Utilization and Challenges of Digital Therapeutics in Industry

Abstract

Today, many medical devices have already been developed, supported by digital technology. Among such devices, this article focuses in particular on Software as a Medical Device (SaMD) and Digital Therapeutics (DTx). First, the short history of DTx is reviewed, and some notable products, which are developed in countries other than Japan, are introduced as notable examples of DTx. Second, the discussion shifts to the situation in Japanese DTx development, with respect to a lag in comparison to that in overseas. The SaMD/DTx in Japan are suffering from several problematic situations: (ⅰ) uncertain profit projection in the insurance reimbursement system, (ⅱ) limited regulatory information due to lack of accumulation of examples, (ⅲ) difficulty in planning of clinical trials and strategy of post-approval software modification (ⅳ) construction of software logistics and authentication system (ⅴ) increasing non-SaMD software as competitive products. Finally, some desirable future situations and expected challenges in digital healthcare development in Japan are proposed, based on the discussion above. A variety of products, not only SaMD/DTx but non-SaMD, will be developed to create an ecosystem and will be interconnected, enabling total healthcare. To improve product development, the above problem situation should be solved step by step. In addition to them, rulemaking is required for the protection and use of personal health records (PHR). Recently, several SaMD developing healthcare companies in Japan has established a unified industry organization, JaDHA. We expect that the difficult situation will be resolved throughout dialogue among companies, regulatory organization and other all related stakeholders.