Medical Device Innovation Forum

Transcription

1 Medical Device Innovation Forum 08:30-12:00, August 28 Co-Chair: Xu Wei Director of Center for Medical Device Evaluation, CFDA, Deputy Chief Physician, Master of Medicine. She once served as the Head of General Affairs of Center for Medical Device Supervision and Registration, SFDA, Director of Medical Device Registration Technical Evaluation Department, Head of Acceptance Office for Medical Device Registration, Head of Medical Device Standard Review Office. Co-Chair: Gert W. Bos Head of Regulatory and Clinical Affairs at BSI Healthcare (NB0086 / NB0535) and Head of Notified Body at BSI-Germany (NB0535). He earned his PhD at Twente University of Technology, Enschede, the Netherlands. He has 21 years of experience in lifesciences (devices and pharma), in university, industry as well as in four Notified Bodies. He is president of the Notified Body association TEAM- NB, vice-chair of the Medical Notified Body forum NB-Med in Brussels, and participates in the Notified Body Recommendation group (NBRG), the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEG workgroups on animal tissue, on MRA's, e-labeling, EUDAMED and on IVD's. He is one of the Regulators representing Europe in the IMDRF Workgroup on regulated Product Submissions. He is a member of the board of the Dutch RA Chapter. 08:30-08:35 Introduction of the Co-Chairs 08:35-09:25 Analysis of Special Review and Approval Procedure for Innovative Medical Device Registration Zhang Shiqing, General Affairs Division of Center for Medical Device Evaluation, CFDA, PhD, Associate Research Fellow. He has published over ten papers in international and domestic core journals as the first author.he was engaged in several guides organized by CFDA. 09:25-10:00 Top Non-conformities in CAPA for MD Manufacturers EU vs. FDA Requirements Gert W. Bos, Head of Regulatory and Clinical Affairs at BSI Healthcare (NB0086 / NB0535) and Head of Notified Body at BSI-Germany (NB0535).He earned his PhD at Twente University of Technology, Enschede, the Netherlands. He has 21 years of experience in lifesciences (devices and pharma), in university, industry as well as in four Notified Bodies. He is president of the Notified Body association TEAM-NB, vice-chair of the Medical Notified Body forum NB-Med in Brussels, and participates in the Notified Body Recommendation group (NBRG), the Clinical Investigation and Evaluation Group (CIE), Medical Device Expert Group (MDEG) and the MDEG workgroups on animal tissue, on MRA's, e-labeling, EUDAMED and on IVD's. He is one of the Regulators representing Europe in the IMDRF Workgroup on regulated Product Submissions. He is a member of the board of the Dutch RA Chapter. 10:00-10:15 Tea Break 21

2 10:15-10:50 Coming to Grips with Specifying High Performance Plastics: A Metal Retractor Case Study Will Qiang, China Sales Development Manager for Solvay Specialty Polymers' healthcare business, graduated with a Master Degree in Polymer Science and Engineering from South China University of Technology. In his role in Solvay, he takes lead the marketing and business development work to grow company's high performance plastics business into medical device industry in China. In 2013, he introduced the Solviva Biomaterials into China implantable medical device industry. 10:50-11:25 Innovation Procurement: Obtaining Regulatory Approval for Products China Wants to Buy Ralph F. Ives, Executive Vice President of Global Strategy and Analysis for the Advanced Medical Technology Association (AdvaMed), from August 2004 to present, responsible for the Association's efforts to provide adequate reimbursement, appropriate regulations, and open market access for medical technology products. He was Assistant U.S. Trade Representative for Asia-Pacific and APEC Affairs, and Assistant U.S. Trade Representative for Pharmaceutical Policy in the Executive Office of the President. 11:25-12:00 Preparation and Characterization of Novel Corneal Regeneration Materials based on Collagen Ren Li, Vice Director of National Engineering Research Center for Tissue Restoration and Reconstruction (NERC-TRR). PhD, Professor. He is mainly engaged in the synthesis, processing and modification of high molecular materials, and his research directions are the biomimetic preparation and modification of biomedical high molecular materials, and biological response mechanism of biological materials. Currently he is the member of Chinese Society for Composite Materials (CSCM), the member of Chinese Society of Biomedical Engineering (CSBE), and the member of Chinese Committee for Biomaterials (CCBM). He has published more than 50 papers at domestic and foreign authoritative journals, and been authorized five patents in the application for eight national patents for invention and one international patent for PCT. He has won many national and international awards, such as the first prize of Outstanding Achievement Award in Scientific Research of Institutions of Higher Education of the Ministry of Education in 2010, and the second prize of National Award for Technological Invention in :30-18:00, August 28 Co-Chair: Liu Bin Deputy Director for Evaluation Division II of Center for Medical Device Evaluation, CFDA, Biomaterial Research Fellow, Vice Chairman of Bone Repair and Instrument Branch, CSBM, Network Review Expert of the Promotion Program for Innovative Talents of Ministry of Science and Technology, Member of Subcommittee on Materials and Orthopedics Implants of National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China. He has 20 years experiences in orthopedic clinical research and technical evaluation for medical device. He has been involved in National Key Technology R & D Program about research on porous tantalum in orthopedic repair. Besides, he is engaged in many national and industrial standards as the main draftsman. 22

