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Medtech Insight Overview

  • Title
    Medtech Insight 2025
  • Program
    Opening Ceremony, Keynote Speech, In-depth Consultations, Investor Presentation
  • Date
    11(Thu)~12(Fri), September 2025, 09:30~18:00
  • Venue
    Eltower, 5th floor
  • Host
    보건복지부 (Ministry of Health and Welfare)
  • Organizer
    한국보건산업진흥원 (Korea Health Industry Development Institute)

Directions to the Venue

  • Location
    Eltower, 5th floor (213, Gangnam-daero, Seocho-gu, Seoul, Republic of Korea)
  • Subway
    22m from Exit 9 of Yangjae Station on Line 3/Shinbundang Line

Sessions

  • S1 | U.S. Market Access - FDA Approved, Proactive Strategies for U.S. Entry Through Insurance Registration

    • Overview of the U.S. Medical Device Insurance Market
      Sang-Soo Lee
      Sang-Soo Lee
      Medtronic Korea / Senior Director
      닫기
      Sang-Soo Lee
      Sang-Soo Lee
      Medtronic Korea / Senior Director

      Overview of the U.S. Medical Device Insurance Market

      • Curriculum Vitae
        • Education

          2015.03~2017.02, Seoul School of Integrated Sciences & Technologies (aSSIST)
          Ph.D. majored in Business Administration

          2002.03~2004.08, Graduate School of Public Health, Seoul National University
          Diploma majored in Health Economics

          1999.08~2000.08, Helsinki School of Economics and Business Administration
          Master of Business Administration, Outstanding performer

          1991.03~1997.02, Sung Kyun Kwan University
          Bachelor majored in Genetic Engineering

        • Professional Experience

          October 2004 ~ Present, Senior Director, Government Affairs & Market Access, Medtroic Korea
          June 1996 ~ October 2004, Reimbursement Manager, Johnson&Johnson Medical Korea

        • Research Interests

          global strategies for medtech market access
          global health policies
          global health technology assessment
          global health economics analysis
          global reimbursement and payment system

        • Honors & Awards

          Novenber 2019 : Innovative Leader Award, Great Place to Work(GPTW) Institute
          February 2015 : Award of Minister of Health and Welfare, Ministry of Health and Welfare(MoHW)

        • Publications

          [Peer-reviewed Journals]
          “Delayed Patient Access to Innovative Medical Technologies in South Korea: A Lead-Time Analysis of Reimbursement Coverage Determinations”, International Journal of Technology Assessment in Health Care, 2019;35(3):229-236
          “Moon Care and Preliminary Benefit Program in South Korea: Innovative Strategies in Post-Market Evidence Generation for Medical Devices”, J Health Tech Assess, 2018;6(1):33-42.
          Etc.

      • Abstract
        • Overview of the U.S. Insurance Market

          This presentation provides a comprehensive overview of the U.S. health insurance system, distinguishing between public programs (e.g., Medicare, Medicaid) and private coverage (e.g., employer-sponsored and commercial insurance). It will cover the scope of benefits under each insurance type and explain the structure and administration of these programs. Furthermore, the session will explore key payment models in the U.S. healthcare system—including Fee-for-Service, Bundled Payments, and Value-Based Payment—and highlight recent policy trends. The presentation aims to offer practical insights for global healthcare stakeholders by focusing on structural elements that are relevant for comparative analysis with the Korean healthcare system.

    • Introduction to Reimbursement for Medical Technology
      Thomas A. Gustafson
      Thomas A. Gustafson
      Arnold & Porter / Senior Policy Advisor
      닫기
      Thomas A. Gustafson
      Thomas A. Gustafson
      Arnold & Porter / Senior Policy Advisor

      Introduction to Reimbursement for Medical Technology

      • Curriculum Vitae
        • Education

          Ph.D. in Economics, Yale University
          B.A., Williams College

        • Professional Experience

          Arnold & Porter LLP (2008–Present)
          Centers for Medicare and Medicaid Services (CMS) (1985–2007)

        • Research Interests

          Health care payment and coverage policy
          Medicare and Medicaid program design
          Reimbursement systems for medical devices and laboratory services
          Health economics and policy innovation

        • Honors & Awards

          Distinguished Executive Presidential Rank Award (2004)
          Meritorious Executive Presidential Rank Award (2000)

      • Abstract
        • Introduction to Reimbursement for Medical Technology

          In this session, Dr. Thomas Gustafson will discuss what medical device manufacturers need to know about reimbursement when entering the United States’ device market: in short, what is needed for healthcare providers to receive payment for a product, once it has received marketing authorization from the Food and Drug Administration.

          He will address the strategy and timing for seeking coverage of devices under third-party insurance, the tactics manufactures can employ to obtain billing codes, and how payment rates are determined.

          The presentation will focus primarily on Medicare, which is the principal health insurance program for the aged and disabled and which is also the largest and most transparent payer. It will also address how reimbursement differs when dealing with private insurance.

          Brief descriptions will be included of Medicare’s payment systems for services in hospital inpatient and outpatient departments, ambulatory surgical centers, and physicians’ offices, as well as for durable medical equipment for use at home.

