This study explores strategic responses that AI-based medical device manufacturers should adopt considering device performance plasticity. We conducted a comparative analysis of AI-based medical devices approved between 2018 and 2023 in Japan and the United States, focusing on the time series changes in the number of approvals, product features and update status, and the attributes of the companies that developed the products. The results showed a greater increase in the number of approvals in the United States than in Japan. In both countries, most of approved products were models without supplemental approval. On the other hand, among products with supplemental approval, Japan tended to have a “function-added” model with multiple different functions, while the United States, with its flexible 510(k) process, showed that many devices adopted an iterative “function-updated” model. Furthermore, foreign companies and startups have actively entered the market. Based on these results, we propose three measures to promote AI-based medical devices development by Japanese medical device manufacturers: (1) strengthening the function-update model, (2) promoting early and continuous dialogue with regulatory authorities, and (3) implementing a short-term product lifecycle that addresses the plasticity of performance, even leading up to approval.
Arima et al. (Thu,) studied this question.