U.S.-German Standards Panel - Medical Technology
DIN and ANSI, the American National Standards Institute, continue to work closely together as partners of the Transatlantic Market Conference and the U.S.-German Standards Panel - the 2016 Panel topic is "Innovation in the medical device sector".
The medical technology sector is very innovative and has an extremely high growth potential. Standards help inventions become established as new products or services on this highly regulated market. Medical devices are also a subject of the Transatlantic Trade & Investment Partnership (TTIP) negotiations between Europe and the USA.
The aim is to bring representatives of industry and the state together to explore opportunities for the joint development of standards in innovative areas. Agreeing upon common standards at an early stage can help bring together these two markets, thus reducing the adverse effects of differing regulatory frameworks. Coming to an understanding on key issues early on can also facilitate the adoption of common standards at a global level.
9:00 | Welcome address Joe Bhatia, President and CEO, American National Standards Institute (ANSI) Welcome address Rüdiger Marquardt, Member of the Executive Board, DIN |
9:15 | Keynote Speech Recent developments in electronic medical records – Implications for standardization and public policy Tim Büthe, Associate Professor of Political Science and Public Policy, Duke University |
9:45 | The Transatlantic Trade and Investment Partnership (TTIP) Moderator: Sibylle Gabler, Senior Manager Government Relations, DIN |
| TBT Chapter and Annex on Medical devices Isabel Pastor Arenillas, Trade Counselor, EU Delegation to the USA |
| U.S. perspective Ashley Miller, Director, Industrial Goods Market Access (TTIP sectors), USTR |
10:30 | Coffee Break |
10:45 | Standards in the EU and US – A tool for meeting global requirements Moderator: Gordon Gillerman, Director, Standards Coordination Office, NIST, US DoC |
| Harmonized Standards (EU) Matthias Marzinko, Director International Standards Management, Drägerwerk AG & Co. KGaA |
| Recognized Standards (US) Scott Colburn, Director, Standards, US FDA |
| Conformity Assessment – Keys to Multiple Market Access Dr. Royth von Hahn, Global Director Functional Safety and Software, Medical and Health Services, TUV SUD Product Service Division |
| What Global Companies are Doing Elisabeth George, Vice President of Global Government Affairs, Standards & Regulations, Philips Healthcare, USA |
| Brief Panel Discussion |
12:05 | Standards in Regulation - Use cases |
| Current issues - disposable medical products Herrmann Riesenberger, Head of Working Group Standardization, BVMed, The German Medical Technology Association |
| Electromedical devices Pamela Gwynn, Principal Engineer for Medical and Home Healthcare Equipment, Underwriters Laboratories (UL) |
| Standards and Medical Imaging Diane Wurzburger, Executive, Regulatory Affairs, GE Healthcare/MITA |
| Brief Panel Discussion |
12:50 | Lunch |
13:45 | Interoperability in the medical device sector Moderator: Hermann Behrens, Head of department Innovation, DIN |
| Internet of Medical Systems and IT Services Prof. Dr. J.-Uwe Meyer, CEO, CTO, MT2IT GmbH & Co. KG |
| Implementing Information Exchange Standards in Healthcare Facilities Dezso Csipo, President, Object Forge, Inc. |
| Interchange formats of medical documents – IT-specifications Dr. Georg Heidenreich, Manager Healthcare IT Standards, Siemens Healthcare GmbH |
| Safety and Security Standards for Medical Application Platforms John Hatcliff, University Distinguished Professor, Department of Computing and Information Science, Kansas State University |
| Medical Robots Mike Yramategui, Fellow Regulatory Engineer, Intuitive Surgical, USA |
15:25 | Coffee Break |
15:45 | Innovative future topics Moderator: Carol Herman, Senior Vice President, Standards & Policy Programs, AAMI |
| Safe and dynamic networking in operating room and hospital Björn Andersen, Research Assistant, University of Lübeck Institute of Medical Informatics |
| Risk management of 3D printed medical devices Roderick McMillan, Materials Development Manager, DePuy Synthes |
| Biocompatibility and evolution of risk management in safety evaluation of medical devices Jon Cammack, Global Vice President of R&D/Clinical Quality, AstraZeneca |
| Innovation and Adaptation in the Development of Standards for Absorbable Implants Byron Hayes, Biomaterials Research and Development, W.L. Gore & Associates, Inc. |
| Standardization in the field of regenerative medicine Prof. Dr. Michael Doser, Deputy director, Head of development in Biomedical Engineering, Institute of Textile Technology and Process Engineering |
17:05 | Panel Discussion on innovative future topics
|
17:45 | Closing remarks |
| Rüdiger Marquardt and Joe Bhatia |
