Sean Fenske, Editor-in-Chief06.06.23
One aspect of manufacturing is the ability to address challenges as they come. Ideally, a proactive approach would reduce the impact of these problems ahead of time, but what does a company do when these obstacles are unexpected?
Within the packaging and sterilization segment of medical device manufacturing, it seems several unanticipated challenges are emerging all about the same time. Sure, there have been indications that some would arrive, but others were sudden and negatively impacted these areas of product development.
Perhaps at the top of this list is the growing concerns around the use of ethylene oxide (EtO) gas for the terminal sterilization of medical devices. This modality is used for approximately half of all medical devices manufactured in the U.S. Unfortunately, the chemical is a known carcinogen and, as such, it is critical to control any release of the gas outside of a sterilization facility. Several incidents have brought it under the direct purview of the U.S. Environmental Protection Agency (EPA). As such, some device makers are asking questions about what sterilization method they should use for their products.
Meanwhile, material shortages—primarily Tyvek—have been another thorn in the side of packaging service providers. Companies had been asking their partners about alternatives as lead times grew almost exponentially. While the challenges of the shortage have since lessened, it’s still at the top of mind of many within the industry.
Further, a rapidly growing interest in sustainability and greater need for environmental considerations adds additional stress to medical device packaging solutions. Various stakeholders are asking for reduction in the waste created from the medical device package. Others are seeking a smaller footprint from the product’s container.
In many instances, these challenges are coupled, increasing the difficulty of eliminating them with a single solution. Medical device packaging and sterilization service providers need to be creative and flexible in their approaches to projects. Fortunately, to help facilitate a better understanding of both the problems the industry is facing as well as some of the proposed solutions being offered, almost a dozen experts shared their thoughts in the following Q&A. Participating in this article are:
• John Baumwoll, Production Manager at WESTPAK Inc.
• Keri Brang, Global Product Manager of Barrier Solutions at TekniPlex Healthcare
• Seán Egan, Director of Global Marketing at Nelipak Healthcare Packaging
• Nic Hunt, Global Head of Sustainability for Nelipak Healthcare Packaging
• Phil Littlefield, Sr. Vice President and General Manager at Life Science Outsourcing
• Stephanie McGee, VP of Sales at Command Medical Products
• Roy Morgan, President and CEO of Eagle Medical Packaging, Sterilization Inc. (EMPS)
• Olivia Radcliffe, Marketing and Technical Services Specialist at E-BEAM Services Inc.
• Greg Schwinghammer, General Manager at WESTPAK Inc.
• Ben White, Director of Technical Services at Millstone Medical Outsourcing
• Tom Williams, General Manager at Millstone Medical Outsourcing
Sean Fenske: What are the most prominent trends currently within medical device packaging?
Keri Brang: Customers are requiring their packaging—and therefore their packaging suppliers—to address a multitude of challenges. Naturally, product protection always will remain paramount, but increasingly, sustainability is also high on the priorities list. This may entail value-engineering an existing design to reduce overall materials usage (which can also lower cost), or requesting alternative materials that are either inherently more sustainable or manufactured more sustainably.
Other notable trends include an increased focus on business continuity planning, addressing the U.S. Department of Commerce foil tariff proposal, ensuring compliance with PFAS (per- and poly-fluoroalkyl substances) regulations, and preparing for the European Medical Device Regulations (MDR).
Regarding business continuity, acute and chronic supply chain challenges continue in the medical device packaging arena, prompting companies to actively pursue dual sourcing. For that reason, an activity historically handled by procurement personnel has now garnered engineering resources to expedite the process.
Lastly, as barrier requirements for medical devices expand beyond sterility, we are subsequently seeing packaging engineers broaden their research for materials beyond foil into transparent applications. Among other benefits, transparent packaging offers heightened product identification and ease of use for hospital staff and caregivers.
Nic Hunt: OEMs are expecting their partners to participate in environmentally responsible practices. New regulatory requirements require healthcare providers to include sustainability as criteria and sustainability questionnaires are increasingly becoming a requirement for OEMs to bid into hospital environments. Packaging, which is a key part of the supply chain and critical to protecting and delivering product to its point of use, has been expressly called out as a driver of future sustainability gains. There is a significant opportunity to reduce waste through increased healthcare packaging design innovation, and process and material optimization.
As customers look into enhancing the sustainability of packaging options and including more recyclable packaging components, medical device packaging manufacturers are increasing the emphasis they place on the sustainability of their products and operations. Greater sustainability and waste reduction can be best achieved by optimizing packaging design, which can reduce material usage as well as improve packaging functionality and allow for better product protection during sterilization, shipping, transport, and storage. Packaging manufacturers may look to reduce packaging, eliminate unnecessary components, and streamline shipments whenever possible. Some are even working with the end-user hospitals to increase education around proper recycling and reuse.
Phil Littlefield: At present, our clients are increasingly seeking comprehensive, end-to-end solutions, encompassing packaging design, testing, and validation services. Additionally, they expect us to oversee supply chain management for packaging materials.
To successfully address these evolving requirements, a CMO (like our organization) has to be well-positioned with a dedicated team of packaging engineers, an in-house machine shop for prompt tool and prototype development, certified testing laboratories on-site, and a robust network of strategic partnerships across the supply chain.
Roy Morgan: A prominent trend that has the potential to disrupt the industry is the evolution of pre-validated packaging. We recently launched our True-Validated line of packaging, which is a fully validated solution that can reduce packaging development timelines from months to weeks, and includes a comprehensive document set (proving validation) that streamlines the submission process. This enables device developers to gain a short-route—not a short-cut—to packaging validation in the race to market. That’s a game changer.
Greg Schwinghammer: With the ASTM F1980-21 update and the need to consider using humidity, we have seen an increasing number of customers needing accelerated aging at +55°C and 50% relative humidity. Also, from our perspective, given the pace of new product development in the medical device industry, the need for package testing is strong.
Tom Williams: Over the last three years, we’ve seen several major influences shape medical device packaging as the prominent trends from 2020 to present. These include the realities of EU MDR enforcement driving conversion to sterile packaging; changes in packaging for procedures being performed in ambulatory surgery centers (ASCs); changes and challenges in sterilization method; and the difficulties of supply chain pressure and fragility, especially as they relate to shortages affecting packaging materials. It’s been a tumultuous period, though we are now seeing some of these pressures settle. Of these, one to watch is how the COVID shift toward ASCs is driving the market toward single-use instrument sets, as it is bringing sustainability considerations ever more centrally into packaging design considerations to reduce single-use plastic waste.
