1.Healthcare Experts’ Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea:Introduction of Clinical Unmet Needs-Based Intended Use Establishment (CLUE) Templates
You Kyoung LEE ; Eugene LIH ; MinYoung KIM ; Soo Young KIM ; Ki Chang NAM ; Jaesoon CHOI ; Il-Ho PARK ; Su-Kyoung LEE ; Soe Ye Yint TUN ; Ei Shwe Yi PHOO ; Jin Woo LEE
Journal of Korean Medical Science 2024;39(40):e311-
		                        		
		                        			 Background:
		                        			A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. 
		                        		
		                        			Methods:
		                        			The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. 
		                        		
		                        			Results:
		                        			The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. 
		                        		
		                        			Conclusion
		                        			The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use. 
		                        		
		                        		
		                        		
		                        	
2.Metabolic Dysfunction-Associated Steatotic Liver Disease in Type 2 Diabetes Mellitus: A Review and Position Statement of the Fatty Liver Research Group of the Korean Diabetes Association
Jaehyun BAE ; Eugene HAN ; Hye Won LEE ; Cheol-Young PARK ; Choon Hee CHUNG ; Dae Ho LEE ; Eun-Hee CHO ; Eun-Jung RHEE ; Ji Hee YU ; Ji Hyun PARK ; Ji-Cheol BAE ; Jung Hwan PARK ; Kyung Mook CHOI ; Kyung-Soo KIM ; Mi Hae SEO ; Minyoung LEE ; Nan-Hee KIM ; So Hun KIM ; Won-Young LEE ; Woo Je LEE ; Yeon-Kyung CHOI ; Yong-ho LEE ; You-Cheol HWANG ; Young Sang LYU ; Byung-Wan LEE ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2024;48(6):1015-1028
		                        		
		                        			
		                        			 Since the role of the liver in metabolic dysfunction, including type 2 diabetes mellitus, was demonstrated, studies on non-alcoholic fatty liver disease (NAFLD) and metabolic dysfunction-associated fatty liver disease (MAFLD) have shown associations between fatty liver disease and other metabolic diseases. Unlike the exclusionary diagnostic criteria of NAFLD, MAFLD diagnosis is based on the presence of metabolic dysregulation in fatty liver disease. Renaming NAFLD as MAFLD also introduced simpler diagnostic criteria. In 2023, a new nomenclature, steatotic liver disease (SLD), was proposed. Similar to MAFLD, SLD diagnosis is based on the presence of hepatic steatosis with at least one cardiometabolic dysfunction. SLD is categorized into metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction and alcohol-related/-associated liver disease, alcoholrelated liver disease, specific etiology SLD, and cryptogenic SLD. The term MASLD has been adopted by a number of leading national and international societies due to its concise diagnostic criteria, exclusion of other concomitant liver diseases, and lack of stigmatizing terms. This article reviews the diagnostic criteria, clinical relevance, and differences among NAFLD, MAFLD, and MASLD from a diabetologist’s perspective and provides a rationale for adopting SLD/MASLD in the Fatty Liver Research Group of the Korean Diabetes Association. 
		                        		
		                        		
		                        		
		                        	
3.Imaging of Sequestered Lumbar Discs
Gangwon JEONG ; Heecheol PARK ; Sun Joo LEE ; Dae-Hyun PARK ; Sung Hwa PAENG ; Eugene LEE
Journal of the Korean Society of Radiology 2024;85(1):3-23
		                        		
		                        			
		                        			 Intervertebral disc herniation is frequently encountered in radiological practice. Sequestered disc herniation occurs when the disc material undergoes degeneration and completely loses continuity with the parent nucleus pulposus. Sequestered discs can reside within and outside the spinal canal, exerting a mass effect on adjacent structures, compressing nerve pathways, and eliciting a range of clinical symptoms. In particular, sequestered discs within the dura cannot be identified without durotomy. Therefore, precise preoperative localization is crucial for surgical planning. On MRI, the signal intensity of the sequestered disc may vary due to independent degeneration processes. Additionally, most sequestered disc fragments show varying degrees of peripheral enhancement depending on the degree of angiogenesis and granulation around the isolated tissue. In this article, we review various imaging findings and the location of the sequestered disc to provide patients with an accurate diagnosis and appropriate treatment direction. 
		                        		
