The Consortium for Technology & Innovation in Pediatrics: CTIP 3.0

技术联盟

• 批准号: 10817563
• 负责人: Yaniv Bar-Cohen
• 金额: $ 115万
• 依托单位: LURIE CHILDREN'S HOSPITAL OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10817563
• 关键词: Consortium; Technology; Innovation; Pediatrics; CTIP

Project Summary The Consortium for Technology & Innovation in Pediatrics (CTIP 3.0) is a pediatric medical device consortium based at Lurie Children’s Hospital (LCH) and Children’s Hospital Los Angeles (CHLA) established in 2011 and funded by the FDA in 2013 and 2018. CTIP facilitates the development and commercialization of pediatric medical devices by simultaneously engaging and coordinating clinicians, engineers, regulators, hospital administrators, industry, patients, and the business community to guide and support medical device development for children. For portfolio companies, CTIP fosters networking opportunities, clinical partnerships, research and evidence generation, and direct and indirect financial support and expert guidance on issues related, but not limited to, intellectual property, prototyping, engineering, testing, grant writing, business development, regulatory strategy, and clinical trial design. CTIP has established a network of children’s hospitals, academic institutions, accelerators, incubators, and ecosystem partners to support the commercialization of pediatric medical devices. Over the past ten years, CTIP has expanded from southern California, to the entire west coast, and now to a national consortium with academic and industry partners in California, Oregon, Washington, Illinois, Colorado, Michigan, Missouri, and Wisconsin. CTIP’s overarching goals are: 1) Accelerate pediatric MedTech forward, no matter how small or large the step, through non-dilutive funding and comprehensive wrap-around services at every stage of the total product life cycle; 2) Connect pediatric medical device innovators to our national network of experts and multidisciplinary stakeholders to foster research, clinical, and business partnerships; and 3) Advocate for pediatric health equity and champion pediatric-specific innovation through research, publications, public events, education, and collaborations. The systematic barriers to pediatric device innovation are too complex for any one entity to address, so we have worked tirelessly to be effective partners to the other PDCs, the FDA, healthcare organizations, investors, and other ecosystem partners. By coordinating with larger organizations, we multiply our efforts and reach in the field of pediatric medical devices. For the next funding cycle, CTIP plans to continue to deliver excellent support to all of our portfolio members, and expand our activities in four key areas: 1) business development and follow-on funding opportunities to ensure our companies have the financial runway they need to bring their devices to market; 2) growing our robust pediatric medical device clinical trials infrastructure and services; 3) engaging patients and families intentionally as partners in device development and advocacy; and 4) addressing founders’ critical knowledge gaps in healthcare informatics, including data integration, interoperability, cybersecurity, and EHR workflows. These new activities will help CTIP continue to build a sustainable, needs-driven pipeline of new pediatric medical devices, with the ultimate goal of having more and better devices available on the market that are designed to specifically meet the health needs of children.

项目摘要 儿科技术与创新联盟（CTIP 3.0）是一个儿科医疗器械联盟 2011年成立的Lurie儿童医院（LCH）和洛杉矶儿童医院（CHLA）， 由FDA在2013年和2018年资助。CTIP促进了儿科药物的开发和商业化 通过同时参与和协调临床医生、工程师、监管机构、医院 管理人员、行业、患者和企业界指导和支持医疗器械 儿童的发展。对于投资组合公司，CTIP促进网络机会，临床合作伙伴关系， 研究和证据生成，以及直接和间接的财政支持和专家指导 相关的，但不限于，知识产权，原型设计，工程，测试，授权写作，业务 开发、监管策略和临床试验设计。CTIP建立了一个儿童网络， 医院，学术机构，加速器，孵化器和生态系统合作伙伴，以支持 儿科医疗器械的商业化。在过去的十年里，CTIP从南部扩展到南部， 从加州到整个西海岸，现在又到一个由学术界和工业界合作伙伴组成的全国性联盟， 加州、俄勒冈州、华盛顿、伊利诺伊州、科罗拉多、密歇根州、密苏里州和威斯康星州。CTIP的总体目标 我们的目标是：1）通过非稀释的方式，加速儿科医疗技术的发展，无论步伐有多大或多小。 在整个产品生命周期的每个阶段提供资金和全面的环绕式服务; 2）连接 儿科医疗器械创新者到我们的国家专家和多学科利益相关者网络， 促进研究，临床和商业伙伴关系;和3）倡导儿科健康公平和冠军 通过研究、出版物、公共活动、教育和合作进行儿科学的具体创新。的 儿科器械创新的系统性障碍太复杂，任何一个实体都无法解决，因此我们 不知疲倦地工作，成为其他PDC、FDA、医疗保健组织、投资者的有效合作伙伴， 其他生态系统合作伙伴。通过与较大的组织协调，我们加倍努力， 儿科医疗器械领域。在下一个融资周期，CTIP计划继续提供出色的 支持我们所有的投资组合成员，并扩大我们在四个关键领域的活动：1）业务发展 以及后续融资机会，以确保我们的公司拥有所需的财务跑道， 器械上市; 2）发展我们强大的儿科医疗器械临床试验基础设施和服务; 3） 有意识地让患者和家属作为器械开发和宣传的合作伙伴参与;以及4） 解决创始人在医疗保健信息学方面的关键知识差距，包括数据集成， 互操作性、网络安全和EHR工作流程。这些新的活动将有助于CTIP继续建立一个 可持续的，以需求为导向的新型儿科医疗器械产品线，最终目标是拥有更多， 市场上有更好的设备，专门满足儿童的健康需求。