Fenske: What are the most prominent trends currently within medical device sterilization?
Brang: The lack of sterilization capacity is limiting the ability of MDMs to grow. In light of this limited capacity, we are seeing companies research alternate sterilization modalities while also altering their existing sterilization cycles to shorter cycles, with the goal of increasing overall throughput. To date, we haven’t seen customers declare the “best” alternative to EtO and gamma and, when asked, customers understandably are keeping their strategies close to the vest. For that reason, it is somewhat difficult to obtain a comprehensive view of these developments.
Seán Egan: EtO continues to face challenges in the U.S. from the EPA and potential lawsuits linked to health concerns while in Europe, capacity constraints continue. In addition to sustainably reducing package size to minimize waste, OEMs also seek to increase load factor to maximize sterilization cycle throughput, which also includes shortening cycle time. In some cases, customers are looking at alternative methods to sterilize product as demand grows for either putting sterilization on site or investigating other sterilization processes such as X-ray, e-beam, steam, or VHP.
Littlefield: Presently, the industry is encountering capacity constraints in ethylene oxide (EtO) sterilization, primarily attributed to stringent U.S. EPA regulations and subsequent facility closures of high-volume sterilizers. This scenario has led to limited options for clients, necessitating small-batch sterilization solutions or just-in-time quantities.
These challenges have prompted contract manufacturers, including our organization, to offer in-house sterilization solutions. Since it is crucial to address these prevailing trends within the medical device sterilization sector, a CMO must have established in-house sterilization capabilities to expedite EtO exposure turnaround and validation protocols for novel product development while substantially mitigating lead time and complexities associated with ongoing validated sterilization services.
Morgan: We’re all still searching for that elusive EtO alternative. Different gases have shown promise, but EtO is just so effective, affordable, and necessary that it maintains significant presence and likely always will. However, the time is coming for a transition to less toxic modalities of sterilization and the FDA has removed some of the developmental barriers. That said, it still remains a slow-moving process.
At Eagle, we are leading the way with our own vertically integrated hydrogen peroxide gas plasma sterilization that offers a viable and FDA “Established” mode of sterilization. This offers device developers a meaningful alternative to current constrained EtO and Gamma pathways.
Olivia Radcliffe: With industry constraints, we're definitely seeing a search for alternative technologies for the sterilization of existing and new products. More companies are exploring radiation sterilization methods as well as other gas sterilization technologies.
Ben White: Over the last three years, the industry has been shaped by the realities and challenges of EtO. This period has pushed OEMs to consider revalidation toward more environmentally friendly parameters or even different sterilization methods. Now we are seeing increased availability—and adoption—of X-ray sterilization. As OEMs move forward, it’s essential to consider product and packaging materials to determine appropriate sterilization methods, and to weigh forward planning in sterilization decision-making. Validations are costly and time-intensive, and revalidation after product launch can introduce complications and delays.
Fenske: Have material/component shortages caused medical device manufacturers to seek/consider packaging alternatives?
John Baumwoll: Customers have been required to evaluate alternative materials and vendors due to supply chain issues.
Brang: Yes! Packaging is integral to delivering products to customers, and shortages on both the top and bottom of tray packaging have created significant churn in the market. These shortages have prompted the increase in business continuity planning and dual-sourcing initiatives to mitigate the risk of future supply chain disruptions.
Hunt: The supply chain situation has improved over the last 12 months for most materials. Shortages with some materials have seen OEMs looking to reduce risk through qualifying alternative sources or materials. In many cases, the shortages have seen manufacturers speed up sustainability projects, reducing package sizes, or lightweighting to reduce material usage. Increasingly, customers are looking at recycled content in those packaging components that do not pose a risk to the device through direct contact; this can include secondary plastic or board. A greater emphasis on recyclability post-use is evident to allow end-users to easily separate packaging into their respective recycle streams as demand for quality waste increases, driven by chemical recycling capacity entering the market.
Littlefield: Indeed, supply chain disruptions and shortages have prompted manufacturers to explore various options, including qualifying secondary sources or alternate suppliers, assessing alternate materials, and validating packaging materials that are more easily accessible. Furthermore, these challenges have led medical device manufacturers to streamline their packaging designs and components, focusing on eliminating non-essential packaging elements and simplifying the supply chain complexity.
Stephanie McGee: Prolonged material shortages (particularly coated Tyvek inserts and pouches) unquestionably created sourcing concerns for our clients. Although Tyvek material became readily available at the beginning of 2022, the increase in safety stock buying by many medtech companies created a huge stress on capacity and planning levels at packaging suppliers. As a result, lead times were extended, which is impacting most of us now in 2023.
Command Medical has seen an increased interest from our clients in designing new products suitable for e-beam sterilization vs. traditional EtO. The change in sterilization modality allows them to buffer against the Tyvek scarcity issues the industry weathered over the last few years.
Morgan: Yes. The challenge remains to determine if an alternate supplier or supply channel can be validated sooner than markets will correct. Olefin plastics raw materials and refined materials like Tyvek and similar items are often the longest lead time for CMOs in the industry. The resulting scramble to obtain sufficient supply to meet customer demands is not likely to fully resolve until mid-2024. EMPS keeps watch on the markets for materials to provide lead time intelligence to our customers, and when sensible, works with customers to establish safety-stock of crucial materials for device manufacture. It’s all part of our approach to customer satisfaction to keep lead times as short as possible in a market that can often be upside down.
Schwinghammer: We have seen more of our customers qualifying second source suppliers and needing shelf-life validations.
Williams: In a word, yes. These have ranged from material shortages or delays early in the pandemic to ongoing scenarios such as the PETG and Tyvek shortages. Given validations and regulatory requirements, simple substitutions are not a solution. OEMs have had to work through responses from revalidation through strategic allocation to ensure production as well as to protect product launch timelines. As OEMs work through these challenges, it’s an ideal time to consider whether universal or prevalidated packaging solutions fit your product and needs. Such packaging solutions can fit up to 80% of spinal and extremity implants and can cut time to market by up to 50%.
