In this episode, Karen Greene CPP speaks on the verity of medical device pouch testing methods. Charlie Webb CPP gains clarity on the ASTM F-88 test method and learns how her company (life pack labs) approaches medical device package testing.


Guest  Description:

Karen Greene is a tenured packaging professional, A CPP certified through the institute of packaging professionals. with more than 20 years of experience in the medical device and pharmaceutical packaging industries.

The first seven years of her 30+ year career were in the food packaging industry where she held professional positions with Nabisco Brands and Thomas J. Lipton Company.

Her medical device and pharmaceutical packaging experience included leadership positions with IMED Corporation (now Cardinal Health), Edwards Lifesciences, and Allergan.

She has led teams of individuals responsible for medical device and pharmaceutical package development, validation, and production implementation. She has also led teams responsible for documentation, configuration management, and label development and control.

Karen has published several articles in her area of specialization, (the packaging of terminally sterilized medical devices) and she presents frequently at industry conferences such as Medical Design and Manufacturing conference.

Karen is also the Co-President of the Southern CA Chapter of IoPP and she is the Chair of the Task Group Subcommittee of the IoPP Medical Device Packaging Technical Committee.

You can learn more about her package engineering services that include package design, prototyping, as well as validation consulting by visiting her website.

www.lifepacklabs.com

Charlie A. Webb CPP asks. "Is it time to upgrade your medical device packaging machinery? Charlie points out: "My advice is don’t get duped with the pointless bells and whistles that are really at the end of the day just marketing pitches that may add no value in creating better/stronger seals on your pouches. On the flip side don’t hang onto outdated equipment because you fear re-validation, this is a recipe for disaster. Re-validation can feel like a herculean task however if new packaging machinery better manages potential "Infection risk to patients" than it is time to push into better equipment and refresh your validation plan…

Guest  Description:

Charlie Webb is the founder and President of Van der Stahl Scientific he manages the company’s new technology development through the company’s vendor partners. Charlie is a certified packaging professional “CPP” certified through the institute of packaging professionals as well as a “Six Sigma Master Black Belt”. Charlie has been in sterile device packaging for 25 years and has been involved in numerous FDA and ISO audits as a regulatory advisor. Charlie has multiple granted and pending patents on medical device packaging machinery and pouch testing systems. His current patent-pending technologies include a sterile containment system for the processing of human donor tissue as well as a 100% inspection system for medical device trays. 

In this episode, Nick Webb the nations leading technology futurist and best selling author speaks about innovation pitfalls in medical device development. Nick Webb has been awarded over 40 patents by the U.S. Patent and Trademark Office for breakthrough technologies in a wide range of industries including consumer products, as well as one of the world’s smallest medical device implants. 

Nicholas Webb calls out disruptive innovation as the leading way to break away from traditional innovation methodology that bogs down the product and device development. He also calls out invalid VOC (voice of the customer) data collection that may miss what the customer truly desires.

Guest  Description:
A prolific writer and bestselling author, his most recent book, “What Customers Crave,” is used by top brands to design their customer experience and innovation strategies. “What Customers Crave” was featured as Mashable’s “Top 50 Marketing Books to Read” in 2017 and LinkedIn’s “Top Summer Read” for 2017. His other groundbreaking books include “The Innovation Playbook” and “The Digital Innovation Playbook.”

His next breakthrough book, “The Innovation Mandate,” will be published by HarperCollins Leadership in 2019.

In recognition of his contributions to healthcare innovation and policy, Nick Webb was awarded his Doctorate from Western University of Health Sciences, where he serves as an adjunct professor and the director of Innovation.

Nick is also the founder of  WebbLogic®, a research and development project that is reinventing the way in which consumers access and engage with healthcare and other consumer products and services, and is dedicated to creating the next generation of wearable technologies.

Charlie discusses the "lifecycle approach" to medical device packaging. Some medical device manufacturers do not continue to watch the arc of their sterile packaging validation plan and failures, therefore, happen as a result. Validation is a living process that needs constant monitoring at all levels to thwart potential packaging failures that could result in a sterility loss of the device. Also on this episode guest Rod Jennings a nuclear power plant field engineer discusses human systems like checklists and acronyms. These systems help guide critical process to better control expected outcomes.  

This episode we speak with Andy D'Esposito a technical account executive for Merrill’s Packaging. He is a CPP (certified packaging professional) he is certified through the Institute of packaging professionals where he is an active member of his local chapter. Andy provides a look into the process of developing a packaging program with thermoformed trays. Andy discusses the human factors in tray design as well as particulate control and material options. 

Charlie Webb and Cord Burnham talks about the critical value of medical device packaging machine service and maintenance. Medical device package failures have been traced back to poorly maintained packaging machines. Listen in on this important conversation centered around the essential steps on staying on track with your maintenance plan. 

Charlie Webb explains what will be covered on the Sterile packaging on track podcasting on upcoming episodes. 

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