As Korea entered a super-aged society last year, the digital medical device industry is emerging as a new growth engine. The application scope of digital devices is rapidly expanding, from managing chronic diseases based on information and communication technology (ICT) to early detection of diseases using artificial intelligence (AI). The status of “K-medical devices” is also rising in overseas markets such as the United States, Europe, and Japan.
According to the Ministry of Food and Drug Safety (MFDS) on July 13, the production and export values of domestic digital medical devices last year recorded 547.2 billion won and $334 million, respectively. These figures represent increases of 252% and 178% compared to the production value (155.2 billion won) and export value ($120 million) of 2020. This is encouraging compared to the overall medical device production value, which grew by 12% during the same period, while the export value actually decreased by 8%. An MFDS official said, “Recently, with the increase in software development utilizing AI technology, various functional digital medical devices are emerging.”
Digital medical devices are gaining attention as a key field that can solve social problems such as reducing medical costs in a super-aged society while driving industrial growth. Recently, technologies that allow patients to predict and manage diseases on their own at home, rather than in hospitals, are emerging one after another, gradually shifting the focus of medical care from treatment-centered to prevention-centered, and from doctor-centered to patient-centered. In particular, Korea has very favorable conditions for establishing a real-world usage environment for digital medical devices based on advanced infrastructure such as 5th generation (5G) communication.
For example, Kakao Healthcare has developed “Pasta,” a mobile health management solution linked to continuous glucose monitoring (CGM), which analyzes diet, exercise, and sleep data of diabetic patients and shares this with medical institutions, helping to manage chronic diseases. Sears Technology’s bed monitoring solution “Think” analyzes patients’ vital signs in hospitals to detect risks such as cardiac arrest, falls, and sepsis early and notifies medical staff, reducing the burden of patient management on hospitals. Lunit is supporting earlier diagnosis of major cancers such as lung cancer and breast cancer using the AI image diagnostic software “Lunit INSIGHT.”
Overseas expansion is also active. Kakao Healthcare plans to launch the Pasta service in Japan in September, and Sears Technology is also in the process of obtaining FDA approval for its arrhythmia diagnosis service “MobiCare” to enter overseas markets. Lunit is also accelerating its entry into overseas medical institutions and the public sector after acquiring Volpara, a U.S. company with over 100 million medical data points.
The government is also actively providing institutional support for this growth trend. The Digital Medical Product Act, implemented in January this year as a world first, is a prime example. This law reflects the characteristics of AI digital medical devices that frequently learn from data, allowing minor changes to be reported when obtaining product approval while strengthening transparency by requiring the disclosure of AI learning data information.
However, regulatory improvements are still necessary to accelerate the growth of the digital medical device industry. Medical devices using advanced technology currently require up to 490 days from approval to confirmation of health insurance coverage and new medical technology evaluation. While the government has announced the implementation of an “immediate market entry system” to reduce this to a maximum of 140 days, the industry insists that the “dual regulation” of having to undergo a new medical technology evaluation even after receiving approval from the Ministry of Food and Drug Safety must be abolished. An industry official emphasized, “We need to establish a foundation to fully utilize Korea’s potential in the rapidly growing medical device market.”
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