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Subject The Korea University Guro Hospital are focused on specialized R&BD platform management, the In-Vitro Diagnostic Medical Device
Selection News Date 2015-11-12 Read 8726

The Korea University Guro Hospital has shown rapid growth on establishment of research–oriented environment to strengthen technology industrialization through Industry-University, research, and activation of hospital convergence research. As a result, the Guro Hospital was appointed as the Research-driven hospital by the Ministry of Health-Welfare. 

As the medical industry is considered to be a new growth engine for the future, The Korea University Guro Hospital is focusing on realizing commercialization model of the successful research result and establishing open-convergence technology development platform among subject of Industry-University, research, and hospital through outstanding research accomplishment and accumulated know-how on technology development. In particular, the in-Vitro Diagnostic medical device industry is shows the fast growth since it includes relatiely short period of developing time and has higher thecnological competitiveness through the easy intergration with IT technology, comparing with the new medicine development industry with high risk and reuqring long period of developing time and enormous expense.


Meanwhile, The Korea University Guro Hospital has accumulated know-how in medical device development managing various centers according to the stages. In 2005, the Guro hospital founded the Medical Device Clinical Trial Center in the frist time in Korea. In 2009, the center was appointed as the national supported medical device clinical trial center and granted the research funds as the amount of 5 billion won for 5 years from the Ministry of Health-Welfare. In addition, the center has been it's domestic and international reputation by receiving received the International standard(ISO9001, ISO14001) for the first time as a Korean medical device clinical trial center, and the EC/IRB Recognition from the FERCAP(Forum for Ethical Review Committees in Asia and the Western Pacific).
Moreover, The Korea University Guro Hospital has established Development-Intermediate Clinical Supporting Center for In-Vitro Diagnostic medical device specialization, and built a close cooperation process including 9 government-affiliated institutes, various laboratories, hospitals, and major universities overseas along with high-tech medical device development support center, and Osong/Deagu-Gyeongbuk medical innovation foundation to perform In-Vitro Diagnostic medical device clinical test, test product manufacturing, function evaluation, and licensing to enter market in advance. Not only that, through the collaboration with about 70 companies engaged in manufacturing and consulting business information with industrial site are exchanged to play an important role to connect medical and industry field for effective medical device development.


Based on such experience, facility, system, and research capacity, The Korea University Guro Hospital Development-Intermediate Clinical Supporting Center has been in charge of omnidirectional supports needed for clinical test, and licensing, the vital elements of medical device technology development and product industry and selected as ‘Medical Device Intermediate Clinical Supporting Center R&D business pre-research agency.’


Researchers of the pre-research department of Korea University Guro Hospital medical device Intermediate Clinical Supporting Center, secure specialized career in developing In-Vitro Diagnostic medical device. Professor Chae-seung Lim, the leader of the diagnosing chip development who has experience of diagnostic reagent and device development, also secures a specialized background bio chip development and blood diagnosis technology as he received FDA approval for the first time in Korea under the recognition of blood-analysis device. Professor U-ju Kim, Department of Infectious Diseases, who is in charge of Influenza a virus subtype H1N1 governmental department management team is proceeding Influenza A virus subtype H1N1 diagnosing chip as the start of other various development task regarding diagnosing chip. Professor Hae-ryong Song, Department of Orthopedic Surgery, has his own know-how over protocol development for clinical test and commercialization technology by expediting bone densitometer and movable ultrasonic instrument development. Moreover, he has been managing Bone defect and disease fusion-therapy center and considered to be the representative leader of research over diagnosing and analyzing chips for gene of patient with dwarfism.


One of the competencies of Korea University Guro Hospital is the establishment of wide range of network with experts in academic circles. Professor Sin Se-hyeon, the department of mechanics, the Korea University engineering college, is acknowledged as an authority in enhancement of new technology that diagnoses thrombosis early by applying Biomimetics and rigorous analysis to the microchip. Professor Hyeok Choi, Department of Medical Science, Korea University, is taking an important role as a reliability expert in applying such analytic technology as FEMA, FTA and RCA to the medical device. He also secures 6 patent registrations and Application record regarding In-Vitro Diagnostic medical device.


Now and for ever, the Korea University Guro Hospital will build In-Vitro Diagnostic medical device medical device Intermediate Clinical test supporting infrastructure and focus on establishment of cooperation research system small and venture business and researcher.

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