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

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

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

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)

[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.

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.

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

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

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

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

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.

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

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

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

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

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

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.

2008 Samcheok National University 2008 Samcheok National University

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

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

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

Associate Professor, School of International Studies, Hanyang University

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

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

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

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

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

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.

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.

Graduated from Yonsei University, School of Business, MBA

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

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.

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

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

Medical AI

National Junior Research Fellow

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)

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

PhD in Mechanical Engineering from the University of Michigan – Ann Arbor

2015– present Co-Founder, COO and CTO at APrevent
2009 – 2015 Senior Engineer at Talas Engineering (San Francisco Bay Area)

Biomechanics, material properties, machine learning

2024 Medtech Innovator APAC Grand Prize
2022 Qualcomm Innovate in Taiwan Challenge (QITC) Winner
2009 John Paul Stapp Best Paper Award
2008 Stapp Student Paper Award

1. Misbullah, A., Yeh, H.W., Chang, C.Y. “Dysarthric Speech Recognition System with Life-Long Learning Technique in Taiwan Mandarin,” Data Science and Artificial Intelligence, 2024
2. Lin, Y.Y., Zheng, W.Z., Chu, W.C., Han, J.Y., Huang, Y.H., Ho, G.M., Chang, C.Y., Lai, Y.H. “A Speech Command Control-Based Recognition System for Dysarthric Patients Based on Deep Learning Technology,” Applied Sciences, 11, 2477, 2021
3. Hsiao, C.J., Han, J.Y., Zheng, W.Z., Ho, G.M., Chang, C.Y., Lai, Y.H. “Performance Enhancement of a Pathological Voice Quality Evaluation System Using a Self-Attention Model,” 43rd Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2021
4. Misbullah, A., Lin, H.H., Chang, C.Y., Yeh, H.W., Weng, K.C. “Improving Acoustic Models for Dysarthric Speech Recognition using Time Delay Neural Networks,” 2020 ICELTIC
5. Chang, C.Y., Desautels, D.M., White, K., Serina, E.R. “Lumbar Loads while Operating Vehicles in an Industrial Environment,” 7th World Congress of Biomechanics, Boston, MA, July 2014.
6. Chang, C.Y., Serina, E.R., “Industrial Helmet Effectiveness in Mitigating Head Accelerations in Impacts with Rigid Surfaces,” 7th World Congress of Biomechanics, Boston, MA, July 2014.
7. Chang, C.Y., Rupp, J.D., Reed, M.P., Ashton-Miller, J.A., Hughes, R.E., Kikuchi, N., Schneider, L.W. (2009) Prediction of the Effects of Lower-Extremity Muscle Forces on Knee, Thigh, and Hip Injuries in Frontal Motor Vehicle Crashes. Stapp Car Crash Journal 53.
8. Hu, J., Rupp, J.D., Lamb, T., Chang, C.Y., Schneider, L.W. (2009) Finite Element Investigation of Effects from Muscle Tension, Preimpact Posture, Seat position, and Torso Restraint on the Risk of Knee-Thigh-Hip Injuries in Frontal Crashes.
9. Chang, C.Y., Rupp, J.D., Kikuchi, N., Schneider, L.W. (2008) Development of a finite element model to stud the effects of muscle forces on knee-thigh-hip injuries in frontal crashes. Stapp Car Crash Journal 52: pp. 475-504.
10. Liu, D.S., Chang, C.Y., Fan, C.M., Hsu, S.L. (2003). Influence of environmental factors on energy absorption degradation of polystyrene foam in protective helmets. Engineering Failure Analysis 10, pp.581-591.
11. Computational Injury Biomechanics. Invited Presentation. UMTRI student seminar, July 2008.
12. Development of a lower-extremity finite element model to study the effects of muscle forces on knee-thigh-hip injuries in frontal crashes. 2006 Injury Biomechanics Symposium, Columbus OH, May 2007.

