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Film and foil laminations used for pouching applications across the healthcare packaging industry serve a vital purpose in protecting single use medical device, diagnostic, and pharmaceutical products. They are excellent microbial barriers and stand up to a variety of sterilization modalities. The large selection available of multi-layer structures allows packaging engineers flexibility in choosing the right structure for a given performance need or application. This might include added strength and puncture resistance, peelability, moisture and oxygen barrier properties, printing, or even a combination of these or other functional requirements. But how are these layers all combined? Generally speaking, most pouching laminates used in our industry are converted using either adhesive lamination or extrusion lamination. Let’s explore the difference between these two methods, and why it matters both for film and foil construction as well as final sterile barrier application.

In a world where there is so much waste, why choose single-use healthcare packaging?

The answer: A continuous goal to enhance patient safety and reduce risk of contamination in the healthcare environment. In medical and home settings alike, single-use packaging is not only easy to use, but convenient. The sterility of the product inside is crucial, as it comes in direct contact with the patient. Through single-use packaging, the risks of cross-contamination and infection are significantly reduced.

In medical packaging, our focus is often on compliance and quality due to our direct impact on human health. A lot of new packaging trends begin in food and consumer goods, but what if some of the high-tech packaging from consumer goods could be adapted to our more “serious” needs?  

In medical packaging, we hear the word aseptic a lot. By definition, the word aseptic means free from pathogenic microorganisms. But how does it relate to the manufacturing process? Aseptic manufacturing is the process of producing products free from contamination. It takes place in various industries but is a common requirement for the pharmaceutical and medical device industries because of the need to prioritize patient safety. Following stringent aseptic guidelines ensures that a product’s integrity is not compromised before use.

Disclaimer: This article was written for fun only. It is not intended to serve as medical advice of any kind.

For many children around the world, Halloween has become a much-anticipated, fun-filled celebration of dress up and treats of every kind. We’re getting into the spirit and decided to join in on the Halloween fun by digging into some of the more interesting candy-related information available online. Here are a few of our favorites:

One year ago, my whole life changed. I went from excellent health, running 4 miles each day, to a hospital bed, in a matter of days. My nightmare started with a simple scope procedure performed at a Southern California hospital. Little did I know that this routine procedure would result in a Heliobacter pylori (H. pylori) infection, a common bacterial infection of the stomach. In my case, this infection caused a bleeding ulcer, leading to blood loss that had me collapsing in my home. An intense ambulance ride to the nearest hospital and a blood transfusion were required to save my life. This illness nearly killed me, and it was several bedridden months before I was back on my feet due to this needless infection.

It is amazing how quickly priorities change. Medical packaging industry buzz is no different. In 2014, “sustainability,” (while growing in prominence in other sectors) was in its infancy as far as the medical packaging industry was concerned. In 2017, our industry eyes shifted to the ticking clock of enforcement for the new EU MDR. And in 2020, every conversation went silent except for one, everywhere. By 2022 business was back, yet it took time to regroup: just where did we leave off?

Whether big or small, medical inventions have not only etched milestones in medical history but have transformed patient safety and quality of life. Born from next-level human determination, these devices have paved the way toward a healthier future for humankind.

This 2021 article offered three recommended practices for handling sterile packaged medical products. You may be asking yourself: So, why revisit old news? The answer is simple. Looking back can offer an interesting perspective on what beliefs and strategies endure and when a flawed belief becomes a lesson learned instead.

Behind every packaged medical device lies a multi-faceted manufacturing process that relies on robust packaging, engineering, stringent quality controls, and unwavering adherence to regulatory standards. While the specific steps may vary depending on the type of device and its packaging requirements, here is an outline of the standard packaging process.  

It was 12 years ago this past summer, but I can remember it all like it was yesterday. I was getting headaches that were a stinging pain in the back of my head. They would come and go, and often with a quick movement the pain would change. I was also suffering from a stiff neck that I could crack repeatedly. Being only 13 years old, my symptoms were dismissed as growing pains by my pediatrician. We were told the odds of something actually being in my brain were less than 5%, so why do an MRI?

As a material that took 15 years to fully develop and another 15 years to hit the mainstream market, the story of DuPont™ Tyvek® is one of humble beginnings. Fast forward to today, Tyvek® is recognized as a global leader in sterile packaging and shows no signs of slowing down.

When facing customer inquiries about packaging materials, some of the most common questions we encounter are: What is the thickness of the film material; how do you convert mil and ga; and, how thick is X ga material? When selecting packaging materials, material thickness is a very intuitive concept. Due to differences among regions, industries, material characteristics, and more, different materials use different units of measurement for description. A proficient understanding of the relationship between units of measurement, combined with material characteristics, composition, and other aspects, provides better direction when choosing packaging materials. This is especially true in the field of medical packaging, where the final selection of material specifications directly relates to the quality of medical products, the safety of medical instruments, and the well-being of patients. 

When “high-tech” is mentioned, most of the time, very precise, fast moving, highly advanced technology comes to mind. Sterile packaging may not be classified as part of the high-tech industry itself, but it does rely on and incorporate various technological advancements.  

Healthcare packaging is designed to protect. The medical devices, pharmaceuticals, and therapies we package very often go into the body and therefore must be extremely clean and sterile. Through sterilization, bacterial contamination is extinguished; however, particulate is not removed in this process. Particulate can include small items like dust or ink flakes, or bigger things like hair or even small insects. To ensure that particulate is minimized, medical packaging is often produced in a cleanroom environment.

You’ve finished the development of your device or medication. What’s next? The last step to ensuring the safety and integrity of your medical product is all in the packaging. There are two main types of packaging to think of when developing protective layers, primary and secondary packaging, and you’ll need both. Today, we’re going to discuss the critical differences between the two types of packaging, things to keep in mind when choosing your device package, and examples of what packaging solutions fall into these categories.

Over the past few years, pharmaceutical research and technology have allowed for tremendous growth in the development of drug delivery systems. These systems are not only effective and convenient but have enabled patients to take an active role in their care, allowing for improved health and quality of life.

Kenneth De Muynck to Lead Expansion with New Manufacturing Plant in Malaysia

Singapore, 7 August 2023—Oliver Healthcare Packaging, a leading supplier of sterile barrier flexible packaging solutions to the global healthcare market, today announced the appointment of healthcare industry veteran Kenneth De Muynck as General Manager of its Asia Pacific division. In this new role, De Muynck will lead strategy and growth across Asia Pacific and will be based in Singapore, Oliver’s regional headquarters. De Muynck will leverage his vast experience in the healthcare and life sciences industries to provide general direction and oversight of all programs that impact productivity, continuous improvement, and customer satisfaction. 

In late June, Oliver Healthcare Packaging announced the acquisition of German-based packaging company EK-Pack Folien GmbH. The announcement was well received by the industry, and our team is excited to begin this journey together. To that end, we sat down with Oliver CEO Mike Benevento to talk about why expansion like this is so important. Here is what he had to say.

Many packaging engineers in the healthcare space are familiar with supplier material data sheets, and the “typical” characteristics and standard material test results commonly found in these resources—attributes such as basis weight and thickness, tensile strength, elongation, and oxygen/moisture transmission rates. These results can be helpful when trying to get an initial understanding of a material’s compatibility with a certain application, or for comparing two or more materials at a high level. However, there are other tests in our industry that are being used more and more to better understand how a material and final package will perform in a real-life scenario, or to troubleshoot performance test failures. Here, we will explore a few of these tests; why they matter, and what they might indicate in terms of true application and the ability of a material or sterile barrier system to withstand the full operational, sterilization, and distribution environment.  

When I started working in healthcare packaging in September 2008 (first at a Sterile Packaging Manufacturer from the United States and since 2018 at DuPont™), I could not have imagined that such exciting things would be happening as they are today.

Instructions for Use (IFU) play an important role in any medical device or combination product packaging and far too often they are treated as an afterthought. Just like packaging, they are easily overlooked but the sooner you can start designing the better.

Research shows that 70% of human factors (HF) practitioners report design and content of instructions for use as common drivers of FDA requests for information (RFI) when reviewing HF protocols and submissions. In this recent article by MDDI, they breakdown this further to help readers understand the importance of developing an IFU and why it should be started early and alongside device development.

