packaging education and design Articles

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.

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.

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?

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?

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? 

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.

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. 

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.

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.  

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.

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. 

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.

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.  

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. 

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.

“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. 

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.  

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. 

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.

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. 

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.

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.

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.  

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.

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.  

“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

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.

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.

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.

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.

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.  

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! 

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.

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. 

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.

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.

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. 

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).

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.

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.

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.

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.

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.

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

A few years ago, I started a journey on behalf of packaging professionals everywhere—to validate or debunk the 1 lb. standard for seal strength testing. For as long as I can remember, it has been a popular topic of conversation and debate in every gathering or get-together with veteran and beginning packaging engineers alike. We discuss where the 1 lb. standard came from, why 1 lb. became the go-to metric, and if 1 lb. is right for every package out there.

One day, I was talking with a colleague about the challenges in sealing. She works in application development, so she hears a lot about the different challenges medical device manufacturers are facing with packaging and sealing – from no-brainers to rocket-scientist-level conundrums. In many cases though, it turns out that an earlier focus on sealing process development, and package design in general, would have certainly helped.

Oliver Healthcare has achieved several milestones in sectors of Healthcare and Pharmaceuticals and a credible position. We would like you to share some views and ideas about your company, plans, future and your outlook on the industry.

I began my career in IT, found my way to marketing, but since birth have been raised as the son of an engineer. Any engineer’s house is full of projects and the Pepe’s were no exception. The TV split open on the dining room table, the washing machine pulled apart to fix that darn wobble … and don’t even go near the garage.

Coating technologies reduce particulate generation by up to 96% in pharmaceutical manufacturing.

As the demand for prefilled and prefillable syringe applications grow, one consideration for many pharmaceutical manufacturers is particulate; in particular, how particulate can be reduced in the manufacturing process.

Medical device packaging is an important part of delivering your device to market safely and securely, yet there is no doubt that navigating the process can be a bit confusing and complex for device manufacturers. With decades of experience in assisting device manufacturers with their packaging design solutions, we offer the following three tips for a successful packaging design as a way of avoiding costly and time-consuming mistakes.