Michael Barbella, Managing Editor02.08.21
It’s coming. Advancing in fits and starts, slowly but surely, the post-pandemic world is gradually taking shape.
And it likely will look significantly different than its predecessor. New social patterns will abound, along with new work habits, new travel and housing trends, and new business strategies.
In short, it will be a whole new world with lots of new “normals.”
Still, there may be some familiarity to this new world order, as some old challenges are sure to resurface. Healthcare’s struggle with supply chain visibility and globalization, for example, will indubitably continue long after COVID-19 is finally reigned in.
Similarly, the controversy surrounding ethylene oxide (EtO) sterilization is bound to persist. The debate, in fact, is expected to flare up this year before the “new normal” arrives, when the U.S. Environmental Protection Agency (EPA) issues its final federal rule limiting emissions of the colorless gas from commercial medtech sterilization plants.
The EPA originally intended to release the rule in 2020, but high demand for sterile medical equipment during the coronavirus pandemic’s early days prompted the agency to allow medtech companies to increase (or in some cases, restart) device sterilization operations at previously shuttered facilities.
EtO—used to clean roughly 50 percent of all medical devices that require sterilization—has been under national scrutiny since the gas was found to be at least 30 times more carcinogenic than previously understood. Public outcry over EtO emissions in the last two years have prompted sterilization plants in several states to either close or considerably scale back their operations.
The closures have left the medtech industry scrambling for alternative solutions, and warning of potential product shortages in the future. Meanwhile, the EPA has been fielding public comments and analyzing data from several commercial sterilization companies on facility characteristics, control devices, work practices, and costs for emissions reductions in order to draft its new rule.
The new decree, however, will do little to quell the ongoing debate over EtO’s safety. Residents living near sterilization facilities will continue to press for safer emissions (New Mexico’s attorney general has stepped into the fray, filing suit over environmental pollution in Santa Teresa), while industry will undoubtedly remain vigilant in its defense of the cleaning process.
The truth, of course, lies somewhere in between.
“Like thousands of other compounds used around the world, ethylene oxide is enormously useful when safely used, and potentially harmful when misused,” an October 2020 Heartland Institute policy brief states. “The same can be said of virtually any substance, from gasoline to table salt, from natural gas to nutritional supplements. Ethylene oxide has been, and is, extensively regulated. The rules that EPA first put into place to establish ethylene oxide sterilization procedures were carefully designed and extremely stringent. And as strict as federal standards are, many states have promulgated their own air toxics programs to supplement, not supersede, the federal rules. In a world filled with thousands upon thousands of chemicals, natural and manmade, defining ‘safe’ exposure levels to any one of them is an incredibly complex exercise. The risk associated with exposure depends on the state of a person’s health, other exposures and risk factors, the frequency of exposure, genetic predispositions, and many other factors.”
Regardless of outcome, the EPA’s new rule will be just one of the many new normals the orthopedic industry will have to face once the pandemic ends. To gain insight into other changes being fostered by the pandemic, Orthopedic Design & Technology spoke with various experts over the last few weeks. They included:
Jose Arevalo, global business development manager, Tyvek Healthcare; Jennifer Benolken, CPP - MDM and regulatory specialist, packaging engineer, Tyvek Healthcare; Dan Floyd, MDM and regulatory specialist, microbiologist, Tyvek Healthcare; and Nick Packet, MDM specialist, packaging engineer, Tyvek Healthcare; at specialty products giant DuPont.
Tim Eells, marketing manager at WESTPAK Inc., a third-party, independent test laboratory specializing in product and package testing.
Seán Egan, global marketing director and VoC development at Nelipak Healthcare Packaging, a Cranston, R.I.-based designer, developer, and manufacturer of custom designed thermoformed packaging for medical device and pharmaceutical firms.
Jennifer Gygi, expert technical consultant and Wendy Mach, senior expert, technical consulting, at Nelson Laboratories, a Sotera Health company. The firm is a global provider of laboratory testing and expert advisory services, performing more than 800 microbiological and analytical lab tests across the medical device, pharmaceutical, and tissue industries.
Stephanie McGee, vice president of sales and marketing at Command Medical Products Inc., a provider of contract manufacturing services, including finished device packaging and subassembly, to the medical device industry.
Samantha Smith, senior category manager, packaging and labeling, at Medtronic plc.
Don Tumminelli, senior technical manager, client services, at HIGHPOWER Validation Testing & Lab Services, a Rochester, N.Y.-based validation and testing laboratory that focuses primarily on reusable medical devices that require cleaning, packaging, and sterilization procedures.
Tom Williams, general manager at Millstone Medical Outsourcing, a provider of customized outsourcing solutions to the medical device industry.
