The Second Part: Apps and Wearable Devices in Sleep

Insomnia Disorders and Therapeutic Apps

Many of you are probably aware that interest in health care is growing every year and that the number of applications is increasing in correlation with this interest.

The development of therapeutic applications is also progressing. These are referred to as programmed medical devices or SaMD (Software as a Medical Device) to distinguish them from applications aimed at improving health for the general public. They began to spread in Europe and the United States. In Japan, their introduction has been gaining momentum since the Ministry of Health, Labour and Welfare (referred to below as "MHLW") newly established the reimbursement for programmed medical devices in the fiscal year 2022. Therapeutic applications are considered to be those that have undergone clinical trials based on the GCP ordinance, medical evidence, and approval by the MHLW. Use is limited to patients diagnosed and prescribed by a physician.

The application for insomnia disorders, which SUSMED, Inc is involved in developing, is one of the programmed medical devices. ^１) Despite the fact that insomnia disorders are a risk factor for multiple other diseases, cognitive behavioral therapy, which is the first treatment option overseas, has not become widespread in Japan. An application for treating insomnia disorder as a cognitive-behavioral therapy has been developed to improve the current situation where people are forced to rely on pharmacotherapy. After conducting clinical trials and achieving the goals of the primary endpoints, the company is currently in the process of applying for regulatory approval. 

Increasing the number of treatment options is a welcome development for patients and the medical professionals who provide treatment. Avoiding excessive drug therapy will also minimize the impact of side effects. The system is also expected to be introduced to patients who cannot spend long periods in the outpatient clinic. 

Challenges
The first challenge in the development and diffusion of programmed medical devices for sleep disorders is the rising cost of research and development. According to the Japan CRO Association's 2021 Performance Report, monitoring costs account for about half of outsourcing costs. ^２) SUSMED, Inc is working to reduce costs and improve efficiency in clinical trials by utilizing blockchain technology.

Second, the hurdle for approval of programmed treatment devices in Japan is high. In the U.K., the National Institute for Health and Clinical Excellence (NICE), under the jurisdiction of a government agency, has recommended the use of therapeutic applications in insomnia disorders in May 2022. ^３) It is hoped that this will lead to widespread use in the U.K.

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