Interpretation of the methodological framework of clinical research on innovative medical devices_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

GUO Qiong ¹ , FENG Kun ² , LONG Youlin ^1,2 , LIN Yifei ^1,3 , XIANG Jin ⁴ ,  HUANG Jin ^1,2 ,  DU Liang ^1,2,5

1. Medical Device Regulatory Research and Evaluation Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
2. Chinese Evidence-Based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
3. Precision Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
4. Clinical Trials Center, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;
5. Department of Periodical Press, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China;

Corresponding author：

HUANG Jin, Email: michael_huangjin@163.com; DU Liang, Email: duliang0606@vip.sina.com

Keywords：

Medical device; IDEAL framework and recommendation; IDEAL-D framework; clinical research; methodological framework

DOI：

10.7507/1007-4848.202205018

Video：

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The pre-market approval and clinical application of innovative medical devices should be based on high-quality evidence, proving their reliability, safety and effectiveness. In 2016, the IDEAL (Idea, Development, Exploration, Assessment and Long-term follow-up) collaboration modified the original IDEAL framework and recommendation to the IDEAL-D methodological framework for the entire life cycle evaluation of innovative medical devices. The framework included five stages, namely the preclinical development stage, idea stage, exploration stage, assessment stage and long-term follow-up stage. This paper aims to interpret the study purpose, content and design at each step of the IDEAL-D framework based on IDEAL framework and recommendation (2019) to provide practical methodological guidance for the design and conduct of clinical research on innovative medical devices.

Citation： GUO Qiong, FENG Kun, LONG Youlin, LIN Yifei, XIANG Jin, HUANG Jin, DU Liang. Interpretation of the methodological framework of clinical research on innovative medical devices. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2022, 29(7): 828-833. doi: 10.7507/1007-4848.202205018 Copy

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7.	Brown BL, Kesselheim AS. How should clinicians and organizations assess risks and benefits of first-in-human implantation of investigational devices? AMA J Ethics, 2021, 23(9): E673-E678.
8.	Miclăuş T, Valla V, Koukoura A, et al. Impact of design on medical device safety. Ther Innov Regul Sci, 2020, 54(4): 839-849.
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12.	锁涛, 黄丽红, 纪颖, 等. 外科学创新技术评估方法: IDEAL框架. 中国医院管理, 2019, 39(11): 32-35.
13.	Sedrakyan A, Campbell B, Merino JG, et al. IDEAL-D: A rational framework for evaluating and regulating the use of medical devices. BMJ, 2016, 353: i2372.
14.	Hirst A, Philippou Y, Blazeby J, et al. No surgical innovation without evaluation: Evolution and further development of the IDEAL framework and recommendations. Ann Surg, 2019, 269(2): 211-220.
15.	陕飞, 尹道馨, 李子禹, 等. 外科临床研究方法学指引—IDEAL框架及指南介绍与解读. 中国实用外科杂志, 2020, 40(1): 93-101.
16.	国家药品监督管理局. 《医疗器械动物试验研究注册审查指导原则第一部分: 决策原则(2021年修订版)》(2021年第75号). URL: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20210927153130147.html.
17.	国家药品监督管理局. 《医疗器械动物试验研究注册审查指导原则第二部分: 试验设计、实施质量保证》(2021年第75号). URL: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20210927153130147.html.
18.	Marcus HJ, Payne CJ, Hughes-Hallett A, et al. Making the leap: The translation of innovative surgical devices from the laboratory to the operating room. Ann Surg, 2016, 263(6): 1077-1078.
19.	Marcus HJ, Bennett A, Chari A, et al. IDEAL-D framework for device innovation: A consensus statement on the preclinical stage. Ann Surg, 2022, 275(1): 73-79.
20.	Ryan JW, Murray AS, Gilligan PJ, et al. MRI safety management in patients with cardiac implantable electronic devices: Utilizing failure mode and effects analysis for risk optimization. Int J Qual Health Care. 2020, 32(7): 431-437.

