For the second year, the PCL team (Matthew TerBush, Sarah Rosenblum, and Cassie Ladd) is back with their favorite sessions. This year, they had 35 sessions and 50+ speakers to choose from.

the[PACK]out is a 2.5-day conference that takes place in the second week of May each year. The conference was created by healthcare packaging professionals, for healthcare packaging engineers.

Cassie and Sarah represented Packaging Compliance Labs as Founding Members of the[PACK]out while Matthew presented on Day two (read more about his session below!).

General Session Cluster: Leveraging Advanced Recycling Technologies for Sustainably-Sourced Medical Packaging Materials

with Katherine Hofmann, PhD, Zack Patterson, Cliff Labbe, Rod Patch, DeepaRampura, and Anna Thomas

• MT: This cluster of sessions was the first time advanced recycling came full circle for me. They helped connect the dots for understanding advanced recycling and how exactly it can change within the medical device supply chain. Now I understood how it can make a major difference.
• SR: It can feel like the term ‘sustainability’ is thrown around in our industry. Everyone wants to be more sustainable and use advanced recycled materials in their packaging, but it can be difficult to pinpoint how you put it into practice. Rod and Cliffe’s session was the first time I’d ever heard of a large MDM using advanced recycled materials for their packaging.
• CL: The first time I’d heard of advanced recycling was during Andrew Green’s presentation at the[PACK]out last year. That session was an excellent introduction to advanced recycling. This cluster of sessions built on that knowledge and taught me that using packaging made with advanced recycled material isn’t just a possibility, it’s a reality.

Tenured Track Theme: The Path from Distribution to Validation

with Nora Crivello, Jan Gates, and Seema Momin

• MT: Since I’ve worked a lot on packaging validations at PCL, I found Jane’s, Seema’s, and Nora’s sessions on dynamic testing really interesting. They were great overviews of how the application of standards is applied differently. Specifically, I liked hearing about Jan’s insights from her experience with the FDA as well as the different strategies Seema discussed for how to handle bracketing or worst-case validation and how to leverage previous studies and testing based on things like size, weight, and different materials.

Industry Power Hour

with Matt Daum, PhD, Jen Benolken, Henk Blom, PhD, Peylina Chu, PE, David DiVaccaro, Tyler Boyd, Hanna Harris, Dhuanne Dodrill, Austin Liu

• MT: It was energizing to hear all the different groups that pertain to the medical device packaging and all the different ways to get involved even if it’s just a small amount of time.

Can your Package “Take a Licking” and “Keep On Ticking”? How to Tackle Human Nature and Mother Nature with Robust Package Design

with Brian Farison

• CL: When Brian discussed package testing and packaging engineering, he piqued the following questions: What is truly the worst case? Are we planning for unnatural extremes? What can be done to ensure MDMs pass their validations without major roadblocks? How many problems have been solved with feasibility testing instead of constantly firefighting? A helpful tactic Brian highlights is performing feasibility testing before your full transit validation. At PCL, we conducted a case study years ago that discovered about 33% of all transit studies that come through our lab have failures. This is why we always recommend feasibility testing to our clients.
• MT: This session prompted me and our engineering team to make updates to our protocols. Specifically, the terminology “typical worst case” was a term that Sean Coast, Devon Buckley (packaging engineers at PCL), and I made a note of updating our protocols to say instead of “worst case”.

Tenured Track:  Reducing Sealing Variability and Increasing Process Capability

with Lynne Barton, and Ben White

• SR: Lynne and Ben’s session showed an example of an MDM who was having issues with their sealer in process and explained how they mitigated that. It was interesting to learn about their strategies to solve that problem since what they discussed applies to what we do at PCL every single day.

Usability Sessions:

Tenured Track Theme: User-Centered Packaging: Beyond a Container: Connected Combination Products Elevate User Experience

Mathias Romacker, and Lisa Pierce

Tenured Track: Medical Packaging From the Patient’s Perspective

Michael Johnston

Foundational Track: Building a Plane While Flying is Not Easy – Learn How ASTM is Developing a Guide to Help the Industry Meet or Exceed Requirements of ISO 11607 Section 7

Broc Couling, Arti Roth, PhD, and Matt TerBush

• SR: Lisa and Mathius discussed the innovative ways that design is changing all the way up to E-IFU’s and holograms that can tell you how to use a device/product at home. Their session took usability and put it in the patients’ hands for in-home device use. After their and Micheal Johnstons’ session, I started thinking about how we talked so much about the usability and the feedback from nurses. Both sessions touched on the fact that there is a whole element of usability that isn’t just end-user-focused, rather it’s also patient-focused. Their sessions were interesting to me because as an industry, we usually talk about engineering packaging for engineers, which is the problem. The current fix to that problem is engineers engineering packaging for nurses.
• While that is a positive step in the right direction, at the end of the day, there isn’t much consideration for the person that the device is going into or being used on. Ultimately, that patient should be the person who is invested in the most. Usability as far as regulations go is focused on the nurse. Usability with a humanized motivation should be focused on the patient. For that instead, the motivation isn’t regulatory, but personal/emotional value.
• MT: The last few years we’ve taken major strides in usability, but those two sessions specifically made me think even more forward on aspects that aren’t being forced by regulations right now but are ultimately what we all wake up for every day which is the patient experience.
• During my session on usability evaluation with Arti Roth and Broc Couling, we had a hands-on activity where everyone in the room got a sealed pouch with various mock devices inside. The challenge was to aseptically open and dump the contents of the packaging onto a target in the middle of the table. The purpose of this activity was to show everyone that it’s more difficult than it seems to open a pouch and correctly transfer the device inside to a precise location. The guidance of the standard alone is starting to pick up in terms of needing some sort of guidance on what the heck we should do here. It was exciting to hear the feedback from attendees who listened to our session and hear that there is such a need for this standard in our industry.

Visit thepack.com to view the 2023 agenda. To be updated with the 2024 location and dates, sign up for the newsletter!