DDL has been providing package testing services for the medical device industry for over two decades. Looking back over the past 20 years, we have seen a lot of changes in the packaging industry and more specifically the package testing industry. Packaging continues to be taken more seriously by medical device manufacturers (MDMs) and is not just an afterthought at the end of a product launch. This increased awareness has caused MDMs to rethink package design, which has also increased the need for testing.

Some key reasons why the package testing industry has changed over the past 20 years include:

• The implementation of recognized testing standards issued by ASTM, ISTA and ISO along with their accessibility and diversity. The publication of ISO 11607 revolutionized the medical device industry through global standardization and harmonization; it also resulted in new standards being developed. ASTM F1929 and F2096 are two other well known examples of standards in the industry.
• An increased expectation concerning quality and functionality of products by customers has resulted in testing becoming one of the primary means to ensure that satisfaction is being met.
• A more educated end user base due to the early pioneers that first interpreted the science of package testing together with today’s packaging engineers who have helped take these principles to another level.
• Technological advancements, such as field replication instruments, software, bar coding and photography, have allowed labs to streamline processes, become more efficient, and service customers better.
• The availability of more diverse materials and substrates used for packaging has increased the need for verification and validation so that performance is met or exceeded when compared to the traditional tried and true materials.
• The need for test systems, such as puncture resistance testing, to become more portable has also increased. This allows testing to be carried out at the manufacturing line and to be done where the various materials are used allowing for more immediate test results which in turn result in more timely decisions.

Future of Testing

While all these changes have helped to shape the testing industry as we know it today, there are still two primary factors that drive most testing decisions: cost and lead time. The need and desire to get to market as quickly, efficiently and cost effectively as possible still reigns, and I don’t anticipate that changing anytime soon. Another consideration, however, that is gaining steam and could soon become as influential in testing decisions as cost and lead time is sustainability.

Cost is the number one criteria when evaluating sustainability today. By the year 2022, it is estimated that lifecycle analysis and recyclability will be the two highest criteria when evaluating a sustainable package and the emphasis will be on a reduction in waste through recyclability and reusability. While these considerations are important and noble for the future of packaging and testing, they must be considered in a responsible way because cost will always be a factor as much as we may or may not want to admit.

Another future advancement in testing is Virtual Testing / FEA (finite element analysis). This method allows you to predict a component’s response when subjected to real life data through computer simulation. This tool will help with the increased demand to bring products to market quicker as it reduces the amount of R&D time. While this might reduce some need for testing during the R&D iterations, there still would be the need for final design validation. One could also assume that the realized costs savings from one R&D project could be applied to a new project that might otherwise fall by the wayside or be delayed.

Through sustainability, globalization and the innovative spirit of industry, the next twenty years in package testing promises to have just as much change as the last twenty years. Implementing these new initiatives along with meeting customer satisfaction demands will ultimately be achieved through testing.

Note: this blog post is a summary of a recent article authored by Corey Hensel, General Manager at DDL, published in the September 2013 issue of PMPNews. Please click here to read the entire article.