medical packaging updates Articles

Challenge #1: What do I test?  

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

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.  

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

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

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

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

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

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

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. 

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. 

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

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

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

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

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

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

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

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

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

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

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.

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.

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.

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.

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

Part 2: Regulation Speeds Up Due to COVID-19

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

“It’s very much a change. In areas of high unmet need, FDA seems to be committed to getting medicines to these people as fast as possible.”

–Alethia Young, biotechnology analyst, Cantor Fitzgerald

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.

It is common to see headlines that cite the aging population for one reason or another. It is almost as common to see news of medical or pharmaceutical breakthroughs offering new hope of improving quality of life or even extending life span altogether.

I’ve never had such an appreciation for time, and how I spend it, as I do now as a working parent. There are so many things I try to squeeze into the few hours a day I get to spend with my son before his bedtime, and the last thing I want to do is spend that free time running errands (not to mention how much more difficult it is to run errands with an infant). I’ve found myself trying to simplify in as many ways as possible, avoiding the quick stops I would have made before.

As Blow-Fill-Seal (BFS) manufacturing technology grows in popularity, pharmaceutical and biologics companies are forced to consider new challenges around cleanliness.

Emerging standards of care increasingly focus on personalized treatment, even to the level of a single patient at a time. Genetic traits and other uniquely individual factors are becoming the foundation for disease management. These advancements present new challenges and layers of complexity to formulation, packaging, labeling, distribution channels and patient safety for drugmakers—and the packaging of those drugs.

Have we also mentioned the growing push for sustainable packaging practices?

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:

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.