Michael Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Jose Arevalo, Jennifer Benolken, Dan Floyd, and Nick Packet: Tyvek has always been a great material for orthopedic devices that require breathable packaging—it is strong, durable, and well-suited to handle some of the heavier orthopedic devices out there. Even with Tyvek, though, there are challenges that both sterilization technology and packaging are facing, in general. These challenges make for great opportunities for the packaging and sterility assurance disciplines (as well as some other disciplines) to collaborate and innovate. High level, these opportunities include making changes to optimize sterilization (tailoring cycles for specific products vs. one size fits all model, reducing EtO concentration, EtO exposure, etc.) and packaging (of being more strategic in processing—see packaging postponement below, space used, package form, and contents contained)—both as individual activities as well as in conjunction with each other. In the past, companies have been reticent to modify existing sterilization and packaging on commercialized product, as it is often cost consuming to make the changes and does not always pay off—small tweaks as well as major changes can allow companies to save money and be more sustainable. Contrary to popular belief, it does not always have to mean downgauging the sterile barrier to accomplish these goals; we’ve seen companies maintain the amount of Tyvek they’re using (and in some cases increase it), make changes to their processing and other parts of their device/package system, and save money while also being more sustainable. These strategies are not necessarily specific to orthopedic manufacturers, but can be applied within any realm of medical devices.
Packaging postponement is a packaging strategy that some companies are looking at as a means of reducing the amount of cellulosic material in their packaging (reducing aeration time post-EtO cycle)—adding the IFU (and possibly performing destination labeling at point of ship) after sterilization.
Tim Eells: Well-proven tests such as Accelerated Aging (ASTM F1980), Shipping/Distribution (ASTM D4169, ASTM D642), and Seal Strength/Peel (ASTM F88) continue regular usage by the orthopedic industry. However, I'm unaware of test protocol working groups in these or any areas focused on future revisions for the orthopedic industry.
Seán Egan: Packaging engineers are being challenged to cut costs by reducing the amount of packaging required to ship orthopedic (and other) devices—without compromising product integrity or the sterile barrier. With new product introductions, lead times for packaging development needs to be considered, as do new packaging formats or materials that require extensive validation testing, and if the trials are unsuccessful, costly delays can be avoided. Consequentially, OEMs are still reluctant to embrace new packaging formats unless there is a strong business need to work outside of tried and tested solutions. Furthermore, instances of particulates inside of packages can cause a recall due to manufacturing issues, so it’s important to work with a packaging contract manufacturer that is ISO 13485-certified and can demonstrate strong Good Manufacturing Practice (GMP), producing product in ISO-classified cleanrooms.
Samantha Smith: Packaging technology is advancing with more unique materials that reduces scuffing, elimination of foam, and unique designs that allow multiple sized products within the same package. It’s becoming more apparent that major packaging suppliers are thinking more about orthopedic products in their material offerings. It’s possible that the materials have been available for a long time, but not applied to orthopedics before—but now they’re recognizing these materials can be more widely used within the orthopedic segment and they are doing focused marketing toward that market for those materials.
There hasn’t been anything apparent for sterilization that is specifically focused on orthopedics.
Don Tumminelli: Reusable wrappers are being designed to minimize and optimize dry times of heavier sets, for single use devices, once again, are being reconsidered for possible repackaging in materials that harbor less EtO residuals.
Tom Williams: Over the last few years, we’ve seen a rise in the use of pre-validated and universal packaging solutions. These packaging solutions have enabled OEMs to manage risk and uphold quality while controlling costs and accelerating time to market. Innovation in the use of materials and quality processes will continue to push these solutions forward.
This year, we’ve focused on using technology as a way to work smarter. Given that manufactured batch sizes tend to be smaller in orthopedics, packaging isn’t a function we’ll ever be able to fully automate, but we can incorporate automation strategically to drive down cost while managing risk and augmenting our human capital. An example is our implementation of a proprietary vision system to ensure precise, correct alignment of assemblies. Going forward, we anticipate that automation as a complement to the human touch may open up new possibilities for innovation and efficiency.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Arevalo, Benolken, Floyd, Packet: For all sterile products, the sterile package (and sterilization) is equally as important as the device itself in the case of terminally sterile products (device + package + sterilization = sterile product). It’s a simple premise—without a functional package and appropriate sterilization method that allow a device to be used in a sterile state, you don’t have a product. By starting earlier versus later in the design and development process, concerns regarding the device design and expected manufacturing setting (angular/sharp edges and surfaces, weight distribution, manufacturing, sterilization, equipment needed, volumes) can be brought to light without causing a (potentially major) delay in the product’s development and subsequent commercialization. Nothing is worse than having the package fail testing just prior to submission and/or expected launch because there is an issue with the package. There isn’t a lot of time in any product development process to be “off” on your package design. By having the packaging voice in the room during the device design process, modifications can be made to the device to eliminate or reduce harm the device’s shape could potentially cause to the packaging (and possibly prevent additional costs in trying to create a quick fix by adding packaging at the back end of the development process to compensate for a device that is damaging the package’s ability to maintain sterility).
Eells: The specialized requirements of orthopedic products make excellent candidates benefitting from early engineering involvement. One of the most significant advantages is reducing the likelihood of expensive mistakes resulting from unknown stakeholders and team members, new or updated product or regulatory requirements, market or customer requirements, unstated material or design assumptions, test protocols, pass/fail differences, etc. There generally aren't extra resources or time available to deal with mistakes occurring late in the process that shouldn't have happened in the first place.
Egan: By considering packaging as early as possible in the development process, orthopedic OEMs and packaging providers can better ensure devices and packaging will be well-suited for each other. Some OEMs don’t realize how critical innovation is early on in the design phase of their packaging. Medical packaging manufacturers can be more than just product suppliers—they should become true partners to the OEM that work collaboratively with them to design optimized products fit-for-purpose, reduce waste, and even improve the experience for the end-user.
