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4th Semi-Annual Medical Device Packaging: Innovations in Design and Testing Conference

April 25-26, 2016 | Alexandria, VA

DAY ONE | DAY TWO

DAY ONE

7:00 REGISTRATION & MORNING COFFEE

7:50 CHAIRPERSON’S OPENING REMARKS
Nick Fotis, Global Director Packaging, Cardinal Health and Co-Chair AAMI WG7 Packaging, CARDINAL HEALTH

8:00 OPENING KEYNOTE: STATE OF MEDICAL DEVICE PACKAGING INDUSTRY ADDRESS
As regulatory bodies continually increase requirements for medical device packaging, executives are frequently searching for innovative ways to ensure efficiency, safety and innovation all while adhering to the changing regulatory landscape. As devices and regulations become more complex, it is important to have a strategy to ensure safety  and compliance of the breadth of their packaging solutions and the role packaging plays within the medical device & healthcare industry. Add all of this to the compliance and pressure to deliver lower cost products, the packaging engineer has a tough challenge to address. An overview of the realities that medical device packaging teams are facing and strategies to keep in mind to ensure packaging can be compliant, robust, cost effective and more valuable to the customers will be shared.

Judy Bickart, Senior Director, Global Packaging & Labeling, MEDTRONIC

 

8:45 FDA EXPECTATIONS FOR MEDICAL DEVICE PACKAGING
With multiple requirements for medical device packaging deemed mandatory by the FDA, many companies look for clarification and a refresher on some of the current guidelines regarding aging tests and validation practices. Curiosity surrounds common causes for 483’s, as well as what medical device packaging teams are still missing from testing policies and packaging systems. With many standards organizations and regulations to abide by, packaging teams seek guidance from the FDA for insight into industry trends on what packaging departments are doing correctly and what areas need improvement to ensure compliance.

Victoria Rodriguez, Ph.D., Biomedical Engineer, FDA

Nicole Goodsell, ME, Biomedical Engineer, FDA

Hiren Mistry, MSE, Biomedical Engineer, FDA

 

9:30 COFFEE & NETWORKING BREAK

 

10:00 NEW DATA LOGGER SYSTEM: MONITORING DISTRIBUTION HAZARDS FOR MEDICAL DEVICE PRODUCT/PACKAGING
Packaging engineers continually find challenges when predicting what a medical device package will endure during transport. With many unpredictable outside factors, executives must use innovative ways to ensure the package will not be compromised after leaving the facility. Through an academic research perspective, attendees will gain insight into a new data logger system that allows the user to immediately view the collected data through multiple devices utilizing Global Positioning System (GPS), when using an android or secure website. In real time, this device will monitor the transport and handling factors such as temperature, humidity, shock, vibration, light and atmospheric pressure.

Dr. Changfeng Ge, Department of Packaging Technology
ROCHESTER INSTITUTE OF TECHNOLOGY

 

10:45 ASTM D-4169: INTERPRETING THE STANDARD FOR TRANSPORTATION AUTOMATION TO MINIMIZE PACKAGING FAILURES
For medical device packaging engineers, ensuring that the packaging is not compromised or damaged during transport to a healthcare facility is of utmost importance requiring a multitude of testing and compliance with industry standards. ASTM D-4169, a widely used standard specific to transportation automation testing, is not comprehensive in its explanation regarding the concentrated impact portion and package size in addition to how many sides on which a package should be dropped for adequate validation. Prior to package distribution, executives must simulate what the package will encounter in worst case scenarios from the moment it leaves the loading dock to the container being dropped or rattled.

Dhuanne Dodrill, Chairman, ASTM COMMITTEE

 

11:15 THE FUTURE OF ASTM STANDARDS AND THE INFLUENCE ON PACKAGING TEAMS
With the medical device industry frequently evolving, packaging engineers are in constant catch-up mode when trying to stay ahead of developing initiatives. Standards organizations such as ASTM are repeatedly progressing with the industry while expanding current standards as well as initiating new criteria, leaving packaging engineers curious for 2016 changes and additions. An update from ASTM will provide executives with insight into current works in progress that range from:

  • Transforming the levels for random vibration tests
  • Impact of new validation guidance for packaging
  • Modifications for package integrity testing

Dhuanne Dodrill, Chairman, ASTM COMMITTEE

 

11:45 ISO 11607 REVISION? INTERPRETATION? COMPLIANCE!
It is hard to imagine a sterile medical packaging world without the 11607 ISO standard, but it was not too long ago that each company was left on to determine how to evaluate, qualify, validate and implement medical packaging.  The issuance of 11607 was a turning point for the medical device packaging engineer, and that pivotal document is now undergoing revision. This session will describe the process for establishing and revising an ISO standard, along with up-to-date information on possible details of the revision and timing for those potential changes. Additionally, interpretation of the standard along with rules and tools to assist providing a good defense, both internal and to auditors will also be addressed. Finally, the importance of validating sterile medical packaging, including conducting the validation with statistically significant sample sizes will be discussed.

