packaging drivers Articles

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.

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?  

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.

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.

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.

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.

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? 

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. 

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!   

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.  

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?  

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.  

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.  

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.  

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.

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

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.

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.

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! 

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.

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.

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.

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.

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).

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.

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.

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

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.

“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. 

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.

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. 

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.

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.

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.

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.

Recently, China decided to ban imports of foreign recyclable material. At the same time, the EU is waging its own war against plastic waste.  As a result of these major initiatives, manufacturers from all industries have started to feel the pressure to create more sustainable solutions. Among suppliers of plastics, the packaging industry is on the frontline to introduce innovations and smarter design alternatives that reduce plastic output. The EU has set a goal to make all packaging reusable or recyclable by 2030 (Boffey, 2018). It is noteworthy to mention that the recycling of any plastic is challenging and requires a good infrastructure. As the EU is pushing for a “circular economy” and China investing in more plastic recycling infrastructure, all global partners should be laying their own groundwork for sustainable plastics practices.

Innovations in medical device technology, materials and manufacturing capabilities continue to affect how we, as suppliers, work with our MDMs. Ever-tightening and deepening regulatory requirements and global markets also affect how MDMs must produce their packaged medical devices. Amid those opportunities and constraints, those in procurement must coordinate all the details involved across the entire span of the global supply chain. A dynamic environment, to say the least.

Are you using machine vision systems in your medical device or pharmaceutical inspection processes? The prospect of automated, consistent quality inspections is thrilling to every medical and pharmaceutical producer. Yet, if the concept is so great, why isn’t every health care manufacturer already on board?

Industry talk continues about a future with less or no EtO sterilization. It is a sea change, even though the controversy first appeared decades ago. It is a far cry from the buzz of a 1928 discovery that the gaseous compound was an effective insecticide. EtO quickly earned a prominent role in fumigating hospital rooms and treating WW II troop rations. These successes, no doubt, fueled the expansion of EtO use to the supply side of the medical field, sterilizing instruments.

Last week, I joined Oliver’s European team in Dusseldorf for Compamed 2019. The show is one of our largest of the year and is a subset of a greater exhibition called Medica. For me, a show this big is almost TOO big. But with that said, it was still interesting to walk the 17(!) different halls to decipher the latest trends in healthcare. Between the 25,000 steps walked, here were 4 trends that stood out to me:

There is no dispute about why the med-tech industry is highly regulated. No matter how robust the sterilization or disinfection process, if the packaging and seal closures of a medical pouch are compromised, there is a significant risk of product contamination during shipping and storage that could pose a danger to the end-user. Moreover, we all know that “end-user” ultimately means you, me or someone we love. 

By now, we are all familiar with the recent discussion around sterilization in the medical device industry. Ethylene oxide or EtO is the most popular sterilization modality in the industry accounting for approximately half of the market. EtO is a colorless gas, and long-term exposure can pose serious health risks. Some US communities located in and around EtO sterilization facilities have become increasingly concerned, ultimately forcing the FDA to take action. 

If you are a medical device manufacturer (MDM) or work in a support industry to the global medical device market, you are probably familiar with the date May 15, 2020. It is then that the three-year transition to the Medical Device Regulations (MDR) governing document (adopted by European Parliament in 2017), comes to a close. Every MDM that markets products in the EU is impacted by the MDR.