Jennifer A. Gygi: Sterilization and packaging should always be considered as early in the design process as possible. From a packaging perspective, orthopedic devices tend to be heavier for their size compared to many typical medical devices and usually have features like textured surfaces and sharp or protruding elements that present a challenge to packaging. Most orthopedic devices are not suitable for an “off the shelf” pouch and will likely require custom packaging. Custom packaging requires extra time to design and fabricate and may require additional considerations in regard to the sealing equipment. Thinking ahead in the design process to what the packaging requirements will be for the device can allow a device manufacturer to perform some of the custom packaging design steps in parallel with the product design, potentially saving weeks or months on the overall timeline.
Wendy Mach: It helps companies meet their market launch dates by ensuring that any issues associated with the packaging, design, and compliance to the standards have been managed before you actually get the appropriate phase of the test and find failures that could have been prevented by incorporation early in the design.
McGee: With the current state of sterilization capacity constraints, early on in the product design is the ideal time to consider material compatibility, packaging configuration and sterilization method.
A sterilization SME is able to offer insight into best sterilization method based on design inputs, material sensitivities and density. If our customers are not tied to a particular method on a new design, we encourage them to consider their alternatives.
Smith: Orthopedic items can be sharp, pointy, and abrasive—if you don’t take the packaging into account early on, you can run into a lot of problems at the end of the project, when it is not a desirable time to have problems come up. Depending on the packaging (and sterilization method), if you’re designing and developing a product for a specific type of sterilization and don’t take that into account, that can also lead to problems. While this concept is generally known, it still can and does happen if the product engineers aren’t working with the packaging and sterilization engineers from the beginning—it is all one system. It could be the greatest product in the world, but if you can’t package and sterilize it? It doesn’t matter.
Tumminelli: It is critical in the early stages to make sure the packaging is first of all compatible with the required sterilization process chosen. Not all materials are compatible with each sterilization modality. Also, the durability of the packaging material must be considered, especially for reusable devices that may be shipped around the world. A transpiration study must take in to account, shipping, dropping, pressure differentials in air transpiration, temperature variations, stacking and pallet loading.
Williams: It really comes down to three reasons. First, especially for packaging, it’s beneficial for OEMs to consider product and package design at the same time. Doing so can accelerate time to market while ensuring quality and ultimately patient safety. There can be pitfalls in the package design and validation process that can add significantly to time to market if not considered early and solved with expertise. These include testing for the stresses of distribution and the accelerated aging process.
The second reason to consider sterilization and packaging early on has to do with efficiency. Taking a strategic and proactive approach to the necessary resources and capacity puts an OEM in a much more advantageous position. Management can make better decisions about resource allocation and profitability.
Ultimately, what it comes down to is managing and minimizing risk. When you’ve baked your full spectrum of post-manufacturing needs into your planning process, you are less likely to encounter unwelcome surprises that can compromise quality and safety or delay your time to market. Of course, delayed time to market—or failure to get to market at all—puts your R&D investment and even your bottom line at risk.
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
Arevalo, Benolken, Floyd, Packet: We are monitoring and responding to the dynamic situation regarding COVID-19. Consistent with our core values, DuPont is also actively managing the impacts to our people and locations and are taking additional steps as the situation unfolds. We have focused and capable teams working this issue around the world, and we are prepared to navigate through these challenging circumstances with our Core Values at the forefront of everything we do. There’s been an emphasis on medical and personal protection applications for Tyvek, and we are addressing the demand. New opportunities with existing and downstream customers have sprung up requiring quick action. A few of our partnerships from the past 12 months include ASP partnership for mask decontamination, Applied Medical swabs for COVID-19 testing, and Operation Airbridge (expedited shipping of PPE).
Eells: As the pandemic began in mid-March, we immediately shut down for a few days to understand local and OSHA requirements, create necessary documentation, and form safety implementation leads and teams. It all worked great from the start, and continues to do so. Of course, the priority is ensuring everyone's safety, whether an employee-owner, a partner-client, or service provider visiting either of the test laboratories. As an essential business, we pivoted with a full operational test team following strict COVID-19 sanitation protocols within just a few days. All indirect employee-owners who could work from home did beginning that first week, and most have been doing so ever since. A lean, hard-working test team remains working regular shifts on-site to support our partner-clients' uninterrupted test needs.
Egan: While COVID-19 certainly upended daily life and created economic uncertainty around the world, lives depend on the healthcare industry and it is even more critical now than ever. Doctors, dentists, clinics, and hospitals globally resumed routine appointments and elective procedures under new norms as soon as it was deemed safe enough to do so, and the need for effective healthcare packaging remains—and even continues to grow.
Nelipak management has taken significant steps throughout our global manufacturing network to keep production lines running as an essential business in support of our customers, supply chain partners, and ultimately the patients we collectively serve. Despite the challenges of COVID-19, Nelipak has continued to make great progress on a range of new initiatives, including investments in our plants, improving quality, raising customer service levels, driving innovation, and building our organization and capabilities to supply customers with both rigid and flexible packaging. As an essential business, we consistently remained open for business at all 10 of our facilities worldwide to keep our customers up and running with no significant supply disruptions. From the onset of the pandemic, we implemented a formal COVID-19 monitoring process led by Nelipak global executive leadership and involving a cross-functional team. We continue to take action to promote employee and community safety in line with WHO, CDC, ECDC, and local government guidelines.
