncture by sharp edges or protrusions on the device itself. To the extent these are similar to the conditions encountered by other medical tests and devices of similar size, shape and basic chemistry already on the market, it may be possible to adapt or even adopt existing packaging to meet the needs of the new product. This is true even though the new product may be intended for entirely different medical applications. If slight modifications are required, they could easily be less expensive and time consuming than developing entirely new packaging completely from scratch.

Another important consideration is the need for tamper-resistant features or tamper-evident design, an increasingly important packaging option in today’s environment. Exploring new options in the developmental stage can add significantly to the cost and time requirements of a completely new design. Many times, however, it is possible to realize significant savings, in both cost and time, by adopting existing security solutions.

For all of these reasons, it is important to choose a packaging supplier with broad experience and a robust portfolio of other medical test and device solutions to which the new device’s requirements can be compared. A good first step is to make sure your potential supplier is accredited by a recognized quality standards organization. Others include reviewing the potential manufacturer’s list of current customers in your industry, determining to what extent the supplier’s constructions are FDA DMF listed, identifying to what extent your manufacturer is vertically integrated and qualifying the supplier’s ability to develop an entirely new package in the event that one of their stock constructions cannot be used for your application. This is your assurance of a completely unbiased recommendation.

When considering flexible packaging options for a new product, be sure to thoroughly evaluate the packaging needs your product requires, as well as how those demands align with stock packaging options before considering a custom solution.