Fenske: How has the growing interest in sustainability impacted packaging design and/or material selection for packaging?
Baumwoll: We're getting increasing test requests for packaging made from sustainable materials. The industry trend for eco-friendly packaging has increased over the years and will likely continue.
Brang: While patient safety is always the utmost concern, sustainability is increasingly prevalent in discussions and developments. In every facet of medical device packaging—from coated products to laminations—we are fielding requests for more sustainable options. Whether this involves downgauging a current material or finding alternatives to barrier materials such as foil, we are seeing this trend become more and more substantive.
Regulatory issues such as PFAS, and more stringent laws coming from the EU and California, will also help drive changes and trends in medical packaging.
Hunt: OEMs want packaging engineers to lower costs, reduce material usage, and use materials that are recyclable, while maintaining superior product quality, device protection, and seal integrity. This can best be achieved by good product design, which requires close collaboration between the packaging engineer and the OEM early in the conceptualization and R&D processes. OEMs and packaging vendors should be working together as early in the design process as possible to achieve the best outcomes.
Littlefield: Sustainability and environmental stewardship have indeed become crucial factors in packaging design. Manufacturers are now focusing on enhancing packaging design and durability to minimize material usage and waste generation. The initial packaging design phase presents an optimal opportunity to incorporate sustainability into medical device packaging.
Suppliers are investigating novel materials and polymers, such as bio-based materials as an alternative to petroleum-based ones. Additionally, outer packaging materials, particularly non-contact corrugated materials, are being sourced from recyclable content or alternative, more sustainable materials.
McGee: We have not seen any significant impact to the change in our client’s packaging relevant to sustainability initiatives. The most common changes to the packaging designs were driven by the need to reduce product footprint and costs.
Morgan: It is now beginning to have an effect in our industry. Through pioneering efforts of some of the largest raw material manufacturers and chemical companies, we are seeing recycling channels open up. Finding cost-effective ways to return materials into those flow streams remains our toughest challenge, but as with any worthwhile effort, the early stages will be challenging. EMPS works closely with device developers in the early stages of packaging design, offering cost effective and minimalist approaches to material usage and selection to create final designs that are less wasteful, and ways to more easily bring waste into the existing recycling channels available to patient care facilities.
White: As more procedures have shifted into ASCs and day surgery centers over the last two to three years, the industry has seen an increase in single-use packaging in response to the needs and realities of these venues. It’s bringing considerations on sustainability more into planning and packaging design decisions, as ours and many other industries work toward circular packaging. Overall, there has been a trend for some time toward achieving a more streamlined packaging footprint for medical devices. It’s more environmentally friendly as well as more cost-effective—a win-win for OEMs and for the industry as a whole.
Fenske: What impact have the questions around EtO sterilization availability in the future affected packaging selection/design/materials?
Brang: Sterilization is not “one-size-fits-all,” since different devices require distinct sterilization methods. That said, not all materials can be sterilized by all methods, so it becomes a balancing act for customers to choose materials compatible with their required sterilization method and offer the protection a device requires. Of course, with the questions surrounding EtO, customers are researching alternatives and are seeking materials compatible with a variety of sterilization methods.
Egan: There’s interest in a reduction of the package size to increase load factors in EtO chambers—more product per cycle while reducing material use and footprint. Greater use of X-ray, gamma, or e-beam could change demand for some packaging materials where breathability is not required, while some sterilization methods such as steam will require materials compatible with the process.
Littlefield: As the capacity for EtO sterilization continues to decline, customers are increasingly investigating alternative sterilization methods such as gamma and e-beam sterilization. In response to these alternative methods, it becomes essential to carefully consider packaging design to ensure feasibility and compatibility with the selected sterilization technique. Consequently, packaging selection, design, and materials are directly impacted by the ongoing shifts in sterilization approaches within the industry.
Moreover, in-house small-batch EtO and steam sterilization has emerged as a current solution to address the challenges associated with sterilization capacity constraints. This approach enables manufacturers to maintain a reliable sterilization process while adapting to the evolving landscape of sterilization methods and packaging requirements.
McGee: Recently, the FDA announced a Radiation Sterilization Master Pilot Program to promote reduction of current agents used in sterilization and to encourage the development of alternative sterilization methods that are less harmful to our environment while still meeting the needs of safety and effectiveness for end-users. This is coupled with new proposed controls by the EPA also released recently for air emission standards, protection for workers, and other restrictions. There are 86 commercial sterilizers likely to be impacted by the proposed ruling if passed into law.
I believe EtO will remain a viable modality for a good while based on the dependency of the medical device industry on this sterilization method. The sheer number of devices that would require requalification to migrate to an alternative sterilization method and the capacity required to support this sterilization shift is expansive. I think the costs for EtO are going to continue to rise at unprecedented levels due to new regulations. Increasing costs, EtO capacity constraints, and packaging material scarcity are all factors companies are talking about. It will be interesting to see how quickly our industry pivots and who will be in front of the curve.
Morgan: Every client that comes through our doors has questions about this. Many have correctly perceived that tightening service-supply by constrained existing providers will have several years before fully resolving. We provide guidance to select materials that have multi-modal applications across chemical and irradiation sterilization modalities, so customers can focus on necessary design features and work with us to get them through the validation processes to market.
Radcliffe: Ethylene oxide as well as other gas-based technologies require a breathable package. Some other sterilization modalities, like electron beam sterilization, do not need breathable packaging. This frees manufacturers from some previous constraints and opens the door to other packaging options that might be more readily available and cost-efficient.
White: One of the reasons EtO has been an enduring sterilization method is its extensive material compatibility. Other methods, such as gamma ray, can affect polymers and other materials, causing degradation, discoloration, or other damage. In the wake of EtO facility closures and the capacity constraints of other methods (primarily gamma), OEMs and their strategic partners have had to step back and consider sterilization method possibilities, which is of course tied to packaging selection, materials, and design.
Fenske: Do you expect any significant change in EtO availability when a decision from the EPA finally comes? What is your prediction based on the limited available information?
Brang: Given the historical slow rate of change in the industry, the concern for patient safety, and the lack of near-term alternatives, we don’t expect significant changes to EtO availability in the short-term. Significant changes could cause further supply chain disruptions and, for the time being, we don’t see that occurring in an already tumultuous environment. However, TekniPlex will continue to look to the future and employ our materials science expertise, remaining ready to serve our customers as sterilization methods shift over time.