McGee: There are many lessons our organization has learned during this pandemic. We have periodically throughout the year looked at things we have done well and areas where we can make process improvements. Communication was strong throughout the pandemic. Having very clear and constant communication channels within our organization as well as outside with our suppliers and customers allowed business to flow amid significant fluctuations in demands, staffing and work schedules. Our meetings tend to be more productive and focused and we hope to continue that trend as team members return to the office.
Our organization was also able to capture the pride and compassion of our employees as we were building disposable devices that directly supported COVID-19 recovery. This fact resonated throughout our organization. As we worked extra hours to increase output, we were grateful to be a very small part of the recovery effort. This activity bonded us as a company and we shared in the comfort that the products we made were working to help those negatively impacted by this pandemic.
Smith: Like all companies—adjustments had to be immediately made without any planning. People started working from home, there were PPE shortages, and elective surgeries were down. People were/are afraid of going to the hospital (especially elderly people, the ones needing more orthopedic devices). In general, there has been an uptick in the elective orthopedic surgeries, allowing hospitals to earn money again, after having lost money through the beginning of the pandemic. We’ve also collectively learned a lot more about the virus, allowing us to find ways to prevent it better in the healthcare setting.
With Medtronic’s ventilators, we were able to continue making them the entire time, we also shared the design specifications for one of the ventilators (which would still need FDA/regulatory approval), allowing more ventilators to become available sooner, to help people who needed them.
Tumminelli: New protocols for movement around company, employee spacing, along with allowing those who could work remotely to do so. Lessons learned are all it takes is one employee who could have been infected to infect others and create a possible company shutdown. Fortunately, to date the company has not experienced this and the policies appear to be working as expected.
Williams: Millstone went into 2020 with orders from Q3 and Q4 2019 already in process. Orthopedic devices have long lead times, so these orders bridged us through the lockdown period. Because of this, we had some business continuity in place, and we turned our attention to our team, policies, and communication during this time.
We focused on our team members to ensure they were healthy physically and mentally during this stressful time. We also ensured we had the most up-to-date health and safety protocols in place to protect our team, and that we kept up with changes as they came (like mask mandates, social distancing and other safeguards). We also strove to be open, flexible, and transparent with our customers and team about challenges we were facing. As a high-growth company, we’re always working to stay ahead of our trajectory from the perspective of both people and process, and our focus remained proactive during this time.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Arevalo, Benolken, Floyd, Packet: DuPont Tyvek remains committed to servicing our customer base. We are striving every day to deliver the needed supply to the COVID-19 response with DuPont Personal Protective garments and Tyvek Medical & Pharmaceutical Packaging. This is what we are and what we do. DuPont is proud to support the dedicated healthcare professionals on the frontlines as well as their patients impacted by the virus.
We are able to do this by understanding that maintaining constant contact with customers is critical—demand can shift very quickly and unpredictably based on surgical procedure volume changes or as virus surges continue to pulse through the world. Frequent communication and trust is crucial to understand how different modes of recovery can be supported, and making potential supply chain disruptions minimal or prevented altogether.
Eells: Perhaps the best risk mitigation is to plan well in advance, allocating sufficient resources in preparation for the worst-case scenario which hopefully never comes. It's not easy, but the closest you can get to that, the better.
Egan: Our ability to seamlessly scale production to meet demand recovery depends upon how well we can work together with our customers to proactively coordinate the ramp-up of their production needs. Without effective collaborative forecasting and pre-planning, Nelipak would not be able to service all customers within standard lead-times given the supply chain disruptions caused by the pandemic.
Throughout the pandemic, we have encouraged clear and proactive communication with our customers. Our sales and customer service teams reach out frequently, but we also ask that customers communicate to us on a regular basis about what they are seeing in their business and the market segments they serve. By working together, we can help anticipate customer needs and give our respective teams and the customers we collectively serve the best chance to succeed as business ramps back up.
Smith: Shortages have been most noticed in corrugated boxes—with so much more commerce (consumer) happening via shipping, it has put constraints on the availability of shipping containers for medical device manufacturers. Because the supply is low and demand is high, the prices and lead times for corrugated products have increased. We have not seen any other shortages/issues in supply for needed packaging materials or sterilization, due to the pandemic.
What has been realized is there isn’t always a contingency plan for many of the packaging materials currently in use—which could have been an issue, had a shortage occurred. New strategies are being developed to allow for more flexibility in future and mitigate potential future issues that might arise.
Tumminelli: Expanding capacity and staff to make up for employee absences.
Williams: We’ve learned a few key lessons as an industry. Savvy OEMs have been rethinking their sourcing and considering dual sourcing as feasible. This is because we’ve all confronted supply chain vulnerabilities in goods and materials sourced from China during the pandemic. We’ve also seen how critically important communication and transparency are in supply chain coordination: You must be able to rely on your supplier, and industry expertise continues to be indispensable. Finally, we’ve also seen increased focus on forecasting accuracy. We’ve been working with OEMs and helping them understand the details and realities of forecasting, so that forecasts are developed, accurate, robust, and relevant to their business.
And it likely will look significantly different than its predecessor. New social patterns will abound, along with new work habits, new travel and housing trends, and new business strategies.
