The packaging used for a medical device may seem inconsequential. As a result, it is not always included as part of the product development process. In fact, some design teams address the packaging once the product is moving to manufacturing and at design freeze. Unfortunately, this eliminates synergies that can be realized with a packaging design that truly complements the device.
When working on packaging alongside the development of the device, the two can be performed in tandem such that the packaging becomes an extension of the device, providing benefits beyond protection. In addition, the sterilization modality can be considered and optimized with the packaging to be the most effective in ensuring sterility.
Fortunately, Alan Evans, Head of Medical Package Testing and Senior Sales Manager at Life Science Outsourcing, has taken time to address a number of questions around device packaging, its design, and its relevance to sterilization modality. He addresses topics including why packaging is critical for orthopedic devices, its relationship to sterilization, and overlooked considerations.
Sean Fenske: When it comes to orthopedic devices, why can the packaging be especially critical?
Alan Evans: Given the significant investment of time, research, and capital that goes into developing orthopedic devices, it's imperative to extend the same rigorous standards to their packaging. We often find OEMs reach design freeze without a finalized package, and in these instances, we can provide packaging design, validation, testing, and production solutions.
Package design is also a critical component of sterilization validation. Once the package design is finalized, we perform both packaging validations to ISO 11607 and sterilization validations to ISO 11135, ISO 17665, and ISO 11137.
The choice of a sterilization method is another essential consideration. Packaging serves dual purposes: it should protect the device and be compatible with the chosen sterilization method, whether that's ethylene oxide (EtO), steam, or radiation techniques like gamma or E-beam. This compatibility ensures the device remains sterile until it reaches the end user.
While the design of the package is undeniably crucial, mastering the broader commercialization pathway is equally vital. The considerations span far beyond the immediate: from intricate shipping methodologies to navigating complex environmental challenges like fluctuating temperatures, and ensuring meticulous package handling throughout the supply chain. It's in these intricacies where expertise shines. OEMs stand to gain immeasurably by aligning with partners who not only understand every facet of the commercialization process but also bring unmatched expertise in medical package testing, sterilization and validation, and the ever-evolving landscapes of quality and regulatory standards.
Fenske: With questions swirling around device sterilization, especially with the controversy surrounding EtO, what are the common methods often used for orthopedic devices?
Evans: EtO remains the industry standard for sterilizing orthopedic devices, despite recent scrutiny over its health risks to operators and environmental implications. Recognizing these concerns, many manufacturers are transitioning to small-batch EtO sterilization. This method uses a minimal amount of EtO, reducing both health risks and environmental footprint compared to larger, pallet-sized EtO chambers.
Novel sterilization methods like chlorine dioxide (CD) and nitrous dioxide (NO2) are gaining attention. However, these are still in their early stages of adoption, and the lack of extensive validation standards and long-term data present challenges. At LSO, as a contract manufacturing organization (CMO), we have experts familiar with these emerging techniques. Furthermore, partnering with a CMO that has expert microbiologists on staff is crucial for OEMs, ensuring they have access to comprehensive knowledge and expertise.
Given the current landscape, small-batch EtO sterilization remains predominant. Orthopedic device manufacturers may continue to rely heavily on small-batch EtO for the time being, even as knowledge expands about alternative methods.
Fenske: How can choice of sterilization method impact the packaging design?
Evans: Selecting the appropriate sterilization method is a critical component in the development of your medical device packaging design. Not all materials are compatible with all forms of sterilization, making it essential to align your chosen sterilization technique—be it EtO, steam, or radiation methods like gamma or E-beam—with the materials used in your packaging.
One key factor to evaluate is the heat resistance of the packaging material. This consideration is particularly important if you're contemplating using steam sterilization, as the material must be able to withstand high temperatures. Materials like Tyvek, paper, foil, and nylon each come with their unique set of parameters that dictate their compatibility with various sterilization methods. Therefore, conducting thorough studies and exposure tests is highly recommended to ascertain the suitability of the materials.
The design of your packaging serves a dual purpose: it must both protect the medical device and maintain its sterility post-sterilization. The ultimate objective is to ensure the device reaches the end user free from any harmful microorganisms and fully compatible for its intended use. A vital aspect of achieving this goal is the design of the sterile barrier system.
The sterile barrier acts as the primary and most crucial line of defense, preserving the sterility of the device throughout its distribution journey. It is imperative to subject your design, specifically the sterile barrier, to ASTM validation tests. These tests help confirm your packaging will perform to the standards envisioned, offering assurance the medical device within remains both safe and sterile.
Fenske: What regulatory considerations must be taken into account, such as ISO 11607, prior to developing the orthopedic device packaging?
