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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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.	陜飛, 尹道馨, 李子禹, 等. 外科臨床研究方法學指引—IDEAL框架及指南介紹與解讀. 中國實用外科雜志, 2020, 40(1): 93-101.
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1. 中華人民共和國國務院. 《醫療器械監督管理條例》(國務院令第739號). URL: https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20210318084145148.html.
2. 鄭珂, 關巧賢, 許佳銳. 2020全國醫療器械產業數據盤點. 中國食品藥品監管, 2021, 2: 96-103.
3. 國家藥品監督管理局. 國家藥品監督管理局2021年度醫療器械注冊工作報告. 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. Micl?u? 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. 喻佳潔, 陜飛, PeterMcCulloch, 等. 外科創新技術/器械臨床研究方法學—IDEAL框架與推薦系列文章之一: IDEAL框架與推薦介紹. 中國胸心血管外科臨床雜志, 2021, 28(2): 131-136.
12. 鎖濤, 黃麗紅, 紀穎, 等. 外科學創新技術評估方法: IDEAL框架. 中國醫院管理, 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. 陜飛, 尹道馨, 李子禹, 等. 外科臨床研究方法學指引—IDEAL框架及指南介紹與解讀. 中國實用外科雜志, 2020, 40(1): 93-101.
16. 國家藥品監督管理局. 《醫療器械動物試驗研究注冊審查指導原則第一部分: 決策原則(2021年修訂版)》(2021年第75號). URL: https://www.nmpa.gov.cn/ylqx/ylqxggtg/20210927153130147.html.
17. 國家藥品監督管理局. 《醫療器械動物試驗研究注冊審查指導原則第二部分: 試驗設計、實施質量保證》(2021年第75號). 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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