Sustainability is no longer an option in the corporate world. 

The concept once regarded as a moral obligation has morphed into a strategic imperative that is shaping both business plans and market dynamics. Companies are reworking their supply chains, procurement tactics, and product development approaches to align with an eco-friendlier world. Such a paradigm shift not only is helping reduce industrialized societies’ environmental footprint but also unlocking new value creation and long-term growth.

“Sustainability is no longer just a competitive advantage,” International Institute for Management Development (IMD) Chief Sustainability Officer Natalia Olynec wrote in an online article last December. “…it is the foundation for enduring impact in an era defined by rapid change and complex challenges. The scaling of impactful sustainability initiatives—from circular business models to biodiversity-positive strategies—signals a shift from experimentation to execution, positioning leaders to capitalize on emerging opportunities.”

In the medtech industry, those opportunities are manifesting as reduced carbon footprints (Stryker Corp., for example, is aiming for carbon neutrality in five years), streamlined raw material usage (BD’s Emerald syringe line uses 30% less material than its conventional counterparts), lower emissions, and product and/or packaging recyclability, among others.

The latter opportunity has been feasible through simple green initiatives. Cases in point: Welch Allyn makes a recyclable blood pressure cuff with detachable tubes, and the syringes used with BD’s Emerald line can be collected, sterilized, and reprocessed into new sharps waste containers. 

True product recycling can be challenging due to material contamination and degradation, biohazard concerns, and stringent regulations, but orthopedic implant manufacturers and materials specialists are proving their loyalty to Mother Earth with planet-pleasing packaging initiatives.

Medtronic, for instance, shrank the packaging volume for its spinal cord stimulation needles, and Smith+Nephew followed suit with its ALLEVYN foam dressings.

Arthrex, meanwhile, now ships its products in recycled packaging material (i.e., cardboard boxes or paper-based wrapping) if possible and Johnson & Johnson MedTech packs 250 of its orthopedic products in post-consumer recycled paperboard (93%), replacing white boxes made with 100% virgin paperboard. 

Globus Group, on the other hand, uses biodegradable packaging across its product portfolio. “As an important part of our overall business strategy,” Head of Quality/Sustainability Pete Lee said, “we are committed to bringing greener solutions into our product range, our manufacturing processes, and our distribution network.” 

Medical packaging developer Coveris’ commitment to greener solutions spawned a new recyclable co-extruded film that is ideal for thermoforming and offers excellent puncture resistance. Formpeel P is available on either a peelable polyethylene or polyolefin base, depending on usage, and is compatible with fits with ethylene oxide (EtO) sterilization, plasma, and/or gamma irradiation. The company also launched a new division in 2023 (ReCover) dedicated to unique recycling solutions for the packaging industry. “The waste repurposing process is closing the loop by using a highly effective de-inking and mechanical recycling technology, reusing high-quality feedstock from plastic packaging to produce new packaging material,” Coveris Medical Segment Director Jan-Willem Bruijsten explained. “At Coveris, we have built our entire strategy around a vision of No Waste because we believe that fighting waste in all its forms is the driving force behind a more sustainable future.”

That future is also dependent upon a cleaner environment, and the medtech industry is begrudgingly working toward that goal with some help from the U.S. Environmental Protection Agency (EPA). Last spring, the organization set new EtO and chloroprene emissions standards designed to improve air quality around sterilization and chemical plants. 

Through two separate final rules, the EPA now requires commercial sterilizers to reduce EtO emissions by 21 tons annually (90%) and synthetic organic chemical manufacturers to cut their annual EtO and chloroprene discharge by 54 tons and 14 tons, respectively. 

The rule faced fierce opposition from the medtech industry, which relies on ethylene oxide to sterilize half of all medical devices manufactured in the United States annually (20 billion products). The new rule’s two- to three-year compliance deadlines leaves the medtech industry with a short window to find suitable sterilization alternatives.

Last winter, the U.S. Food and Drug Administration (FDA) officially recognized vaporized hydrogen peroxide as an alternative sterilization method in an effort to facilitate its broader adoption.

