Annual Report 2022
Department for The Promotion of Medical Device Innovation
Masaaki Ito, Tomonori Yano, Nobuyoshi Takeshita, Hiroaki Ikematsu, Hiroaki Sunakawa, Keiichiro Nakajo, Tetsuya Sakai, Kazuo Watanabe, Hiro Hasegawa, Shingo Sakashita, Toshifumi Tomioka, Tatsuya Ohnishi, Joji Sameshima, Mariko Kikuta, Yumi Kinebuchi, Daichi Kigatuchi, Kyoko Ryu, Shin Takenaka, Yuki Furusawa, Norihito Kosugi, Kazuyuki Hayashi, Younae Lee, Yuto Ishikawa, Atsushi Yamada, Ken Kaneta, Masami Namihira, Kenji Ohtsuka, Rina Azuma, Haruki Mitarai, Ryosuke Kondo, Miyo Takanashi, Hibiki Kondo, Yuriko Harai, Harumi Naoi, Yoko Hatanaka, Atsuki Tanaka, Mayumi Yamada, Saki Minamimatsu, Yoshiko Tomita, Tomoko Ohe, Yuko Hitomi, Yukari Nagatsuma, Yuka Takahashi, Hajime Tachiki, Yoshie Kasahara, Hiroko Homma, Kayoko Ogawa, Ryuko Shimoda, Yoko Furuichi, Kazue Ando, Nana Nagayama, Haruya Takasaki, Sachiko China, Yuzuru Tomioka, Koji Nakamura, Yasuyuki Yoshida, Ryo Sekiguchi, Takuya Ishii, Norio Yamamoto, Kayo Suzuki, Megumi Kawakami, Yuka Mitsuke, Mieko Shono
Introduction
The Center of New Surgical and Endoscopic Development for Exploratory Technology (NEXT) was founded in the National Cancer Center Hospital East on May 8, 2017. It 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 according to clinical needs.
- Introducing the 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 according to clinical needs.
The Department for the Promotion of Medical Device Innovation is based in the NEXT Medical Device Innovation Center and promotes medical device innovation in NCCHE.
The Team and What We Do
The mission of the Department for the Promotion of Medical Device Innovation is "to change the world with the medical device innovation". We undertake research and development on innovative medical devices and exploratory technology based on clinical needs in industry-academia-government and medical-engineering collaboration. Specifically, we target instruments, devices and digital systems used in/around the endoscopic and laparoscopic surgery fields. We promote their development in partnership with medical device businesses, "monozukuri" (manufacturing) companies, academia, local governments (especially Chiba Prefecture and Tokyo), and incubators. Furthermore, we support clinical trials in collaboration with the Office of Clinical Research Support, provide training for medical staff, and disseminate information as an advanced incubation facility.
Research Activities
The Department for the Promotion of Medical Device Innovation has initiated 39 new research and development collaborations with industry and academia partners. Especially, we have developed artificial intelligence (AI) applications for the medical field. Two active projects on the medical applications of AI technology research and development adopted by the Japan Agency for Medical Research and Development (AMED) as a funding support program have been ongoing since the year before last. In addition, we have promoted a project to develop a medical device that supports surgery and to create a database of surgical images of endoscopic surgery to improve the efficiency and safety of surgery. We have also developed AI applications for endoscopic diagnosis, applications for 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" continuously since FY2019.
Furthermore, we have promoted collaboration with venture companies in the development of medical devices with the aim 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 28 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 (CRYO-SCAR) (Last patient out)
2) A double-blind randomized Control trial to Evaluate mitigation of CIPN by LImb-cooling Apparatus in breast cancer patients who undergo weekly paclitaxel (CECILIA) (Recruiting)
3) The double-blind randomized control trial to relief the diStress from cheMotherapy-Induced peripheraL nEurophathy by magnetic field (SMILE) (Recruiting)
Education
We held the "NEXT seminar" 5 times to develop human resources for creating innovative medical devices in our hospital. The "NEXT seminar" provided participants lectures on the Act on the Protection of Personal Information, intellectual properties, entrepreneurship, and development of surgical support robots. In our clinical field observation program, 243 individuals from 18 institutions have visited the operating room, endoscopy room and radiation therapy room in our hospital to assess the clinical needs.
Future Prospects
We will continue to 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 the system for clinical field observation programs, support obtaining POC through animal tests, and further promote cooperation with venture companies that possess innovative technology solutions. Furthermore, we will start a program aimed at starting a venture company from NCC based on the clinical needs of our hospital in collaboration with science and technology academia and venture capitalists.