Mark Chang is an entrepreneur and engineering problem solver. He likes science and technology and is constantly on the hunt for new challenges and opportunities to make an impact. Mark is the Co-Founder and Chief Operation Officer and Chief Technical Officer of APrevent. Their mission is to offering the most advanced technologies for individuals with voice and speech disorders, with the goal of dramatically improving their quality of life.
Mark went to graduate school at the University of Michigan in Ann Arbor and earned his PhD degree in Mechanical Engineering. He was an engineering consultant at San Francisco Bay Area for 6 years before starting APrevent.

1987~1991 Electrical Engineering BS degree from Seoul National University
1997~1999 MBA from Fuqua School of Business at Duke University

1994~1997 LG U+ (formerly known as DACOM)
1998 JP Morgan
1999~2002 Nortel Networks
2004~2007 Samsung USA
2007~2009 Toshiba America
2010~2013 3M
2014~2017 JS Link (formerly known as DNA Link)
2017~ CEO of MedySapiens, Inc.
2024~ Adjunct Professor of PharmMBA, Dongguk University

Biomedical, Digital Healthcare, AI

2023 Ministry of SME (Small and Medium Enterprises) and Startups award
Fortune Korea’s top 40 Innovation 2025
Forbes Asia 100 to Wach companies

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

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

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

2020 Korea’s Top 10 Mechanical Technologies of the Year

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.

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)

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.

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

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

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.

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.

1997-2003 Seoul National University College of Medicine, Seoul, Korea MD (Medical Doctor)
2005-2007 Graduate School, Seoul National University College of Medicine, Seoul, Korea MS (Master of Science)
2011-2015 Graduate School, Seoul National University College of Medicine, Seoul, Korea Ph.D. (Doctor of Philosophy)

2011-2012 Instructor, Department of Urology Seoul National University Hospital, Seoul, Korea
2012-2013 Instructor, Department of Urology Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2013-2017 Clinical Assistant Professor, Department of Urology Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2018-2023 Associate Professor, Department of Urology Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2021-Present Deputy Director, Office for Scientific Planning & Coordination, Asan Institute for Life Sciences, Asan Medical Center

Pediatric Urology
Robot-assisted & Minimally Invasive Surgery
Congenital Urologic Anomalies & Reconstruction
Ultrasound, AI-based Diagnostics in Urology

2015.11.10 Best Video Award, The Korean Urological Association Annual Meeting 2015
2017.05.28 Award of Excellence, The Korean Society for Urological Ultrasonography 2017
2017.09.28 Best Research Award, The Korean Urological Association Annual Meeting 2017
2018.04.07 Best Research Award (Ferring Award), The Korean Society of Pediatric Urology 2018
2018.10.04 Best Poster, The 38th Congress of the Societe Internationale d’Urologie (SIU 2018)
2021.04.17 Best Research Paper Award, The Korean Society of Pediatric Urology 2021
2021.10.08 Best Video Award, 2nd place, Pediatrics & Benign Disease, the 1st KSER Robotic Uroilogic Surgical Video Congress
2021.11.05 Best Abstract Presentation Award, The Korean Urological Association Annual Meeting 2021
2022.04.02 Best Research Award (Ferring Award), The Korean Society of Pediatric Urology 2022
2022.05.29 Research Grant Award, The Korean Society for Urological Ultrasonography 2022
2022.10.22 Best Presentation Award (Diamond Prize), The 22nd Annual Congress of Asia-Pacific Association of Pediatric Urologists (APAPU 2022)
2023.04.08 Best Research Award (Yunulro Award), The Korean Society of Pediatric Urology 2023

Book Chapter
1) Surgical Techniques in Pediatric and Adolescent Urology, Chapter 59: Ureterocele Incision, Jaypee Brothers Medical Publishers, The Health Sciences Publisher, New Delhi/London, ISBN: 978-93-5270-204-6
2) 비뇨의학 제 6판, 성분화이상, Chapter 35, 대한비뇨의학회, 일조각, ISBN: 978-89-337-0764-7 93510

