HEALTHPACK 2020 SPEAKERS

 

 

Keynote: Sam Onukuri

Head and Senior Fellow
Johnson & Johnson 3D Printing

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


As Head of Johnson & Johnson 3D Printing Innovation and Customer Solutions, Sam Onukuri leads the integration of 3D printing across Johnson & Johnson businesses to evolve the way it creates and delivers products and solutions. He and his dedicated team advance new materials and 3D printing technologies to innovate the design, manufacturing and delivery ecosystem.

Sam works closely with R&D, Supply Chain, Commercial, Quality, Regulatory, Legal and IT to drive 3D printing initiatives across Johnson & Johnson's medical device, consumer and pharmaceutical businesses. Those initiatives include bioprinting, point of care solutions, precision medicine, electronics and sensors, advanced metals and ceramics, polymers and natural materials and 3D enabled innovative designs.

Sam is responsible for cultivating a network of partners and strategic collaborators that allow us to tap into a range of expertise from the top minds around the world. These collaborations help ensure Johnson & Johnson remains on the cutting edge of 3D printing, which promises to help it serve more patients globally with personalization, waste reduction, speed and efficiency.

Sam has more than 25 years of experience in medical devices and an extensive background as a metallurgist and in material sciences. His other Johnson & Johnson roles include Advanced/Front-end Technology leadership for Medical Devices and Senior Fellow within the Ethicon family of companies. Prior to Johnson & Johnson, Sam worked at General Electric and Baxter Healthcare. He is based in Cincinnati, Ohio at the Ethicon Campus.


 

Jose Arevalo

Global Business Development Manager – Tyvek® Medical
DuPont

Presentation: The Physics and Science of Sealing


Jose Arevalo is Global Business Development Manager for DuPont Tyvek® Medical Packaging. During his 15-year tenure at DuPont he has worked all around the world developing the medical packaging competence of individuals and corporations at all levels of the medical device market. He is a subject matter expert in Tyvek® and in most aspects of the packaging of medical devices.  Prior to joining DuPont, Jose held various technical and marketing management positions for global leaders in the packaging, healthcare and pharmaceutical industries. Jose earned his master's and Bachelor of Science in Packaging Science from Rochester Institute of Technology.


Jennifer Benolken, CPPL

MDM and Regulatory Specialist, Packaging Engineering
Tyvek® Medical Packaging, DuPont

Panel: Polling with the Panel: Audience Polled, Panel Verified


Jennifer Benolken, CPPL, is the Western Region Medical Device and Pharmaceutical Manufacturer and Regulatory Specialist with DuPont Tyvek® Medical Packaging; she works with downstream customers at medical device and pharmaceutical organizations, providing education and answering questions about Tyvek® packaging and sterilization. Jen has worked in the medical device community since 1991 in a variety of packaging related roles— packaging/labeling/sterilization engineer (in both operations and R&D roles), flexible packaging sales representative, and manager of packaging engineering and labeling groups.

While Jen earned her undergraduate degree in Manufacturing Systems Engineering at Kettering University (Flint, MI), she came to love packaging through her collegiate co-operative work experience at CPI/Guidant. Jen furthered her education by obtaining a Masters of International Management degree from St. Thomas University (St. Paul, MN). She is currently the sub-committee chairperson for ASTM F02.50, Package Design and Development, as well as co-chair for AAMI’s ST/WG 7, Packaging Working Group, the US’s mirror group to ISO TC198/WG7.

Jen is also an active member of the Institute of Packaging Professionals (IoPP) where she attained her lifetime Certified Packaging Professional (CPPL) certification in 2012. As part of IoPP, Jennifer has recently been elected to the Board of Directors and is also Vice Chair on its Medical Device Packaging Technical Committee (MDPTC) board. Jennifer is currently working with industry leaders as the editor for the upcoming 3rd edition of the Medical Device Packaging Handbook.



Dhuanne Dodrill is the CEO of PAXXUS, a global, vertically integrated flexible health care packaging manufacturer. With more than 30 years of experience in the flexible packaging industry, Dhuanne has worked in a variety of technical, quality assurance and management positions. She is the immediate past chair of ASTM’s Committee F02 on Primary Barrier Packaging, is the Chair of the Sterilization Packaging Manufacturers Council, serves on the Executive Board of Directors of the Flexible Packaging Association, is active with IoPP’s Medical Device Packaging Technical Committee, and is on the Board of Directors of Summit Insurance. She loves the science behind packaging and is passionate about promoting the role that packaging can play in improving patient outcomes.

Dhuanne has a B.S. in Chemical Engineering (with honors) from the University of Illinois Urbana-Champaign.