Egan: Still too early to say, but with over 50 billion products sterilized using EtO, it is not an easy option to swap out. Unless a competing technology that is cheap and effective comes along, EtO is here to stay for a while.
Environmental issues have not been an issue in Europe, where regulation is tougher around the process, but this comes at a cost where capacity is still seen as tight. In the medium-term, new EPA regulations may reduce capacity in the U.S. Efforts are ongoing to streamline the process, but in the meantime, many companies are investigating alternative methods and looking to ramp up capacity.
Littlefield: In my estimation, the ongoing U.S. EPA rulings may further diminish EtO sterilization availability in the United States, as facilities grapple with capacity limitations and the financial burden of ensuring compliance. These factors could exacerbate the existing challenges within the sterilization market.
Morgan: At the moment, current proposed EPA regulation is aggressive and is being met with industry skepticism about its viability of implementation in the short-term. That said, EtO is far too critical to the device/drug supply chain and any further constriction of EtO availability would have severe negative consequences in the marketplace. The most important element of future directives from regulatory entities is to have a harmonized approach for sterilization-dose targets to help prevent industry-wide constraints from becoming unbearable. That will enable industry to get behind new statutes, and begin the multi-year long efforts at new plant construction or existing plant retrofits.
Radcliffe: We are already hearing of some capacity concerns with EtO. Further, the installation of new sites/additional capacity takes time and is not happening at the same rate as market growth. But the reality is, ethylene oxide is an essential modality for sterilizing a great number of medical devices that cannot be sterilized using other technologies (such as medical devices with polymers that are not compatible with radiation sterilization methods). To help with the capacity concerns, manufacturers with products that can be sterilized using other methods should look to validate elsewhere, leaving the existing EtO capacity for those products that cannot.
Fenske: Have customers inquired more about sterilization options for new projects than they may have previously due to the questions surrounding EtO?
Brang: TekniPlex has received very limited requests to date. Our approach is to keep asking so we can help benchmark our products against available and developing methods, so we’re ready when an industry transition happens.
Egan: Customers are pretty tuned in to what is going on in the market. When discussing new packaging projects, our team finds customers are pretty clear on what sterilization method they are going to use when we raise the question.
In most cases, they have done their homework and know what they want. They do ask what we see and hear in the market as another source to keep their finger on the pulse of the industry, but generally they have investigated alternatives to understand any potential impact to their device, and packaging tends to be an afterthought.
Littlefield: Indeed, customers have been increasingly inquiring about the compatibility of new and existing packaging designs with alternative sterilization methods, as they contemplate alternatives to EtO. Consequently, we have observed growing capacity challenges with alternative methods, such as gamma sterilization, due to the heightened demand for these options.
Morgan: We’ve seen a fairly dramatic uptick in sterilization inquiries the past few years. Developers are exploring how to migrate away from EtO primarily due to the protracted validation lead times, and some are concerned about its long-term availability, if harmonized targets are not set by regulatory entities in the near future. Any delays or wrangling on a joint agency agreement, particularly about what emissions and TWA/PEL exposure is permissible, delays the mating of targets for appropriate level sterilant injections to achieve adequate SAL (sterility assurance level). This, in turn, only further strains a system that is already approaching a breaking point.
Radcliffe: Yes, we have definitely seen an increase in inquiries regarding sterilization for new projects as well as from customers with existing products that are currently being sterilized using EtO. The biggest concerns we are hearing are regarding the public health concerns around the use of ethylene oxide, the lack of existing or future available capacity, and unprecedented wait times for validation and routine sterilization.
White: Yes. At Millstone, we have seen both an increase in inquiries regarding sterilization options as well as increased interest in the value of a single expert point of contact for all postmanufacturing and aftermarket needs. Forward-thinking OEMs are looking to streamline, integrate, and consolidate to protect legacy production and meet product launch dates; sterilization is one of those key steps in the production process.
Fenske: Do you have any additional comments you’d like to share regarding packaging and/or sterilization for the medical device industry?
Baumwoll: We perform all the standard tests on packaged medical devices. In addition, new and exciting company start-ups remain part of our customer mix.
Littlefield: I would like to emphasize the importance of adaptability and innovation in the medical device industry, particularly concerning packaging and sterilization. The current trends and challenges faced by the industry—supply chain disruptions, material/component shortages, the growing interest in sustainability, and the uncertainties surrounding EtO sterilization—require manufacturers to be proactive and forward-thinking.
Exploring alternative sterilization methods, adopting sustainable packaging designs, and streamlining packaging components are essential steps in adapting to the evolving landscape. Collaborative efforts between manufacturers, suppliers, and regulatory bodies are also crucial in addressing these challenges and ensuring the continued safety and effectiveness of medical devices.
In conclusion, the medical device industry must continue to prioritize innovation and collaboration to navigate the complexities of packaging and sterilization while maintaining the highest standards of quality and accelerating the delivery of cutting-edge products to the market.
Morgan: The emerging trend toward drug-devices and other home-use devices requiring sterility, have forced packaging designers to be more creative. Packaging and sterilization limitations, as well as good logistics management for sterile components along with those that are non-sterile, have previously prevented these devices from entering the marketplace. Here at Eagle, we continue to work with our partners and industry leaders to develop novel solutions to accommodate varying packaging requirements through our creative techniques paired with appropriate, cost-effective sterilization modalities to achieve our clients’ goals.
Radcliffe: In our opinion, the most important thing is making sure sterile medical devices continue to be available as needed, regardless of sterilization modality. With the current and potential future capacity concerns, this could mean a need for a strategic look at how capacity at the different modalities is utilized. If you have a question or concern about your products, we would be happy to provide a free consultation with a recommendation for whichever modality we think would be the best fit for your products.
Schwinghammer: The need for medical device package testing in 2023 was uncertain as the pandemic passed. However, we've seen the need for testing remains strong. In addition, customers need quick turnaround times, especially with their new products.
Williams: In a heavily regulated industry, it can be easy to be resistant to change. But resistance stifles innovation, and it’s really with innovation that we move the needle on key issues like sustainability. We’ve moved past some of the most significant challenges of the last three years while we are moving into new ones. Seeking out expertise and a high-level industry viewpoint can help safeguard product launches, business goals, and patient safety—and ultimately help OEMs overcome the challenges of packaging and sterilization to succeed.
