World’s First, Localized, and Social Problem–Solving Medical Devices
“10 selected from 869 outcomes across 90 institutions”
Ten technologies to be announced annually and fostered as leading innovations
Officials from the research institutions implementing the Top 10 Flagship Projects selected at the “2023 Performance Report Meeting,” hosted on the 23rd by the Pan-Ministry Full-Cycle Medical Device R&D Program Committee at the Westin Josun Hotel in Jung-gu, Seoul, pose for a commemorative photo. / Reporter Yang-hyeok Kim
The government announced 10 key technologies aimed at boosting medical device exports to approximately KRW 21 trillion by 2027 and elevating Korea to the world’s fifth-largest medical device exporter. The announcement shared a wide range of promising domestic medical device development efforts—from devices expected to be developed for the first time in the world, to the localization of medical devices previously dependent on imports, as well as technologies addressing health security and social challenges. The government plans to identify and foster 10 flagship projects each year, starting with the inaugural selection announced this year, to cultivate future growth engines.
On the 23rd, the Pan-Ministry Full-Cycle Medical Device R&D Program Committee held the “2023 Performance Report Meeting” at the Westin Josun Hotel in Jung-gu, Seoul, where it announced the Top 10 Flagship Projects. The event was jointly sponsored by four ministries—the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety—and marked the first performance report meeting since the committee’s launch.
Regarding the selected projects, Beop-min Kim, Head of the Program Committee, stated, “Since our launch, we have supported a wide range of research projects to improve the success rate of medical device R&D and have established a full-cycle support system as a platform to ensure the creation of outstanding outcomes.” He added, “We will actively communicate with researchers to drive the commercialization of medical devices.” He further explained, “The flagship projects selected each year may include technologies that were previously selected, as well as entirely new ones.”
The flagship projects selected this time are expected to serve as a central driving force in achieving the Yoon Suk Yeol administration’s goal of becoming the world’s fifth-largest medical device exporter. Earlier this February, the government announced plans to increase medical device exports from USD 8.6 billion in 2021 to USD 16 billion by 2027, positioning Korea among the top five exporting countries globally.
The 10 projects announced span a range of promising fields, including medical imaging diagnostics, in vitro diagnostics, dental technologies, and digital health. Among them, three projects are expected to earn the distinction of being the world’s first in their respective areas.
Kim explained, “The projects were selected through an evaluation based on the appropriateness of R&D execution and the technological, medical, social, and economic ripple effects, from among 869 outcomes submitted by 90 institutions.”
Below is a list of the Top 10 medical device projects currently underway since 2020, along with the selected institutions and their development status.
A schematic of a patient-specific integrated dental model. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
① Development of an AI-Oriented Intelligent Chairside K-Dental Solution
A project led by Imagoworks, ODX, and Vatech aims to become the world’s first to implement a patient-specific integrated dental model. By utilizing dental diagnostic software, the project establishes AI-based, patient-optimized diagnoses and treatment plans.
Development is scheduled to run from September 1, 2020, to December 31, 2024, with KRW 13.9 billion in government funding. To date, the project has also secured a total of KRW 13.9 billion in external investment through Series A and B rounds. Additionally, it has recorded five technology transfer agreements totaling KRW 3.5 billion.
A brain-dedicated positron emission tomography (PET) system. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
② Development of a Brain-Dedicated PET System and Convergent Molecular Imaging Platform Technology to Overcome Degenerative Brain Diseases
Brightonics Imaging is pursuing the localization of medical devices by developing Korea’s first brain-dedicated positron emission tomography (PET) system targeting age-related diseases such as dementia and Parkinson’s disease. Currently, diagnosis of age-related neurological disorders typically requires linkage with computed tomography (CT) and magnetic resonance imaging (MRI); this technology, however, enables disease assessment by imaging only changes in glucose metabolism within specific regions of the brain.
The project has received the Korea Innovation Startup Award and the Minister of Science and ICT Award. The research period runs from September 1, 2020, to December 31, 2025, with government funding of KRW 11.606 billion.
A peripheral microvascular ultrasound–photoacoustic fusion imaging device. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
③ Development and Commercialization of a Peripheral Microvascular Ultrasound–Photoacoustic Fusion Imaging Device
A project led by the POSTECH Industry–Academic Cooperation Foundation aims to develop a peripheral microvascular diagnostic device by fusing ultrasound and photoacoustic imaging, without invasion, contrast agents, or radiation, a world-first approach. Peripheral vascular disease involves impaired blood circulation in distal parts of the body such as the hands or feet and, in severe cases, can lead to necrosis or even amputation. However, more than half of patients show no externally visible symptoms, making early diagnosis difficult.
