Beekeeper Administrative Core for COSMIIC HORNET

COSMIIC HORNET 的养蜂人管理核心

• 批准号: 10701810
• 负责人: KEVIN L. KILGORE
• 金额: $ 73.49万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-10 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10701810
• 关键词: Adoption; Agreement; Apidae; Applications Grants; Area; Arrhythmia; Autonomic nervous system; Bladder; Blood Vessels; Brain; Budgets; CBL gene; California; Cerebral Palsy; Charge; Clinic; Clinical Trials; Communication; Communities; Congestive Heart Failure; Data; Devices; Diabetes Mellitus; Disease; Documentation; Education; Electrodes; Electronics; Endocrine; Engineering; Ensure; Ethics; Family; Feedback; Foundations; Funding; Goals; Grant; Healthcare Systems; Heart; Heart Atrium; Human; Hypertension; Implant; Incontinence; Institution; Intestines; Label; Los Angeles; Macular degeneration; Marketing; Medical; Menopause; Michigan; Monitor; Motor; Myocardial Infarction; Names; Nerve Pain; Obesity; Ohio; Pain; Peripheral Nerves; Persons; Process; Property; Research; Resources; Retina; Retinitis Pigmentosa; Running; Schedule; Scientist; Sex Functioning; Skeletal Muscle; Specific qualifier value; Spinal Cord; Spinal Ganglia; Spinal cord injury; Stomach; Stroke; Synapses; System; Technology; Testing; Universities; bioelectricity; bioelectronics; body system; clinical application; design; disability; first-in-human; implant design; implantable device; innovation; interest; manufacture; meetings; neural; neuroregulation; novel; online community; open source; operation; patient population; pelvic organ prolapse; recruit; spasticity; spinal cord and brain injury; web site

The primary goal of this COSMIIC HORNET project is to enable the research field to not only have access to new implantable technology, but also, where possible, to establish the ability to modify and innovate around that implantable technology. In order to achieve this goal, it is absolutely necessary that the COSMIIC HORNET project is directly applicable to the bioelectronic research community and provides the appropriate resources. To achieve this, we have formed a team of over 30 experts in neural interface technologies and their clinical applications. This “Beekeeper Team” will provide administrative oversight for the project. A key feature of our Beekeeper core is that it has broad representation of the spectrum of clinical applications for our implantable open source neuromodulation technology. The long-term objective of this project is widespread use of the COSMIIC modules to develop new medical treatments for a wide range of applications. This requires a focus on early dissemination and sustainability. The administration of this project will therefore have the following three specific aims: Aim 1) Ensure the widespread utility of the novel modules. The beekeepers will provide feedback on novel designs early in the design process to ensure that the device specifications and modes of operation will serve a wide community of users. In conjunction with an external advisory board, the administrative team will also monitor progress on the scheduled project milestones. Aim 2) Evaluate the distributed resources for completeness and safe ethical use. The COSMIIC HORNET modules will be designed for use by research teams with strong engineering expertise, who must have a thorough understanding of the devices they will use. The Beekeeper team will evaluate design and regulatory documentation prior to distribution to the public Aim 3) Create a community of early adopters who can serve as a resource for others. Each beekeeper has a personal interest in using this technology for their own research. During the course of this project, they will lay the groundwork for that use at the end of three years through FDA communications and grant applications. Each of the application represented by the beekeepers has a larger community of scientists who may benefit from using these devices. Beekeepers will serve as an ambassador for these novel devices within that community and we will also support and incorporate additional users who wish to become early adopters. At the end of this project, the existing modules already in human use will be fully open-sourced including all regulatory communications. Novel designs will be complete, and well documented. There will also be an online community of users at a variety of stages of adoption.

COSMIIC HORNET 项目的主要目标是使研究领域不仅能够 获得新的植入技术，而且在可能的情况下建立修改和创新的能力 围绕植入技术。为了实现这一目标，COSMIIC 绝对有必要 HORNET项目直接适用于生物电子研究界，并提供适当的 资源。为了实现这一目标，我们组建了一支由 30 多名神经接口技术专家组成的团队 他们的临床应用。这个“养蜂人团队”将为该项目提供行政监督。 我们的 Beekeeper 核心的一个关键特征是它具有广泛的临床代表性 我们的植入式开源神经调节技术的应用。本次活动的长远目标 该项目广泛使用 COSMIIC 模块来为广泛的领域开发新的医疗方法 应用程序。这需要注重早期传播和可持续性。本项目的管理 因此，将有以下三个具体目标： 目标1）确保新颖模块的广泛实用性。养蜂人将提供反馈 在设计过程的早期进行新颖的设计，以确保设备规格和操作模式将 服务广大用户群体。管理团队将与外部顾问委员会一起 还监控预定项目里程碑的进展。 目标 2) 评估分布式资源的完整性和安全道德使用。宇宙信息中心 HORNET 模块将设计供具有强大工程专业知识的研究团队使用，他们必须 对他们将使用的设备有透彻的了解。养蜂人团队将评估设计和 向公众分发之前的监管文件 目标 3) 创建一个早期采用者社区，为其他人提供资源。每个养蜂人 个人有兴趣使用该技术进行自己的研究。在这个项目的过程中，他们 将通过 FDA 沟通和拨款，在三年结束时为该用途奠定基础 应用程序。以养蜂人为代表的每个应用程序都有一个更大的科学家群体，他们 可能会从使用这些设备中受益。养蜂人将担任这些新颖设备的大使 该社区和我们还将支持并吸纳希望成为早期采用者的其他用户。 在这个项目结束时，已经投入使用的现有模块将完全开源 包括所有监管沟通。新颖的设计将是完整的，并且有据可查。还会有 成为处于不同采用阶段的用户的在线社区。