The Critical Role of Early Regulatory Planning and Intended Use Definition in Achieving Successful Global Market Entry
Korea’s medical device industry is growing at a remarkable pace. Domestic companies are earning global recognition across artificial intelligence-based medical devices, digital healthcare, and robotics — with R&D investment for international expansion continuing to accelerate. Collaboration between pharmaceutical and medical device companies is increasing, and AI-powered medical device development leveraging Korea’s advanced IT capabilities is progressing rapidly.
A particularly notable trend is the rise of clinician-led device development and spin-off ventures driven by unmet clinical needs identified at the point of care. This reflects a broader transformation of Korea’s medical device sector — evolving from a manufacturing-focused industry into an innovation-driven one, rooted in solving real-world clinical problems.
Yet for those working in clinical development and regulatory strategy, a recurring challenge emerges across companies regardless of their technological sophistication: development begins before the intended use and clinical strategy have been sufficiently defined.
The Intended Use Problem: A Gap Between Developer and Regulator
In the in vitro diagnostics (IVD) space, for example, companies frequently seek to define “early diagnosis” as their intended use. From a developer’s perspective, this concept seems intuitive — a test that detects abnormal signals in patients not yet formally diagnosed, enabling faster initiation of treatment.
However, regulatory agencies interpret “early diagnosis” far more stringently. Substantiating such a claim typically requires enrollment of pre-symptomatic subjects, followed by long-term prospective follow-up to confirm actual disease onset. As a result, many companies find themselves required to provide years of longitudinal clinical data — or are asked to revise or remove the term from their intended use statement entirely.
Similar challenges arise in AI-based imaging devices. A company developing software to detect lesions and flag abnormal findings may seek approval for “diagnostic assistance” — only to be told that the available clinical evidence is insufficient to support a final diagnostic claim. The intended use is then narrowed to providing risk indicators or prompting further evaluation, rather than supporting diagnosis directly.
These may appear to be subtle differences in wording, but their implications are significant. A change in intended use alters the primary endpoints, the target patient population, and the fundamental design of the clinical trial — requiring the entire study to be reconsidered.
The Hidden Gap in AI Biomarker Development
Commentary by Eunhye Kim, Director, BXPLANT
A growing number of companies are leveraging AI to identify novel biomarkers and develop diagnostic products based on these findings. Analyzing large-scale datasets to uncover previously unrecognized biological signals or patterns — and translating these into diagnostic algorithms — represents one of the most exciting frontiers in medical device innovation.
However, a critical step is frequently overlooked in this process: establishing the clinical relevance between a newly proposed biomarker and the disease in question. Even if AI detects a compelling pattern in the data, a clear understanding of how that indicator relates to actual disease onset or progression must be established before a diagnostic product development pathway can be justified. Without this foundation, the path from discovery to approved device remains uncertain.
Technology Is Not Enough: Strategy Must Come First
These examples share a common lesson. In medical device development, what matters is not only the technology itself, but the strategic framework that defines the clinical problem it addresses and the evidence required to substantiate its value. Clinical and regulatory considerations must be integrated from the outset — beginning at the stage of intended use definition and clinical strategy formulation — not retrofitted after the technology has been built.
Encouragingly, government agencies and industry bodies are expanding consulting programs and support initiatives to assist medical device companies with development strategy. However, these resources remain underutilized in many cases. Greater industry-wide awareness of the value of early strategic consulting — and an environment that actively encourages its use — is needed.
Korea’s medical device industry already possesses exceptional technological capability and innovative thinking. When these strengths are paired with rigorous clinical development strategy and regulatory expertise, the industry is well-positioned to achieve meaningful and sustained growth in global markets.
source : “The Next Leap for Korea’s Medical Device Industry: Why Clinical Strategy Matters as Much as Technology”, Medical News BOSA, 2026.03.23., https://www.bosa.co.kr/news/articleView.html?idxno=3000514
