The Art of Collaboration in Medtech Packaging & Sterilization

The medical device industry has always been known for its highly regulated packaging/sterilization environment. In general, packagers and sterilizers are reluctant to change or innovate unless absolutely necessary, preferring well-validated procedures. However, restrictions on ethylene oxide (EO) use have now opened the door for innovation in medical device sterilization. Of course, changes in sterilization technologies also bring changes in packaging, where companies sometimes work together holistically.

“Industry has begun to consider packaging from a whole new perspective, and that shift is creating opportunities—for example, lower-impact materials, sterilization-compatible packaging systems, and designs optimized for product protection and sustainability—that simply did not exist before,” said Michelle Scott, CEO for Mobile, Ala.-based Gulf Sterilization, a contract sterilization facility that provides ambient-temperature chlorine dioxide gas sterilization for medical device manufacturers (MDMs) seeking alternatives to EO. 

As a result, packaging and sterilization have evolved from end-of-line requirements into strategic supply chain priorities. The medical device industry faces a more complex operating environment than ever before, driven by tighter regulatory scrutiny, continued pressure on EO capacity, and growing interest in alternative modalities. MDMs are also demanding faster, more integrated pathways from finished assembly to validated sterile product. “EO remains critical for many devices, but FDA and EPA activity has elevated sterilization strategy to a board-level supply chain consideration, rather than a back-office function,” said Matt Jordan, CEO for LYNX Medical, a Solana Beach, Calif.-based provider of assembly, packaging, and sterilization processing services for MDMs, with operational facilities in New Jersey and Pennsylvania.

A key area of the medical and pharmaceutical packaging industry is cold chain performance, where maintaining strict temperature controls from manufacturer/distribution to hospital/pharmacy end user is critical. Expanded polystyrene (EPS) remains the industry’s preferred material for insulated shippers. “Although alternative materials are often positioned as more sustainable, many of them lack long-term performance and lifecycle data to validate these claims, “said Todd Bergstrom, Ph.D., senior director of products and compliance with Atlas Molded Products, an Atlas Roofing Corporation division that manufactures block- and shape-molded EPS for industrial, architectural, and packaging applications. Atlas Roofing Corporation is based in Atlanta, Ga. “As a result, EPS solutions continue to lead the cold chain packaging industry, due to a balance of reliability, durability, and temperature stability—all crucial elements for successful medical shipments.”

There is also the growing pressure around sustainability, recyclability, and packaging waste reduction—”particularly with regulations emerging from Europe such as the Packaging and Packaging Waste Regulation [PPWR],” said Nick Kirichkow, medical segment manager at Taunton, Mass.-based Harpak-ULMA Packaging, which provides end-to-end weighing, distribution, and packaging solutions. “Medical manufacturers are now being challenged to balance sterile barrier performance with environmental responsibility, and that is beginning to influence everything from material selection to package design and long-term operational planning.”

Some market uncertainties still exist (for example, unexpected shocks in the olefin market) in 2026 that are reminiscent of the COVID-19 pandemic years, “but with a new higher-speed twist from global conflicts and trade war tactics that will affect the future of product strategy for years to come,” predicted Roy Morgan, CEO for Eagle Medical, a Paso Robles, Calif.-based provider of FDA-compliant contract manufacturing, assembly, packaging, and sterilization services for the medical device industry. “Forward-thinking companies are looking at integration strategies that can combine supply chains, resulting in fewer stops in the product realization ‘strip-mall’ of companies needed to make it happen.” 

Latest Trends

The medical packaging industry is moving toward greater flexibility, smarter process control, and packaging systems that are easier to validate and scale globally. “Manufacturers are looking for validation-ready platforms, integrated track-and-trace capabilities, and advanced vision inspection systems that improve quality control while supporting increasingly strict compliance requirements,” said Kirichkow. “At the same time, there is growing interest in automation and data-driven packaging systems that can help manufacturers maintain sterility, improve operational efficiency, and adapt more quickly to evolving global regulations around traceability and sustainability.”

These efficiencies can be gained by incorporating sterilization and packaging earlier into the design phase. “Some clients are interested in validating more than one sterilization modality for their device to mitigate capacity constraints or protect business continuity from the unknown next crisis,” said Stephanie McGee, vice president of sales operations for Command Medical Products, an Ormond Beach, Fla.-based full-service contract manufacturing organization (CMO) specializing in fluid management systems for single-use complex disposable and diagnostic devices. “Risk mitigation, guaranteed capacity, sustainability, and cost containment continue to be key areas of interest.”