    • U.S. Market Entry Methods (Distributors vs. Direct Sales)
      Alexander W. Pastuszak
      Alexander W. Pastuszak
      University of Utah / MD, PhD
      닫기
      Alexander W. Pastuszak
      Alexander W. Pastuszak
      University of Utah / MD, PhD

      U.S. Market Entry Methods (Distributors vs. Direct Sales)

      • Curriculum Vitae
        • Education

          B.S., Yale University
          M.D./Ph.D., University of California, San Francisco (Ph.D. in molecular and cellular biology)
          Residency, Urology — Baylor College of Medicine
          Fellowship, Male Reproductive Medicine & Surgery — Baylor College of Medicine

        • Professional Experience

          Associate Professor of Surgery (Urology) & Chief, Section for Surgical Innovation — University of Utah School of Medicine
          Board-certified urologist specializing in male infertility, erectile dysfunction (ED), hypogonadism, Peyronie’s disease, and sexual dysfunction
          Co-founder & CEO — Paterna Biosciences (in vitro gamete maturation technologies for infertility)
          Former President of Clinical Care & Chief Medical & Scientific Officer — Vault Health (led national clinical practice; diagnostics, clinical research & development)
          Advisor/investor/board member to multiple healthcare and biotech ventures

        • Research Interests

          Genetics of male infertility
          Biological mechanisms of erectile dysfunction
          Pathophysiology of Peyronie’s disease
          Translational sexual medicine and outcomes research
          Innovation in reproductive technologies, including in vitro spermatogenesis

        • Honors & Awards

          Ongoing NIH research funding
          Urology Care Foundation “Rising Stars in Urology” Award
          Invited international speaker and educator in men’s health and urology

        • Publications

          140+ peer-reviewed articles
          Numerous book chapters
          Editor of two textbooks on reproductive and sexual health

      • Abstract
        • Introduction to Reimbursement for Medical Technology

          Alexander W. Pastuszak, MD, PhD, is a board-certified urologist and Associate Professor at the University of Utah, where he serves as Chief of the Section for Surgical Innovation in the Department of Surgery. An internationally recognized leader in men’s reproductive and sexual health, he specializes in male infertility, ED, hypogonadism, and Peyronie’s disease, and leads NIH-funded research in reproductive genetics and sexual medicine.
          He has authored 140+ peer-reviewed papers, multiple book chapters, and two textbooks. Dr. Pastuszak is also a serial entrepreneur having founded or cofounded numerous companies, with several exits. He currently serves as co-founder and CEO of Paterna Biosciences.

    • Cases of Entry into the U.S. Insurance Market
      Minsoo Seo
      Minsoo Seo
      TaeWoong Medical USA / Chief Executive Officer
      닫기
      Minsoo Seo
      Minsoo Seo
      TaeWoong Medical USA / Chief Executive Officer

      Cases of Entry into the U.S. Insurance Market

      • Curriculum Vitae
        • Education

          2008 Samcheok National University 2008 Samcheok National University

        • Professional Experience

          2018.12 - Present : TaeWoong Medical, CA, USA - Chief Executive Officer
          2016.07 – 2018.11 : DWD Medical, CA, USA - Sales & Marketing General Manager
          2012.11 – 2015.07 : Guerbet LLC, CA, USA - Imaging National Manager
          2010-2012 : Guerbet Korea, Seoul - Medical Sales Team
          2008 - 2010 : Taewoong Medical, Ilsan Gyeonggi-do, South Korea - Sales Representative

        • Research Interests

        • Honors & Awards

        • Publications

      • Abstract
        • Cases of Entry into the U.S. Insurance Market

          Centered on the real-life case of Taewoong Medical’s successful entry into the U.S. medical device market, this presentation shares strategies for obtaining reimbursement information, building effective market entry plans, and executing them while gaining insights through trial and error. It also introduces approaches for entering the non-reimbursed market prior to securing insurance coverage, as well as case studies on product adoption among hospitals and healthcare professionals—providing practical guidance for Korean companies seeking entry into the U.S. market.
          - Strategies for obtaining reimbursement information
          - Market entry tactics and implementation process
          - Trial-and-error experiences and key insights

  • S2 | K-MedTech: Practical Open Innovation for Global Expansion

    • Open Innovation Trends Shaping Global Industry
      Roh, Taewoo
      Roh, Taewoo
      School of International Studies, Hanyang University / Associate Professor
      닫기
      Roh, Taewoo
      Roh, Taewoo
      School of International Studies, Hanyang University / Associate Professor

      Open Innovation Trends Shaping Global Industry

      • Curriculum Vitae
        • Education

          B.A. in Business Administration, Korea Aerospace University
          M.A. in International Studies (International Trade), Graduate School of International Studies, Seoul National University
          Ph.D. in Business Administration (Strategy/ International Business), College of Business Administration, Seoul National University

        • Professional Experience

          Associate Professor, School of International Studies, Hanyang University

        • Research Interests

          Nonmarket Strategy, Global Strategy, Open Innovation, Digital Strategy, Institutional Theory

        • Honors & Awards

          2025 The Korean Academic Society of Business Administration, Maeil Business Newspaper Early Career Scholar Paper Award
          2025 Springer Nature Editorial Contribution Award
          2025 Hanyang University Top Researcher Award
          2024 Stanford/Elsevier Top 2% Scientist
          2024 Emerald Literati Awards, Outstanding Reviewer
          2024 Korean Academy of International Business, Best International Paper Award
          2024 Korean Academy of Trade, Early Career Scholar Award
          2023 Korean Academy of Trade, Academic Grand Prize

        • Publications

          Published over 190 papers in prestigious domestic (90+) and international journals (90+)

