2nd Annual MEDICAL DEVICE PACKAGING: INNOVATIONS IN DESIGN AND TESTING APRIL 30 - MAY 1, 2015 | BETHESDA, MD Optimizing Medical Device Package Design through Incorporating End User Feedback, Leveraging Legacy Testing Studies & Identifying Innovative Materials, while Maintaining Validation & Verification Standards through Examining Test Methods to Satisfy Global Regulatory Expectations DISTINGUISHED PRESENTERS INCLUDE: Abhishek Gautam Daniel Burgess Dhuanne Dodrill Manager, Packaging Engineering Principal Packaging Engineer Chairman CONMED CORPORATION BOSTON SCIENTIFIC ASTM INTERNATIONAL COMMITTEE F02 Catherine Olson, MSN, RN Charlie Rivera Director, Institute for Quality, Safety and Corporate Packaging Operations Manager A.J. Gruber Injury Prevention CONMED CORPORATION Executive Vice President EMERGENCY NURSES ASSOCIATION ISTA Nora Crivello Philip Desjardins Vice President Dawn Fowler Counsel WESTPAK INC. Senior Manager, Labeling & ARNOLD & PORTER LLC Documentation Shirley Gibson ENDOLOGIX Michael H. Scholla, Ph.D. Associate Vice President of Nursing Global Director, Regulatory and VCU HEALTH SYSTEM Tomas Pla Standard Sr. Development Packaging Engineer DUPONT PACKAGING Paul Marshall EXACTECH Manager, Global Packaging Art Castronovo Technologies Jonathan Bull Dir. of Labeling and Packaging SMITH & NEPHEW Director Gas and Heat Sterilization Engineering JOHNSON & JOHNSON SMITHS MEDICAL Santosh Madival Sr. Packaging Engineer Rod Patch Rients Van Werven EDWARDS LIFESCIENCES Senior Director, Execution Excellence Manager GSG Package Development COE Packaging and Product Labeling Ron Valerio JOHNSON & JOHNSON ETHICON ENDO-SURGERY Sr. Manager Medical UFP TECHNOLOGIES Darian Flewellen Dawn Hamblett Development Engineer, Packaging OR Clinical Product Coordinator Maimunatu Mansaray EXACTECH GEORGE WASHINGTON Operating Room Nurse UNIVERSITY HOSPITAL HOWARD UNIVERSITY HOSPITAL Alison Tyler Director of Technology Katie Tran Ewald Heersema BEACON CONVERTERS, INC. Lab Supervisor Technical Business Manager WESTPAK ZOTEFOAMS INC Chetan Patadiya Sr. Packaging Engineer Dr. Javier de la Fuente Changchun Liu, PHD EDWARDS LIFESCIENCES Assistant Professor Research Assistant Professor CALIFORNIA POLYTECHNIC STATE UNIVERSITY OF PENNSYLVANIA Dan Penny UNIVERSITY Director of Packaging Engineering CARDINAL HEALTH CONFERENCE SPONSORS: PREMIER SPONSORS: 500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com MEDICAL DEVICE PACKAGING: INNOVATIONS IN DESIGN & TESTING APRIL 30 - MAY 1, 2015 | BETHESDA, MD PROGRAM OVERVIEW: PREVIOUS ATTENDEES INCLUDE: Reducing costs while maintaining innovation in packaging continues to be of top Director, Engineering, ACUMED priority throughout the medical device industry as the healthcare landscape moves Product Manager, ACUMED towards a customer-centric business model engaging the end-user throughout the Sr. Engineer to Project Engineer, ALLERGAN product lifecycle. Engineers are tasked with the responsibility of creating innovative Senior Packaging Engineer, AMERICAN MEDICAL SYSTEMS packaging that will protect lifesaving medical devices throughout the supply chain Senior Quality Engineer, APOLLO ENDOSURGERY and lifecycle of the product while also reducing cost and remaining compliant with Manager, Packaging Engineering, ARTHROCARE CORP regulatory guidelines. This year’s conferencewill build upon the concerns of last TEN-E Packaging Services (D10 Chair), ASTM COMMITTEE year’s event by addressing the current concerns of packaging engineers through case Chairperson, ASTM COMMITTEE studies, panel discussions and end user small group feedback. Director EHS and Sustainability, BAXTER Attendees of this year’s program will be provided with the unparalleled opportunity to R&D Manager/ HPRC committee Member, BD discuss testing validation and verification challenges through case studies surround- Package Engineering Manager, BD DIAGNOSTICS ing good manufacturing practices including identifying where legacy studies can be Packaging Engineer, BD DIAGNOSTICS leveraged or testing is needed. Testing presentations will also address sterilization, Staff Engineer, Packaging, BD MEDICAL shelf life, sample size and unique testing methods available. End user concerns includ- Team Leader - Graphics and Packaging, BD MEDICAL ing sterility and ease-of-use will be addressed through small group discussions where Senior Manager, BECKMAN COULTER nurses will examining and provide feedback on packages provided by attendees. Manager, Packaging Engineering, BOSTON SCIENTIFIC Principal Packaging Engineer, BOSTON SCIENTIFIC KEY CONFERENCE SPEAKERS INCLUDE: Corporate Packaging Operations Manager, CONMED Manager of Packaging Engineering, CONMED-LINVATEC Dr. Javier de la Fuente Packaging Engineering