Tuesday, March 18, 2014

HealthPack 2014 and the Road Ahead for Medical Device Packaging

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By Eric Carlson, CPP

Last week, I had the opportunity to attend HealthPack for the ninth consecutive year. In case you missed it, this blog will recap the annual event and highlight what you should look out for in the medical device packaging industry in the year ahead.

First, let me start by mentioning that 2013 marked the bittersweet end of an era; it was then that the dynamic co-hosting duo of Curt Larsen and John Spitzley finished their lauded run. Many thanks to both of them for helping shape the conference with quality and relevance, making it the premiere medical device packaging conference in the U.S. An additional round of kudos goes to the newly-minted HealthPack Advisory Committee that currently consists of a group of remarkably talented women:
  • Daphne Allen | Editor, Pharmaceutical and Medical Packaging News
  • Jan Gates | Owner & Principal Packaging Engineer, PackWise Consulting
  • Karen Greene, CPP | VP of Sales and Technology, Life Packaging Technology
  • Jennifer Griffin, CPP | Principal Packaging Engineer, Medtronic Vascular
  • Laure Larkin, CPP | Manager of Packaging Qualification, DePuy Synthes

HealthPack 2014 returned to Albuquerque with new host Jim George. Jim is Director of Education at the Kellen Corporation, the same company that took over the national management of IoPP in late 2011 after it merged with Landon Farrey & Associates.

Programming this year was fairly consistent in regards to the quality of content and variety of topics related to medical device packaging.  New this year was a pre-conference group discussion led by Daphne Allen. It was designed to mine the collective knowledge of the attendees about trends and possibly a glimpse into future developments in the industry. I would not be surprised to see this return in 2015.

HealthPack 2014 was well attended; each session had near capacity crowds.

The conference officially kicked off with a keynote presentation by Jackie Elkin (Medtronic) speaking on a very relevant topic, unique device identification (or UDI). The complexities, trends, and challenges were well expressed and, like all the other presentations, will be available for attendees to download. Jackie indicated there will be many challenges lie ahead for the global harmonization of UDI. There also appears to be lingering challenges related to the implementation of current FDA rules.

A recurring and popular program has been the IoPP Medical Device Packaging Technical Committee (MDPTC) Nurses Panel & Survey. Here, too, there were changes in personnel; however, these changes were driven by the coincidental family planning of the esteemed Jennifers (Foreman and Benolken). Congratulations to the moms!

Russell Darley of Sealed Air stepped in to host the nurses panel this year along with Charlie Robnett, the new Education Subcommittee Chair, also with Sealed Air. As usual, the nurses were frank and candid in their feedback and also, as usual, this program elicited the most audience participation. The annual nurses survey was replaced this year by a new Voice of the Customer (VOC) survey that specifically looked at our own medical device packaging community; the survey was led by Clemson grad student Kathryn Thompson. Hats off to Russell and Kathryn for including instant polls in the presentation; the polls truly seemed to engage the audience and were effective at collecting instant feedback from the audience.

The first day also included a slot for standards updates. There are many updates from ASTM, AAMI and ISTA.  Be aware that ASTM D4169 is going through a substantial rewrite specifically in the truck vibration profiles. Karen Polkinghorne (DuPont) provided an update on Tyvek transition. Two additional interesting presentations by Drs. Ondrea Kassarjian and Laura Bix led us to think further about the human and package interface and the application of affordances for intuitive design, respectively. I believe most of us were faced with a new definition and use of the word "affordances."

The keynote session on day two was an overview of the U.S.-E.U. Free Trade Agreement by Julian Carroll. Julian gave a fascinating and well-delivered discussion of the challenges ahead. Following Julian was Laure Larkin who shared her concepts of applying Quality by Design (QbD) developed for pharmaceuticals to perform stability studies for medical devices.

Also, I personally have not heard a more engaging speaker on the topic of statistics, so I give a shout out to Steven Walfish of Becton Dickenson. Brian Ingram also discussed heat seal coatings which was a sort of pros and cons presentation. A panel discussion was next on the agenda to explore several package testing developments. There were many questions from the floor and the panel – consisting of Dan Burgess, Jennifer Griffin, Scott Levy, Wendy Mach and Oliver Stauffer – handled the tough questions extremely well.

The MDPTC then gave an update of their activities to the main group. New officer elections will be held soon, but it appears the leadership team will remain fairly stable over the next two years. Similar to the standards update, the MDPTC also asked for volunteers and participants to become more involved.

Finally, Dr. Henk Blom ended the program with an interesting presentation in which he is trying to tease-out some predictive modeling from Taber rub tester data. He, or rather his plucky staff of interns, has performed thousands of rub tests on many polymer materials. More work needs to be done, but the data indicates that additional work and some inter-laboratory studies may help drive out variability in the methods and narrow the data variability.

Overall, it was another good conference. I look forward to attending next year when it’s held March 3-5 in Norfolk, VA.

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