Evans: Central to the realm of medical device packaging is the ISO 11607-1:2019 standard, which holds paramount importance for professionals in this domain. It’s the international benchmark that meticulously delineates the specifications concerning materials, sterile barrier systems, and packaging systems. These specifications are intricately designed to uphold the sterility of a medical device until it is ready for use.
It's worth noting this standard does not encompass the directives for sterile barrier and packaging systems specifically tailored to aseptically manufactured medical devices. However, it comprehensively outlines the testing requirements necessary to ensure compliance with the standard's prerequisites.
One key regulatory guideline to keep in mind is the FDA 510(k). FDA 510(k) clearance holds paramount significance for medical package designs, as medical packaging plays a pivotal role in safeguarding the safety and efficacy of medical devices. Manufacturers are obligated to submit a 510(k) notification to the FDA when introducing new devices or making significant modifications, including changes to packaging. This process necessitates demonstrating substantial equivalence to legally marketed devices, ensuring the same intended use and safety. FDA 510(k) clearance, while not signifying approval, indicates the FDA has reviewed the device and found it safe and effective for its intended use.
Having FDA 510(k) clearance for your medical packaging design offers distinct advantages. It signifies your packaging has undergone FDA scrutiny, providing a competitive edge. It can attract investors, reduce regulatory risk, simplify FDA device approval, and ensure your packaging is safe and effective, instilling confidence in regulators and users alike.
Fenske: When selecting the packaging partner for an orthopedic device, what should an OEM be looking for? What considerations are most important?
Evans: Choosing the right partner for your medical device packaging needs is a decision that involves multiple factors, not the least of which is expertise across all facets of packaging. A partner with an in-house testing facility is particularly advantageous. Not only can they offer invaluable advice on optimizing your package design, but they can also directly assess its efficiency in their own testing lab. This enables a streamlined process from design consultation to performance validation, including the use of virtual imaging and prototyping capabilities, extending to even carton design.
Another key attribute to consider in a potential partner is their prowess in managing supply chains, particularly for critical materials. In an era where disruptions are frequent—recent long lead times for materials like Tyvek serve as a prime example—a well-connected partner with multiple sourcing avenues becomes invaluable. They should not only be adept at navigating supply chain challenges but also be proactive in researching alternative materials that can enhance your supply chain's efficiency and resilience.
Finally, consider whether your partner can provide swift, effective solutions when traditional avenues fail. One of the most impactful solutions in such instances is the availability of pre-validated packaging. At LSO, we offer pre-validated packaging, which can save significant time and cost savings as the design, testing, and validation phases have already been completed. This can expedite your time-to-market by up to six months. Pre-validated packaging minimizes risk, especially for orthopedic device manufacturers. These packages have already proven their ability to withstand sterilization processes and maintain sterility over a predetermined period, with extensive validation data available to back these claims.
Fenske: What are the often overlooked aspects of the packaging design? What do OEMs often neglect to keep in mind for orthopedic device packaging?
Evans: It's a common oversight among orthopedic OEMs to focus extensively on external threats to the sterile barrier while neglecting the potential impact of internal movement. While it's crucial to design packaging that prevents external objects from compromising the sterile barrier, it's equally important to consider the movement of the medical device—and any secondary or tertiary packaging—within the sterile barrier itself.
Uncontrolled movement can jeopardize the integrity of the sterile barrier, leading to failures that compromise the device's sterility. To mitigate this risk, it's essential to design packaging that minimizes the internal movement of the device as well as any accompanying packaging elements. By doing so, not only is the device better protected during its journey to the end user, but the sterility of the device is also safeguarded from internal threats.
The sterile barrier needs to be designed to resist abrasion, both from the inside and the outside. Constant rubbing or chafing against the barrier could weaken its structure over time, leading to potential breaches. While it's vital to guard against external threats to the sterile barrier, internal movement is an often-overlooked factor that needs equal attention. A well-designed sterile barrier will minimize internal movement, thereby reducing the risks of both device damage and sterility compromise.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
Evans: Packaging is more than just one aspect of a checklist that needs to be checked off before getting your medical device to market; it’s a tool, and it needs to integrate seamlessly into the whole process. When your packaging partner can offer additional streamlined services like device assembly, sterilization, and testing, it plays directly into a streamlined process that ultimately accelerates your time to market.
The key to a successful medical device isn’t just getting it to market; it's being able to do so in accelerated time to capture back your return on investment as soon as possible. When your packaging partner can mitigate risk and strengthen your supply chain with in-house capabilities, it will not only help ensure the device's safety in the packaging aspect but can also help keep it in the market by reducing costs and time. In an industry that's ever-changing, it's important to align yourself with strategic partners that have demonstrated resilience over the years, even in the face of constant industry shifts and evolving regulations.
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