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U.S. Department of Health and Human Services

Medical Devices

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Japan - U.S. HBD West 2007 Think Tank Meeting Update

On January 10 and 11, 2007, HBD West 2007 Think Tank Meeting was held in Durham, North Carolina, U.S.A and hosted by Duke University and the Duke Clinical Research Institute (DCRI). The Think Tank meeting was co-sponsored by the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), the Duke University (Duke) and AdvaMed (Advanced Medical Technology Association). Representatives from more than 25 academic institutions, industry organizations and companies as well as government regulators from the United States and Japan attended the discussion packed two-day HBD Think Tank meeting. The HBD structure and introduction of the initial four HBD Working Group missions were emphasized throughout the meeting.

Provocative presentations, topics and objectives from the four HBD Working Groups were offered and discussed. 

Highlighted discussions from each Working Group included:

Working Group 1: Global Cardiovascular Device Trials
Co-Chairs: Mitchell Krucoff, Duke University Medical Center
Shigeru Saito, Shonan Kamakura General Hospital

Working Group 1 emphasized the themes of operational and regulatory challenges to executing single clinical protocols for device evaluation in Japan and the USA, as well as “Integration and Independence of Timelines for Single Protocol Studies.” The work of this group is multifaceted, including the address of issues of data poolability, challenges to multi-national randomization, and integrated submission strategies.

Working group 2: Post Market Registries
Co Chairs: Eric Chen, US Food and Drug Administration
Kazuhiro Sase, Juntendo University Medical School

Working group 2 initially focused on a post-market LV assist devices registry in conjunction with the NIH-sponsored INTERMACS program. They presented on facilitating the timely global introduction of new medical technologies through the identification of specific pre- and post-market barriers. Future post-market proof-of-concept projects will be identified to “test” possible solutions to the recognized barriers.

Working Group 3: Clinical Research Infrastructure
Co-Chairs: John Alexander, Duke University Medical Center
Yoshihiro Arakawa, Tokyo University Hospital

In keeping with the Working Group 3 theme of clinical research infrastructure, mission, topics and discussions revolved around improved design of (global) studies that fit into clinical sites in Japan and the United States, as well as the necessary steps to improve clinical research infrastructure in both nations. Approaches to enhancing infrastructure and metrics for measuring such improvement that could be tested with proof of concept projects were discussed.

Working Group 4: Regulatory Convergence & Communication 
Co-Chairs: Carole Carey, US Food and Drug Administration
Shinichi Takae, Japan Ministry of Health, Labour and Welfare

Working Group 4 discussed their mission to facilitate the timely global introduction of new medical technologies by identifying and addressing specific regulatory barriers, emphasizing the value of early consultation with U.S. and Japanese regulatory bodies, developing solutions and demonstrating these solutions through proof-of-concept projects. Initial work done to establish a recognizable translation of medical device good clinical practices (GCP) regulations, compare Japanese and U.S. standards, identify differences, characterize differences as barrier or non-barrier, and propose solutions to barriers that could be tested in proof of concept projects was presented as a specific approach to regulatory convergence. Additional topics discussed included those that could be approached with a similar style of process, including use of GHTF’s (Global Harmonization Task Force) STED (Summary Technical Documentation) submission formats.

Plenary session

In addition to presentations by each Working Group evening plenary session included presentations by:

Robert Califf, M.D.,
Vice Chancellor for Clinical Research,
Director, Duke Translational Medicine Institute

Murray M. Lumpkin, M.D.,
Deputy Commissioner for International and Special Programs,
United States Food and Drug Administration

Hiroshi Maruyama,
Associate Center Director
Japan Pharmaceuticals and Medical Devices Agency.

The plenary session offered high-level, thought-provoking presentations, which emphasized the high priority of the HBD Initiative and mission.

The meeting concluded with a summary of the progress made during the meeting and a reminder that the HBD participants must build on the accomplishments of this meeting prior to the next HBD East 2008 Think Tank meeting in Japan.