    • Navigating APAC : Insights for successful commercial partnership
      Jully Kim
      Jully Kim
      Roche Diagnostics APAC / SubChapter Lead of Innovation & Partnering
      닫기
      Jully Kim
      Jully Kim
      Roche Diagnostics APAC / SubChapter Lead of Innovation & Partnering

      Navigating APAC : Insights for successful commercial partnership

      • Curriculum Vitae
        • Education

          Jul.2018 – Dec.2018 | Online MBA_SHAPE, Sogang University, South Korea
          Mar.1990 – Feb.1994 | Bachelor’s degree in Organic Chemistry, MyongJi University, South Korea

        • Professional Experience

          Oct. 2024 – Present | Subchapter Lead of Innovation & Partnering in Roche Diagnostics, APAC
          Nov. 2023 – Sep. 2024 | Head of Strategic Business Development in Roche Diagnostics, Korea (LT member, IWN APAC Ambassador lead)
          Jan.2021 – Oct. 2023 | Head of Pathology Lab in Roche Diagnostics, Korea (LT member, One Roche Ambassador, IWN APAC Ambassador lead)
          Jan.2019 – Dec. 2020 | Marketing director of CPS in Roche Diagnostics, Korea (LT member)
          Mar.2017 – Dec. 2018 | Senior Marketing Manager of CPS in Roche Diagnostics, Korea
          Jan.2016 – Feb.2017 | Medical Value Marketing Manager of CPS in Roche Diagnostics, Korea
          Jan.2013 – Dec.2015 | Medical Marketing Team Leader of CPS in Roche Diagnostics, Korea

      • Abstract
        • I will begin with an introduction to Roche and discuss our current partnership projects across the APAC region.
          Additionally, I will share insights and offer advice to companies interested in collaborating with Roche Diagnostics, highlighting key considerations for successful partnerships.

    • Open Innovation: Strategic Pathways for Global Expansion of Korean Medical Devices
      Lim, Minhyuk
      Lim, Minhyuk
      Korea Medical Devices Industry Association / Managing Director
      닫기
      Lim, Minhyuk
      Lim, Minhyuk
      Korea Medical Devices Industry Association / Managing Director

      Open Innovation: Strategic Pathways for Global Expansion of Korean Medical Devices

      • Curriculum Vitae
    • Medtech Innovator APAC LIVE: Where Medtech Innovation Meets Opportunity
      Fredrik Nyberg
      Fredrik Nyberg
      MTI APAC / Managing Director
      닫기
      Fredrik Nyberg
      Fredrik Nyberg
      MTI APAC / Managing Director

      Medtech Innovator APAC LIVE: Where Medtech Innovation Meets Opportunity

      • Abstract
        • Fredrik is the Managing Director Asia Pacific at MedTech Innovator, the world’s largest accelerator for startups in medical devices, digital health and in vitro diagnostics. He is based in Singapore. Under his leadership, 124 startups have graduated from the accelerator program and gone on to raise well over US$ 200 million in follow-on funding.

          Prior to joining MedTech Innovator, Fredrik was the Founding CEO of Asia Pacific Medical Technology Association (APACMed). He brings over 30 years of healthcare industry experience, 25 of which were spent in Asia-Pacific. He has held senior sales/ marketing, general management and strategic consulting positions. Fredrik serves as Board Member and advisor to several healthcare startup ventures and is a frequent speaker on the healthcare industry in Asia-Pacific. He holds a BSc from Gothenburg University, Sweden, and an MBA from Henley Management College, UK.

    • Panel Discussion: Real Talk with MTI APAC Alumni: Stories of Collaboration and Growth
      [Chairperson] Sung Eun Hwang
      [Chairperson] Sung Eun Hwang
      KHIDI / Director
      닫기
      [Chairperson] Sung Eun Hwang
      [Chairperson] Sung Eun Hwang
      KHIDI / Director

      Panel Discussion: Real Talk with MTI APAC Alumni: Stories of Collaboration and Growth

      • Curriculum Vitae
        • Education

          Graduated from Yonsei University, School of Business, MBA

        • Professional Experience

          2021.9 ~ Director, Department of Medical Device Industry, KHIDI
          2017. 9 - 2021.8 Director General, KHIDI Abu Dhabi, KHIDI
          2016. 2 - 2017.8 Director, Department of Global Healthcare, KHIDI
          2014. 12 - 2016.1 Team Leader, Department of Global Healthcare, KHIDI
          2013. 8 - 2014.12 Team Leader, Department of Medical Device Industry, KHIDI
          2002~2013 Director, Life Care Solution, GE Healthcare

    • [Panel] Fredrik Nyberg
      [Panel] Fredrik Nyberg
      MTI APAC / Managing Director
      닫기
      [Panel] Fredrik Nyberg
      [Panel] Fredrik Nyberg
      MTI APAC / Managing Director

      • Abstract
        • Fredrik is the Managing Director Asia Pacific at MedTech Innovator, the world’s largest accelerator for startups in medical devices, digital health and in vitro diagnostics. He is based in Singapore. Under his leadership, 124 startups have graduated from the accelerator program and gone on to raise well over US$ 200 million in follow-on funding.

          Prior to joining MedTech Innovator, Fredrik was the Founding CEO of Asia Pacific Medical Technology Association (APACMed). He brings over 30 years of healthcare industry experience, 25 of which were spent in Asia-Pacific. He has held senior sales/ marketing, general management and strategic consulting positions. Fredrik serves as Board Member and advisor to several healthcare startup ventures and is a frequent speaker on the healthcare industry in Asia-Pacific. He holds a BSc from Gothenburg University, Sweden, and an MBA from Henley Management College, UK.

