Skip to main content


  • Sunday, Mar 10th
    8:00 AM – 11:40 AM ET
    FDA Japan | Session One [Non-CME]
    Location: Monroe
    Program Director: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
    Program Director: Neal E. Fearnot, PhD – Cook Group Incorporated
    Innovation
  • Sunday, Mar 10th
    8:00 AM – 8:15 AM ET
    Introduction to Harmonization by Doing: 20 Years of Achievements
    Location: Monroe
    Speaker: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Innovation
  • Sunday, Mar 10th
    8:00 AM – 8:50 AM ET
    PLENARY SESSION: CURRENT AND FUTURE US-JAPANESE COLLABORATIONS
    Location: Monroe
    Moderator: Neal E. Fearnot, PhD – Cook Group Incorporated
    Moderator: Shohei Kurosawa – Ministry of Health, Labour and Welfare
    Innovation
  • Sunday, Mar 10th
    8:15 AM – 8:30 AM ET
    CDRH International Update
    Location: Monroe
    Speaker: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
    Innovation
  • Sunday, Mar 10th
    8:30 AM – 8:50 AM ET
    Update on Japanese Medical Device Regulatory Initiatives
    Location: Monroe
    Speaker: Shohei Kurosawa – Ministry of Health, Labour and Welfare
    Innovation
  • Sunday, Mar 10th
    8:50 AM – 9:00 AM ET
    Update on HBD for Children Activities
    Location: Monroe
    Speaker: Wakako Sakamoto, PhD – Office of Medical Device I, Pharmaceuticals and Medical Device Agency (PMDA)
    Innovation
  • Sunday, Mar 10th
    8:50 AM – 10:00 AM ET
    HBD FOR CHILDREN – GLOBAL PEDIATRIC DEVICE DEVELOPMENT
    Location: Monroe
    Moderator: Nicole Gillette – FDA
    Moderator: Sung-Hae Kim, MD – Shizuoka Children's Hospital
    Innovation
  • Sunday, Mar 10th
    8:50 AM – 10:00 AM ET
    HBD FOR CHILDREN – GLOBAL PEDIATRIC DEVICE DEVELOPMENT
    Location: Monroe
    Moderator: Nicole Gillette – FDA
    Moderator: Sung-Hae Kim, MD – Shizuoka Children's Hospital
    Innovation
  • Sunday, Mar 10th
    9:00 AM – 9:10 AM ET
    POC Project update – Renata Medical
    Location: Monroe
    Speaker: Evan Zahn, MD – Cedars-Sinai Medical Center
    Innovation
  • Sunday, Mar 10th
    9:10 AM – 9:20 AM ET
    Update on Academic Research Consortium (ARC) Efforts
    Location: Monroe
    Speaker: Takanari Fujii, MD, phD – Pediatric Heart Disease and Adult Congenital Heart Disease Center, Showa University Hospital
    Innovation
  • Sunday, Mar 10th
    9:20 AM – 9:30 AM ET
    Regulatory Advances in Pediatric Device Availability
    Location: Monroe
    Speaker: Emily Olszewski, PhD – Food and Drug Administration
    Innovation
  • Sunday, Mar 10th
    9:30 AM – 10:00 AM ET
    Panel Discussion
    Location: Monroe
    Panel Moderator: Nicole Gillette – FDA
    Panel Moderator: Sung-Hae Kim, MD – Shizuoka Children's Hospital
    Panel Discussant: Takanari Fujii, MD, phD – Pediatric Heart Disease and Adult Congenital Heart Disease Center, Showa University Hospital
    Panel Discussant: Emily Olszewski, PhD – Food and Drug Administration
    Panel Discussant: Wakako Sakamoto, PhD – Office of Medical Device I, Pharmaceuticals and Medical Device Agency (PMDA)
    Panel Discussant: Evan Zahn, MD – Cedars-Sinai Medical Center
    Innovation
  • Sunday, Mar 10th
    10:00 AM – 10:15 AM ET
    BREAK
    Location: Monroe
    Innovation
  • Sunday, Mar 10th
    10:15 AM – 10:30 AM ET
    Japanese Perspective on Global Medical Device Ecosystem
    Location: Monroe
    Speaker: Takahiro Uchida, MD, MSc – Sanamedi, Inc.
    Innovation
  • Sunday, Mar 10th
    10:15 AM – 11:30 AM ET
    GLOBAL DEVICE DEVELOPMENT: LESSONS LEARNED
    Location: Monroe
    Moderator: Eric A. Chen, MS – Abbott
    Innovation
  • Sunday, Mar 10th
    10:30 AM – 10:45 AM ET
    Start-up Environment in Japan: Has It Changed?