In short, it will be a whole new world with lots of new “normals.”
Still, there may be some familiarity to this new world order, as some old challenges are sure to resurface. Healthcare’s struggle with supply chain visibility and globalization, for example, will indubitably continue long after COVID-19 is finally reigned in.
Similarly, the controversy surrounding ethylene oxide (EtO) sterilization is bound to persist. The debate, in fact, is expected to flare up this year before the “new normal” arrives, when the U.S. Environmental Protection Agency (EPA) issues its final federal rule limiting emissions of the colorless gas from commercial medtech sterilization plants.
The EPA originally intended to release the rule in 2020, but high demand for sterile medical equipment during the coronavirus pandemic’s early days prompted the agency to allow medtech companies to increase (or in some cases, restart) device sterilization operations at previously shuttered facilities.
EtO—used to clean roughly 50 percent of all medical devices that require sterilization—has been under national scrutiny since the gas was found to be at least 30 times more carcinogenic than previously understood. Public outcry over EtO emissions in the last two years have prompted sterilization plants in several states to either close or considerably scale back their operations.
The closures have left the medtech industry scrambling for alternative solutions, and warning of potential product shortages in the future. Meanwhile, the EPA has been fielding public comments and analyzing data from several commercial sterilization companies on facility characteristics, control devices, work practices, and costs for emissions reductions in order to draft its new rule.
The new decree, however, will do little to quell the ongoing debate over EtO’s safety. Residents living near sterilization facilities will continue to press for safer emissions (New Mexico’s attorney general has stepped into the fray, filing suit over environmental pollution in Santa Teresa), while industry will undoubtedly remain vigilant in its defense of the cleaning process.
The truth, of course, lies somewhere in between.
“Like thousands of other compounds used around the world, ethylene oxide is enormously useful when safely used, and potentially harmful when misused,” an October 2020 Heartland Institute policy brief states. “The same can be said of virtually any substance, from gasoline to table salt, from natural gas to nutritional supplements. Ethylene oxide has been, and is, extensively regulated. The rules that EPA first put into place to establish ethylene oxide sterilization procedures were carefully designed and extremely stringent. And as strict as federal standards are, many states have promulgated their own air toxics programs to supplement, not supersede, the federal rules. In a world filled with thousands upon thousands of chemicals, natural and manmade, defining ‘safe’ exposure levels to any one of them is an incredibly complex exercise. The risk associated with exposure depends on the state of a person’s health, other exposures and risk factors, the frequency of exposure, genetic predispositions, and many other factors.”
Regardless of outcome, the EPA’s new rule will be just one of the many new normals the orthopedic industry will have to face once the pandemic ends. To gain insight into other changes being fostered by the pandemic, Orthopedic Design & Technology spoke with various experts over the last few weeks. They included:
Jose Arevalo, global business development manager, Tyvek Healthcare; Jennifer Benolken, CPP - MDM and regulatory specialist, packaging engineer, Tyvek Healthcare; Dan Floyd, MDM and regulatory specialist, microbiologist, Tyvek Healthcare; and Nick Packet, MDM specialist, packaging engineer, Tyvek Healthcare; at specialty products giant DuPont.
Tim Eells, marketing manager at WESTPAK Inc., a third-party, independent test laboratory specializing in product and package testing.
Seán Egan, global marketing director and VoC development at Nelipak Healthcare Packaging, a Cranston, R.I.-based designer, developer, and manufacturer of custom designed thermoformed packaging for medical device and pharmaceutical firms.
Jennifer Gygi, expert technical consultant and Wendy Mach, senior expert, technical consulting, at Nelson Laboratories, a Sotera Health company. The firm is a global provider of laboratory testing and expert advisory services, performing more than 800 microbiological and analytical lab tests across the medical device, pharmaceutical, and tissue industries.
Stephanie McGee, vice president of sales and marketing at Command Medical Products Inc., a provider of contract manufacturing services, including finished device packaging and subassembly, to the medical device industry.
Samantha Smith, senior category manager, packaging and labeling, at Medtronic plc.
Don Tumminelli, senior technical manager, client services, at HIGHPOWER Validation Testing & Lab Services, a Rochester, N.Y.-based validation and testing laboratory that focuses primarily on reusable medical devices that require cleaning, packaging, and sterilization procedures.
Tom Williams, general manager at Millstone Medical Outsourcing, a provider of customized outsourcing solutions to the medical device industry.
Michael Barbella: How is packaging and sterilization technology advancing to meet the needs of orthopedic manufacturers?
Jose Arevalo, Jennifer Benolken, Dan Floyd, and Nick Packet: Tyvek has always been a great material for orthopedic devices that require breathable packaging—it is strong, durable, and well-suited to handle some of the heavier orthopedic devices out there. Even with Tyvek, though, there are challenges that both sterilization technology and packaging are facing, in general. These challenges make for great opportunities for the packaging and sterility assurance disciplines (as well as some other disciplines) to collaborate and innovate. High level, these opportunities include making changes to optimize sterilization (tailoring cycles for specific products vs. one size fits all model, reducing EtO concentration, EtO exposure, etc.) and packaging (of being more strategic in processing—see packaging postponement below, space used, package form, and contents contained)—both as individual activities as well as in conjunction with each other. In the past, companies have been reticent to modify existing sterilization and packaging on commercialized product, as it is often cost consuming to make the changes and does not always pay off—small tweaks as well as major changes can allow companies to save money and be more sustainable. Contrary to popular belief, it does not always have to mean downgauging the sterile barrier to accomplish these goals; we’ve seen companies maintain the amount of Tyvek they’re using (and in some cases increase it), make changes to their processing and other parts of their device/package system, and save money while also being more sustainable. These strategies are not necessarily specific to orthopedic manufacturers, but can be applied within any realm of medical devices.