    • [Panel] Hyun-Jin Bae
      [Panel] Hyun-Jin Bae
      Promedius / CEO
      닫기
      [Panel] Hyun-Jin Bae
      [Panel] Hyun-Jin Bae
      Promedius / CEO

      • Curriculum Vitae
        • Education

          Ph.D. in Astronomy at Yonsei University
          MSc in Astronomy at Yonsei University
          BSc in Astronomy & Physics at Yonsei Universit

        • Professional Experience

          Post-doc at Asan Medical Center
          Research Fellow at University of Ulsan College of Medicine
          Visiting Scholar at Carnegie Institution for Science

        • Research Interests

          Medical AI

        • Honors & Awards

          National Junior Research Fellow

        • Publications

          M Jang, HJ Bae, Image Turing test and its applications on synthetic chest radiographs by using the progressive growing generative adversarial network, Scientific Reports (2023)
          HY Park, HJ Bae, Realistic high-resolution body computed tomography image synthesis by using progressive growing generative adversarial network: visual turing test, JMIR Medical Informatics (2021)
          M Kim & HJ Bae, Data Augmentation Techniques for Deep Learning-Based Medical Image Analyses, JKSR (2020)

      • Abstract
        • This panel discussion will introduce the MedTech Innovator APAC program and share the experiences and insights gained through participation in the program.

    • [Panel] Mark Chang
      [Panel] Mark Chang
      APrevent Medical Ltd. / COO
      닫기
      [Panel] Mark Chang
      [Panel] Mark Chang
      APrevent Medical Ltd. / COO

    • [Panel] Sanggoo Kang
      [Panel] Sanggoo Kang
      MedySapians / CEO
      닫기
      [Panel] Sanggoo Kang
      [Panel] Sanggoo Kang
      MedySapians / CEO

  • S3 | The Success Conditions of Medical Robots from the Medical Staff's Perspective

    • Medical Robotics: Current Trends and Commercialization Experiences
      Jaesoon Choi
      Jaesoon Choi
      University of Ulsan College of Medicine & Institute of Biomedical Engineering, Asan Medical Center / Professor
      닫기
      Jaesoon Choi
      Jaesoon Choi
      University of Ulsan College of Medicine & Institute of Biomedical Engineering, Asan Medical Center / Professor

      Medical Robotics: Current Trends and Commercialization Experiences

      • Curriculum Vitae
        • Education

          B.S. in Control and Instrumentation Engineering, College of Engineering, Seoul National University
          M.S. in Biomedical Engineering, Graduate School, Seoul National University
          Ph.D. in Biomedical Engineering, Graduate School, Seoul National University

        • Professional Experience

          2016–Present Associate Professor (2016), Professor (2022–present), Department of Biomedical Engineering, University of Ulsan College of Medicine / Institute of Biomedical Engineering, Asan Medical Center
          2012–2016 Associate Research Professor, Institute of Biomedical Engineering, Asan Medical Center, Seoul
          2007–2012 Research Professor, College of Medicine, Korea University

        • Research Interests

          Surgery robot, Intervention robot, Rehabilitation robot, Mechatronics, Simulation, Medical device safety standard

        • Honors & Awards

          2020 Korea’s Top 10 Mechanical Technologies of the Year

      • Abstract
        • Medical Robotics: Current Trends and Commercialization Experiences

          This presentation explores the evolution and emerging future of surgical robotics through the framework of Physical AI. Physical AI marks a significant paradigm shift from traditional industrial robotics, enabling surgical robots to respond to intraoperative variability such as tissue deformation and unexpected events like bleeding. Looking ahead, the field is expected to evolve toward greater levels of supervised autonomy, enhanced human-robot collaboration, miniaturization, and integration of foundation models such as large language and vision-language models. The advancement of digital healthcare—including AI and robotics—should be viewed as an ongoing iterative process of digital transformation.

    • The endoluminal non-invasive surgery robot for kidney stone treatment
      Lee, Dongho
      Lee, Dongho
      ROEN Surgical Inc. / Chief Technology Officer
      닫기
      Lee, Dongho
      Lee, Dongho
      ROEN Surgical Inc. / Chief Technology Officer

      The endoluminal non-invasive surgery robot for kidney stone treatment

      • Curriculum Vitae
        • Education

          2016.09 ~ 2021.08 Ph. D. (in progress) in Robotics Program, Korea Advanced Institute of Science and Technology(KAIST)
          2014.09 ~ 2016.08 M.S in Robotics program, Korea Advanced Institute of Science and Technology(KAIST)

        • Professional Experience

          2024.02 ~ Present Chief Technology Officer(CTO), ROEN Surgical Inc.
          2022.07 ~ 2024.01 Header of the research division, ROEN Surgical Inc.
          2021.04 ~ 2022.06 Senior Researcher, ROEN Surgical Inc.