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MORE INFO: The Use of Vaporized Hydrogen Peroxide for Device Sterilization—A Medtech Makers Q&A

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“Vaporized hydrogen peroxide’s addition as an established sterilization method helps us build a more resilient supply chain for sterilized devices that can help prevent medical device shortages,” Suzanne Schwartz, M.D., director of the Office of Strategic Partnerships and Technology Innovation in the FDA’s Center for Devices and Radiological Health, said in a statement. “As innovations in sterilization advance, the FDA will continue to seek additional modalities that deliver safe and effective sterilization methods that best protect public health.”

And the environment.

Balancing ecological concerns with safe medical products is a complex undertaking, requiring a holistic approach that prioritizes patient safety, efficacy, and product sterility. And while they typically are associated with the final stages of device development, sterilization and packaging solutions are as important to the final product as design and should be considered upon the concept phase.

To better understand the juggling act medtech sterilization and packaging providers must perform when devising solutions, Orthopedic Design & Technology spoke to more than a dozen experts over the last several weeks. Input came from:

• Devon Buckley, engineering manager; Ryan Ott, vice president of Quality; Ryan Putschko, senior manufacturing engineer; and Anna Thomas, senior sales engineer at Packaging Compliance Labs.
• Seán Egan, director of Global Marketing and VoC Development, Nelipak Healthcare Packaging.
• Stu Krupnik, senior marketing director at UFP Technologies.
• Cory Layman, business development manager at Guardian Medical.
• Luke A. D. Miller, president, Eurofins Infinity Laboratory Group Inc.; Dragan Stjepanovic, managing director, Eurofins Inpac Medizintechnik GmbH; and Elizabeth Sydnor, director of microbiology, Eurofins Medical Device Services.
• John Nino, CEO of Life Science Outsourcing.
• Derek Prince, Ph.D., president of Prince Sterilization Services.
• Aaron Swanson, president, Pro-Tech Design & Manufacturing.
• Tom Williams, general manager, Millstone Medical Outsourcing.

Michael Barbella: What is the biggest challenge in packaging/sterilizing orthopedic products, and how does that differ from other branches of healthcare?

Devon Buckley, Ryan Ott, Ryan Putschko, Anna Thomas: Orthopedic products are often heavy and/or sharp and contain porous coatings. These design features require extremely durable (and often custom) packaging solutions to pass transit studies. Items like cannulas are often made of soft materials and are lightweight, meaning that they can often be packaged in a simple pouch without any additional protective packaging considerations.

Seán Egan: Orthopedic products present unique challenges. Their complex geometries—think implants and surgical instruments—often require highly customized packaging. They’re also heavier and sometimes sharper than products in other sectors, which means the materials need to be incredibly durable to prevent punctures or breaches. Compared to cardiovascular devices, for example, orthopedic products often demand greater structural protection. It’s a different level of complexity, but one that we’re well-equipped to handle.

Dragan Stjepanovic: Orthopedic products are challenging due to their large size, complex shapes, and mixed materials like metals and polymers. These require tailored sterilization methods and robust packaging to maintain sterility and product integrity. In comparison, other devices are smaller and more uniform, making their packaging less complex but with perhaps stricter demands on biocompatibility.

Luke Miller: Another big issue we address with orthopedic devices in both package testing and sterilization is the number of devices inside an individual shipper and the amount of empty space around the device inside the shipper. Both of these issues cause problems during the compressibility testing portion of package testing and the ability of the sterilization mode to penetrate the device for full sterilization to occur. 

John Nino: Orthopedic devices often require packaging that accommodates their size, weight, and unique geometries, presenting challenges in maintaining sterility and durability. In contrast, cardiovascular devices typically focus on precision and miniaturization, which involve different considerations. Addressing these unique orthopedic packaging needs requires tailored solutions that ensure product integrity and regulatory compliance while minimizing costs and delays. By partnering with experts, orthopedic device manufacturers gain access to innovative strategies and solutions that streamline packaging development, enhance product safety, and ensure readiness for market distribution.

Derek Prince: The biggest challenge in sterilizing orthopedic products is managing the complex geometries and material properties of implants, instruments, and components, especially given the increasing use of advanced materials like titanium alloys, ceramics, and polymers. Sterilants must penetrate these areas effectively to ensure complete sterilization. These geometries are less common in cardiovascular or other medical fields, where devices like catheters or stents are relatively simpler in structure. 

Aaron Swanson: Orthopedic products have large distributions of sizes and components that lead to a high SKU mix and smaller run sizes. PRO-TECH’s systems and packaging has been designed to ensure we can run small, medium, and large orders efficiently. We also give customer real-time tracking on order progress to ensure customers have full visibility into our manufacturing processes.

