“Children are not little adults” is a common saying in medical pediatrics, with clinical practitioners underscoring the many differences in pediatric health compared to that of adults. However, in terms of medical devices, current availability requires some pediatric patients to be treated as “little adults” because a device designated specifically for them does not exist..

“儿童不是小成人”是医学儿科学中的常见说法，临床医生强调儿科健康与成人相比存在许多差异。但是，就医疗设备而言，当前的可用性要求某些儿科患者被视为“小成年人”，因为不存在专门为他们指定的设备。。

Now, the National Institute of Health (NIH) and industry are partnering to narrow this gap in care.

现在，美国国立卫生研究院（NIH）和工业界正在合作缩小这种护理差距。

The NIH, in partnership with both public and private entities, recently announced the launch of a design phase addressing the lack of medical devices specifically designed and approved for children in the United States. The partnership will bring together resources from US government agencies and private organizations, including industry and nonprofits, to develop a “national pediatric medical device ecosystem that augments the foundation developed from the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) effort lead by FDA,” according to NIH..

美国国立卫生研究院与公共和私人实体合作，最近宣布启动一个设计阶段，解决缺乏专门为美国儿童设计和批准的医疗设备的问题。这种伙伴关系将汇集美国政府机构和私人组织（包括工业和非营利组织）的资源，开发一个“国家儿科医疗器械生态系统，加强由美国国立卫生研究院领导的儿科医疗器械创新医院系统（SHIP-MD）的基础。。

“It takes a village to support the development, evaluation, regulatory approval, and commercialization of medical devices that meet the unique needs of children,” said Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a press release announcing the partnership.

Eunice Kennedy Shriver国家儿童健康与人类发展研究所所长Diana W.Bianchi博士说：“需要一个村庄来支持满足儿童独特需求的医疗器械的开发，评估，监管审批和商业化。”宣布合作伙伴关系的新闻稿。

“We look forward to building a public-private partnership to enhance child health by increasing the number of approved medical devices for children.”.

“我们期待通过增加批准的儿童医疗器械数量，建立公私合作伙伴关系，以增强儿童健康。”。

Currently, despite several legislative, regulatory, and scientific advancements, pediatric medical device development continues to lag behind their adult counterparts by as much as 10 years, according to the American Academy of Pediatrics. Over the past two decades, the FDA has introduced a number of regulatory and programmatic initiatives for pediatric medical device advancement including the expansion of the HDE program, the launch of the Pediatric Device Consortia Program, a collaboration with the National Evaluation System for Health Technology to create pediatric Real World Evidence demonstration projects, and the System of Hospitals for Innovation Pediatrics – Medical Devices.

据美国儿科学会称，目前，尽管有几项立法，监管和科学进步，儿科医疗器械的开发仍比成人医疗器械落后多达10年。在过去二十年中，FDA为儿科医疗器械的发展引入了一系列监管和计划举措，包括扩大HDE计划，启动儿科器械联盟计划，与国家卫生技术评估系统合作创建儿科现实世界证据示范项目，以及儿科医疗器械创新医院体系。

However, commentary published in the Journal of American Medical Association Pediatrics (JAMA Pediatrics) noted “The substantial financial and market barriers faced by pediatric medical device innovators need to be addressed by a broad coalition of stakeholders, not just the FDA.”.

然而，发表在“美国医学会儿科杂志”（JAMA Pediatrics）上的评论指出，“儿科医疗器械创新者面临的重大财务和市场障碍需要由广泛的利益相关者联盟解决，而不仅仅是FDA”。

“Although individuals younger than 18 years represent nearly one-quarter of the US population, less than 12% of the National Institutes of Health budget funds pediatric research, and less than 10% of all health care spending is for pediatrics,” according to JAMA Pediatrics commentary. “Pediatric medical devices, which are critical tools for the diagnosis and treatment of disease in children, also are affected by this disparity and have long lagged behind their adult counterparts in terms of availability, options, and innovation.”.

“虽然18岁以下的人占美国人口的近四分之一，但美国国立卫生研究院预算中不到12%用于儿科研究，不到10%的医疗支出用于儿科，”JAMA pediatrics评论。“儿科医疗器械是诊断和治疗儿童疾病的关键工具，也受到这种差异的影响，在可用性，选择和创新方面长期落后于成人。

As a result, children with certain diseases are faced with zero device options, inadequate options, or adult devices that are modified and used off-label with a lack of robust scientific evidence of its safety and effectiveness in children, according to NIH.

因此，根据美国国立卫生研究院的说法，患有某些疾病的儿童面临零设备选择，选择不足或成人设备的修改和使用，缺乏强有力的科学证据证明其对儿童的安全性和有效性。

Other factors that contribute to this problem include a lack of technical innovation for devices that meet child-specific needs. “For example, children are smaller and generally more active than adults, and they undergo frequent developmental changes,” according to NIH.

导致这一问题的其他因素包括缺乏满足儿童特定需求的设备的技术创新。美国国立卫生研究院表示：“例如，儿童比成年人小，通常比成年人更活跃，并且经常发生发育变化。”。

Device manufacturers, according to the institute, may also view the development of pediatric devices to have a low return on investment due to the relatively small market and challenges of conducting clinical research for pediatric patients.

据该研究所称，设备制造商也可能认为，由于相对较小的市场和为儿科患者进行临床研究的挑战，儿科设备的开发投资回报较低。

Over the next year, private and public partners will develop the national pediatric medical device ecosystem. The design phase will be led by the Foundation of the National Institutes of Health, a nonprofit that creates and manages partnerships with public and private institutions that support NIH. Additionally, NIH, the Center for Devices and Radiological Health at FDA, and the division of Research, Innovation, and Ventures at the Biomedical Advanced Research and Development Authority will provide scientific and regulatory insight, expertise, and funding for the effort.

明年，私营和公共合作伙伴将开发国家儿科医疗器械生态系统。设计阶段将由美国国立卫生研究院（National Institutes of Health）的基金会领导，该机构是一家非营利性机构，与支持NIH的公共和私人机构建立和管理伙伴关系。此外，NIH，FDA的设备和放射卫生中心以及生物医学高级研究与发展局的研究，创新和企业司将为这项工作提供科学和监管的见解，专业知识和资金。

Within NIH, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Biomedical Imaging and Bioengineering will be leading in the program’s development, with other institutes and centers also engaged through the NIH Pediatric Research Consortium.

在NIH内部，Eunice Kennedy Shriver国家儿童健康与人类发展研究所和国家生物医学成像与生物工程研究所将领导该计划的发展，其他研究所和中心也将通过NIH儿科研究联盟参与。

Additional funding and expertise will be provided by private donors..

私人捐助者将提供额外的资金和专业知识。。

“This partnership is essential to expand the pediatric medical device ecosystem and develop products to improve health outcomes for the youngest and most vulnerable populations,” said Bruce Tromberg, PhD, director of the National Institute of Biomedical Imaging and Bioengineering, in the release. “From medical imaging to diagnostics and interventions, devices need to be designed and built for children so they can receive the highest quality of care possible.”.

国家生物医学成像和生物工程研究所主任布鲁斯·特罗姆伯格博士在该版本中说：“这种伙伴关系对于扩大儿科医疗器械生态系统和开发产品以改善最年轻和最脆弱人群的健康结果至关重要。“从医学成像到诊断和干预，设备需要为儿童设计和制造，以便他们能够获得最高质量的护理。”。