        • Research Interests

          Medical Robotics, Flexible endoscopic surgical robot, Surgical AI, and Physical AI

        • Honors & Awards

          Best Paper Award, Asian Conference on Computer Aided Surgery 2018, Nov. 2018, China
          Overall Winner & Best Application Award at the Surgical Robot Challenge, Hamlyn Symposium 2018, June, 2018, UK
          Presidential Prize, International Robot Contest 2012, Oct. 2012, Korea

      • Abstract
        • This talk presents how “ZAMENIX” has been developed and commercialized; the endoluminal non-invasive surgery robot for kidney stone treatment. ZAMENIX is for ureter and renal stone removal that is capable of teleoperation of a flexible ureteroscope, a laser fiber, and a stone basket. The surgeon can select whether laser dusting or stone retrieval technique depending on the surgical condition or preference. The system can equip commercial flexible ureteroscopes. The system provides intuitive and comfortable remote manipulation of the ureteroscope and instruments by a single operator without wearing an X-ray protection lead gown. Moreover, the system provides assistive functions for enhanced surgical efficiency and safety. One is an automation capability that can record and replay the ureteroscope motion, making repetitive tasks such as stone retrieval easy and efficient. Another is the detection of oversized stone retrieval to prevent ureteral injury. The other is the respiratory motion compensation which allows precise positioning of the laser while the kidney of the patient is moving by breathing. A first-in-human trial for approval by the Korean Ministry of Food and Drug Safety has finished with a favorable stone-free rate and without any major complications. Further validation is being concentrated to ascertain how much this robotic assistance improves patient treatment outcomes.
          For the commercialization of medical devices, we experienced many challenges such as approval of GMP, and ISO13485, and the product had to go through mechanical/electrical safety tests, electromagnetic compatibility, and biological safety assessments. All development and manufacturing information must be documented to be traceable. Another challenge is we had to acquire the funds to support the organization, R&D, clinical trials, production, and sales. The ultimate challenge was to acquire the reimbursement code from the NECA (National Evidence-based Healthcare Collaborating Agency, Korea)
          The author sincerely wishes my experience can encourage many robotic researchers to dream about their own startup with their research results.

    • Global Case Studies in Surgical Robot Implementation
      Chester Koh
      Chester Koh
      Texas Children’s Hospital; Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC) / Professor; Executive Director
      닫기
      Chester Koh
      Chester Koh
      Texas Children’s Hospital; Southwest-Midwest National Pediatric Device Innovation Consortium (SWPDC) / Professor; Executive Director

      Global Case Studies in Surgical Robot Implementation

      • Abstract
        • Success Factors for Surgical Robots from the Clinician’s Perspective: International Cases

          This presentation will take place during the “Medical Robotics Special Session” at the K-Medtech Insight 2025 event. Dr. Koh will share his insights on robotic platform launches in the U.S.—including experiences with Da Vinci, Hugo, Asensus, and others—that is expected to be highly valuable and engaging for the audience.

    • Introduction of Surgical Robots and the Role of Hospitals
      송상훈
      송상훈
      서울아산병원 교수
      닫기
      송상훈
      송상훈
      서울아산병원 교수

      Introduction of Surgical Robots and the Role of Hospitals

      • Curriculum Vitae
    • Panel Discussion: Clinical Implementation of Surgical Robots — What Determines Success?
      [Chairperson] Yi Seong
      [Chairperson] Yi Seong
      Dept. of Neurosurgery, College of Medicine, Yonsei University / Professor
      닫기
      [Chairperson] Yi Seong
      [Chairperson] Yi Seong
      Dept. of Neurosurgery, College of Medicine, Yonsei University / Professor

      Panel Discussion: Clinical Implementation of Surgical Robots — What Determines Success?

      • Curriculum Vitae
        • Education

          1996: Bachelor of Medicine, College of Medicine, Yonsei University
          2003: Master of Medicine, Graduate School, Yonsei University
          2008: Doctor of Medicine (Ph.D.), Graduate School, Yonsei University

        • Professional Experience

          Director, Korea Medical Robot Center
          Chairperson, Robotic Surgery Committee, Korean Spinal Neurosurgery Society
          Executive Board Member, Asia Pacific Cervical Spine Society (APCSS)
          Executive Board Member & Secretary General (2024), Korean Minimally Invasive Spine Surgery Society
          2nd President, Korea Unilateral Biportal Endoscope (UBE) Society
          Chair of Scientific Committee, ISASS Asia Pacific 2023
          Chair of Scientific Committee, KOSASS

        • Research Interests

          Spine surgery
          Robot development and innovation in Spine Surgery
          Cervical artificial disc & device development
          Minimally invasive spinal surgery (MIS)
          Endoscopic spine surgery
          MIS lumbar & thoracic fusion
          Robotic spinal surgery (in the pioneer days)
          Spinal cord tumor, Intramedullary
          Brain and cognitive engineering
          Neural prosthesis
          Brain computer interface
          Radiosurgery of brain and spine, Cyberknife

        • Honors & Awards

          2006. Best Paper (Uh Jeong Hyun) Award, The Korean Neurosurgical Society.
          2007. Best Research Paper (Lami) Award, The Korean Spinal Neurosurgery Society.
          2022. Ministerial Citation, Ministry of Health and Welfare.