If this development is successfully completed, it is expected to enable early diagnosis, thereby preventing severe outcomes such as necrosis and amputation. The research period runs through December 31, 2024, with government funding of KRW 5.333 billion.
A wearable insulin automatic delivery system by EOFlow. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
④ Development of the World’s First Wearable Automatic Insulin Delivery System for Insulin-Dependent Diabetes Patients
The project aims to develop an automatic insulin delivery system based on a world-leading artificial pancreas (AP). EOFlow has been developing the system for patients with chronic diabetes since September 2020 through the end of this year. A patch is attached to areas such as the abdomen or upper arm, replacing injections; the system measures blood glucose levels every five minutes, automatically adjusts the insulin dose, and delivers insulin accordingly.
This system became the first Korean medical device to be designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). A single device can be used for up to 84 hours, and it can be attached or detached during activities such as showering or exercise. Its greatest advantage is the ability to continuously monitor the system through a mobile application. The product has already been exported to countries including Italy, Indonesia, and the United Arab Emirates.
AI-based ultra-fast magnetic resonance imaging (MRI) software developed by AIRS Medical. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑤ Development of an Innovative AI-Based Ultra-Fast MRI Imaging Software
AIRS Medical is working to contribute to public healthcare welfare and address social challenges by significantly reducing MRI scan times and enhancing image resolution through AI-based technologies. The software delivers high-quality medical images while reducing conventional MRI scan times by up to one-tenth.
The technology gained global recognition after ranking first at a global MRI accelerated imaging deep learning reconstruction competition hosted by Facebook, outperforming major companies such as Philips and Siemens. AIRS Medical has also demonstrated strong external validation of its technological capabilities, having secured more than KRW 25 billion in Series B funding.
A conceptual diagram of a radiation sensitivity diagnostic kit for head and neck cancer patients. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑥ Development of a Radiation Sensitivity Diagnostic Kit for Head and Neck Cancer Patients
The project aims to predict the effectiveness of radiation therapy in advance for patients with head and neck cancer, thereby enhancing patient benefit and enabling personalized treatment. The head and neck region contains vital organs involved in eating, speaking, and breathing, making organ-preserving treatment strategies critically important. However, the effectiveness of radiation therapy and the incidence of side effects vary significantly from patient to patient.
By using the radiation sensitivity diagnostic kit, patients who are predicted to respond poorly to radiation therapy can be identified in advance, supporting clinical decision-making to replace radiation therapy with non-radiation treatments such as surgery or chemotherapy. The research is currently being conducted by the Gachon University Industry–Academic Cooperation Foundation.
A portable cardiopulmonary circulatory support device. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑦ Commercialization of a Portable Cardiopulmonary Circulatory Support Device Using Counterpulsation Control
This project aims to localize (domestically manufacture) extracorporeal membrane oxygenation (ECMO) systems for the first time in Korea, thereby strengthening emergency medical response capabilities and national health security during infectious disease outbreaks. Although demand for ECMO increased significantly during the MERS and COVID-19 pandemics, Korea experienced severe equipment shortages due to export restrictions imposed by overseas manufacturing countries, which made imports unavailable.
As a result, domestic production has become urgent to ensure a stable supply and price competitiveness. The development is being carried out through a collaboration among Samsung Medical Center, Kangwon National University Industry–Academic Cooperation Foundation, Insung Medical, and CGBio, with completion targeted for the end of 2025.
Mandro myoelectric prosthetic hand (electronic prosthesis). / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑧ Development of an Integrated In-Finger and Palm Drive System for Myoelectric Prosthetic Hands
This project aims to develop, for the first time in Korea, a domestic drive system—including ultra-compact motors, gear reducers, and controllers, which are the core components of myoelectric prosthetic hands (electronic prostheses).
Currently, most myoelectric prosthetic hands rely on imported components, resulting in high prices and an extremely low domestic adoption rate of approximately 0.1%. Although some domestically manufactured products exist, they still depend on foreign-made motors, preventing them from achieving sufficient price competitiveness.
Mand.ro plans to launch a competitively priced product within the year, offering a clear cost advantage compared to overseas products priced at more than KRW 40 million.
MediInTech gastrointestinal electronic endoscope. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑨ Development and Commercialization of a High-Performance Smart Flexible Electronic Endoscope System for Gastrointestinal Use Based on AI and Motorization Technologies
This project aims to achieve world-class image quality during endoscopic procedures by utilizing ultra-compact optical systems, LED light sources, and image-processor-based technology. The current endoscopy market is dominated by Japanese companies.