3 Co-Chair: Zhang Mingdong Chief Medical Officer, Boston Scientific China. He worked as Assistant Professor of Epidemiology, Medical Officer/Epidemiologist, US FDA, Chinese University of Hong Kong, Special Volunteer (Adjunct Investigator), Viral Epidemiology Branch, Division of Cancer Epidemiology and Genetics, NCI, NIH. He got Ph.D. at Molecular Virology in Baylor College of Medicine and published more than forty research articles internationally. 13:30-13:35 Introduction of the Co-Chairs 13:35-14:15 Reflections on Listing Bottlenecks of Medical Devices for Personalized Customization Liu Bin, Deputy Director for Evaluation Division II of Center for Medical Device Evaluation, CFDA, Biomaterial Research Fellow, Vice Chairman of Bone Repair and Instrument Branch, CSBM, Network Review Expert of the Promotion Program for Innovative Talents of Ministry of Science and Technology, Member of Subcommittee on Materials and Orthopedics Implants of National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China. He has 20 years experiences in orthopedic clinical research and technical evaluation for medical device. He has been involved in National Key Technology R & D Program about research on porous tantalum in orthopedic repair. Besides, he is engaged in many national and industrial standards as the main draftsman. 14:15-14:50 Listing Approaches of Innovative Medical Devices - Comparison between American FDA and Chinese CFDA Tim Missios, Regulatory Affairs Director for Boston Scientific Corporation for the Americas and Asia Pacific Region. B.Sc., MBA. He has over 18 years Regulatory Affairs and Quality experience. For the past 14 years Tim has held regulatory affairs leadership roles for Boston Scientific in Canada and the Asia Pacific and Latin America regions. He was the Vice Chair and Canadian Industry representative for Study Group 4 of the Global Harmonization Task force (GHTF). He is an active member of numerous AdvaMed working groups, participates in many international conferences and has been a frequent lecturer/presenter on a variety of regulatory and quality topics at numerous conferences globally, including RAPS, GHTF, APEC, AHWP, ASEAN and Latin America. 14:50-15:25 Virtual Orthopaedic Database and 3D Printing Wang Aiguo, General Manager of Trauson (China) Medical Instrument Co., Ltd, Ph.D. of Materials Science, University of Cambridge. He has 22 years of experience in medical devices industry including 8 years in executive leadership roles. He is world renowned research leader in orthopaedic biomaterials, biomechanics, biotribology, and advanced manufacturing with more than 120 scientific publications and 20 plus US patents; a visiting professor of three of China's top universities, a 3-time winner of Stryker Corporate Best Invention Awards and Editorial Board Member, WEAR. 15:25-15:40 Tea Break 23