		                        		
		                        		
		                        	
4.Healthcare Experts’ Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea:Introduction of Clinical Unmet Needs-Based Intended Use Establishment (CLUE) Templates
You Kyoung LEE ; Eugene LIH ; MinYoung KIM ; Soo Young KIM ; Ki Chang NAM ; Jaesoon CHOI ; Il-Ho PARK ; Su-Kyoung LEE ; Soe Ye Yint TUN ; Ei Shwe Yi PHOO ; Jin Woo LEE
Journal of Korean Medical Science 2024;39(40):e311-
		                        		
		                        			 Background:
		                        			A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. 
		                        		
		                        			Methods:
		                        			The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. 
		                        		
		                        			Results:
		                        			The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. 
		                        		
		                        			Conclusion
		                        			The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use. 
		                        		
		                        		
		                        		
		                        	
5.Metabolic Dysfunction-Associated Steatotic Liver Disease in Type 2 Diabetes Mellitus: A Review and Position Statement of the Fatty Liver Research Group of the Korean Diabetes Association
Jaehyun BAE ; Eugene HAN ; Hye Won LEE ; Cheol-Young PARK ; Choon Hee CHUNG ; Dae Ho LEE ; Eun-Hee CHO ; Eun-Jung RHEE ; Ji Hee YU ; Ji Hyun PARK ; Ji-Cheol BAE ; Jung Hwan PARK ; Kyung Mook CHOI ; Kyung-Soo KIM ; Mi Hae SEO ; Minyoung LEE ; Nan-Hee KIM ; So Hun KIM ; Won-Young LEE ; Woo Je LEE ; Yeon-Kyung CHOI ; Yong-ho LEE ; You-Cheol HWANG ; Young Sang LYU ; Byung-Wan LEE ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2024;48(6):1015-1028
		                        		
		                        			
		                        			 Since the role of the liver in metabolic dysfunction, including type 2 diabetes mellitus, was demonstrated, studies on non-alcoholic fatty liver disease (NAFLD) and metabolic dysfunction-associated fatty liver disease (MAFLD) have shown associations between fatty liver disease and other metabolic diseases. Unlike the exclusionary diagnostic criteria of NAFLD, MAFLD diagnosis is based on the presence of metabolic dysregulation in fatty liver disease. Renaming NAFLD as MAFLD also introduced simpler diagnostic criteria. In 2023, a new nomenclature, steatotic liver disease (SLD), was proposed. Similar to MAFLD, SLD diagnosis is based on the presence of hepatic steatosis with at least one cardiometabolic dysfunction. SLD is categorized into metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction and alcohol-related/-associated liver disease, alcoholrelated liver disease, specific etiology SLD, and cryptogenic SLD. The term MASLD has been adopted by a number of leading national and international societies due to its concise diagnostic criteria, exclusion of other concomitant liver diseases, and lack of stigmatizing terms. This article reviews the diagnostic criteria, clinical relevance, and differences among NAFLD, MAFLD, and MASLD from a diabetologist’s perspective and provides a rationale for adopting SLD/MASLD in the Fatty Liver Research Group of the Korean Diabetes Association. 
		                        		
		                        		
		                        		
		                        	
6.Metabolic Dysfunction-Associated Steatotic Liver Disease in Type 2 Diabetes Mellitus: A Review and Position Statement of the Fatty Liver Research Group of the Korean Diabetes Association
Jaehyun BAE ; Eugene HAN ; Hye Won LEE ; Cheol-Young PARK ; Choon Hee CHUNG ; Dae Ho LEE ; Eun-Hee CHO ; Eun-Jung RHEE ; Ji Hee YU ; Ji Hyun PARK ; Ji-Cheol BAE ; Jung Hwan PARK ; Kyung Mook CHOI ; Kyung-Soo KIM ; Mi Hae SEO ; Minyoung LEE ; Nan-Hee KIM ; So Hun KIM ; Won-Young LEE ; Woo Je LEE ; Yeon-Kyung CHOI ; Yong-ho LEE ; You-Cheol HWANG ; Young Sang LYU ; Byung-Wan LEE ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2024;48(6):1015-1028
		                        		
