Medical Device Design and Innovation; Orthopaedic Implant Failure Analysis and Redesign

医疗器械设计与创新；

• 批准号: 10614004
• 负责人: Steven M Tommasini
• 金额: $ 4.15万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-05-01 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10614004
• 关键词: Address; Adverse event; Biocompatible Materials; Biomedical Engineering; Biomedical Technology; Caring; Cell Nucleus; Clinical; Clinical Engineering; Collaborations; Complex; Complication; Computer software; Device Designs; Device Safety; Devices; Diagnostic; Ecosystem; Educational Curriculum; Educational process of instructing; Elements; Engineering; Environment; Equipment Malfunction; Faculty; Failure; Fellowship; Finite Element Analysis; Frustration; Future; Goals; Grant; Health Professional; Healthcare; Healthcare Systems; Hour; Human; Immersion; Implant; Journals; Knowledge; Learning; Machine Learning; Medical; Medical Device; Medical Device Designs; Medical Device Failures; Medical Errors; Medical Research; Medical Technology; Mentors; Modeling; Needs Assessment; Nurses; Orthopedics; Pain; Paper; Participant; Patient-Focused Outcomes; Patients; Physicians; Procedures; Process; PubMed; Public Health; Publishing; Regulatory Affairs; Resources; Risk Management; Rotation; Scientist; Series; Source; Structure; Students; Surgeon; Surgical Error; Techniques; Technology; Training; Translating; Underrepresented Minority; Universities; Work; career; commercialization; cost; design; experience; fabrication; falls; hazard; health care delivery; image processing; improved; improved outcome; indexing; innovation; instrumentation; interest; invention; lectures; medical complication; medical specialties; member; novel; online course; prevent; programs; project-based learning; prototype; research and development; responsible research conduct; simulation; skills; summer student; technological innovation; tool; undergraduate student

PROJECT SUMMARY The proposed team-based Medical Device Design and Innovation course will prepare undergraduate junior and senior biomedical engineering students with a robust toolkit to be innovators of medical technologies with the skills necessary to design devices that reduce medical errors and device failure hazards. A summer clinical immersion, with a focus on identifying potential sources of preventable complications from medical device adverse events and failures, will provide the students a widened perspective regarding the safe delivery of healthcare. In addition, training during the semester long course in analyses of common causes of medical device failure will provide the students the skills to develop devices responsibly. The program will start in the summer with a clinical immersion for up to 10 students rotating through an 8-week long rotation with Yale physicians and surgeons from 6 different specialties. Students will work with their physician mentors to identify causes of preventable medical/surgical errors, device user-related hazards and device failure hazards, with the goal of addressing these preventable complications with medical device design projects. In addition, students will participate in didactics with a structured summer curriculum focusing on needs identification, assessment and risk management. In the Fall, the 10 summer students will continue their clinical immersions by shadowing 1 day a week, and participate in a campus wide “device design speaker series”. Within the Spring semester course, each summer Fellowship student will form the nucleus of a design team of 3-5 members. Based on needs / problems / preventable medical errors identified within the summer and fall clinical immersion, the students, following the biodesign innovation process, will design a functioning prototype and commercialization plan. Concurrently, throughout the Spring semester, students will work on a separate failure analysis project to learn how to pinpoint and simulate potential critical medical device failure mechanisms. Didactic lectures will include topics such as the device design process, regulatory affairs, human factors engineering, responsible conduct of research, and off-campus trips to medical device R&D facilities. At the end of the course, open access content will be published as a free online curriculum, and students will submit papers to PubMed indexed journals. The innovation of this application is to embed engineering students within a clinical environment, exposing them to potential sources of preventable medical complications and device failures, as well as teaching them how to identify, simulate and model critical failure mechanisms. This course, which seeks to attract underrepresented minorities, will result in an improved pipeline of future scientists whose practical experience in a clinical environment will facilitate their entry into biomedical engineering careers. The course will utilize the engineering, innovation and medical research resources at Yale University. The University biomedical engineering ecosystem will also benefit from collaboration between engineering faculty and clinicians.

项目总结 拟开设的基于团队的医疗器械设计与创新课程将培养本科三年级学生 和生物医学工程专业的大四学生，拥有强大的工具包，成为医疗技术的创新者 设计可减少医疗差错和设备故障风险的设备所需的技能。夏季诊所 沉浸，重点是找出医疗器械可预防并发症的潜在来源 不良事件和失败，将为学生提供关于安全交付的更广阔的视角 医疗保健。此外，在长达一学期的课程中，进行了分析医学常见原因的培训 设备故障将为学生提供负责任地开发设备的技能。 该项目将于夏季开始，为最多10名学生提供临床沉浸，轮流参加为期8周的 与来自6个不同专业的耶鲁内科医生和外科医生长期轮换。学生们将使用他们的 医生指导，以确定可预防的医疗/手术错误的原因、与设备用户相关的危险和 设备故障危险，目的是通过医疗设备设计解决这些可预防的并发症 项目。此外，学生还将参加有组织的暑期课程，重点是 需要识别、评估和风险管理。 在秋季，10名暑期学生将继续他们的临床沉浸，每周跟踪一天，以及 参加校园范围内的“设备设计音箱系列”活动。在春季学期的课程中，每年夏天 奖学金学生将组成一个由3-5名成员组成的设计团队的核心。根据需要/问题/ 在夏季和秋季临床沉浸中发现的可预防的医疗错误，学生们遵循 生物设计创新过程中，将设计出具有功能的原型和商业化计划。同时， 在整个春季学期，学生们将从事一个单独的故障分析项目，以学习如何 准确定位并模拟潜在的关键医疗设备故障机制。说教讲座将包括主题 如设备设计流程、法规事务、人因工程、负责任的行为 研究，以及校外医疗器械研发设施的旅行。在课程结束时，开放访问内容 将作为免费在线课程发布，学生将向PubMed索引期刊提交论文。 这个应用程序的创新之处在于将工科学生嵌入临床环境中，暴露 向他们介绍可预防的医疗并发症和设备故障的潜在来源，并教导他们 如何识别、模拟和模拟关键失效机制。这门课程旨在吸引 代表不足的少数族裔，将导致未来科学家的渠道得到改善，他们的实际经验 临床环境将有助于他们进入生物医学工程职业生涯。本课程将利用 耶鲁大学的工程、创新和医学研究资源。大学生物医学 工程学生态系统也将受益于工程学教师和临床医生之间的合作。