The medical device industry has long depended on effective packaging and sterilization to ensure patient safety by maintaining sterility and product integrity throughout the supply chain. However, the industry is now at a pivotal juncture, balancing innovation with regulatory demands and sustainability goals. 

As a result, packaging and sterilization play a more strategic role in the medical device industry than ever before. With increasing regulatory expectations, new sterilization methods, the growth of patient-specific devices, and ongoing supply chain challenges, these functions are no longer seen as end-of-line tasks. Instead, they are being integrated earlier in the product development cycle to help reduce risk, improve efficiency, and ensure reliable performance from manufacturing through to clinical use.

“As the complexity of devices, particularly in robotics and orthopedics, continues to rise, MDMs increasingly acknowledge the importance of incorporating packaging and sterilization into the design process—at the beginning,” said Tom Williams, general manager for Millstone Medical Outsourcing, a Fall River, Mass.-based provider of medical packaging outsourcing services, including inspection, sterile and non-sterile packaging, kit processing, and field inventory management.

Packaging and sterilization are two of the most critical elements in medical device development and manufacturing. While many proven methods are well-established, both suppliers and medical device manufacturers (MDMs) are looking ahead by focusing on environmental impacts and long-term sustainability within their supply chains. 

This is an interesting time for sterilization in the medical device industry. For the past several years, ethylene oxide (EtO) has been under scrutiny by the EPA due to it being a risk to human health. One facility has closed and the others must now meet tougher new EPA requirements. This has driven many companies to reduce their dependence on EtO. “Alternatives to EtO include radiation [e-beam, x-ray, gamma] and several gas options such as chlorine dioxide, nitrous dioxide, and vapor hydrogen peroxide,” said Rose LaRue-Slater, director of sales for SteriTek, a Fremont, Calif.-based provider of e-beam and X-ray sterilization services for the medical device industry.

Even with these challenges, EtO sterilization remains prevalent due to its efficacy, especially for radiation and heat- and moisture-sensitive devices. “However, there is a significant push towards alternative sterilization methods and sustainable packaging solutions to address safety and environmental challenges,” said Kyle Dion, general manager for Blue Line Sterilization, a Novato, Calif.-based sterilization provider specializing in EtO sterilization services for small batches of medical devices. “Even with this push, there is still no replacement for what EtO currently offers in terms of high-yield loads and sensitive sterilization for most devices.”

Looking to the future, gamma radiation also prompts concern, based on the radioactive cobalt needed for the process. Also, with the world’s cobalt supply managed by one entity, MDMs are concerned about the availability of the isotope and the environmental effects of disposal. “Because of this, we have seen an increase in available e-beam and X-ray facilities in the U.S.,” said LaRue-Slater. “The first X-ray facility opened in 2022 in the U.S., with another coming online in 2025 and more slated for the years between 2025 and 2028. X-ray is a proven method in Europe.”

Perhaps the biggest concern in 2025 for many MDMs is the uncertainty regarding the Trump Administration’s tariff implementations and the potential impacts they will have on the medical device industry and its value chain. “All the classic playbook responses and countermeasures are now in play in our industry, including raw materials forward purchasing,” said Roy Morgan, president and CEO of Eagle Medical Packaging Sterilization, a Paso Robles, Calif.-based provider of assembly, packaging, and hydrogen peroxide, gamma, and e-beam sterilization services. “However, if those materials are foreign-sourced, it may already be too late.”

The pressures this places on smaller converters and downstream suppliers of packaging-related services are perhaps the largest part of the uncertainty affecting the packaging and sterilization market. “Customers seeking converted packaging materials will likely see some degree of cost increase to their packaging materials stream through the integration processes embedded in both existing production lines, as well as any new product introduction on the near-term horizon,” said Morgan.

Latest Trends

Several key trends are defining the sterilization and packaging needs of MDMs in 2025. These include a shift toward early-stage integration, “where OEMs engage packaging and sterilization partners during design freeze or even prototyping,” said Alan Evans, medical package testing manager for Life Science Outsourcing, a Brea, Calif.-based contract manufacturer that provides assembly, packaging, sterilization, and specialized capabilities in diagnostics packaging and design for medical devices. This is a key change because late-stage packaging decisions often lead to delays and validation failures.

