• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

支持儿科设备开发的商业环境、资源面临的挑战及气候状况。

Challenges and climate of business environment and resources to support pediatric device development.

作者信息

Iqbal Corey W, Wall James, Harrison Michael R

机构信息

Department of Surgery, Children's Mercy Hospital, Kansas City, Missouri.

Department of Surgery, Lucille-Packard Children's Hospital Stanford, Palo Alto, California.

出版信息

Semin Pediatr Surg. 2015 Jun;24(3):107-11. doi: 10.1053/j.sempedsurg.2015.02.006. Epub 2015 Mar 2.

DOI:10.1053/j.sempedsurg.2015.02.006
PMID:25976144
Abstract

The incidence of pediatric disease conditions pales in comparison to adult disease. Consequently, many pediatric disorders are considered orphan diseases. Resources for the development of devices targeting orphan diseases are scarce and this poses a unique challenge to the development of pediatric devices. This article outlines these challenges and offers solutions.

摘要

与成人疾病相比,儿科疾病的发病率较低。因此,许多儿科疾病被视为罕见病。用于开发针对罕见病的设备的资源稀缺,这给儿科设备的开发带来了独特的挑战。本文概述了这些挑战并提供了解决方案。

相似文献

1
Challenges and climate of business environment and resources to support pediatric device development.支持儿科设备开发的商业环境、资源面临的挑战及气候状况。
Semin Pediatr Surg. 2015 Jun;24(3):107-11. doi: 10.1053/j.sempedsurg.2015.02.006. Epub 2015 Mar 2.
2
Orphan and paediatric medical devices in Europe: recommendations to support their availability for on-label and off-label clinical indications.欧洲的孤儿药和儿科医疗器械:支持其在标签内和标签外临床适应证使用的建议。
Expert Rev Med Devices. 2024 Oct;21(10):893-901. doi: 10.1080/17434440.2024.2404257. Epub 2024 Sep 20.
3
Additional peculiarities of medical devices that should be considered in their development process.医疗器械在开发过程中应考虑的其他特殊问题。
Expert Rev Med Devices. 2013 May;10(3):411-20. doi: 10.1586/erd.12.89.
4
FDA's pediatric device consortia: national program fosters pediatric medical device development.FDA 的儿科设备联盟:国家计划促进儿科医疗器械的开发。
Pediatrics. 2013 May;131(5):981-5. doi: 10.1542/peds.2012-1534. Epub 2013 Apr 8.
5
Partnership Between Japan and the United States for Early Development of Pediatric Medical Devices - Harmonization By Doing for Children.日美携手早期开发儿科医疗器械——为了孩子而共同努力实现协调统一。
Circ J. 2020 Apr 24;84(5):786-791. doi: 10.1253/circj.CJ-19-1092. Epub 2020 Apr 1.
6
Pathways to approval of pediatric cardiac devices in the United States: challenges and solutions.美国儿科心脏设备的批准途径:挑战与解决方案
Pediatrics. 2009 Jul;124(1):e155-62. doi: 10.1542/peds.2008-3726.
7
Pediatric emergency office equipment.儿科急诊室设备。
Pediatr Emerg Care. 1988 Sep;4(3):212-4. doi: 10.1097/00006565-198809000-00015.
8
Another design input: reimbursement issues.
Med Device Technol. 2000 Dec;11(10):32-4, 37.
9
Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive?孤儿器械:昨日已成历史;明日仍是未知:迈向欧洲孤儿器械指令?
Orphanet J Rare Dis. 2016 Mar 3;11:22. doi: 10.1186/s13023-016-0393-3.
10
Economic considerations for device design and development.设备设计与开发的经济考量
Med Device Technol. 1997 Nov;8(9):18-26.

引用本文的文献

1
Allocation of seed-stage investments for paediatric health technology.
BMJ Surg Interv Health Technol. 2025 Mar 5;7(1):e000368. doi: 10.1136/bmjsit-2024-000368. eCollection 2025.
2
Minimal Access in Pediatric Surgery: An Overview on Progress towards Dedicated Instrument Developments and Anesthesiologic Advances to Enhance Safe Completion of Procedures.小儿外科中的微创技术:专用器械研发及麻醉学进展以提高手术安全完成度的进展概述
Children (Basel). 2024 Jun 3;11(6):679. doi: 10.3390/children11060679.
3
A method for phenylalanine self-monitoring using phenylalanine ammonia-lyase and a pre-existing portable ammonia detection system.一种使用苯丙氨酸解氨酶和现有的便携式氨检测系统进行苯丙氨酸自我监测的方法。
Mol Genet Metab Rep. 2023 Mar 21;35:100970. doi: 10.1016/j.ymgmr.2023.100970. eCollection 2023 Jun.
4
Orphan devices: yesterday is history; tomorrow is mystery: towards a European orphan device directive?孤儿器械:昨日已成历史;明日仍是未知:迈向欧洲孤儿器械指令?
Orphanet J Rare Dis. 2016 Mar 3;11:22. doi: 10.1186/s13023-016-0393-3.