Part 1 of this article discussed the history of medical and drug regulations and regulatory agencies in the United States, Britain, and the European Union, read it here. 

Part 2 continues, moving to three of Asia’s top medical markets, including China, Japan, and India.

Acquisition of EK-Pack latest investment to bolster commitment to customers throughout Europe.

Philadelphia United States AND Wiggensbach Germany (29 June 2023) – Oliver Healthcare Packaging, a leading supplier of sterile barrier flexible packaging solutions to the global healthcare market, today announced the acquisition of EK-Pack Folien GmbH, a manufacturer of high-quality film and foil technology, located in Ermengerst-Wiggensbach, Bavaria, Germany. This acquisition includes Vacopack H. Buchegger AG, a fully owned subsidiary of EK-Pack, based in northeastern Switzerland. 

Endoscopy is perhaps best known as two things: colonoscopy or “lower GI” and “upper GI” scoping through the mouth to view the esophagus and stomach. The field of endoscopy now encompasses every anatomical entry into the human body, and those that use tiny incisions to create the entry point. In addition to the esophagus, stomach and colon, ears, nose, throat, joints, heart, and abdomen are viewable through endoscopy. This often-overlooked medical specialty refers to seeing and/or interacting with internal anatomy from an external location. It is distinct from all other imaging technology because a scoping tool is inserted directly into the organ or anatomy it is examining. The medical needs addressed by endoscopy include screening to check health, such as colonoscopy, diagnostic procedures to identify a cause or disease, and even to treat, such as direct delivery of medication to an internal organ or area and photodynamic therapy that uses light and laser to kill tumor cells.

Lower! Lower! Lower! A phrase viewers and participants alike scream on the popular television game show, The Price is Right, and now the healthcare industry is screaming it too. And as frustrating as it might be that costs are constantly on the rise, there is a reason. From diagnostic tests to medical devices, packaging serves as a protective barrier against contamination, but this essential aspect of a complete product comes at a cost. The cost of packaging for your medical product is influenced by a variety of factors from packaging materials, sustainability efforts, supply chain complexities, and more. How do you know when to spend and where to save? Let’s dive into the cost of packaging and the challenges in balancing safety and affordability.

Part 1 - A Focus on the U.S and Europe

The world history of consumer regulations and regulatory agencies began, unsurprisingly, with products consumed by mouth—food and medicines. As we look at some global markets and their entry into formal regulation of products, we see the triggering mishaps and mayhem around food, drink, and drugs. The prioritization of packaging, particularly for medicines and medical devices, was slower to come under the regulatory eye. Perhaps best summed up by now-retired packaging director Nicholas Berendt was his lament to drug and device makers that medical packaging “is not a dust cover.” Fortunately, everyone, regulators included, would come to understand the significance of packaging, paving the way for greater protection and safety in global healthcare.

Our industry spends a lot of time around ISO 11607, the well-established standard for the packaging of terminally sterilized medical devices. Continual change across the global community can make it challenging to deliver timely and coherent technical guidance. A look back at the evolution of ISO 11607 is a great way to learn from the past while forging a healthy tomorrow.

The Japan and Korea Medtech markets had a busy week, starting 17 May.

I had the pleasure of attending two major events, Medtec and COPHEX, held across these two Medical Device industry power houses. At each of these events, it was clear that there are some emerging trends, particularly around technology, in the healthcare industry.

It's often said that "everything you see comes in a package." But have you ever stopped to think about what goes into creating that package? Or even WHO? Behind every great package is a packaging engineer—a niche profession. Those who are familiar with what a packaging engineer does would say the role of a packaging engineer is to design and develop packaging that protects, contains, communicates, promotes, and positions a product, all while ensuring utilization. Depending on the industry or product a package is being developed for, some of those needs hold more importance than others. For instance, if a packaging engineer is developing a package for laundry detergent, containment and utilization are likely the key factors during the development process. Whereas a package designed for a medical device requires protection of the device (both from physical harm and contamination) and utilization (ability for the device to be aseptically transferred). But in my experience, the role of a packaging engineer is much more complex than designing and developing packaging

Last week, I had the opportunity to attend the[PACK]out with the support and sponsorship of Oliver Healthcare Packaging. the[PACK]out is a healthcare packaging conference focused on providing industry professionals the opportunity to connect, collaborate, and learn about three important pillars: design, usability, and sustainability.

The Covid-19 pandemic exposed severe weaknesses in the global supply chain for medical device packaging. As a result, Oliver is committed to investing in regionalizing our supply chain. Recently, Oliver CEO, Mike Benevento, sat down with Medical Device Development magazine to discuss key developments, such as the expansion of our Venray, Netherlands facility, in preparation for any similar disruptions in the future. 

Every industry has its own lingo. Yet, among all profession-specific languages, one of the pillars of med tech is surely the use of acronyms. As a bit of trivia for your next industry conversation, the use of acronyms evolved out of telegraph code, where creative abbreviations for words were born to save time (and money, if you were the sender).

When talking about sustainability in healthcare packaging, the conversation almost always starts with recycling. It makes sense since medical packaging often includes plastic, therefore a primary focal point must be on processing plastic and other packaging materials in the most sustainable way possible.

Packaging used for terminally sterilized products in the healthcare industry has one main priority – keep the patient safe by maintaining sterility until the point of use. Common packaging configurations used in this space today (such as pouches, thermoform fill seal or TFFS, lids and trays, and backer cards with pouches) have been designed to meet the needs of a manufacturing and sterilization process, provide product protection through rigorous distribution channels, and allow for aseptic presentation. The materials used in these packaging configurations play an essential role in creating and preserving the sterile barrier system and have evolved over time to reduce patient risk as much as possible.

The Food and Drug Administration (FDA) began regulating medical devices in 1976, when U.S. President Gerald Ford signed into law the Medical Device Amendments Act (MDAA) to the Federal Food, Drug, and Cosmetic Act of 1938. From those amendments, the FDA wrote proposed rules to ensure medical devices were compliant with the MDAA. The body of finalized rules was promulgated in 21 CFR Parts 800-1299. That federal code ushered in the FDA’s classifications of medical devices based on the level of risk to end users: Class I, II, and III.

Simply put, not all healthcare packaging is created equal. Product packaging is dictated by product needs, with medical device and pharmaceutical drug packaging requirements differing greatly. High quality and effective packaging play a large role in ensuring that products maintain proper storage conditions during transport, ultimately ensuring patient safety. But how exactly does the packaging differ, and why is it important?

Challenge #1: What do I test?  

Whatever is the current representation of your medical device, the answer to this question for most manufacturers is the same: test its worst-case product packaging system. Going a step further, by testing the “bookends” of the device, you can preempt many potential issues down the road. By bookends, we identify what is the largest or heaviest component and then what is the smallest or lightest component. These represent the most vulnerable aspects and likely contributors to packaging failures.  

Regardless of whether you are new to the healthcare industry or an industry veteran, we’ve all heard about the “sterile field.” Thinking about the sterile field probably brings a few words to mind … operating room (OR), surgery, patient. Maybe you also think of blue gowns, gloves, and scrub caps. But what exactly is considered the sterile field, how is a sterile field created, and why is it important?

Diabetes monitoring and treatment has been a hot topic in the healthcare sector recently. The prevalence of diabetes globally cannot be denied. According to the World Health Organization (WHO), over 422 million people in the world have Type 1 or Type 2 diabetes, and that number continues to rise. (For some background reading on diabetes, check out this PackTalk article.)

I recently had the opportunity to attend a leadership and networking event, hosted by the Berwind Corporation, a fifth-generation family-owned investment management company. During this event, held in center city Philadelphia, more than 50 executive leaders across seven operating companies gathered to collaborate and bring about positive change in our organizations. We discussed critical topics like DE&I advocacy, what it means to be a change agent, and how we can better amplify & support others in their leadership journey.

Singapore, 20 February 2023 - Oliver Healthcare Packaging (Oliver), a leading healthcare company driving quality and innovation in medical packaging, has announced that it will establish a new manufacturing facility in the southern state of Johor in Malaysia, its largest regional plant. The company broke ground on the 122,000-square foot facility today, which is located within the i-Tech Valley, an integrated industrial park in the established economic zone of Iskandar Puteri, Johor. The plant is scheduled to open in the first quarter of 2024 and will supply its rapidly growing Asia-Pacific customer base. 

