Packaging and sterilization play a crucial role in the safety, performance, and regulatory compliance of orthopedic devices. As implants and instruments become more complex, the means used to protect and sterilize them must evolve in tandem.

Effective packaging isn’t merely a protective layer for transport and storage. It’s a crucial component of the device system, designed to maintain sterility, preserve material integrity, and support efficient clinical use.

Sterilization is a high-stakes process that directly affects patient outcomes. Orthopedic devices often incorporate advanced materials, tight tolerances, and modular designs, which can all present challenges during sterilization. Choosing the appropriate sterilization modality and validating it effectively requires a deep understanding of device design and packaging performance.

Today’s regulatory environment demands that manufacturers navigate more stringent global standards, increasing sustainability expectations, a pressure to reduce costs without sacrificing quality. Because of this, packaging and sterilization strategies are no longer downstream considerations, but core elements of product development and lifecycle management.

In order to explore the key considerations, challenges, and emerging trends in packaging and sterilization in the orthopedic device industry, ODT spoke to nearly a dozen experts:

John Abraham, President, Atlas Vac Machine
Douglas Constable, CEO, Life Science Outsourcing
Diana Cortes Covington, M.S., Principal Scientist, Sterigenics, a Sotera Health company
Seán Egan, Director of Global Marketing, Nelipak Healthcare Packaging
Brandon Hoser, Business Development & Marketing, Packworld USA
Cory Layman, Business Development Engineer, Guardian Medical USA
Stephanie McGee, VP of Operations, Command Medical Products
Derek Prince, Ph.D., President, Prince Sterilization Services
Joachim Pruessner, Product Development Manager, Komet Medical USA
Tom Williams, EVP & GM, Millstone Medical Outsourcing

Sam Brusco: What are the dominant market forces at play in your niche of the orthopedic device industry?

John Abraham: The expectation is that the equipment (tray sealer) should last 20-30 years, making costly and time-consuming equipment validation an afterthought. But electronic components and software OS are constantly morphing and becoming obsolete. How do you keep equipment in the field operating 20+ years?

The other interesting market challenge is that if this equipment does last that long, how does the customer overcome that familiarity when it’s time to realize the same brand has evolved to provide so much more when it comes time for a replacement machine? I have a hot 1965 Mustang fastback, but it is brutally basic when compared to today’s new Mustang. How do you effectively update someone’s understanding of what advancements have been made within your brand?

Douglas Constable: Orthopedic manufacturers adapt to faster development cycles while managing greater complexity. Devices reach the market more quickly and in a growing number of configurations, which adds pressure on development teams. At the same time, supply chain conditions remain variable, affecting material availability and lead times. Regulatory expectations around risk management and documentation have also increased. Together, these factors have pushed packaging and sterilization considerations earlier in the development process and increased the need for closer coordination across engineering, quality, and manufacturing.

Diana Cortes Covington: Orthopedic device manufacturers are being more selective toward robust and adaptable sterilization and packaging strategies. It can be explained by pressures such as regulatory scrutiny, supply chain reliability, and accelerated innovation. Capacity availability, geographic flexibility, and proven process control are critical factors in their processes. Speed to market is also a critical driver, reinforcing the value of early technical engagement and reliable validation execution to reduce risk and support timely product launches.

Seán Egan: Sustainability is a major one, as companies look for ways to reduce waste and support their decarbonization and Scope 3 strategies. Regulatory expectations are also rising, with frameworks like Europe’s MDR, the EU Packaging and Packaging Waste Regulation, and new EPA guidance around ethylene oxide (EtO) shaping how packaging materials and sterilization techniques are selected.

The devices themselves are becoming more complex. Orthopedic implants and instruments often have challenging geometries, heavier components, and sharp edges that require robust and highly durable sterile barriers. The growth of “smart” orthopedic technologies adds new requirements around protecting sensitive electronics and ensuring compatibility with alternative sterilization methods. As always, cost-efficiency remains a constant consideration for OEMs and healthcare providers.

Brandon Hoser: An inherent goal of all packaging is to protect product along its travels, but orthopedics has the additional and critical need to maintain sterility until its point of use, which mitigates patient infection risks. We manufacture heat sealing equipment, providing a high-quality tool to device manufacturers so these sterile barrier systems can be created. 

Good hermetic heat sealing is key but there is also a cosmetic aspect involved. A heat seal may functionally test well but if a cosmetic blemish is present, it casts doubt on the sterility and would be discarded in an operating room, if not discarded earlier. Any function that supports process control is desired, if not required. Features such as user-specific password protection to lock down machine access, data logging, and product locating aid process control.

