A Focus on the Essentials of Medical Device Packaging—A Medtech Makers Q&A

By Sean Fenske, Editor-in-Chief

A medical device can be a sophisticated, sensitive piece of healthcare technology. As such, it must be protected, remain sterile, and benefit the patient who needs it. Packaging is a critical component that ensures all of this. This means medtech OEMs may need to consider the development and manufacture of the packaging almost as much as the device itself.

With this in mind, the packaging design and production must be handled with the utmost care and consideration for potential problems. This is where testing comes into play. Through a series of testing protocols, a partner can help ensure the package will fulfill its responsibilities as intended. This effort can confirm the right design was developed or, if performed earlier in the process, can help steer toward the best solution.

To gain insights on the numerous testing methods, validation strategies, and design input such partners can provide, Greg Schwinghammer, Principal Engineer at WESTPAK, participated in the following interview. In this Q&A, he speaks to ISO 11607, the impact of the home healthcare trend, packaging for combination products, and more.

Sean Fenske: Why do medical device packaging failures still occur, and what can be done to prevent them?

Greg Schwinghammer: Packaging failures often come down to something that was not fully challenged before final validation. We commonly see issues involving marginal seals, material variability, product movement inside the package, or distribution stresses that were greater than expected.

One risk manufacturers can underestimate is the cumulative effect of multiple hazards. A package may perform well in one test, but aging, temperature and humidity exposure, vibration, shock, compression, and handling can combine to reveal weaknesses. That is where testing provides real value. Distribution simulation, seal strength testing, package integrity testing, and aging studies can expose vulnerabilities before a product reaches the market.

At WESTPAK, our role is to reproduce defined conditions in a controlled laboratory environment and provide objective data on how the package performs. Finding a weak seal or damaged sterile barrier during testing allows the manufacturer to address the issue. Finding the same problem after commercialization can mean complaints, delays, recalls, regulatory concerns, or patient risk.

Fenske: Can you share packaging validation strategies that will accelerate time-to-market?

Schwinghammer: The fastest validation programs are usually the ones that avoid surprises. Manufacturers can reduce delays by defining their package configuration, sterilization exposure, aging requirements, distribution environment, acceptance criteria, and test sequence early enough to allow development testing before final validation begins.

Pre-validation testing can be especially valuable. It gives the manufacturer objective information about how the package performs before committing final validation samples, production schedules, and other resources.

From WESTPAK’s perspective, our role is to perform the required testing accurately, consistently, and efficiently and to clearly document what occurred. When a failure is observed, the data can help the manufacturer understand where the package did not meet the established acceptance criteria. That can prevent a problem from first appearing during formal validation, when changes are generally more disruptive and expensive.

Speed-to-market should not come from reducing necessary testing. It comes from having the right samples, requirements, protocols, and laboratory resources ready when testing begins.

Fenske: When it comes to ISO 11607, can you share some common misconceptions and compliance challenges?

Schwinghammer: One misconception about ISO 11607 is that compliance is simply about passing individual tests. The bigger issue is demonstrating that the sterile barrier system continues to perform as intended through sterilization, distribution, storage, aging, and handling.

From the laboratory side, we frequently see how important clearly defined acceptance criteria, representative samples, worst-case configurations, and complete documentation are to the validation process. Testing may include package integrity, seal strength, distribution simulation, accelerated aging, and other methods depending on the package and validation requirements. The results become part of the objective evidence manufacturers use to support their compliance documentation.

Regulatory scrutiny makes traceability especially important. The protocol should clearly establish what is being tested, which methods are being used, what constitutes acceptance, and how the results relate to the validated package configuration.

WESTPAK’s role as an independent third-party laboratory is to execute testing to the applicable methods and provide accurate, defensible documentation. Good validation data should be clear enough to stand on its own.

Fenske: With the increase in home healthcare, can you explain what the impact of e-commerce and direct-to-patient delivery is on medical device packaging?

Schwinghammer: A medical device shipped to a hospital loading dock may experience a very different distribution environment from one delivered directly to a patient’s home. Direct-to-patient shipping can involve more parcel handling, sorting operations, transfers, drops, uncontrolled orientations, and last-mile delivery. Temperature and humidity exposure can also vary considerably. The important point is that the distribution test being used should represent the defined distribution environment. A familiar test protocol is not automatically the right one for every shipping channel.

At WESTPAK, we perform distribution simulation testing that can include vibration, shock, compression, environmental conditioning, altitude, and other hazards required by the selected test procedure. The objective is to expose the packaged product to controlled, repeatable laboratory conditions and document how it performs. That information helps manufacturers determine whether their packaging can withstand the shipping environment they have defined.

As distribution models continue to evolve, one principle remains the same: the validation needs to reflect how the product is actually expected to move through the supply chain.

Fenske: Sustainability has consistently grown in importance within healthcare. With medical device packaging, how can companies balance environmental goals with sterility requirements?

Schwinghammer: Sustainability is particularly challenging in medical device packaging because reducing material cannot come at the expense of package performance. A sterile barrier system still has to survive sterilization, distribution, handling, and aging while maintaining package integrity for the intended shelf life. Even relatively small changes can affect performance. A lighter material, smaller package, new supplier, recycled content, different cushioning system, or reduced secondary packaging may change seal strength, durability, or distribution performance. Independent testing gives manufacturers objective data to compare those changes against established requirements.

At WESTPAK, we can evaluate revised package configurations using methods such as distribution simulation, seal testing, package integrity testing, and aging studies. The manufacturer can then use those results as part of its change assessment and validation process.

