Making The Call On Pre-Validated Packaging

By Jim Kasic, Boulder BioMed

We know that getting a medical device to market from ideation to market launch is a project requiring tremendous skill, knowledge, time, money, and, often, some luck.

When focus is on the road to commercialization, design, engineering, regulatory affairs, and manufacturing often take center stage. Packaging can seem like a stereotypical lonely stepchild, ignored and unprioritized until late in the development process. Yet packaging can be the bottleneck that breaks a bottom line. Packaging validation alone can add weeks or months to a project timeline, and its impacts can even force changes to device design.

Against that backdrop, the idea of pre-validated packaging sounds good — really good. Using packaging that has already undergone extensive testing seems fast, easy, and less expensive. Is it truly the answer? Yes. Maybe. Sometimes. It depends.

Here, we’ll look at when it makes sense for a medical device developer to use pre-validated packaging and when it doesn’t.

The Validation Process

The main purposes of packaging validation are to maintain the sterile barrier and to protect a device during shipping. Often, medical device developers talk about seal validation and package validation. In reality, the validation process is a continuum. And while “seal validation” and “packaging validation” are sometimes used synonymously, they are not the same things.

Primary packaging of medical devices happens in one of two ways. One is to put the device into a pouch, then seal the pouch. The other is to place the device in a thermoformed plastic tray and seal the tray with Tyvek, a breathable, microbial-resistant material. The tray protects the device, while the Tyvek serves as a lid that can be peeled off — much like the seal on a yogurt cup — and let sterilizing gases pass through.

Validation begins with seal validation, ensuring that the seal used in the primary packaging lasts. Once the sealing process is validated, a package will undergo aging and distribution testing. Next will be measurement of strength and seal integrity on the packaged device. The final step proves the device cannot break through its seal under vibration, compression, or drops or in extreme temperature or humidity environments.

The key testing standards involved in package validation are ISTA 3A, ISO 11607, and ASTM D4169.

• ISTA 3A is a standard for individual packages that weigh 150 pounds or less and that will be shipped through parcel delivery services. It looks at how a package and its contents handle real-world conditions through a defined sequence of vibration, compression, drop, and extreme environment tests.
• ISO 11607 is the main international standard that applies to terminally sterilized medical device packaging. It evaluates the sterile barrier system to ensure it maintains package integrity and sterility over the stated shelf life.
• ASTM D4169 is a flexible, risk-based standard that validates whether a packaged device will withstand the conditions it will likely face in transportation, handling, and storage as it moves through the supply chain.

What Is Pre-Validated Packaging?

Think of pre-validated packaging as off-the-shelf sterile barrier systems and packaging materials (such as pouches or trays) that have already been tested against these established industry standards. In simple terms, these systems and materials have been tested against conditions as demanding, if not more than, imaginable for your device.

Then, with a documented rationale, it’s possible to conclude that your device falls within the requirements. A sound rationale will address a consistent set of variables, including mass, external dimensions, types of materials that would touch the sterile barrier, geometry, and any sharp or protruding features. Also important is whether the same sealing equipment and parameters were used.

As one simple illustrative example, consider a rigid box containing a device. The box would be placed into a pouch or tray, sealed, and undergo all seal and package testing. If another device comes along, as long as the mass and dimensions of that device are less than what was validated, a manufacturer could reasonably rationalize that the seal will hold for this second device.

When You Can Say ‘Yes’ To Pre-Validated Packaging

The concept of choosing packaging configurations with documented performance data meeting standard requirements is understandably appealing. Manufacturers don’t need to start from scratch with packaging, meaning they could reduce development risk, project timelines, and costs.

Pre-validated packaging makes sense when a manufacturer is working with a device that is extremely similar to an existing one and that uses the same base package and packaging machine. So, for instance, if a manufacturer has an 8.5” x 11” package and has already completed a package validation, they should be able to reuse the packaging configuration without issue for another device of the same size and mass that is no more likely to puncture the sterile barrier than the validated one and that uses the same sealer.