Cory Layman: For sterile packaging of orthopedic devices, sustainability and usability are major areas of focus. The goal to reduce packaging materials drives OEMs and sterile packaging manufacturers to convert from dual sterile barriers to single sterile barrier systems to reduce materials. Historically, sterile packaging has utilized dual sterile barrier systems to reduce risk of sterile barrier breaches, because traditional packaging materials such as peel pouches are susceptible to punctures and tears. According to ISO requirements, a sterile barrier system is “the minimum packaging configuration that provides a microbial barrier and allows aseptic presentation (sterile opening) of the product until point of use”. New innovations in sterile barrier systems like our CapSure technology enable single sterile barriers and are resilient enough that no secondary packaging is required to protect the seal. 

One of the most recent revisions to ISO 11607 Part 1 is the requirement for a documented usability evaluation to assess the performance of the packaging system to be opened safely and aseptically transfer the device to the sterile field. OEMs also recognize usability of the package can add value to their surgeon customers by improving OR efficiency. The CapSure system was designed with usability and aseptic transfer as a critical performance criterion and offers device identification, controlled opening, and aseptic sterile transfer.

Stephanie McGee: Most of the momentum is around keeping costs down, improving efficiency, and simplifying where possible. Companies look closely at packaging and materials to reduce waste, streamline designs, and make things easier to scale while staying within very strict regulatory and sterility requirements in all areas of medical device packaging, not just orthopedics.

There’s also a continued shift toward single-use, procedure-ready products, which puts more pressure on packaging to perform reliably over time. Sustainability is increasingly part of the conversation, especially when it comes to recyclable or plant-based materials, but adoption is still careful and selective. For the most part, the industry is trying to move forward without taking on unnecessary risk, sticking with proven solutions while keeping an eye on what’s coming next.

Derek Prince: Orthopedic device manufacturers increasingly turn to outsourced packaging, sterilization, and WFI wash and pack service partners as devices, packaging systems, and regulatory expectations continue to grow more complex. Many OEMs prioritize flexibility and scalability, opting to leverage external expertise while focusing on core competencies and reducing in-house investments in infrastructure, equipment, personnel, and regulatory considerations. This shift is driven by the need to manage facility layouts and capacity constraints, shorten development timelines, secure supply chains, and ensure consistent compliance with cGMP, FDA, and ISO 13485 requirements.

Joachim Pruessner: Key forces include increasing regulatory scrutiny, strong cost pressure from OEMs, demand for faster time-to-market, and growing preference for turnkey partners that can deliver sterile, private-label products at scale while maintaining consistent quality and supply reliability. OEMs no longer buy manufacturing capacity alone, but increasingly buy risk reduction, regulatory certainty, and supply chain resilience.

Tom Williams: As total joint cases accelerate the move to ASCs, the industry is moving away from massive, multi-tray “loaner” sets. ASCs lack the sterile processing infrastructure of large hospitals, forcing a shift toward single-use, sterile-packed implants and instruments. 

As of Feb. 2, 2026, the FDA has officially transitioned to the Quality Management System Regulation (QMSR), aligning with ISO 13485:2016, closing the gap between U.S. and international quality standards. For packaging, this has heightened the focus on Risk-Based Design Controls. It’s no longer about simply validating the sterile barrier; we are proving—with data—that the packaging system mitigates specific clinical risks identified in the device’s risk file.

The industry is aggressively diversifying away from ethylene oxide (EtO) due to environmental regulations and capacity constraints. We are seeing a surge in X-ray sterilization and low-dose EtO cycles. These transitions require re-validating materials to ensure they don’t become brittle or lose their sterile barrier integrity under new modalities.

Brusco: How early in the product development process should packaging/sterilization be considered and why?

Abraham: You can’t purchase capital equipment on Amazon, and it seems some people have fallen into that deadline trap. Planning ahead is a habit that portends success. Often, the package design goes through several iterations based on good feedback—from the end user, the packaging supplier, the device manufacturing employees, and the packaging equipment engineers.

How many times have I heard that no one asked if the packaging equipment (tray sealer) is already 100% utilized on current product throughput. Or someone didn’t hear that a missing design feature on a current package would have been great to have on the next new package developed. Or what is the tradeoff of cheaper/thinner materials against productivity and quality?

Constable: Packaging and sterilization should be considered when design inputs are first established. Early decisions related to device geometry, materials, and configuration directly affect packaging performance and sterilization compatibility. When these elements are addressed late, teams often face redesigns, additional testing, or extended validation timelines. Early planning helps align product design with manufacturing and reduces the risk of delays as programs move toward commercialization.