“There is also rising interest in flexible, hybrid solutions that leverage pre-validated packaging components combined with custom inserts or backers, especially for modular or patient-specific devices,” Evans continued. Pre-validated packaging systems can be highly effective in reducing time to market.

“Packaging designs must also be sterilization-friendly and able to withstand multiple sterilization modalities, as well as global shipping conditions,” said Williams.

To avoid the risks of EtO and gamma radiation, MDMs are searching for advanced sterilization modalities, such as vaporized hydrogen peroxide (VH₂O₂), nitrogen dioxide, chlorine dioxide, gamma irradiation, and supercritical carbon dioxide (although scalability remains a challenge). “The increasing availability of e-beam and X-ray is directly related to the regulatory and industry concerns about EtO safety and gamma availability,” said LaRue-Slater.

The FDA’s recent reclassification of VH₂O₂ as an established Category A sterilization method has encouraged its wider adoption as a safer alternative to EtO, particularly for heat-sensitive devices. “However, when regulatory requirements are responsibly met,” said Dion, “EtO is just as safe as any other modality.”

Across the medtech industry, “there is a strong focus on automating packaging and sterilization processes to improve efficiency, reduce costs, and ensure consistent quality,” said David Pascutti, vice president of business development for Youngsville, N.C.-based Robling Medical, a provider of assembly and packaging services for medical devices, ranging from single-use sterile Class II and III devices to complex electromechanical systems. “At the same time, companies are prioritizing the development of sustainable, eco-friendly packaging solutions to meet environmental goals and evolving customer expectations.”

Sustainability-driven material innovation is one way MDMs can meet their global sustainability goals. “With sustainability in mind, forward-thinking MDMs are moving toward ‘design for recyclability’ sterile barrier solutions, incorporating more renewable raw materials, eco-friendly monomaterials, or biodegradable materials,” said Chris M. Simon, global intelligence and public affairs director for Paris, France-based Sterimed Group, which provides sterilization and packaging services for medical device manufacturers, including specialty substrate manufacturing and ready-to-use packaging. 

While sustainability continues to shape thinking about materials of construction, MDMs are gaining a greater understanding of the advantages of exit channels to create “sustainability loops” for used materials. This pushes materials suppliers into “molecular deconstruction” methods of recycling and exploring the energy economics of how these processes can limit the total amount of new plastic that enters the production stream.

“What is helpful about this approach,” said Morgan, “is that due to the heating and forming processes involved, the bioburden that is part of such a process is dramatically reduced through thermal destruction, yielding much cleaner recycled materials. This puts much less burden of proof of cleanliness on subsequent thermoforms, films, tapes, and injection-molded parts used in the packaging industry and lowers the risk profiles for device manufacturers and contract assemblers/packagers working with Class IIa and Class III devices.”

Due to increased MDM orders and fewer EtO providers, EtO sterilization queue times are lengthy—for example, large-scale pallet sterilization providers across the U.S. are operating at full capacity, resulting in long queue times—often nine to 12 months to just begin validation. To provide faster service, companies such as Blue Line specialize in small-batch EtO sterilization, with validation timelines of just eight to 12 weeks and no queue. “Customers can start their validation with Blue Line while reserving a place in the queue with a larger pallet sterilizer,” said Dion. “This dual-track approach lets them capitalize on that otherwise idle waiting period—getting their product to market faster without compromising their long-term sterilization plan.”

What MDMs Want

MDMs seek more data-driven validations from their supply chains. Manufacturers want partners that can guide material selection and packaging configurations in ways that minimize test failures and reduce rework, without compromising speed, predictability, and flexibility.

“MDMs are under constant pressure to get to market faster and be agile enough to handle market shifts, which puts packaging and sterilization in the spotlight,” said Evans. “Customers want pre-validated cycles, material guidance, and a vertically integrated partner that can handle everything under one roof. They are looking for efficiency, but not at the expense of quality, timelines, or regulatory confidence.”