Within the packaging and sterilization segment of medical device manufacturing, it seems several unanticipated challenges are emerging all about the same time. Sure, there have been indications that some would arrive, but others were sudden and negatively impacted these areas of product development.
Perhaps at the top of this list is the growing concerns around the use of ethylene oxide (EtO) gas for the terminal sterilization of medical devices. This modality is used for approximately half of all medical devices manufactured in the U.S. Unfortunately, the chemical is a known carcinogen and, as such, it is critical to control any release of the gas outside of a sterilization facility. Several incidents have brought it under the direct purview of the U.S. Environmental Protection Agency (EPA). As such, some device makers are asking questions about what sterilization method they should use for their products.
Meanwhile, material shortages—primarily Tyvek—have been another thorn in the side of packaging service providers. Companies had been asking their partners about alternatives as lead times grew almost exponentially. While the challenges of the shortage have since lessened, it’s still at the top of mind of many within the industry.
Further, a rapidly growing interest in sustainability and greater need for environmental considerations adds additional stress to medical device packaging solutions. Various stakeholders are asking for reduction in the waste created from the medical device package. Others are seeking a smaller footprint from the product’s container.
In many instances, these challenges are coupled, increasing the difficulty of eliminating them with a single solution. Medical device packaging and sterilization service providers need to be creative and flexible in their approaches to projects. Fortunately, to help facilitate a better understanding of both the problems the industry is facing as well as some of the proposed solutions being offered, almost a dozen experts shared their thoughts in the following Q&A. Participating in this article are:
• John Baumwoll, Production Manager at WESTPAK Inc.
• Keri Brang, Global Product Manager of Barrier Solutions at TekniPlex Healthcare
• Seán Egan, Director of Global Marketing at Nelipak Healthcare Packaging
• Nic Hunt, Global Head of Sustainability for Nelipak Healthcare Packaging
• Phil Littlefield, Sr. Vice President and General Manager at Life Science Outsourcing
• Stephanie McGee, VP of Sales at Command Medical Products
• Roy Morgan, President and CEO of Eagle Medical Packaging, Sterilization Inc. (EMPS)
• Olivia Radcliffe, Marketing and Technical Services Specialist at E-BEAM Services Inc.
• Greg Schwinghammer, General Manager at WESTPAK Inc.
• Ben White, Director of Technical Services at Millstone Medical Outsourcing
• Tom Williams, General Manager at Millstone Medical Outsourcing
Sean Fenske: What are the most prominent trends currently within medical device packaging?
Keri Brang: Customers are requiring their packaging—and therefore their packaging suppliers—to address a multitude of challenges. Naturally, product protection always will remain paramount, but increasingly, sustainability is also high on the priorities list. This may entail value-engineering an existing design to reduce overall materials usage (which can also lower cost), or requesting alternative materials that are either inherently more sustainable or manufactured more sustainably.
Other notable trends include an increased focus on business continuity planning, addressing the U.S. Department of Commerce foil tariff proposal, ensuring compliance with PFAS (per- and poly-fluoroalkyl substances) regulations, and preparing for the European Medical Device Regulations (MDR).
Regarding business continuity, acute and chronic supply chain challenges continue in the medical device packaging arena, prompting companies to actively pursue dual sourcing. For that reason, an activity historically handled by procurement personnel has now garnered engineering resources to expedite the process.
Lastly, as barrier requirements for medical devices expand beyond sterility, we are subsequently seeing packaging engineers broaden their research for materials beyond foil into transparent applications. Among other benefits, transparent packaging offers heightened product identification and ease of use for hospital staff and caregivers.
Nic Hunt: OEMs are expecting their partners to participate in environmentally responsible practices. New regulatory requirements require healthcare providers to include sustainability as criteria and sustainability questionnaires are increasingly becoming a requirement for OEMs to bid into hospital environments. Packaging, which is a key part of the supply chain and critical to protecting and delivering product to its point of use, has been expressly called out as a driver of future sustainability gains. There is a significant opportunity to reduce waste through increased healthcare packaging design innovation, and process and material optimization.
As customers look into enhancing the sustainability of packaging options and including more recyclable packaging components, medical device packaging manufacturers are increasing the emphasis they place on the sustainability of their products and operations. Greater sustainability and waste reduction can be best achieved by optimizing packaging design, which can reduce material usage as well as improve packaging functionality and allow for better product protection during sterilization, shipping, transport, and storage. Packaging manufacturers may look to reduce packaging, eliminate unnecessary components, and streamline shipments whenever possible. Some are even working with the end-user hospitals to increase education around proper recycling and reuse.
Phil Littlefield: At present, our clients are increasingly seeking comprehensive, end-to-end solutions, encompassing packaging design, testing, and validation services. Additionally, they expect us to oversee supply chain management for packaging materials.
To successfully address these evolving requirements, a CMO (like our organization) has to be well-positioned with a dedicated team of packaging engineers, an in-house machine shop for prompt tool and prototype development, certified testing laboratories on-site, and a robust network of strategic partnerships across the supply chain.
Roy Morgan: A prominent trend that has the potential to disrupt the industry is the evolution of pre-validated packaging. We recently launched our True-Validated line of packaging, which is a fully validated solution that can reduce packaging development timelines from months to weeks, and includes a comprehensive document set (proving validation) that streamlines the submission process. This enables device developers to gain a short-route—not a short-cut—to packaging validation in the race to market. That’s a game changer.
Greg Schwinghammer: With the ASTM F1980-21 update and the need to consider using humidity, we have seen an increasing number of customers needing accelerated aging at +55°C and 50% relative humidity. Also, from our perspective, given the pace of new product development in the medical device industry, the need for package testing is strong.
Tom Williams: Over the last three years, we’ve seen several major influences shape medical device packaging as the prominent trends from 2020 to present. These include the realities of EU MDR enforcement driving conversion to sterile packaging; changes in packaging for procedures being performed in ambulatory surgery centers (ASCs); changes and challenges in sterilization method; and the difficulties of supply chain pressure and fragility, especially as they relate to shortages affecting packaging materials. It’s been a tumultuous period, though we are now seeing some of these pressures settle. Of these, one to watch is how the COVID shift toward ASCs is driving the market toward single-use instrument sets, as it is bringing sustainability considerations ever more centrally into packaging design considerations to reduce single-use plastic waste.