“Providers of gaseous method sterilization, regardless of the modality, are all looking at ways packaging can be changed in order to reduce consumables, shorten cycle times, and ultimately optimize cycles,” Scott added.

Another trend is the somewhat unexpected move to reduce foams in packaging. Whether in bulk packaging or 1UP configurations, foams are out and films are in due to the reduction of overall bulk solids in the waste stream. “The trick is in the re-design and managing the harmonic and impulse response of products to the change,” said Morgan. “This emerging trend underscores the need for packagers to have both a design-side capacity as well as a strong testing-side capability, or strong industry alliances to shore those up. Being able to work with customers to address their sustainability moves quickly with solid design and test data is what makes the difference here.” 

There is also heavy emphasis on validation and strong packaging material change controls. It has been volatile from a raw material supply standpoint and “we have had to conduct many validations to confirm substitute raw materials are equivalent in our processing steps, even if the converters supplying them have already done so,” said McGee. “Helping our clients develop a strong risk-based rationale and action plan to execute while running parallel to production is what our customers need and want.”

What MDMs Want

“It’s all about value,” said Dr. Bergstrom—“the outcome determined by putting cost and performance together. As a component supplier to the cold chain industry, our challenge is to work with our customers to develop a solution to keep shipments within tight temperature ranges for the duration of shipping. We’re also seeing a trend toward more requests for customization options, where insulated shippers are customized to meet any need, from the smallest medical shipment to an entire pallet.”

In an effort to control costs and reduce timelines, some MDMs are asking their manufacturing partners to leverage publicly available, reliable datasets, which really means “do you have any packaging systems that you’ve done for other customers that can be leveraged in validation?” These, however, are validated under strict non-disclosure agreements and cannot be shared. “Forward-thinking companies are working toward licensable datasets, which can form the foundation of a structured offering that makes validation fast, one-time, and affordable,” said Morgan. “Taking out the simpler elements of design and adding in the more complex elements of material compatibility creates options for robust product retention and layer-specific sustainability.”

MDMs are increasingly looking for customized packaging and sterilization solutions that integrate seamlessly into full production line operations, rather than standalone pieces of equipment. They want partners that understand the entire packaging process—from materials and validation to automation, inspection, and downstream integration—while also helping them navigate evolving compliance requirements. “There is a stronger emphasis on industry collaboration and connected solutions, where packaging suppliers, material providers, sterilization experts, and automation partners work together to reduce risk, accelerate implementation, and improve long-term operational performance,” said Kirichkow.

Ultimately, OEMs are asking for certainty. They want shorter lead times, fewer handoffs, less regulatory risk, more predictable sterilization capacity, and partners that can integrate packaging and sterilization considerations early in development. “Increasingly, they are looking for strategic supply chain partners that can provide robust validation support, comprehensive documentation, and coordinated downstream solutions that improve efficiency, enhance reliability, and accelerate speed to market,” said Jordan.

New Technology, Tools, and Materials

Innovative thinking is happening at the intersection of design for manufacturability (DFM), packaging engineering, and sterilization science. “Instead of designing a device first and then asking how to sterilize it, leading MDMs are asking what materials, packaging configuration, density, load pattern, and sterilization modality will create the most reliable path to market,” said Jordan.

One of the biggest areas of advancement in medical packaging is material innovation. There is growing interest in alternatives to traditional Tyvek and PETG structures, along with new mono-materials and downgauged material options that can reduce packaging weight and waste while still maintaining sterile barrier performance. At the same time, “improvements in process control, sealing consistency, and vision inspection technology allow manufacturers to run thinner or more sustainable materials with greater confidence, which is critical as the industry balances validation requirements with emerging sustainability regulations,” said Kirichkow.

The compatibility of the sterilization modality with traditional packaging materials is one of the first questions MDMs want to discuss for their products. For example, although chlorine dioxide is considered relatively new to the field of medical device sterilization, “it has a long history of use in food safety, water treatment, and the decontamination of highly regulated healthcare and pharmaceutical facilities—meaning there already is a substantial body of data on compatibility with the vast majority of packaging materials, including cellulose,” said Scott. “Gulf Sterilization has refined its load modeling tools so it can assess packaging configurations before a single physical run is conducted. The result is a faster road to cycle development and ultimately reduction in validation timelines.”

In general, the packaging industry is very sensitive to sustainability concerns. To address this, “Atlas Molded Products introduced ReGenX Technology in 2025 to help close the loop and support circularity,” said Dr. Bergstrom. “This process puts 30% recycled content back into our products, reducing the demand for new materials. It enables the creation of more sustainable cold chain packaging and insulation products that perform as well as those made from virgin materials, at no added cost.”