Packaging postponement is a packaging strategy that some companies are looking at as a means of reducing the amount of cellulosic material in their packaging (reducing aeration time post-EtO cycle)—adding the IFU (and possibly performing destination labeling at point of ship) after sterilization.
Tim Eells: Well-proven tests such as Accelerated Aging (ASTM F1980), Shipping/Distribution (ASTM D4169, ASTM D642), and Seal Strength/Peel (ASTM F88) continue regular usage by the orthopedic industry. However, I'm unaware of test protocol working groups in these or any areas focused on future revisions for the orthopedic industry.
Seán Egan: Packaging engineers are being challenged to cut costs by reducing the amount of packaging required to ship orthopedic (and other) devices—without compromising product integrity or the sterile barrier. With new product introductions, lead times for packaging development needs to be considered, as do new packaging formats or materials that require extensive validation testing, and if the trials are unsuccessful, costly delays can be avoided. Consequentially, OEMs are still reluctant to embrace new packaging formats unless there is a strong business need to work outside of tried and tested solutions. Furthermore, instances of particulates inside of packages can cause a recall due to manufacturing issues, so it’s important to work with a packaging contract manufacturer that is ISO 13485-certified and can demonstrate strong Good Manufacturing Practice (GMP), producing product in ISO-classified cleanrooms.
Samantha Smith: Packaging technology is advancing with more unique materials that reduces scuffing, elimination of foam, and unique designs that allow multiple sized products within the same package. It’s becoming more apparent that major packaging suppliers are thinking more about orthopedic products in their material offerings. It’s possible that the materials have been available for a long time, but not applied to orthopedics before—but now they’re recognizing these materials can be more widely used within the orthopedic segment and they are doing focused marketing toward that market for those materials.
There hasn’t been anything apparent for sterilization that is specifically focused on orthopedics.
Don Tumminelli: Reusable wrappers are being designed to minimize and optimize dry times of heavier sets, for single use devices, once again, are being reconsidered for possible repackaging in materials that harbor less EtO residuals.
Tom Williams: Over the last few years, we’ve seen a rise in the use of pre-validated and universal packaging solutions. These packaging solutions have enabled OEMs to manage risk and uphold quality while controlling costs and accelerating time to market. Innovation in the use of materials and quality processes will continue to push these solutions forward.
This year, we’ve focused on using technology as a way to work smarter. Given that manufactured batch sizes tend to be smaller in orthopedics, packaging isn’t a function we’ll ever be able to fully automate, but we can incorporate automation strategically to drive down cost while managing risk and augmenting our human capital. An example is our implementation of a proprietary vision system to ensure precise, correct alignment of assemblies. Going forward, we anticipate that automation as a complement to the human touch may open up new possibilities for innovation and efficiency.
Barbella: Why is it important for orthopedic manufacturers to consider sterilization and packaging early in the product design process?
Arevalo, Benolken, Floyd, Packet: For all sterile products, the sterile package (and sterilization) is equally as important as the device itself in the case of terminally sterile products (device + package + sterilization = sterile product). It’s a simple premise—without a functional package and appropriate sterilization method that allow a device to be used in a sterile state, you don’t have a product. By starting earlier versus later in the design and development process, concerns regarding the device design and expected manufacturing setting (angular/sharp edges and surfaces, weight distribution, manufacturing, sterilization, equipment needed, volumes) can be brought to light without causing a (potentially major) delay in the product’s development and subsequent commercialization. Nothing is worse than having the package fail testing just prior to submission and/or expected launch because there is an issue with the package. There isn’t a lot of time in any product development process to be “off” on your package design. By having the packaging voice in the room during the device design process, modifications can be made to the device to eliminate or reduce harm the device’s shape could potentially cause to the packaging (and possibly prevent additional costs in trying to create a quick fix by adding packaging at the back end of the development process to compensate for a device that is damaging the package’s ability to maintain sterility).
Eells: The specialized requirements of orthopedic products make excellent candidates benefitting from early engineering involvement. One of the most significant advantages is reducing the likelihood of expensive mistakes resulting from unknown stakeholders and team members, new or updated product or regulatory requirements, market or customer requirements, unstated material or design assumptions, test protocols, pass/fail differences, etc. There generally aren't extra resources or time available to deal with mistakes occurring late in the process that shouldn't have happened in the first place.
Egan: By considering packaging as early as possible in the development process, orthopedic OEMs and packaging providers can better ensure devices and packaging will be well-suited for each other. Some OEMs don’t realize how critical innovation is early on in the design phase of their packaging. Medical packaging manufacturers can be more than just product suppliers—they should become true partners to the OEM that work collaboratively with them to design optimized products fit-for-purpose, reduce waste, and even improve the experience for the end-user.
