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Paul Hernandez | Marketing Director
500 N. Dearborn Street, Suite 500
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4th Semi-Annual Medical Device Packaging: Innovations in Design and Testing Conference

April 25-26, 2016 | Arlington, VA

DAY ONE | DAY TWO

DAY ONE

7:00 REGISTRATION & MORNING COFFEE

7:50 OPENING REMARKS

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. In the first quarter of 2014, 53 percent of medical device recalls were due to packaging issues, highlighting the extreme importance of packaging and the role it plays within the medical device and healthcare industry. As scrutiny rises on medical device companies and expectations increase, a brief retrospective analysis of medical device packaging will allow for executives to reflect on past challenges, continuous improvement as well as the evolution of medical device packaging.

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.

Bradley Quinn, 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, rattled or shook.

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 DEFENDING INTERPRETATIONS OF ISO 11607 TO ENSURE COMPLIANCE WITH MEDICAL DEVICE PACKAGING
With a number of necessary technical standards in place ensuring the security of medical device packaging, executives are certain to have questions surrounding different requirements. Standards for materials, sterile barrier and packaging systems outlined in ISO 11607-1 provide a general step-by-step guide for how these guidelines should be executed, but do not take in to account the customization of products and the defined risk tolerance set forth by the individual company. This creates various options for implementation that may or may not be compliant. Through this interactive debate, executives will gain insights into how other companies are interpreting Part 1 of ISO 11607 and defending that interpretation to regulatory bodies.

  • Using design inputs to assess single barrier v. double barrier
  • Creating defects to ensure test methods are validated
  • Justifying sample size based on interpretation of 11607

Nick Fotis, Global Director, Packaging, CARDINAL HEALTH

 

12:30 LUNCHEON

 

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, Chapter President
NATIONAL ASSOCIATION OF HISPANIC NURSES

Isolina Pistolessi, RN, Acting Vice President
NATIONAL ASSOCIATION OF HISPANIC NURSES

Yaritza Javier, RN, NATIONAL ASSOCIATION OF HISPANIC NURSES

 

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 packaging design, testing and sterilization.
MODERATOR:
Katie Tran, Lab Manager, WESTPAK

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

Isolina Pistolessi, RN, Acting Vice President
NATIONAL ASSOCIATION OF HISPANIC NURSES

Yaritza Javier, RN, NATIONAL ASSOCIATION OF HISPANIC NURSES

 

4:15 CASE STUDY: ORIGINATION TO PRE-TESTING TO INCREASE SPEED TO MARKET

  • Innovation and rapid prototyping in Consumer Goods vs. Medical Device
  • Communicating the value of cross functional teams in innovation sessions
  • Leveraging the creativity of suppliers and choosing the best design to pursue
  • Pre-Testing to raise confidence and minimize risk with new packaging designs

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

 

5:00 CASE STUDY: PROACTIVELY COLLABORATING WITH STERILIZATION TO ENSURE PACKAGING TIMELINES
Packaging and sterilization teams have similar questions regarding a medical device’s characteristics and constraints when developing an optimal package and sterilization procedure. Material selections, product dimensions and shelf life are some of the many factors considered when making key packaging and sterilization decisions. Rather than working separately, proactive collaboration can speed up packaging and sterilization timelines, ultimately bringing an innovative medical device to market at a quicker pace.

  • Communication strategies between packaging & sterilization
  • Design inputs, product material and other considerations
  • Aligning timelines appropriately to ensure efficiencies
  • Evaluating constraints in tandem for packaging & sterilization

Jonathan Bull, Director, Sterilization & Heat, JOHNSON & JOHNSON

Rod Patch, Director, Package Development, Center of Excellence
JOHNSON & JOHNSON

 

5:45 END OF DAY ONE

 

DAY ONE | DAY TWO

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