    Location: Monroe
    Speaker: Fumiaki Ikeno, MD – Stanford University
    Innovation
  • Sunday, Mar 10th
    10:45 AM – 11:00 AM ET
    Medical Device Business Considerations in Japan
    Location: Monroe
    Speaker: Kazuhisa Senshu, PhD – Terumo Corporation
    Innovation
  • Sunday, Mar 10th
    11:00 AM – 11:30 AM ET
    Panel Discussion
    Location: Monroe
    Panel Moderator: Eric A. Chen, MS – Abbott
    Panel Discussant: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
    Panel Discussant: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
    Panel Discussant: Shohei Kurosawa – Ministry of Health, Labour and Welfare
    Panel Discussant: Kazuhisa Senshu, PhD – Terumo Corporation
    Panel Discussant: Kate Stohlman, MBA, RAC – Corvia Medical, Inc.
    Panel Discussant: Takahiro Uchida, MD, MSc – Sanamedi, Inc.
    Innovation
  • Sunday, Mar 10th
    11:30 AM – 11:40 AM ET
    Closing Remarks
    Location: Monroe
    Speaker: Neal E. Fearnot, PhD – Cook Group Incorporated
    Innovation
  • Sunday, Mar 10th
    11:40 AM ET
    Adjourn
    Location: Monroe
    Innovation
  • Monday, Mar 11th
    8:00 AM – 12:00 PM ET
    FDA Japan | Session Two [Non-CME]
    Location: Monroe
    Program Director: Kenneth J. Cavanaugh, Jr., PhD – U.S. Food and Drug Administration
    Program Director: Neal E. Fearnot, PhD – Cook Group Incorporated
    Innovation
  • Monday, Mar 11th
    8:00 AM – 8:10 AM ET
    Welcome and Opening Comments
    Location: Monroe
    Speaker: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
    Innovation
  • Monday, Mar 11th
    8:10 AM – 8:20 AM ET
    Regulatory Update: Japan
    Location: Monroe
    Speaker: Madoka Murakami, PhD – Pharmaceuticals and Medical Devices Agency
    Innovation
  • Monday, Mar 11th
    8:10 AM – 9:10 AM ET
    ADVANCES IN DIGITAL HEALTH
    Location: Monroe
    Moderator: Stephen Browning, BSE – FDA/CDRH
    Moderator: Madoka Murakami, PhD – Pharmaceuticals and Medical Devices Agency
    Innovation
  • Monday, Mar 11th
    8:20 AM – 8:30 AM ET
    Regulatory update: US
    Location: Monroe
    Speaker: Stephen Browning, BSE – FDA/CDRH
    Innovation
  • Monday, Mar 11th
    8:30 AM – 8:40 AM ET
    Change Controls: Global Experience
    Location: Monroe
    Speaker: Cassie A. Scherer, JD – Medtronic
    Innovation
  • Monday, Mar 11th
    8:40 AM – 8:50 AM ET
    International Collaborations in AI/ML
    Location: Monroe
    Speaker: Fumiaki Ikeno, MD – Stanford University
    Innovation
  • Monday, Mar 11th
    8:50 AM – 9:10 AM ET
    Panel Discussion
    Location: Monroe
    Panel Moderator: Stephen Browning, BSE – FDA/CDRH
    Panel Moderator: Madoka Murakami, PhD – Pharmaceuticals and Medical Devices Agency
    Panel Discussant: Cassie A. Scherer, JD – Medtronic
    Innovation
  • Monday, Mar 11th
    9:10 AM – 9:20 AM ET
    Regulatory Update: US
    Location: Monroe
    Speaker: Hiren Mistry, MSE – Food and Drug Administration
    Innovation
  • Monday, Mar 11th
    9:10 AM – 10:20 AM ET
    DEVICE-BASED HYPERTENSION THERAPIES IN US AND JAPAN
    Location: Monroe
    Moderator: Misti Malone, PhD – FDA
    Moderator: Hiroyoshi Yokoi, MD – Fukuoka Sanno Hospital
    Innovation
  • Monday, Mar 11th
    9:20 AM – 9:30 AM ET
    Regulatory Update: Japan
    Location: Monroe
    Speaker: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
    Innovation
  • Monday, Mar 11th
    9:30 AM – 9:40 AM ET
    Clinical Perspective
    Location: Monroe
    Speaker: Hiroyoshi Yokoi, MD – Fukuoka Sanno Hospital
    Innovation
