DAY TWO | TUESDAY, JUNE 27
8:00 FORECASTING CHANGES TO ISO 11607: ANTICIPATED UPDATES AND THE IMPLICATIONS FOR MEDICAL DEVICE PACKAGING
In December 2016, the AAMI committee met to deliberate comments and proposed revisions to the current draft of ISO 11607. This meeting will be followed by the ISO meeting in April 2017, and the revised version of ISO 11607 is anticipated to be finalized and released in early 2019. Attendees will receive an update directly from AAMI committee members on the anticipated changes for this guidance based on the December meeting.
- Forecasting changes expected in final draft
- Overview of ISO Spring 2017 committee meeting
- Update on proposed revisions to 11607-1 and 11607-2
Curtis Larsen, Member, AAMI
8:45 SEAL STRENGTH TEST METHOD
Abishek Gautam, Sr Manager Packaging Engineer, MEDTRONIC
9:30 COFFEE & NETWORKING BREAK
10:00 CASE STUDY: ENHANCING PACKAGE DESIGN BASED ON USER FEEDBACK
Obtaining the customer perspective for improvements of packaging is essential to enhance design and increase user efficiency with a medical device. Packaging engineers need to create a robust strategy to incorporate customer feedback into a package layout and must consider cost efficiency of the updated package design, the need for re-qualification for material changes, and planning to proactively share prototypes with end users to ensure the package changes are consistent with customer requests. Researching and incorporating end-user feedback into package design will set package engineers ahead of the curve and improve overall customer satisfaction.
- Addressing areas of potential customer concern
- Obtaining a firm grasp of customer needs
- Design evolutions based on end-user feedback
Stephanie Volk, Senior Project Engineer, K2M
10:45 TRENDS IN STERILITY FAILURES: OVERCOMING COMMON ERRORS IN PACKAGING STERILITY
Maintaining sterility of a device is an essential function of packaging, but sterility failures often occur despite careful engineering and package interaction. Packaging sterility failures can occur at various times within the product life cycle, from manufacturing to distribution. Investigating common failures within package sterility will allow for manufacturers to become mindful of these errors and rework packaging procedures to promote sterility.
- Over-sealing in manufacturing & effects on sterility
- Pinholes and tears compromising package sterility
- Package compatibility with specific medical devices
Nirav Bhatt, Senior Packaging Engineer, DEXCOM
11:15 PACKAGE STERILIZATION: INSIGHT INTO MATERIALS THAT CAN INCREASE STERILIZATION EFFECTIVENESS
An essential consideration for packaging executives is utilizing materials in package designs that are conducive to the sterilization process. Through collaborative cross-departmental partnerships, packaging and sterilization teams can jointly decide what packaging materials are most appropriate for certain sterilization methods, ultimately streamlining the sterilization process while also ensuring ongoing sterility of the package and the medical device. A sterilization expert will bring clarity to how different materials are affected by various sterilization methods and offer guidance on optimal materials for preventing sterility failures.
- Packaging materials that endure Ethylene Oxide sterilization
- Accelerating product launches through sterility in package design
- Enhancing communication between sterilization and packaging teams
Tim Carlson, WW Sterilization Program Manager, BECTON DICKINSON
1:00 NURSES SIMULATION: UNCOVERING END USER FEEDBACK ON MEDICAL DEVICE PACKAGING
Engineers have traditionally focused on manufacturability and overall functionality of packaging designs as the main criteria to incorporate into packaging blueprints. Trends in the industry have shifted towards focusing on voice of the customer and designing around end-user handling of devices. In this simulation, nurses will analyze and interact with a medical device and its packaging while providing initial impressions and feedback of usability within a hospital workplace.
Santiago Beltran, Principal Packaging Development Engineer, NUVASIVE
2:30 QUALITY BY DESIGN IN MEDICAL DEVICE PACKAGING: A BLUEPRINT FOR EFFICIENCY AND CONSISTENCY
A commonly used strategy in pharmaceutical development, Quality by Design is a proactive approach to ensuring the quality and efficacy of packaging through a product’s shelf life by defining and building quality characteristics into early package design and development. The use of QbD in packaging design provides ample benefits as it can resolve stability concerns and reduce the amount of testing and validation required. This case study presentation will offer attendees an overview of the fundamentals of QbD along with real world examples of successfully incorporating QbD into early package design phases.
- Identifying testing and validation process
- Quality by Design and shelf life of packaging
- Accounting for unknowns in Quality by Design
Laure Larkin, Associate Director of Stability, ETHICON
3:15 END OF DAY 2