Corresponding anthor
Song SH 외. Long-term Outcomes of Endoscopic Anti-reflux Surgery in Pediatric Patients with Vesicoureteral Reflux. J Korean Med Sci. 2018.
Han JH, Song SH 외. Best ultrasound parameter for prediction of adverse renal function outcome after pyeloplasty. Int J Urol. 2020.
Song SH 외. Preoperative Bladder Bowel Dysfunction... after Robot Assisted Laparoscopic Ureteral Reimplantation. J Endourol. 2021.
Song SH 외. Deep-learning segmentation of ultrasound images... hydronephrosis. Investig Clin Urol. 2022.
Kim YI, Song SH 외. Deep-Learning Segmentation of Urinary Stones... J Endourol. 2023. Song SH 외. Mesenchymal stem cells with an enhanced antioxidant capacity... Clin Transl Med. 2024.
Kim DS, Song SH 외. Transurethral resection of an uncommon Brunn's cyst... Urology Journal. 2024.

Etc
2009-present Member, Korean Urological Association
2012-present Member, Korean Society of Pediatric Urology
2015-2018 Committee member, Korean Urological Association
2015-2018 Committee member, Korean Society of Pediatric Urology 2021-present Committee member, Korean Urological Association
2021-2023 Secretary-General, Korean Society of Pediatric Urology
2021-2023 Executive Director of Academic Committee, Korean Children’s Continence and Enuresis Society
2021-present Committee member, The Korean Prostate Society
2021-2023 Committee member, The Korean Society for Urological Ultrasonography 2021-present Committee member, The Korean Society of Endourology and Robotics
2023-present Deputy Secretary-General, Korean Urological Association
2023-present Executive Director of Partnership Development Committee, Korean Society of Pediatric Urology
2023-present Executive Director of Partnership Development Committee, Korean Children’s Continence and Enuresis Society

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

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

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

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.

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

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

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

2020 Korea’s Top 10 Mechanical Technologies of the Year

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.

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)

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.

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

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

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.

1997-2003 Seoul National University College of Medicine, Seoul, Korea MD (Medical Doctor)
2005-2007 Graduate School, Seoul National University College of Medicine, Seoul, Korea MS (Master of Science)
2011-2015 Graduate School, Seoul National University College of Medicine, Seoul, Korea Ph.D. (Doctor of Philosophy)

2011-2012 Instructor, Department of Urology Seoul National University Hospital, Seoul, Korea
2012-2013 Instructor, Department of Urology Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2013-2017 Clinical Assistant Professor, Department of Urology Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2018-2023 Associate Professor, Department of Urology Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
2021-Present Deputy Director, Office for Scientific Planning & Coordination, Asan Institute for Life Sciences, Asan Medical Center

Pediatric Urology
Robot-assisted & Minimally Invasive Surgery
Congenital Urologic Anomalies & Reconstruction
Ultrasound, AI-based Diagnostics in Urology

2015.11.10 Best Video Award, The Korean Urological Association Annual Meeting 2015
2017.05.28 Award of Excellence, The Korean Society for Urological Ultrasonography 2017
2017.09.28 Best Research Award, The Korean Urological Association Annual Meeting 2017
2018.04.07 Best Research Award (Ferring Award), The Korean Society of Pediatric Urology 2018
2018.10.04 Best Poster, The 38th Congress of the Societe Internationale d’Urologie (SIU 2018)
2021.04.17 Best Research Paper Award, The Korean Society of Pediatric Urology 2021
2021.10.08 Best Video Award, 2nd place, Pediatrics & Benign Disease, the 1st KSER Robotic Uroilogic Surgical Video Congress
2021.11.05 Best Abstract Presentation Award, The Korean Urological Association Annual Meeting 2021
2022.04.02 Best Research Award (Ferring Award), The Korean Society of Pediatric Urology 2022
2022.05.29 Research Grant Award, The Korean Society for Urological Ultrasonography 2022
2022.10.22 Best Presentation Award (Diamond Prize), The 22nd Annual Congress of Asia-Pacific Association of Pediatric Urologists (APAPU 2022)
2023.04.08 Best Research Award (Yunulro Award), The Korean Society of Pediatric Urology 2023