Cortes Covington: Packaging and sterilization should be considered as early as the concept and design-input phase. Early alignment enables manufacturers to select materials and package designs that are modality compatible, support sterility assurance, and meet residual requirements reducing the risk of late-stage redesign. Early involvement also reduces development risk, shortens validation timelines, and helps ensure a smoother path through regulatory review—particularly important for orthopedic products with complex geometries, heavy instruments, or mixed materials.

Egan: Packaging and sterilization should be part of the conversation from the very beginning, ideally in the concept phase. Early planning ensures the packaging materials and design support both the performance of the device and the chosen sterilization method. It also reduces the risk of late-stage redesigns, which can be costly and time-consuming.

If sustainability goals are in play, early alignment becomes even more important. This is when teams can evaluate recyclable mono-material options, trays containing recycled content, or circular solutions like reusable transport trays. Early collaboration also supports efficient prototyping, validation planning, and regulatory readiness, which are critical as requirements continue to expand and evolve.

Hoser: I believe any packaging engineer would advocate for involvement as early as possible in the process. Packaging can sometimes be an afterthought when bringing a new device to market, but devices never get to market unless dependable packaging is developed. There is the potential for substantial delays if packaging and sterilization modes are considered too late.

Layman: We remind clients that packaging is part of the product and developing a safe and efficient sterile barrier system early in the process will result in reduced resources, costs, and ultimately speed-up time to market. However, when selecting pre-validated packaging systems, early packaging considerations become far less critical in the product development process. The required testing and validation for the sterile barrier system have already been completed, with results readily available. Our pre-validated packaging solutions save OEMs significant time, resources, and capital, enabling shorter development lead times and providing a competitive advantage in getting products to market faster.

McGee: Packaging and sterilization must be part of the conversation from day one. Early choices around materials, package design, and sterilization methods end up driving regulatory strategy, validation timing, and overall risk more than many teams expect. When those decisions are made too late, they often lead to rework or delays.

We also see regulators encourage manufacturers to plan for change through predetermined change control plans (PCCPs). PCCPs allow manufacturers to predefine potential future changes—alternate sterilization methods, material substitutions, or process adjustments—along with the associated risk assessments and validation plans. When done correctly, this enables changes to be implemented without new regulatory submissions, reducing supply disruption.

That means thinking early about what might need to change down the road—whether that’s a sterilization method or a packaging material—and having a clear, validated path for making those changes if needed. The benefit is greater flexibility and fewer surprises later, even though it does require more upfront planning while teams are already working under tight timelines and budgets.

Prince: Packaging and sterilization should be considered during feasibility and design, not as a late-stage “check the box” type activity. Early alignment helps ensure the device, packaging, and sterilization modality are compatible and material selection, design features, residual considerations, sterile barrier requirements, and distribution performance are interconnected. Addressing these items early reduces surprises during validation, avoids rework and timeline slip, and supports a smoother path to scale. Where devices may have challenging geometries, multi-component kits, and higher handling demands—front-end planning can significantly improve manufacturability, sterility assurance, and overall time to market.

Pruessner: For us as a CDMO—on day one. Material selection, geometry, and packaging configuration directly impact sterilization feasibility, validation coverage, and overall project timelines. Early alignment avoids redesigns and delays. We still see project delays because packaging and sterilization were treated as downstream considerations rather than integral design elements.

Williams: If you’ve started the device design, you should have already started the packaging design. Orthopedic implants (like bone screws or rasps) are inherently aggressive. If packaging isn’t designed early, these devices will puncture the sterile barrier during the ASTM D4169 distribution testing, sending you back to a six-month redesign loop.

Early involvement also allows us to run “worst-case” validation studies, allowing for time to course correct if issues arise, potentially shaving months off the commercial launch timeline.

Brusco: How are corporate sustainability concerns impacting packaging/sterilization processes/techniques?

Abraham: We are on the back side of that issue, where it is hard for us to be proactive. We offer support to the packaging engineer when asked to reach a good nominal set more quickly and accurately of sealing parameters at the beginning of the validation process. It is our objective, therefore, to reduce waste of packaging materials caused by “shotgunning” recipe changes.

Constable: Sustainability is increasingly a part of packaging discussions, though sterile barrier performance and regulatory compliance remain the primary drivers in orthopedics. Most progress comes through practical steps such as right-sizing packaging, simplifying configurations, and improving process efficiency to reduce waste. In sterilization, sustainability efforts often focus on improving reliability and first-pass yield, which lowers rework and unnecessary reprocessing. These considerations are most effective when they are addressed early and built into the process before validation, rather than introduced after development decisions have been finalized.

Cortes Covington: Manufacturers are exploring right-sized packaging, material reduction, and recyclable structures, while still maintaining sterile barrier integrity and distribution performance. From a sterilization perspective, sustainability also emphasizes efficient process design, reduced EtO usage, minimized rework, and adoption of advanced emissions-control technologies. These efforts support environmental responsibility without compromising product safety or performance.

