Medical Device Consortium at the Children's Hospital of Philadelphia

摘要/摘要 解决儿童疾病治疗方面未得到满足的需求导致了费城儿科 医疗器械联盟(PPDC)在4.5年前成立。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 为发明者提供种子资金和商业、法律、营销、临床、工程和科学资源 前景看好的儿童医疗器械，将造福于儿童，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领先地位，并与充满活力的医学 在我们地区正在发展的设备开发生态系统中，我们已经取得了成功。在过去5年中 多年来，PPDC已经在开发过程中帮助了60多台设备，与我们的7台 同行PDC，PPDC负责一半的调查设备豁免 申请、20%的510K和71%的提交前会议。 由各自领域的杰出专家组成的PPDC网络提供的支持，他们自愿花时间提供建议 PPDC设备创新者让PPDC成为节省使用联邦资金的领导者。从… PPDC Instination，NAMSA-世界上最大的专门从事医疗器械的合同研究组织- 协助了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-临床医生和科学家是各自领域的领先者-评估技术 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、投资者和其他人组成 医疗设备业务领导者-评估价值主张、报销、监管、营销和 每台推荐设备的业务战略。所有这些服务都是由PPDC免费提供的。 在上述成功的基础上，我们提出了新的倡议和加强的伙伴关系，将 提高我们协助创新者的能力。首先，我们与匹兹堡大学的麦高恩合作 科研院所，一家全球三类医疗器械开发企业，一直走在 调查、测试和翻译在再生医学中发挥关键作用的医疗器械 在过去的二十五年里。McGowan的合作伙伴关系为PPDC带来了两个战略优势：1) McGowan的III类设备开发能力扩展了PPDC的能力。2)麦高恩有一个 儿科设备倡议，其杰出的教职员工正在为儿科患者调整成人设备 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。这个 宾夕法尼亚大学刚刚推出了“宾夕法尼亚健康科技”，以促进医疗设备的创新，以及 PPDC正在与这一努力合作。我们的工作效率也将因现实世界的数据/结果而得到提升 项目建立在CHOP专业知识的基础上，研究与复苏结果有关的儿科设备终端。

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.