We are seeing companies investigate right-sizing, material reduction, improved cushioning efficiency, and elimination of unnecessary packaging components. One thing that we have seen come up is the new EU requirement to have less than a 50% empty space ratio in grouped transport and e-commerce packaging. This means if you were shipping your device in your ten-up shipper box and filling the rest with void fill, you will now need to have an additional shipper that can ship one sample.

The opportunity is significant, but the standard remains the same: sustainability improvements still have to demonstrate acceptable package performance and protection of the medical device.

Fenske: In terms of shelf-life validation, what’s the difference between accelerated aging and real-time aging? When should I use one over the other?

Schwinghammer: Accelerated aging can provide manufacturers with data to support an initial shelf-life claim without waiting years for real-time aging to be completed. Real-time aging remains important because it confirms how the package actually performs over the claimed shelf life.

The quality of the study depends heavily on the conditions established before testing begins. Common problems include incorrect or poorly supported aging parameters, non-representative samples, unclear acceptance criteria, and package configurations that do not reflect the validated product.

Material changes also deserve close attention. A change in film, adhesive, coating, resin, supplier, or manufacturing process can affect how a packaging system behaves over time. Existing aging results may not automatically represent the changed configuration.

WESTPAK performs both accelerated and real-time aging studies under controlled laboratory conditions. Our role is to maintain the specified environment, document the exposure, and perform the required post-aging testing. Accelerated aging can help support commercialization timelines. Real-time aging provides the long-term evidence needed to confirm that the packaging continues to perform as expected.

Fenske: How should distribution testing be handled in this age of global supply chains?

Schwinghammer: Global supply chains expose medical devices to more handoffs, transportation modes, storage conditions, carriers, and climates than many traditional distribution models. One of the most underestimated risks is the cumulative nature of transportation hazards. A single vibration event, drop, compression load, or altitude exposure may not cause an obvious failure, but repeated stresses can damage the device, weaken seals, shift components, or compromise the package. Distribution testing allows those hazards to be reproduced under controlled and repeatable laboratory conditions.

At WESTPAK, that may include vibration, shock, compression, altitude, environmental conditioning, and other testing required by the specified distribution test procedure. The value is that problems can be observed before large quantities of product enter the supply chain. A damaged component, opened seal, abrasion point, or other failure identified during laboratory testing provides objective information the manufacturer can evaluate. A failure discovered in the laboratory is contained. The same failure in distribution can result in product loss, customer complaints, regulatory concerns, or patient risk. Distribution testing helps reveal those vulnerabilities before they reach the field.

Fenske: Can you speak to packaging for high-value and combination medical devices? What concerns or challenges emerge from the packaging of these types of products?

Schwinghammer: High-value and combination products can raise the consequences of packaging failure because the products are often complex, sensitive, and expensive. The packaging may need to do much more than maintain sterility. It can also need to control product movement, absorb shock, withstand vibration, maintain orientation, protect delicate components, or limit exposure to environmental conditions. Combination products can create additional challenges because the packaged system may include different materials, delivery components, and product sensitivities. Testing provides a way to determine how the completed packaged product responds to those hazards.

At WESTPAK, we perform independent testing that can expose the package and device to defined distribution, environmental, aging, and integrity challenges. The resulting data shows how that specific configuration performed under the specified conditions. For high-value products, that information is particularly important because failures can carry significant financial, regulatory, and patient-safety consequences. The package may be outside the device, but its ability to protect the product throughout distribution and storage is an essential part of delivering that device successfully to the end user.

Fenske: What is the relationship between packaging validation and risk management?

Schwinghammer: Packaging validation data plays an important role in risk management because it replaces assumptions with measurable evidence. Different test methods answer different questions. Distribution testing can reveal whether vibration, impact, compression, or other transportation hazards damage the package or device. Seal strength and integrity testing provide information about sterile barrier performance. Aging studies show whether package performance is maintained over time. That data allows the manufacturer to evaluate packaging risks using actual test results.

Testing resources can also be focused more effectively when the manufacturer has clearly defined the package configurations, hazards, acceptance criteria, and validation requirements before laboratory work begins.

At WESTPAK, our responsibility is to perform the specified testing independently and provide accurate documentation of the results. We do not make the manufacturer’s risk-management decisions. We provide objective evidence they can use in making those decisions. That distinction is important. A successful validation program is not simply about accumulating test reports. It is about generating reliable data that demonstrates how the packaging system performs against established requirements.

Fenske: How can a medical device manufacturer leverage independent testing laboratories as strategic development partners?

Schwinghammer: OEMs benefit from engaging an independent testing laboratory early enough to understand laboratory requirements, sample needs, test durations, equipment availability, and sequencing before formal validation begins. That does not mean the laboratory designs the packaging system or makes the manufacturer’s validation decisions. The value comes from ensuring the required testing can be executed accurately and efficiently when the samples are ready. Early communication can prevent practical issues such as insufficient sample quantities, incorrect configurations, unrealistic schedules, or misunderstandings about the specified test method.

When selecting a laboratory, manufacturers should look for technical capability, experienced personnel, appropriate equipment, quality systems, responsiveness, clear documentation, and familiarity with medical device packaging standards. Independence also matters. An independent third-party laboratory provides objective test results without having a stake in the package design.

At WESTPAK, that is our role. We perform testing, document what happened, and provide reliable data the manufacturer can use in its validation process. The best laboratory relationship is built on technical competence, consistency, transparency, and trust in the results.

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