Considerable research is being performed in the area of renewable carbohydrate-based polymers. While still young in its technological evolution, it is a promising area that could lead to robust low moisture-vapor transmission rates, in films of sufficient tensile toughness and durability, that could eventually replace olefin-based polymers. “Packagers need to continue to push their supply chains for pilot-level programs that test these materials for their potential use as full-fledged sterile barriers,” said Morgan. “It is only through both ‘push’ and ‘pull’ efforts that our industry will arrive at viable solutions, at the right layer in package designs that steadily and surely advance meaningful and useful sustainability.” 

Regulatory Challenges

ISO 11607-3 is currently in process and expected to be published sometime in 2026. ISO 11607, which was introduced in the 1990s, provides guidance on terminally sterilized packaging for medical devices. Updates to the standard have occurred over the years. “Upcoming Part 3 of ISO 11607 will include discussion about the minimum features required in heat sealing equipment to help manufacturers select a properly designed machine for terminally sterilized medical devices,” said Brandon Hoser, business development and marketing manager for Packworld USA, a Nazareth, Pa.-based provider of turnkey, validatable heat sealing machines for life science applications, including medical devices.

Part 3 will also address equivalency among different machines. Heat sealing equipment from different manufacturers, or even from the same manufacturer but different models or build specifications, can yield varying heat seal results, even with the same process parameters. Different machines may deliver heat more quickly or slowly, or through a different modality such as impulse, constant heat, ultrasonics, or radio frequency. “There is plenty of old or inadequate equipment that is still operating in the field today,” said Hoser. “The cost and time required to validate better equipment may deter manufacturers from process improvement, but ignoring ill-suited equipment or processes can introduce liability and risk to patient outcomes and the organization’s success.”

The FDA’s recognition of the latest version of TIR 17 on material compatibility is a tool that can be utilized as a starting point for industry to begin making initial decisions about potential sterilization fit for a given device. Gulf Sterilization, along with other industry experts in AAMI’s Working Group 11, is in the final drafting stage of TIR 124, a technical report specifically focused on the validation of chlorine dioxide sterilization. ASTM guidance documents are also being drafted for aspects of chlorine dioxide validation and residual testing. 

“Manufacturers that may have been content with the status quo are now actively engaging with regulators earlier in the process, and sterilization providers such as Gulf Sterilization are well-positioned to support those conversations,” said Scott. “We have developed a complete regulatory submission support structure at Gulf, and that is something MDMs consistently tell us gives them significant peace of mind and reduces the burden of the sterilization portion of the 510(k) submission.”

Another significant development in sterilization regulation is EPA’s March 2026 proposal to reconsider its 2024 EO emissions rule. The original rule introduced highly stringent, risk-based requirements for sterilization facilities, including continuous emissions monitoring, strict aeration controls, and facility design changes. The proposed reconsideration would roll back several of these provisions, signaling a shift away from a purely risk-driven framework toward a more flexible, technology-based approach.

“As of now, the rule is in a state of regulatory uncertainty,” said McGee. While the 2024 requirements technically remain in place, the proposal, published March 17, 2026, with comments closing May 1, means the final direction is still pending. “This has created a regulatory gray zone, with companies reassessing the timing and scale of compliance investments while balancing regulatory risk against sterilization capacity and supply continuity concerns,” added McGee.

FDA’s updated QMSR/ISO13485 on harmonization will also have a significant impact on packaging and sterilization. The new adoption brings risk-based assessments front and center in how validations will be evaluated by FDA. “I don’t think that many packagers are thinking hard about how this affects them,” said Morgan, who put forth the following possibilities:

• Human factors will get a fresh look as the basis for most of the packaging risk assessment, including sterile field transfer, inspectability, and connection contamination risk.
• Distribution simulation sample sizing will now have to deal with assembly fragility, understanding/analysis to determine proper fixation, and packaging design for damping.
• End-of-shelf-life risk assessments for day 1,459 use on a five-year expiry dated package and its sterility capability, which means more focus on real-time aging.
• Understanding when the consensus of ASTM International/International Safe Transit Association (ISTA) testing is too much or too little to correctly validate a packaged product.

“We are already hearing about increased scrutiny on submissions, and we expect that these areas will likely get a second look in the year ahead,” Morgan added. “Find experienced partners that truly understand risk-based decision processes. Get them on your approved supplier lists today to make tomorrow’s validation work easier.”

