NESTcc Renewal -Continuation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)

项目摘要/摘要 医疗器械创新联盟(MDIC)正在申请继续担任国家评估机构 卫生技术协调中心系统(NESTCC)。NESTCC是一个协作网络，由一个 协调中心(MDIC)、美国食品和药物管理局(FDA/CDRH)、网络合作者和 代表FDA、行业及其相关行业协会、临床医生/临床医生的管理委员会 团体、学术卫生系统和研究组织、数字卫生和技术公司、付款人、 以及患者/患者权益倡导团体。 NESTCC的目标是：(1)通过可持续的多方利益攸关方支持实施NEST 合作伙伴关系；(2)开发新的数据收集/分析系统，以允许未来的活跃医疗设备 市场后风险识别；(3)支持开发和获取可以 用于医疗器械性能和相关结果的综合评价 利益攸关方；(4)开发方法学方法/系统，以促进使用真实世界的证据 在整个设备生命周期中进行监管决策，并供其他利益相关者使用。 作为NESTCC，MDIC将继续为下一个周期提供强有力的科学监督和得到证实的支持 这笔拨款的主要职责是在现实世界证据(RWE)研究中发挥领导作用 研究研究和项目的网络、运营和项目管理、医疗设备安全(MDS) 主动监控、协作社区(CC)；开发和部署创新基础设施和 工具；研究设计和统计方法的新方法；以及Nest的管理和分配 资金。NESTCC将管理其合作伙伴之间的关系，以促进使用RWD了解医疗 以对利益相关者社区有意义的方式使用设备。NESTCC将监督、促进和促进 用于医疗设备评估的基础设施开发，而不仅仅是用于监管决策 而是对更广泛的利益相关者社区。NESTCC将优化成本、获取途径、质量和共享 与医疗器械评估相关的数据；促进采用莱茵集团的最佳实践；制定 评估和传播医疗器械安全性和有效性的透明和简化的程序 信息；并发展可持续的商业模式。我们建议的方法代表了一种强大的、经验丰富的 领导团队确保高效的科学和行政支持，利用先进和创新 技术。 MDIC首席执行官帕梅拉·戈德伯格(Pamela Goldberg)和弗洛拉·桑德拉·西阿米(Flora Sandra Siami)共同提出了多重PI领导计划 (MDIC高级副总裁兼NESTCC负责人)，明确界定了领导和指导NESTCC的角色和责任。

PROJECT SUMMARY/ABSTRACT The Medical Device Innovation Consortium (MDIC) is applying to continue its role as the National Evaluation System for health Technology Coordinating Center (NESTcc). NESTcc is a cooperative network that consists of a coordinating center (MDIC), the U.S. Food and Drug Administration (FDA/CDRH), Network Collaborators, and a Governing Committee that represents the FDA, industry and their relevant trade associations, clinicians/clinician groups, academic health systems and research organizations, digital health and technology companies, payors, and patients/patient advocacy groups. The objectives of NESTcc are to: (1) Support implementation of NEST through sustainable multi-stakeholder partnerships; (2) Develop new systems of data collection/analysis to permit prospective active medical device postmarket risk identification; (3) Support the development of and access to high quality data sources that can be used in comprehensive evaluation of medical device performance and associated outcomes by multiple stakeholders; (4) Develop methodological approaches/systems that facilitates the use of real-world evidence for regulatory decision-making, and for uses by other stakeholders, throughout the entire device lifecycle. As NESTcc, MDIC will continue to provide robust scientific oversight and proven support for the next cycle of this grant, with key responsibilities for leadership in real-world evidence (RWE) research for the Research Network, operational and project management of research studies and projects, medical device safety (MDS) for active surveillance, Collaborative Community (CC); development and deployment of innovative infrastructure and tools; novel approaches for study design and statistical methodologies; and management and distribution of NEST funds. NESTcc will manage relationships among its partners to facilitate the use of RWD in understanding medical devices in a way that is meaningful for the stakeholder communities. NESTcc will monitor, promote, and facilitate infrastructure development for use of RWE for medical device evaluation, not just for regulatory decision-making but for the wider community of stakeholders. NESTcc will optimize the cost of, access to, quality of, and sharing of data related to medical device evaluation; promote the adoption of best practices using RWE; develop a transparent and streamlined process for evaluating and disseminating medical device safety and effectiveness information; and develop a sustainable business model. Our proposed approach represents a strong, experienced leadership team to ensure efficient scientific and administrative support to NEST using advanced and innovative technologies. A multiple PI leadership plan is proposed shared by Pamela Goldberg (MDIC CEO) and Flora Sandra Siami (MDIC SVP and head of NESTcc), with clearly delineated roles and responsibilities for leading and directing NESTcc.