Book Chapter
1) Surgical Techniques in Pediatric and Adolescent Urology, Chapter 59: Ureterocele Incision, Jaypee Brothers Medical Publishers, The Health Sciences Publisher, New Delhi/London, ISBN: 978-93-5270-204-6
2) 비뇨의학 제 6판, 성분화이상, Chapter 35, 대한비뇨의학회, 일조각, ISBN: 978-89-337-0764-7 93510

Corresponding anthor
Song SH 외. Long-term Outcomes of Endoscopic Anti-reflux Surgery in Pediatric Patients with Vesicoureteral Reflux. J Korean Med Sci. 2018.
Han JH, Song SH 외. Best ultrasound parameter for prediction of adverse renal function outcome after pyeloplasty. Int J Urol. 2020.
Song SH 외. Preoperative Bladder Bowel Dysfunction... after Robot Assisted Laparoscopic Ureteral Reimplantation. J Endourol. 2021.
Song SH 외. Deep-learning segmentation of ultrasound images... hydronephrosis. Investig Clin Urol. 2022.
Kim YI, Song SH 외. Deep-Learning Segmentation of Urinary Stones... J Endourol. 2023. Song SH 외. Mesenchymal stem cells with an enhanced antioxidant capacity... Clin Transl Med. 2024.
Kim DS, Song SH 외. Transurethral resection of an uncommon Brunn's cyst... Urology Journal. 2024.

Etc
2009-present Member, Korean Urological Association
2012-present Member, Korean Society of Pediatric Urology
2015-2018 Committee member, Korean Urological Association
2015-2018 Committee member, Korean Society of Pediatric Urology 2021-present Committee member, Korean Urological Association
2021-2023 Secretary-General, Korean Society of Pediatric Urology
2021-2023 Executive Director of Academic Committee, Korean Children’s Continence and Enuresis Society
2021-present Committee member, The Korean Prostate Society
2021-2023 Committee member, The Korean Society for Urological Ultrasonography 2021-present Committee member, The Korean Society of Endourology and Robotics
2023-present Deputy Secretary-General, Korean Urological Association
2023-present Executive Director of Partnership Development Committee, Korean Society of Pediatric Urology
2023-present Executive Director of Partnership Development Committee, Korean Children’s Continence and Enuresis Society

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

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

Vascular intervention
Robotic intervention

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

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

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

2019 – Present CIRS Group BD Manager of Medical Device Division

Optimization of Medical Device Registration Strategy

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.

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

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

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

Chinese toxicologist
Medical device registration engineer
QMS Internal Auditor

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.

Mar. 1991 – Feb. 1995: B.S. in Industrial Engineering, College of Engineering, Seoul National University
Mar. 1995 – Feb. 1997: M.S. in Industrial Engineering, College of Engineering, Seoul National University
Aug. 2004 – Feb. 2008: Ph.D. in Industrial Engineering, College of Engineering, Seoul National University

Aug. 2004 – Sept. 2008: Researcher/Adjunct Research Professor, Radiology Research Institute, Ulsan University College of Medicine
Sept. 2008 – Oct. 2009: Post-doctoral Research Fellow, University of Utah
Apr. 2010 – Feb. 2014: Assistant Professor, Department of Radiology, Ulsan University College of Medicine/Asan Medical Center
Mar. 2014 – Present: Associate/Concurrent/Full Professor, Convergence & Radiology, Ulsan University College of Medicine/Asan Medical Center

Dedicated to translational convergence research using medical AI, 3D printing, and robotics. Collaborates with various clinical departments such as radiology, pathology, pulmonology, gastroenterology, anesthesiology, (pediatric) intensive care, emergency medicine, oncology, surgery, otolaryngology, and dentistry for research on various diseases.