A catheter offers another example. The market supports many catheters that are very similar. A new one from a given manufacturer might be in the same product family, just slightly longer, with the same tip geometry and coating, and weigh the same or less. At that point, the catheter becomes almost a commodity product in terms of packaging, and the opportunity for pre-validated packaging is good. The closer a device matches the intended design envelope of the packaging system, the greater the likelihood that existing validation data can be applied.

The Caveats

Indeed, pre-validated packaging can save a developer a great deal of time. But it’s a complex call. Key considerations include:

• Novel devices. Developers introducing truly novel devices will find it very difficult to use pre-validated packaging. New devices generally need their own packaging and their own validation. The more novel the device, the less likely pre-validated packaging could be a consideration. Plus, as complexity increases, customization becomes more practical and cost-effective than trying to adapt an existing platform.
• Regulatory risk. Pre-validated packaging does not eliminate a manufacturer's responsibility for validating a final packaged device. The rationalization process with regulatory bodies to verify pre-validated packaging is rigorous. In practice, few devices will qualify, and the risk that a regulatory body will reject the rationale is real.
• Industry practices. The medical device and packaging industries favor custom packaging. As with most products of every type – from protein bars to cell phones – the bottom line is that there’s more money to be made. In medical device development, non-standard pouch sizes really are the standard, and it is difficult to find an off-the-shelf tray.

The Upside To Not Using Pre-Validated Packaging

What many developers don’t know is that customized packaging can often save them more time.

Startup and early-stage developers generally will work with a third-party (contract) company for packaging, as they typically won’t have the necessary in-house facilities or know-how. Likewise, contracted specialists working with novel designs typically do not do much pre-validated packaging because it simply isn’t appropriate for these devices.

However, these specialists can often perform validation much faster than a developer could do in-house. Good ones will also be able to look at the project holistically, since packaging usually doesn’t happen in a vacuum (literally or figuratively). Sometimes, for instance, packaging issues are actually design or engineering issues. Solving the root problem can save significant time and money.

For these reasons, incorporating packaging design early in the development process pays big dividends. Thinking and planning ahead affords time and opportunity to adjust design when consequences are minor.

The real-life example of a developer that designed its own packaging illustrates the point. The company designed the package to be 24” wide. It was not until after they completed design that they discovered the sealer they intended to use was also 24” wide. (A sealer’s usable width is smaller than its nominal width to allow for margins, so a 24” sealer will not accommodate a 24” package.) Their answer was to purchase a new larger sealer at great expense, an effort that also slowed down the go-to-market timeline.

If they had worked with experts who understood package design’s place in the project development phase, they could have identified the issue early on and designed the device to be 2” narrower (which, in this case, had no impact on functionality) or designed different packaging. Late in the development process, the company was attached to their design and did not want to make adjustments. Yet doing so would have saved substantial time and money.

Conclusion

Pre-validated packaging can help medical device manufacturers shorten project timelines and decrease costs – in some cases. Standard devices stand to benefit the most, while novel devices will generally require customized packaging solutions. Developers of these devices also will usually find that they can still gain the key benefits of lower costs and faster time to market by working with specialists who can incorporate package design and testing early in the development process.

About The Author:

Jim Kasic is the founder and chairman of Boulder BioMed. With more than 30 years of experience in the Class I, II, and III medical device industry, he holds more than 40 U.S. and international patents. His career includes experience with companies ranging from large multinational corporations to startups with a national and international scope. Kasic has served as president and CEO of Sophono, Inc., a multinational manufacturer and distributor of implantable hearing devices, which was acquired by Medtronic. He also was the president of OrthoWin, acquired by Zimmer-BioMed. He received a B.S. in physics and an M.S. in chemical/biological engineering from the University of Colorado and an MBA from the University of Phoenix. He can be reached at jim.kasic@boulderiq.com or on LinkedIn.