Contributing to the Medical Device Package Industry


WESTPAK sent two representatives to attend and speak at the Q1 Medical Device Labeling & Packaging conference which was held September 29-30, 2016 in Phoenix, Arizona.  The two-day event, focused on Medical Device Package Testing, brought together over 40 speakers from FDA, Industry, Academia, Standards Committees, and Healthcare Practice.  The event was a balanced blend of presentations, education, and networking.

 

The first presentation to highlight was the FDA discussing their expectations for medical device packaging. With many standards and regulations to abide by, packaging teams seek guidance from the FDA for insight into industry trends reflecting common package best practices as well as areas needing improvement to ensure compliance.  It was great having a presenter from the FDA to help shed some light on what they are looking for in validations.

Another great presentation was given by a representative of ASTM.  ASTM standards are used in a majority of our tests and they are always evolving and being revised.  The presentation highlighted the new revision of ASTM D4169-16, as well as outlined a few more medical device testing relevant ASTM standards that are currently under review for revisions later this year.  As always, once those standards get approved, WESTPAK will provide our customers with the relevant information to make any adjustments to their validation plans.

 

WESTPAK has never been a silent attendee and this year was no exception!  Both of our representatives participated in the conference. WESTPAK ’s Director of Engineering Services and Operations, Harmony Reynolds, was the moderator for the “Balancing Sustainability and Safety in Medical Device Packaging” panel.  Harmony was joined by representatives from W.L. Gore & Associates, Brentwood, and K2M discussing the industry’s challenge to balance sustainable packaging with hospital regulations.

 

WESTPAK San Diego’s Engineering Services Manager, Andrew Bevil, discussed “Decreasing Packaging Failures through the Evaluation of Integrity Test Methods.” The focus of Andrew’s presentation was to educate the participants on each sterile barrier integrity test so that they can evaluate their package design for potential failure risks prior to going through the validation testing process.

WESTPAK would like to thank the organizers and all of the speakers for a wonderful conference.  We look forward to attending next year.