1.Grounded theory study on developing competency model for medical technical managers in transformation of medical R&D findings
Qiufan SUN ; Qing LI ; Yanrui QIU ; Keyu CHEN ; Yuncheng LU ; Zhimin HU
Chinese Journal of Medical Science Research Management 2025;38(3):227-232
Objective:This article studies the abilities and quality that medical technical managers should possess and provides a reference for promoting the professional training and development of medical technical managers.Methods:The data were obtained through semi-structured interviews and literature collection. The interview subjects were 20 scientific researchers with transformation projects and 10 management staffs with technical manager certificates in medical colleges. The documents are 6 articles related to ″technical manager capabilities″ collected on open academic platforms. Grounded theory was used to code and analyze above data.Results:After three-level coding and combining with the iceberg competency model, the knowledge, skills, self-awareness, traits and motivation of medical technology managers were sorted out, totalling 5 core categories, 10 main categories, and 50 initial categories, to construct a competency model for medical technology managers.Conclusions:Based on the complex knowledge structure and high occupational requirements of medical technology managers, policy insights such as systematic knowledge training, raising skill requirements in practice, and enriching assessment standards and communication channels are proposed.
2.Quantitative Analysis of Policy Texts of Biomedical Industrial Parks in China Based on Policy Tools:Taking Three Biomedical Industrial Parks in Jiangsu Province as Examples
Qiufan SUN ; Zhimin HU ; Qianqian ZHAO ; Runping MA ; Ziyan MENG ; Keyu CHEN ; Qing LI
Herald of Medicine 2025;44(2):325-332
Objective This article focuses on the investment promotion policies at the municipal and district levels(park management committee level)of biomedical industrial parks in China at different development stages.It aims to reveal the characteristics and patterns of these policies,providing a reference for the formulation of development policies for biomedical industrial parks in China.Methods A total of 166 policies issued by three biomedical industrial parks(LifeBay,Nanjing Biotech and Pharmaceutical Valley and BioBay)from January 2013 to June 2023 were coded and quantitatively analyzed using a three-dimensional analytical framework of policy tool-development stage-issuing body.Results At the municipal level,the use of policy tools by administrative development is supply-oriented and environmental-oriented.At the district level,the types of policy tools used are closely related to the stage of the park.Start-up parks have a high proportion of supply-based policy tools,growth parks have a high proportion of demand-based policy tools,and mature parks have a high proportion of environmental policy tools.Conclusion Policy insights such as the strategic use of policy tools according to the development stage of the park,the optimization of the internal structure of the tools and the enhancement of the complementarity and coordination among the tools,and the use of policy tools to promote industrial agglomeration in line with local realities are put forward.
3.Quantitative Analysis of Policy Texts of Biomedical Industrial Parks in China Based on Policy Tools:Taking Three Biomedical Industrial Parks in Jiangsu Province as Examples
Qiufan SUN ; Zhimin HU ; Qianqian ZHAO ; Runping MA ; Ziyan MENG ; Keyu CHEN ; Qing LI
Herald of Medicine 2025;44(2):325-332
Objective This article focuses on the investment promotion policies at the municipal and district levels(park management committee level)of biomedical industrial parks in China at different development stages.It aims to reveal the characteristics and patterns of these policies,providing a reference for the formulation of development policies for biomedical industrial parks in China.Methods A total of 166 policies issued by three biomedical industrial parks(LifeBay,Nanjing Biotech and Pharmaceutical Valley and BioBay)from January 2013 to June 2023 were coded and quantitatively analyzed using a three-dimensional analytical framework of policy tool-development stage-issuing body.Results At the municipal level,the use of policy tools by administrative development is supply-oriented and environmental-oriented.At the district level,the types of policy tools used are closely related to the stage of the park.Start-up parks have a high proportion of supply-based policy tools,growth parks have a high proportion of demand-based policy tools,and mature parks have a high proportion of environmental policy tools.Conclusion Policy insights such as the strategic use of policy tools according to the development stage of the park,the optimization of the internal structure of the tools and the enhancement of the complementarity and coordination among the tools,and the use of policy tools to promote industrial agglomeration in line with local realities are put forward.
4.Grounded theory study on developing competency model for medical technical managers in transformation of medical R&D findings
Qiufan SUN ; Qing LI ; Yanrui QIU ; Keyu CHEN ; Yuncheng LU ; Zhimin HU
Chinese Journal of Medical Science Research Management 2025;38(3):227-232
Objective:This article studies the abilities and quality that medical technical managers should possess and provides a reference for promoting the professional training and development of medical technical managers.Methods:The data were obtained through semi-structured interviews and literature collection. The interview subjects were 20 scientific researchers with transformation projects and 10 management staffs with technical manager certificates in medical colleges. The documents are 6 articles related to ″technical manager capabilities″ collected on open academic platforms. Grounded theory was used to code and analyze above data.Results:After three-level coding and combining with the iceberg competency model, the knowledge, skills, self-awareness, traits and motivation of medical technology managers were sorted out, totalling 5 core categories, 10 main categories, and 50 initial categories, to construct a competency model for medical technology managers.Conclusions:Based on the complex knowledge structure and high occupational requirements of medical technology managers, policy insights such as systematic knowledge training, raising skill requirements in practice, and enriching assessment standards and communication channels are proposed.