As we continue to learn more about the world we live in, we explore the best ways to support optimal conditions for humans and nature to co-exist. Creating a better world for present and future generations is important, and global sustainability is a key piece of this equation. For this reason and many others, sustainable packaging is becoming a focus for companies around the world as they work to understand how they can do their part.

This article is Oliver’s official coverage of the changing Medical Device Regulation (MDR) in Europe. New insights will be added to the top of the page. Please bookmark this page and return to stay updated on the latest news and insight on MDR changes. 

The world has lived in an age of expiration dates for about 50 years. Britain’s Marks & Spencer stores started putting expiration dates on foods in 1972 after overhauling their chain-wide line of cakes that was steadily losing ground. The dates were intended to boost sales with proof of quality-mindedness more than anything else.

This week, my son Owen turns ten. Each year, I'm brought back to the day he was born and the whirlwind of activity in the hospital. His birth was my first realization of the role packaging plays in saving lives.

Red, orange, yellow, green, blue, indigo, violet – ROY G BIV. This popular acronym started as a way to identify a common color sequence, like that of a rainbow. And it’s the varying shades of these colors that change the way we see the world each day; from the moment we get dressed to the foods we eat. But with all the colors in the rainbow (and so many in between), why do we see mostly blue or white in healthcare? Are we simply conditioned to choose those colors or is there a purpose for using them in medical packaging? If all packaging is the same color, how does the end user differentiate between products on the shelf? 

Happy Lunar New Year, from our team to yours! Around the world, more than two billion people celebrate the holiday. 2023 is the year of the rabbit (in Vietnam, the rabbit is replaced by a cat). In Chinese culture, the rabbit is known as the luckiest out of all twelve animals. The rabbit symbolizes mercy, elegance, and beauty, and 2023 is expected to be a year of calm and peace.  

In the world of medical devices and healthcare packaging, patient safety is the top priority, and a key reason why those of us in the industry do what we do every day. For terminally sterilized products, packaging is a primary contribution to the sterile barrier system and understanding how to meet the requirements to validate the safety and effectiveness of a solution can be daunting. Packaging Compliance Labs, a medical device packaging engineering, packaging validation lab, and contract packaging facility, has created an educational tool called “4 Pillars of Packaging Validation" to help guide packaging engineers through the process of meeting ISO 11607 expectations.

A sterile barrier system is often present (and mandated by regulation) in the medical packaging industry. The concept of sterilization—or rather, the need for it—has been around for a long time. In the mid 1800s, Louis Pasteur, who is recognized as one of the founding fathers of microbiology, identified that microorganisms were the root cause of food contamination. He introduced heating as a way to kill microorganisms. This same theory of sterilization has played out time and time again—from food to medicines to medical grade packaging.

Cold shock failure is a rare problem in the packaging world. During my time as a packaging engineer, I can count on my hand the number of times I have seen this occur—and I’ve only ever seen it take place with rigid thermoformed trays and lids.

When we launched our PackTalk blog three years ago, our goal was simple: Create a community – a way for industry experts to connect with one another about the latest news, innovations & trends in healthcare. Each week, we showcase varying perspectives on trending hot topics like overcoming supply chain barriers, sustainability efforts, innovations that are transforming the healthcare industry, and educational articles that help keep you in the know. We enjoy sharing these articles with you each week and we’re glad you like them!

Although technical professionals at healthcare packaging companies often do a lot of their work behind the scenes, we enjoy collaborating with our customers and joining their journey to bring new medical devices and pharmaceutical products to market. 

Since its inception, the pharmaceutical industry has been required to meet myriad, sometimes conflicting, priorities. And while patient safety has always been the cornerstone, early warnings still serve as sobering reminders for constant watch in an ever-evolving marketplace. 

Over the past couple of years, supply chain issues have been a common concern for everyone in the medical device and packaging industry. Companies have had to find ways to pivot or make do with the supply they have, and all of this has companies thinking. Some of the questions I’ve been hearing from colleagues in the industry are: How can we be better prepared should the industry experience supply chain issues in the future? Are medical device manufacturers’ (MDMs) specifications too restrictive? Do tradenames need to be listed in specifications? Why can’t the focus be on what really matters to us—performance characteristics?  

Jurgen Van Roosbroeck, Medical Segment Leader for the EMEA region at Oliver Healthcare Packaging, started his career in nursing, where he spent 10 years working in the emergency room, the intensive care unit, and the operating room. Years later, after working in the medical device market, Jurgen began a career in healthcare packaging. His experience as an end user, a manufacturer, and a packaging provider informs his perspective today, and how he works to navigate a complex industry. We sat down with Jurgen to learn more. Here is what he had to say.

The health and safety of patients is the number one priority when it comes to sterile barrier packaging and sterilization. As a packaging engineer, it is important to understand the relationship between radiation sterilization modalities and flexible sterile barrier packaging materials, as well as the impact and dependency on each other.

While attending the MD&M Minneapolis trade show last week, I spent time with many packaging professionals and MDMs, including Connie Anderson, a Regional Manager with Oliver Healthcare Packaging. Connie is a true industry expert, having been in packaging for over 25 years. We sat down with Connie for a quick interview we thought you’d enjoy.

In honor of Halloween week, which is admittedly one of my very favorite holidays, we thought it would be fun to take a detour from our more serious content and shift our focus to an article we’re calling: Scary Good Packaging.

Over the past two and a half years, I have had the pleasure of co-leading the Kilmer Innovations in Packaging Sustainability and End of Life Solutions Group with Kiley Djupstrom. Together, we have worked with a talented and passionate group of industry professionals across the value chain who are committed to improving sustainability in healthcare packaging. To be honest, when I started co-leading this group, I did not know what to expect. I thought it would be a nice way to engage with the industry, help drive an important mission forward, and uncover unmet needs. I did not expect to be as inspired as I have been by the possibilities and opportunities we have in front of us.

As a packaging professional in the healthcare industry, it’s important to understand the basics of adhesive coatings, including why they’re important, and their impact on packaging materials. A better understanding of adhesive coatings will help you  design and troubleshoot your sterile barrier system. 

Back by popular demand. A few weeks ago, we published a blog article: Something Wicked This Way Comes to Packaging. In it, we highlighted a ground-breaking new KiiP project called Wicked Stability … a project that could make a significant impact in medical packaging in the future.  

That article was so popular, sparking a lot of positive discussion within the industry, that we decided to highlight even more information from the project team below. Enjoy Part 2 of this series.

The chance to improve the lives of people dealing with medical conditions is just one of the many rewards of being a part of the medical industry. Companies whose work support pharma and medical device developers, like packaging, contribute the practical magic to help deliver hope to patients. For millions of patients living with the daily reminders of serious conditions like diabetes, relief from even a single sign of disease progression can feel like a victory. The progressive outcomes of Diabetes Type 1, with open wounds, loss of vision, limb amputation and other major effects can be devastating. Type 2, while less deadly, is also rampant. Together, they make what is happening today in diabetes innovation both necessary and inspiring.  

If you remember the summer and fall of 2020, when people were still adjusting to their new post-COVID-19 “normal”, you remember how hard it was to find certain things. People were spending a lot more time at home, which caused a surge in demand for things like patio furniture, and outdoor heating units. Buying behavior was focused on making homes more comfortable, and manufacturers answered that call. But as COVID became more manageable, people adjusted their lifestyles and preferences. They learned to live with COVID, started taking vacations again, and stayed home less. Demand preferences changed quickly, but it took the supply side longer to adjust. As a result, big box stores now have an abundance of patio furniture and heating units simply because the need (or demand) is lower than it once was.

Surgical simulation centers serve as a critical tool for healthcare professionals, offering a means for education, training, and practice for a variety of surgical scenarios in a realistic operating room environment. But these centers can also function as an innovative way for others in the healthcare industry to gain important insights into the challenges faced by personnel in the OR, including medical device packaging engineers. I recently interviewed Dr. Robert Cuff, vascular surgeon and director of the Jacob and Lois Mol Cardiovascular Simulation Center in Grand Rapids, to understand a bit more about the type of information packaging engineers can use to better design with the end user and patient in mind.

