DAY TWO | WEDNESDAY, MAY 15
8:30 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 PANEL: ENHANCING PRODUCT COMPLIANCE THROUGH PACKAGING AND LABELING TEAM COLLABORATION
While managing individual internal teams with separate priorities and tasks, packaging and labeling executives must evaluate areas of collaboration in order to streamline internal operations, support efficient timelines and finalize product packaging. Regulatory actions and updates, such as the EU MDR, which contains changes to the product label that directly impacts packaging design and procedure, require packaging and labeling executives to remain in constant communication to prevent conflict and error. Bringing together executives on each side will highlight collaboration efforts and considerations for blending packaging and labeling internal operations to support industry compliance.
Alejandro Manunta, INTEGER HOLDINGS CORPORATION
Zachary Macht, BECTON DICKINSON
Roger Peterson, ARTHREX
Lynne Kenison, HOLOGIC
9:45 EU MDR: STRATEGIES TO SUPPORT INTERNAL PROCESS CHANGES TO ENSURE PACKAGING COMPLIANCE
The 2017 EU MDR proposed a multitude of changes for medical device labels, including language translation and consumer transparency with the unique device identifier (UDI), all leading to increased label size or notable redesign. As implementation of the new requirements continues, medical device packages are directly impacted and require an in depth analysis on how new package design should support EU MDR compliant labels. With a comprehensive understanding of the EU MDR requirements, internal collaboration with labeling teams and procedures to quickly implement these changes, medical device packaging executives can better prepare for the 2020 compliance dates.
- EU MDR implications on device labeling and packaging
- Gap analysis: Identifying changes impacting package design
- Timeline of procedures to ensure packaging 2020 compliance
Alejandro Manunta, Manager, Packaging & Labeling Center of Excellence, INTEGER HOLDINGS CORPORATION
10:30 COFFEE AND NETWORKING BREAK
11:00 WORKSHOP: CONDUCTING RISK ASSESSMENTS TO DETERMINE OPTIMAL SAMPLE SIZE
Determining the number of packaging samples to test remains one of the most asked questions in the medical device packaging industry, due to varying products and minimal guidance from regulatory bodies. As evaluating risk is step one in determining sample size, packaging engineers must ensure a thorough risk assessment is completed and translated into a statistically valid rationale. By understanding how to successfully conduct and analyze packaging risk assessments, and the influence on confidence level and reliability, packaging engineers will be prepared to determine appropriate sample size.
- Developing risk assessments for packaging
- Identifying risk priority number
- Translating risk to end user impact
- Analyzing confidence and reliability levels
- Additional factors influencing sample size
Jennifer Van Mullekom, Ph.D, Associate Professor of Statistical Practice, VIRGINIA TECH
12:00 LUNCHEON FOR ALL PARTICIPANTS
1:15 EXCHANGE GROUPS: NAVIGATING CHALLENGES IN SAMPLE PLAN DEVELOPMENT
The multiple stages of sampling plan development requires an in depth understanding of singular components, and how characteristics and results have direct influence on determining sample size. Expanding discussion on the development of sampling plans for product packaging engineers, attendees will be asked to breakout into groups, discussing key components of sampling plan development, sharing individual experiences and best practices.
- Calculating risk priority numbers from risk evaluation
- Establishing sample size with confidence & reliability levels
- Qualitative testing method sample size development
Jennifer Van Mullekom, Ph.D, Associate Professor of Statistical Practice, VIRGINA TECH
Dan Burgess, Chairman, ASTM COMMITTEE F02
Fellow Packaging Engineering, BOSTON SCIENTIFIC
2:00 INTEGRATING END USER CONSIDERATIONS AND HUMAN FACTORS IN PACKAGE DESIGN
The ability for HCPs to intuitively interact with the device packages and comply with the intended use are crucial components of medical device package design, as early interaction and evaluation directly impact a more user centered, finished product. With an overall increase of human factors in medical device industry, and recent encouragement from the FDA, human factors presents a strong opportunity for packaging engineers to increase package quality and usability. Understanding where opportunities exist for interaction with HCPs, and developing procedures to gain essential end user feedback will better prepare medical device packaging engineers for human factors validation.
- Documentation and evaluation of human factors studies
- Testing strategies for human factors and usability
- Mitigating design flaws based on user feedback
Javier de la Fuente, PhD, IDSA, Assistant Professor, Industrial Technology & Packaging
CALIFORNIA POLYTECHNIC STATE UNIVERSITY
3:00 EXCHANGE GROUPS: COST REDUCTION OPPORTUNITIES WITHIN MEDICAL DEVICE PACKAGING
As medical device manufacturers look for areas and instances to reduce cost, packaging engineers are seeking opportunities within design, production, quality and distribution for areas of savings for the entire organization. Reducing costs while maintaining package quality and preserving innovation, requires executives to look at all aspects of product packaging such as design considerations, alternative materials and strategies to minimize potential redesign. To foster exchange, delegates will break into smaller groups based on company size to discuss cost saving opportunities within device packaging.
GROUP 1: SMALL TO MID-SIZE COMPANY
Santiago Beltran, Packaging Development, R&D, NUVASIVE
GROUP 2: LARGE COMPANY
Ellen Le, Senior Packaging Engineer, STRYKER
3:45 CLOSING REMARKS AND CONFERENCE CONCLUSION