Nick Fotis, Global Director Packaging, Cardinal Health & Co-Chair AAMI WG7 Packaging
CARDINAL HEALTH

 

12:30 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS

 

1:30 ACADEMIC CASE STUDY: COMMUNICATING THROUGH INTUITIVE PACKAGE DESIGN TO ENHANCE USABILITY
Traditionally, package design has been very product-focused in nature; design decisions were largely driven by factors regarding production efficiencies, product protection, effective processing (e.g. sterilization) and maintenance of the sterile barrier system. Although these are, and will always be, important drivers in design decisions, more and more frequently packaging designers are also employing a user-centered approach to packaging design. When viewed through this paradigm, packaging has the potential to impact health outcomes; it is no longer a commodity, but a way to add value to the entire system. This presentation will present the concept of affordances, the actionable possibilities that a physical object offers to an end user and how it communicates the same. Illustration of the concept will be provided with two laboratory experiments from healthcare.

Laura Bix, Associate Professor, MICHIGAN STATE UNIVERSITY

 

2:15 NURSES SIMULATION: HOW END USERS INTERACT WITH MEDICAL DEVICE PACKAGING
As the healthcare landscape navigates towards a patient-centric driven indus¬try, it is more important than ever that medical device manufacturers produce products that fit seamlessly into this model. Oftentimes the deciding factor for devices selected ends with the nurse or clinician choosing the most appropriate product for the patient. Ease-of-use, sterilization abilities and historical success rates are just a few examples of the elements customers evaluate in choosing a medical device. By inviting nurses and other clinicians to analyze packaging from medical devices provided by conference attendees, engineers will have the unique and valuable opportunity to receive first-hand feedback from healthcare providers.

Sarah Roque, MPH, RN, NATIONAL ASSOCIATION OF HISPANIC NURSES

Isolina Pistolessi, RN, NATIONAL ASSOCIATION OF HISPANIC NURSES

Alice Namata Andam, PHILIPPINE NURSES ASSOCIATION OF METROPOLITAN D.C., CHILDREN’S NATIONAL MEDICAL CENTER IN WASHINGTON, D.C.

Precious Jose Andam, PHILIPPINE NURSES ASSOCIATION OF
METROPOLITAN D.C.

Lorna Imperial Seidel, PHD RN CNS, PHILIPPINE NURSES ASSOCIATION OF METROPOLITAN DC, MARYLAND BOARD OF NURSING

Emilie Gaborne Dearing, MSN, BSN, RN, PMHCNS-BC, PHILIPPINE NURSES ASSOCIATION OF METROPOLITAN DC

 

3:00 COFFEE & NETWORKING BREAK

 

3:30 PANEL DISCUSSION: THE LIFECYCLE OF MEDICAL DEVICE PACKAGING FROM THE END USER PERSPECTIVE
Following the analysis of multiple medical device packages, participating nurses and clinicians will join conference attendees for 30 minutes of Q&A, allowing packaging engineers the opportunity to gain vital insights on the lifecycle of medical device packaging. Once a medtech product is delivered to a hospital, it is useful for packaging teams to understand the step-by-step process for how end users interact with the medical device, from storage to OR prep. Through this interactive panel discussion, packaging engineers will receive valuable take-aways from the end user perspective as it relates to packaging design, testing and sterilization.
MODERATOR:
Mark Escobedo, Engineering Services, WESTPAK

PANELISTS:
Sarah Roque, MPH, RN, NATIONAL ASSOCIATION OF HISPANIC NURSES

Isolina Pistolessi, RN, NATIONAL ASSOCIATION OF HISPANIC NURSES

Alice Namata Andam, PHILIPPINE NURSES ASSOCIATION OF METROPOLITAN D.C., CHILDREN’S NATIONAL MEDICAL CENTER IN WASHINGTON, D.C.

Precious Jose Andam, PHILIPPINE NURSES ASSOCIATION OF
METROPOLITAN D.C.

Lorna Imperial Seidel, PHD RN CNS, PHILIPPINE NURSES ASSOCIATION OF METROPOLITAN DC, MARYLAND BOARD OF NURSING

Emilie Gaborne Dearing, MSN, BSN, RN, PMHCNS-BC, PHILIPPINE NURSES ASSOCIATION OF METROPOLITAN DC

 

4:15 CASE STUDY: ORIGINATION TO PRE-TESTING TO INCREASE SPEED TO MARKET
For medical device packaging engineers, challenges can surround the introduction of completely new and innovative packaging due to the needs of extensive testing. Experience and insight into packaging design and the process to new innovation with confidence will be presented. Utilizing the tools at hand and some more hidden resources can be the key to success for ensuring products reach the market.

  • Innovation and Rapid Prototyping in Consumer Goods vs. Medical Device
  • The value of cross functional team members in innovation sessions
  • Leveraging the creativity of suppliers
  • Choosing the best design(s) to pursue
  • Pre-Testing to raise confidence and minimize risk with new packaging designs

Heather Killmeyer, Sr. Packaging Engineer, Packaging & Labeling, CONVATEC

 

5:00 END OF DAY ONE CONFERENCE ACTIVITIES

 

PACKAGING CONFERENCE SUPPLEMENT: REGISTER TO THE INTENSIVE DEVICE LABEL TRANSLATION WORKSHOP!
On Wednesday April 27th, Q1 will host an engaging and interactive intensive workshop sponsored by Argos Multilingual, addressing challenges in device label translation management and solutions for successful achievement of compliant translated labels. Session formats compile presentations, break-outs and small group discussions to ensure peer-to-peer learning and maximize take-home messages. Do not miss this exclusive opportunity!

Click here to learn more and register.

Exclusive Workshop Sponsor: Argos Multilingual

 

DAY ONE | DAY TWO

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