1970: Olympus Optical Co., Ltd. (now Olympus Corporation)
2007: Executive Managing Director
2009: Executive Managing Director, Director of R&D Center, Head of R&D General Affairs, and Head of Medical Technology Development Division
2010: Executive Managing Director, President of Life and Industrial Systems Company, and General Manager of the Supervisory Division
2011: Executive Vice President, Imaging Business Group President
2011: President and Executive Director, also Imaging Business Group President
2012: Resigned
2017–Present: Current position
2018–Present: Program Supervisor at the Japan Agency for Medical Research and Development

1970: Olympus Optical Co., Ltd. (now Olympus Corporation)
2007: Executive Managing Director
2009: Executive Managing Director, Director of R&D Center, Head of R&D General Affairs, and Head of Medical Technology Development Division
2010: Executive Managing Director, President of Life and Industrial Systems Company, and General Manager of the Supervisory Division
2011: Executive Vice President, Imaging Business Group President
2011: President and Executive Director, also Imaging Business Group President
2012: Resigned
2017–Present: Current position
2018–Present: Program Supervisor at the Japan Agency for Medical Research and Development

Seminar Outline

According to the "Aging Society White Paper" (2017) by the Cabinet Office, it is predicted that by 2025, the baby boomer generation will be over 75 years old, and the number of dementia patients will exceed 7 million. As a result, medical expenses are expected to increase, and with the decrease in the working-age population, there are growing concerns about the social security system that supports the elderly. Additionally, the number of people leaving their jobs to care for dementia patients is increasing, which could potentially affect Japan's productivity. Addressing these social issues is an urgent task. It is necessary to prevent the onset of dementia by detecting signs of dementia before its onset and providing appropriate treatment early. While there are various causes of dementia, it is possible to prevent it by identifying and treating declines in vision and hearing, deterioration of bone and muscle function, and changes in brain function. As a result, this can lead to the resolution of current social issues, while enabling many elderly people to lead happy lives and continue working, and also reducing the caregiving burden on the generation at the heart of productive activities. This seminar will introduce research tackling such social challenges as new business opportunities.

In 2008, completed the Graduate School of Medicine at the University of Tokyo, obtaining a Doctor of Medicine degree for research on epilepsy brains using nuclear medicine. The same year, began working as an Assistant Professor at the University of Tokyo Hospital, and from 2014, served as a Lecturer involved in nuclear medicine clinical practice. Since 2018, has been conducting research and development at the Quantum Science and Technology Research and Development Organization (QST) necessary for the precision enhancement of PET devices and nuclear medicine clinical practice.

Seminar Outline

A definitive diagnosis of dementia is made by observing the pathological features seen in brain sections removed post-mortem. However, once it reaches the post-mortem stage, it's too late for intervention. Nuclear medicine offers a way to diagnose during a patient's lifetime, serving as an alternative to pathological diagnosis. It aims to detect diseases at an earlier stage, or even at their onset, by quantitatively capturing molecular-level changes deep within the body. The true nature of dementia is difficult to discern through symptom observation alone. Positron Emission Tomography (PET) serves as a method to reveal clinical pictures that are not outwardly manifested, introducing the latest PET technologies and their potential.
Dementia diagnosis through nuclear medicine
Understanding changes in brain function
The medical goals of the latest PET technology

Graduated from Osaka University Faculty of Medicine (MD) in 2008, completed the Graduate School of Orthopaedic Medical Engineering and Regenerative Medicine at Osaka University (PhD) in 2017, served as a Visiting Research Fellow at the University of Utah's Department of Orthopaedics from 2017 to 2019, worked as a Specially Appointed Assistant Professor at the Nara Institute of Science and Technology from 2020 to 2021, became an Assistant Professor in Orthopaedic Surgery at Osaka University in 2021, and has been a Lecturer in Orthopaedic Medical Engineering and Regenerative Medicine at Osaka University since May 2023 to the present.