Ryan Erickson

Vice President, Packaging Engineering
Packaging Compliance Labs

Presentation: Human Factors and Usability: A Case Study


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


Brian K. Farison, CPP, MBB

Senior Manager, Medical Device Package Development
Johnson & Johnson

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


Brian has 35 years' combined experience in packaging, medical devices and process excellence and currently leads a global team of packaging professionals. His career expertise spans the areas of structural and medical device package design, process development and validation, Six Sigma and lean process improvement, project management, quality and compliance, risk mitigation and technical team leadership and development. Brian is a member of ASQ, holds seven U.S. patents, three WorldStar package design awards and six AmeriStar package design awards. He is a Certified Six Sigma Master Black Belt and a Certified Packaging Professional-Lifetime with IoPP. He is also a contributing author to The Medical Device Validation Handbook (edited by Max Sherman) on the topics of Six Sigma and Test Method Validation.  Brian holds a B.S. in packaging from Michigan State University and is a past HealthPack speaker.


 

Georgianna Gallegos

Vice President of Global Quality
Oliver Healthcare Packaging

Panel: Polling with the Panel: Audience Polled, Panel Verified


Georgianna is the Vice President of Global Quality at Oliver Healthcare Packaging. In this role, she is responsible for creating, implementing and maintaining the Quality Management System. In addition, Georgianna launched a Six Sigma training program at Oliver, and continues to lead this program as the executive sponsor. With more than 30 years of medical packaging experience, Georgianna has held a variety of roles within Operations and Quality throughout her career. She is a Six Sigma Black Belt, a certified Quality Engineer, and a veteran of the United States Air Force.


Jenn Goff

Director of Product Marketing
Oliver Healthcare Packaging

Presentation: Kilmer Packaging: Collaborate to Innovate
Panel: Experts Panel: Career Conversation for Newer Professionals


With a packaging degree from Michigan State University, Jenn has been dedicated to improving patient safety over the past 14 years. She has partnered with cross-functional teams across multiple organizations to bring lifesaving technologies to the health care market. Jenn began her career as a packaging engineer at Edwards Lifesciences where she held roles in new product development, global operations and quality engineering. She then moved to Stryker, taking on roles with increasing responsibility and complexity to further help drive change, reduce costs and develop talent. With a diverse background in packaging engineering, labeling, quality engineering and electrical approvals engineering, she can effectively identify and solve various problems in the healthcare sector. She now holds the role of Director, Product Marketing at Oliver Healthcare Packaging where she is responsible for delivering new products to customers to solve unmet needs.


Elon Goldbaum

Director of Client Solutions
Network Partners

Presentation: CAPA & Packaging

As Director of Client Solutions, Elon (Lon) brings over 20 years of experience in the medical device field, with a diverse background specializing in package engineering, labeling, project management, quality, and CAPA systems. Lon’s multifaceted background provides support and leadership to Network Partners’ packaging and project management consulting, quality assurance, labeling, and the Apprentice program.

Prior to joining Network Partners, Lon held various roles with increasing levels of responsibilities at Baxter Healthcare, Edwards Lifesciences, and Danaher with responsibilities, ranging from implementing and managing packaging and labeling processes, cost savings,  UDI implementation to microbiology and sterilization requalifications, CAPA remediation, and rebuilding CAPA systems.

Lon earned his Bachelor of Science degree in Package Engineering from Michigan State University.


Jennifer Griffin

Senior Principal Packaging Engineer
Medtronic

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


Jennifer Griffin is a Senior Principal Packaging Engineer for Medtronic’s CardioVascular business. In 2019, she became a Technical Fellow at Medtronic. Jennifer is celebrating 13 years at Medtronic in January 2020.  She has a Bachelor’s degree in Packaging Science from Rochester Institute of Technology and a Master’s degree in Plastics Engineering from UMASS Lowell. Prior to Medtronic, Jennifer worked in new package development for electronics and computers, optics and imaging equipment, consumer goods, medical devices, industrial products and food.


Ondrea Kassarjian

Senior Manager of Global Packaging
Hollister Incorporated

Panel: Polling with the Panel: Audience Polled, Panel Verified


Dr. Ondrea Kassarjian is Senior Manager of Global Packaging at Hollister Incorporated, where her team develops packaging and labeling systems for ostomy, continence care and critical care products. She earned her PhD and Master of Science in Packaging and her Bachelor of Science in Horticulture from Michigan State University. She has held other medical device packaging industry roles in business and product development, quality management, testing and education. Her professional interests include serving on the ASTM D10 and F02 committees, understanding the human-package interaction, adding value through packaging, and transforming major work systems.


 

Cliff Labbe

Director Package Development
Ethicon

Presentation: Tray Cracking Conundrum


Clifford Labbe, Jr. holds a BS and MS in Materials Science and Engineering from the University of Cincinnati. After graduation, he worked for Cymetech where he developed light truck and automotive components manufactured with purified poly-DCPD.

