Innovator Subprojects Core

创新者子项目核心

• 批准号: 10707086
• 负责人: Ralph Etienne-Cummings
• 金额: $ 647.09万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10707086
• 关键词: Acceleration; Address; Area; Clinical; Collaborations; Development; Dreams; Ecosystem; Equity; Evaluation; Failure; Funding; Goals; Human; Industry Standard; Institutional Review Boards; Investments; Medical Device; Mentors; Mentorship; Monitor; Outcome; Participant; Patients; Population; Recommendation; Research Project Grants; Resource Allocation; Resources; Technology; Technology Assessment; United States National Institutes of Health; Work; commercialization; design; first-in-human; programs; prototype; recruit; risk mitigation; success; timeline; tool

PROJECT SUMMARY INNOVATOR CORE The goal of the Blueprint Medtech Program is “To accelerate patient access to groundbreaking, safe, and effective medical devices.” To assure that these investments are effective, however, requires frequent oversight and assistance. The Innovator Core (IC) will be responsible for providing this oversight, monitoring progress towards milestones, assisting with unexpected delays, and reducing or recommending to NIH to discontinue funding when it becomes clear that a project will not meet the expected outcomes. The NeuroTech Harbor (NTH) IC will provide close mentorship to funded teams during the tenure of the subproject, as well as oversee progress with project management tools, to successfully deliver first in human prototypes. The IC begins interacting with and managing a subproject once funding approval for that subproject is received. All subproject PIs will have a single point of contact in the NTH for all issues through the IC. At this point, the project milestones, timeline, and deliverables will have been defined. An assessment of the technology's stage of development will be available after the Deep Dive analysis (Evaluation Core (EC)), identifying the critical areas of assistance necessary to achieve a prototype that is ready for first-in-human studies. Additional resources will also have been allocated. The crucial steps moving forward will be to work with the Innovators to develop and document a project management plan for the duration of the subproject and oversee its progress and that of the resources allocated to the subproject. Specifically, the IC will accomplish these goals with the followings aims: (OC Aim 1) To maximize subproject success, the Innovator Core will work closely with Innovators to monitor the progress of the subproject and any associated resources. (OC Aim 2) To mitigate the risk of failure, the Innovator Core, in collaboration with the Evaluation Core and the Steering Committee, will address any issues that could interfere with reaching identified milestones. (OC Aim 3) To continue to encourage Innovators to consider the principles of universal design throughout development to increase population served. The IC will identify a Dream Tech Team for each subproject which includes a project facilitator, as the single point of contact to NTH, a clinical advisor, commercialization advisor, steering committee mentor, and a project manager (PM) tool Trainer. The project facilitator will work with the subproject PI, using industry-standard project management tools, to document milestones, deliverables, and timelines (MD&T) for both the subproject and collaborate with the Resource Core (RC) to similarly document MD&T for funded Resources. The Dream Tech Teams will meet with Innovators at least monthly to monitor progress and identify any issues that might interfere with progress. In line with our Equitech approach, we expect to recruit URM participants to the Dream Tech Team who will work with their Innovators to continue to consider how their solution designs can address equity and accessibility criteria.

创新者核心项目概要 蓝图医疗技术计划的目标是“加速患者获得突破性的，安全的， 有效的医疗器械”。然而，要确保这些投资是有效的，就需要经常进行监督 和援助。创新者核心（IC）将负责提供这种监督， 对里程碑，协助意外延误，并减少或建议NIH停止 当一个项目显然不能达到预期结果时，就需要提供资金。神经科技港（NTH） 在子项目实施期间，IC将为受资助的团队提供密切的指导，并监督进展情况 使用项目管理工具，成功地交付第一个人类原型。 一旦子项目的资金获得批准，IC就会开始与该子项目互动并管理该子项目 收到。所有子项目PI将在NTH中有一个单一联系点，负责通过IC处理所有问题。在这个 在这一点上，项目里程碑、时间轴和可交付成果都将被定义。的评估 技术的发展阶段将在深潜分析（评估核心（EC））之后， 确定实现可用于首次人体试验的原型所需的关键援助领域 问题研究还将分配更多的资源。向前迈进的关键步骤将是与 创新者在子项目持续期间制定并记录项目管理计划， 监督其进展情况以及分配给次级项目的资源的进展情况。具体而言，IC将实现 这些目标包括以下目标：（OC目标1）为了最大限度地提高子项目的成功率，创新者核心将发挥作用 与创新者密切合作，监控子项目的进展和任何相关资源。(OC目标2） 降低失败的风险，创新者核心，与评估核心和指导 委员会将解决任何可能干扰实现已确定的里程碑的问题。(OC目标3） 继续鼓励创新者在整个开发过程中考虑通用设计原则， 增加服务人口。 IC将为每个子项目确定一个梦想技术团队，其中包括一个项目主持人，作为单一的 NTH的联系人，临床顾问，商业化顾问，指导委员会导师和项目 经理（PM）工具培训师。项目协调人将与子项目PI合作，使用行业标准项目 管理工具，记录子项目和 与资源核心（RC）合作，以类似方式记录MD&T的资助资源。梦想科技 团队将至少每月与创新者会面，以监控进度并确定可能干扰的任何问题 有进展。根据我们的Equitech方法，我们希望招募URM参与者加入Dream Tech 团队将与创新者合作，继续考虑他们的解决方案设计如何解决公平问题 和可访问性标准。