Innovative Thinking 

More MDMs are looking at the package as part of the sterilization strategy, not just as a container that protects the product afterward. Package design, headspace, material selection, and pack density can all influence sterilization efficiency and overall process performance. “With regulations pushing companies to reduce excess packaging, there is an opportunity to optimize both sustainability and sterilization outcomes at the same time,” said Kirichkow.

As industry begins to look at ways to move away from multi-walled traditional, corrugated cardboard shipping boxes, companies are exploring alternative shipping and transport packaging systems that enable direct loading from truck to presentation to sterilizer. This kind of system thinking is going to be crucial for scaling alternative sterilization modalities effectively. “The facilities and logistics workflows of the future are going to look quite different from what most manufacturers are accustomed to today, and the packaging decisions being made right now are laying that foundation,” said Scott.

Atlas Molded Products has partnered with Paragonix, a company that offers innovative solutions to support the transplant community, “to mold unique customer geometries that meet very specific customer needs,” said Dr. Bergstrom. “When it comes to organ transplants, packaging is a matter of life and death and requires rigorously controlled and validated shipping systems that preserve precise temperature ranges and protect organ viability from the second the organ leaves the donor to the second it arrives with the recipient. Working with Paragonix, we have created a custom solution using molded EPS to extend the viability of transplant organs from door to door.”

Packaging and sterilization are often treated as the last step in the development process, which can limit opportunities for optimization. When speed to market becomes the priority, companies may lock in product and process decisions before fully evaluating packaging efficiency, material options, or sterilization impacts. “Bringing packaging and sterilization experts into the DFM process earlier can reduce redesign risk, improve validation planning, and uncover opportunities for cost savings or sustainability improvements,” said Kirichkow.

Team Development

New technology and innovation lead to more complexity for packagers and sterilizers. In many cases, packaging configuration, material choice, load density, and process design can materially improve sterilization outcomes. However, switching to an alternative sterilization is not a simple swap—it requires material compatibility, packaging validation, biocompatibility consideration, dose or cycle development, and regulatory planning. As devices become more complex, with tighter quality and regulatory controls, plus time and cost restrictions, MDMs, sterilizers, and packagers increasingly work together to achieve these goals.

“The convergence of smarter packaging design and more precisely controlled sterilization environments is where I see the most exciting near-term potential,” said Scott. 

“What is especially rewarding,” added Jordan, “is that packaging and sterilization are finally being recognized as strategic infrastructure within the medical device supply chain. As MDMs face increasing pressure around speed to market and supply chain resilience, they are looking beyond standalone sterilization vendors toward integrated partners that can manage the entire downstream delivery process—combining packaging, assembly, and sterilization into a coordinated platform that reduces handoffs, shortens timelines, and eliminates logistics costs and/or delays between manufacturing and sterilization.”

The level of collaboration depends greatly on the complexity of the project and the MDM’s network of suppliers. 

The most successful projects are almost always the result of early collaboration between the MDM, the packaging supplier, and the sterilizer. When those conversations happen at the design stage, rather than after the device is locked, the outcomes are dramatically better, observed Scott. “We have been working with packaging vendors proactively to understand the specific requirements of a chlorine dioxide cycle so they can recommend the right materials to their mutual customers,” she said. “That kind of cross-functional partnership ultimately shortens timelines and reduces costly surprises late in the validation process. It’s a model we actively encourage.”

The most effective solutions are developed through collaboration across the entire downstream supply chain. “Successful programs typically involve packaging engineers, sterilization experts, packaging test laboratories, and microbiological testing partners responsible for biological indicator, sterility, EO residual, and related validation testing,” said Jordan. “Bringing this broader group together early helps ensure the final solution is manufacturable, sterilizable, compliant, and scalable. The earlier the full ecosystem collaborates, the better the outcome for the MDM in terms of efficiency, speed, and long-term reliability.”

Although it is still a relatively young organization, the West Coast Device Alliance (WCDA) is a collaborative effort that is changing how industry can address MDM needs by streamlining and expediting the product launch process. The objective of the WCDA is to help customers navigate the complex landscape of product realization with efficiency and agility, while still keeping in mind the product launch and its specific environment. “The organization provides over 100 years of collective know-how, experience, and fault-tolerant operations to support customers on the end-to-end journey of medical device product realization,” said Morgan.

Although this model is not new in the greater business environment, it is a first in the medical device space. By bringing this level and caliber of alliance partners together, customers win with a multi-point of entry system that provides the consistent support and guidance needed to avoid costly pitfalls and mistakes that can stall development. “If you need to find a way to distill the right pathway on the first try,” said Morgan, “look for collaborations and alliances such as the WCDA, which are good bets to ensure your success.”

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.