Medical Device Consortium at the Children's Hospital of Philadelphia

费城儿童医院医疗器械联盟

• 批准号: 9768955
• 负责人: Robert J Levy
• 金额: $ 100万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9768955
• 关键词: Medical; Device; Consortium; Children; Hospital

Abstract/Summary Addressing unmet needs for treating childhood illnesses lead to the creation of the Philadelphia Pediatric Medical Device Consortium (PPDC) 4.5 years ago. Founded at the Children’s Hospital of Philadelphia (CHOP) with funding from the FDA Pediatric Device Consortia (PDC) program, the mission of the PPDC is to provide seed funding and business, legal, marketing, clinical, engineering and scientific resources to inventors of promising pediatric medical devices that will benefit children and have a strong commercialization potential. CHOP has national prominence in both clinical care and research, and combined with the vibrant medical device development ecosystem that is developing in our region, we have found success. Over the past 5 years, the PPDC has assisted more than 60 devices along the development pathway, and compared to our 7 peer PDCs, the PPDC has been responsible for responsible for half of the Investigational Device Exemption applications, 20% of 510Ks, and 71% of pre-submission meetings. The support offered by the PPDC network of preeminent experts in their field who volunteer their time to advise PPDC device innovators has allowed the PPDC to be a leader with parsimonious use of federal funds. From PPDC inception, NAMSA - the world’s largest contract research organization specializing in medical devices – has assisted every device project that the PPDC has considered for support. Our Clinical and Scientific Advisory Committee – clinicians and scientists who are thought-leaders in their fields – evaluate the technical merit of every device project. Our Oversight Committee – consisting of luminary CEOs, Investors, and other medical device business leaders – evaluate the value proposition, reimbursement, regulatory, marketing and business strategy of each proposed device. All of these services are provided free of charge by the PPDC. Building on the aforementioned success, we propose new initiatives and enhanced partnerships that will increase our ability to assist innovators. First, we are partnering with the University of Pittsburgh’s McGowan Institute, a global Class III medical device development enterprise which has been at the forefront of investigating, testing and translating medical devices that have played a critical role in regenerative medicine for the past twenty-five years. McGowan’s partnership brings two strategic advantages to the PPDC: 1) McGowan’s Class III device development capabilities expands the capability of the PPDC. 2) McGowan has a pediatric device initiative in which their outstanding faculty are adapting adult devices for the pediatric population. The PPDC will continue our partnerships with Philadelphia-based academic, engineering, business and medical experts. We will enhance our ties with the University of Pennsylvania and Drexel University. The University of Pennsylvania has just launched “Penn Health-Tech,” to catalyze medical device innovation, and the PPDC is partnering with this effort. Our productivity will also be enhanced by our real world data/results project building on CHOP expertise studying pediatric device endpoints concerning resuscitation outcomes.

摘要/总结 为了解决儿童疾病治疗方面未得到满足的需求，费城儿科中心成立了 医疗器械联盟 (PPDC) 4.5 年前。成立于费城儿童医院 (CHOP) 在 FDA 儿科设备联盟 (PDC) 计划的资助下，PPDC 的使命是提供 为发明人提供种子资金和商业、法律、营销、临床、工程和科学资源 有前途的儿科医疗器械将使儿童受益并具有强大的商业化潜力。 CHOP 在临床护理和研究方面具有全国领先地位，并与充满活力的医学相结合 我们地区正在发展的设备开发生态系统，我们已经取得了成功。过去 5 多年来，PPDC 已在开发道路上协助了 60 多个设备，相比之下我们只有 7 个设备 与同行 PDC 相比，PPDC 负责一半的研究器械豁免 申请、510K 的 20% 以及提交前会议的 71%。 由 PPDC 网络提供的支持，该网络由各自领域的杰出专家组成，他们自愿花时间提供建议 PPDC 设备创新者使 PPDC 成为节约使用联邦资金的领导者。从 PPDC成立，NAMSA——世界上最大的专门从事医疗器械的合同研究组织—— 已协助 PPDC 考虑支持的每个设备项目。我们的临床和科学 咨询委员会——各自领域的思想领袖临床医生和科学家——评估技术 每个设备项目的优点。我们的监督委员会 – 由杰出首席执行官、投资者和其他人士组成 医疗器械业务领导者 – 评估价值主张、报销、监管、营销和 每个提议设备的业务策略。所有这些服务均由 PPDC 免费提供。 在上述成功的基础上，我们提出了新的举措和加强的伙伴关系，这将 提高我们协助创新者的能力。首先，我们与匹兹堡大学的 McGowan 合作 研究院，一直处于行业前沿的全球三类医疗器械研发企业 研究、测试和翻译在再生医学中发挥关键作用的医疗设备 过去二十五年来。 McGowan 的合作伙伴关系为 PPDC 带来了两大战略优势：1) McGowan 的 III 类设备开发能力扩展了 PPDC 的能力。 2) 麦高恩有一个 儿科设备倡议，其中他们的杰出教师正在为儿科调整成人设备 人口。 PPDC 将继续与费城的学术、工程、商业领域建立合作伙伴关系 和医学专家。我们将加强与宾夕法尼亚大学和德雷塞尔大学的联系。这 宾夕法尼亚大学刚刚推出了“Penn Health-Tech”，以促进医疗设备创新， PPDC 正在配合这项工作。我们的现实世界数据/结果也将提高我们的生产力 该项目以 CHOP 专业知识为基础，研究与复苏结果相关的儿科设备终点。