Packaging Drivers
Things Are Happening in the Healthcare Packaging World
July 18, 2023
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.
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Packaging Drivers
The Cost of Medical Packaging
June 20, 2023
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.
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Packaging Education and Design, Packaging Drivers
The Colors in Medical Packaging
January 30, 2023
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?
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Packaging Education and Design, Packaging Drivers
The 4 Pillars of Packaging Validation
January 17, 2023
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.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
A Shift to Data Driven Material Selection
November 28, 2022
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?
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Packaging Education and Design, Packaging Drivers
The Impact of Radiation Sterilization Modalities on Flexible Sterile Barrier ...
November 15, 2022
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.
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Sustainability, Packaging Education and Design, Packaging Drivers
Unpacking Sustainability in Healthcare Packaging
October 25, 2022
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.
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Packaging Education and Design, Packaging Drivers, Medical Packaging Updates
Kilmer Innovations in Packaging Presents: Wicked Stability Part 2
October 11, 2022
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.
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Packaging Education and Design, Packaging Drivers, Medical Packaging Updates
From Finger Prick to Automation: How Technology Has Changed Millions of Lives
September 30, 2022
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.
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Packaging Drivers
When will the supply chain recover?
September 27, 2022
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.
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Packaging Education and Design, Packaging Drivers
Who Was Your Package Developed For? An Interview with a Usability Expert
August 17, 2022
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.
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Packaging Drivers, Medical Packaging Updates
Sterilization 101: What You Should Know as a Packaging Engineer
August 9, 2022
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.
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Regulations and Standards, Packaging Drivers
Unwritten Rules of ISO 11607
June 13, 2022
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.
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Sustainability, Packaging Drivers
Sustainability: The Drum Beat is Getting Louder
April 20, 2022
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!
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Sustainability, Packaging Drivers
Advanced Recycling Conversations Start Here
March 28, 2022
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.
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Packaging Drivers
Mapping Your Supply Chain Risk
January 7, 2022
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.
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Packaging Education and Design, Packaging Drivers
Cleaner, Faster, Safer Pharma Production
December 21, 2021
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.
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Packaging Drivers, Medical Packaging Updates
The Future Gamma Irradiation
December 20, 2021
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?
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
Unique Device Identification System for Medical Devices – Part 1
November 29, 2021
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.
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Packaging Education and Design, Packaging Drivers
Apple’s Influence on Medical Packaging
November 22, 2021
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.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
Human Factors & Usability Interview: Part 2
October 26, 2021
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.
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Packaging Education and Design, Packaging Drivers
Human Factors & Usability: An Interview with Expert Shannon Hoste
October 19, 2021
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.
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Sustainability, Packaging Drivers, Medical Packaging Updates
Sustainability in Healthcare Packaging: A Grassroots Effort
September 22, 2021
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.
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Sustainability, Packaging Drivers, Medical Packaging Updates
One Doctor’s Request for Sustainable Change in Asia
September 14, 2021
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.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
Power to the PDUFA
August 31, 2021
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.
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Packaging Drivers
The Next Decade of Medical Packaging Belongs to China – Part 3
July 12, 2021
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
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Regulations and Standards, Packaging Drivers
Updates on China’s New Regulations for Medical Devices
June 15, 2021
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.
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Packaging Drivers, Medical Packaging Updates
True or False: Thicker Foil Is Best
June 8, 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.
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Regulations and Standards, Packaging Drivers
Country-by-Country: Asia’s Regulations on Medical Packaging
June 1, 2021
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.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
MDR Starts on May 26; Read This to Get Ready
May 25, 2021
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.
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Sustainability, Packaging Drivers, Medical Packaging Updates
Takeda’s Manufacturing Leader on Dealing with Climate Change
May 19, 2021
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.
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Packaging Drivers
Two Nurses Explain the Difference Between OR and ER Packaging
May 5, 2021
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.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers, Medical Packaging Updates
Improved Labelling for Sterile Barrier Systems
March 15, 2021
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!
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Regulations and Standards, Packaging Education and Design, Packaging Drivers
ISO 11040-7: Packaging In-Process Pharma and Prefilled Syringe Tubs
January 13, 2021
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.
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Sustainability, Packaging Education and Design, Packaging Drivers
Behind the Scenes of Our Nurses Speak Up Video Series
November 16, 2020
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!