    • [Panel] Jaesoon Choi
      [Panel] Jaesoon Choi
      University of Ulsan College of Medicine & Institute of Biomedical Engineering, Asan Medical Center / Professor
      닫기
      [Panel] Jaesoon Choi
      [Panel] Jaesoon Choi
      University of Ulsan College of Medicine & Institute of Biomedical Engineering, Asan Medical Center / Professor

      • Curriculum Vitae
        • Education

          B.S. in Control and Instrumentation Engineering, College of Engineering, Seoul National University
          M.S. in Biomedical Engineering, Graduate School, Seoul National University
          Ph.D. in Biomedical Engineering, Graduate School, Seoul National University

        • Professional Experience

          2016–Present Associate Professor (2016), Professor (2022–present), Department of Biomedical Engineering, University of Ulsan College of Medicine / Institute of Biomedical Engineering, Asan Medical Center
          2012–2016 Associate Research Professor, Institute of Biomedical Engineering, Asan Medical Center, Seoul
          2007–2012 Research Professor, College of Medicine, Korea University

        • Research Interests

          Surgery robot, Intervention robot, Rehabilitation robot, Mechatronics, Simulation, Medical device safety standard

        • Honors & Awards

          2020 Korea’s Top 10 Mechanical Technologies of the Year

      • Abstract
        • Medical Robotics: Current Trends and Commercialization Experiences

          This presentation explores the evolution and emerging future of surgical robotics through the framework of Physical AI. Physical AI marks a significant paradigm shift from traditional industrial robotics, enabling surgical robots to respond to intraoperative variability such as tissue deformation and unexpected events like bleeding. Looking ahead, the field is expected to evolve toward greater levels of supervised autonomy, enhanced human-robot collaboration, miniaturization, and integration of foundation models such as large language and vision-language models. The advancement of digital healthcare—including AI and robotics—should be viewed as an ongoing iterative process of digital transformation.

    • [Panel] Lee, Dongho
      [Panel] Lee, Dongho
      ROEN Surgical Inc. / Chief Technology Officer
      닫기
      [Panel] Lee, Dongho
      [Panel] Lee, Dongho
      ROEN Surgical Inc. / Chief Technology Officer

      • Curriculum Vitae
        • Education

          2016.09 ~ 2021.08 Ph. D. (in progress) in Robotics Program, Korea Advanced Institute of Science and Technology(KAIST)
          2014.09 ~ 2016.08 M.S in Robotics program, Korea Advanced Institute of Science and Technology(KAIST)

        • Professional Experience

          2024.02 ~ Present Chief Technology Officer(CTO), ROEN Surgical Inc.
          2022.07 ~ 2024.01 Header of the research division, ROEN Surgical Inc.
          2021.04 ~ 2022.06 Senior Researcher, ROEN Surgical Inc.

        • Research Interests

          Medical Robotics, Flexible endoscopic surgical robot, Surgical AI, and Physical AI

        • Honors & Awards

          Best Paper Award, Asian Conference on Computer Aided Surgery 2018, Nov. 2018, China
          Overall Winner & Best Application Award at the Surgical Robot Challenge, Hamlyn Symposium 2018, June, 2018, UK
          Presidential Prize, International Robot Contest 2012, Oct. 2012, Korea

      • Abstract
        • This talk presents how “ZAMENIX” has been developed and commercialized; the endoluminal non-invasive surgery robot for kidney stone treatment. ZAMENIX is for ureter and renal stone removal that is capable of teleoperation of a flexible ureteroscope, a laser fiber, and a stone basket. The surgeon can select whether laser dusting or stone retrieval technique depending on the surgical condition or preference. The system can equip commercial flexible ureteroscopes. The system provides intuitive and comfortable remote manipulation of the ureteroscope and instruments by a single operator without wearing an X-ray protection lead gown. Moreover, the system provides assistive functions for enhanced surgical efficiency and safety. One is an automation capability that can record and replay the ureteroscope motion, making repetitive tasks such as stone retrieval easy and efficient. Another is the detection of oversized stone retrieval to prevent ureteral injury. The other is the respiratory motion compensation which allows precise positioning of the laser while the kidney of the patient is moving by breathing. A first-in-human trial for approval by the Korean Ministry of Food and Drug Safety has finished with a favorable stone-free rate and without any major complications. Further validation is being concentrated to ascertain how much this robotic assistance improves patient treatment outcomes.
          For the commercialization of medical devices, we experienced many challenges such as approval of GMP, and ISO13485, and the product had to go through mechanical/electrical safety tests, electromagnetic compatibility, and biological safety assessments. All development and manufacturing information must be documented to be traceable. Another challenge is we had to acquire the funds to support the organization, R&D, clinical trials, production, and sales. The ultimate challenge was to acquire the reimbursement code from the NECA (National Evidence-based Healthcare Collaborating Agency, Korea)
          The author sincerely wishes my experience can encourage many robotic researchers to dream about their own startup with their research results.

    • [Panel] 송상훈
      [Panel] 송상훈
      서울아산병원 교수
      닫기
      [Panel] 송상훈
      [Panel] 송상훈
      서울아산병원 교수

      • Curriculum Vitae
    • [Panel] Jongyun Won
      [Panel] Jongyun Won
      College of Medicine, Yonsei University / Professor
      닫기
      [Panel] Jongyun Won
      [Panel] Jongyun Won
      College of Medicine, Yonsei University / Professor

      • Curriculum Vitae
        • Education

          Feb, 1991 Yonsei University College of Medicine (M.D.)
          Feb, 2006 Ph.D. of Medicine, Graduate school, Yonsei University College of medicine

        • Professional Experience

          Radiologist (Interventional Radiology)
          Currently Professor of Radiology Yonsei University College of Medicine, Seoul, Korea

        • Research Interests

          Vascular intervention
          Robotic intervention

        • Honors & Awards

          Journal of vascular intervention – Best original research 2023 : Robot assisted Hepatic artery embolization

        • Publications

          Robot-Assisted Transarterial Chemoembolization of Hepatocellular Carcinoma Using a Coaxial
          Microcatheter Driving Controlle-Responder Robot System: Clinical Pilot Study. JVIR 2023 etc..

