“Celebrating World Medical Device Day: From South Korea to the U.S.” < Opinion < Article

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The Ministry of Food and Drug Safety (MFDS) has celebrated May 29, the day Korea enacted and proclaimed the Medical Device Act, as Medical Device Day since 2008. This day is commemorated with ceremonies aimed at enhancing consumer understanding of medical devices and fostering unity and communication among government, industry, academia, and consumer organizations involved in the medical device sector. As the event marks its 17th anniversary, Korea Biomedical Review will publish four congratulatory columns worldwide. This is the first installment.—Ed.


John Gatewood is AdvaMed (Advanced Medical Technology Association)’s vice president of global strategy and analysis, and Carolyn Hull is its senior director.


 


Introduction


AdvaMed works on behalf of members to ensure patient access to life-changing technologies. It leads the effort to advance medical technology for healthier lives and economies across the globe. AdvaMed also has a new Medical Imaging Division, representing a wide range of companies allowing professionals to diagnose, treat, and monitor patients. From AI-based innovations, data-driven insights, and digital health tech, these tools lead to better individual patient outcomes and benefits to the entire healthcare system. Saving lives and improving the quality of life for patients are core aspects of our industry. Our industry not only produces healthcare innovation and quality improvement, it creates jobs and invests significantly in R&D ($42 billion globally in 2022).


AdvaMed Vice President of Global Strategy and Analysis Joe Gatewood (left) and AdvaMed Senior Director Carolyn Hull
AdvaMed Vice President of Global Strategy and Analysis Joe Gatewood (left) and AdvaMed Senior Director Carolyn Hull


 


Growth statistics


The medical technology industry is one of the few in which saving lives and improving the quality of life for patients is at its core. In addition to improving health outcomes for patients, the medtech industry creates jobs and supports the economies of both the U.S. and South Korea. Our industry not only produces healthcare innovation and quality improvement, it creates jobs and invests significantly in R&D ($42 billion globally in 2022). The medtech industry is responsible for over two million jobs in the U.S. South Korea’s total market size was over $9.18 billion (12.6 trillion won) in 2022. (Korea Medical Devices Industry Association, or KMDIA, may be able to provide Korea employment figures for our industry to include here. The figures I saw indicated over 125,000 in Korea, but that was limited to med tech manufacturing only).


Since the outbreak of COVID-19 in 2020, there have been substantial changes in the Korean medical device market. Before the pandemic, Korea tended to be more of an import-driven country for medical devices. However, the high global demand for Korean-manufactured PPE and diagnostic test kits, starting in 2020, has led to increased importance assigned to domestic manufacturing capacity. Korea’s in vitro diagnostic market has grown dramatically over the last several years, aided by technological advances, commitments to manufacturing, and the implementation of Korea’s IVD Act in 2020. Additionally, the value of medical device imports into Korea rose by 20 percent in 2021. While total imports decreased from $5.4 billion in 2021 to $4.9 billion in 2022, the total Korean medical device market grew from $8.0 billion in 2021 to $9.2 billion in 2022 as domestic products gained market share. Of those devices imported into Korea, approximately 40 to 50 percent are manufactured by U.S. companies.


 


Global Collaboration-Stronger Together


KMDIA and AdvaMed have worked collaboratively for many years, including ensuring the passage of the Korea-U.S. Free Trade Agreement. We’ve also worked together in global organizations, such as the Global Medical Technology Alliance (GMTA) and the Global Diagnostics Imaging, Healthcare IT and Radiation Therapy Trade Association (DITTA). These groups work together on matters facing the medtech industry in the U.S., South Korea, and globally. Activities range from tracking regulations on AI and medical software to technical standards and trade facilitation. Collaboration between AdvaMed, KMDIA, and these groups helps set the tone for global harmonization and adoption of best regulatory practices.


 


Regulator Involvement


The U.S. Food and Drug Administration and South Korea’s Ministry of Food and Drug Safety work together as International Medical Device Regulators Forum members. Via this forum, regulators cooperate on documents that can later serve as harmonized regulations for IMDRF members and other jurisdictions. The IMDRF also allows regulators to share information and learn from each other. Korea and the U.S. maintain close alignment by adhering to globally harmonized regulatory standards, as advanced through IMDRF and supported by the FDA and MFDS. Continued work and focus on global regulatory harmonization are vital in improving the global landscape for medical technology and ensuring patient access to treatment.


KMDIA and AdvaMed also participate in IMDRF meetings and track their activities. Through participation in our trade associations and in groups such as GMTA and DITTA, members may submit technical experts to participate in IMDRF Working Groups and share knowledge in public workshops. This results in the sharing of best practices that benefit everyone involved.


This Medical Device Day, we recognize the outstanding collaboration and excellent work of KMDIA to improve public health and patients’ access to medical technology and wish you the best for your commemorative ceremony.


 

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