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Annual Report 2020

Next Medical Device Innovation Center

Masaru Konishi, Masaaki Ito, Tomonori Yano, Yusuke Yoda, Nobuyoshi Takeshita, Yusuke Hashimoto, Kenji Takashima, Hiro Hasegawa, Takahiro Igaki, Daichi Kitaguchi, Nobushige Takeshita, Shigehiro Kojima, Shin Takenaka, Kei Nakajima, Yoshito Shibusawa, Yumi Kinebuchi, Akihiro Hirao, Yuki Furusawa, Norihito Kosugi, Kazuyuki Hayashi, Hiroki Matsuzaki, Yuto Ishikawa, Shun Takahashi, Lee Younae, Atsushi Yamada, Toru Fujino, Mika Makari, Mayumi Yamada, Tomoko Ohe, Yuko Hitomi, Yukari Nagatsuma, Yuka Takahashi, Reria Sato, Megumi Kawakami, Mayumi Yamada, Miyuki Kondo, Machiko Kakihara, Ryuko Shimoda, Mariko Kikuta, Yoko Furuichi, Yoko Hatanaka, Emi Konno, Kazue Ando, Yoshiko Tomita, Ryo Sekiguchi, Ibuki Watanabe, Norio Yamamoto, Yuko Tanabe, Yuka Mitsuke

Introduction

 The Center for New Surgical and Endoscopic Development for Exploratory Technology (NEXT) was founded in the National Cancer Center Hospital East on May 8, 2017. The center provides state-of-the-art medical care to patients and develops medical devices and technologies, especially in surgical and endoscopic fields with the following aims:

- Providing currently available state-of-the-art medical care

- Developing next-generation medical devices and technologies based on clinical needs

- Introducing developed medical devices and technologies to clinical practice

- Developing the next generation of leaders in the cancer care field

 The NEXT Medical Device Innovation Center is included in the NEXT and develops next-generation medical devices and technologies based on clinical needs.

The Team and What We Do

 The NEXT Medical Device Innovation Center undertakes research and development of innovative medical devices in exploratory technology based on clinical needs in industry-academia-government and medical-engineering collaboration. We especially target instruments and devices used in/around the endoscopic and laparoscopic surgery fields. We promote device development in partnership with medical device businesses, “monozukuri” (manufacturing) companies, academia, and local agencies and communities in the Chiba area. Furthermore, we support clinical trials and act as an advanced incubation facility providing training for surgeons and disseminating information.

Research activities

 The NEXT Medical Device Innovation Center has undertaken 75 research and development collaborations with partners in industry and academia partners. We have developed artificial intelligence (AI) applications for the medical field. Two active projects on the medical application of AI technology research and development by the Japan Agency for Medical Research and Development (AMED) as a funding support program have been ongoing since last year. We have also promoted a project to develop a medical device that supports surgery and to create a database of surgical images of endoscopic surgery for the purpose of improving surgical efficiency and safety. We have developed AI technology applications for endoscopic diagnosis, applications of oxygen saturation imaging endoscopes, surgical and endoscopic procedure training devices, and surgical support robots. In recognition of these efforts in medical device development, our hospital was adopted as one of the 14 medical device development bases nationwide in AMED's “Support Program on Collaborative Innovation Networks for Medical Device “(FY2019-2023) last year, and we have continued the program.

 Furthermore, we have promoted collaboration with venture companies in developing medical devices with the idea of matching clinical needs and engineering seeds. To accelerate the matching and collaboration with venture companies, we held the "Medical Device Innovation in Kashiwanoha" symposiums on October 26 as well as last year.

Clinical trials

1) Cryoablation using the CryoBalloon Ablation System (CBAS) for superficial esophageal squamous cell carcinoma on or near the scar after endoscopic treatment: Efficacy and safety study.

2) Clinical evaluation trial about prediction of treatment effect of chemotherapy or chemoradiotherapy for gastrointestinal cancer using oxygen saturation imaging endoscopy.

Education

 We held "NEXT seminar" six times to develop human resources for creating innovative medical devices in our hospital. The "NEXT seminar" has given lectures on intellectual properties, quality management and entrepreneurship related to medical device development, as well as lectures on clinical developments related to in vitro diagnostics. In our clinical field observation program, 360 individuals from 9 institutions have visited the operating room and intensive care unit (ICU) in our hospital to learn the clinical needs. Furthermore, we also collaborated with "Biodesign Seminar" organized by Tsukuba University and the "Medical Device Manufacturing Introductory Seminar" sponsored by Chiba Prefecture.

Future Prospects

 We will increasingly promote all-Japan medical device development as one of the most active bases of medical device development while working with other bases supported by AMED in the “Support Program on Collaborative Innovation Networks for Medical Device”. We will improve a system for clinical field observation program, support the achievement of POC through animal testing, and further promote cooperation with venture companies that possess innovative technology solutions. In addition, we will initiate a program aimed at starting a venture company from NCC based on the clinical needs in our hospital, in collaboration with venture capitalists.