Public-private partnership coordinating center for National Evaluation System

医疗器械创新联盟（MDIC），501（c）3公私合作伙伴关系和治理 这种结构最适合将器械制造商、付款人、监管机构、患者团体 医生、供应商和其他相关利益相关者制定国家医疗器械评价系统 （NMDES）协调中心。我们的方法是建立一个CC，负责监督开发， 通过分散的数据评估实施集体现代化医疗器械监督计划 系统.我们利用并开发数据获取、信号检测、数据处理和 报告. CC和治理体系将立足于多元化的利益相关者包容，最高的道德标准， 标准，以患者为中心的结果，以及效率和问责制的商业文化，以创造 信任、透明度、可扩展性、可持续性和问责制的基本原则。 目标1：建立一个由主要利益攸关方组成的治理委员会， NMDES具有包容性，以患者为中心，以公平和透明为基础。目标2：确定范围， 战略（权力下放、利益相关者参与、独立于偏见、开放科学和数据共享， 目标优先次序），结构（主要数据过程和次要数据及结果传播）， 标准（数据、方法、报告和数据访问、审计和认证），以分散和联合的方式， NMDES。目标3：确保包容性的竞争性创新和持续现代化之路 通过分散的数据仓库和集成。目标4：开展试点项目， 使证据生成和数据使用方法可操作化，展示跨医疗保健的可扩展性 系统和设备类型和制造商，并证明了NMDES可持续性的原则。 我们的第一个以患者为中心的第一阶段试点集中在需要跟踪的高风险类别设备上， 来自使用现代数据收集手段的医院系统的EHR数据。MDIC的支持信来自 战略患者和行业合作伙伴表示，他们将致力于为这些飞行员提供最先进的安全保障 具有公共卫生重要性的医疗技术的监测方法。第二阶段试点将建立 NMDES对更广泛的医疗技术生态系统的可持续性。 MDIC将建立NMDES CC，并为持续运营制定可持续发展计划。这将允许 以有效的方式使用真实世界数据，快速识别市场上设备的新安全问题 最佳和适当地依靠现实世界的证据来支持公共卫生产品的批准 重要性，可能将上市前数据收集转移到上市后环境，并满足上市后 通过现代化系统进行数据收集，利用电子健康信息， 临床和家庭环境。

The Medical Device Innovation Consortium (MDIC), a 501(c)3 Public-Private Partnership and governance structure is best suited to bring together device manufacturers, payers, regulatory agencies, patient groups, physicians, providers and other relevant stakeholders to develop a National Medical Device Evaluation System (NMDES) Coordinating Center (CC). Our approach is to develop a CC that oversees the development and operations of a collective modernized medical device surveillance program via decentralized data evaluation systems. We leverage and develop standards for data procurement, signal detection, data processing, and reporting. The CC and governance system will be anchored on diverse stakeholder inclusion, highest ethical standards, patient-centered outcomes, and a business culture of efficiency and accountability to create the foundational principles of trust, transparency, scalability, sustainability and accountability. AIM 1: Establish a governance committee of the key stakeholders charged with inaugurating a CC for the NMDES that is inclusive, patient-focused, and anchored in equity and transparency. AIM 2: Establish scope, strategy (decentralization, stakeholder engagement, independence from bias, open science and data sharing, objective prioritization), structure (primary data processes and secondary data and results dissemination), standards (data, methods, reporting, and data access, audit and certification), in a decentralized and federated NMDES. AIM 3: Guarantee an inclusive pathway for competitive innovation and continual modernization through decentralized data warehousing and integration. AIM 4: Conduct pilot projects to develop, verify and operationalize methods of evidence generation and data use, demonstrate scalability across healthcare systems and device types and manufactures, and prove out principles of NMDES sustainability. Our first Phase 1 patient focused pilots are centered on high-risk category devices that require tracking and EHR data from hospital systems that use modern means of data collection. MDIC's letters of support from strategic patient and industry partners indicate a commitment to these pilots to establish state-of-the-art safety surveillance methods for medical technologies of public health importance. Phase 2 pilots will establish sustainability of the NMDES to the broader medical technology ecosystem. MDIC will establish the NMDES CC and create a sustainability plan for continued operations. This will allow the use of real-world data in an efficient manner to quickly identify new safety problems for devices on the market and optimally and appropriately rely on real-world evidence to support product approvals of public health importance, to potentially shift premarket data collection to the postmarket setting, and to meet postmarket data collection commitments through a modern system that leverage electronic health information generated in the clinical and home setting.