Growth of Clinical Trials in Korea’s Medical Device Industry

The clinical trial landscape in Korea’s medical device industry has seen significant changes over recent years. If you’re involved in this field, you’ll want to understand the trends and data driving these shifts.

Doubling of Clinical Trials in Seven Years

From 2018 to 2024, the number of clinical trial approvals for medical devices nearly doubled. Here’s a quick breakdown:

2018 saw 88 clinical trial approvals.
By 2024, approvals increased to 160.
Total trials from 2018 to 2024 amounted to 990.

Despite the fluctuations in yearly approvals, the general trend is upward.

Comparison with Pharmaceutical Trials

For perspective, drug trials far outnumber those for medical devices:

Drug trial approvals from 2018 to 2024 were 5,262.
Medical device trials were about five times fewer.

The reason for fewer medical device trials? Most devices are similar or modified versions that don’t need fresh clinical trials unless they are brand new or carry higher risk.

Emergence of Exploratory Clinical Trials

The trend shows an increase in exploratory clinical trials, albeit slowly. These trials assess the initial safety and efficacy of new device types:

In 2018, only 29 exploratory trials were approved.
By 2023, the number grew to 80.
Although it dropped to 57 in 2024, the long-term trend indicates growth.

Rise of Software-Based Medical Devices

Software-based devices are gaining traction. In the past three years, their clinical trials comprised 44.8% of all medical device trials:

In 2018, there were just 6 software device trials.
By 2023, this number surged to 105.
Overall, 301 software device trials were conducted from 2018 to 2024.

Advancements in digital healthcare and medical AI fuel this growth.

Purpose and Challenges of Clinical Trials

Korean medical device companies undertake trials primarily for marketing and regulatory purposes:

Marketing: 45%
Regulatory approval: 35%

Challenges include:

Cost: a critical issue for many companies.
Lack of specialized workforce.

Characteristics of Clinical Trials

Company surveys reveal additional details:

Trial types: 52% single-arm trials vs. 48% comparative trials.
Information sources: 38% use the Ministry of Food and Drug Safety’s electronic portal; 20% turn to CROs (Clinical Research Organizations).

Financial Insights

The financial demands of clinical trials are notable:

46.1% of trials cost under 100 million KRW.
28.2% range between 100 to 200 million KRW.
10.2% surpass 500 million KRW.

Government Support

Government participation varies:

54% receive 60% or less financial support.
Many rely on their funds to proceed with trials.

Key Challenges for Companies

The primary issues companies face in conducting trials include:

Significant financial burdens.
Securing execution partners.
Insufficient skilled personnel.

Conclusion

The Korean medical device industry’s clinical trials have seen considerable growth and transformation. Software-based medical devices are at the forefront of this change. However, financial and resource constraints remain a hurdle for many companies. Keep these trends in mind if you’re navigating this evolving landscape.