Jennifer A. Gygi: Sterilization and packaging should always be considered as early in the design process as possible. From a packaging perspective, orthopedic devices tend to be heavier for their size compared to many typical medical devices and usually have features like textured surfaces and sharp or protruding elements that present a challenge to packaging. Most orthopedic devices are not suitable for an “off the shelf” pouch and will likely require custom packaging. Custom packaging requires extra time to design and fabricate and may require additional considerations in regard to the sealing equipment. Thinking ahead in the design process to what the packaging requirements will be for the device can allow a device manufacturer to perform some of the custom packaging design steps in parallel with the product design, potentially saving weeks or months on the overall timeline.
Wendy Mach: It helps companies meet their market launch dates by ensuring that any issues associated with the packaging, design, and compliance to the standards have been managed before you actually get the appropriate phase of the test and find failures that could have been prevented by incorporation early in the design.
McGee: With the current state of sterilization capacity constraints, early on in the product design is the ideal time to consider material compatibility, packaging configuration and sterilization method.
A sterilization SME is able to offer insight into best sterilization method based on design inputs, material sensitivities and density. If our customers are not tied to a particular method on a new design, we encourage them to consider their alternatives.
Smith: Orthopedic items can be sharp, pointy, and abrasive—if you don’t take the packaging into account early on, you can run into a lot of problems at the end of the project, when it is not a desirable time to have problems come up. Depending on the packaging (and sterilization method), if you’re designing and developing a product for a specific type of sterilization and don’t take that into account, that can also lead to problems. While this concept is generally known, it still can and does happen if the product engineers aren’t working with the packaging and sterilization engineers from the beginning—it is all one system. It could be the greatest product in the world, but if you can’t package and sterilize it? It doesn’t matter.
Tumminelli: It is critical in the early stages to make sure the packaging is first of all compatible with the required sterilization process chosen. Not all materials are compatible with each sterilization modality. Also, the durability of the packaging material must be considered, especially for reusable devices that may be shipped around the world. A transpiration study must take in to account, shipping, dropping, pressure differentials in air transpiration, temperature variations, stacking and pallet loading.
Williams: It really comes down to three reasons. First, especially for packaging, it’s beneficial for OEMs to consider product and package design at the same time. Doing so can accelerate time to market while ensuring quality and ultimately patient safety. There can be pitfalls in the package design and validation process that can add significantly to time to market if not considered early and solved with expertise. These include testing for the stresses of distribution and the accelerated aging process.
The second reason to consider sterilization and packaging early on has to do with efficiency. Taking a strategic and proactive approach to the necessary resources and capacity puts an OEM in a much more advantageous position. Management can make better decisions about resource allocation and profitability.
Ultimately, what it comes down to is managing and minimizing risk. When you’ve baked your full spectrum of post-manufacturing needs into your planning process, you are less likely to encounter unwelcome surprises that can compromise quality and safety or delay your time to market. Of course, delayed time to market—or failure to get to market at all—puts your R&D investment and even your bottom line at risk.
Barbella: How did COVID-19 impact your company? What lessons can providers like yours take from the pandemic and apply to their services going forward?
Arevalo, Benolken, Floyd, Packet: We are monitoring and responding to the dynamic situation regarding COVID-19. Consistent with our core values, DuPont is also actively managing the impacts to our people and locations and are taking additional steps as the situation unfolds. We have focused and capable teams working this issue around the world, and we are prepared to navigate through these challenging circumstances with our Core Values at the forefront of everything we do. There’s been an emphasis on medical and personal protection applications for Tyvek, and we are addressing the demand. New opportunities with existing and downstream customers have sprung up requiring quick action. A few of our partnerships from the past 12 months include ASP partnership for mask decontamination, Applied Medical swabs for COVID-19 testing, and Operation Airbridge (expedited shipping of PPE).
Eells: As the pandemic began in mid-March, we immediately shut down for a few days to understand local and OSHA requirements, create necessary documentation, and form safety implementation leads and teams. It all worked great from the start, and continues to do so. Of course, the priority is ensuring everyone's safety, whether an employee-owner, a partner-client, or service provider visiting either of the test laboratories. As an essential business, we pivoted with a full operational test team following strict COVID-19 sanitation protocols within just a few days. All indirect employee-owners who could work from home did beginning that first week, and most have been doing so ever since. A lean, hard-working test team remains working regular shifts on-site to support our partner-clients' uninterrupted test needs.
Egan: While COVID-19 certainly upended daily life and created economic uncertainty around the world, lives depend on the healthcare industry and it is even more critical now than ever. Doctors, dentists, clinics, and hospitals globally resumed routine appointments and elective procedures under new norms as soon as it was deemed safe enough to do so, and the need for effective healthcare packaging remains—and even continues to grow.
Nelipak management has taken significant steps throughout our global manufacturing network to keep production lines running as an essential business in support of our customers, supply chain partners, and ultimately the patients we collectively serve. Despite the challenges of COVID-19, Nelipak has continued to make great progress on a range of new initiatives, including investments in our plants, improving quality, raising customer service levels, driving innovation, and building our organization and capabilities to supply customers with both rigid and flexible packaging. As an essential business, we consistently remained open for business at all 10 of our facilities worldwide to keep our customers up and running with no significant supply disruptions. From the onset of the pandemic, we implemented a formal COVID-19 monitoring process led by Nelipak global executive leadership and involving a cross-functional team. We continue to take action to promote employee and community safety in line with WHO, CDC, ECDC, and local government guidelines.