  • Monday, Mar 11th
    9:40 AM – 9:50 AM ET
    Industry Perspective on US vs Japanese Opportunities 1
    Location: Monroe
    Speaker: Leisa Martinez – Medtronic
    Innovation
  • Monday, Mar 11th
    9:50 AM – 10:00 AM ET
    Industry Perspective on US vs Japanese Opportunities 2
    Location: Monroe
    Speaker: Helen Reeve-Stoffer, PhD – Recor Medical Inc
    Innovation
  • Monday, Mar 11th
    10:00 AM – 10:20 AM ET
    Panel Discussion
    Location: Monroe
    Panel Moderator: Misti Malone, PhD – FDA
    Panel Moderator: Hiroyoshi Yokoi, MD – Fukuoka Sanno Hospital
    Panel Discussant: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
    Panel Discussant: Leisa Martinez – Medtronic
    Panel Discussant: Hiren Mistry, MSE – Food and Drug Administration
    Panel Discussant: Helen Reeve-Stoffer, PhD – Recor Medical Inc
    Innovation
  • Monday, Mar 11th
    10:20 AM – 10:35 AM ET
    BREAK
    Location: Monroe
    Innovation
  • Monday, Mar 11th
    10:35 AM – 10:45 AM ET
    First Trans-Pacific Single Protocol Prospective RCT (PAD) - The Zilver-PTX Stent
    Location: Monroe
    Speaker: Neal E. Fearnot, PhD – Cook Group Incorporated
    Innovation
  • Monday, Mar 11th
    10:35 AM – 12:00 PM ET
    20 YEARS OF GROUNDBREAKING PROJECTS
    Location: Monroe
    Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Moderator: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
    Innovation
  • Monday, Mar 11th
    10:45 AM – 10:55 AM ET
    First Trans-Pacific Single Protocol RCT (CAD) - The HARMONEE Study
    Location: Monroe
    Speaker: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
    Innovation
  • Monday, Mar 11th
    10:55 AM – 11:05 AM ET
    First Trans-Pacific Early Feasibility Study (Mitral valve)
    Location: Monroe
    Speaker: Katherine Kumar, PhD, RAC – 4C Medical Technologies, Inc.
    Innovation
  • Monday, Mar 11th
    11:05 AM – 11:15 AM ET
    First Trans-Pacific Pediatric Device (Pulmonic valve)
    Location: Monroe
    Speaker: Declan Dineen, BSc, MSc – Medtronic Inc.
    Innovation
  • Monday, Mar 11th
    11:15 AM – 11:25 AM ET
    First Trans-Pacific Disruptive Technology (Tricuspid valve)
    Location: Monroe
    Speaker: Stephen M. Rowland, PhD – OrbusNeich Medical Inc.
    Innovation
  • Monday, Mar 11th
    11:25 AM – 11:35 AM ET
    First Trans-Pacific Device Classification Reconciliation (Aortic graft)
    Location: Monroe
    Speaker: Robert Thatcher, MBA – Diaxamed, LLC
    Innovation
  • Monday, Mar 11th
    11:35 AM – 11:55 AM ET
    Panel Discussion
    Location: Monroe
    Panel Moderator: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Panel Moderator: Shigeru Saito, MD, FACC, FSCAI – Shonan Kamakura General Hospital
    Panel Discussant: Declan Dineen, BSc, MSc – Medtronic Inc.
    Panel Discussant: Marika Doi, PhD – Pharmaceuticals and Medical Devices Agency (PMDA)
    Panel Discussant: Neal E. Fearnot, PhD – Cook Group Incorporated
    Panel Discussant: Nicole Ibrahim, PhD – U.S. Food and Drug Administration
    Panel Discussant: Katherine Kumar, PhD, RAC – 4C Medical Technologies, Inc.
    Panel Discussant: Stephen M. Rowland, PhD – OrbusNeich Medical Inc.
    Panel Discussant: Robert Thatcher, MBA – Diaxamed, LLC
    Innovation
  • Monday, Mar 11th
    11:55 AM – 12:00 PM ET
    Closing Comments
    Location: Monroe
    Speaker: Mitchell Krucoff, MD, FACC – Duke University Medical Center/Duke Clinical Research Institute
    Innovation
  • Monday, Mar 11th
    12:00 PM ET
    Adjourn
    Location: Monroe
    Innovation