They also look for supply chain consolidation for the final steps in medical device manufacturing, especially final assembly, packaging, labeling, and sterilization management. “The more downstream control suppliers can provide, the lower the risk to product availability, putting MDMs in better position to meet critical clinical demands,” said Pascutti.

Customized packaging solutions that balance cost efficiency with high performance, sustainability, and global regulatory compliance are in high demand. “Our customers prioritize packaging that ensures product integrity throughout the supply chain and employs sterilization methods that are both effective and environmentally friendly,” said Simon. “Additionally, they emphasize simplified logistics, ease of use, and faster time to market.” 

“The biggest ask we get is if the package can withstand long storage periods and maintain sterility during storage,” said Don Tumminelli, technical manager of client services for HIGHPOWER Validation Testing & Lab Services, a Rochester, N.Y.-based medical device validation and testing laboratory, with a special focus on reusable medical devices. “Tears and holes create serious setbacks and delays in day-to-day logistics. Many two-ply wraps now come in different colors. This allows for easier detection of holes by observing a color contrast through a rip or tear if present.”

Ultimately, OEMs seek faster validation timelines, flexible sterilization methods, and scalable solutions. They want packaging partners that can decrease time to market for sterile products by providing comprehensive, integrated services to reduce supply chain challenges. “More customers are also requiring late-stage labeling, kitting, and packaging customization to meet regional requirements and reduce inventory burden,” said Williams. 

For example, in the reusable device setting in hospitals, customers have been asking for large pouches for heavy trays and sets. “This can speed up the packing process and possibly the unwrapping and aseptic presentation on the back table in the operating room,” said Tumminelli.  

Recent Advances

The development of revalidated packaging solutions—for example, streamlining packaging design to reduce validation delays—is accelerating time to market. Reinforced cellulose and polymer-based materials provide superior mechanical performance and sterility maintenance while reducing fossil resource consumption. MDMs also have a keen interest in solventless sealing coatings or film laminating adhesives because they are better for the environment. Companies are also gaining traction with artificial intelligence (AI) by using it to model for design and optimization, “opening the door for the next generation of AI-powered solutions,” said Simon.

As EtO continues to fall out of favor, MDMs are seeking suitable alternative materials and methods. For example, outer packages made from Tyvek or corrugated plastics are being used to overcome the shortcomings of cardboard. “In particular, cellulosic material such as medical-grade paper and cardboard should avoid the VH₂O₂ process whenever possible,” said Derek Prince, Ph.D., and president of Prince Sterilization Services, a Pine Brook. N.J.-based provider of moist heat steam, vaporized hydrogen peroxide, and dry heat sterilization and depyrogenation services. “For steam, we are seeing higher-quality packaging, including Tyvek lids and tub lids and liners, be compatible with moist heat steam processes, enabling this preferred sterilization modality as an option for various devices such as nest- and tub-type products, as well as thermoformed trays.”

Some new forms of packaging on the development horizon incorporate sterilant directly into the materials of construction. The sterilant can be triggered by light sources, or other excitation energies, to start the cascade of sterilant release. “This has been tried in decades past, but newer, more precise forms of molecular binding appear to be yielding better ‘dosing’ and exposure,” said Morgan. “What remains to be seen is if the time of exposure, combined with dose levels, are capable of delivering adequate sterilization without producing excessive residuals when tested post-sterilization.”  

Smart packaging technologies integrate systems like radio frequency identification (RFID) and near field communication (NFC) to enhance traceability, ensure product authenticity, and improve inventory management. Each technology is also suitable for EtO sterilization. For inspection needs, Millstone Medical Outsourcing has recently developed and implemented advanced automated vision systems that act as a final, critical layer of error-proofing for the company’s complex medical kit assembly process. “These intelligent systems meticulously verify the contents of each multi-component kit before packaging, guaranteeing that surgical teams receive precisely what they need, when they need it—ultimately contributing to smoother and safer procedures,” said Williams. 