Tom Williams: The biggest challenge in packaging and sterilizing orthopedic devices is their variety, from tiny screws to large, heavy implants. This variety requires custom packaging solutions that protect the devices during shipping and maintain their sterility, though do so in a cost effective manner.

Another unique challenge is cleaning. Orthopedic devices often have machined components, requiring rigorous cleaning protocols to remove debris and contaminants from manufacturing. These protocols ensure the highest level of cleanliness, support patient safety, and maintain the device’s integrity throughout the sterilization and packaging process.

Millstone overcomes these challenges with customized cleaning, packaging, and sterilization processes. We continuously test and validate each step to meet regulatory standards and support patient safety. Our processes maintain greater oversight, reduce turnaround times, and ensure consistent cleanliness, sterility, and quality—no matter the device’s size, shape, or complexity.

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

Buckley, Ott, Putschko, Thomas: This is coming from someone who used to be a packaging engineer, but it’s never too early. Packaging can often be a consideration for the overall manufacturing processes involved. An example would be the last device I worked on before coming to PCL. There were a lot of different sets of tubing that were part of the device. By being involved early, I was able to integrate a coiling system into the initial production line that could simply be snapped into the thermoformed tray that held the finished device. Had I not been involved at the start, the package would have likely used simply “wire chases” in the tray and would have been a tangled mess for the operators to work with. Also, since package testing is usually the last leg of the development process, early involvement can help to avoid delays in the homestretch of the product launch.

Egan: Packaging and sterilization should absolutely be part of the conversation from the very beginning—during the concept phase. Early planning ensures that the materials and designs are compatible with the chosen sterilization methods. It also helps avoid costly redesigns later in the process. And with regulatory requirements becoming more complex, starting early gives you the time to validate packaging and sterilization solutions, ensuring compliance. Plus, if sustainability is a priority, you want that baked into the design from the start.

Stu Krupnik: Packaging needs to be considered as early on in the development process as possible. It is a key component of the overall device and performs important functions such as containment, protection, instructions for use, and product identification. Some of the many questions to answer upfront include design, sterilization method(s), materials, required testing, ease of use, and cost.

Cory Layman: Packaging should be included in the design input requirements discussion early in the product development process. Timing and approach will depend on whether you select a pre-validated sterile barrier packaging system or developing a custom sterile barrier system. Some of the benefits of using a pre-validated sterile barrier system include:

Late-stage packaging decisions: If you select a pre-validated packaging system, decisions can be made later in the product development process due to the sterile barrier already being validated. In which case packaging specifications, regulatory requirements, and sterility assurance are already covered.

Cost and resource allocation: A major benefit of using a pre-validated system is it simplifies the development process and reduces time and capital investment needed to complete sterile packaging validation. Guardian Medical’s pre-validation provides the necessary raw data for regulatory submissions, allowing the OEM to focus on product-specific validations and optimize capital and resource allocation.

Regulatory readiness and risk mitigation: Readily available validation data ensures that Guardian’s customers have confidence the sterile barrier system complies with regulatory requirements, which expedites the approval process for markets like the U.S. (FDA) and Europe (CE mark). 

With pre-validated packaging systems, OEMs can afford to make packaging decisions later in the development process because the sterile barrier›s validation and regulatory requirements are already established, saving significant time and cost. Guardian Medical’s pre-validated CapSure technology enables OEMs to mitigate risk and focus on their products and services.

Miller: Packaging an package testing should be a part of the Biological Evaluation Plan, and as a best practice is done early in the product development process to optimize both cost and time to market as well as during the product lifecycle. This ensures the packaging effectively protects the product during distribution; the packaging is compliant with any regulations; and that the final packaging is on brand and works for the end user. Conversely, we have seen situations where leaving the design and testing of the packaging to later in the design process has led to costly changes to both the packaging and the product, and significant delays in launch, particularly when the design of the packaging does not hold up over time.

Nino: Packaging should be considered from the initial design phase. Early involvement allows for a cohesive approach to ensuring device sterility, compliance with regulatory requirements, and compatibility with sterilization methods. This proactive approach also accelerates time-to-market by addressing potential obstacles before they arise.

