Program

AGENDA                           PRESENTERS

Speakers to be announced—check back for updates.

Keynote Speaker

Dr. Laura Bix
Assistant Dean for Teaching, Learning and Academic Analytics
Michigan State University School of Packaging

Dr. Laura Bix is the Associate Director of the School of Packaging at Michigan State University and an Adjunct Associate Professor at Clemson University. A frequent speaker at HealthPack, she has served as an expert to international and national panels convened by ISO, the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the Consumer Healthcare Products Association (CHPA) and the Gertontological Society of America (GSA). Her multidisciplinary approach and the value that she places in unique collaborations have been honored in numerous ways including appointment as a CIC Academic Leadership Fellow (2015-2016), a Phi Kappa Phi Excellence in Interdisciplinary Scholarship Award (2014) and being named one of the most notable people in the medical device industry by MDDI (2008).

Presentation: The Evolution of Packaging: Time to Move from Commodity to a Value-Added Proposition

Nirav Bhatt
R&D Manager, Package Engineering
Dexcom

Nirav Bhatt is an R&D Manager of Packaging Engineering with Dexcom Inc. based in San Diego, California. He manages a team of packaging engineers to lead new product development and sustaining projects across the organization. He has more than 12 years of progressive package development and engineering experience in the medical device and pharmaceutical industries. Bhatt's experience includes leading and managing packaging projects from start to end process for sterile and non-sterile medical devices. 

Presentation: Usability for Medical Device Packaging

David DiVaccaro
President
DiVaccaro Consulting

David DiVaccaro is a Six Sigma Certified Process Excellence Black Belt with bachelor and master’s degrees in packaging from Michigan State University. He has worked in the medical device and pharmaceutical industries for more than 25 years with companies such as Johnson & Johnson-DePuy Synthes, Sanofi, Johnson & Johnson-Cordis, Baxter and Telectronics (now part of St. Jude Medical). Currently, he is a consultant with the DiVaccaro Consulting Group, LLC. David has expertise in package design, process validation, machinery selection, package risk assessment, remediation and supplier relationships. His package designs have earned two IoPP Ameristar Awards. David is a contributing author for “The Medical Device Validation Handbook.” He is a longtime member of the Institute of Packaging Professionals and serves as Ombudsman for the IoPP Medical Device Packaging Technical Committee.

Panel: Packaging Validation Process and Design

Ryan Erickson
VP-Packaging Engineer
Packaging Compliance Labs

Ryan Erickson earned his packaging engineering degree at Michigan State University. He began his career with Cardinal Health in Chicago. At Cardinal Health, Erickson served as a packaging engineer and developed skills in packaging validation and testing. Upon returning to his hometown, Grand Rapids, Michigan, Erickson became Packaging Engineering Manager for Vention Medical, a large contract manufacturer for many large OEMs in the medical device industry. In late 2014, Erickson co-founded Packaging Compliance Labs with partner Matthew Lapham. They formed PCL with the mission to help medical device and pharmaceutical clients speed their products to market by breaking down barriers that relate to packaging. As the Vice President, Packaging Engineer at PCL, Erickson serves as the technical expert on the team, guiding training, lean events and engaging in the medical device community as an opinion leader.

Panel: Packaging Validation Process and Design

Brian Farison, CPP
Senior Manager, Package Development
Johnson & Johnson

Panel: Packaging Validation Process and Design

Changfeng Ge
Graduate Program Director-Department of Packaging Science
Rochester Institute of Technology

Changfeng Ge, Ph.D., is a Professor in Packaging Science at the Rochester Institute of Technology (RIT). He joined RIT in 2005 and has served as the Founding Director of the American Packaging Corporation Center for Packaging Innovation at RIT since 2008. Ge is the Editor-in-Chief of the Journal of Applied Packaging Research, ASTM D10.13 Chair and a Board Member of IAPRI. Ge’s primary research interest includes protective packaging, field measurement for lab simulation and the modeling of the package in distribution. 

Presentation: Design and Evaluation of Thermal Insulation Packaging for Temperature-Sensitive Medical Products

Jenn Goff
Director of Product Marketing
Oliver Healthcare Packaging

Jenn Goff is the Director of Product Marketing at Oliver Healthcare Packaging, where she is responsible for delivering new products to customers in the medical device and pharmaceutical industries, with a specific focus on product development to solve unmet needs within the market. Goff is based in Grand Rapids, Michigan, and is an established leader in the medical packaging field. Prior to joining Oliver, Goff led a group of shared services teams within new product development at Stryker. While at Stryker, Goff gained valuable leadership experience and expanded her knowledge by taking responsibility for labeling and electrical approvals in addition to packaging engineering. Goff began her career at Edwards Lifesciences, where she held a variety of packaging and quality engineering roles. Goff graduated with a B.S. in Packaging from Michigan State University. Her passion for packaging in the Med Tech market pairs well with her commitment to quality and patient safety.