Unlike the 1962 Ray Bradbury novel, however, Wicked Stability (WS) has nothing to do with creepy traveling carnivals. News of this ambitious and ground-breaking Kilmer Innovations in Packaging (KiiP) project is traveling fast, and its implications are timely, relevant, and positive.

There has been plenty of talk about Wearable Medical Devices (WMD) in recent years. Wearable Medical Devices are one of the ultimate healthcare advancements for patients. A wearable can provide reassurance when monitoring a serious health condition, making them both convenient and empowering. The patient is alerted if something changes in their condition, building confidence, enhancing decision-making, and positively impacting daily life. 

Thirty months into the COVID-19 pandemic, I’m exhausted thinking of all the ways society has evolved. Our attention to societal health is certainly more advanced. Our approach to travel is permanently altered. And our comfort level with sticking a swab up our nose, awaiting a test result, is now strangely normal.

Usability has become a hot topic in the healthcare industry as regulatory bodies around the world have enhanced focus on the subject. To better understand packaging’s role in this area, I spoke with human factors engineering (HFE) expert David Grosse-Wentrup, a Sr. Research Manager with Design Science, a usability research firm focused on products in the healthcare space. 

The type (or modality) of sterilization used for a medical device can impact the materials chosen for the sterile barrier system. Therefore, as a packaging engineer, it’s important to understand what sterilization is, the different types of sterilization, and why it is important.

It’s no secret that packaging for the medical industry comes with many non-negotiable requirements. The highly technical, one-of-a-kind innovations we pursue are our passion. Still, the industry is quick to agree that packaging innovation often starts in consumer goods and food packaging.  

When you say healthcare packaging, people often think immediately about sterilization methods. The focus of the conversation will then quickly turn to whether or not a breathable substrate is needed, what coating might work best, and the optimal sealing parameters for the pouch combination.

Like many of you, wherever I am, I find myself constantly involved in conversations about the current (fractured) global supply chain. It’s painful right now—for everyone. It is becoming increasingly harder to source and obtain goods, and we’re seeing the prices reflect this challenge as well. Fuel prices are soaring. Grocery prices continue to rise. And in fact, the US consumer price index saw the largest increase in May this year since 1981. We certainly feel it as consumers, but what does this all mean for the medical packaging industry? How can we avoid future supply chain disruptions? 

The recently-concluded InnoPack Pharma Confex in Mumbai, India took place 9-10 June 2022.

With India being a key exporter of drugs and medicines, the event attracted over 600 participants, including 40 exhibitors, 25 speaking tracks and saw participation from top pharmaceutical companies like Dr Reddy’s, Glenmark, Cipla, GSK, Sanofi, and others.  

The amount a medical device packaging professional needs to know is astounding. I grew up as it was evolving and was able to learn what I know in stride – and I’m still learning more all the time! While it is still evolving, there is still a large “barrier to entry” that junior professionals need to take on when they first start. Not only by understanding the regulations and standards they need to abide by in conducting the technical side of their jobs – all the way down to basic quality systems.

Thirty years ago, when I first entered the medical device manufacturing world, I was warmly welcomed by the engineers supporting the sterile packaging operations and design functions. They spent time teaching me – they had the time to teach me. They had me do things that had become mundane to them, but were new and exciting to me. I was allowed to “fail” and not know things – there was time to learn and they didn’t give me anything that could have significantly impacted either the design of or manufacture of the medical devices we made. They allowed me to grow in knowledge over time, giving me more and more autonomy as I grew, such that at the end of my time there, I was a fully functional packaging engineer. I fell in love.

Last week I had the pleasure of attending the Kilmer Conference, a 3-day conference dedicated to the disciplines of sterility assurance, microbiology, and chemistry. This year was the first time packaging played a prominent role in the agenda. Thanks to the Kilmer Innovations in Packaging Executive Committee, multiple KiiP groups presented on projects, findings, and significant contributions to the healthcare packaging space. In addition, discussions generated novel ideas around continuity and challenging the status quo. Here are a few presentations that stood out.  

Many industry veterans know that parts of ISO 11607 are up for interpretation. There are portions you shall (must) follow, and there are areas that are left up to you and your organization to determine how they relate to your products. This is our quick, expert guide to the areas of ISO 11607 that are more open to interpretation than others. 

In May 2022, Medical Fair India and AusMedTech mark the resumption of in-person  meetings for the India and Australia respectively after a hiatus brought about by the pandemic. Not surprisingly, both shows met with resounding responses of “We get to make connections in person again!” 

With the push for reducing carbon footprint and increasing recyclability in materials becoming greater priorities by the day, med tech producers are looking for new ways to do more with less. Plastic films have long played a major role in the medical packaging industry. Currently, the desire for thinner films is driving the quest for new varieties that will increase performance and address sustainability while reducing costs. Novel film types must maintain the quality and integrity required for medical packaging, as they also respond to trending industry needs. 

This May, a new healthcare packaging conference launched in Austin, TX—the[PACK]out—created for the industry, by the industry. The goal of the event was to rethink and retool the concept behind industry conferences.  

Industry experts and companies came together to redefine what a healthcare packaging conference looked like. 3 days, 2 tracks, and 1 workshop—meant to foster education and connection between colleagues, peers, and competitors within the industry.  

The April 2022 biannual gathering of the European Sterile Barrier Association offered its industry professionals business-as-usual – familiar discussions of healthcare trends, sterile barrier packaging issues, and group work on a member project, yet there was also a sense of reward and nostalgia about. Indeed, this meeting marked the 30th anniversary of the SBA, giving cause to celebrate the organization’s achievements amid the tasks at hand.  

Long catheter systems can be a complicated problem when it comes to package design. As the name suggests, they are long and awkward to handle for manufacturing personnel, storage facilities, and end users. Considering alternative packaging configurations, such as curving or coiling the catheter, is an opportunity to simplify the user experience and gain efficiencies throughout the product life cycle. I recently discussed this topic with Vipul Rajpara, a Packaging Leader at Edwards Lifesciences with 15+ years of experience, much of which has been dedicated to long catheter packaging development. He is knowledgeable and passionate about the cross-functional proficiency needed by Packaging Engineers to succeed in this space. Here are some things he recommends considering when approaching package development.

In our articles, we often focus on doctors and nurses, but there are so many people in other settings that support life changing procedures. This article is for them, with a specific focus on Registered Radiologic Technologists (RT), and the important role they play. 

“It feels so good to be back in person” was a sentiment that was echoed loud and clear throughout the MD&M West event last week. 

 Last week, the Anaheim Convention Center was filled with over 1,400 exhibitors and 13,000 attendees—obvious that this year’s show was back to pre-Covid level participation. The many handshakes, conversations, and the common question of “so tell me what’s new” was evidence that attendees were happy to be back to face-to-face collaboration. 

For the last ten years, I have had the privilege of guest lecturing at Michigan State University’s School of Packaging. Every semester I get to meet a new group of students and provide education on the healthcare packaging industry in their Packaging 102: Packaging Seminar class. Recently, I reflected on a trend that has been reoccurring over the last few years. Not a single lecture ends without a student asking about sustainability initiatives and how our industry is supporting this important topic. Lately, this has made me realize that the changemakers are coming!   

As college graduations once again approach, packaging students will begin searching for their first industry roles. To gain more insight into the process of securing that first job and applying their knowledge to healthcare packaging, I met up with my good friend and peer, Chris Kelley.  

Increasing sustainability throughout medical product development and packaging processes can feel like attempting to climb Mt. Everest in a pair of sneakers. Our industry is dominated by “one-of-a-kinds.” Our material requirements are demanding, often unusual, and stringent. Our end users are patients, thus safety and sterility are the highest priority. These facts rule out many renewables emerging for other consumer product producers.  

When you first enter the medical packaging industry, you’ll frequently hear about ISO 11607. But what does it mean, and why do you need to know about it? Here, we share the top six things you need to know about ISO 11607. 