Prince: As early as possible. Sterilization experts should be consulted during the early concepts and design stages. It is important to ensure the device and its packaging are engineered in a way to facilitate proper sterilization. This may vary depending on the sterilization modality selected.

Swanson: Ideally as soon as the form factors are being determined. Packaging must be efficient and cost effective for long-term success. Other than design and procurement there are also requirements for validation like aging and distribution that take time to complete. PRO-TECH also provides a host of validated in-stock packaging for those who don’t have the luxury of time.

Williams: Packaging and sterilization should be considered early in product development, ideally during the design and prototype phases. Every material choice, device geometry, and assembly method impacts how a product is cleaned, packaged and sterilized. Delaying these considerations until after product development often leads to costly delays. Involving packaging and sterilization experts early in product development cycle ensures that device materials and design are compatible with regulatory requirements and preferred sterilization methods. This proactive approach streamlines design, validation, production, in process testing, and regulatory approval.

Barbella: Medical devices and products are becoming increasingly “smart,” with embedded electrical or optical components that can be damaged easily by traditional sterilization methods. How have these solutions impacted the sterilization and packaging processes/techniques use for these products?

Buckley, Ott, Putschko, Thomas: While we don’t have a lot of visibility to devices like this, we have seen a slight trend to smaller batch EtO sterilization. It allows for less pressure and humidity by utilizing small totes and bags with EtO cartridges, rather than a whole pallet (or several pallets) in a large chamber.

Egan: Smart devices often contain sensitive electrical or optical components that can’t tolerate traditional sterilization methods like high heat or moisture. This has driven the adoption of alternatives such as hydrogen peroxide gas plasma and vaporized hydrogen peroxide. Designing packaging for these devices requires extra care to ensure they’re not only sterilized effectively but also protected during transit and storage.

Layman: Electronics integration into medical devices has significantly impacted the sterilization processes used in medical devices and sterile packaging. Traditional methods such as gamma radiation and steam autoclaving can increase the probability of damaging delicate electrical components. Manufacturers and packaging providers are adapting to innovate sterilization technologies to ensure devices remain functional and safe. 

The need for alternative sterilization techniques is growing and the alternatives being developed aim to sterilize without damaging the complex materials within the device. Guardian Medical’s packaging systems are proud to be included in early-stage feasibility studies that are challenging the boundaries of sterilization modalities which is indicating positive results.

Miller: This is an exciting area in medical device development. We are seeing more requests for both package testing and sterilization of devices with embedded electronic components. We recommend completing an R&D evaluation of the impact of the testing on a small number of devices before proceeding to validation and full production testing/sterilization. Given the expense of implantables, there is a possibility, with client discussion, to use a placebo device with the same volume, dimensions, and weight in lieu of the full device in order to test the device packaging alone, when it is apparent that the rigor of the testing runs will damage the device inside the packaging. When testing the embedded device with sensitive electronics and batteries, there are concerns around the impact of the actual sterilization process, particularly the heat and humidity used in the process, to address and communicate with clients.

Nino: Smart devices require specialized sterilization methods like low-temperature hydrogen peroxide or ethylene oxide sterilization to protect delicate components. Packaging must also shield these devices from environmental factors during transportation and storage. The rise of “smart” devices has led to a shift toward more delicate sterilization methods and highly protective packaging solutions. 

Prince: Device manufacturers are now integrating sterilization considerations into the design process: Encasing sensitive electronics in hermetically sealed compartments. Using biocompatible, sterilization-resistant materials. Low temperature modalities like VH2O2 are a good option for heat materials and electronics.

Swanson: There are several sterilization methods that are friendly to electronic or optical components. Ethylene oxide remains the most common and we are working with our sterilization partners to reduce EtO exposure due to environmental concerns. There are also other technologies like Vaporized Hydrogen Peroxide that work well but with limited scalability. Our stock program has sterile barrier packaging that is friendly to both.

Williams: “Smart” medical devices with embedded electrical and optical components have introduced new challenges for sterilization and packaging. Traditional sterilization methods, such as ETO (ethylene oxide) and gamma radiation, can compromise the integrity of electronic components or degrade sensitive materials. Addressing these challenges requires early consideration of materials, sterilization methods, and packaging needs during product development.

Rather than relying on standard approaches, OEMs must design a process that ensures the final result maintains product integrity and performance. This requires a holistic view of materials, sterilization compatibility, and packaging design. For instance, devices with sensors, microchips, or optical systems often require specially engineered packaging to shield them from environmental stressors like shock, moisture, and static during sterilization and transit.