Manager, COVIDIEN Assistant Professor Sr. Design Engineer- Packaging, COVIDIEN CALIFORNIA POLYTECHNIC Sr. Sterile Packaging Engineer, DEPUY SYNTHES STATE UNIVERSITY Manufacturing Eng. Packaging Manager, DSM BIOMEDICAL Senior Packaging Manager, DSM BIOMEDICAL EDWARDS LIFESCIENCES Dr. de la Fuente serves as Assistant Professor of Packaging Engineer, ENDO THERAPEUTICS Industrial and Packaging Technology in the Orfalea Manufacturing Engineer Manager, College of Business at the California Polytechnic Sr. Manager, Document Control and Labeling, ENDOLOGIX State University. He teaches courses in design think- Director of Filling & Finishing, FUJIREBIO DIAGNOSTICS ing, product design and development, computer Supervisor, Operating Room, GEORGE WASHINGTON HOSPITAL aided design, and packaging.r. de la Fuente’s back- OR Product Coordinator, GEORGE WASHINGTON HOSPITAL ground includes industrial and graphic design, packaging, and scientific research. Packaging Engineering Manager, HEARTWARE, INC. His research interest lies in the area of user-centered design, universal/inclusive Packaging Manager, HOLLISTER design, communication of functionality (affordances), and healthcare packaging. Manager, Packaging, INTEGRA LIFESCIENCES He has more than 30 publications including books chapters, peer-reviewed articles, Manager of Packaging, INTEGRA LIFESCIENCES refereed conferences, and trade-press articles. He has co-authored the “Packaging Sr. Packaging Engineer, INTUITIVE SURGICAL Design and Development” and the “Medical Device Packaging” chapters in the last edi- VP Sterile Process Technology, JOHNSON & JOHNSON tion of the Wiley Encyclopedia of Packaging Technology. One of his papers won the pres- K2M tigious Best Paper Award at the Cambridge Workshop on Universal Access and Assis- Project Engineer, tive Technology organized by the Engineering Department at University of Cambridge. Packaging Engineer 1, KIMBERLY CLARK HEALTHCARE Vice President of Technology, LANSMONT A.J. Gruber Senior Packaging Engineer, LIFECELL CORP Executive Vice President Packaging Engineer, LIFECELL CORP ISTA Principal Quality Engineer lead statistician, MEDTRONIC Associate Packaging Engineer, MEDTRONIC Packaging Engineer Manager, MEDTRONIC A.J Gruber is the Executive Vice President for the Associate Professor, HUMAN MEDICINE International Safe Transit Association. He is respon- VP of sterilization Operations, NOVOSCI sible for both internal and external relationships PACKWISE CONSULTING which include interacting and communicating with Principal Packaging Engineer, staff across functional areas, motivating a team Marketing Manager, PETOSKEY PLASTICS commitment to the ISTA’s vision and mission, and Contract Sterilization Manager, REVOX STERILIZATION representing the Association through public speak- Eastern Regional Manager, REVOX STERILIZATION ing and communications with members and other industry partners. Also responsible Product Manager, REVOX STERILIZATION for overseeing the processes through which ISTA maintains contact with members or Packaging Engineer, RTI SURGICAL other stakeholders ensuring that the relationships remain conducive to the success Project Manager, Marketing, SHL GROUP of the Association. Before joining ISTA, A.J. held roles within UPS as an Engineering Packaging Development Engineer, SMITH & NEPHEW Solutions Specialist and Supervisor of Dangerous Goods. A.J. currently also resides Dir., Global Packaging Development, SMITH & NEPHEW as the chair of IoPP Transport Packaging Committee and is on the board of the Mich- Sr. Packaging Engineer, SMITH & NEPHEW ORTHOPEDICS igan State University Packaging Alumni Association. Lifecycle Packaging Engineer, STRYKER Associate Project Engineer, STRYKER RAPS CERTIFICATION: Packaging Engineering Manager, STRYKER This conference has been pre-approved by the Regulato- Packaging Engineer, STRYKER Principal Packaging Engineer, STRYKER ry Affairs Professionals Society (RAPS) as eligible for up Senior Packaging Engineer, STRYKER to 12 credits towards a participant’s RAC recertification Senior Packaging Engineer, STRYKER upon full completion. Director, Packaging Design, STRYKER 500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com MEDICAL DEVICE PACKAGING: INNOVATIONS IN DESIGN & TESTING DAY ONE | THURSDAY, APRIL 30 7:00 REGISTRATION & MORNING COFFEE 12:15 LUNCHEON FOR ALL ATTENDEES, SPEAKERS & SPONSORS 7:50 CHAIRPERSON’S OPENING REMARKS 1:30 PANEL DISCUSSION: CHOOSING COST EFFECTIVE AND INNOVATIVE PACKAGING MATERIAL 8:00 BALANCING REGULATORY COMPLIANCE AND INNOVATIVE Medical device manufacturers need to develop packaging that not only pro- PACKAGING DESIGN tects and sterilizes a product but also satisfies end-user desires to maintain To remain competitive