KAMDA conference

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October 23, 2025 · Reed Smith LLP, 22nd Floor, 599 Lexington Ave, New York, NY 10022

The 1st KAMDA Conference

“Facing the Real Barriers: Korean Medical Device Companies' Strategic Entry into the U.S.”

Who it was for

  • Korean-American medical device industry professionals
  • Healthcare providers
  • FDA, insurance and legal experts
  • Investors and related stakeholders

Program highlights

  • Expert session on U.S. FDA regulations
  • Insurance and reimbursement system overview
  • Sponsor presentations
  • Panel discussion: strategic entry into the U.S. market
  • Networking dinner and pre-event meetings

2025 registration

  • $40 per person
  • $100 for up to 3 participants
  • $150 for up to 5 participants or more
TimeSessionSpeakerAffiliation
9:30 to 10:30 AMRegistration & Networking
10:30 to 11:00 AMWelcome RemarkHeaYeon Lee, Ph.D.CEO, MARA Nanotech; Vice President, KAMDA
Congratulatory RemarkSeongSoo KimConsulate General of the Republic of Korea, New York
Congratulatory RemarkSoonMahn ParkHead of Korea Health Industry Development Institute, Boston Office
Congratulatory RemarkSungWoo BaekDirector, New York Global Business Center, Korea SMEs & Startups Agency
Congratulatory RemarkMyeongSeon KimDirector, Korea Venture Investment Corp., New York office
11:00 to 11:20 AMOpening Plenary: Technology Trends and Market Status of Biosensors in U.S.HeaYeon Lee, Ph.D.CEO, MARA Nanotech; Conference Chair, KAMDA
11:20 AM to 12:00 PMKeynote: Significance of KAMDA Establishment & Success Case in the U.S. Market (AccessBio)YoungHo ChoiChairman, Access Bio; Co-Chair, KAMDA
12:00 to 1:00 PMLunch
1:00 to 1:40 PMSpecial Session I: FDA Trends & Global Regulation InsightsHaja Sittana El Mubarak, Ph.D.Wasela Diagnostics LLC
1:40 to 2:00 PMFDA Approval Strategies and Success CasesByungSik Chang, Ph.D.CEO, Nano-Ditech; Co-Chair, KAMDA
2:00 to 2:20 PMFDA Preparation and Approval Strategy (CRO)JungYoup Han, Ph.D.CSO, Target Health; Treasurer, KAMDA
2:20 to 2:40 PMAppropriate Risk Allocation in the FDA WorldSung ParkReed Smith
2:40 to 2:50 PMCoffee break
2:50 to 3:30 PMSpecial Session II: Understanding the U.S. Healthcare Insurance System (Reimbursement system)MinSoo SeoCEO, Taewoong Medical USA
3:30 to 3:50 PMMarket Entry Strategy for the U.S. (Applications of LDT and CLIA Lab)JungHee Cho, Ph.D.CEO, LabG USA; Executive Secretary, KAMDA
3:50 to 4:10 PMMarket Entry Strategy for the U.S. (Case Studies of U.S. Local Company Acquisitions)Curie ChoiDirector, Immunostics; Operations Committee, KAMDA
4:10 to 4:30 PMUnderstanding IP and ComplianceEunjean JeMorgan, Lewis & Bockius LLP
4:30 to 5:15 PMSponsored Session
5:15 to 5:30 PMCoffee break
5:30 to 6:30 PMPanel: U.S. Market Entry and Medical Device Market StrategyModerator: HeaYeon Lee, Ph.D.Panel: MinSoo Seo, YoungHo Choi, ByungSik Chang, JungHee Cho, JungYoup Han
6:30 to 6:40 PMClosing ceremony
6:40 to 8:30 PMDinner & Networking

Program as published by KAMDA in September 2025.