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HealthPack 2020 Conference Summary

Each year medical device packagers, engineers, directors, managers and quality teams meet to discuss upcoming industry trends, regulatory updates, and issues associated with common packaging ordeals and this year’s event in Charlotte, North Carolina was no exception. Due to current events associated with COVID-19, Healthpack 2020 was one to remember. From adjusting to last minute cancellations, through addressing the logistics of remote speakers, we overcame the challenges and the conference ended up being one of the most noteworthy sessions to date.
Some of this year’s highlights included two separate presentations discussing human factors as they apply to packaging and usability. With an increase of packaging failures in the field, and regulatory observations continuing their upward trend, the focus on packaging design being correct and intentional prior to market release is a hot topic. There were several opinions presented on how to evaluate this newly added section of the ISO 11607-1:2019; from complex studies utilizing specific facilities designed around human factor testing to the establishment of complex teams that include expert clinical consultants.

In conjunction with the discussions about failed packaging, a well-received presentation on cracked trays and the problem-solving process associated with them was given. Taking an in-depth look at a seemingly easy problem to solve (using previous experience and technical expertise), evolved into a very complex process. This process centered not only on working through the root cause of the failure but also on the impact it had on the product. It also focused on assessing the risk while implementing each correction. Solving package failures is not a process to be attempted by the device manufacturers alone; this process takes the coordinated efforts of material characterization experts, design engineers, and suppliers.

The nurse’s panel and audience polling event are always a highlight. The nurse’s panel continued with the same theme as in previous years, that package recycling is not a common practice in hospitals. However, the possibility of cross contamination of blood, soil, etc. on packaging was as one reason suggested why hospitals do not invest in the process.

The newly integrated polling during the expert panel gave an opportunity to address results in real time, vs. in previous years where results were presented but no explanation provided. This change allowed for those in the industry the opportunity to respond anonymously to common questions presented in the packaging field and then addressed by experts regarding the correct interpretation.

Additional presentations included discussion about 3D printing with point of care development and packaging’s role when the sample size is one. The physics behind seals and ensuring the difference between seal strength and peel strength was discussed. They also covered packaging changes as outlined in the MDR, including a comprehensive list of specific areas to evaluate and address.

Overall, the 2.5 days of the conference were filled with relevant educational topics, great networking, and opportunities to learn about new products on the market.

Wendy Mach

Wendy Mach

RM (NRCM), CQA (ASQ)
Packaging Expert

Wendy Mach has over 24 years of medical device manufacturing and laboratory experience. She worked in the medical manufacturing environment in Minnesota for seven years, performing ethylene oxide (EO) and gamma radiation sterilization validations. While at the manufacturing site, she also insourced the microbiology tests for sterility assurance and related equipment validation. Wendy also spent...