Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: P
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Future development of artificial organs related with cutting edge emerging technology and their regulatory assessment: PMDA’s perspective Nobuhiro Handa1,4 · Shuichi Mochizuki1 · Yasuhiro Fujiwara2 · Masafumi Shimokawa3 · Rika Wakao3 · Hiroyuki Arai3 Received: 5 January 2020 / Accepted: 5 February 2020 © The Japanese Society for Artificial Organs 2020
Abstract Future development of innovative artificial organs is closely related with cutting edge emerging technology. These technologies include brain machine or computer interface, organs made by three dimensional bioprinting, organs designed from induced-pluripotent stem cell for personalized tissue or organ, and xenotransplantation. To bridge the gap between scientific innovation and regulatory product review, pharmaceuticals and medical devices agency of Japan (PMDA) started the science board to discuss about the new scientific topics regarding medical products including medical device and regenerative products with external experts since 2012. Topics which PMDA raised for science board included cellular and tissue-based products from iPS cells, artificial intelligence and genome editing technology. In addition, PMDA started the horizon scanning to identify a new cutting edge technology which could potentially lead to innovative health technology or product, which has a strong impact on clinical medicine. Although the effectiveness and safety of the medical products must be reasonably assured before clinical use, PMDA introduced Sakigake review assignment (a review partner of device development) and conditional approval system to balance between pre-market and post-market evaluation. Keywords Cutting edge new technology · PMDA · Regulatory review · Science board · Horizon scanning
Introduction In the last decade, several artificial organs were outstandingly progressed and were widely introduced into the clinical medicine. For example, implantable left ventricular assist device (LVAD) was used for patients with end-stage heart This article was read at the 8th annual meeting of the International Federations of Artificial Organs. * Nobuhiro Handa handa‑[email protected] 1
Office of Medical Device, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
2
Office of Regenerative Medicine, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
3
Regulatory Science Center, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan
4
Medical Device Unit, Pharmaceuticals and Medical Devices Agency, 3‑3‑2, Shin‑Kasumigaseki Building 11F, Kasumigaseki, Chiyoda‑ku, Tokyo 100‑0013, Japan
failure as a bridge to heart transplantation or final destination therapy [1]. Prosthetic heart valve, either mechanical or tissue valve replace the failing heart valves [2]. Prosthetic vascular graft prevents the rupture of aortic aneurysm or aortic dissection [3]. These artificial organs made of artificial material are permanently implanted and improve the prognosis of the patients. Meanwhile, artificial joint prosthesis for shoulder, hip, knee or ot
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