Seminar Outline

Osteoporosis-associated fragility fractures and sarcopenia lead to a decline in the activity levels of the elderly, accounting for 25% of the factors leading to the need for support or care. Although it is estimated that there are potential patient numbers of 13 million for osteoporosis and 5 million for sarcopenia, the issue is that only a fraction of these cases are diagnosed and treated, and there is a demand for early diagnosis and treatment intervention. We are developing a system that uses CT images, which are taken approximately 30 million times a year, to diagnose osteoporosis and sarcopenia and facilitate treatment intervention. Here, we present our progress and current efforts towards societal implementation.
About osteoporosis and sarcopenia
Development of an AI-based screening system
Challenges towards societal implementation

2011: Graduated from Hiroshima University Faculty of Medicine
2015: Department of Ophthalmology, Hiroshima University Hospital
2019: Medical Guidance and Audit Officer, Medical Affairs Division, Health Insurance Bureau, Ministry of Health, Labour and Welfare
2021: Assistant Professor, Center for Clinical Research and Development, Hiroshima University Hospital

Seminar Outline

As society ages, the number of patients with blindness is predicted to increase. In Japan, more than half of blindness cases are caused by fundus diseases such as glaucoma and diabetic retinopathy. These diseases are characterized by the absence of symptoms until they reach an advanced stage, and even if treatment is started at this late stage, blindness can still occur. Therefore, it is necessary to start diagnosis and treatment at an early stage before symptoms appear. However, fundus examinations are not included in regular health check-ups. People without symptoms rarely visit an ophthalmologist, and often, by the time they do, it is too late. This presentation will introduce the potential of early diagnosis of fundus diseases using a simple fundus camera and an AI-based remote fundus diagnosis program that we are developing, and will also share future prospects.

With the progression of an aging society, the number of blindness patients is expected to increase.
More than half of the causes of blindness in Japan, such as glaucoma and diabetic retinopathy, are fundus diseases characterized by the absence of symptoms until the advanced stage, and blindness can occur even if treatment is started at this late stage.
We will introduce the potential for early diagnosis of fundus diseases using a simple fundus camera and an AI-based remote fundus diagnosis program we are developing, and share future prospects.

Since April 2022, affiliated with the Ohara Memorial Kurashiki Central Medical Organization Clinical Medical Research Institute, Department of Otorhinolaryngology at Kurashiki Central Hospital. Graduated from Ehime University Faculty of Medicine in 2009 and obtained a medical license. Worked in otorhinolaryngology and clinical research support at Kurashiki Central Hospital and Ehime University Faculty of Medicine Hospital. From 2020 to 2022, engaged in administrative work for the promotion of the medical and welfare device industry, mainly focusing on programmed medical devices, at the Ministry of Economy, Trade and Industry.

Seminar Outline

Hearing loss is the largest preventable factor of dementia, but due to the lack of self-awareness symptoms, early detection and intervention through screening are required. In Japan, hearing loss screenings are conducted for young people as part of workplace health examinations mandated by the Occupational Safety and Health Act, but screenings for middle-aged and older adults are limited due to job separation or changes in employment status. Therefore, we aim to realize a society where everyone can easily undergo hearing loss screening. This involves discussing the social issues surrounding hearing loss and dementia, the importance of early detection and monitoring in daily life, as well as the regulations and development of the hearing test device we are developing.

Hearing loss screening and dementia prevention
Regulation and device development of SaMD/hardware medical devices
Regulation of monitoring devices developed for use in daily living settings

1970: Olympus Optical Co., Ltd. (now Olympus Corporation)
2007: Executive Managing Director
2009: Executive Managing Director, Director of R&D Center, Head of R&D General Affairs, and Head of Medical Technology Development Division
2010: Executive Managing Director, President of Life and Industrial Systems Company, and General Manager of the Supervisory Division
2011: Executive Vice President, Imaging Business Group President
2011: President and Executive Director, also Imaging Business Group President
2012: Resigned
2017–Present: Current position
2018–Present: Program Supervisor at the Japan Agency for Medical Research and Development