1. 中华人民共和国国务院. 《医疗器械监督管理条例》(国务院令第739号). URL: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20210318084145148.html.
2. 郑珂, 关巧贤, 许佳锐. 2020全国医疗器械产业数据盘点. 中国食品药品监管, 2021, 2: 96-103.
3. 国家药品监督管理局. 国家药品监督管理局2021年度医疗器械注册工作报告. URL: https://www.nmpa.gov.cn/ylqx/ylqxjgdt/20220127090648139.html.
4. Daigle B, Torsekar M. The EU medical device regulation and the US medical device industry. J Int Econ, 2019: 1.
5. Páez A, Rovers M, Hutchison K, et al. Beyond the RCT: When are randomized trials unnecessary for new therapeutic devices, and what should we do instead? Ann Surg, 2022, 275(2): 324-331.
6. Dubin JR, Simon SD, Norrell K, et al. Risk of recall among medical devices undergoing US Food and Drug Administration 510(k) clearance and premarket approval, 2008-2017. JAMA Netw Open, 2021, 4(5): e217274.
7. Brown BL, Kesselheim AS. How should clinicians and organizations assess risks and benefits of first-in-human implantation of investigational devices? AMA J Ethics, 2021, 23(9): E673-E678.
8. Miclăuş T, Valla V, Koukoura A, et al. Impact of design on medical device safety. Ther Innov Regul Sci, 2020, 54(4): 839-849.
9. Pennell CP, Hirst A, Sedrakyan A, et al. Adapting the IDEAL framework and recommendations for medical device evaluation: A modified Delphi survey. Int J Surg, 2016, 28: 141-148.
10. McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: The IDEAL recommendations. Lancet, 2009, 374(9695): 1105-1112.
11. 喻佳洁, 陕飞, PeterMcCulloch, 等. 外科创新技术/器械临床研究方法学—IDEAL框架与推荐系列文章之一: IDEAL框架与推荐介绍. 中国胸心血管外科临床杂志, 2021, 28(2): 131-136.
12. 锁涛, 黄丽红, 纪颖, 等. 外科学创新技术评估方法: IDEAL框架. 中国医院管理, 2019, 39(11): 32-35.
13. Sedrakyan A, Campbell B, Merino JG, et al. IDEAL-D: A rational framework for evaluating and regulating the use of medical devices. BMJ, 2016, 353: i2372.
14. Hirst A, Philippou Y, Blazeby J, et al. No surgical innovation without evaluation: Evolution and further development of the IDEAL framework and recommendations. Ann Surg, 2019, 269(2): 211-220.
15. 陕飞, 尹道馨, 李子禹, 等. 外科临床研究方法学指引—IDEAL框架及指南介绍与解读. 中国实用外科杂志, 2020, 40(1): 93-101.
16. 国家药品监督管理局. 《医疗器械动物试验研究注册审查指导原则第一部分: 决策原则(2021年修订版)》(2021年第75号). URL: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20210927153130147.html.
17. 国家药品监督管理局. 《医疗器械动物试验研究注册审查指导原则第二部分: 试验设计、实施质量保证》(2021年第75号). URL: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20210927153130147.html.
18. Marcus HJ, Payne CJ, Hughes-Hallett A, et al. Making the leap: The translation of innovative surgical devices from the laboratory to the operating room. Ann Surg, 2016, 263(6): 1077-1078.
19. Marcus HJ, Bennett A, Chari A, et al. IDEAL-D framework for device innovation: A consensus statement on the preclinical stage. Ann Surg, 2022, 275(1): 73-79.
20. Ryan JW, Murray AS, Gilligan PJ, et al. MRI safety management in patients with cardiac implantable electronic devices: Utilizing failure mode and effects analysis for risk optimization. Int J Qual Health Care. 2020, 32(7): 431-437.

Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Interpretation of the methodological framework of clinical research on innovative medical devices

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