Women’s History Month Reflection: Growing up in India in the 90s, there were several formative experiences that come to mind: economic liberalization (neighborhoods that watched TV together could now afford one in each house), acute water crisis (my mother would ration our showers) and the Kargil War (as a teenager, it got me to pay attention to the news). Given I chose to work for a company that enables electronics and communication, water solutions and industry leading products that keep frontline workers and patients safe, it does appear that life progresses towards circularity.

Today is International Women’s Day (IWD), global day of celebration for all of the social, economic, cultural, and political achievements of women. IWD has occurred for well over a century, with the first IWD gathering in 1911. Today, IWD belongs to all people. IWD is not country, group, or organization specific, and Oliver is proud to be a part of the celebration. Please enjoy these perspectives from some of our favorite leaders. 

One of the main trends that has emerged recently in the diagnostics industry is a shift for simple testing—from a doctor’s office or lab to the home. While in-home testing existed before the COVID-19 pandemic (think pregnancy, allergy, and DNA tests), people have become much more comfortable checking their health status from a box, while conveniently sitting in their own home. No longer are people afraid of performing a finger prick, or nasal or saliva swab. Our desire to know “for sure” brought home-use test kits to the forefront of family life everywhere. Soon, we realized the convenience of at-your-fingertips, self-administered tests, and most importantly, the valuable health information they delivered.

Packaging engineers are familiar with this common packaging failure: the dreaded pinhole. Having been through it myself as a medical device packaging engineer—and helping customers design and analyze their packaging as the Technical Director at Oliver Healthcare Packaging—I’ve learned how to reduce or avoid pinholes altogether. When packaging failures are discovered in the eleventh hour of a product launch, there can be a significant impact to the overall cost and speed of the project.

There are countless aspects of the medical product production process that require attention. As industry capabilities, demands, and technology continue to evolve at a white-knuckle pace, particulate contamination reduction remains a critical area of focus for injectable products. 

It’s no secret that one of the biggest challenges faced by today’s healthcare packaging engineers is change management. The industry is moving faster than ever. Both external and internal forces are requiring packaging engineers to be much more proactive as they consider changes that may impact the packaging system; and all of this comes as international regulatory bodies heighten their expectations of healthcare organizations. 

On February 1st, 2022, our entire team in China, along with our Chinese partners and many people around the globe celebrate the 2022 Spring Festival and enter the Lunar New Year, the Year of Tiger. The tiger is one of China’s zodiac symbols. In Chinese culture, the tiger is an ambitious and energetic animal. It symbolizes dignity, passion, and confidence, and is resolute in its approach to goals and tasks.

It’s 2022, and there’s a new experience taking the stage! Grab your duffel and toothbrush and get ready: you’re going to love this, guaranteed.

Looking ahead at 2022, we asked packaging experts to share their thoughts on emerging trends, top strategic priorities for the year, and their best professional development advice.

Last year at this time, we were hoping 2021 would restore smooth, and even improved, supply chain operations after a full year of COVID-19 chaos. Little did we know that the global supply chain would continue to experience significant challenges, both from the pandemic and impossible-to-predict disruptions like the Houston, Texas freeze.  

Robotics, biometrics, and isolator technology are proving cleaner, faster, and safer than traditional manual methods for pharmaceutical production.

Recently, Healthcare Packaging posted an article about how modern technology is impacting the Pharmaceutical industry. Learn how.

As industries that thrive on the discovery of the new and the next, medical device and pharma can be equally dogged in defense of what has worked before and will work now. Both perspectives have a place in our work. A perfect example is our enduring reliance on gamma irradiation as a sterilization mainstay. Gamma irradiation has been around for more than 70 years yet remains the most popular irradiation sterilization modality for medical devices today. Gamma irradiation is effective. It is well-suited to many applications, packaging types, and is scalable. But what if it became less available?  

It’s a pleasure to share a few thoughts at the invitation of my Oliver Healthcare colleagues on the PackTalk blog. For those who don’t know me, it makes sense to start with a brief background of how I arrived where I am today, as Principal Packaging Engineer for Medtronic in Plymouth, Minnesota.  

Now that we know more about the what and why of UDI let’s understand the where, who, and “now what.”

Under various medical device regulatory jurisdictions worldwide, the Unique Device Identification (UDI) System is being developed to facilitate adequate medical device identification through distribution and use. Healthcare providers, distributors, group purchasing organizations, payors, researchers, and others are using UDI for supply chain efficiency, tracking medical devices in the electronic health record including track and trace, comparative effectiveness research, electronic procurement, and a multitude of other information. This article, the first in a 2-part series, will give you a quick overview of the basics of UDI and its importance in the track and trace process at medical device companies. In this part, let’s talk through the basics–including what it is and why it matters.

Today, consumer packaging has become a part of branding. A lot of thought goes into packaging and the consumer experience, and how the product is presented is a way for it to stand out. But packaging hasn’t always been considered in such a thoughtful way. In fact, a lot of times, packaging was simply looked at as a real drag to the bottom line.  

Over the last couple decades, the world has been gradually confronted with the stark reality that many of our habits are wreaking havoc on the natural environment. We saw the haze of air pollution, and waves of oceans filled with plastics. Now that the bleak outlook of unmanaged consumption has started to sink in, it’s time to get creative. It’s time for all manufacturing sectors to rethink and retool what we make, how we make it, and how to do it more sustainably.

2021 is coming to a close, and while we are optimistic for a return to a more traditional environment in 2022, we recognize the valuable shift we’ve seen to more virtual and hybrid industry events.

As a senior at the University of Wisconsin—Stout, I’m just on the edge of entering the workforce and starting my full-time career as a packaging engineer. Because I have such a passion for this major—and for this industry—I want people to know more about what it is, and what a career path might look like. Right now, there are more packaging engineering jobs available than there are graduating students to fill them, which is great news for us! Traditionally, students choose this industry because they know someone in it, or because they transfer into the major after hearing more about it. I, however, have known that packaging was the industry I wanted to pursue since high school.  

Last week, we had the pleasure of talking with Shannon Hoste, President of Agilis Consulting Group, about her expertise in human factors and usability. Shannon led the CDRH Human Factors team and is also on the AAMI HE – Human Factors Engineering Committee. Here is the second part of our interview with Shannon. Read Part 1 of our interview.

The FDA perspective on human factors and usability in health care was first published on July 18, 2000, with the issuance of US FDA draft document, “Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management.” That non-binding guidance kicked off industry discussion for more than a decade. On June 21, 2011, the US FDA issued new information in an updated guidance draft.  

Evolution in the healthcare packaging industry is much quicker in developing nations than it is in more developed countries. Continuous improvement is all about minimizing risk while getting products to market quickly is still a top priority. So, what are the unique, foreseeable trends for 2022, and how are markets evolving in Asia, post pandemic? 

“Personal development is your springboard to personal excellence. Ongoing, continuous, non-stop personal development literally assures you that there is no limit to what you can accomplish.” – Brian Tracy

When I first sat down to write this article, a myriad of topics came to mind. There is a LOT going on right now–technical, business, professional development, and more… I think what I’m going to go after today is a bit more abstract than normal, but hopefully, it will resonate with you, nonetheless.

Last month during MDM West, I had the pleasure of sharing the stage with Kiley Djupstrom (Plastic Ingenuity) and Jennifer Benolken (DuPont) in a moderated session on sustainability in medical packaging. Kiley and I lead a team of industry professionals as part of the Kilmer Innovations in Packaging group focused on sustainability. Our goal: Make progress in sustainability of healthcare packaging. This is no easy feat, but the goal is progress, and we have a team of passionate individuals across the value chain who are committed to showing up and doing the work. 

152 kilograms. 4500 tonnes. 134 hectares. No matter how you say it, it’s not positive or sustainable. These numbers reflect the amount of medical waste from just one surgery, in a study from four hospitals over three months in New Zealand. 152 kilograms is equivalent to the weight of an empty refrigerator, a small piano, and even a baby elephant! Let that sink in. Perhaps even more alarming is the fact this is just a small percentage of the medical waste generated in New Zealand and a drop in the bucket of the medical waste collected around the world each year.  

I recently read an article from Medtech Insights on how device giants Stryker and Baxter embrace a quality first culture – and yield positive results. In the article, Stryker’s Medha Trivedi, the company’s senior director of global quality and operations said something that resonated.