Former Terumo Director and Senior Executive Officer
Part-time Lecturer at the Graduate School of Public Policy, University of Tokyo
Senior Researcher at the Medical Device Industry Research Institute, Japan Association for the Advancement of Medical Equipment

2019-Present: Siemens Healthineers (Malvern, PA)
• Head of Regulatory Policy – North America
2001-2018: Becton, Dickinson and Company (Franklin Lakes, NJ)
• Director, Technical and Regulatory Policy / Corp. Regulatory Affairs and Operations (2010–2018)
• Director, Corporate Regulatory Affairs/Japan Region (2009)
• Corporate Regulatory Affairs Liaison, Japan (2001–2008)
2000-2001：Electro-Diagnostic Imaging, Inc. (San Mateo, CA)
• Chief Operating Officer
Leadership positions held:
• Board of Directors, President and Chair (RAPS)
• Chair, Standards Committee (Medical Imaging & Technology Alliance, MITA)
• Voting Member, International and Regional Standards Committee (IRSC), Standards and Conformity Assessment Policy Committee (SCAPC), NEMA
• Co-chair, Postmarket WG, and Washington Representative (AdvaMed)
Special Recognition:
• Fellow, Regulatory Affairs Professional Society
• Regulatory Affairs Certification (RAC) for the US and Europe

Seminar Outline

Medical devices range from low to high risk, employ software and advanced algorithms, and vary in size from very small to very large, like MRI machines. Regulations governing these devices are changing rapidly, especially in the field of software, where there is active discussion about regulations concerning products using AI/ML. This seminar will provide an overview of the direction of medical device regulations in North America, which are undergoing rapid changes, and will also introduce the progress of regulatory reforms such as the 510(k) process in the United States as much as possible.

The progress and future prospects of regulatory reforms such as the 510(k) in the United States

Since September 2020, at BSI (British Standards Institution), pursuing excellence in "predictable" delivery for EU MDR/IVDR, UKCA, MDSAP, ISO 13485, and PMDA certifications. Engaged as the Commercial Operations Director within the Regulatory Services business stream, specializing in the examination and certification of medical devices.
Before moving to BSI, spent approximately 18 years at a German certification body, serving in various roles including the head of medical device testing, examination, and certification business for the Asia-Pacific region and Japan.

Seminar Outline

The European Union (EU) and the United Kingdom are in the midst of an unmissable reform period, further highlighted by the EU AI Act, the world's first AI regulation. The introduction of Regulation EU 2023/607 marks a new phase under both regulatory schemes, where balancing the continued marketing of existing devices declared compliant under old directives with the marketing of new products is a top priority for legal manufacturers and certification bodies driven to foster innovation. BSI, being the largest EU Notified Body and one of the few UK Approved Bodies for the new UKCA marking scheme post-Brexit, has accumulated the most examination and certification achievements. This year, incorporating insights from the forefront of examination and certification, we will clearly discuss strategic efforts and key points for achieving early certification completion, including the EU AI Act.

The latest trends in EU 2023/607 and regulations for medical devices and in vitro diagnostic medical devices in the European Union and the United Kingdom
The new phase brought about by the EU AI Act, the world's first AI regulation
Experiences and insights gained from the forefront of examination and certification projects
Strategic efforts and key points for achieving early certification completion

2013: Joined Sysmex Corporation
2022: Member of the Regulatory Affairs Department, Sysmex Corporation
2022: Chief of the Regulatory Affairs Department, Sysmex Corporation

Seminar Outline

Since the revision of regulations related to medical devices and in vitro diagnostic reagents in China began in 2020, major regulatory revisions have been completed by November 2021, and their implementation has started. In 2022 and 2023, there has been a significant issuance of general or product/item-specific guidance principles, leading to a substantial strengthening of the regulatory requirements for application materials needed for regulatory submissions. This presentation will introduce the current situation and latest trends regarding the process of obtaining licenses and approvals for medical devices (including IVD products) in China, focusing on key points to consider during the application process.