Presentation: Get Your Ideas Heard in a Complex Organization: A How-To Guide for Packaging Engineers

Dr. Javier de la Fuente
Assistant Professor
California Polytechnic State University

Dr. Javier de la Fuente is an Assistant Professor of Industrial Technology and Packaging at California Polytechnic State University (Cal Poly) where he teaches healthcare packaging, design thinking and innovation, packaging development, and computer-aided design. He is the healthcare packaging curriculum and research lead. Dr. de la Fuente also serves as an Adjunct Faculty at the Universidad de Monterrey where he teaches product usability at the graduate level.

Dr. de la Fuente’s background includes product design, graphic design, packaging, and scientific research. His research interest lies in the area of user-centered design, inclusive design, communication of functionality (affordances), and healthcare packaging.  He holds a five-year degree in Industrial Design summa cum laude from the Universidad de Buenos Aires and a Master and Doctorate in Packaging from Michigan State University.

He has more than 30 publications including books chapters, peer-reviewed articles, refereed conferences, and trade-press articles. He has co-authored the “Packaging Design and Development” and the “Medical Device Packaging” chapters in the last edition of the Wiley Encyclopedia of Packaging Technology. He is currently co-writing the human factors chapter of the upcoming edition of the “Medical Device Packaging Handbook.” One of his research articles won the prestigious Best Paper Award at the Cambridge Workshop on Universal Access and Assistive Technology organized by the Engineering Department at the University of Cambridge.

Dr. de la Fuente is also co-founder and partner at Factor IDD, a design and innovation consulting firm specializing in packaging, product design, and brand identity.

Presentation: Mobile Eye-Tracking: Getting into the Mind of the Customer

Paul Marshall, CPPL
Managing Director
Conversant Packaging

Paul Marshall has more than 20 years of experience within the packaging industry that covers a variety of different industries such as military/defense, retail, industrial, pharmaceuticals, and medical device packaging applications. The majority of his career has focused within the medical and pharmaceutical packaging sectors. Over his career, Marshall has earned several awards for excellence in packaging development, including three Ameristar Awards, one Worldstar Award and one US/International patent. Paul is an IoPP Certified Packaging Professional with Lifetime status (CPPL) and Project Management Professional (PMP). He has been employed with Smith & Nephew for the last six years as a Manager of Global Packaging Technologies. In his role, Marshall is responsible for ensuring global compliance to global regulatory bodies packaging requirements. He also manages the Memphis Packaging Lab and supports testing for Smith & Nephew sites globally. In addition, Marshall manages both the Packaging Process Engineering and Packaging Sustaining Engineering teams across the Americas. In the past several years, Marshall’s team has been responsible for developing sustainable packaging solutions, supporting Smith & Nephew business goals and objectives through productivity and cost savings initiatives, standardizing and harmonizing S&N to global standards and remediating legacy product lines.

Moderator: Packaging Validation Process and Design

Thom McNabb
Principal Project Engineer
Medtronic Neurovascular

Thomas McNabb holds a master’s degree in Packaging Science from Rochester Institute of Technology in addition to a bachelor’s degree in Economics from California State University in Los Angeles. He has been in the packaging industry for more than 25 years including positions at UPS, Black & Decker, Johnson & Johnson, B. Braun and Edwards Lifesciences. McNabb is a member of the Institute of Packaging Professionals and is a member on the ASTM International F02 and D10 committees. He has developed expertise in package testing, thermoforming, medical device packaging, package prototyping and value improvement. Thomas is currently Principal Project Engineer at Medtronic Neurovascular.

Panel: Packaging Validation Process and Design

Aditya Nallur
Staff Engineer, R&D Packaging
Stryker Neurovascular

Presentation: Navigating the Complexities of Packaging and Labeling Postponement

Nicholas Packet
Packaging Engineer
DuPont

Nick Packet is an MDM Specialist and Packaging Engineer at DuPont who has been working in the medical device packaging field since 2004.  Starting his career as a packaging engineer, he supported the design, development and qualification of sterile packaging systems and packaging equipment. Prior to joining DuPont, Packet led a team of packaging engineers who supported new product development and sustaining engineering projects, working for Boston Scientific and Covidien. He’s dedicated to helping organizations understand the importance of the packaging function and the value it can bring to their business. Packet is a graduate of the Rochester Institute of Technology, where he earned a Bachelor of Science degree in Package Engineering.

Presentation: Flexible Packaging Material: Challenges and Opportunities for Recycling

Rod Patch
Senior Director, Packaging CoE
Johnson & Johnson

Rod Patch is Senior Director, Packaging Center of Excellence, Medical Devices at Johnson & Johnson. He is an accomplished leader with a broad base of experiences in sterile barrier package design, with a track record of implementing innovative packaging systems and packaging strategies that elevate the quality, compliance and customer-delight experiences across Johnson & Johnson medical devices packaging systems. Career experiences include package structural design with a focus on sterile barrier packaging systems, package assembly, sealing and labeling, design verification, design validation, project management, program management, new facility and equipment installation, process qualification, standards and regulation compliance, risk mitigation and cross-functional team development. 

