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: 10468507
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10468507
• 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/概要 为了满足儿童疾病治疗的未满足需求，费城儿科医院成立了 医疗器械联盟（PPDC）4.5年前。费城儿童医院（CHOP） 在FDA儿科器械联盟（PDC）计划的资助下，PPDC的使命是提供 种子资金和商业，法律的，市场营销，临床，工程和科学资源的发明者， 有前途的儿科医疗器械，将使儿童受益，具有很强的商业化潜力。 CHOP在临床护理和研究方面都具有全国性的突出地位，并与充满活力的医学相结合。 设备开发生态系统正在我们地区发展，我们已经取得了成功。过去5 多年来，PPDC已经沿着开发路径协助了60多个设备，与我们的7个相比， 同行PDC，PPDC负责一半的试验用器械豁免 申请，510 K的20%，以及71%的预提交会议。 PPDC网络提供的支持，该网络由各自领域的杰出专家组成，他们自愿抽出时间提供咨询意见。 PPDC设备创新者允许PPDC成为使用联邦资金的领导者。从 PPDC成立，NAMSA -世界上最大的医疗器械专业合同研究组织- 为PPDC考虑支持的每一个设备项目提供协助。我们的临床和科学 咨询委员会-临床医生和科学家谁是思想领袖在各自的领域-评估的技术 每个设备项目的优点。我们的监督委员会-由杰出的首席执行官，投资者和其他 医疗器械业务领导者-评估价值主张、报销、监管、营销和 每一个提议的设备的业务策略。所有这些服务都由PPDC免费提供。 在上述成功的基础上，我们提出新的倡议和加强伙伴关系， 提高我们帮助创新者的能力。首先，我们与匹兹堡大学的麦高恩合作， 研究所，一家全球性的第三类医疗器械开发企业，一直走在世界前列， 调查、测试和翻译在再生医学中发挥关键作用的医疗设备 在过去的二十五年里。麦高恩的合作伙伴关系为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，其中他们的优秀教师正在调整成人设备，以适应儿科 人口PPDC将继续与费城的学术，工程，商业 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。的 宾夕法尼亚大学刚刚推出了“宾夕法尼亚健康技术”，以促进医疗设备创新， PPDC正在与这一努力合作。我们的生产力也将通过我们的真实的世界数据/结果得到提高 基于CHOP专业知识的项目，研究与复苏结局相关的儿科器械终点。