  • S4 | Optimal Strategy for China NMPA Registration and Clinical Trial Response Plan

    • Establishing Optimal Strategies for Medical Device Registration in China
      Yolanda(颜佳靓)
      Yolanda(颜佳靓)
      Medical Devices Department, CIRS Group / BD Manager
      닫기
      Yolanda(颜佳靓)
      Yolanda(颜佳靓)
      Medical Devices Department, CIRS Group / BD Manager

      Establishing Optimal Strategies for Medical Device Registration in China

      • Curriculum Vitae
        • Education

          Telecom Ecole de Management(Institut Mines Telecom Business School)
          Master Degree, Major in IMS

        • Professional Experience

          2019 – Present CIRS Group BD Manager of Medical Device Division

        • Research Interests

          Optimization of Medical Device Registration Strategy

      • Abstract
        • Establishing Optimal Strategies for Medical Device Registration in China

          Having worked in the medical device industry for 6 years, familiar with medical device registration, clinical evaluation, clinical trials, and quality management systems. skilled at designing appropriate registration and clinical evaluation paths for domestic and imported medical devices.

    • Clinical Evaluation Pathways for Medical Devices in China: Strategic Response Plan for Devices Requiring Non-Exempt Trials
      Cindy Fu(傅赛珍)
      Cindy Fu(傅赛珍)
      Medical Devices Department, CIRS Group / ViceGeneral Manager
      닫기
      Cindy Fu(傅赛珍)
      Cindy Fu(傅赛珍)
      Medical Devices Department, CIRS Group / ViceGeneral Manager

      Clinical Evaluation Pathways for Medical Devices in China: Strategic Response Plan for Devices Requiring Non-Exempt Trials

      • Curriculum Vitae
        • Education

          Zhejiang University of Technology
          Master Degree, Major in Mechanical Design and Theory

        • Professional Experience

          2009.10.15~2011.12.31 Hangzhou foresee Biotechnology Co., Ltd
          2012.1.1~2013.6.30 ACCB Biotechnology Co., Ltd. (Beijing, Jiaxing)
          2013.9.9~now Hangzhou CIRS Technology Group Co., Ltd

        • Research Interests

          Medical Device and In Vitro Diagnostic Reagent Regulatory Tracking
          NMPA registration for medical devices and in vitro diagnostic reagents
          Clinical trials of medical devices and in vitro diagnostic reagents
          Clinical evaluation of medical devices and in vitro diagnostic reagents
          Establishment of Quality Management System for Medical Devices and In Vitro Diagnostic Reagents

        • Honors & Awards

          Chinese toxicologist
          Medical device registration engineer
          QMS Internal Auditor

      • Abstract
        • Clinical Evaluation Pathways for Medical Devices in China: Strategic Response Plan for Devices Requiring Non-Exempt Trials

          Graduated with a Master's degree in Mechanical Design and Theory from Zhejiang University of Technology in 2009. A nationally certified medical device registered engineer, a medical device quality system auditor, a Chinese toxicologist, and a cooperative expert of the China Medical Device Industry Association. Provide at least 5 on-site and online training sessions per year. Have rich experience in technology research and development, production, quality management system, clinical trials, and product registration in the field of medical devices and in vitro diagnostic reagents. Over the past 16 years, has obtained more than 600 registration certificates for over 100 enterprises and completed over 40 clinical trial projects.

  • S6 | CE MDR : A General Overview with NB Perspective

  • S7 | Comprehensive Briefing on the Entire Lifecycle of Medical Devices

    • Introduction to the Medical Device Industry Support Center
      Jung, Taeyoung
      Jung, Taeyoung
      Korea Health Industry Development Institute(KHIDI) / Principal Researcher
      닫기
      Jung, Taeyoung
      Jung, Taeyoung
      Korea Health Industry Development Institute(KHIDI) / Principal Researcher

      Introduction to the Medical Device Industry Support Center

      • Curriculum Vitae
        • Education

          Master’s Degree in International Relations, Hankuk University of Foreign Studies
          Bachelor’s Degree in International Trade, Hankuk University of Foreign Studies

        • Professional Experience

          Principal Researcher, Department of Medical Device and Cosmetics Industry, Korea Health Industry Development Institute (KHIDI)

      • Abstract
        • Introduction to the Medical Device Industry Support Center

    • Medical Device Approval Process in Korea
      Kim, Sejung
      Kim, Sejung
      Ministry of Food and Drug Safety(MFDS) / Deputy Director
      닫기
      Kim, Sejung
      Kim, Sejung
      Ministry of Food and Drug Safety(MFDS) / Deputy Director

      Medical Device Approval Process in Korea

    • Health Insurance Listing Procedure (Medical Practice)
      Lee, Yujin
      Lee, Yujin
      Health Insurance Review & Assessment Service(HIRA) / Head of Medical Practice Listing Division
      닫기
      Lee, Yujin
      Lee, Yujin
      Health Insurance Review & Assessment Service(HIRA) / Head of Medical Practice Listing Division

      Health Insurance Listing Procedure (Medical Practice)

    • Medical Device Approval Process in Korea (Medical Supplies)
      Um, Hyunsin
      Um, Hyunsin
      Health Insurance Review & Assessment Service(HIRA) / Head of Medical Supply Benefits Listing Division
      닫기
      Um, Hyunsin
      Um, Hyunsin
      Health Insurance Review & Assessment Service(HIRA) / Head of Medical Supply Benefits Listing Division