The system also introduces a motorized control mechanism, enabling the endoscope “scope”—which detects abnormalities inside the patient’s body—to be moved electrically, similar to a game joystick, rather than being manipulated manually.
MediInTech plans to develop an endoscope incorporating AI and motorization technologies by 2025, thereby contributing to the localization (domestic production) of medical endoscopy devices.
Bioneer fully automated, high-throughput molecular diagnostic PCR system with integrated sample preparation. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑩ Validation of In Vitro Diagnostic Reagents for HBV, HCV, and HIV to Obtain European IVD Certification
This project aims to conduct clinical trials and obtain overseas regulatory approvals for the world’s first fully automated, high-throughput molecular diagnostic PCR system with integrated sample preparation.
The system is capable of simultaneously diagnosing five infectious diseases, including Hepatitis B virus (HBV), Hepatitis C virus (HCV), and Human Immunodeficiency Virus (HIV).
Developed and manufactured domestically, the system is expected to replace equipment and diagnostic reagents currently dominated by major overseas diagnostic companies under exclusive supply structures.
Bioneer is proceeding with the project with the goal of completion by 2025.
View the original article
- 조선비즈: https://biz.chosun.com/science-chosun/medicine-health/2023/05/23/GKD5BHJNF5GMRPQ2534EWHGZDI/
- 의학신문: http://www.bosa.co.kr/news/articleView.html?idxno=2197787
- 파이낸셜뉴스: https://www.fnnews.com/news/202305231305124949
- 세계일보: https://www.segye.com/newsView/20230523513771?OutUrl=naver
- 히트뉴스: http://www.hitnews.co.kr/news/articleView.html?idxno=45601
- 이데일리: https://www.edaily.co.kr/news/read?newsId=02601046635611872&mediaCodeNo=257&OutLnkChk=Y
- 한국경제TV: https://www.wowtv.co.kr/NewsCenter/News/Read?articleId=A202305230180&t=NN
- 디지털타임스: https://www.dt.co.kr/contents.html?article_no=2023052302109923039003&ref=naver
- 서울신문: https://n.news.naver.com/article/081/0003363295?sid=101
- 라포르시안: https://www.rapportian.com/news/articleView.html?idxno=161167
- 아주경제: https://www.ajunews.com/view/20230523142927603
World’s First, Localized, and Social Problem–Solving Medical Devices
“10 selected from 869 outcomes across 90 institutions”
Ten technologies to be announced annually and fostered as leading innovations
Officials from the research institutions implementing the Top 10 Flagship Projects selected at the “2023 Performance Report Meeting,” hosted on the 23rd by the Pan-Ministry Full-Cycle Medical Device R&D Program Committee at the Westin Josun Hotel in Jung-gu, Seoul, pose for a commemorative photo. / Reporter Yang-hyeok Kim
The government announced 10 key technologies aimed at boosting medical device exports to approximately KRW 21 trillion by 2027 and elevating Korea to the world’s fifth-largest medical device exporter. The announcement shared a wide range of promising domestic medical device development efforts—from devices expected to be developed for the first time in the world, to the localization of medical devices previously dependent on imports, as well as technologies addressing health security and social challenges. The government plans to identify and foster 10 flagship projects each year, starting with the inaugural selection announced this year, to cultivate future growth engines.
On the 23rd, the Pan-Ministry Full-Cycle Medical Device R&D Program Committee held the “2023 Performance Report Meeting” at the Westin Josun Hotel in Jung-gu, Seoul, where it announced the Top 10 Flagship Projects. The event was jointly sponsored by four ministries—the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health and Welfare, and the Ministry of Food and Drug Safety—and marked the first performance report meeting since the committee’s launch.
Regarding the selected projects, Beop-min Kim, Head of the Program Committee, stated, “Since our launch, we have supported a wide range of research projects to improve the success rate of medical device R&D and have established a full-cycle support system as a platform to ensure the creation of outstanding outcomes.” He added, “We will actively communicate with researchers to drive the commercialization of medical devices.” He further explained, “The flagship projects selected each year may include technologies that were previously selected, as well as entirely new ones.”
The flagship projects selected this time are expected to serve as a central driving force in achieving the Yoon Suk Yeol administration’s goal of becoming the world’s fifth-largest medical device exporter. Earlier this February, the government announced plans to increase medical device exports from USD 8.6 billion in 2021 to USD 16 billion by 2027, positioning Korea among the top five exporting countries globally.
The 10 projects announced span a range of promising fields, including medical imaging diagnostics, in vitro diagnostics, dental technologies, and digital health. Among them, three projects are expected to earn the distinction of being the world’s first in their respective areas.
