Evidence map›Paper›PMID 36199144›Full record

ReviewCost effectiveness and resource allocation : C/E2022

Health technology assessment of medical devices: current landscape, challenges, and a way forward.

Jian Ming, Yunzhen He, Yi Yang, Min Hu, Xinran Zhao, Jun Liu, Yang Xie, Yan Wei, Yingyao Chen

Open access · goldAbstract readReview
In one paragraph

Review in Cost effectiveness and resource allocation : C/E, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
10.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  3. A life-cycle approach to digital health technology assessment.International journal of technology assessment in health care · 2026
    Review
  4. The FemTech revolution: Unlocking the potential of new technology for optimizing pregnancy outcomes in low- and middle-income countries and remote areas.International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics · 2026
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  19. Journal of preventive medicine and hygiene · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 3 institutions in 2 countries.

Jian Ming *Real World Solutions, IQVIA, Shanghai, 200124, China.
Yunzhen He *Real World Solutions, IQVIA, Shanghai, 200124, China.
Yi YangNational Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, 200032, China.
Min HuNational Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, 200032, China.
Xinran ZhaoReal World Solutions, IQVIA, Shanghai, 200124, China.
Jun LiuReal World Solutions, IQVIA, Shanghai, 200124, China.
Yang XieReal World Solutions, IQVIA, Shanghai, 200124, China.
Yan WeiNational Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, 200032, China. yanwei@fudan.edu.cn.
Yingyao ChenNational Health Commission Key Laboratory of Health Technology Assessment, School of Public Health, Fudan University, Shanghai, 200032, China. yychen@shmu.edu.cn.
IQVIA (United Kingdom) · GBNational Health and Family Planning Commission · CNFudan University · CN

Funding

National Key Research and Development Program of China No. 2018YFC1312900
6 · The paper itself

Abstract

backgroundHealth Technology Assessment (HTA) has been widely recognized as informing healthcare decision-making, and interest in HTA of medical devices has been steadily increasing. How does the assessment of medical devices differ from that of drug therapies, and what innovations can be adopted to overcome the inherent challenges in medical device HTA?

methodHTA Accelerator Database was used to describe the landscape of HTA reports for medical devices from HTA bodies, and a literature search was conducted to understand the growth trend of relevant HTA publications in four case studies. Another literature review was conducted for a narrative synthesis of the characteristic differences and challenges of HTA in medical devices. We further conducted a focused Internet search of guidelines and a narrative review of methodologies specific to the HTA of medical devices. MAIN BODY: The evidence of HTA reports and journal publications on medical devices around the world has been growing. The challenges in assessing medical devices include scarcity of well-designed randomized controlled trials, inconsistent real-world evidence data sources and methods, device-user interaction, short product lifecycles, inexplicit target population, and a lack of direct medical outcomes. Practical solutions in terms of methodological advancement of HTA for medical devices were also discussed in some HTA guidelines and literature.

conclusionTo better conduct HTA on medical devices, we recommend considering multi-source evidence such as real-world evidence; standardizing HTA processes, methodologies, and criteria; and integrating HTA into decision-making.

Indexed as

ChallengesHealth technology assessmentMedical devicesReal-world evidenceReview

Identifiers

PMID36199144
PMCPMC9533595
OpenAlexW4301585960

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.