The Prescription Drug User Fee Act was passed into law by Congress in 1992. The PDUFA implemented a fee-based framework for New Drug Applications and Biologics License Applications. One of its primary objectives was to provide funding to speed up the glacial pace of the FDA’s new drug review process. Specifically, the fees generated would allow expansion of staffing for FDA reviews, in addition to other performance goals. To further track its effectiveness and refine direction over time, the Act would require a reauthorization vote by Congress every five years. The FDA is currently operating under PDUFA VI. In 2022, Congress will hold a vote on PDUFA VII to govern fiscal years 2023-2027.

Working in a niche industry, like medical packaging, comes with a responsibility to really understand your customers. The packaging you provide is specific and custom for each company, so the questions can vary greatly. Understanding the needs of all these different customers is key to a successful collaboration.

Even prior to the COVID-19 pandemic, companies across all industries had started to question the traditional tradeshow, wondering if they still made sense in our digital world. The cost to participate in a show, including sponsorship and exhibition cost, is a big expense. In March of 2020, when all in-person tradeshows came to a crashing halt, we saw a gradual shift to virtual events … some of which were successful, while others left a lot to be desired.  

This article explains how different packaging materials are bonded together in a sterile barrier pouch, the difference between coated and uncoated pouches, and the potential challenges involved in using an uncoated pouch.   

From discovering and developing a new drug, testing to ensure its safety & effectiveness, determining how the drug should be delivered, and the demanding regulatory environment, most drugs take years before they are introduced into a market. Add in the fact that 7 in 10 products that reach market never recover the cost of development, and the challenging nature of the pharmaceutical industry becomes clear.

COVID-19 has put a public spotlight on the economic global demands and challenges related to cold chain drug supply and delivery. And while the growth trends in the world of cold chain packaging are not new, the focus is certainly heightened, leading to demands in product monitoring and packaging standardization, as well as stricter regulatory requirements. Temperature controlled pharmaceuticals are growing at twice the rate of the overall industry. According to supply chain research in the pharmaceutical space, global spend in the pharmaceutical cold chain segment is expected to grow 24% between 2020 and 2024, with approximately 25% of that spend dedicated to packaging.  

In the midst of a pandemic raging across the world, pharmaceutical companies are more and more alerted to the dangers and risks of drug product contamination. The recent FDA-ordered destruction of 60 million vaccine doses is one very prominent example. One source of contamination is particulate generation. Pharma companies are researching smarter control of particulate in hopes to specifically reduce or eliminate particulate in injectable products.

The final part of our three-part series examines China’s role in the global supply chain for medical devices and packaging. A strong central government and experience managing pandemics led the country to a rapid rebound ahead of other economies.

Part 3: Supply Chains Before and After the Pandemic

Dye penetration tests are commonly used to test the seal integrity of sterile barriers. Are you familiar with the essentials of this test? Do you know how it is properly performed? Let's take a look together!

In Vitro Diagnostic (IVD) testing is newer than some of the related, more traditional industries like medical device and pharmaceuticals. IVD is generally viewed as a vast field of testing performed by clinicians, technicians, and labs. While serving the same market, particularly given its reach, diagnostics is an intriguing industry that will continue to evolve for years to come. The potential for breakthroughs in IVD is promising, but complex. Diagnostics stands to take on new leadership in redefining the “what,” “who,” and “how” of testing and monitoring as a way of empowering patients.

In late March 2021, China’s National Medical Products Administration (NMPA, formerly CFDA) published the revised Regulations on the Supervision and Administration of Medical Devices. This version of regulations was postponed until March 2021 due to re-prioritization of tasks of NMPA in response to the COVID-19 pandemic. The updated regulatory framework was slated to take effect on June 1, 2021.

False. Although common sense would lead us to believe that thicker packaging will always offer better protection, this is not the case with foils. That’s because with any continuous foil, where there are no holes in the foil layer itself, thickness doesn’t matter. Foils are always considered impermeable by their very nature.

Asia is emerging as one of the fastest-growing regional markets in the East. A number of dynamics are driving growth, including expansive government expenditure, increasing healthcare needs of aging populations, and greater accessibility to healthcare overall.  As Asia opens these new dimensions, it is bringing economies, commerce, marketing and social issues such as healthcare, to the fore. The double-digit growth has highlighted the need for more standardized, precise medical device regulations, which have varied widely across APAC countries, until now. 

MDR has been a part of our vocabulary since 2017. It was postponed last year, but the time is finally here. On May 26, 2021, the European Union Medical Device Regulation (or, EU MDR) will finally be implemented. Since the announcement of this new regulation, all notified bodies and medical device manufacturers across Europe have been actively preparing. By now, stakeholders are aware of what must be done. But with that said, it is an extensive regulation, so we also know companies who are wondering if they’ve interpreted MDR correctly, and more importantly, if they comply or not.

Whether your company is all-in, looking the other way, or waiting to follow, addressing climate change in your supply chain management model is no longer a vague notion or cheap buzzword. A proactive approach now can help circumvent crisis mode later.

The In Vitro Diagnostics (IVD) industry is fascinating, and as precision medicine is prioritized more heavily around the world, it is important that we understand the industry from even the most basic level. When I was talking with a colleague recently about packaging for the IVD industry, it became clear just how diverse the landscape is, and how quickly it is evolving. For example, specialized DNA testing, a wearable glucose monitor, and a simple urine test are all considered diagnostics. To put it simply, anything that is used to provide a diagnosis belongs in this category. Additionally, as I’m sure you can imagine, the setting for package opening and use are quite different too, depending on the IVD. For example, a diagnostic might be used in a regulated setting like a healthcare facility, hospital, or a laboratory. Some diagnostics though, like allergy testing kits, are used in personal homes.

We know how valuable it is to gain insight from nurses; they are the core end-users of sterile healthcare packaging. Have you ever considered the myriad environments, procedures, and medical devices they manage, or how this vast diversity impacts a nurse’s experience with medical packaging? I recently interviewed two nurses to explore just that – Brooke Wieferich (RN, BSN, CEN in the ER) and Amber Wagner (RN, BSN in the cardiovascular OR and ER). Read on to understand more about the differences between the operating room (OR) and emergency room (ER), how these differences impact the sterile field and packaging interaction, and what matters most to these critical end-users in their respective environments.

Part two of our three-part series examines how China’s evolving medical device market helped the country during the pandemic. It also looks back at what changes took place as the healthcare sector found itself at center stage of the world’s COVID-19 response.  

Part 2: Regulation Speeds Up Due to COVID-19

Your project team has come to the critical stage where you need to consider how you will package, sterilize, and ship your product. How do you ensure your medical device arrives safely at the various medical facilities, hospitals, and clinics? With so many packaging options, how do you find the perfect sterile barrier system for your product? In my role at Oliver Healthcare Packaging, I am often the first person a new customer works with. Here is how I get them started.

As Bob Dylan once said … The Times, They Are A-Changin’. This year, though, that was even more true than ever before. Navigating the global pandemic, while simultaneously implementing EU MDR, made us all feel like the world was upside down. Slowly but surely, we are getting back to some semblance of normal, but there are some learnings we can take into the future with us.

Learning the steps to successfully develop a sterile barrier packaging system can be challenging. From designing, meeting regulatory requirements, to passing testing and validation, there are many important stages and stakeholders. It is daunting and complex, and there is little room for error. Recently,  Associate Product Marketing Manager, Alyssa Flaschner and I presented a webinar on an overview of the sterile barrier packaging development process, focusing on a pouch configuration. We shared requirements, best practices, and real life experiences to cover the major hurdles a package must go through to get a device safely to market.  Watch the full webinar here.  

I raise up my voice—not so I can shout, but so that those without a voice can be heard. We cannot succeed if half of us are held back.

- Malala Yousafzai, recipient of the Nobel Peace Prize

This week, multiple states in the USA announced an accelerated timeline for vaccine eligibility. Connecticut and Michigan are making all residents 16 and up eligible staring April 5th. President Biden has set the challenge out to every governor that every adult be eligible by May 1st with a broader goal to reopen the country around July 4th.

