A Japanese preeminent digital therapeutics startup called Susmed, is concentrating on the study and development of smartphone applications as software therapeutic devices for handling of diseases such as insomnia. It recently declared that “Regulatory Sandbox System”, pilot plans led by the Japanese government, on the “Explanation of Clinical Data Monitoring System Using Blockchain Technology”, hereinafter quoted to as “the pilot project”, has been approved by the Minister of Economy, Trade and Industry, and the Ministry of Health, Labor, and Welfare.
Susmed is generating a Clinical Data Managing System, from now on designated to as “the system,” leveraging its expertise in developing smartphone therapy applications as medical software designs. In addition to operating as a platform system for a smartphone application for the remedy of various diseases, this system will execute the blockchain technology that has been widely researched and generated by Susmed, enabling the system to reliably secure quality data for clinical development. The project will thoroughly reform current labor-intensive monitoring procedures and streamline clinical advancement while adding to the sustainability of social safety.
In this one of a kind project, the system utilizes blockchain technology, which is assumed to be more cost-effective than traditional methods in the monitoring of clinical examinations and to ensure data efficiency during follow-up. In partnership with the National Cancer Research Center, Susmed will administer the clinical study to generate an exercise program that encourages behavioral change for cancer survivors who do not regularly exercise. Through this pilot scheme, they strive to prove that the authenticity of data can be guaranteed even if monitors do not attend to check the origin data and the report substance.
The research indication points towards the impact of home-based high-intensity intermittent exercise and behavioral modification. It is being done by utilizing information and communication technology on cardiorespiratory health and exercise practices among inactive breast cancer survivors: habit-B study obligation for a randomized controlled experiment.
Susmed strives to find solutions that unite IoT technology to medical needs, attempting to achieve sustainable medical attention at an affordable cost for society while assuring that we obtain quality medical attention. Medical treatment with IoT is assumed to contribute to the sustainability of social security payments and the development of productivity, and these advancements in medical devices are promoted through dialogues connecting doctors and engineers.
About the new technology pilot plan “Regulatory Sandbox System.”
The main aim is to support business activities using innovative technologies and business standards based on the Productivity Improvement Special Measures Act, which appeared into effect on June 6, 2018, the Japanese government began to lead the “New Technology Demonstration System,” so-called “Regulatory Sandbox System”. In this system, immediate demonstrations can be facilitated through limiting span and participants, as well as developing an environment where events of new technologies can be administered without being subject to the administration of existing regulations. This is a method that promotes regulatory reformation by making it feasible to utilize the information and materials collected in the demonstration.
A little knowledge of Clinical Development Support System advancement utilizing Blockchain Technology includes that clinical development has been implemented after the incorporation of Good Clinical Practice, GCP, in 1998, outsourcing expenses to contracted development companies such as the SMO (Site Management Organization) or CRO (Contract Research Organization) and have proceeded to increase. To assure the quality and trustworthiness of data in clinical trials, the expense of monitoring work has also raised, and the cost of development has grown due to the values of the literal review of raw materials. This is assumed to enhance further the importance of clinical development, which may direct to delays in clinical development. To approach these problems, Susmed is manifesting this new method using blockchain technology. Additionally, it administers research and development by implementing this system to free medical practice, along with receiving multiple related patents and publishing journals. The capableness of clinical development decreases the costs of developing new medical technologies and generates an ecosystem through an improvement in products of pipelines of pharmaceutical corporations and medical startup businesses. Through these actions, it can decrease the high prices of new medical technology and add to the balance between sustainable social safety costs and technological modernization.