DAY ONE | MONDAY, JUNE 26
8:00 KEYNOTE: CRACKING THE CODE OF MEDICAL DEVICE PACKAGING INNOVATION
Packaging engineers strive to find innovative and out-of-the-box solutions when creating medical device packaging, in order to incorporate end-user feedback into package design while ensuring cost-effectiveness and regulatory compliance. With changes in the healthcare environment and continued pressures to develop the most safe and effective package, packaging teams can explore a wealth of potential opportunities to advance package design and development through a variety of industry resources and outside industry specialists. In this opening session, a seasoned industry expert will set the tone for the conference by reviewing with attendees the current challenges that packaging engineers face while also inspiring the audience to discover advanced packaging solutions – from increasing efficiencies and streamlining production to finding alternative materials for package design.
- Interpreting varying regulatory expectations for packaging
- Reducing cost while also meeting the needs of end users
- Ensuring safety through proficient testing and validations
- Trends on the horizon for innovative packaging materials & design
- Internal team collaborations to streamline packaging production
- Proactively obtaining voice of customer to ensure usability
Karl Rosenblum, Head, Global Manufacturing Capacity Planning, ALCON
8:45 HUMAN FACTORS IN MEDICAL DEVICE PACKAGING: BLENDING THE SCIENCE OF ENGINEERING WITH HUMAN PREDISPOSITION
Human interaction with packaging is a vital consideration in an engineer’s design, since the individual interacting with medical device packaging can vary from seasoned medical professionals with full physical capabilities to patients with diminishing strengths and dexterities. Incorporating the conversion of varying end-user capabilities into technical package design is essential for improving the efficacy of overall packaging. In addition to accounting for inherent physical abilities of an end user, engineers need to consider the manner in which an end user intuitively perceives and interacts with the packaging, as end users often subconsciously handle medical device packaging based on previous experiences with consumer products. An expert in human factors and packaging research will outline best practices for designing medical device packaging around human variables.
- Consumer packaging influences on medical device
- Designing around end-user product interaction
- Adequately testing packaging for human factors
Andrew Hurley, Assistant Professor, CLEMSON UNIVERSITY
9:30 COFFEE & NETWORKING BREAK
10:00 SAMPLE SIZE RATIONALE FOR MEDICAL DEVICE PACKAGE VALIDATION
Tim Eels, WESTPAK
10:45 ASTM UPDATE ON TIMELY AND RELEVANT COMMITTEE PROJECTS AND UPCOMING CHANGES TO PACKAGING STANDARDS
ASTM’s bi-annual committee meeting will take place the first week of April 2017, in which updates and changes to ASTM standards will be discussed. Dhuanne Dodrill, chairman of the ASTM committee, will provide an insightful summary of key takeaways from the recent meeting. Attendees will benefit from hearing the latest in potential updates to packaging standards along with forecasting the implications of these changes.
Dhuanne Dodrill, Chairman, ASTM COMMITTEE
11:30 CASE STUDY: CONDUCTING EFFECTIVE DISTRIBUTION SIMULATION TESTING
Efficiently demonstrating that a package is able to withstand the variabilities of distribution and will remain intact during worst case scenarios is a common hurdle for packaging executives. To effectively demonstrate the durability of a package, medical device manufacturers can use varying degrees of intensity when conducting distribution testing. Regardless of the testing strategy chosen, packaging teams must be able to expertly justify the methodology and outcome.
- Simulating varying levels of truck vibrations
- ASTM D4169 as a guidance for testing
- Justification of rationale for testing methodology
Jan Gates, Co-President, Southern California Chapter, IOPP
1:15 MATERIAL INNOVATIONS ROUND-UP
Packaging teams are constantly seeking innovative materials that can streamline the design process, increase safety and effectiveness of a medical device and lower overall manufacturing costs. As such, the 2017 Medical Device Packaging Conferences will provide attendees an opportunity to learn more about innovative materials that can be utilized to advance packaging design, development and execution. At each round table in the main conference room, material suppliers and packaging engineers will share characteristics of alternative materials and recent applications in the industry. During this 60-minute interactive session, attendees will spend 15 minutes at four different tables with the goal of uncovering new suppliers that may offer a unique packaging solution.
Yash Chaudhari, Packaging Development Engineer, NUVASIVE
2:15 OVERVIEW OF AUDIT & INSPECTION CRITERIA FOR MEDICAL DEVICE PACKAGING
Auditing of packaging by the FDA is a significant concern for packaging engineers, as medical device companies want to ensure that all documentation and data are in compliance with regulatory expectations. During this presentation, an FDA representative will review common pitfalls in packaging compliance and will provide first-hand insights into the inspection process. From how to ensure a robust documentation process to timelines for correcting inspection observations, attendees will have an opportunity to hear directly from the FDA on regulatory expectations for continued compliance in packaging procedures.
Elaine Tseng, Partner, KING & SPALDING
3:00 COFFEE & NETWORKING BREAK
3:30 HOSPITAL PANEL: UNVEILING THE LAST THOUSAND FEET – A DISCUSSION OF MEDICAL DEVICE STORAGE
Packaging engineers strive to create robust and effective designs by anticipating a medical device’s journey from a manufacturing plant to a hospital this insight can be difficult to obtain since many manufacturers are not able to witness the specific device handling once distribution is completed. Through a panel discussion format, attendees will hear directly from those working with medical devices in a hospital to gain in-depth knowledge of device usage and storage once the product exits a manufacturer’s supply chain.
- Visual examples displaying storage layouts
- Insights into varying storage sizes amongst hospitals
- First-hand accounts of storage protocol
Michelle Bezdek, Packaging Engineer, WL GORE & ASSOCIATES
4:30 FORECASTING MEDICAL DEVICE ADVANCEMENTS: SMART PACKAGING & NANOTECHNOLOGY IN THE FOOD INDUSTRY
Innovations in medical device packaging often originate within consumer packaging, and staying current with packaging developments outside industry will allow medical device packaging executive remain ahead of the curve. Nanotechnology and smart packing are revolutionizing the food packaging space and have the potential to actively control environment inside the packaging, alert consumers of safety breeches and facilitate recycling. Nanotechnology expert on the forefront of these developments will outline current use of nanotechnology in food packaging and potential applications to medical device packaging.
- Nanocomposites as high barrier packaging materials
- Silver nanoparticles as potent antimicrobial agent
- Nanosensors and nanomaterial-based assays detection
Ajay Kathuri, Assistant Professor, CALIFORNIA POLYTECHNIC STATE UNIVERSITY
5:15 END OF DAY ONE