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Michael Benevento
CEO, Oliver Healthcare Packaging
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medical packaging updates Articles

How Particulate Control Can Save or Destroy Your Next Launch

July 21, 2021

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.

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A Packaging Investment that Pays Off and Saves Lives

July 2, 2021

Child Resistance and Senior Friendly (CR/SF) packaging has come a long way over the years. But with it being such a specific expertise, there is still a lack of accurate information circulating within the industry. Many are surprised to learn that CR/SF testing is not mandatory, but a choice made by the pharmaceutical company distributing the product. This leads to companies questioning if CR/SF testing is worth the cost.

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In Vitro Diagnostics: Leading the Path to Patient Empowerment

June 22, 2021

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.

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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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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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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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The Next Decade of Medical Packaging Belongs to China – Part 2

May 3, 2021

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

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Material Science: A Game Changer for a More Sustainable Future?

April 12, 2021

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.

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No Corners Cut: Vaccine Development

March 23, 2021

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.

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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 safelyMost 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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Conversations in the Medical Device Industry

February 9, 2021

“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. 

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Packaging 101: ISO 11607

February 2, 2021

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. 

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The Healthcare Digital Revolution

January 19, 2021

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.

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MD&DI Interviews FDA Commissioner

November 3, 2020

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.

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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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FDA Pilots Programs to Enhance Traceability

July 30, 2020

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

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Heat Sealing Advances Heat Up

July 28, 2020

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

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Do It Yourself Healthcare

July 22, 2020

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.

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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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The Ventilator Project

July 13, 2020

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

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New Nylon Opens Door for Companies Looking to Upgrade Packaging

June 30, 2020

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.

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Analysts Report Positive Signs for Elective Procedure Volume Recovery

June 16, 2020

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. 

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Eli Lilly Starts Human Study of Potential COVID-19 Antibody Test

June 4, 2020

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.

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The FDA Authorizes First COVID-19 Saliva-Based Test for Home

May 20, 2020

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

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COVID-19 and the Road to Recovery

May 6, 2020

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.

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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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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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Clinical Trials in Europe Show Promise for Treatment of COVID-19

April 17, 2020

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

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Innovation & Sustainability in a Challenging Environment

April 15, 2020

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.

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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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The War Against Novel Coronavirus

April 1, 2020

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?

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Packaging’s Part in Drive-Thru Testing

March 31, 2020

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.

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Pulling Together To Fight COVID-19

March 23, 2020

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

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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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Treating Disease at the Speed of Life?

January 31, 2020

“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

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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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Get Smart! Pairing Technology with Health Condition Monitoring

January 16, 2020

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.

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When Innovation & Convenience Come Together: Prescription Delivery by Drone

January 8, 2020

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.

 

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Blow-fill-seal Technology Innovates Pharmaceutical Manufacturing

December 17, 2019

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

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Is One-off Packaging Our Future?

December 10, 2019

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?

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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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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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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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