      Medical Device Approval Process in Korea (Medical Supplies)

    • New Health Technology Assessment Procedure
      Choi, Wonjung
      Choi, Wonjung
      National Evidence-based Healthcare Collaborating Agency(NECA) / Project Manager
      닫기
      Choi, Wonjung
      Choi, Wonjung
      National Evidence-based Healthcare Collaborating Agency(NECA) / Project Manager

      New Health Technology Assessment Procedure

      • Curriculum Vitae
        • Education

          Ph.D. in Public Health

        • Professional Experience

          Health Insurance Review & Assessment Service(HIRA) (2006–2010)
          National Evidence-based Healthcare Collaborating Agency(NECA) (2010–Present)

        • Research Interests

          Health Policy

      • Abstract
        • New Health Technology Assessment Procedure

    • Regulatory Strategies for Major Export Markets Including the United States and Europe
      Jung, Kyungho
      Jung, Kyungho
      Korea Testing & Research Institute(KTR) / Director of Electrical & Medical Device Evaluation Center
      닫기
      Jung, Kyungho
      Jung, Kyungho
      Korea Testing & Research Institute(KTR) / Director of Electrical & Medical Device Evaluation Center

      Regulatory Strategies for Major Export Markets Including the United States and Europe

      • Curriculum Vitae
        • Education

          Ph.D. in Engineering

        • Professional Experience

          Former Chief Researcher at LG Electronics
          Former Reviewer for the Institution of Engineering and Technology (IET)
          Current a Director at Korea Testing & Research Institute (KTR)
          Current Evaluation Committee Member for New Excellent Technology (NET) Certification, Ministry of Trade, Industry and Energy (MOTIE), Korea

        • Research Interests

          Digital medical devices, Domestic and International Regulatory Approval for Medical Devices

        • Honors & Awards

          Commendation from the Minister of Trade, Industry and Energy (Trade Day)

      • Abstract
        • Explanation of the Ministry of Health and Welfare’s “International Certification Support Program for Medical Devices” and Strategic Responses Based on Regulatory Analysis of Export Markets such as CE MDR in Europe and FDA in the United States

    • Presentation on Successful Market Entry Cases Utilizing Consultations from the Medical Device Industry Support Center
      Ryoo, Eunju
      Ryoo, Eunju
      BiLab / Executive Director
      닫기
      Ryoo, Eunju
      Ryoo, Eunju
      BiLab / Executive Director

      Presentation on Successful Market Entry Cases Utilizing Consultations from the Medical Device Industry Support Center

      • Curriculum Vitae
        • Education

          Bachelor’s Degree in Public Administration, Kyungpook National University

        • Professional Experience

          Research Affairs Office, POSTECH (Nov. 2005 – Sep. 2020)
          BiLab (Sep. 2020 – Present)

      • Abstract
        • BiLab is a company that develops and manufactures cardiopulmonary monitoring devices based on Electrical Impedance Tomography (EIT). We aim to introduce products that are not yet available in the market. In this presentation, we would like to share how we utilized the Medical Device Industry Support Center to overcome challenges related to market entry, and the positive outcomes we achieved through this collaboration.

    • Case Study: Entering the Innovative Medical Device Market through Commercialization of Novel Medical Technologies
      Inchul Yang
      Inchul Yang
      Solmedix Co., Ltd / CEO
      닫기
      Inchul Yang
      Inchul Yang
      Solmedix Co., Ltd / CEO

      Case Study: Entering the Innovative Medical Device Market through Commercialization of Novel Medical Technologies

      • Curriculum Vitae
        • Education

          Dept. of Medical Biotechnology, Dongguk Univ. (Ph.D Completion)
          Dept. of Advance Technology Fusion,Konkuk Univ. (M.S.)
          Dept. of Biomedcial Eng., Konkuk Univ. (B.S.)

        • Professional Experience

          Adjunct Professor, Department of Medical Device Industry, Dongguk Universirty, Korea
          Founder, CEO, Solmedix Co., Ltd, Korea
          Visiting Scholar, Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA

        • Research Interests

          Minimal Invasive Medical Device
          Bio-convergence Implantable Medical Device
          Medical Device Open Innovation Business Model

        • Honors & Awards

          Minister of SMEs and Startups, Commendation, 2022 (Venture Entrepreneurship Promotion)
          Minister of Health and Welfare, Commendation, 2022 (Technical Commercialization Merit)

        • Publications

          Inchul Yang, Suryeon Kim, Hochul Kang, Hyegyeong Lee, Jiyean Kwon, Sungmin Kim, “ A Study on Evaluation of Bioabsorbable Anchor (PLGA+ β-TCP) Through Mechanical Test Under Moisture Difference”, Journal of Medical Devices, Vol. 10, September2016, pp. 030962-1-2.
          Kwonsoo Chun, Inchul Yang, Namhoon Kim, Dosang Cho, “Effect of Device Rigidity and Physiological Loading on Spinal Kinematics after Dynamic Stabilization : An In-Vitro Biomechanical Study”, J Korean Neurosurg Soc, 58(5), 2015, pp.412-418

      • Abstract
        • Case Study: Entering the Innovative Medical Device Market through Commercialization of Novel Medical Technologies

          Technology commercialization process based on ideas from clinical settings
          Product development experience of an innovative medical device for percutaneous vocal cord injection through hospital technology adoption
          Open innovation model for medical device technology commercialization

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