Innovative Thinking

One of the most important shifts in packaging/sterilization is toward modular, scalable validation strategies. Instead of reinventing the wheel for every device, packagers/sterilizers are helping clients build systems where components can be reused or adapted across multiple SKUs. This saves time and money while still meeting strict regulatory thresholds. “We’re also seeing more interest in front-loading validation logic—that is, making packaging decisions earlier, with input from sterilization and usability experts at the table,” said Evans. “This kind of cross-functional thinking leads to cleaner validations and stronger real-world performance.”

There is also growing emphasis on customized solutions tailored to specific device needs, as well as recyclable packaging materials to reduce environmental impact. For example, Sterimed is considering single-stream “designed for recycling” solutions, such as 100% cellulose-based packaging that can be sorted with cardboard or PA/PE (nylon/polyethylene) coextruded films compatible with the polyolefin recycling stream. To reduce logistics complexity, Sterimed is also designing systems for machine compatibility and automation needs. “These advancements are made possible through increased collaboration between MDMs, packaging engineers, vendors, and sterilization providers,” said Simon. “This collaboration involves co-development by cross-functional teams of tailored solutions and new materials.”

Innovation is also happening in packaging at the printed level. More sulphated box substrate (SBS) shelf-box manufacturers are using large-format, short-run, multi-color capable, high-resolution box printing. “This is not something that is always usable at the prototype level, but for established products with well-understood artwork requirements, this approach can be a lifesaver,” said Morgan. “This is especially true for low volume/high mix products, which still have the need for higher-end marketing requirements for shelf space.” When combined with “tool-less” patterning for SBS cutting, what was once a hugely expensive short-run packaging project can now be performed at a much more reasonable cost.

Millstone Medical Outsourcing has implemented a Tier-1 service model that combines supply chain management, cleanroom packaging, testing, sterilization, and logistics into a single quality system. This integration simplifies compliance, enhances visibility, and breaks down the silos that frequently delay product readiness. “This allows us to create modular packaging platforms that we validate once and use multiple times, especially for spine and trauma device families,” said Williams.

Eagle Medical has developed a packaging validation process called PATH that represents the digital transformation of packaging validation and provides a complete data package of validation evidence using an extremely challenging proxy device for pouching solutions for small device technology. This approach can dramatically shorten validation and submission timelines for packaging validation. “I’m seeing some bold approaches in how to leverage single experiments in the early stages of packaging design with advanced design of experiments to investigate materials of construction simultaneously with materials for packaging. It sounds complicated, and it can be, but if it’s done the right way, what results is a rank-ordered, risk-categorized list of what works best, not only for your device, but also for your packaging.”

AI, of course, is at the forefront of Internet of Things technologies. While AI adoption in packaging and sterilization is still in its early stages, the industry is beginning to explore its deeper potential. Predictive modeling, for example, is being tested to evaluate seal integrity, transit resilience, and the likelihood of passing validation based on historical data inputs. It can also identify potential failure modes during transit simulations and select optimal packaging materials based on device profiles and sterilization methods. Generative AI is also being explored as a support tool for drafting documentation, such as instructions for use or validation summaries, based on product specifications. Some sterilizers use AI to perform final sterilization certificate completions for delivery to customers. 

Future applications of AI may include generating optimized pouch and tray geometries, automating workflows, predicting sterilization outcomes, and simulating aging and sterilization impacts without extensive prototyping. However, even with these possibilities, MDMs are moving cautiously with AI due to the stringent risk-management constraints in the healthcare sector.

Regulatory Challenges

The regulatory landscape continues to evolve, with an emphasis on stricter validation requirements and the need for more robust data to support sterilization and packaging claims. Regulatory agencies also have a greater focus on documentation, traceability, and cross-functional alignment. Regulators now expect integrated evidence, where packaging validation, sterilization data, and labeling strategies are not treated as separate elements, but as a unified part of the submission.

