医疗器械开发策略:用户和利益相关者的看法
I-Ching Tsai1, Ching-Da Wang1, Peng-Ting Chen1,2
1Department of Biomedical Engineering, National Cheng Kung University, No. 1, University Road, Tainan City 701, Taiwan.
Journal of healthcare engineering
|June 7, 2023
概括
医疗器械开发需要一个结构化的方法,首先关注组织因素,然后是技术能力和环境,最后是用户的行为. 这确保了产品的安全性和有效性.
科学领域:
- 生物医学工程 生物医学工程
- 卫生政策和管理卫生政策和管理
背景情况:
- 医疗器械开发是复杂的,用户安全和监管合规是关键因素.
- 在设计过程中不充分考虑用户,环境和组织会增加风险.
- 现有的研究缺乏对影响医疗器械开发的关键因素的系统评估.
研究的目的:
- 系统地识别和评估影响医疗器械开发的关键因素.
- 建立一个优化医疗器械开发途径的模型.
- 为加强医疗器械开发战略提供可行的建议.
主要方法:
- 进行了全面的文献审查.
- 与医疗器械行业专家进行了采访.
- 影响采用因素-新监管模式 (FIA-NRM) 的制定和应用.
主要成果:
- 组织特征是稳定的医疗器械开发的基础.
- 加强技术能力和使用环境是随后的优先事项.
- 用户的行为必须在开发的最后阶段考虑.
结论:
- FIA-NRM模型为医疗器械开发提供了一个结构化的途径.
- 建议侧重于安全和有效性的战略资源配置.
- 优化的开发途径提高了产品安全性和用户成果.
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