Egan: Many companies now view packaging as a key component of their emissions and waste-reduction strategies. This has accelerated interest in mono-material trays and inserts that support circularity, as well as designs that incorporate post-consumer recycled content to meet emerging regulatory requirements like PPWR. Right-sizing packaging has become a priority as well, since reducing material volume, shipping density, and storage needs can cut both environmental impact and cost. Digital simulation tools, including pallet load studies, help teams evaluate these changes and quantify improvements.

Sterilization is evolving alongside these efforts. Manufacturers are exploring methods that reduce emissions or rely on lower energy use, such as hydrogen peroxide gas plasma or vaporized hydrogen peroxide for devices that cannot tolerate heat or humidity. Transparency across the supply chain has also become increasingly important, with companies seeking better visibility into the sourcing and environmental footprint of packaging materials.

Hoser: Sustainability is a focal point for many organizations. Life science industries like orthopedics are conservative and slow to change, which can be a beneficial trait for risk mitigation but creates slower adoption rates for more sustainable materials used in packaging or less environmentally damaging sterilization methods such as alternatives to ethylene oxide. That said, it is difficult to find a conference which is not talking about sustainability. Progress will just be slower in a risk-averse market.

Layman: This is a topic that’s been highly visible in recent years causing many changes in the industry to reduce materials, footprint, and increase recyclability of sterile barrier packaging waste. Sterilization modalities such as EtO are also being scrutinized due to its carcinogenic health and environmental risks. The EPA has finalized amendments under several different environmental laws to limit the exposure in protecting human health and the environment. OEMs are evaluating compatible sterilization modalities that’ll maintain product performance such as gamma, e-beam, and X-ray. Our packaging systems deliver a 50%-75% reduction in footprint compared to traditional sterile barrier pouches and tray configurations, creating cost savings across the entire value chain. They are made from mono materials that are compatible with today’s recycling stream, unlike multi-layer materials, which often create challenges during recycling processes.

Prince: Corporate sustainability initiatives are driving orthopedic manufacturers to re-evaluate packaging and sterilization modalities, with growing interest in vaporized hydrogen peroxide (VH2O2) and steam sterilization as environmentally responsible alternatives to certain legacy methods. Both technologies are well established, highly effective, and do not rely on toxic or persistent chemicals; VH2O2 breaks down into water and oxygen, while steam uses only heat and purified water. 

Compared to some traditional sterilization approaches that involve hazardous gases or extensive aeration and abatement requirements, VH2O2 and steam offer reduced environmental impact, simpler waste handling, and improved workplace safety. As a result, manufacturers are increasingly selecting these modalities to meet sustainability goals while maintaining robust sterility assurance and regulatory compliance.

McGee: We don’t have any direct client implementations we can point to, but we actively watch the market and track how sustainability influences material choices across the medical device space. We see a growing interest in plant-based and bio-derived materials, particularly at the packaging and material development level.

Plant-based bioplastics like PLA and PHA are starting to show up in medical packaging discussions and early applications. Companies such as BASF (with Ecovio), Corbion (PuriPlast), Danimer, and Mesh Bioplastics help push the industry toward lower-impact sterile barrier films and packaging components as sustainability goals become more prominent.

At the same time, biodegradable polymers are already being used directly in orthopedic products themselves. Examples like PLA- or PHA-based pins and resorbable materials such as PURASORB implants demonstrate that renewable, bio-derived materials can meet clinical and performance requirements. That existing use in devices helps support the case for expanding these materials into packaging applications as well.

Adoption is still early and often company-specific. Regulatory approval, sterilization compatibility, shelf-life performance, and mechanical validation remain key challenges that must be worked through before these materials see broader, industry-wide implementation.

Pruessner: Sustainability initiatives are driving reduced packaging volume, material optimization, and increased use of recyclable or lower-impact materials, while still meeting sterility and regulatory requirements.

Sterilization processes and workflows are also being evaluated for energy efficiency and environmental footprint without compromising patient safety. However, sustainability efforts must always operate within clearly defined regulatory and sterility boundaries, as patient safety and compliance are non-negotiable.

Williams: Sustainability is becoming a formal procurement requirement. Large hospital systems are demanding carbon-footprint data for the products they buy.

Optimize packaging volumes as much as possible. Using custom-sized trays and pouches to reduce the volume of air shipped, which lowers the carbon footprint of every truckload and reduces the amount of secondary waste the hospitals must ultimately deal with.

There is a significant move toward EtO reduction cycles. By optimizing the amount of gas used and improving aeration times, chemical waste, and energy consumption are reduced without compromising sterility.