Moderator: A Fireside Chat with the FDA

Michael Scholla
Global Director, Regulatory & Standards
DuPont

Mike is the Global Director, Regulatory & Standards and Medical Packaging Fellow for the DuPont Medical and Pharmaceutical Protection business within DuPont Protection Systems. He is actively involved in numerous industry groups including the Association for the Advancement of Medical Instrumentation (AAMI) where he has served on the Board of Directors for over twelve years and was elected Chair in June 2014. He currently serves as Immediate Past Chair. He also serves on the AAMI Foundation Board. He serves as co-chair of the Sterilization Standards Committee which is the US Mirror Group for ISO TC198 and a former member of the Committee on Standards Strategy. Mike is the Convener of ISO TC198/WG7 on Medical Packaging, responsible for the globally harmonized standard EN ISO 11607 and guidance EN ISO TS 16775; a member of the editorial board for Pharmaceutical and Medical Packaging News; and a 30-year member of the American Society for Microbiology.

Mike has a diverse research background and is credited with six U.S. patents and more than 60 published papers and articles. Prior to joining DuPont in 1988, he was a member of the faculty at the University of Memphis. Mike earned BS and MS degrees in microbiology from the University of Central Florida and was awarded the Ph.D. from North Carolina State University. In 1994, he received the UCF College of Health and Public Affairs Professional Alumni Achievement Award. He was honored again by the Burnett College of Biomedical Sciences in 2006. He received Standards Developer Awards from AAMI in 2010 and 2015

Presentation: ISO 11607 Update

Tristan Steichen
Project Manager
Healthcare Plastics Recycling Council

Tristan Steichen is Project Manager at the Healthcare Plastics Recycling Council and Manufacturing Segment Leader at Antea Group USA, an environmental, health, safety and sustainability consulting firm. With more than 20 years of experience, he specializes in EHS program development, strategic environmental liability management planning, regulatory compliance, e-learning and knowledge management solutions. Steichen is actively engaged in the REMADE Institute and CE100 Programme, developing a deep understanding of the EHS and sustainability-related challenges manufacturing companies face around reuse, recycling and remanufacturing of materials. He holds a Bachelor of Science degree in Environmental Science from Virginia Tech.

Presentation: Flexible Packaging Material: Challenges and Opportunities for Recycling

Randy Troutman
Business Development Manager
Printpack Medical

Randy Troutman is Director of Sales, Marketing and Technology at Printpack Medical. He has an extensive background as a business development professional in R&D, FDA requirements, medical devices, strategic negotiations and business process improvement. He has an MBA in Leadership and Business Management from Christian Brothers University and a Packaging Engineering Degree from the University of Wisconsin-Stout.

Moderator: Live Audience Polling Session

Thierry Wagner
Regulatory Affairs Director, Europe, Middle East & Africa
DuPont Medical and Pharmaceutical Protection

Thierry Wagner has spent nearly 30 years working for DuPont in its polyester films and nonwovens businesses in a variety of assignments ranging from process development and project management to operations and business management. He is chairman of the board of the Sterile Barrier Association (SBA), member of the Parenteral Drug Association (PDA) and actively involved in various ISO and CEN technical committees on medical and pharmaceutical packaging like ISO TC198 “Sterilization of Health Care Products—Packaging” (ISO 11607), CEN TC102 “Sterilizers for Medical Purposes—Packaging” (EN868), and ISO TC76 “Transfusion, infusion and injection equipment for medical and pharmaceutical use”. Thierry is also a member of ISO/TC 210 in charge of ISO 13485 and ASTM Committee F02 – Flexible Barrier Packaging and of the CEN ABHS (Advisory Board for Healthcare Standards-Europe).

Thierry Wagner earned a master’s degree in mechanical and process engineering from ETH Zürich in Switzerland. He is a featured speaker at international conferences and seminars on medical and pharmaceutical packaging regulatory aspects.

Presentation: ISO 16775—The Way Forward
Preconference Workshop: ISO 16775

Patrick Weixel
Acting Deputy Office Director of Patient Safety and Product Quality
Food & Drug Administration

Patrick Weixel is Acting Deputy Office Director for Patient Safety and Product Quality at the Food and Drug Administration’s CDRH/Office of In Vitro Diagnostics. He received his BS from Frostburg State University in 1989. He has been with the FDA for more than 25 years. He started as an investigator and primarily conducted medical device inspections. In 1999, he accepted a position in the Center for Device and Radiological Health (CDRH). Weixel’s primary responsibilities included the review of establishment inspections reports and regulatory, classification of recalls, participate in training courses and to conduct reviews that involved sterilization or packaging issues. He was also involved in assignments dealing with reprocessing of single use devices. He then became a Postmarket Team Leader within the Division of Radiological Health/Office of In Vitro Diagnostics and Radiological Health, evaluating inspection reports to determine if the device manufacturer is complying with the quality system regulations.

Weixel regularly participates in standards meetings and is the FDA representative for the AAMI Radiation Sterilization working group, Technical Expert for the AAMI Quality Systems for Device Reprocessing working group, the ASTM standards committees F02 - Flexible Barrier Packaging Materials and E61 - Radiation Processing.

Presentation: A Fireside Chat with the FDA


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