团队负责人
团队成员
程云章、李维奇、张天逸
团队简介
介入医学工程与监管科学团队是依托上海介入医疗器械工程技术研究中心（省部级科研平台）和“一带一路”医疗器械监管科学研究院建立的高水平、创新型交叉学科研究团队。研究团队主要研究方向为：（1）心脑血管介入器械血流动力学和力学分析与仿真；（2）智能医疗装备开发；（3）数智化监管科学评价方法和工具研究等。
代表性成果
1.科研项目
[1]2024-2026，国家自然科学基金-青年基金项目，儿童颅脑非线性应力传递特性及冲击损伤机理研究
[2]2023-2025，上海市科委白玉兰人才计划浦江项目，冲击载荷下儿童颅脑非线性模型构建及损伤生物力学机理研究
[3]2026，上海市人民政府决策咨询重点课题，上海深化生物医药“研发+临床+制造+应用”一体化布局的路径研究
[4]2026-2027，上海市产教融合项目，医疗器械网络安全关键性能检测系统开发
[5]2024，省级药品监管部门课题，构建激发产业创新活力的上海医疗器械监管新策略研究
[6]2023-2025，企业委托，“一带一路”重点国家医疗器械产业和监管研究
[7]2023-2025，省级药品监管部门委托，婴儿培养箱重点监测项目风险评估
[8]2023-2024，省级卫生研究部门委托，手术机器人技术的发展现状和评估需求分析
[9]2024，省级药品监管部门委托，产业发展与法规变化背景下医疗器械上市后监管策略研究
[10]2024，省级药品监管部门委托，国内外医疗器械行业前沿技术和监管法规信息采集和处理
[11]2024，省级药品监管部门委托，医疗器械不良事件监测数据整理分析（2024年度）
[12]2024，省级药品监管部门委托，编撰《医疗器械行业发展报告》
[13]2026，省级药品监管部门委托，基于风险导向的医疗器械智能警戒体系构建与协同治理研究
2.标准指南制定
[1]GB/T 45663-2025《麻醉和呼吸设备 麻醉期间用于贴示在含药的注射器上的标签 颜色、图案和特性》.国家标准化管理委员会
[2]T/YLXHB000010-2023无拘束智能床垫技术要求.上海市养老服务行业协会
[3]T/YLXHB000011-2023居家养老服务 住户行为异常监测系统数据技术要求. 上海市养老服务行业协会
[4]TCRHA 147—2025皮肤病家庭紫外线光疗规范.中国研究型医院学会
[5]2024, 腔镜手术机器人操作培训中国专家共识（2024版）,机器人外科学杂志(中英文)
3.科技成果奖
[1]2023，上海市药品监督管理局优秀课题一等奖
[2]2025, 上海市药品监督管理局优秀课题三等奖
[3]2025, 中国卫生经济学会重点研究课题二等奖
4.学术论文
[1] Dynamics of soft connective tissues and implications for synthetic biomaterials: interfacing the frequency and time domains[J]. Journal of the Mechanical Behavior of Biomedical Materials, 2025: 107143.
[2] Frequency and time dependent viscoelastic characterization of pediatric porcine brain tissue in compression[J]. Biomechanics and Modeling in Mechanobiology, 2024, 23(4): 1197-1207.
[3] Image Quality Assessment of Diabetic Retinopathy Based on ADD-Net[J]. IEEE Access, 2023，11：105130-105139.
[4] Multiple-image Encryption and Multiplexing Using a Modified Gerchberg–Saxton Algorithm in Fresnel-transform Domain and Computational Ghost Imaging[J]. Current Optics and Photonics, 2023, 7(4): 362-377.
[5]Analysis of influence of surgical instruments on accuracy of magnetic navigation system for craniofacial surgery robots[J]. Computer Assisted Surgery, 2023, 28(1): 2210744.
[6] Fundus Image Generation and Classification of Diabetic Retinopathy Based on Convolutional Neural Network[J]. Electronics, 2024, 13(18): 3603.
[7] Research on adverse event classification algorithm of da Vinci surgical robot based on Bert-BiLSTM model[J]. Frontiers in Computational Neuroscience, 2024, 18: 1476164.
[8] Evaluating Augmented Reality Head-Mounted Devices in Healthcare: A Review of Hardware, Software, and Usability Approaches[J]. Medical Devices: Evidence and Research, 2025: 427-445.
[9] AI-Driven Medical Device Risk Management: A New Paradigm Integrating Large Language Models and Prompt Engineering for Standard-Risk Knowledge Graph Construction and Application[J]. Risk Management and Healthcare Policy, 2026: 1-17.
[10] Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study[J]. JMIR Medical Informatics, 2026, 14(1): e83745.
[11] Intelligent Prediction Platform for Sepsis RiskBased on Real-Time Dynamic Temporal Features: Design Study. JMIR Med Inform2025;13:e74940.
[12] Establishing a standardized training programfor robotic surgeons in China. Int J Surg. 2026;112(1):1898-19003.
[13] Construction and Explanation Analysis of a Hypotension RiskPrediction Model in Hemodialysis Based on Machine Learning. ELECTRONICS,2024,13,3773.
[14] The Dichotomous Role of Tertiary Lymphoid Structures in Hepatocellular Carcinoma: From Spatial Location to Clinical Implications.Immunological investigations,2025,54(8):1-38.
[15] An Innovative Stepwise C-Means Clustering Approach for Classification of Adolescent Idiopathic Scoliosis. Orthopaedic Surgery,2025,17(6):1804-1816.
[16] Differentiating Ischemic From Nonischemic T-Wave Inversion Using a Multimodal Vision-Language Model With Reinforcement Learning (ECG-R1): Development and Validation Study. JMIR Med Inform. 2026 Jun 19;14:e87227.