Fenske: What are the most prominent trends currently within medical device sterilization?
Brang: The lack of sterilization capacity is limiting the ability of MDMs to grow. In light of this limited capacity, we are seeing companies research alternate sterilization modalities while also altering their existing sterilization cycles to shorter cycles, with the goal of increasing overall throughput. To date, we haven’t seen customers declare the “best” alternative to EtO and gamma and, when asked, customers understandably are keeping their strategies close to the vest. For that reason, it is somewhat difficult to obtain a comprehensive view of these developments.
Seán Egan: EtO continues to face challenges in the U.S. from the EPA and potential lawsuits linked to health concerns while in Europe, capacity constraints continue. In addition to sustainably reducing package size to minimize waste, OEMs also seek to increase load factor to maximize sterilization cycle throughput, which also includes shortening cycle time. In some cases, customers are looking at alternative methods to sterilize product as demand grows for either putting sterilization on site or investigating other sterilization processes such as X-ray, e-beam, steam, or VHP.
Littlefield: Presently, the industry is encountering capacity constraints in ethylene oxide (EtO) sterilization, primarily attributed to stringent U.S. EPA regulations and subsequent facility closures of high-volume sterilizers. This scenario has led to limited options for clients, necessitating small-batch sterilization solutions or just-in-time quantities.
These challenges have prompted contract manufacturers, including our organization, to offer in-house sterilization solutions. Since it is crucial to address these prevailing trends within the medical device sterilization sector, a CMO must have established in-house sterilization capabilities to expedite EtO exposure turnaround and validation protocols for novel product development while substantially mitigating lead time and complexities associated with ongoing validated sterilization services.
Morgan: We’re all still searching for that elusive EtO alternative. Different gases have shown promise, but EtO is just so effective, affordable, and necessary that it maintains significant presence and likely always will. However, the time is coming for a transition to less toxic modalities of sterilization and the FDA has removed some of the developmental barriers. That said, it still remains a slow-moving process.
At Eagle, we are leading the way with our own vertically integrated hydrogen peroxide gas plasma sterilization that offers a viable and FDA “Established” mode of sterilization. This offers device developers a meaningful alternative to current constrained EtO and Gamma pathways.
Olivia Radcliffe: With industry constraints, we're definitely seeing a search for alternative technologies for the sterilization of existing and new products. More companies are exploring radiation sterilization methods as well as other gas sterilization technologies.
Ben White: Over the last three years, the industry has been shaped by the realities and challenges of EtO. This period has pushed OEMs to consider revalidation toward more environmentally friendly parameters or even different sterilization methods. Now we are seeing increased availability—and adoption—of X-ray sterilization. As OEMs move forward, it’s essential to consider product and packaging materials to determine appropriate sterilization methods, and to weigh forward planning in sterilization decision-making. Validations are costly and time-intensive, and revalidation after product launch can introduce complications and delays.
Fenske: Have material/component shortages caused medical device manufacturers to seek/consider packaging alternatives?
John Baumwoll: Customers have been required to evaluate alternative materials and vendors due to supply chain issues.
Brang: Yes! Packaging is integral to delivering products to customers, and shortages on both the top and bottom of tray packaging have created significant churn in the market. These shortages have prompted the increase in business continuity planning and dual-sourcing initiatives to mitigate the risk of future supply chain disruptions.
Hunt: The supply chain situation has improved over the last 12 months for most materials. Shortages with some materials have seen OEMs looking to reduce risk through qualifying alternative sources or materials. In many cases, the shortages have seen manufacturers speed up sustainability projects, reducing package sizes, or lightweighting to reduce material usage. Increasingly, customers are looking at recycled content in those packaging components that do not pose a risk to the device through direct contact; this can include secondary plastic or board. A greater emphasis on recyclability post-use is evident to allow end-users to easily separate packaging into their respective recycle streams as demand for quality waste increases, driven by chemical recycling capacity entering the market.
Littlefield: Indeed, supply chain disruptions and shortages have prompted manufacturers to explore various options, including qualifying secondary sources or alternate suppliers, assessing alternate materials, and validating packaging materials that are more easily accessible. Furthermore, these challenges have led medical device manufacturers to streamline their packaging designs and components, focusing on eliminating non-essential packaging elements and simplifying the supply chain complexity.
Stephanie McGee: Prolonged material shortages (particularly coated Tyvek inserts and pouches) unquestionably created sourcing concerns for our clients. Although Tyvek material became readily available at the beginning of 2022, the increase in safety stock buying by many medtech companies created a huge stress on capacity and planning levels at packaging suppliers. As a result, lead times were extended, which is impacting most of us now in 2023.
Command Medical has seen an increased interest from our clients in designing new products suitable for e-beam sterilization vs. traditional EtO. The change in sterilization modality allows them to buffer against the Tyvek scarcity issues the industry weathered over the last few years.
Morgan: Yes. The challenge remains to determine if an alternate supplier or supply channel can be validated sooner than markets will correct. Olefin plastics raw materials and refined materials like Tyvek and similar items are often the longest lead time for CMOs in the industry. The resulting scramble to obtain sufficient supply to meet customer demands is not likely to fully resolve until mid-2024. EMPS keeps watch on the markets for materials to provide lead time intelligence to our customers, and when sensible, works with customers to establish safety-stock of crucial materials for device manufacture. It’s all part of our approach to customer satisfaction to keep lead times as short as possible in a market that can often be upside down.
Schwinghammer: We have seen more of our customers qualifying second source suppliers and needing shelf-life validations.
Williams: In a word, yes. These have ranged from material shortages or delays early in the pandemic to ongoing scenarios such as the PETG and Tyvek shortages. Given validations and regulatory requirements, simple substitutions are not a solution. OEMs have had to work through responses from revalidation through strategic allocation to ensure production as well as to protect product launch timelines. As OEMs work through these challenges, it’s an ideal time to consider whether universal or prevalidated packaging solutions fit your product and needs. Such packaging solutions can fit up to 80% of spinal and extremity implants and can cut time to market by up to 50%.
Fenske: How has the growing interest in sustainability impacted packaging design and/or material selection for packaging?
