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HBD East 2017 Think Tank Meeting


Through the U.S. - Japan Medical Device Harmonization by Doing (HBD), the US FDA, Japanese regulators, academia, and industry developed internationally agreed upon standards for global clinical trials related to cardiovascular devices, and addressed regulatory barriers that may delay timely medical device approvals in both countries.
HBD East 2017 Think Tank Meeting was held on December 7, 2017 at the National Center for Global Health and Medicine in Tokyo.
In this meeting, recent hot topics such as Early Feasibility Study and Real World Evidence were discussed in addition to WG activity update. In the Round Table Discussion, HBD members and other experts shared their experiences and had a free discussion to overcome the challenges in medical device clinical trials.
164 participants from many stakeholders joined the meeting and had fruitful discussions towards the U.S. - Japan Medical Device Harmonization.


Ministry of Health, Labour and Welfare (MHLW)
The Japan Federation of Medical Device Associations (JFMDA)


Pharmaceuticals and Medical Devices Agency (PMDA)
National Center for Global Health and Medicine (NCGM)


Joint Center for Researchers, Associates and Clinicians (JCRAC)


Thursday, December 7,  2017


National Center for Global Health and Medicine, Main Conference Room
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, Training Center 5F


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Scenes from the meeting

Dr. Kondo, Chief Executive of PMDA  Dr. Kokudo, President of NCGM
   Dr. Kondo, Chief Executive of PMDA         Dr. Kokudo, President of NCGM

Lecture session  Group Photo of HBD members
                        Lecture session                  Group Photo of HBD members

Presentation Materials

Presenter Theme PDF
Mitchell Krucoff
Chair, HBD


Keynote Speeches
Toshiyoshi Tominaga
Associate Executive Director, PMDA
What Makes HBD So Unique and Significant? PDF
Kazuaki Sekiguchi
Chair, JFMDA HBD Sub-committee
Clinical Investigations in Japan then and now PDF
Neal Fearnot
Vice President, Cook Group Inc.
Changes Brought About by HBD and Future Direction PDF
Session1: Update of HBD Activities
Christopher Volker
Cardiovascular Systems, Inc.
Orbital Atherectomy for Calcific Coronary Lesions PDF
Stephen M. Rowland
OrbusNeich Medical, Inc.
Coronary Stent Innovation: EPC Capture PDF
Noah Bartsch
TVA Medical, Inc.
Endovascular AV Fistula PDF
Satoshi Yasukochi
Nagano Children’s Hospital
HBD for Children: Progress and Challenges PDF
Session 2: Real World Evidence
Danica Marinac-Dabic
National and International Efforts for Developing Real World Evidence PDF
Kazuhiro Sase
Juntendo University
View from Japanese Academia PDF
Akihide Konishi
Challenges and Efforts; PMDA’s View PDF
Misti Malone
Use Experience of Real World Evidence in the Actual Review PDF
Andy Crosbie
Use of Real World Evidence under MDR PDF
Neal Fearnot
Cook Group, Inc.
Expectation from Medical Device Industry PDF
Session 3: Early Feasibility Study
Shigeru Saito
Shonan Kamakura General Hospital
Expectation from Japanese Physician PDF
Robert Thatcher
4C Medical Technologies, Inc.
Challenges in Development of Innovative Device PDF
Yumiko Aoyagi
Regulations on Clinical Studies in Japan PDF
Ken Cavanaugh
FDA Considerations for Initiating EFS PDF
Ken Kozuma
Teikyo University Hospital
Experience of First in Human Study in Japan PDF
Round Table Discussion: Let’s Join Forces to Overcome the Challenges in Medical Device Clinical Trials!
Seigo Nakano
Terumo Corporation, Japan
Issues Brought Up by Japanese Medical Device Industry PDF

Survey Results

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JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan


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HBD East 2017 Think Tank Meeting