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.
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.
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.
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.
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.
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.
Unwritten Rules of ISO 11607
March 9, 2021
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.
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.
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!
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
Heat Sealing Advances Heat Up
July 28, 2020
"The benefit of machine-intelligence technology is risk mitigation." - Kent Hevenor
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.
July 7, 2020
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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:
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.
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.