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Packaging Education and Design, Packaging Drivers
MedTech Conference Hot Topics
November 9, 2020
AdvaMed’s conference takes on medtech’s need to actively increase diversity and inclusion and fight racism, now.
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Packaging Drivers
How to Assess a Failure Observed Post-Transit
October 29, 2020
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.
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Packaging Education and Design, Packaging Drivers
Package Design for Seniors
October 20, 2020
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.
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Packaging Drivers
The Role of Robotics in Packaging Automation
October 14, 2020
The medical packaging industry goes all-in on the role of robotics in retooling how we design, produce, and distribute products.
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Sustainability, Packaging Drivers
Can Packaging Postponement Find Its Way into the Medical Device Market?
October 7, 2020
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.
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Packaging Education and Design, Packaging Drivers
What Medical Packaging and Airline Travel Have in Common
September 30, 2020
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).
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Packaging Drivers
4 Things I Learned from Not Being Able to Attend Trade Shows
September 16, 2020
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.
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Packaging Education and Design, Packaging Drivers
Where Device and Drug Makers Come Together
August 21, 2020
As industry innovators seek to master the growing injectables market, partnering across disciplines helps overcome regulatory and practical challenges.
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Packaging Education and Design, Packaging Drivers
Sterile Barrier Packaging: The Impact of Sterilization Modalities
August 19, 2020
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.
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Regulations and Standards, Packaging Drivers
Out with the old? Changes to EO sterilization may help meet new challenges.
August 12, 2020
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.
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Packaging Drivers, Medical Packaging Updates
Embracing the Human Factor
August 7, 2020
An expert translates surgical nurses’ device packaging wish lists into roadmaps that help engineers make those wishes come true.
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Packaging Education and Design, Packaging Drivers
How A Film-to-Film Packaging Design Can Impact the Results of Distribution ...
August 5, 2020
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.
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Packaging Drivers, Medical Packaging Updates
Heat Sealing Advances Heat Up
July 28, 2020
"The benefit of machine-intelligence technology is risk mitigation." - Kent Hevenor
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Packaging Drivers, Medical Packaging Updates
Where COVID-19 and Innovation Collide
July 15, 2020
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.
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Regulations and Standards, Packaging Drivers
“They”
July 7, 2020
“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.
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Packaging Drivers
Healthcare Agility in the Time of COVID-19
June 11, 2020
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.
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Packaging Drivers
Saluting Nurses Everywhere—Thank You
June 8, 2020
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.
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Regulations and Standards, Packaging Drivers
Global Medical Device Regulations & Harmonization Efforts of Sterile Medical ...
May 26, 2020
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.
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Packaging Drivers
What Mass Testing Means for the Packaging World
May 18, 2020
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.
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Sustainability, Packaging Drivers
The Quest for Sustainability
April 30, 2020
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.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
ISO 11607 & EU MDR: Getting Clarity on Risk Management
April 29, 2020
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.
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Packaging Drivers, Medical Packaging Updates
5 Pharmaceutical Trends & Their Impact on Packaging
April 20, 2020
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.
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Sustainability, Packaging Drivers, Medical Packaging Updates
Will the Coronavirus Halt Initiatives for Sustainable Packaging?
April 3, 2020
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.
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Regulations and Standards, Packaging Education and Design, Packaging Drivers, Medical Packaging Updates
Seal Strength Testing: Is 1 lb. Still the Go-To Metric? ASTM WK57656 Update
March 13, 2020
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.
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Sustainability, Packaging Drivers
Looking Ahead: The Future is Flexible
February 28, 2020
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.
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Packaging Drivers
The Importance of Supplier Diversification
February 13, 2020
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.
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Regulations and Standards, Packaging Drivers
Finding Clarity with Vision Systems
February 6, 2020
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?
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
160 Years of EtO
January 20, 2020
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.
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Sustainability, Packaging Drivers, Medical Packaging Updates
4 (and a half) Packaging Trends from Compamed 2019
December 5, 2019
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:
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Regulations and Standards, Packaging Drivers
Med Tech Regulatory Bosses Around the World
November 14, 2019
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.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
Sterilization and the FDA Innovation Challenge
November 7, 2019
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.
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Regulations and Standards, Packaging Drivers, Medical Packaging Updates
Are You Ready For MDR?
October 18, 2019
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.
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