The process of obtaining licenses and approvals for medical devices in China:

The impact of legislative changes
A) Requirements related to the scope of reference standards
B) Trends in the revision of national standards and industry standards for electrical safety (compliance with IEC 61010 3.1 edition)
C) Trends observed in the requirements for application materials

1996: Graduated from the Faculty of Science and Engineering, Tokyo Denki University
2005: Completed the Graduate School of Engineering Management, Shibaura Institute of Technology
2006: Completed the Biomedical Curriculum at Tokyo Women's Medical University
2008: Completed the Doctoral Program in Engineering at the Graduate School of Engineering, Shibaura Institute of Technology
1996–: Employed at the Foundation, working in the Pharmaceutical Affairs Department and the Research and Development Department, Medical Device Industry Research Institute
2014–: Executive Director at the Foundation



1996: Graduated from the Faculty of Science and Engineering, Tokyo Denki University
2005: Completed the Graduate School of Engineering Management, Shibaura Institute of Technology
2006: Completed the Biomedical Curriculum at Tokyo Women's Medical University
2008: Completed the Doctoral Program in Engineering at the Graduate School of Engineering, Shibaura Institute of Technology
1996–: Employed at the Foundation, working in the Pharmaceutical Affairs Department and the Research and Development Department, Medical Device Industry Research Institute
2014–: Executive Director at the Foundation

Seminar Outline

In Japan, medical device regulatory policy is governed by the Pharmaceuticals and Medical Devices Law, with system design thoroughly incorporating international alignment. However, the specifics are constantly changing due to rapid societal shifts post-COVID, changes in the medical environment, and technological advancements.
The promotion of medical DX (Digital Transformation) is particularly expected to drive changes in medical device regulations going forward.
This presentation will introduce the latest topics in medical device regulations, considering these backgrounds:

The concept of regulatory approval for Software as a Medical Device (SaMD)
The concept of regulatory approval for AI medical devices
The international expansion of Japan's regulatory approval system

Former Terumo Director and Senior Executive Officer
Part-time Lecturer at the Graduate School of Public Policy, University of Tokyo
Senior Researcher at the Medical Device Industry Research Institute, Japan Association for the Advancement of Medical Equipment

Graduated from the Faculty of Engineering, University of Tokyo in 2002, and completed his graduate studies at the same university in 2007. Ph.D. in Science. Assistant Professor at the Advanced Biomedical Sciences Research Institute, Tokyo Women's Medical University. From September 2014 to March 2021, he worked at the Medical Device Center, a public interest incorporated foundation, engaged in research and study on medical devices, as well as support for medical-engineering collaboration, academia-industry collaboration, and commercialization. Since April 2021, he has transferred to the Certification Department, where he is involved in product and QMS (Quality Management System) audits.

In 2010, graduated from the Clinical Engineering Department of the Faculty of Health Sciences at Kyourin University and obtained a Clinical Engineer license. Worked as a clinical engineer at Tokyo Metropolitan Tama General Medical Center, gaining extensive experience in various aspects including extracorporeal circulation (including ECMO), blood purification, artificial respirators (ventilators, ECMO), and medical device management. Has been in the current position since October 2019. Holds certifications as a Type 2 and Type 1 Medical Equipment Engineer from the Japan Society for Medical and Biological Engineering, a former Certified Extracorporeal Circulation Technician, and a Certified Respiratory Therapist jointly certified by three societies.

Seminar Outline

Starting this April, reforms to physicians' working conditions are being implemented, with limits placed on working hours. Meanwhile, in an aging society, the demand for medical services is increasing. However, it is unacceptable for the quality of medical care to decline. To address these seemingly contradictory societal demands, there is a need for the social implementation of new technologies that can transform the medical process.

In this lecture, we will outline the overall picture of the reforms to physicians' working conditions and introduce examples of advanced medical devices that contribute to addressing these challenges.

