The government is moving to establish a “fast track” to help AI-powered digital medical device companies overcome market entry barriers and expand adoption in clinical settings. / Courtesy of News1

The government will establish a “fast track” system to accelerate the commercialization of artificial intelligence (AI)-based digital medical devices, aiming to help companies overcome market entry barriers and expand adoption in the healthcare sector, the Ministry of Health and Welfare said Monday.

The ministry outlined the initiative during a briefing session for its “Rapid Commercialization Support Project for AI Applications,” explaining the program’s objectives, structure and participation requirements to digital medical device manufacturers.

The project is part of the broader, cross-government “AX-Sprint” initiative — a $5.03 billion program designed to fast-track AI transformation across industries. The effort brings together 11 government ministries to support the rapid deployment of AI-powered products that can be commercialized within one to two years.

Within the healthcare sector, the ministry plans to allocate $300 million, including $53.3 million for digital medical devices and $60 million for chronic disease management programs.

The initiative is intended to address a key bottleneck in the healthcare AI ecosystem. Even after securing regulatory approval from authorities such as the Ministry of Food and Drug Safety, companies often face lengthy and complex clinical validation and evaluation processes before their products can be adopted in real-world medical settings — a phase commonly referred to as the “Death Valley” of commercialization.

To bridge this gap, the program will require AI medical device developers and hospitals to form consortia. Selected participants will receive multi-year support across all stages of market entry, including multi-center clinical validation, real-world data accumulation and cost-effectiveness evaluations.

The ministry said the program will also cover marketing expenses to support hospital adoption and revenue generation, positioning the initiative as a comprehensive pathway from research and development to full-scale commercialization.

Further details are available on the Asia Health Industry Development Institute website. Applications for the program will be accepted through April 24.

The government will establish a “fast track” system to accelerate the commercialization of …

Health Ministry to build “fast track” for commercialization of AI digital medical devices