Duffy Summer, Krishnan Anita, Yazdi Youseph, Quan Xina, Hughes Minerva, Marsal Ana Loloei, Peiris Vasum, Frassica Joe J, Eskandanian Kolaleh, Sen Danielle Gottlieb
Division of Pediatric Cardiac Surgery, Department of Surgery, The Johns Hopkins University School of Medicine, Baltimore, Maryland.
Department of Pediatric Cardiology, Children's National Hospital, Washington, DC.
Ann Thorac Surg. 2024 Dec 21. doi: 10.1016/j.athoracsur.2024.11.034.
Medical device innovation and development for pediatric care lags behind that of adults. With higher technical risks, challenges in accumulating data, smaller market sizes, and limited return on investment, there is less incentive for pediatric device development. Consequently, translation of medical devices specifically designed to improve pediatric care is limited. However, a changing landscape and novel programs may support an expansion of pediatric device development.
A keyword-based search was conducted in PubMed; market databases and Food and Drug Administration guidance documents were also used in this review. A total of 18,017 articles underwent a title and abstract review, and 190 articles were reviewed by the expert authors.
Collectively, challenges with evidence generation and business and technical forces have disincentivized innovators from pursuing pediatric device innovation. Innovative programs such as the System of Hospitals for Innovation in Pediatrics-Medical Devices and the existing Pediatric Device Consortia, if strategically leveraged, may foster a robust national pediatric device innovation ecosystem.
Whereas there is a higher opportunity cost for pediatric device development, leveraging the programs and incentives available in a "pediatric-first" approach may provide effective paths to larger total addressable markets for innovators.
儿科护理医疗器械的创新和发展落后于成人护理领域。由于技术风险更高、数据积累面临挑战、市场规模较小以及投资回报率有限，儿科医疗器械开发的动力不足。因此，专门为改善儿科护理而设计的医疗器械的转化受到限制。然而，不断变化的形势和新的项目可能会支持儿科医疗器械开发的扩展。
在PubMed中进行了基于关键词的搜索；本综述还使用了市场数据库和美国食品药品监督管理局的指导文件。共有18017篇文章进行了标题和摘要审查，190篇文章由专家作者进行了审查。
总体而言，证据生成方面的挑战以及商业和技术力量阻碍了创新者进行儿科医疗器械创新。如果能战略性地利用儿科医疗设备创新医院系统和现有的儿科器械联盟等创新项目，可能会培育出强大的国家儿科医疗器械创新生态系统。
虽然儿科医疗器械开发的机会成本较高，但采用“儿科优先”的方法利用现有项目和激励措施，可能为创新者提供通往更大潜在市场的有效途径。