Agenda:

Overview of reforms to physicians' working conditions
Challenges posed by reforms to physicians' working conditions
Introduction of medical devices contributing to reforms in physicians' working conditions

Since 1993, I have been employed as a sales representative for respiratory, anesthesia, and surgical-related equipment at a medical equipment specialized trading company. After gaining experience in sales and planning at several foreign medical device manufacturers, I joined Nippon Photoelectric Industry Co., Ltd. in 2008. Primarily, I have been engaged in planning activities related to artificial respiration and anesthesia equipment, including introducing new products from partner manufacturers to the domestic market, developing new products in-house, and introducing them to the global market.

Seminar Outline

In Japan, the number of general anesthesia surgeries is increasing, reaching approximately 2.2 million cases. However, chronic shortages of anesthesiologists, regional disparities, and long working hours are significant challenges. Nippon Photoelectric Industry Co., Ltd. (NPI) released the ROP-1680 (AsisTIVA) software for automatic control of intravenous anesthetic drug administration via syringe pumps during surgery in 2023. This product, developed with support from the Japan Agency for Medical Research and Development (AMED) since 2018, underwent physician-led clinical trials and development in collaboration with multiple hospitals, including Fukui University and the National Center for Global Health and Medicine Hospital, obtaining approval as a Program Medical Device in September 2022. By leveraging this software, NPI aims to reduce the workload of anesthesiologists, enhance medical safety, and contribute to the appropriate use of medical costs such as medications. This presentation will introduce the development process of this product, its usage in clinical settings, and the challenges faced, as well as outline future product development plans.

Development of Closed-Loop Control Robot Anesthesia Systems
Current Status and Challenges of Robot Anesthesia Systems
Future Product Planning and Development

Graduated from Teikyo University School of Medicine in 2010. After working in orthopedic surgery at Teikyo University Hospital, founded Fast Doctor Co., Ltd. in 2016. With a mission to "eliminate the anxieties of consumers and the burdens of medical professionals," the company provides an emergency medical platform accessible to 70 million people. Holds certifications as a specialist in orthopedic surgery from the Japanese Orthopaedic Association, a certified spinal cord disease specialist from the Japanese Orthopaedic Association, serves as a council member of the Japan Society for Home Medical Emergencies, and works as a part-time lecturer at Teikyo University School of Medicine.

Seminar Outline

Currently, initiatives related to healthcare workforce, such as reforms in physicians' working conditions and strategies to address physician maldistribution, are being promoted in a coordinated manner. These efforts are aimed at preparing for the peak in healthcare demand projected for 2040 due to aging demographics and the imbalance in supply and demand caused by the decline in the working-age population. There is a strong emphasis on enhancing the productivity of healthcare.

Fast Doctor aims to achieve sustainability in healthcare by aggregating approximately 5,000 physicians and healthcare professionals onto its platform. It achieves this by building an on-demand healthcare system tailored to the needs of individuals and by leveraging technology to enhance the efficiency of healthcare delivery. In this session, we will explain how Fast Doctor contributes to improving productivity in the healthcare industry and its contribution to regional healthcare through case studies of "Virtual First Care" and "Building a Regional Healthcare System through Specialization and Collaboration".

Fast Doctor's Virtual First Care
Building a Regional Healthcare System through Specialization and Collaboration
Improving Productivity in the Healthcare Industry

After graduating from the Faculty of Science and Engineering at Waseda University and the Faculty of Medicine at Osaka University, Ken Ando joined Panasonic (now Panasonic Holdings) in 2011. He has been consistently involved in research and development in the field of robotics, leading to commercialization. Currently, he serves as the Director of the Robotics Promotion Office at Panasonic. Additionally, he holds positions as a visiting professor at Osaka Institute of Technology and serves as a committee member of various academic societies, including the Robot Revolution Initiative Council. Dr. Ando holds a Ph.D. in Engineering.