One key function of medical packaging is to inform the end user about the packaged device and how to use it safely. Most of us know the iconic symbols found in medical packaging such as “sterile” or CE that effectively communicate to healthcare professionals about the device. Additionally, packaging design cues like chevron pouches and thumb notches help healthcare professionals to use proper opening techniques required for aseptic presentation. Things get more complicated with double or triple barrier packages when the validated sterile barrier is not clearly identifiable at the point-of-use. Thankfully, new sterile barrier symbols from the Sterile Barrier Association (SBA) will help to indicate just that! 

Our team in China, along with many people around globe, just celebrated the 2021 Spring Festival and entered the Lunar New Year, the Year of Ox. Ox is one of China’s Zodiac and in Chinese culture the ox is a hard-working and docile animal. It symbolizes diligence, dependability, strength, and determination. In Western culture, the ox symbolizes wealth and power, and Hinduism sees ox as representing good luck. 

What comes to mind if I ask you to think of a medical sterile barrier pouch? Whether you’re new to or experienced in healthcare packaging, I bet a chevron seal is the image that pops into your head. It is, after all, the go-to design across the industry, for good reason. Chevron seals have provided healthcare personnel with better opening control and aseptic presentation into the sterile field. Still, a variety of alternative pouch seal designs and features are available in the market.

“By failing to prepare, you are preparing to fail.” - Benjamin Franklin

Benjamin Franklin was right. We must apply lessons learned to current industry action plans. 

Around this same time last year, I wrote an article regarding the importance of supplier diversification. In that article, I talked about how important it was to focus on qualifying other suppliers as a way of diversifying your supply chain and reducing your risk. This year, the focus on regionalizing your healthcare supply chain has taken the front seat.

In 1972, the Regenstreif Institute proudly rolled out the first electronic medical records (EMRs) to physician practices. The electronic forms touted the ability to centralize data, reduce or eliminate paper files, and access data from multiple computer stations. Even with the distinction of “first” and “only” labels, the response of the medical community was decidedly lackluster, thanks to high costs and many questions. Around 1982, PCs began to go mainstream and in 1993 the Internet was born. These advances reignited the possibility that centralized, electronic records could enhance administrative and patient care management, after all.

For those in the medical device and healthcare packaging industries, whether you are just starting out or have been in the field for 30 years like me, we understand ISO 11607. We live and breathe it every day. Whether we are considering the device itself, the package design, making a material selection, or considering sterilization and transportation, ISO 11607 is our guide.

Not everything that is designed can be manufactured. This is why the concept of Design for Manufacture (DFM) is so important in the packaging industry. 

The fight against COVID-19 hit a critical turning point last week with the approval of Pfizer-BioNTech’s vaccine trial for emergency use by the UK government. For a helpful summary of all the latest vaccine news, follow the New York Times’ Coronavirus Vaccine Tracker. Pfizer/BioNTech is hopefully the first of many vaccine treatments that will help to control and end the pandemic. Getting these vaccines to every part of the world is now the greatest packaging and distribution challenge of our lifetime. For fans of military history, packaging now plays the role of the Higgins Boat.

2020 has been a year that has required us to pivot, adapt and constantly find ways to connect outside of traditional tradeshows and networking events. Earlier this month, Informa held their first ever Virtual Engineering Week, which ran from November 30th to December 4th. The week was full of exhibitors, keynote speeches, panel discussions, and live Q&A sessions.

The road to market for new drugs and pharmaceutical products is long and complicated. Each stage of drug development is highly scrutinized by the FDA, enabling patient populations and providers to confidently rely on the product.

Thanksgiving is a holiday of the heart, through the lens of gratitude. The year of COVID-19 has made that message shine brighter than any other year, if nothing else.

Recently, I had the pleasure of virtually interviewing five operating room scrub nurses. I interviewed them as a part of our new video series, PackTalk: Nurses Speak Up. The goal of these interviews was to get real, honest feedback from healthcare professionals who open medical packaging every day. And that is exactly what we got!

AdvaMed’s conference takes on medtech’s need to actively increase diversity and inclusion and fight racism, now.

How the FDA continues to generate the science and data of a pandemic, keep the public health on active duty, and serve innovation, in the year that upended the world.

Transit failures happen. In fact, one in three transit or distribution studies that come through our lab fail. Sometimes intentionally to test the limits of a package, other times it can be unexpected and bring a project to a halt. When we know what caused the failure, we can make the correct recommendation for the packaging so the client can continue launching their device to market.

Designing medical packaging for seniors is like designing packaging for day and night. This is because when designing for seniors you must also solve for child resistance needs, which often contradict each other. 

The medical packaging industry goes all-in on the role of robotics in retooling how we design, produce, and distribute products.

As we all adjust to the "new normal" brought on by the COVID-19 pandemic, many medical device companies are doing the same. The downturn in elective medical and surgical procedures has upended our businesses. This begs several questions.

Before COVID-19 put most airline travel on hold, I traveled quite a bit for my job. I enjoy visiting our customers, attending trade shows and industry conferences, and giving educational seminars in person. When I sit on a commercial aircraft, climbing to altitude and experiencing the physical aspects of pressure changes, I sometimes think about the impact that pressure differentials can have on sterile barrier systems (SBS).

Trevose, Pennsylvania, USA – Tuesday, September 29, 2020 – Last week, Oliver Healthcare Packaging Company celebrated the grand opening of an expanded manufacturing facility in Feasterville, Pennsylvania.

Around the world, we have all felt the impact of COVID-19. In the United States, where Oliver is headquartered, we started to really notice the effect in late February / early March. Almost every major industry has been impacted by the pandemic, and healthcare has felt a profound shift. Healthcare workers around the world have been fighting COVID-19 heroically from the frontline. Major pharmaceutical companies are working hard to develop a vaccine that will stop the spread. And companies like Oliver are working to keep the medical supply chain stocked and ready to support the industry.

It’s no secret that trade shows are a staple in the medical device and packaging industry. They are a place where everyone comes together to learn about the newest technologies, innovations and best practices, and network with friends and colleagues. Typically, our global teams attend nearly 20 trade shows throughout the year. This year, as a result of the global COVID-19 pandemic, we’ve attended three. A drastic change for our team, business, and industry.

I started my career with Richards Medical in Memphis, Tennessee, working in a product design role that later evolved into packaging engineering. At the time, I had no experience in packaging, and was therefore learning on the job. My degree was in operations management from the University of Memphis, but when the opportunity presented itself in packaging engineering, I quickly said “yes”. As the company grew and evolved, so did my role. I had the opportunity to manage an engineering team very early in my career. Even then, I knew I wanted to lead people; the opportunity to build and create something new together has always been exciting to me.

Trevose, Pennsylvania, USA – August 25, 2020 – Oliver Design LLC, a new business unit of Oliver Healthcare Packaging Company, a leading provider of global healthcare packaging, today announced the acquisition of Kansas City Design (KCD). KCD is a premier product and packaging design firm, having served customers in the life sciences industry since 2004 from their design center in Lambertville, New Jersey. KCD has deep expertise in the design and development of complex packaging systems for pharmaceutical and biopharmaceutical therapies. Some of these therapies include cold form foil, blister packaging, prefilled syringes, autoinjectors, transdermal and microneedle patches, wearable devices, and other biomedical therapeutic applications.

As industry innovators seek to master the growing injectables market, partnering across disciplines helps overcome regulatory and practical challenges.

Sterilization is a defining factor when it comes to healthcare products—it’s an essential step in the commercialization process for most single-use medical devices. The cleanliness of a hospital environment is crucial, and sterilization and correlating sterile barrier systems are key factors in ensuring your medical device remains free from contamination until the point of use.

Ethylene oxide (EO) sterilization has remained largely unchanged for decades, but recent changes have shaken up the industry. Concerns with the carcinogenic nature of EO and the alleged levels of emissions from sterilization facilities led to subsequent closures of some contract sterilization facilities. EO is a highly effective sterilant with many advantages, but it is also toxic and classified by the U.S. Environmental Protection Agency (EPA) as a known carcinogen.

An expert translates surgical nurses’ device packaging wish lists into roadmaps that help engineers make those wishes come true.

You decide on your medical device packaging and are ready to launch to market, but you discover you have forgotten a key part of getting your device launch – packaging validation. Depending on your timeline, this could be a major roadblock for your product launch. Validation is a necessary step required by the FDA and the only option is to comply and get the ball rolling as fast as possible.

