Program

This preliminary program is subject to change. Check back for more information.

Tuesday, March 10, 2020

Noon – 7 p.m.

Attendee Registration

Noon – 4:30 p.m.

Exhibitor Set-Up

Noon – 3:30 p.m.

Cancelled: Preconference Sterigenics Tour

Sterigenics has cancelled the tour of its Charlotte sterilization facilities in order to prioritize the safety of its employees amid the ongoing COVID-19 outbreak.

We apologize for this inconvenience and are issuing full refunds for the tour to those who registered for it.

4 – 5 p.m.

IoPP Medical Device Packaging Technical Committee Meeting

5 – 7 p.m.

Welcome Reception

Wednesday, March 11, 2020

7 – 8:15 a.m.

Attendee Registration and Breakfast Buffet

8:15 – 8:30 a.m.

Welcome & Opening Remarks

8:30 – 9:15 a.m.

Keynote Address
Innovations and Disruptions in Medical Devices through 3D Printing, Bioprinting and Point of Care Models

Sam Onukuri
Head and Senior Fellow
Johnson & Johnson 3D Printing

3D printing technologies promise to radically change how we conceptualize, design, manufacture and deliver solutions. The result will be the delivery of unique, cutting-edge 3D printed applications and a transformed global supply chain, allowing companies to pursue new avenues of innovation and novel personalized healthcare solutions for patients and consumers.

9:15 – 10 a.m.

The Physics and Science of Sealing

Jose R. Arevalo
Global Business Development Manager – Tyvek® Medical
DuPont
Miami, FL

During the transition protocol, DuPont made and opened 1.1 million packages to insure transition Tyvek® would be functionally equivalent in its peel performance to the legacy Tyvek®. The scientists had to understand and quantify the science and physics of peeling. This presentation covers the science and important discoveries around seal testing and measuring.

10 – 10:30 a.m.

Networking Break

10:30 – 11:15 a.m

An Inside Look at Packaging Engineering Work Load for EU MDR Changes

Jennifer Griffin
Senior Principal Packaging Engineer
Medtronic
Danvers, MA

The EU MDR replaces two previous directives in the European Union—the Active Implantable Medical Devices Directive and the Medical Devices Directive. Sweeping changes create plenty of opportunity for packaging engineers to provide leadership in aligning optimized approaches to satisfy new requirements and to be a focal point for implementing these changes.

This presentation will cover:

Examples of approaches to adding languages and content to usage instructions and patient implant cards with respect to package performance testing, package shelf life and sterilization validations
Examples of approaches to added symbols and languages on product labels
Examples of approaches to filling gaps in design verification and process validation testing
Adding UDI, if not already present
Tightening internal procedures and processes to ensure compliance
Providing rigorous technical documentation for regulatory submissions

11:15 – 11:30 a.m.

IoPP Medical Device Packaging Technical Committee Update

11:30 a.m. – 1 p.m.

Lunch & Exhibitor Showcase

1 – 1:45 p.m.

The Power and Pitfalls of Standardization: A Tale of Two Case Studies

Brian K. Farison, CPP, MBB
Senior Manager, Medical Device Package Development
Johnson & Johnson
Cincinnati, OH

Have you ever tried to standardize processes across business units, locations or quality systems? J&J Medical Device Package Development has implemented a standardized approach for transit testing using ASTM D4169-19 across multiple business units and has learned some valuable lessons worth sharing! We are also pursuing a standardized approach for establishing minimum seal strength and seal width for medical device packaging. Come learn from two process case studies to see how you can bridge organizational differences in practice while preserving flexibility and business value, even when dealing with knowledge areas where multiple stakeholder opinions must be considered. In this session, you’ll learn about the “Harmonization Model” and how it can help you determine when standardization can be beneficial and when it should be avoided for maximum process flexibility. Concepts of standardization, customization and harmonization will be defined and explored.

1:45 – 2:30 p.m.

CAPA & Packaging

Elon Goldbaum
Director of Client Solutions
Network Partners
Huntington Beach, CA

This presentation will provide insights on how to address packaging engineering failure modes, corrective actions and/or preventive actions through a CAPA. The presenter will provide an understanding on how to use various root cause analysis tools, as well as provide the fundamentals of DMAIC methodologies, which will help strengthen and drive an engineers' problem solving skill set. The presenter will discuss how CAPAs and CAPA activities tie to packaging engineering and how to utilize real packaging test cases in relation to CAPA. The presenter will also share how to resolve packaging issues from a technical perspective using root cause analysis techniques and applying those techniques from studies to commercial product non-conformities.

The presentation will answer the following questions:

What is a CAPA and the regulations that govern it?
How do you conduct a root cause analysis?
What is DMAIC Methodology and how does it relate to CAPA and packaging?
How do CAPAs affect packaging engineers?