		                        			
		                        			 Since the role of the liver in metabolic dysfunction, including type 2 diabetes mellitus, was demonstrated, studies on non-alcoholic fatty liver disease (NAFLD) and metabolic dysfunction-associated fatty liver disease (MAFLD) have shown associations between fatty liver disease and other metabolic diseases. Unlike the exclusionary diagnostic criteria of NAFLD, MAFLD diagnosis is based on the presence of metabolic dysregulation in fatty liver disease. Renaming NAFLD as MAFLD also introduced simpler diagnostic criteria. In 2023, a new nomenclature, steatotic liver disease (SLD), was proposed. Similar to MAFLD, SLD diagnosis is based on the presence of hepatic steatosis with at least one cardiometabolic dysfunction. SLD is categorized into metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction and alcohol-related/-associated liver disease, alcoholrelated liver disease, specific etiology SLD, and cryptogenic SLD. The term MASLD has been adopted by a number of leading national and international societies due to its concise diagnostic criteria, exclusion of other concomitant liver diseases, and lack of stigmatizing terms. This article reviews the diagnostic criteria, clinical relevance, and differences among NAFLD, MAFLD, and MASLD from a diabetologist’s perspective and provides a rationale for adopting SLD/MASLD in the Fatty Liver Research Group of the Korean Diabetes Association. 
		                        		
		                        		
		                        		
		                        	
7.Healthcare Experts’ Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea:Introduction of Clinical Unmet Needs-Based Intended Use Establishment (CLUE) Templates
You Kyoung LEE ; Eugene LIH ; MinYoung KIM ; Soo Young KIM ; Ki Chang NAM ; Jaesoon CHOI ; Il-Ho PARK ; Su-Kyoung LEE ; Soe Ye Yint TUN ; Ei Shwe Yi PHOO ; Jin Woo LEE
Journal of Korean Medical Science 2024;39(40):e311-
		                        		
		                        			 Background:
		                        			A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. 
		                        		
		                        			Methods:
		                        			The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. 
		                        		
		                        			Results:
		                        			The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. 
		                        		
		                        			Conclusion
		                        			The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use. 
		                        		
		                        		
		                        		
		                        	
8.Imaging of Sequestered Lumbar Discs
Gangwon JEONG ; Heecheol PARK ; Sun Joo LEE ; Dae-Hyun PARK ; Sung Hwa PAENG ; Eugene LEE
Journal of the Korean Society of Radiology 2024;85(1):3-23
		                        		
		                        			
		                        			 Intervertebral disc herniation is frequently encountered in radiological practice. Sequestered disc herniation occurs when the disc material undergoes degeneration and completely loses continuity with the parent nucleus pulposus. Sequestered discs can reside within and outside the spinal canal, exerting a mass effect on adjacent structures, compressing nerve pathways, and eliciting a range of clinical symptoms. In particular, sequestered discs within the dura cannot be identified without durotomy. Therefore, precise preoperative localization is crucial for surgical planning. On MRI, the signal intensity of the sequestered disc may vary due to independent degeneration processes. Additionally, most sequestered disc fragments show varying degrees of peripheral enhancement depending on the degree of angiogenesis and granulation around the isolated tissue. In this article, we review various imaging findings and the location of the sequestered disc to provide patients with an accurate diagnosis and appropriate treatment direction. 
		                        		
		                        		
		                        		
		                        	
9.Metabolic Dysfunction-Associated Steatotic Liver Disease in Type 2 Diabetes Mellitus: A Review and Position Statement of the Fatty Liver Research Group of the Korean Diabetes Association
Jaehyun BAE ; Eugene HAN ; Hye Won LEE ; Cheol-Young PARK ; Choon Hee CHUNG ; Dae Ho LEE ; Eun-Hee CHO ; Eun-Jung RHEE ; Ji Hee YU ; Ji Hyun PARK ; Ji-Cheol BAE ; Jung Hwan PARK ; Kyung Mook CHOI ; Kyung-Soo KIM ; Mi Hae SEO ; Minyoung LEE ; Nan-Hee KIM ; So Hun KIM ; Won-Young LEE ; Woo Je LEE ; Yeon-Kyung CHOI ; Yong-ho LEE ; You-Cheol HWANG ; Young Sang LYU ; Byung-Wan LEE ; Bong-Soo CHA ;
Diabetes & Metabolism Journal 2024;48(6):1015-1028
		                        		
