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 US Food and Drug Administration (FDA), the US Centers for Disease Control and Prevention (CDC), the Consumer Healthcare Products Association (CHPA) and the Gertontological Society of America (GSA). Her multi-disciplinary approach and the value that she places 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

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Nirav Bhatt
R&D Manager, Package Engineering

Presentation: Usability: Formative Versus Summative Testing

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

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, MI, 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 BS 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

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Javier de la Fuente
Healthcare Packaging Curriculum & Research Lead
California Polytechnic State University

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

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Jordan Montgomery
Senior Principal Packaging Engineer

Preconference Workshop: ISO 16775 

Aditya Nallur
Staff Engineer, R&D Packaging
Stryker Neurovascular

Presentation: Navigating the Complexities of Packaging and Labeling Postponement

Nicolas Packet
Packaging Engineer

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

Michael Scholla
Global Director, Regulatory & Standards

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

Tristen 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

“As an MDM, hearing about the research that peer companies are doing is great! This is the only venue that allows this sort of discussion.”

–Anonymous HealthPack attendee

See more praise for HealthPack.

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