“Rapid Fire with Medical Packaging Trailblazers” on June 15 during Virtual Engineering Days will cover several pressing issues in medical device packaging. Rod Patch, senior director, package engineering and product labeling, Johnson & Johnson Vision, and Jennifer Benolken, CPPL, medical device and regulatory package engineering specialist with DuPont Tyvek Medical Packaging, will lead a panel speaking on the latest topics for medical device packaging. The session is sure to be a timely one. Patch and Benolken have been driving Kilmer Innovations in Packaging (KiiP), which has grown to more than 200 members on its LinkedIn group. (One of KiiP's projects, Wicked Stability, led by Patch, just won a research grant from AAMI Foundation’s new Kilmer Fund, which provides funds for research designed to “advance the science of microbiological quality and sterility assurance.”)
Joining Patch and Benolken for the rapid-fire session on June 15 will be:
- Jordan Montgomery, distinguished packaging engineer at Medtronic Cardiac Rhythm & Heart Failure, who will speak on “Sizzling Accomplishments in Test Methods: Humidity Considerations.” Montgomery has been a key leader in package engineering and has also been recognized as a Medtronic Technical Fellow. He recently co-authored the article published in MD+DI, "Humidity as a Use Condition for Accelerated Aging of Polymers," which explored the impact of absorbed moisture content in polymers.
- Geoff Pavey, technical fellow for Oliver Healthcare Packaging, who will speak on “Sizzling Accomplishments in Test Methods: Minimum Seal Strength.” Pavey is responsible for technical service and support as well as material and product development. Pavey spoke on this topic in the 2018 webinar, "Developing a New Industry Standard for Seal Strength Testing."
- Thierry Wagner, global director, regulatory & standards – healthcare, DuPont – Safety & Construction, who will present “Hot off the Press – Revised Standards for Medical Packaging – ISO 11607.” Wagner is convenor of ISO/TC 198/WG7 “Sterilization of Health Care Products—Packaging” and CEN/ TC 102/WG4 “Sterilizers and associated equipment for processing of medical devices – Packaging” as well as chairman of the Sterile Barrier Association.
- Dan Burgess, fellow, packaging engineering at Boston Scientific, who will speak on “Sizzling Accomplishments in Test Methods: Determining Equivalence.” Burgess supports the packaging engineering team at Boston Scientific as a subject matter expert on packaging design, manufacturing processes, and testing.
Wagner, for instance, will discuss the current efforts to harmonize standards to support the European Union’s new Medical Device Regulation, namely the reharmonization of ISO 11607, Packaging for Terminally Sterilized Medical Devices, Parts 1 and 2.
“Europe introduced the MDR in 2017 with the objective to improve the quality, safety, and reliability of medical devices,” Wagner explained in a May 25 video shared in DuPont’s newsletter, The Wrap-up: Monthly Highlights by the Tyvek Healthcare Team. The regulation moves “to a lifecycle approach, taking risk management to the next level, with a strong focus on clinical evaluations and postmarket clinical follow-up. The request in the MDR is that technical specifications included in harmonized standards support the attainment of those objectives and principles.”
ISO 11607 Parts 1 and 2, which were recently harmonized with the Medical Device Directive and the Active Implantable Medical Device Directive, are now being revised to offer more details on risk management and then will be harmonized with the MDR, Wagner explained.
Register today to hear the latest in medical packaging from Patch, Benolken, Montgomery, Pavey, Wagner, and Burgess. The session will be on-demand for 30 days after the live event.