More than half of Innovative Medical Device Software Companies Chose JNPMEDI's Maven CDMS

More than half of Innovative Medical Device Software Companies Chose JNPMEDI's Maven CDMS. Compared to existing medical devices, digital medical devices have rapidly developed related technologies such as AI and sensors, so the entire process of research, development, clinical trials, and licensing needs to be carried out quickly to keep up with them. Therefore, a clinical data management solution that can smoothly support data connection with external devices such as mobile and wearable devices and decentralized clinical trial (DCT) functions is essential, and that's why JNPMEDI's Maven CDMS was chosen by innovative medical device software companies.

In November last year, the Ministry of Food and Drug Safety made headlines by announcing the establishment of a dedicated organization that oversees the licensing, screening, and regulatory support of artificial intelligence (AI) medical devices and digital therapeutics (DTx). The new organization is welcoming the industry by revealing that it is trying to respond to the developing medical device industry by combining advanced digital technology in Korea.

In the United States, which is called an advanced medical country, the FDA has already approved a drug addiction digital treatment developed by Fair Therapeutics in 2017. Regulators around the world are actively supporting digital medical devices, such as Germany, which has a similar insurance system to Korea, passing the Digital Health Care Act (DVG) in 2019 and announcing digital health app prescriptions and benefits in August 2020.

The Ministry of Food and Drug Safety in Korea also established a certification system for innovative medical device software manufacturers in 2021 to support rapid commercialization by exempting some data when applying for product licenses. Since Vuno was selected as the first company, Lunit, Coreline Soft, and Huron have been selected, and recently Medical AI has newly joined the ranks as the fifth company. All the selected companies are Korea's leading digital medical device companies that are advancing to receive insurance fees after developing software based on excellent AI technology and going through clinical trials.

What is noteworthy is that more than half of these digital medical device companies chose JNPMEDI as their partner in clinical trials. Launched in March 2021, Maven CDMS (Clinical Data Management System) provides a user interface (UI/UX) with a convenient design that differentiates it from existing products and introduces a customizable software as a service (SaaS)-based billing structure to help customers quickly and accurately conduct clinical trials.

Compared to existing medical devices, digital medical devices have rapidly developed related technologies such as AI and sensors, so the entire process of research, development, clinical trials, and licensing needs to be carried out quickly to keep up with them. Therefore, a clinical data management solution that can smoothly support data connection with external devices such as mobile and wearable devices and decentralized clinical trial (DCT) functions is essential, and that's why JNPMEDI's Maven CDMS was chosen by these companies.

JNPMEDI launched Maven DTx Suite', a pre-term clinical support service, in March to closely support digital therapy companies, and plans to grow into a key partner in the industry in line with the evolving digital medical device trend.