Baumwoll: We're getting increasing test requests for packaging made from sustainable materials. The industry trend for eco-friendly packaging has increased over the years and will likely continue.
Brang: While patient safety is always the utmost concern, sustainability is increasingly prevalent in discussions and developments. In every facet of medical device packaging—from coated products to laminations—we are fielding requests for more sustainable options. Whether this involves downgauging a current material or finding alternatives to barrier materials such as foil, we are seeing this trend become more and more substantive.
Regulatory issues such as PFAS, and more stringent laws coming from the EU and California, will also help drive changes and trends in medical packaging.
Hunt: OEMs want packaging engineers to lower costs, reduce material usage, and use materials that are recyclable, while maintaining superior product quality, device protection, and seal integrity. This can best be achieved by good product design, which requires close collaboration between the packaging engineer and the OEM early in the conceptualization and R&D processes. OEMs and packaging vendors should be working together as early in the design process as possible to achieve the best outcomes.
Littlefield: Sustainability and environmental stewardship have indeed become crucial factors in packaging design. Manufacturers are now focusing on enhancing packaging design and durability to minimize material usage and waste generation. The initial packaging design phase presents an optimal opportunity to incorporate sustainability into medical device packaging.
Suppliers are investigating novel materials and polymers, such as bio-based materials as an alternative to petroleum-based ones. Additionally, outer packaging materials, particularly non-contact corrugated materials, are being sourced from recyclable content or alternative, more sustainable materials.
McGee: We have not seen any significant impact to the change in our client’s packaging relevant to sustainability initiatives. The most common changes to the packaging designs were driven by the need to reduce product footprint and costs.
Morgan: It is now beginning to have an effect in our industry. Through pioneering efforts of some of the largest raw material manufacturers and chemical companies, we are seeing recycling channels open up. Finding cost-effective ways to return materials into those flow streams remains our toughest challenge, but as with any worthwhile effort, the early stages will be challenging. EMPS works closely with device developers in the early stages of packaging design, offering cost effective and minimalist approaches to material usage and selection to create final designs that are less wasteful, and ways to more easily bring waste into the existing recycling channels available to patient care facilities.
White: As more procedures have shifted into ASCs and day surgery centers over the last two to three years, the industry has seen an increase in single-use packaging in response to the needs and realities of these venues. It’s bringing considerations on sustainability more into planning and packaging design decisions, as ours and many other industries work toward circular packaging. Overall, there has been a trend for some time toward achieving a more streamlined packaging footprint for medical devices. It’s more environmentally friendly as well as more cost-effective—a win-win for OEMs and for the industry as a whole.
Fenske: What impact have the questions around EtO sterilization availability in the future affected packaging selection/design/materials?
Brang: Sterilization is not “one-size-fits-all,” since different devices require distinct sterilization methods. That said, not all materials can be sterilized by all methods, so it becomes a balancing act for customers to choose materials compatible with their required sterilization method and offer the protection a device requires. Of course, with the questions surrounding EtO, customers are researching alternatives and are seeking materials compatible with a variety of sterilization methods.
Egan: There’s interest in a reduction of the package size to increase load factors in EtO chambers—more product per cycle while reducing material use and footprint. Greater use of X-ray, gamma, or e-beam could change demand for some packaging materials where breathability is not required, while some sterilization methods such as steam will require materials compatible with the process.
Littlefield: As the capacity for EtO sterilization continues to decline, customers are increasingly investigating alternative sterilization methods such as gamma and e-beam sterilization. In response to these alternative methods, it becomes essential to carefully consider packaging design to ensure feasibility and compatibility with the selected sterilization technique. Consequently, packaging selection, design, and materials are directly impacted by the ongoing shifts in sterilization approaches within the industry.
Moreover, in-house small-batch EtO and steam sterilization has emerged as a current solution to address the challenges associated with sterilization capacity constraints. This approach enables manufacturers to maintain a reliable sterilization process while adapting to the evolving landscape of sterilization methods and packaging requirements.
McGee: Recently, the FDA announced a Radiation Sterilization Master Pilot Program to promote reduction of current agents used in sterilization and to encourage the development of alternative sterilization methods that are less harmful to our environment while still meeting the needs of safety and effectiveness for end-users. This is coupled with new proposed controls by the EPA also released recently for air emission standards, protection for workers, and other restrictions. There are 86 commercial sterilizers likely to be impacted by the proposed ruling if passed into law.
I believe EtO will remain a viable modality for a good while based on the dependency of the medical device industry on this sterilization method. The sheer number of devices that would require requalification to migrate to an alternative sterilization method and the capacity required to support this sterilization shift is expansive. I think the costs for EtO are going to continue to rise at unprecedented levels due to new regulations. Increasing costs, EtO capacity constraints, and packaging material scarcity are all factors companies are talking about. It will be interesting to see how quickly our industry pivots and who will be in front of the curve.
Morgan: Every client that comes through our doors has questions about this. Many have correctly perceived that tightening service-supply by constrained existing providers will have several years before fully resolving. We provide guidance to select materials that have multi-modal applications across chemical and irradiation sterilization modalities, so customers can focus on necessary design features and work with us to get them through the validation processes to market.
Radcliffe: Ethylene oxide as well as other gas-based technologies require a breathable package. Some other sterilization modalities, like electron beam sterilization, do not need breathable packaging. This frees manufacturers from some previous constraints and opens the door to other packaging options that might be more readily available and cost-efficient.
White: One of the reasons EtO has been an enduring sterilization method is its extensive material compatibility. Other methods, such as gamma ray, can affect polymers and other materials, causing degradation, discoloration, or other damage. In the wake of EtO facility closures and the capacity constraints of other methods (primarily gamma), OEMs and their strategic partners have had to step back and consider sterilization method possibilities, which is of course tied to packaging selection, materials, and design.
Fenske: Do you expect any significant change in EtO availability when a decision from the EPA finally comes? What is your prediction based on the limited available information?
Brang: Given the historical slow rate of change in the industry, the concern for patient safety, and the lack of near-term alternatives, we don’t expect significant changes to EtO availability in the short-term. Significant changes could cause further supply chain disruptions and, for the time being, we don’t see that occurring in an already tumultuous environment. However, TekniPlex will continue to look to the future and employ our materials science expertise, remaining ready to serve our customers as sterilization methods shift over time.