Recent updates to standards such as ISO 11607-1 and -2 now mandate risk management as part of packaging system design. “OEMs must identify potential risks, assess their probability, and implement mitigation strategies as a formal part of the packaging validation process,” said Evans. “This shift reflects a broader push toward proactive quality assurance rather than reactive troubleshooting.”

The challenges increase for combination products or devices with pharmaceutical coatings. These products must satisfy both device regulations and pharmaceutical good manufacturing practice standards. In response, innovative contract manufacturers have developed integrated models that combine packaging, sterilization, and regulatory expertise to help MDMs meet these complex requirements more efficiently and with greater confidence.

Staying compliant requires continuous adaptation on a number of fronts, including: 

• Introduction of a new Part 3 within the ISO 11607 series

• Stricter requirements regarding extended producer responsibility and EtO emissions

• European Green Deal recycling and documentation demands 

• New VH₂O₂ sterilization Category A status from the FDA

• FDA’s final rule to harmonize CGMP (current good manufacturing practices) with ISO 13485:2016 and its impact on quality management systems 

Innovation Through Collaboration

As devices become more complex, particularly those with non-standard geometries or sensitive coatings, no single stakeholder can solve packaging and sterilization challenges alone. Packaging teams sometimes coordinate with sterilization partners to ensure barrier systems perform well across the intended method, whether EtO, gamma, or steam. Labeling and instructions for use may also be adapted to reflect how the product will be handled in a clinical setting to preserve sterility. Some packagers work directly with film and substrate providers to evaluate new options before making recommendations to their MDMs. “This kind of upstream coordination helps streamline validation, improve reliability, and reduce the likelihood of rework,” said Evans. “When collaboration happens early, the result is often faster timelines, fewer regulatory hurdles, and packaging systems that perform more predictably in real-world use.”

Collaborative efforts in the industry are gaining traction. For example, Eagle Medical led the creation of the West Coast Device Alliance. Through this collaborative partnership, each of the founding companies shares feedback and looks for innovation that can potentially eliminate entire steps in the validation process for device manufacturers. “Some of these collaborations might seem boringly simple, but they can really make a big difference to startups and mid-box medical OEMs looking to launch new products with limited resources and smaller, perhaps overburdened engineering teams,” said Morgan.  

“This one-stop alliance guides customers through the challenging landscape of product realization,” added Dion. “Participants can develop integrated solutions by combining alliance expertise to create packaging that complements sterilization methods. Joint research initiatives among members can lead to accelerated innovation and time to market. Shared knowledge also ensures adherence to regulatory standards across the product validation lifecycle.”

For MDMs, collaboration through design for manufacturability (DFM) with their contract manufacturers and suppliers should be a top priority to ensure high quality and performance, and speed to market. This is especially true considering the growing complexity of global regulatory requirements, especially the EU Medical Device Regulation (MDR), FDA Unique Device Identification (UDI), and upcoming ISO 11607 updates. To keep pace, MDMs are calling for earlier and more integrated planning for packaging and sterilization through DFM best practices. 

However, “it is not uncommon for MDMs to still delay sterilization and packaging considerations until late in product development,” said Prince. “This can lead to packaging failures, sterilant incompatibilities, and project delays. As a contract sterilizer, we also serve as a DFM partner—offering early-phase consulting, material screening, and packaging guidance to ensure sterilization compatibility is baked into the design process.”

Too often, though, even with DFM, MDMs focus mostly on the device, with packaging or sterilization treated as a follow-up task. But both have downstream impacts on compliance, shelf life, cost, and usability. “When engineers incorporate sterilization and packaging from the outset, it helps avoid expensive tooling adjustments and redesigns, leading to better outcomes and a more streamlined product development process,” said Simon. 

Ultimately, packaging and sterilization are not simply end points in product development, noted Evans—“they are also critical enablers of product success. When packaging and sterilization are treated as strategic from day one, they reduce risk and cost, support faster market entry, and enhance user experience.”

Mark Crawford is a full-time freelance business and marketing/communications writer based in Corrales, N.M. His clients range from startups to global manufacturing leaders. He has written for MPO and ODT magazines for more than 15 years and is the author of five books.