Seminar Outline

Against the backdrop of labor shortages, the utilization of robots is beginning to advance not only in traditional industrial settings but also in various fields. However, merely replacing human tasks with robots may not always yield sufficient results.

In this seminar, we will introduce the concept of Robot Transformation (RX), necessary for effectively utilizing robots across various fields, not limited to the medical field. We will discuss the current status and challenges of the robotics industry, the importance of RX when introducing robots into new fields, and key points to be learned from RX case studies.

Current Status and Challenges of the Robotics Industry
Robot Transformation (RX): Necessities When Introducing Robots into New Fields
Key Points to Learn from RX Case Studies

Graduated from the Faculty of Engineering, University of Tokyo in 2002, and completed his graduate studies at the same university in 2007. Ph.D. in Science. Assistant Professor at the Advanced Biomedical Sciences Research Institute, Tokyo Women's Medical University. From September 2014 to March 2021, he worked at the Medical Device Center, a public interest incorporated foundation, engaged in research and study on medical devices, as well as support for medical-engineering collaboration, academia-industry collaboration, and commercialization. Since April 2021, he has transferred to the Certification Department, where he is involved in product and QMS (Quality Management System) audits.

In 2010, graduated from the Clinical Engineering Department of the Faculty of Health Sciences at Kyourin University and obtained a Clinical Engineer license. Worked as a clinical engineer at Tokyo Metropolitan Tama General Medical Center, gaining extensive experience in various aspects including extracorporeal circulation (including ECMO), blood purification, artificial respirators (ventilators, ECMO), and medical device management. Has been in the current position since October 2019. Holds certifications as a Type 2 and Type 1 Medical Equipment Engineer from the Japan Society for Medical and Biological Engineering, a former Certified Extracorporeal Circulation Technician, and a Certified Respiratory Therapist jointly certified by three societies.

Since 1993, I have been employed as a sales representative for respiratory, anesthesia, and surgical-related equipment at a medical equipment specialized trading company. After gaining experience in sales and planning at several foreign medical device manufacturers, I joined Nippon Photoelectric Industry Co., Ltd. in 2008. Primarily, I have been engaged in planning activities related to artificial respiration and anesthesia equipment, including introducing new products from partner manufacturers to the domestic market, developing new products in-house, and introducing them to the global market.

Graduated from Teikyo University School of Medicine in 2010. After working in orthopedic surgery at Teikyo University Hospital, founded Fast Doctor Co., Ltd. in 2016. With a mission to "eliminate the anxieties of consumers and the burdens of medical professionals," the company provides an emergency medical platform accessible to 70 million people. Holds certifications as a specialist in orthopedic surgery from the Japanese Orthopaedic Association, a certified spinal cord disease specialist from the Japanese Orthopaedic Association, serves as a council member of the Japan Society for Home Medical Emergencies, and works as a part-time lecturer at Teikyo University School of Medicine.

After graduating from the Faculty of Science and Engineering at Waseda University and the Faculty of Medicine at Osaka University, Ken Ando joined Panasonic (now Panasonic Holdings) in 2011. He has been consistently involved in research and development in the field of robotics, leading to commercialization. Currently, he serves as the Director of the Robotics Promotion Office at Panasonic. Additionally, he holds positions as a visiting professor at Osaka Institute of Technology and serves as a committee member of various academic societies, including the Robot Revolution Initiative Council. Dr. Ando holds a Ph.D. in Engineering.

Graduated from the Faculty of Engineering, University of Tokyo in 2002, and completed his graduate studies at the same university in 2007. Ph.D. in Science. Assistant Professor at the Advanced Biomedical Sciences Research Institute, Tokyo Women's Medical University. From September 2014 to March 2021, he worked at the Medical Device Center, a public interest incorporated foundation, engaged in research and study on medical devices, as well as support for medical-engineering collaboration, academia-industry collaboration, and commercialization. Since April 2021, he has transferred to the Certification Department, where he is involved in product and QMS (Quality Management System) audits.