Cliff moved to New Jersey to work for Alcan as a Materials Development Engineer in support of Alcan's squeeze tubes business. He contributed to the look, feel, and performance of Alcan's mono-layer, co-extruded, and laminated tubes. After three years, he moved into the Alcan Continuous Improvement team and received his Lean Six Sigma Black Belt Certification and lead projects that eliminated material waste and slashed production line change-over times.

Cliff started his medical device packaging career with Johnson and Johnson in Cincinnati, Ohio, at Endo-Surgery fourteen years ago. He has developed and launched dozens of medical device packaging systems including materials replacement projects to enhance packaging functional performance and reduce costs.

Cliff is now a Director of Package Development for the Medical Device Division of Johnson and Johnson and has responsibilities that include Ethicon Endo-Surgery surgical devices, DePuy Synthes joints, and Biosense Webster electrophysiology treatment devices.  

Cliff enjoys hiking and family game nights with his wife Stephanie, and twin boys, Miles and Elliott.


Virginia A. Lang, PhD

Chief Scientist and President
HirLan, Inc. and HirLan Institute of Human Factors

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


Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various federal government agencies. Subsequent to Johns Hopkins Medical Center, Virginia entered the field of Human Factors through the doctoral program at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio, and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications providing Medical Device Human Factors by HirLan clients with 30 years of Human Factors experience.

In addition, Virginia has extensive experience in the areas of product design, Customer Centered Participatory Design processes, and product lifecycle management. She is also known in the Human Computer Interaction and Usability communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle. In July 2014, Virginia founded and established the HirLan Institute of Human Factors with labs in Carlsbad, California, and a Consortium arrangement in London, UK. HirLan supports Top Ten pharma/medical device companies as well as start-ups with consulting and testing services. These services are in conjunction with their clients’ FDA 510(k) and CE mark applications.

Virginia holds a PhD in Cognitive-Experimental Psychology from SUNY Binghamton, and a Master of Science (ABT) in Applied Technology, Systems Science from SUNY Binghamton.


Brian K. Muehl

APC Healthcare® Technical Manager
American Packaging Corporation

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


Brian Muehl has been in Applied Research and Development for over 25 years. His roles include product development, material evaluation and testing, and quantifying product-package interactions. He holds various patents in flexible packaging and material use. Brian works for American Packaging Corporation (APC) in their R&D Solutions Team. He and APC collaborate with health care customers to understand product and market needs. Brian and APC are engaged with academic institutions and various organizations to provide sustainable packaging solutions. Brian has a B.S. degree in Chemistry and Mathematics from Ripon College.


Jane Severin, PhD, CPPGl

Vice President of Technical Solutions
Network Partners

Panel: Polling with the Panel: Audience Polled, Panel Verified


As Vice President of Technical Solutions, Jane brings a wealth of knowledge and a unique perspective to Network Partners. Jane started her distinguished career in medical device industry and has spent more than 25 years as a packaging professional. She’s served in several medical device and pharmaceutical roles with Baxter Healthcare, Bayer Corporation, Cardinal Health, Schering-Plough (Merck) Corporation, Oliver™ Healthcare Packaging and Dupont Protection Solutions. Jane also founded two packaging consulting companies.

Jane holds a BS and a PhD in Packaging from Michigan State University and an MBA from Keller Graduate School of Management. In addition, Jane is an IoPP Certified Packaging Professional, Six-Sigma certified, holds two medical device patents and has been an instructor at Michigan State University’s School of Packaging, where she’s currently an adjunct faculty member. 


Vishnu Shankar Vyas

Regulatory & Standards Leader- India/ ASEAN
E. I. DuPont India Pvt. Ltd.

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


Vishnu is the Regulatory & Standards Leader for the DuPontTM Tyvek® Medical and Pharmaceutical Packaging business within the DuPontTM Safety segment. He has been actively involved in numerous industry groups, including the Medical Technology Association of India (MTaI), the Asia Pacific Medical Technology Association (APACMed), the Association of Malaysian Medical Industry (AMMI), etc. for several years.

He has been part of India's delegation to ISO/TC 198/WG7 on Medical Packaging, nominated by the Bureau of Indian Standards as packaging expert, for the last two years.

Prior to joining DuPontTM in 2017, he worked with medical device companies like Edwards Lifesciences, Becton Dickinson and Medtronic as a regulatory/quality leader looking after India and the Indian subcontinent between 2005 and 2016.

Vishnu earned his B. Pharma degree in Pharmaceutical Sciences from the Rajasthan Technical University and his Master’s in Corporate Law from National Law University, Jodhpur.