Kim explained, “The projects were selected through an evaluation based on the appropriateness of R&D execution and the technological, medical, social, and economic ripple effects, from among 869 outcomes submitted by 90 institutions.”
Below is a list of the Top 10 medical device projects currently underway since 2020, along with the selected institutions and their development status.
A schematic of a patient-specific integrated dental model. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
① Development of an AI-Oriented Intelligent Chairside K-Dental Solution
A project led by Imagoworks, ODX, and Vatech aims to become the world’s first to implement a patient-specific integrated dental model. By utilizing dental diagnostic software, the project establishes AI-based, patient-optimized diagnoses and treatment plans.
Development is scheduled to run from September 1, 2020, to December 31, 2024, with KRW 13.9 billion in government funding. To date, the project has also secured a total of KRW 13.9 billion in external investment through Series A and B rounds. Additionally, it has recorded five technology transfer agreements totaling KRW 3.5 billion.
A brain-dedicated positron emission tomography (PET) system. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
② Development of a Brain-Dedicated PET System and Convergent Molecular Imaging Platform Technology to Overcome Degenerative Brain Diseases
Brightonics Imaging is pursuing the localization of medical devices by developing Korea’s first brain-dedicated positron emission tomography (PET) system targeting age-related diseases such as dementia and Parkinson’s disease. Currently, diagnosis of age-related neurological disorders typically requires linkage with computed tomography (CT) and magnetic resonance imaging (MRI); this technology, however, enables disease assessment by imaging only changes in glucose metabolism within specific regions of the brain.
The project has received the Korea Innovation Startup Award and the Minister of Science and ICT Award. The research period runs from September 1, 2020, to December 31, 2025, with government funding of KRW 11.606 billion.
A peripheral microvascular ultrasound–photoacoustic fusion imaging device. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
③ Development and Commercialization of a Peripheral Microvascular Ultrasound–Photoacoustic Fusion Imaging Device
A project led by the POSTECH Industry–Academic Cooperation Foundation aims to develop a peripheral microvascular diagnostic device by fusing ultrasound and photoacoustic imaging, without invasion, contrast agents, or radiation, a world-first approach. Peripheral vascular disease involves impaired blood circulation in distal parts of the body such as the hands or feet and, in severe cases, can lead to necrosis or even amputation. However, more than half of patients show no externally visible symptoms, making early diagnosis difficult.
If this development is successfully completed, it is expected to enable early diagnosis, thereby preventing severe outcomes such as necrosis and amputation. The research period runs through December 31, 2024, with government funding of KRW 5.333 billion.
A wearable insulin automatic delivery system by EOFlow. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
④ Development of the World’s First Wearable Automatic Insulin Delivery System for Insulin-Dependent Diabetes Patients
The project aims to develop an automatic insulin delivery system based on a world-leading artificial pancreas (AP). EOFlow has been developing the system for patients with chronic diabetes since September 2020 through the end of this year. A patch is attached to areas such as the abdomen or upper arm, replacing injections; the system measures blood glucose levels every five minutes, automatically adjusts the insulin dose, and delivers insulin accordingly.
This system became the first Korean medical device to be designated as a Breakthrough Device by the U.S. Food and Drug Administration (FDA). A single device can be used for up to 84 hours, and it can be attached or detached during activities such as showering or exercise. Its greatest advantage is the ability to continuously monitor the system through a mobile application. The product has already been exported to countries including Italy, Indonesia, and the United Arab Emirates.
AI-based ultra-fast magnetic resonance imaging (MRI) software developed by AIRS Medical. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑤ Development of an Innovative AI-Based Ultra-Fast MRI Imaging Software
AIRS Medical is working to contribute to public healthcare welfare and address social challenges by significantly reducing MRI scan times and enhancing image resolution through AI-based technologies. The software delivers high-quality medical images while reducing conventional MRI scan times by up to one-tenth.
The technology gained global recognition after ranking first at a global MRI accelerated imaging deep learning reconstruction competition hosted by Facebook, outperforming major companies such as Philips and Siemens. AIRS Medical has also demonstrated strong external validation of its technological capabilities, having secured more than KRW 25 billion in Series B funding.
A conceptual diagram of a radiation sensitivity diagnostic kit for head and neck cancer patients. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑥ Development of a Radiation Sensitivity Diagnostic Kit for Head and Neck Cancer Patients
The project aims to predict the effectiveness of radiation therapy in advance for patients with head and neck cancer, thereby enhancing patient benefit and enabling personalized treatment. The head and neck region contains vital organs involved in eating, speaking, and breathing, making organ-preserving treatment strategies critically important. However, the effectiveness of radiation therapy and the incidence of side effects vary significantly from patient to patient.
