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: 10683865
• 负责人: Robert J Levy
• 金额: $ 15万
• 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 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10683865
• 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/摘要 解决治疗儿童疾病的未满足需求导致费城小儿的创造 医疗设备财团（PPDC）4。5年前。成立于费城儿童医院（CHOP） 通过FDA儿科设备财团（PDC）计划的资金，PPDC的任务是提供 种子资金和业务，法律，营销，临床，工程和科学资源 有希望的儿科医疗设备将使儿童受益并具有强大的商业化潜力。 CHOP在临床护理和研究中都具有全国性的突出，并与充满活力的医学相结合 我们地区正在开发的设备开发生态系统，我们找到了成功。在过去的5个 多年来，PPDC已在开发途径上协助了60多个设备，并与我们的7个设备相比 PPDC的PEER PDC负责一半的研究设备豁免 申请，510K的20％和审议前会议的71％。 PPDC网络在其领域的杰出专家提供的支持，他们自愿时间来建议 PPDC设备的创新者允许PPDC成为领导者，并使用联邦资金来使用联邦资金。从 PPDC Inception，NAMSA - 全球最大的合同研究组织，专门从事医疗设备 - 已协助PPDC考虑过支持的每个设备项目。我们的临床和科学 咨询委员会 - 临床医生和科学家，他们是其领域的思想领袖 - 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，投资者和其他人组成 医疗设备业务领导者 - 评估价值提议，报销，监管，市场营销和 每个提议的设备的业务策略。 PPDC免费提供所有这些服务。 在理由成功的基础上，我们提出了新的计划和增强伙伴关系 提高我们协助创新者的能力。首先，我们正在与匹兹堡大学的麦克高恩合作 Institute是一家全球III类医疗设备开发企业，一直处于最前沿 调查，测试和翻译在再生医学中发挥关键作用的医疗设备 在过去的二十五年中。 McGowan的合作伙伴关系为PPDC带来了两个战略优势：1） McGowan的III类设备开发功能扩展了PPDC的功能。 2）McGowan有一个 儿科设备倡议，其出色的教职员工正在为小儿改编成人设备 人口。 PPDC将继续我们与费城学术，工程，商业的合作伙伴关系 和医学专家。我们将加强与宾夕法尼亚大学和德雷克塞尔大学的联系。这 宾夕法尼亚大学刚刚推出了“ Penn Health-Tech”，以催化医疗设备创新，并 PPDC正在与此努力合作。我们的现实世界数据/结果也将提高我们的生产率 关于砍伐专业知识的项目大楼，研究有关复苏结果的小儿装置终点。

项目成果

The Reviewer Academy of the Society of Critical Care Medicine: Key Principles and Strategic Plan.

• DOI: 10.1097/ccm.0000000000005962
• 发表时间: 2023-09-01
• 期刊: Critical care medicine
• 影响因子: 8.8