Dataset Information

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

ABSTRACT:

Background

Health 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?

Method

HTA 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.

Conclusion

To 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.

SUBMITTER: Ming J

PROVIDER: S-EPMC9533595 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Ming Jian J He Yunzhen Y Yang Yi Y Hu Min M Zhao Xinran X Liu Jun J Xie Yang Y Wei Yan Y Chen Yingyao Y

Cost effectiveness and resource allocation : C/E 20221005 1

<h4>Background</h4>Health 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?<h4>Method</h4>HTA Accelerator Database was used to describe the landscape of HTA reports for medical devices from HTA bodies, and a lit ...[more]

PMID: 36199144

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Project description:Background: Health-technology assessment (HTA) is a recognized mechanism to determine the relative benefits of innovative medical technologies. One aspect is their health-economic impact. While the process and methodology for pharmaceuticals is well-established, guidance for medical devices is sparse. Aim: To provide an overview of the health-economic aspect in current European HTA guidelines concerning medical devices and identifying issues raised and potential improvements proposed in recent literature. Methodology: Available guidelines by European agencies were each reviewed and summarized. To complement this, a full systematic review of current literature concerning potential improvements to existing HTA practices for medical devices, from PubMed and EMBASE, was conducted; the focus was on health economics. Authors could only review documents in English, French, or German. The systematic review yielded 518 unique articles concerning HTA for medical devices, 32 of which were considered for full-text review after screening of all abstracts. Results: There is very limited consensus in-and mostly a complete lack of-guidance specific to medical devices in official HTA guidelines, for both clinical and economic analyses. Twenty two of 41 European countries had published official HTA guidance in English, French, or German. Among these only 4 (England, France, the Netherlands, and Sweden) dedicated a chapter or separate document to medical devices. In the literature, there is sufficient evidence to suggest medical devices need to be addressed separately from pharmaceuticals. However, mostly challenges are discussed rather than implementable solutions offered. We present the following set of frequently discussed issues and summarize any solutions that pertain to them: a weak evidence base, learning-curve effects, organizational impact, incremental innovation, diversity of devices, dynamic pricing, and transferability. We further combine reviewed information to suggest a set of possible best practices for health-economic assessment of medical devices. Conclusion: For greater efficiency in medical-device innovation, European agencies should look to (re-)address the specific requirements of medical devices in their HTA guidelines. When both the health-economic and data requirements for the HTA of medical devices are defined, the development of practical solutions will likely follow.

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Project description:BackgroundDespite their importance, the number of outcomes research studies conducted in India are lesser than other countries. Information about the distribution of existing outcomes research resources and relevant expertise can benefit researchers and research groups interested in conducting outcomes research studies and policy makers interested in funding outcomes research studies in India. We have reviewed the literature to identify and map resources described in outcomes research studies conducted in India.MethodsWe reviewed the following online biomedical databases: Pubmed, SCIRUS, CINAHL, and Google scholar and selected articles that met the following criteria: published in English, conducted on Indian population, providing information about outcomes research resources (databases/registries/electronic medical records/electronic healthcare records/hospital information systems) in India and articles describing outcomes research studies or epidemiological studies based on outcomes research resources. After shortlisting articles, we abstracted data into three datasets viz. 1. Resource dataset, 2. Bibliometric dataset and 3. Researcher dataset and carried out descriptive analysis.ResultsOf the 126 articles retrieved, 119 articles were selected for inclusion in the study. The tally increased to 133 articles after a secondary search. Based on the information available in the articles, we identified a total of 91 unique research resources. We observed that most of the resources were Registries (62/91) and Databases ( 23/91) and were primarily located in Maharashtra (19/91) followed by Tamil Nadu (11/91), Chandigarh (8/91) and Kerala (7/91) States. These resources primarily collected data on Cancer (44/91), Stroke (5/91) and Diabetes (4/91). Most of these resources were Institutional (38/91) and Regional resources (35/91) located in Government owned and managed Academic Institutes/Hospitals (57/91) or Privately owned and managed non - Academic Institutes/Hospitals (14/91). Data from the Population based Cancer Registry, Mumbai was used in 41 peer reviewed publications followed by Population based Cancer Registry, Chennai (17) and Rural Cancer Registry Barshi (14). Most of the articles were published in International journals (139/193) that had an impact factor of 0-1.99 (43/91) and received an average of 0-20 citations (55/91). We identified 193 researchers who are mainly located in Maharashtra (37/193) and Tamil Nadu (24/193) states and Southern (76/193) and Western zones (47/193). They were mainly affiliated to Government owned & managed Academic Institutes /Hospitals (96/193) or privately owned and managed Academic Institutes/ Hospitals (35/193).ConclusionsGiven the importance of Outcomes research, relevant resources should be supported and encouraged which would help in the generation of important healthcare data that can guide health and research policy. Clarity about the distribution of outcomes research resources can facilitate future resource and funding allocation decisions for policy makers as well as help them measure research performance over time.

Dataset Information

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

Background

Method

Main body

Conclusion

Publications

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

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