		                        			
		                        			 Since the role of the liver in metabolic dysfunction, including type 2 diabetes mellitus, was demonstrated, studies on non-alcoholic fatty liver disease (NAFLD) and metabolic dysfunction-associated fatty liver disease (MAFLD) have shown associations between fatty liver disease and other metabolic diseases. Unlike the exclusionary diagnostic criteria of NAFLD, MAFLD diagnosis is based on the presence of metabolic dysregulation in fatty liver disease. Renaming NAFLD as MAFLD also introduced simpler diagnostic criteria. In 2023, a new nomenclature, steatotic liver disease (SLD), was proposed. Similar to MAFLD, SLD diagnosis is based on the presence of hepatic steatosis with at least one cardiometabolic dysfunction. SLD is categorized into metabolic dysfunction-associated steatotic liver disease (MASLD), metabolic dysfunction and alcohol-related/-associated liver disease, alcoholrelated liver disease, specific etiology SLD, and cryptogenic SLD. The term MASLD has been adopted by a number of leading national and international societies due to its concise diagnostic criteria, exclusion of other concomitant liver diseases, and lack of stigmatizing terms. This article reviews the diagnostic criteria, clinical relevance, and differences among NAFLD, MAFLD, and MASLD from a diabetologist’s perspective and provides a rationale for adopting SLD/MASLD in the Fatty Liver Research Group of the Korean Diabetes Association. 
		                        		
		                        		
		                        		
		                        	
10.Healthcare Experts’ Advisory Unit and Support (HAUS) Program for Medical Device Development in Korea:Introduction of Clinical Unmet Needs-Based Intended Use Establishment (CLUE) Templates
You Kyoung LEE ; Eugene LIH ; MinYoung KIM ; Soo Young KIM ; Ki Chang NAM ; Jaesoon CHOI ; Il-Ho PARK ; Su-Kyoung LEE ; Soe Ye Yint TUN ; Ei Shwe Yi PHOO ; Jin Woo LEE
Journal of Korean Medical Science 2024;39(40):e311-
		                        		
		                        			 Background:
		                        			A clear and precise definition of the “intended use” in developing new medical devices can determine the success of entering the healthcare market. For this, practical collaboration between the clinical and engineering experts is necessary, and an appropriate tool is required for effective information collection and decision-making in the process. 
		                        		
		                        			Methods:
		                        			The Korean Academy of Medical Sciences, in cooperation with the Korean Medical Device Development Fund, implemented the Healthcare Experts’ Advisory Unit and Support (HAUS) program to match advisory clinical experts in medical device development projects. Three and five collaborative academic conferences were held in 2022 and 2023 to raise awareness of the HAUS program. In the consultation meeting, checklists were used to facilitate communications and satisfaction surveys were conducted afterward. Then, the results of the consultation meetings were compiled to build an integrated document. 
		                        		
		                        			Results:
		                        			The HAUS program was conducted with a gradually increasing number of consultation sessions from 31 in 2021 to 128 in 2023. The medical device development teams (development teams) expressed a higher level of satisfaction (91.4% to 100%) compared to the advisors (clinical experts) (78.6% to 100%) across the survey items. Based on the experiences and observations of the HAUS consultation meetings, the “Clinical Unmet Needs-based Intended Use Establishment (CLUE) templates” were developed, which were purposes to improve communication efficiency and to support a systematic approach in establishing the intended use. The CLUE process comprises four main stages for processing:Stage 1, Initial Concept; Stage 2, Expert Consultation; Stage 3, Decision-making; and Stage 4, Intended Use. 
		                        		
		                        			Conclusion
		                        			The HAUS program seemed to be helpful for the development teams by providing opinions of clinical experts. And the resultant product, the CLUE templates have been proposed to facilitate collaboration between the development teams and the advisors and to define robust clinical intended use. 
		                        		
		                        		
		                        		
		                        	
            
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