5.Comparative study on the registration management systems of innovative medical devices in China and the United States
Qianqian ZHAO ; Keyu CHEN ; Ziyan MENG ; Runping MA ; Qiufan SUN ; Lewen FU ; Zekun LIU ; Longping YANG ; Qing LI
Chinese Journal of Medical Science Research Management 2024;37(5):434-440
Objective:This article analyzed the current situation, similarities and differences and main problems of the registration and management systems of innovative medical devices in China and the United States.Methods:This article summarized the requirements and policies for the registration management of innovative medical devices in China and the United States, as well as the development and differences of the registration of innovative medical devices in China and the United States, and the main problems in the registration management of innovative medical devices in China.Results:At present, the development level of medical device industry in China and the United States was different, facing different development problems, and there were differences in the access standards and management methods of innovative medical devices. The registration management system established for innovative medical devices in China was gradually improving, and to a certain extent, it had promoted the enthusiasm of innovative product research and development and registration applications, but there were also problems such as unclear innovation evaluation scales, insufficient early intervention of review resources, and insufficient utilization of post-marketing data.Conclusions:Drawing on the beneficial experience of breakthrough device registration management in the United States, we will improve the registration management system for innovative products and shorten the review and approval cycle by clarifying the identification criteria for innovative medical devices, promoting the placement of review resources in the R&D stage, and further strengthening the use of post-marketing data and regulatory scientific research.
6.Study on the Application of Indocyanine Green Fluorescence Guided Laparo-scopic Lymph Node Resection in Clinical Early Stage Cervical Cancer Staging Surgery
Biao TANG ; Xiaoyan REN ; Ling WU ; Jun CHANG ; Shaolan YU ; Wenjuan WU ; Qiufan LI ; Gang WANG
Journal of Practical Obstetrics and Gynecology 2024;40(9):734-738
Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8%)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P<0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P>0.05).②The visualization rate in the ICG group was 64.71%(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P>0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P<0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P<0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.
7.Study on the Application of Indocyanine Green Fluorescence Guided Laparo-scopic Lymph Node Resection in Clinical Early Stage Cervical Cancer Staging Surgery
Biao TANG ; Xiaoyan REN ; Ling WU ; Jun CHANG ; Shaolan YU ; Wenjuan WU ; Qiufan LI ; Gang WANG
Journal of Practical Obstetrics and Gynecology 2024;40(9):734-738
Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8%)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P<0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P>0.05).②The visualization rate in the ICG group was 64.71%(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P>0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P<0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P<0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.
8.Study on the Application of Indocyanine Green Fluorescence Guided Laparo-scopic Lymph Node Resection in Clinical Early Stage Cervical Cancer Staging Surgery
Biao TANG ; Xiaoyan REN ; Ling WU ; Jun CHANG ; Shaolan YU ; Wenjuan WU ; Qiufan LI ; Gang WANG
Journal of Practical Obstetrics and Gynecology 2024;40(9):734-738
Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8%)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P<0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P>0.05).②The visualization rate in the ICG group was 64.71%(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P>0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P<0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P<0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.
9.Study on the Application of Indocyanine Green Fluorescence Guided Laparo-scopic Lymph Node Resection in Clinical Early Stage Cervical Cancer Staging Surgery
Biao TANG ; Xiaoyan REN ; Ling WU ; Jun CHANG ; Shaolan YU ; Wenjuan WU ; Qiufan LI ; Gang WANG
Journal of Practical Obstetrics and Gynecology 2024;40(9):734-738
Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8%)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P<0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P>0.05).②The visualization rate in the ICG group was 64.71%(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P>0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P<0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P<0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.
10.Study on the Application of Indocyanine Green Fluorescence Guided Laparo-scopic Lymph Node Resection in Clinical Early Stage Cervical Cancer Staging Surgery
Biao TANG ; Xiaoyan REN ; Ling WU ; Jun CHANG ; Shaolan YU ; Wenjuan WU ; Qiufan LI ; Gang WANG
Journal of Practical Obstetrics and Gynecology 2024;40(9):734-738
Objective:To explore the feasibility and application value of indocyanine green(ICG)lymph node tracer in clinical early stage cervical cancer staging surgery.Methods:A retrospective analysis was performed on 31 patients with early clinical stage(ⅠA1-ⅡA1)cervical cancer who underwent laparoscopic radical hysterectomy,pelvic lymph node resection and para-aortic lymph node sampling were selected as the study subjects in Sichuan Provincial Maternal and Child Health Care Hospital from April 1,2022 to July 31,2023.They were divided into the ICG fluorescence tracer group(ICG group,17 cases)and the conventional surgery group(control group,14 ca-ses)based on whether ICG was injected or not.The resected lymph nodes were classified and submitted for ex-amination according to location and whether they presented visualization.The method of contingency coefficient was used to analyze the correlations between lymph node visualization patterns and lymph node metastasis and clinicopathological characteristics,and the perioperative data of the two groups were compared.Results:①The postoperative stage of 8 patients(25.8%)(4 in each group)were improved compared with the preoperative clini-cal stage.The number of resected lymph nodes in the ICG group was less than that in the control group(18±9 nodes/person vs.26±11 nodes/person,P<0.05).There were no statistically significant differences in operation time,intraoperative blood loss,postoperative FIGO(2018)staging,lymph node metastasis rate,and positive rate of resected lymph nodes between the two groups(P>0.05).②The visualization rate in the ICG group was 64.71%(11/17).There was no statistically significant difference in the positive rate between the visualized and non-visualized lymph nodes(P>0.05).There was a significant correlation between lymph node visualization and lymph node metastasis(C=0.707,P<0.05),and a significant correlation was found between lymph node visual-ization and lymph node metastasis in the same patient(C=0.557,P<0.05).Conclusions:The rate of lymph node metastasis in clinical early stage cervical cancer is low.ICG fluorescence visualization can trace lymph nodes and predict the risk of metastasis.By only resecting the visualized lymph nodes under the guidance of ICG tracer,the lymph node metastasis status of early-stage cervical cancer can be fully evaluated,which is worthy of further research.

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