4 15:40-16:15 Scientific Basis of Evaluation on Implantable and Interventional Medical Devices Fan Yubo, President of Institute of Biomedical Engineering, Beijing University of Aeronautics and Astronautics (BUAA), Professor, Doctoral Student Supervisor, Director of Key Laboratory of Biomechanics and Mechanobiology of the Ministry of Education. Cheung Kong Scholar Chair Professor, Winner of National Outstanding Young Investigator Award, Winner of Trans-Century Training Program Foundation for Talents from the Ministry of Education, National Excellent Scientist. He has many professional affiliations, such as President of Chinese Society of Biomedical Engineering (CSBE),Vice President of Chinese Strategic Alliance of Medical Devices Innovation, Fellow of American Institute for Medical and Biological Engineering (AIMBE), Executive Member of International Federation For Medical And Biological Engineering (IFMBE), President-elect of the World Association for Chinese Biomedical Engineers (WACBE), Member of the World Council of Biomechanics (WCB), and Director of Chinese Special Committee of Biomechanics (The fifth). He has published more than 150 SCI papers at journals in biomedical engineering, and been authorized more than 20 national patents for invention. 16:15-16:50 Research and Development of Orthopedic Innovative Products Containing Medicine Geng Fang, R & D Manager of Shanghai MicroPort Orthopedics Co., Ltd, Doctor, Senior engineer, Supervisor of master students at University of Shanghai for Science & Technology. She has been engaged in biomedical material research and development of orthopedic medical device products for 13 years at home and abroad, publishing more than 20 SCI or EI articles, authorized 18 patents. Mastering the key technology of related products in orthopaedic joint, spine, trauma, sports medicine, and biological materials, especially focused on the development of orthopaedic innovative products. 16:50-17:25 Innovations in the Cardio and Cerebral Medical Fields Bassil Akra, Director of the Department IMC/Clinical Affairs (Innovation, Medical Evaluation, Clinical Studies and Assessment of Certification) at TÜV SÜD Product Service GmbH, responsible for a global focus team doing the assessment of the manufacturer's clinical evaluation report since As the senior product specialist for medical devices incorporating medicinal substances, he is leading various consultation processes with competent authorities that are designated by the Member States or the EMA. He used to work for and with medical device companies and was leading a cardiovascular research group at the department of cardiovascular surgery of the university of Munich hospital (LMU) for many years. He graduated from physics engineering department, Aachen University of Applied Sciences - Germany and earned his Master's degree in medical engineering from the Technical University of Munich (TUM) - Germany. Dr. Bassil developed several devices for tissue engineering applications and for testing of medical devices. 17:25-18:00 Proposals for Clinical Application and Product Monitoring of Individualized Orthopaedic Implants Wang Chengtao, Academic Leader of Technology of Clinical Digital Medicine in Engineering Research Center of Digital Medicine of the Ministry of Education, Professor, Doctoral Supervisor, receives the State Council Special Allowance. Honorary Member of Chinese Mechanical Engineering Society (CMES), Vice Chairman of Bio-Manufacturing Branch, Honorary Member of Shanghai Society of Biomedical Engineering, Vice Chairman of Research Society of Rehabilitation Medicine. He is devoted to the interdisciplinary research in the combination of engineering and medicine for nearly 30 years.he hosted "Mechanical Virtual Human of China", the key research project of Natural Science Foundation of China (NSFC), and 15 projects of Asian Major International Joint Research Project on Artificial Joint and the Surface Project, winning 14 prizes of Scientific and Technological Awards in provincial and ministerial level. Besides, he has 4 publications subsidized by national and local scientific works foundations and 30 authorized national patents for invention. 24

5 08:30-12:00, August 29 Co-Chair: Ren Haiping Ren Haiping, Director of Inspection Office on OME Medical Devices, National Institute for Food and Drug Control. Doctor, Senior Title. Her main research directions are active medical devices, and detection and quality control of medical software. She hosted and joined in many science research projects, such as National Major Program "863", National Key Technology Research and Development Program, National Natural Science Foundation of China and Beijing Natural Science Foundation etc. She has published over 60 papers at home and abroad magazines, such as Pattern Recognition and Journal of Optical Society of America A. She is Vice Chairman of Professional Committee on Metrology and Testing of Medical Equipment, Member of National Technical Committee on Medical Electrical Equipment of China, Member of Standing Committee, Chinese Society of Medical Physics (CSMP), Chinese Society of Biomedical Engineering (CSBME), Member of the National Technical Committee on Medical Metrology, China. Co-Chair: Julia Zhu Julia Zhu, Director of Medical &Regulatory Affairs, Stryker Greater China. She's leading a team for Stryker GCR medical, regulatory and quality assurance affairs. She holds a MD degree from Capital Medical University. She has over 20 years' experience in healthcare industry, especially in registration affairs and quality system management. Prior joining Stryker, she served as Director of Regulatory &Quality Assurance for St. Jude Medical, and took several management roles for Boston Scientific, Roche, and Janssen China in medical and regulatory affairs. 08:30-08:35 Introduction of the Co-Chairs 08:35-09:10 Practice and Reflections on Innovative Medical Device Review Lu Zhong, Deputy Director of Center for Medical Device Evaluation, CFDA, Senior Engineer. He used to be Director General of Zhaoqing Drug Administration, Chief of Guangzhou Medical Device Quality Surveillance and Test Institute of SFDA, Director for General Business Affairs Department of Center for Medical Device Technical Evaluation, SFDA. 09:10-09:40 Minimum Requirements for Getting CE Mark Approval and the Requirement for Post-market Interim Reporting when Talking about Innovations Bassil Akra, Director of the department IMC/Clinical Affairs (Innovation, Medical Evaluation, Clinical Studies and Assessment of Certification) at TÜV SÜD Product Service GmbH, responsible for a global focus team doing the assessment of the manufacturers clinical evaluation report since As the senior product specialist for medical devices incorporating medicinal substances, he is leading various consultation processes with competent authorities that are designated by the Member States or the EMA. He used to work for and with medical device companies and was leading a cardiovascular research group at the department of cardiovascular surgery of the university of Munich hospital (LMU) for many years. He graduated from physics engineering department, Aachen University of Applied Sciences - Germany and earned his Masters degree in medical engineering from the Technical University of Munich (TUM) - Germany. Dr. Bassil developed several devices for tissue engineering applications and for testing of medical devices. 25

