Korea has doubled the number of approved clinical trials for medical devices over the past seven years, yet most products cleared by regulators for market use have skipped patient testing entirely. 

From 2018 to 2024, trial approvals for medical devices climbed from 88 to 160 annually, according to data released last Thursday by the Korea Health Industry Development Institute (KHIDI).

But in the same window, pharma trials totaled 5,262, more than five times the volume. And while medtech trial activity is rising, very few products undergo human testing.

Just 1.76 percent of medical devices approved between 2018 and 2023 included clinical data in their filings, according to the report. Even when narrowing the scope to devices likely to need testing, such as new or high-risk types, the share barely cleared 4.49 percent.

The discrepancy reflects Korea’s regulatory structure, where “most devices are either cleared based on documentation or skip trials entirely,” the report states, adding that the current system makes it hard to prove “performance differentiation” between similar devices.

Digital tools dominate what growth there is. Over the past three years, AI tools and remote monitoring tech alone accounted for 44.8 percent of all medical device studies. 

“New device types that didn’t exist before are showing up in clinical trial approvals,” the report notes, signaling that some sponsors are moving earlier into proof-of-concept work.

But most of the trials approved remain small-scale or exploratory. Of the 160 trials approved in 2024, just 56 were exploratory. Only 85 involved software, and hardware-based or implantable innovations barely registered.

“Manufacturers are mainly developing modified or similar products with lower risk,” the report says, instead of pursuing novel, first-in-class technologies.

Beneath the trial statistics lies a larger reality: nearly all Korean medical devices are approved without trials. In 2023, just 132 of 7,065 approvals, or less than 2 percent, were backed by clinical data.

KHIDI notes that 98.2 percent of devices reached the market through “technical document review” alone. And among Class II or higher products, 95 percent were either generics or modifications, exempt from trial requirements.

Companies say cost is still the biggest reason they avoid clinical trials. In a 2023 survey, 46.1 percent of respondents said they spent less than 100 million won (roughly $72,300) per trial. Fewer than 11 percent spent over 500 million won ($360,150).

But money isn’t the only constraint. Recruitment timelines and patient access are also slowing teams down, while many cited “clinical trial design itself” as an emerging bottleneck.

Government funding helps, but it’s inconsistent. Only 24.3 percent of companies reported receiving more than 80 percent of their trial costs through public grants. The majority -- 54 percent -- received less than 60 percent of needed funding and had to finance the rest internally.

Korean device makers aren’t short on funding. According to the government’s 2023 cost disclosures, manufacturers spent an average of 2.45 billion won annually ($1.77 mil.) on clinical development. That number rose to 3.05 billion won for importers. But compared to pharma, it’s a drop in the bucket: drug companies spend 24.5 billion won ($17.7 mil) annually on average for trials -- nearly 10 times as much.

This cost gap speaks to different expectations around evidence and risk. “While pharma must meet stringent efficacy and safety thresholds, most devices face no such obligation,” the report explains.