Atlanta Pediatric Device Consortium

描述(由申请人提供)： 我们的总体目标是为我们的儿科人口提供尽可能好的医疗服务。这项提议旨在利用亚特兰大合作机构的能力的深度和广度，成立亚特兰大儿科设备联盟，目的是增加儿童设备的开发和生产，以改善他们的健康。儿童医院是美国最大的综合保健儿科医院系统。与埃默里大学和佐治亚理工学院合作，儿童医院在儿科研究方面进行了投资，这些研究涵盖了整个医疗保健领域。重要的是，儿童、埃默里和佐治亚理工学院开创了专门面向儿童需求的新型设备开发。该联盟将通过以下方式实现其目标：将佐治亚理工学院生物医学工程与科学翻译研究所(TRIBES)之间的现有关系正规化，该研究所专注于产生商业产品的工程系统的需求；全球医学创新中心，其设计和生产良好的制造实践制造的原型；以及圣约瑟夫翻译研究所的良好实验室实践认证的大型动物设施。 联盟机构将与美国国立卫生研究院赞助的亚特兰大临床转化科学研究所合作，为儿童首次测试和临床提供场所 评估。具体目标包括：为确定新技术提供一整套服务，确定商业化的开发计划，并与财团中心合作协助执行。其他目标包括建立一个临床咨询委员会，以评估拟议设备的科学和医学价值；提供一个产生外部资金的机制；以及培养一支了解儿童设备设计和实施要求的临床医生、科学家和工程师队伍。提出了五个项目，以证明该财团识别、开发和商业化儿科设备的能力。将仔细审查产品开发途径，以确保临床实用。最后，该联盟将提供教育机会，培训学生、临床医生和企业家在医疗保健提供的重要方面。

DESCRIPTION (provided by applicant): The overall goal is to provide the best medical care possible for our pediatric population. This proposal aims to take advantage of the depth and breadth of capabilities at Atlanta's partnering institutions to form the Atlanta Pediatric Device Consortium, with the purpose of increasing the development and production of devices for children that will improve their health. Children's is the nation's largest comprehensive-care pediatric hospital system. In partnership with Emory University and Georgia Tech's College of Engineering, Children's has made an investment in pediatric research that spans the healthcare continuum. Importantly, Children's, Emory and Georgia Tech have pioneered novel device development that is specifically oriented towards the needs of children. The consortium will achieve its goals by formalizing existing relationships between the Georgia Tech Translational Research Institute for Biomedical Engineering and Science (TRIBES), which focuses on the need for engineering systems that results in commercial products; the Global Center for Medical Innovation, which designs and produces Good Manufacturing Practices-manufactured prototypes; and the Good Laboratory Practices-certified large animal facility at St. Joseph's Translational Research Institute. Consortium institutions will partner with the National Institutes of Health-sponsored Atlanta Clinical Translational Science Institute, providing a venue for first-in-child testing and clinical assessments. Specific aims include: providing access to a continuum of services for identifying novel technologies, determining a development plan for commercialization, and partnering with consortium centers to assist with execution. Other goals include establishing a clinical advisory board to assess the scientific and medical merit of proposed devices; providing a mechanism for generating external funding; and developing a cadre of clinicians, scientists, and engineers with an understanding of the requirements for design and implementation of devices for children. Five projects are proposed to demonstrate the consortium's ability to identify, develop, and commercialize pediatric devices. The product development pathway will be scrutinized to ensure clinical utility. Finally, the consortium will provide educational opportunities to train students, clinicians and entrepreneurs in the important aspect of health care delivery.