6 09:40-10:10 Computer Simulation Technology for Preclinical Function Test of Artificial Joints Jin Zhongmin, Distinguished Professor for 'Thousand People Plan' and Cheung Kong Chair Professor at Xi'an Jiaotong University, PhD of Mechanical Engineering at the University of Leeds, Director for Tribology Institute of Chinese Mechanical Engineering Society, Deputy Head for Basic Group, Chinese Associationh of Orthopaedic Surgeons. He was the reviewer and selection expert of application reports for British Engineering Physics Foundation and National Natural Science Foundation. And he won the bronze medal of British Tribology and the second prize of China Machinery Industry Science and Technology Award. He publishes 200 SCI papers. 10:10-10:20 Tea Break 10:20-11:00 Singapore and Malaysia's Regulatory Framework for Medical Device Hwee Ee Tan, Founder, DH RegSys and Co-Founder of MD-CLINICALS Malaysia a CRO 100% medical devices. She has 20 years of experience in the medical industry principally in medical device organizations as a consultant, engineer and senior manager. She provides consulting and training services and product solutions to the medical device and related industries for regulatory bodies such as Singapore HSA, Malaysia MDA, Australia TGA, US FDA, EU and etc. Principle areas of expertise include: External trainer engaged by SGS, International Certification Services Singapore Pte Ltd, Company Audits and Gap Analysis, etc. She is also a member of Working Group 4 (WG4) of the AHWP (Asian Harmonization Working Party). 11:00-11:30 The Power of High Performance Plastics in Healthcare: How Material Innovations are Supporting Next-generation Medical Devices Maria Gallahue-Worl, Global Healthcare Business Manager for Solvay Specialty Polymers, managing Solvay's international business team and strategy focused on growing the company's high performance polymers into the global healthcare marketplace. Her 22-year career in the polymer industry spans a range of business activities including manufacturing, quality engineering, design engineering, product management and marketing. She is an active member of the Society of Plastics Engineers (SPE) and did her undergraduate studies at Rensselaer Polytechnic Institute and the State University of New York, receiving degrees with honors in Mathematics and Physics and also earned a CM from the Darden Business School. 11:30-12:00 The Therapeutic Trend of Multiple Ribs Fracture Yi Yunfeng, Director of Department of Cardiothoracic Surgery, People's Liberation Army Hospital 175, Zhangzhou Fujian. Chief Physician, Professor, Master's Supervisor.Member of Thoracic Surgery Association of Chinese Medical Doctor Association, Vice Chairman of Specialized Committee on Intensive Care Medicine of Nanjing Military Region, Youth Member of Specialized Committee on Thoracic Cardiovascular Surgery of the Whole Army, Standing Member of Specialized Committee on Thoracic Cardiovascular Surgery of Nanjing Military Region. Science and Technology Talent of Nanjing Military Region, Advanced Individual in Research and Innovation. His major research directions are the therapy of diseases in esophagus,lung and heart. He has rich experience in the diagnosis and therapy of multiple injuries and severe thoracic traumas. He has won 3 prizes of the third place of Military Progress Prize in Science and Technology, authorized 2 national patents for invention, with publishing over 80 medical papers. 26