2024 - Minister of Science and ICT Commendation
2023 - 21st Pfizer Medical Award (Translational Medicine)
2023 - President of the Korean Academy of Medical Sciences Award (Korean Society of Medical AI)
2021 - Minister of Health and Welfare Award
2021 - Commissioner of the Korea Food and Drug Administration Award
2020 - Professor of the Year (Research Category, Ulsan University College of Medicine
2017 - Presidential Commendation

Approximately 10,000 citations over the past five years, with an h-index of 47 and i10-index of 248 (as of July 2025, Google Scholar), and 17 papers published in high-impact journals (IF > 10, HanbitSa).

B.S. in Materials Science and Engineering, Kangwon National University
M.S. in Materials Science and Engineering, Sungkyunkwan University
Ph.D. in Biological and Chemical Engineering, Korea Advanced Institute of Science and Technology (KAIST)

Korea National Institute of Health (Nov. 2019 – Aug. 2020)
Korea Health Industry Development Institute (Aug. 2020 – Present)

Operation of the Designation System for Innovative Medical Devices (General & Integrated) (Aug. 2020 – Jul. 2025)
Support for Global Market Entry of Medical Devices (from Jul. 2025 onward)

Commendation from the Minister of Health and Welfare (2022)

KAIST Industrial and Systems Enginneering B.S. / M.A. / Ph.D.

Lunit Co-founder

Artificial Intelligence

1992 – 1998 MD, Seoul National University Medical College
2006 – 2008 PhD, Seoul National University Medical College

2021 – 2022 AI Program Committee Chair, Asian Oceanian Congress of Radiology 2022
2023 – 2024 Secretary General, Korean Society of Thoracic Radiology
2021 – Present Secretary of clinical research, Korean Society of Radiology
2023 – Present Active member of Fleischner Society
2025 – Present President, Korean Society of Artificial Intelligence in Medicine

1. Radiology artificial intelligence (AI): from development to clinical implementation
2. Lung nodules, lung cancer imaging & radiomics
3. Percutaneous lung biopsies and other thoracic interventional procedures

2021 Grand Prize of the Korean Medical Devices Industry Association
2022 KSR-TaeJoon Radiology Award, Korean Society of Radiology
2022 Best Academic Awards, Korean Society of Artificial Intelligence in Medicine
2022 Commendation, Minister of Health and Welfare, Korea
2024 Seoul National University Academic Research and Education Award

260 SCI/SCIE articles & 146 papers as first/corresponding author (H-index = 64)
AI Applications for Thoracic Imaging: Considerations for Best Practice. Radiology. 2025 Feb;314(2):e240650. doi: 10.1148/radiol.240650.
Effect of Human-AI Interaction on Detection of Malignant Lung Nodules on Chest Radiographs. Radiology. 2023 Jun;307(5):e222976. doi: 10.1148/radiol.222976.
AI: Workload Reduction by Autonomous Reporting of Normal Chest Radiographs. Radiology. 2023 May;307(3):e230252. doi: 10.1148/radiol.230252. Epub 2023 Mar 7

This talk shares real-world clinical experiences with AI devices for clinical practices, particularly for radiology, focusing on both development collaboration and practical use in patient care. As a radiologist, I will highlight what worked, what didn’t, and what developers should consider for effective clinical integration.