What is happening with FDA Title II Drug Supply Chain Security Act (DSCSA)?

"The benefit of machine-intelligence technology is risk mitigation." - Kent Hevenor

Chances are that you know someone who lives with a chronic condition that requires ongoing, regular treatment. Often, that treatment includes injections. More than ever, patients and families are finding themselves being transitioned from office visits to self-administration of injections at home.

It’s no shock that COVID-19 has changed (and will forever change) our lives, including the way we do business. Everyone, across every industry, has been challenged to get creative and innovate. Restaurants have created digital menus and mobile applications for online only orders. Fitness centers are providing tools for in-home exercise. Even taking your dog to the vet looks different now.

Tyler Mantel, robotics entrepreneur, creates nonprofit organization to develop new ventilator during COVID-19 pandemic.

“They.”

An entity all its own:

“Why did THEY make it this way?”

“What were THEY thinking?”

How many times have I uttered those or similar phrases about “they” in my career?

Who are “they” anyway?

In my case, my “they” has often been the people who wrote the ISO 11607 or ASTM standards that we use to test our packages. 

To our readers … you know by now that we never push our product through PackTalk. In this blog, we aim to educate & inspire, and ultimately start a discussion. But we’re breaking our own rule for this article.  The healthcare industry is conservative (rightfully so—in healthcare, lives are impacted). But with that said, we get excited when we see innovation in the industry, whether it comes from Oliver or someone else.

During the peak of COVID-19, a majority of non-emergency or elective medical procedures were put on hold. The lack of procedures had a significant impact on the medical device industry and it’s still questionable when we’ll see procedure volume return to normal.

Canaccord Genuity analyst, Kyle Rose, recently completed a survey of 51 orthopedic practices. The survey provided some interesting insights as hospitals begin to resume elective procedures. The survey measured the rates of patient volumes at orthopedic practices since the pandemic and the derivative impacts on orthopedic device makers. 

The healthcare world has faced a massive shift in recent months to focus on fighting the COVID-19 pandemic. The medical system has suffered unprecedented strain, and there has been global coordination in ways we have never before seen. Hospitals have transformed, healthcare workers have been thrown into unfamiliar work, and companies have created new supply chains, seemingly overnight. COVID-19 has been at the forefront of everyone's mind every day. Although these stressors have tested the limits of the medical system’s capacity to take care of patients, ingenuity and adaptability have prevailed in the wake of this crisis. As they navigate the changing landscape, people have been forced to approach problems and leverage resources in promising new ways for our future, post-pandemic world.

Have you ever wondered what a day in the life of a nurse looks like? Behind the Mask, a short video by Carolyn Jones, premiered at the 2020 Virtual AORN Global Surgical Conference and Expo. The video gives us a glimpse into what motivates and drives nurses to show up each day for the patient. The twelve-minute documentary walks us through a patient story of a liver transplant and reveals the compassion, processes, care, technical aptitude, and teamwork required to get through one procedure.

Companies and research institutions around the world are racing to find a viable treatment for COVID-19, which has already caused ~370,000 deaths worldwide and continues to rise. Eli Lilly recently announced their progress, and are moving into the human study portion of their antibody treatment. They have developed this treatment from a blood sample that was taken from one of the first patients in the United States to have recovered from the lung illness caused by COVID-19. 

Eli Lilly is anticipating results to their study by end of June. Read more about the treatment here.

When starting out my career, the biggest attraction, for me, to medical device packaging was the impact it has on the patient. Five years later and as a Senior Packaging Engineer with Alphatec Spine, it’s still what keeps me passionate about the job and it’s always top of mind.

Since the first confirmed COVID-19 case reported in the United States in late January, the nation has seen more than 1.6 million confirmed cases and approximately 96 thousand deaths. This number has risen higher than anticipated while states have been staying under lock-down orders for months. As state and federal governments plan for reopening the economy, promising vaccine candidates are moving into their second clinical trials. This timing pushes the hopeful availability of vaccine for mass production to later this year or next year. With uncertainty around a vaccine, testing capacity may become the next key strategy to ease social distancing and reopen the parts of the country that are still under lock-down.

We are going through a global health crisis which is unprecedented in our lifetime. This is a global pandemic which requires an international response. As such, it becomes even more important to understand global harmonization of best practices in the healthcare industry. 

With COVID-19 test kits in high demand, the FDA has been authorizing new at-home sample collections to help make tests more accessible.

As the world fights the COVID-19 pandemic, the tone in America has shifted since the initial battle cry to “flatten the curve.” The lockdown of schools and non-essential business has passed the 10-week mark and caused a counter-reaction to re-open businesses, states, and the overall economy.

As COVID-19 continues to impact the world and remains a force against US MedTech firms, hold on. The pent-up demand for halted medical procedures is expected to be urgent. Yes, it remains complicated, but the medical device industry could face shortages as recovery begins.

Its pioneering Dispos-a-vent® Barrier Pouch improves sterility and lowers costs for medical device manufacturers.

I don’t eat meat every day of the week, but when I do buy meat, I check to see where it originated. When it is local in origin, I am more likely to buy it. I avoid going to the greengrocer for produce during January. If I find salsify, I won’t buy it outside of salsify season. I spend more money on my jeans than I used to, as I now buy a local brand. My point in sharing my shopping habits is simple: I try to think before I buy, and I try to be conscious about what effect my purchase has on the environment, when it is possible.

A year after the publication of ISO 11607-1/2 revisions, seeking further harmony with 2020’s EU MDR, new changes are in the works.

While a virus demands attention now, chronic diseases and changes in how medicine is delivered will remain for years to come. It’s our job to attend to both.

Roche Phase III Covid-19 clinical trial is under way, as United Kingdom Prime Minister Boris Johnson continues his recovery from the novel coronavirus.

The healthcare packaging industry knows that recycling and reuse can be tricky to synergize with sterility and human medicine and that’s okay. We are always up for a good challenge.

Anxious. Disconnected. Overwhelmed. Grateful. Inspired. Resilient.  

Like many of you, I am feeling all of these. Often within a few minutes of each other, and even at the same time. I am a full-time Oliver employee, working remotely right now, with two young children at home, a first grader and a fourth grader. They each have a distance learning plan at school, utilizing different technology. I am a mom, a wife, a daughter, a sister, a friend, and a colleague. Navigating our new normal during COVID-19 has been challenging, and there have been many moments of laughter and tears. Some days are easier than others. I am accepting that and giving myself grace (I hope you are, too). 

With people on high alert due to potential virus-spreading and cities all over the world implementing and/or rewarding the use of reusable packaging; will the trend toward sustainable packaging subside? This is an unprecedented time. While countries are doing all they can to minimize the spread, there is no doubt that our collective cultures will be changed by the impact of this pandemic.

As 265 million Americans across 32 states live under stay-at-home orders, the US economic outlook also darkens in the wake of climbing COVID-19 cases and deaths. While Congress implements an unprecedented stimulus package to ease wage and business losses, both the private sector and government agencies at different levels face yet another Corona-era challenge: supply chain disruptions in vital sectors such as health care manufacturing. Armed with the Defense Production Act, the Trump administration aims to speed up production of items desperately needed by hospitals everywhere. But will this step succeed in addressing shortages in our interconnected, globalized manufacturing world?

Among the hundreds of articles displaying COVID-19 headlines, you have probably noticed the high emphasis and discussion around testing for the virus. From every angle, significant funds are being invested in this critical effort. In addition to quarantining, social distancing, and working from home, testing availability plays a significant role in slowing the spread of COVID-19. Packaging, as it relates to testing, is equally vital by helping ensure product quality and performance, since the resulting data is the information on which policymakers and healthcare providers will go forward and treat.

Thermo Fisher Scientific, Mayo Clinic, and Roche Get FDA Approval to Help in Fight Against COVID-19.

To Our Valued Customers:

First, let me begin by saying this: I hope you and your families, friends, and colleagues are safe and healthy during this challenging time. I recognize that many in the healthcare community are fighting COVID-19 from the front lines, and we appreciate everything that is being done to protect the health and well-being of people everywhere.