Design and Manufacturing of Medical Devices and Implants: Cultivating a Human- Centered Mindset

技术进步正在彻底改变医疗器械行业；医疗保健是美国最大、增长最快的就业部门之一。然而，由于科学、技术、工程和数学（STEM）领域的职业轨迹与医疗保健领域的职业轨迹之间的传统分离，STEM研究生通常没有在临床环境中接受过培训。因此，许多人不知道在这些环境中与技术开发和使用相关的伦理原则、法律和政策。因此，学术机构在生物医学设备的设计和制造方面取得的进步和创新往往没有适当地解决技术的应用方面的问题。STEM教育的这一差距可以通过开发一个融合不同学科的研究项目来解决。医学技术研究的应用方面的知识是有效和可持续创新的必要条件。这个NSF研究培训（NRT）项目将获奖机构与亚利桑那州的梅奥诊所联合起来，通过一系列结构化和融合的研究和培训活动，在STEM研究生中创造和培养一种以使用为灵感、以人为本的观点，以解决这一差距。该项目预计将培养34名博士生，其中包括17名来自工程、设计、制造和科学学科的资助学员。学员将专注于与成像设备和技术、增材制造植入物和设备、个性化诊断设备、组织修复和再生设备以及网络安全、数据科学和人工智能在医疗设备中的应用相关的研究问题。受训者将遵循由NRT核心课程课程，应用和体验式学习组成的培训计划，包括梅奥诊所住院医师，MedTech加速器参与，研究生-本科生指导（GUM）计划以及体验和专业活动。NRT学员将学习传统上不属于STEM教育的方面，例如医疗和临床环境中技术与人类互动的限制和机会。他们还将获得对道德原则的理解，并培养企业家的心态和才能。该培训经验将通过在三个研究重点领域提供呼吸来增强学生的教育：(1)医疗器械的人机界面，(2)研究和创新的伦理，(3)研究和技术的法律和政策。为每位NRT学员选择跨学科的教师团队作为指导团队；学生将通过论文将这些研究重点中的至少一个整合到他们的具体研究课题中。美国国家科学基金会研究实习生（NRT）计划旨在鼓励开发和实施大胆的、具有潜在变革性的STEM研究生教育培训新模式。该项目致力于通过创新、循证、适应不断变化的劳动力和研究需求的综合培训模式，在高优先级跨学科或融合研究领域对STEM研究生进行有效培训。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

Technological advances are revolutionizing the medical device industry; and healthcare makes up one of the largest and fastest-growing job sectors in the United States. However, due to the traditional separation between career trajectories in science, technology, engineering, and mathematics (STEM) and those in the healthcare sector, STEM graduate students often do not have training in a clinical setting. Consequently, many are not aware of the ethical principles, laws, and policies associated with the development and use of technologies in those settings. As a result, advancements and innovations made in the design and manufacturing of biomedical devices in academic institutions often do not appropriately address the application side of the technology. This gap in STEM education can be addressed by developing a convergent research program that weaves different disciplines together. Knowledge of the applied side of medical technology research is necessary for effective and sustainable innovation. This NSF Research Traineeship (NRT) project brings together the awardee institution with the Mayo Clinic in Arizona, to address this gap by creating and fostering a use-inspired, human-centered outlook in STEM graduate students through a set of structured and convergent research and training activities. The project anticipates training 34 Ph.D. students, including 17 funded trainees from engineering, design, manufacturing, and science disciplines. Trainees will focus on research problems associated with imaging devices and technologies, additively manufactured implants and devices, personable diagnostic devices, tissue repair and regeneration devices, and applications of cybersecurity, data science, and artificial intelligence to medical devices. Trainees will follow a training schedule consisting of NRT core curriculum courses, applied and experiential learning components, including a Mayo Clinic residency, MedTech accelerator participation, a Graduate-Undergraduate Mentorship (GUM) Program, and experiential and professional activities. NRT trainees will learn aspects that are not traditionally part of STEM education, such as limitations and opportunities for technology-human interactions in medical and clinical settings. They will also gain an understanding of ethical principles and develop an entrepreneurial mindset and aptitude. This training experience will enhance students’ education by providing breath in the three research thrust areas: (1) Human-technology interface in medical devices, (2) Ethics in research and innovation, (3) Law and policies in research and technology. Cross-disciplinary teams of faculty are selected as the advising team for each NRT trainee; and tudents will integrate at least one of these research thrusts into their specific research topic through their dissertation.The NSF Research Traineeship (NRT) Program is designed to encourage the development and implementation of bold, new potentially transformative models for STEM graduate education training. The program is dedicated to effective training of STEM graduate students in high priority interdisciplinary or convergent research areas through comprehensive traineeship models that are innovative, evidence-based, and aligned with changing workforce and research needs.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.