2:30 – 3 p.m.

Networking Break

3 – 4 p.m.

Voice of the Customer: Nurses Panel Reviews Medical Device Packages

Led by the IoPP Medical Device Packaging Technical Committee

Panelists:

Alicia Thompson BSN, RN, CNOR, Operating Room Clinical Educator
Cale Banks, MHA, RN, Assistant Director, Operating Room, Iredell Health System
Suzanne Motley, MSN, MHA, RN, CNOR, Service Line Clinical Nurse Educator, Surgical Services Metro Division, Atrium Health
Alan Friedl, Technical Operations Manager for Cardiac Catheterization and acute intervention (STEMI), Atrium Health Carolina Main campus and Mercy hospital

The panelists will offer a look into the challenges and opportunities that nurses encounter when opening packaging for aseptic presentation. The four panelists, who work in various clinical areas, will give feedback while opening medical packaging supplied by a number of manufacturers. After, they will sit down for a lengthy Q&A session to talk to the audience about what packaging features they appreciate and where there’s still room for improvement.

4 – 4:45 p.m.

Q&A with Nurse Panelists

Led by the IoPP Medical Device Packaging Technical Committee

Panelists:

Alicia Thompson BSN, RN, CNOR, Operating Room Clinical Educator
Cale Banks, MHA, RN, Assistant Director, Operating Room, Iredell Health System
Suzanne Motley, MSN, MHA, RN, CNOR, Service Line Clinical Nurse Educator, Surgical Services Metro Division, Atrium Health
Alan Friedl, Technical Operations Manager for Cardiac Catheterization and acute intervention (STEMI), Atrium Health Carolina Main campus and Mercy hospital

Nurse panelists join the conference for a live Q&A on their package reviews.

5 p.m. – 7 p.m.

Networking Reception

Thursday, March 12, 2020

7 – 8:15 a.m.

Breakfast Buffet

7 – 8 a.m.

Experts Panel: Career Conversation for Newer Professionals

Six panelists will discuss potential packaging career paths from the supplier, business and technical points of view. Panelists will share knowledge regarding career paths for packaging professionals in the medical device industry and explore various career paths available for a packaging professional.

Moderators:

Karen Green, Network Partners
Jan Gates, PackWise Consulting

Panelists:

Jenn Goff, Oliver Healthcare Packaging
Paul Marshall, Zimmer Biomet
Andy D’Esposito, Merrill’s Packaging, Inc.
Tom Misik, Belco Packaging Systems
Dhuanne Dodrill, PAXXUS
Nora Crivello, Westpak, Inc.
Marco Ortiz Shields, Becton Dickinson

8 – 8:45 a.m.

Human Factors and Packaging: Designing and Evaluating Packaging for Safe and Effective Use

Virginia A. Lang, PhD
Hirlan
Carlsbad, CA

Frequently, the design and evaluation of the packaging for medical devices is integrated into the summative testing of the medical device. Unfortunately, many times the packaging gets in the way of the end users’ use of the device and results in unsatisfactory testing outcomes. Generally, the cause of such unsatisfactory results is the lack of understanding and/or the implementation of Human Factors to the design of the packaging.

Human Factors is the scientific study of human behavior, cognition and physiology as applied to human interactions. These interactions are not just limited to the device or contents of the packaging! Have you ever bought something, and you were either unable to open the packaging or you injured yourself opening the packaging? The contents of this presentation will cover three main areas:

Best practices for the design of medical device packaging
Packaging evaluation methods
Regulatory requirements for the design and evaluation of medical device packaging

8:45 – 9:30 a.m.

Evolution of Global Regulations and Concurrent Impacts on Emerging Markets: Asia Pacific MedTech Regulatory/Market Prospective

Vishnu Shankar Vyas
Regulatory and Advocacy Leader, Safety and Construction
DuPont
New Delhi, India

The medical device regulatory scenario is changing quite rapidly. For example, the European Union adopted the new EU MDR/IVDR in April 2017, GHTF was replaced by IMDRF with focus on improving the quality of international medical device standards, ISO TC210 published ISO 13485:2016 with significant revision of QMS requirements, and the Medical Device Single Audit Program was established. Apart from these changes, most Asia Pacific (AP) countries have also revised medical device regulations—including India with new Medical Devices Rules in 2017, ASEAN with its Medical Device Directive in 2015, etc. Considering these facts, harmonization of regulations across the region in alignment with global regulations and adoption of international standards has become essential. Vishnu Shankar Vyas will provide the following information:

An overview of global regulatory changes—challenges and opportunities for AP market
AP MedTech market/growth opportunities
Regulatory changes in the region: AMDD (ASEAN) and MDR 2017 (India)
Packaging system performance and stability testing—practical aspects of testing in AP conditions

9:30 – 10 a.m.