McGee: There are many lessons our organization has learned during this pandemic. We have periodically throughout the year looked at things we have done well and areas where we can make process improvements. Communication was strong throughout the pandemic. Having very clear and constant communication channels within our organization as well as outside with our suppliers and customers allowed business to flow amid significant fluctuations in demands, staffing and work schedules. Our meetings tend to be more productive and focused and we hope to continue that trend as team members return to the office.
Our organization was also able to capture the pride and compassion of our employees as we were building disposable devices that directly supported COVID-19 recovery. This fact resonated throughout our organization. As we worked extra hours to increase output, we were grateful to be a very small part of the recovery effort. This activity bonded us as a company and we shared in the comfort that the products we made were working to help those negatively impacted by this pandemic.
Smith: Like all companies—adjustments had to be immediately made without any planning. People started working from home, there were PPE shortages, and elective surgeries were down. People were/are afraid of going to the hospital (especially elderly people, the ones needing more orthopedic devices). In general, there has been an uptick in the elective orthopedic surgeries, allowing hospitals to earn money again, after having lost money through the beginning of the pandemic. We’ve also collectively learned a lot more about the virus, allowing us to find ways to prevent it better in the healthcare setting.
With Medtronic’s ventilators, we were able to continue making them the entire time, we also shared the design specifications for one of the ventilators (which would still need FDA/regulatory approval), allowing more ventilators to become available sooner, to help people who needed them.
Tumminelli: New protocols for movement around company, employee spacing, along with allowing those who could work remotely to do so. Lessons learned are all it takes is one employee who could have been infected to infect others and create a possible company shutdown. Fortunately, to date the company has not experienced this and the policies appear to be working as expected.
Williams: Millstone went into 2020 with orders from Q3 and Q4 2019 already in process. Orthopedic devices have long lead times, so these orders bridged us through the lockdown period. Because of this, we had some business continuity in place, and we turned our attention to our team, policies, and communication during this time.
We focused on our team members to ensure they were healthy physically and mentally during this stressful time. We also ensured we had the most up-to-date health and safety protocols in place to protect our team, and that we kept up with changes as they came (like mask mandates, social distancing and other safeguards). We also strove to be open, flexible, and transparent with our customers and team about challenges we were facing. As a high-growth company, we’re always working to stay ahead of our trajectory from the perspective of both people and process, and our focus remained proactive during this time.
Barbella: How can (should) packaging and sterilization providers better manage supply chain risk in the wake of the pandemic?
Arevalo, Benolken, Floyd, Packet: DuPont Tyvek remains committed to servicing our customer base. We are striving every day to deliver the needed supply to the COVID-19 response with DuPont Personal Protective garments and Tyvek Medical & Pharmaceutical Packaging. This is what we are and what we do. DuPont is proud to support the dedicated healthcare professionals on the frontlines as well as their patients impacted by the virus.
We are able to do this by understanding that maintaining constant contact with customers is critical—demand can shift very quickly and unpredictably based on surgical procedure volume changes or as virus surges continue to pulse through the world. Frequent communication and trust is crucial to understand how different modes of recovery can be supported, and making potential supply chain disruptions minimal or prevented altogether.
Eells: Perhaps the best risk mitigation is to plan well in advance, allocating sufficient resources in preparation for the worst-case scenario which hopefully never comes. It's not easy, but the closest you can get to that, the better.
Egan: Our ability to seamlessly scale production to meet demand recovery depends upon how well we can work together with our customers to proactively coordinate the ramp-up of their production needs. Without effective collaborative forecasting and pre-planning, Nelipak would not be able to service all customers within standard lead-times given the supply chain disruptions caused by the pandemic.
Throughout the pandemic, we have encouraged clear and proactive communication with our customers. Our sales and customer service teams reach out frequently, but we also ask that customers communicate to us on a regular basis about what they are seeing in their business and the market segments they serve. By working together, we can help anticipate customer needs and give our respective teams and the customers we collectively serve the best chance to succeed as business ramps back up.
Smith: Shortages have been most noticed in corrugated boxes—with so much more commerce (consumer) happening via shipping, it has put constraints on the availability of shipping containers for medical device manufacturers. Because the supply is low and demand is high, the prices and lead times for corrugated products have increased. We have not seen any other shortages/issues in supply for needed packaging materials or sterilization, due to the pandemic.
What has been realized is there isn’t always a contingency plan for many of the packaging materials currently in use—which could have been an issue, had a shortage occurred. New strategies are being developed to allow for more flexibility in future and mitigate potential future issues that might arise.
Tumminelli: Expanding capacity and staff to make up for employee absences.
Williams: We’ve learned a few key lessons as an industry. Savvy OEMs have been rethinking their sourcing and considering dual sourcing as feasible. This is because we’ve all confronted supply chain vulnerabilities in goods and materials sourced from China during the pandemic. We’ve also seen how critically important communication and transparency are in supply chain coordination: You must be able to rely on your supplier, and industry expertise continues to be indispensable. Finally, we’ve also seen increased focus on forecasting accuracy. We’ve been working with OEMs and helping them understand the details and realities of forecasting, so that forecasts are developed, accurate, robust, and relevant to their business.
