Is the total review time of new medical devices related to the size of the company?: Medical devices development and its related factors in Japan

Naoki Tomotsugu, Masayuki Kaneko, Akane Takayama, Mamoru Narukawa

Abstract


Japan has one of the largest medical device markets in the world, but most devices used in Japan are pioneered by foreign medical device companies. On the other hand, medical device companies in Japan have significant potential to develop innovative medical devices. Through this research, we aim to elucidate the factors related to the total review time of new medical devices so that innovative medical devices would be developed sooner. Using the lists of approved medical devices disclosed by the Pharmaceuticals and Medical Devices Agency (PMDA), we chose all the new medical devices that were approved in Japan between Fiscal Year (FY) 2009 and 2015. We conducted two main types of analyses based on the total review time after submission and sales of the companies. The total review time tends to decrease with "Year of approval by the PMDA'' in FY 2009 to 2015 (p < 0.001). Moreover, the total review time of small and medium-sized companies is greater than that of large companies (p = 0.004). In conclusion, the total review time of new medical devices in Japan appears to be related to the following two factors: (1) year of approval, and (2) size of the enterprise.

Keywords


medical device, device development, PMDA, Japan

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References


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