By using the radiation sensitivity diagnostic kit, patients who are predicted to respond poorly to radiation therapy can be identified in advance, supporting clinical decision-making to replace radiation therapy with non-radiation treatments such as surgery or chemotherapy. The research is currently being conducted by the Gachon University Industry–Academic Cooperation Foundation.
A portable cardiopulmonary circulatory support device. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑦ Commercialization of a Portable Cardiopulmonary Circulatory Support Device Using Counterpulsation Control
This project aims to localize (domestically manufacture) extracorporeal membrane oxygenation (ECMO) systems for the first time in Korea, thereby strengthening emergency medical response capabilities and national health security during infectious disease outbreaks. Although demand for ECMO increased significantly during the MERS and COVID-19 pandemics, Korea experienced severe equipment shortages due to export restrictions imposed by overseas manufacturing countries, which made imports unavailable.
As a result, domestic production has become urgent to ensure a stable supply and price competitiveness. The development is being carried out through a collaboration among Samsung Medical Center, Kangwon National University Industry–Academic Cooperation Foundation, Insung Medical, and CGBio, with completion targeted for the end of 2025.
Mandro myoelectric prosthetic hand (electronic prosthesis). / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑧ Development of an Integrated In-Finger and Palm Drive System for Myoelectric Prosthetic Hands
This project aims to develop, for the first time in Korea, a domestic drive system—including ultra-compact motors, gear reducers, and controllers, which are the core components of myoelectric prosthetic hands (electronic prostheses).
Currently, most myoelectric prosthetic hands rely on imported components, resulting in high prices and an extremely low domestic adoption rate of approximately 0.1%. Although some domestically manufactured products exist, they still depend on foreign-made motors, preventing them from achieving sufficient price competitiveness.
Mand.ro plans to launch a competitively priced product within the year, offering a clear cost advantage compared to overseas products priced at more than KRW 40 million.
MediInTech gastrointestinal electronic endoscope. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑨ Development and Commercialization of a High-Performance Smart Flexible Electronic Endoscope System for Gastrointestinal Use Based on AI and Motorization Technologies
This project aims to achieve world-class image quality during endoscopic procedures by utilizing ultra-compact optical systems, LED light sources, and image-processor-based technology. The current endoscopy market is dominated by Japanese companies.
The system also introduces a motorized control mechanism, enabling the endoscope “scope”—which detects abnormalities inside the patient’s body—to be moved electrically, similar to a game joystick, rather than being manipulated manually.
MediInTech plans to develop an endoscope incorporating AI and motorization technologies by 2025, thereby contributing to the localization (domestic production) of medical endoscopy devices.
Bioneer fully automated, high-throughput molecular diagnostic PCR system with integrated sample preparation. / Pan-Ministry Full-Cycle Medical Device R&D Program Committee
⑩ Validation of In Vitro Diagnostic Reagents for HBV, HCV, and HIV to Obtain European IVD Certification
This project aims to conduct clinical trials and obtain overseas regulatory approvals for the world’s first fully automated, high-throughput molecular diagnostic PCR system with integrated sample preparation.
The system is capable of simultaneously diagnosing five infectious diseases, including Hepatitis B virus (HBV), Hepatitis C virus (HCV), and Human Immunodeficiency Virus (HIV).
Developed and manufactured domestically, the system is expected to replace equipment and diagnostic reagents currently dominated by major overseas diagnostic companies under exclusive supply structures.
Bioneer is proceeding with the project with the goal of completion by 2025.
View the original article
- 조선비즈: https://biz.chosun.com/science-chosun/medicine-health/2023/05/23/GKD5BHJNF5GMRPQ2534EWHGZDI/
- 의학신문: http://www.bosa.co.kr/news/articleView.html?idxno=2197787
- 파이낸셜뉴스: https://www.fnnews.com/news/202305231305124949
- 세계일보: https://www.segye.com/newsView/20230523513771?OutUrl=naver
- 히트뉴스: http://www.hitnews.co.kr/news/articleView.html?idxno=45601
- 이데일리: https://www.edaily.co.kr/news/read?newsId=02601046635611872&mediaCodeNo=257&OutLnkChk=Y
- 한국경제TV: https://www.wowtv.co.kr/NewsCenter/News/Read?articleId=A202305230180&t=NN
- 디지털타임스: https://www.dt.co.kr/contents.html?article_no=2023052302109923039003&ref=naver
- 서울신문: https://n.news.naver.com/article/081/0003363295?sid=101
- 라포르시안: https://www.rapportian.com/news/articleView.html?idxno=161167
- 아주경제: https://www.ajunews.com/view/20230523142927603