Midwest Pediatric Device Consortium (MPDC)

摘要 中西部儿科设备联盟(MPDC)的成立是为了解决儿科领域未得到满足的需求 医疗器械开发。成立于全国儿童医院(NCH)和俄亥俄州立大学 在俄亥俄州哥伦布市(OSU)，MPDC将使用FDA儿科设备联盟(PDC)计划的资金 支持其提供资金和商业、法律、组织、临床、工程和科学的使命 为具有巨大商业化潜力的儿科医疗器械发明者提供的资源 满足儿科健康需求。国立卫生研究院和俄亥俄州立大学都在临床护理和研究方面保持着全国领先地位。 与其他儿科保健组织合作，包括辛辛那提儿童和克利夫兰诊所 为我区建立充满活力和全面的医疗器械开发生态系统 在领导、参与、社区参与和经济机会方面提供多样性。MPDC也是 由俄亥俄州的贸易组织支持，包括俄亥俄州的乔布斯和俄亥俄州生命科学公司，以利用他们的网络 关系和州立法影响力。最后，MPDC与包括Rev1在内的几个风险基金接洽 风投、CincyTech和Project MedTech，拥有丰富的资源和经验，带来创业 公司向前发展。MPDC的参与组织已经帮助了大量的设备 沿着发展道路，展示必要的商业经验和管理理念 为了节目上的成功。MPDC网络为创新者提供全方位的支持，包括 由各自领域的杰出专家组成，他们将提供建议、教育、指导和资金，帮助引领设备 通过管道开发取得商业成功。我们的执行委员会和咨询委员会 由临床医生、科学家、商业和制造业专家组成，他们是各自领域的思想领袖。 他们将评估每个提交评估和资助的设备项目的临床和商业价值。 MPDC的组织结构包括能够评估其价值的广泛领导 建议的每台设备的建议、报销、监管、营销和业务战略都是免费的 服务。MPDC将实施其全面计划，以促进协作、多样性、公平和包容性，如 作为创建惠及所有儿科患者的全国网络的领导者，MPDC还将提供独特的现实世界 通过专门为捕获数据流和开发收集机制而设计的项目提供证据 支持儿科设备标签扩展的新数据。MPDC将成为儿科医疗设备的灯塔 通过将学术研究人员、发明家、企业家和行业合作伙伴 通过发展新的和所需的技术来改变儿科医疗保健的综合计划。

Summary The Midwest Pediatric Device Consortium (MPDC) has been created to address unmet needs in pediatric medical device development. Founded at Nationwide Children’s Hospital (NCH) and The Ohio State University (OSU) in Columbus, Ohio, MPDC will use funds from the FDA Pediatric Device Consortia (PDC) program in support of its mission to provide funding and business, legal, organizational, clinical, engineering and scientific resources to inventors of pediatric medical devices having significant commercialization potential and that address pediatric health needs. NCH and OSU both maintain national prominence in clinical care and research. Teaming with other pediatric healthcare organizations including Cincinnati Children’s and Cleveland Clinic Children’s establishes a vibrant and comprehensive medical device development ecosystem for our region and provides diversity in leadership, participation, community engagement and economic opportunity. MPDC is also powered by Ohio’s Trade Organizations, including Jobs Ohio and Ohio Life Sciences, to leverage their network of connections and state legislative influence. Lastly, MPDC engages with several venture funds including Rev1 Ventures, CincyTech, and Project MedTech, having considerable resources and experience bringing startup companies forward. Participating organizations of the MPDC have already assisted a large number of devices along the development pathway, demonstrating the business experience and stewardship of ideas necessary for programmatic success. The full range of support is offered to innovators by the MPDC network, comprised of preeminent experts in their field who will provide advice, education, guidance and funding to help lead device development through the pipeline to commercial success. Our Executive Committee and Advisory Committee are made up of clinicians, scientists, business and manufacturing experts who are thought-leaders in their fields. They will evaluate the clinical and business merits of every device project submitted for evaluation and funding. MPDC’s organizational structure includes a broad spectrum of leaders who are able to assess the value proposition, reimbursement, regulatory, marketing and business strategy of each proposed device as a cost-free service. MPDC will implement its comprehensive plan to foster collaboration, diversity, equity, and inclusion as a leader in creating a national network benefiting all pediatric patients MPDC will also provide unique real world evidence through projects specifically crafted to capture data streams as well as develop mechanisms to collect new data to support pediatric device label expansion. MPDC will be a beacon of pediatric medical device innovation through its bridging of academic researchers, inventors, entrepreneurs and industry partners in an integrative program to transform pediatric healthcare through advancement of new and needed technologies.