Networking Break

10 – 10:45 a.m.

Human Factors and Usability: A Case Study

Ryan Erickson
Vice President, Packaging Engineering
Packaging Compliance Labs
Kentwood, Michigan

The Global Biologics market is expected to be $319 billion by 2021 with annual growth of 9.6%. Business research company biotech patent applications’ annual growth has been 25% since 1995 (McKinsey & Co article). The drug device combination product market is expected to be $178 billion by 2024 at an annual growth rate of 8%, with ~33% of new healthcare products being combination products. These metrics illustrate that to properly package healthcare products for the future it is imperative to understand fundamental performance and regulatory requirements of combination products as well as that of the individual device, biologic, or drug. This presentation will focus on combination products, with an emphasis on biologic-device, and why combinations pose unique challenges for packaging professionals. Participants will learn:

What combination products are
Why biologics are unique
Why packaging combinations take us beyond our comfort zone
The FDA’s stance on combination products with relevance to CBER, CDER, CDRH and PMOA

10:45 – 11:30 a.m.

Combination Products: Devices with Biologics/Packaging That May Take Us Beyond Our Comfort Zone

Brian Muehl
Healthcare Technical Manager
American Packaging Corporation
Columbus, Wisonsin

The Global Biologics market is expected to be $319 billion by 2021 with annual growth of 9.6%. Business research company biotech patent applications’ annual growth has been 25% since 1995 (McKinsey & Co article). The drug device combination product market is expected to be $178 billion by 2024 at an annual growth rate of 8%, with ~33% of new healthcare products being combination products. These metrics illustrate that to properly package healthcare products for the future it is imperative to understand fundamental performance and regulatory requirements of combination products as well as that of the individual device, biologic, or drug. This presentation will focus on combination products, with an emphasis on biologic-device, and why combinations pose unique challenges for packaging professionals. Participants will learn:

What combination products are
Why biologics are unique
Why packaging combinations take us beyond our comfort zone
The FDA’s stance on combination products with relevance to CBER, CDER, CDRH and PMOA

11:30 a.m. – 1 p.m.

Lunch & Exhibitor Showcase

1 – 2 p.m.

Polling with the Panel: Audience Polled, Panel Verified

Moderator: Jennifer Benolken, CPPL
MDM and Regulatory Specialist, Packaging Engineering,
Tyvek® Medical Packaging, DuPont
Mendota Heights, Minnesota

Panelists:

Georgianna Gallegos, Vice President of Global Quality, Oliver Healthcare Packaging, Trevose, Pennsylvania
Jane Severin, PhD, CPPGl, Vice President of Technical Solutions, Network Partners, Detroit, Michigan
Ondrea Kassarjian, PhD, Senior Manager, Packaging and Labeling, Hollister Incorporated, Libertyville, Illinois

Have your smartphone ready for our interactive polling session, returning for the fourth year in a row. In one of our most popular sessions, attendees answer questions live using an audience response system on their mobile phones--and see the responses in real time as people submit their answers.

We are preparing a pool of questions on all facets of medical device packaging to ask the audience during the polling session. What issues would you like to see addressed? Let the moderator know here.

Attendees will once again receive a report from this session after the conference.

2 – 2:15 p.m.

Networking Break

2:15 – 3 p.m.

Tray Cracking Conundrum

Cliff Labbe
Director Package Development
Ethicon
Cincinnati, Ohio

Have you ever experienced a failure mode and jumped to a conclusion based on your historic experience that turned out to cause you to narrow your focus on solutions that worked in the past, only to find out there were other probable causes that needed to be addressed to fix the problem? I have a story to tell that starts with a cracked thermoformed tray and ends with our business learning something about PETG we never knew. We leveraged the expertise of our J&J Package Development Team, the thermoform supplier, material providers and FEA analysis to ultimately find all the issues with the tray design and the materials we were leveraging in order to close out the transit issue.

3 – 3:45 p.m.

Kilmer Packaging: Collaborate to Innovate

Jenn Goff
Director of Product Marketing
Oliver Healthcare Packaging
Grand Rapids, Michigan

Dhuanne Dodrill
CEO
PAXXUS
Addison, Illinois

The presenter will discuss awareness and knowledge of the Kilmer Event, its purpose and value to promoting the science and engineering of sterility assurance, and the role packaging has in patient safety of medical devices. This is a call out to the industry to help drive tomorrow’s sterile barrier system in materials, designs, processes and test methods driven by patient safety and measured by improving healthcare outcomes.

3:45 – 4 p.m.

Closing Remarks & Prize Drawings