Seoul National University Department of Clinical Medical Science Seoul, South Korea Master’s degree March 2019 – February 2021
Seoul National University Department of Medicine Seoul, South Korea Bachelor’s degree March 2006 - February 2010
Seoul National University Seoul, South Korea Premedical course March 2004 - February 2006

Chief Research Officer, Medical Group Lead, Medical AI Co.,Ltd., https://medicalai.com, 2021.8 ~
Chief Director, Digital Healthcare Institute, Sejong Hospital Group, 2021.8 ~

Intern, Seoul National University Hospital, 2010
Resident, Emergency medicine, Seoul National University Hospital, 2011-2014
Clinical Fellow, Emergency medicine, Seoul National University Hospital, 2018-2019
Clinical Fellow, Critical care medicine, Seoul National University Hospital, 2018-2019
Associate professor, Emergency medicine, Seoul National University Hospital, 2019-2021

AI-ECG

Artificial intelligence applied to electrocardiogram to rule out acute myocardial infarction: the ROMIAE multicentre study, European Heart Journal, Volume 46, Issue 20, 21 May 2025, Pages 1917–1929. https://doi.org/10.1093/eurheartj/ehaf004
and others.

Artificial intelligence applied to electrocardiography has already transformed cardiovascular medicine. Current applications include detecting left ventricular systolic dysfunction, acute myocardial infarction, and elevated filling pressure, with validated performance across large multicenter studies. Beyond diagnostics, AI-ECG demonstrates prognostic value, enabling risk stratification and monitoring in real-world settings.

Looking ahead, the future of AI-ECG lies in broader implementation—integrating into EMR/PACS systems, wearable devices, and point-of-care tools. Critical challenges remain, including explainability, validation across diverse populations, and adaptation to complex rhythms. With continuous progress, AI-ECG is expected to evolve from disease-specific tools into a universal biomarker platform, bridging screening, monitoring, and precision prognostication.

POSTECH Industrial Management & Engineering B.S. (2010)

Mediwhale co-founder&CEO (2016~)

Diabetes
Cardiovascular, Kidney and Metabolic Syndrome
Obesity

Digital Health Startups Top 50 - 2024 (CB Insights)
NextRise Award 2025 - Top Innovator (KDB 산업은행, KITA 한국무역협회, NST 국가과학기술연구회, KOVA 벤처기업협회, KVCA 한국벤처캐피탈협회)
AstraZeneca CKD Challenge 2023 우승 (AstraZeneca)
2023 CES Innovation Awards (CES)
제5회 스마트대한민국대상 – 창업진흥원장상 (아주경제)
Digital Health Awards 2024 [Provider Diagnostic] – Quarterfinalist (HLTH)
NVIDIA Inception Program (NVIDIA)

“RESToring Clarity: Unpaired Retina Image Enhancement Using Scattering Transform" (Oh, E. J., et al., MICCAI 2023)

University of Southern California, Biological Sciences

Bluepoint Partners Senior Prinicipal
Korea Health Industry Development Institute Researcher

1990 – St.Lawrence University, NY, USA (Economics)

2019~ Business Unit Manager, Eurofins Expert Services Oy, Finland
2022~ Managing Director, Eurofins Electric & Electronics Finland Oy

1999 | Master of Science in Engineering, Tampere University of Technology (Major: Material Science / Minors: Production Engineering, Paper Converting Technology)
1992 | Matriculation Examination, Lievestuoreen Lukio

2021. 1 ~ Present | Business Unit Manager, Eurofins Electric & Electronics Finland Oy
2019. 4 ~ 2021. 12 | Director, Sales and R&D Projects, Arctic Biomaterials Oy
2016. 9 ~ 2019. 4 | Director of Product Development, Inion Oy
2013. 12 ~ 2015. 8 | COO & Head of Production and QA, Regulatory Manager, Valon Lasers Oy

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

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

Health Insurance Review & Assessment Service(HIRA) (2014~)

Coverage of new medical technologies under national health insurance and efforts to improve regulatory frameworks.

1. Overview of the National Health Insurance System
2. Introduction to Therapeutic Materials Covered by Health Insurance
3. Reimbursement Listing Process for Therapeutic Materials
4. Disclosure of Information on Therapeutic Materials

Ph.D. in Public Health

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

Health Policy

Ph.D. in Engineering

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

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

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

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

Bachelor’s Degree in Public Administration, Kyungpook National University

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

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.

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.)

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

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

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

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

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