With our two in-house testing facilities, we continually verify processes to ensure that devices maintain full functionality throughout sterilization and shipping. This approach enables faster lead times and eliminates the delays of relying on third-party testing labs. Millstone helps OEMs design better workflows, ensure compliance, and bring high-tech devices to market more efficiently by controlling the entire process in-house.

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

Buckley, Ott, Putschko, Thomas: This is a challenge based on the history of medical devices and packaging. Industry likes to utilize materials that are well-known and are compatible with devices, sterilization, and the human body in general. Changes from common packaging and device materials requires a significant amount of testing and can draw a lot of attention from regulatory bodies like the FDA. This can create a challenging decision to select more sustainable materials vs. those that are proven in industry. That being said, an approach based on reducing the footprint of the packaging system can reduce the amount of raw materials needed without introducing new materials or technologies.

Egan: Sustainability is a major focus right now. Companies want packaging that’s recyclable or contains recycle content an they’re looking for ways to minimize material waste. Sterilization is part of this conversation, too—there’s interest in methods that reduce emissions and energy use. We’ve also noticed that transparency in the supply chain is becoming more important. Customers want to know where their materials are coming from and whether they align with their sustainability goals.

Krupnik: I think we all would like to have more environmentally-friendly packaging but the challenge is finding recyclable or sustainable materials that are suitable for medical applications and compatible with various sterilization methods. Meanwhile, ESG is becoming more and more important for our clients. Providing a sustainability assessment score from platforms such as EcoVadis or CDP have become part of the requirements to do business with medical device OEMs. 

Layman: Sustainability concerns are drastically shaping the medical device packaging industry, with increasing pressure to reduce environmental impact. A focus on material reduction, recovery, and circularity are at the forefront of corporate sustainability goals. Guardian’s CapSure technology addresses these challenges through its design, which reduces the packaging materials needed to maintain a robust seal from the manufacture to the end user. It eliminates secondary packaging, reducing waste and material use. CapSure also provides a 10-year shelf life reducing resources to manage expiring inventory. 

While sterile packaging in general does result in waste, it is arguably a more sustainable solution, as it eliminates the need for reprocessing devices over and over again, which significantly saves on scarce resources such as power and water. 

The CapSure system promotes circularity by reducing packaging complexity and waste, and lowers the transportation and storage footprint, contributing to sustainability by reducing carbon emissions. It also helps companies comply with evolving sustainability regulations by offering packaging that is more resource-efficient and recyclable. 

Elizabeth Sydnor: Organizations are looking to build contingencies within their validated sterilization methods. This will be helpful in the long term as it could enable manufacturers to consolidate product families and extend certain modalities across varying product families.

Nino: Sustainability is now an expectation rather than an option. OMEs are seeking packaging solutions that align with environmental goals without sacrificing performance or compliance. By adopting recyclable materials, reducing packaging waste, and integrating sustainable practices, OEMs can meet consumer and regulatory demands while potentially reducing costs and enhancing brand value. Strategic guidance from an experienced partner in this area enables OEMs to balance sustainability with efficiency.

Prince: Now more than ever companies are making purchasing decisions based on sustainability goals and initiatives. Together with the EPA mandates and FDA’s guidance, sterilization processes that are effective while also more environmentally and operator friendly will become preferred by the industry.

Swanson: Since most medical device packaging cannot be recycled, the key is reducing the footprint and amount of material used in the packaging. A deep knowledge of packaging design principles is key here to ensure the sterile barrier does not become at risk in the process.

Williams: Sustainability is a critical business priority, driven by corporate social responsibility and the need for cost efficiency. Millstone supports these goals by operating energy-efficient facilities that minimize environmental impact. By optimizing equipment usage and reducing energy waste, we help OEMs lower operational costs while advancing their sustainability initiatives.

Another key area for improvement is packaging. Custom packaging solutions reduce material waste by eliminating the need for excessive fillers and unnecessary packaging components. By designing packaging tailored to the exact size and shape of devices, Millstone helps OEMs reduce shipping volume and waste while maintaining product protection during transit. 

This dual focus on energy efficiency and material reduction positions Millstone as a proactive partner in helping OEMs meet their ESG (environmental, social, and governance) goals.