Egan: Still too early to say, but with over 50 billion products sterilized using EtO, it is not an easy option to swap out. Unless a competing technology that is cheap and effective comes along, EtO is here to stay for a while.
Environmental issues have not been an issue in Europe, where regulation is tougher around the process, but this comes at a cost where capacity is still seen as tight. In the medium-term, new EPA regulations may reduce capacity in the U.S. Efforts are ongoing to streamline the process, but in the meantime, many companies are investigating alternative methods and looking to ramp up capacity.
Littlefield: In my estimation, the ongoing U.S. EPA rulings may further diminish EtO sterilization availability in the United States, as facilities grapple with capacity limitations and the financial burden of ensuring compliance. These factors could exacerbate the existing challenges within the sterilization market.
Morgan: At the moment, current proposed EPA regulation is aggressive and is being met with industry skepticism about its viability of implementation in the short-term. That said, EtO is far too critical to the device/drug supply chain and any further constriction of EtO availability would have severe negative consequences in the marketplace. The most important element of future directives from regulatory entities is to have a harmonized approach for sterilization-dose targets to help prevent industry-wide constraints from becoming unbearable. That will enable industry to get behind new statutes, and begin the multi-year long efforts at new plant construction or existing plant retrofits.
Radcliffe: We are already hearing of some capacity concerns with EtO. Further, the installation of new sites/additional capacity takes time and is not happening at the same rate as market growth. But the reality is, ethylene oxide is an essential modality for sterilizing a great number of medical devices that cannot be sterilized using other technologies (such as medical devices with polymers that are not compatible with radiation sterilization methods). To help with the capacity concerns, manufacturers with products that can be sterilized using other methods should look to validate elsewhere, leaving the existing EtO capacity for those products that cannot.
Fenske: Have customers inquired more about sterilization options for new projects than they may have previously due to the questions surrounding EtO?
Brang: TekniPlex has received very limited requests to date. Our approach is to keep asking so we can help benchmark our products against available and developing methods, so we’re ready when an industry transition happens.
Egan: Customers are pretty tuned in to what is going on in the market. When discussing new packaging projects, our team finds customers are pretty clear on what sterilization method they are going to use when we raise the question.
In most cases, they have done their homework and know what they want. They do ask what we see and hear in the market as another source to keep their finger on the pulse of the industry, but generally they have investigated alternatives to understand any potential impact to their device, and packaging tends to be an afterthought.
Littlefield: Indeed, customers have been increasingly inquiring about the compatibility of new and existing packaging designs with alternative sterilization methods, as they contemplate alternatives to EtO. Consequently, we have observed growing capacity challenges with alternative methods, such as gamma sterilization, due to the heightened demand for these options.
Morgan: We’ve seen a fairly dramatic uptick in sterilization inquiries the past few years. Developers are exploring how to migrate away from EtO primarily due to the protracted validation lead times, and some are concerned about its long-term availability, if harmonized targets are not set by regulatory entities in the near future. Any delays or wrangling on a joint agency agreement, particularly about what emissions and TWA/PEL exposure is permissible, delays the mating of targets for appropriate level sterilant injections to achieve adequate SAL (sterility assurance level). This, in turn, only further strains a system that is already approaching a breaking point.
Radcliffe: Yes, we have definitely seen an increase in inquiries regarding sterilization for new projects as well as from customers with existing products that are currently being sterilized using EtO. The biggest concerns we are hearing are regarding the public health concerns around the use of ethylene oxide, the lack of existing or future available capacity, and unprecedented wait times for validation and routine sterilization.
White: Yes. At Millstone, we have seen both an increase in inquiries regarding sterilization options as well as increased interest in the value of a single expert point of contact for all postmanufacturing and aftermarket needs. Forward-thinking OEMs are looking to streamline, integrate, and consolidate to protect legacy production and meet product launch dates; sterilization is one of those key steps in the production process.
Fenske: Do you have any additional comments you’d like to share regarding packaging and/or sterilization for the medical device industry?
Baumwoll: We perform all the standard tests on packaged medical devices. In addition, new and exciting company start-ups remain part of our customer mix.
Littlefield: I would like to emphasize the importance of adaptability and innovation in the medical device industry, particularly concerning packaging and sterilization. The current trends and challenges faced by the industry—supply chain disruptions, material/component shortages, the growing interest in sustainability, and the uncertainties surrounding EtO sterilization—require manufacturers to be proactive and forward-thinking.
Exploring alternative sterilization methods, adopting sustainable packaging designs, and streamlining packaging components are essential steps in adapting to the evolving landscape. Collaborative efforts between manufacturers, suppliers, and regulatory bodies are also crucial in addressing these challenges and ensuring the continued safety and effectiveness of medical devices.
In conclusion, the medical device industry must continue to prioritize innovation and collaboration to navigate the complexities of packaging and sterilization while maintaining the highest standards of quality and accelerating the delivery of cutting-edge products to the market.
Morgan: The emerging trend toward drug-devices and other home-use devices requiring sterility, have forced packaging designers to be more creative. Packaging and sterilization limitations, as well as good logistics management for sterile components along with those that are non-sterile, have previously prevented these devices from entering the marketplace. Here at Eagle, we continue to work with our partners and industry leaders to develop novel solutions to accommodate varying packaging requirements through our creative techniques paired with appropriate, cost-effective sterilization modalities to achieve our clients’ goals.
Radcliffe: In our opinion, the most important thing is making sure sterile medical devices continue to be available as needed, regardless of sterilization modality. With the current and potential future capacity concerns, this could mean a need for a strategic look at how capacity at the different modalities is utilized. If you have a question or concern about your products, we would be happy to provide a free consultation with a recommendation for whichever modality we think would be the best fit for your products.
Schwinghammer: The need for medical device package testing in 2023 was uncertain as the pandemic passed. However, we've seen the need for testing remains strong. In addition, customers need quick turnaround times, especially with their new products.
Williams: In a heavily regulated industry, it can be easy to be resistant to change. But resistance stifles innovation, and it’s really with innovation that we move the needle on key issues like sustainability. We’ve moved past some of the most significant challenges of the last three years while we are moving into new ones. Seeking out expertise and a high-level industry viewpoint can help safeguard product launches, business goals, and patient safety—and ultimately help OEMs overcome the challenges of packaging and sterilization to succeed.