PackTalk is a blog for the Healthcare Packaging Industry

Packaging's Longest Design Rule That's Ready To Be Broken


Published on February 15, 2021

What comes to mind if I ask you to think of a medical sterile barrier pouch? Whether you’re new to or experienced in healthcare packaging, I bet a chevron seal is the image that pops into your head. It is, after all, the go-to design across the industry, for good reasonChevron seals have provided healthcare personnel with better opening control and aseptic presentation into the sterile field. Still, a variety of alternative pouch seal designs and features are available in the market.

However, depending on the application, there is an opportunity to challenge the status quo in pouch design. And this opportunity could evolve into necessity. External forces continue to pressure medical device and healthcare packaging manufacturers to innovate across design, supply chain, and manufacturing environments. Addressing new needs may call for new seal shapes.

Sterile SealsHAIs and Human Factors 

The CDC reports that on any given day, 1 in 31 hospital patients has at least one healthcare-associated infection (HAI). While much progress has been made in this area over the years, there is more work to be done. Regulatory pressures, such as the growing focus on human factors and usability from EU MDR are strong influences. Calls for more sustainable disposable packaging from policymakers and customers also continue to drive packaging system optimization efforts.  

recent dissertation published by Paula Perez, PhD, at Michigan State University, explored the potential impact of novel pouch seal geometries and opening method. Perez’s paper looked at user experience and HAIs as they relate to packaging. The study revealed that there was statistically significant less device contact with non-sterile surfaces observed with curved seal over traditional chevron seal design.  

Perez’s paper also considered chevron seals that were designed with a pull tab featureWhile no statistically significant reductions in device contamination rates were shown with pull-tabs, 70% of participants preferred this intuitive design feature 

The dissertation studies were completed in a controlled environment with limited materials and pouch sizes. While the findings may not provide a single, definitive answerthe results encourage exploration of novel peel pouch designs such as the curved seal. The other interesting observation and opportunity was the high approval among users of pouches featuring pull tabs. While this is only one study, investigating new pouch seal design options seems promising in the quest to cultivate bettersafer MD experiences for clinicians and patients.   

Can 3D open the door to new designs? 

In addition to exploring how various pouch designs and opening techniques impact HAI risksPerez developed a methodology for creating novel seal geometries. Using 3D rapid prototyping, Perez demonstrated how to quickly and easily test new seal designs at minimal cost. The business case for 3D printing and prototyping will likely increase as the technology improves and becomes more accessible. This study demonstrates howeverthat even now, 3D prototyping can be a creative tool in packaging development. The technology offers the opportunity to analyze design ideas alongside operational SMEs in support of design-to-manufacture. Rapid prototyping may also become increasingly valuable for testing facilities and customer design centers as packaging providers partner directly with customers and end users to study human factors and usability under the scope of EU MDR.  

Medical device and healthcare packaging manufacturers can lead the charge with packaging system innovations that stand to improve patient health and safety, while meeting manufacturing and regulatory demands. Investing time into exploring, challenging, and optimizing today’s medical device pouch designs could lead to a game-changing solution, much like the chevron seal did years ago. 

 
REFERENCES:

 

Haley Schrauben
Product Manager | Oliver Healthcare Packaging

Comments (0)

Related Articles

One Doctor’s Request for Sustainable Change in Asia

September 17, 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...

Learn More

Cracking the Age Old Dilemma: Compliance or Quality?

September 17, 2021

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...

Learn More

Power to the PDUFA

September 17, 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...

Learn More

Stay Informed

To stay up to date on innovative technology and products, as well as industry trends, subscribe to Oliver’s PackTalk blog below.