iQbD:一种TRL索引的医疗器械工程质量设计范式

IF 0.8 4区 医学 Q4 ENGINEERING, BIOMEDICAL
T. Bastogne
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引用次数: 3

摘要

风险评估是医疗器械开发路线图中的关键一步。失效模式、影响和关键性分析是一种基于声明性先验信息的常用方法,事实证明,这种方法对已建立的过程的风险评估是有益的。但在开发的早期阶段,当嵌入创新材料或技术时,这些创新经验的缺乏在FMECA中引入了太多主观性,无法进行稳健的风险评估。自2000年年中以来,制药行业提出了设计质量指南,作为药物开发的一种积极工程方法。这种模式能够在整个开发工作流程中进行数据驱动的风险评估,从而完成FMECA提供的风险评估。然而,其实施指南尚不明确,不够灵活,无法有效应用于医疗器械的开发。为了解决这个问题,提出了一种新的基于创新产品技术准备水平的QbD范式。它涵盖了整个临床前阶段的医疗器械开发,至少由九个学习周期组成。该医疗器械QbD布局的第一部分由三个连续的风险评估周期组成,通过一个真实的研究案例进行评估,目的是证明光漂白控制器在光动力治疗中的概念验证。除了这一实验结果之外,该应用程序还证实了iQbD方法在没有技术创新的先验知识的情况下完成FMECA并为风险评估提供替代解决方案的实际能力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
iQbD: a TRL-indexed Quality-by-Design Paradigm for Medical Device Engineering
Risk assessment is a critical step in the roadmap of medical device development. Failure modes, effects and criticality analysis is a common approach based on declarative prior information that proved beneficial in the risk assessment of well established processes. But at early steps of development when innovative materials or technologies are embedded, the lack of experience on those innovations introduces too much subjectivity in FMECA for a robust risk assessment. Since mid-2000, the Quality-by-Design guideline has been proposed within the pharmaceutical industry as a proactive engineering approach of drug development. This paradigm enables a data-driven risk assessment throughout the development workflow, which completes risk assessment provided by FMECA. Nevertheless, its implementation guide is unclear and not flexible enough to be efficiently applied to the development of medical devices. To address this issue, a new QbD paradigm indexed on the technological readiness level of the innovative product is proposed. It covers the development of medical devices throughout the whole preclinical phase and is composed of at least nine learning cycles. The first part of this medical device QbD layout, composed of three consecutive risk assessment cycles, is evaluated through a real study case with the objective to demonstrate the proof of concept of a photobleaching controller in photodynamic therapy. Beyond this experimental result, this application has confirmed practical ability of the iQbD approach to complete FMECA and to provide an alternative solution to risk assessment when prior knowledge on the technological innovation is not available.
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来源期刊
CiteScore
1.80
自引率
11.10%
发文量
56
审稿时长
6-12 weeks
期刊介绍: The Journal of Medical Devices presents papers on medical devices that improve diagnostic, interventional and therapeutic treatments focusing on applied research and the development of new medical devices or instrumentation. It provides special coverage of novel devices that allow new surgical strategies, new methods of drug delivery, or possible reductions in the complexity, cost, or adverse results of health care. The Design Innovation category features papers focusing on novel devices, including papers with limited clinical or engineering results. The Medical Device News section provides coverage of advances, trends, and events.
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