Markus Siebert1
Estimated H-index: 1
Louis Christian Clauss1
Estimated H-index: 1
(Baxter International)
+ 7 AuthorsAntoinette Wenk Lang1
Estimated H-index: 1
(Boston Scientific Corporation)
Objective: To inform about the specifics of medical devices and the resulting consequences for health technology assessment (HTA) and to present the European industry position on this topic. Methods: The paper is based on an intensive debate within Eucomed, the European trade association in the field of medical devices, informed by an HTA Experts Group, comprising experts from within and outside the medical device industry. Results: Based on the specifics of medical devices, there are a number of methodologic considerations that require a tailored HTA, differing from the approach taken for, for example, pharmaceutical products. These differences have an impact on the selection of the technology, the timing of the assessment, the study design, and the patient population. Conclusion: The European medical device industry can commit to an HTA that takes into consideration the specifics of medical technologies, which is appropriate and fair. and which is done under full participation of industry. Under these circumstances HTA can be a useful tool to support rational decision making in health care.
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  • Citations (31)
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Cited By31
#1Vinayak Smith (Monash University, Clayton campus)H-Index: 1
Last. Euan M. Wallace (Monash University, Clayton campus)H-Index: 46
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Early Health Technology Assessment (EHTA) is an evolving field in health policy which aims to provide decision support and mitigate risk during early medical device innovation. The clinician is a key stakeholder in this process and their role has traditionally been confined to assessing device efficacy and safety alone. There is however, no data exploring their role in this process and how they can contribute towards it. This motivated us to carry out a systematic review to delineate the role of...
#2Theresa HungerH-Index: 5
Last. Uwe Siebert (Harvard University)H-Index: 58
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Abstract Objectives The aim of the study was to review existing recommendations on study design, conduct, analysis, and reporting for primary studies of therapeutic medical devices (TMDs) and the closely related field of interventional procedures. Study Design and Setting We performed a targeted literature review of publications with recommendations for study design, conduct, analysis, and reporting for primary studies of TMDs and related technologies. We combined an electronic database search w...
5 CitationsSource
Objectives: The aim of this study was to identify good practice principles for health technology assessment (HTA) that are the most relevant and of highest priority for application in Latin America and to identify potential barriers to their implementation in the region. Methods: HTA good practice principles proposed at the international level were identified and then explored during a deliberative process in a forum of assessors, funders, and product manufacturers. Results: Forty-two representa...
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Objectives: Latin American countries are taking important steps to expand and strengthen universal health coverage, and health technology assessment (HTA) has an increasingly prominent role in this process. Participation of all relevant stakeholders has become a priority in this effort. Key issues in this area were discussed during the 2017 Latin American Health Technology Assessment International (HTAi) Policy Forum. Methods: The Forum included forty-one participants from Latin American HTA age...
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#1Edmund A. M. Neugebauer (Witten/Herdecke University)H-Index: 59
#2Ana Rath (French Institute of Health and Medical Research)H-Index: 14
Last. Christian Gluud (Copenhagen University Hospital)H-Index: 77
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Background Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on...
19 CitationsSource
#1Leandro Pecchia (Warw.: University of Warwick)H-Index: 16
Health Technology Assessment (HTA) of Medical Devices (MDs) remains an open challenge in particular for Low and Middle Income Countries (LMICs). Wide literature investigated how economical constrains may affect HTA in LMICs. Much less has been done in analyzing systematically how MDs safety and efficacy depend from environmental conditions (e.g., users, plants, and operational spaces) and how this affect HTA. After recalling the main differences among MDs and drugs, in order to highlight depende...
4 CitationsSource
#2Cynthia P IglesiasH-Index: 31
Last. Uwe Siebert (Harvard University)H-Index: 58
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Evaluation of clinical effectiveness of medical devices differs in some aspects from the evaluation of pharmaceuticals. One of the main challenges identified is lack of robust evidence and a will to make use of experimental and observational studies (OSs) in quantitative evidence synthesis accounting for internal and external biases. Using a case study of total hip replacement to compare the risk of revision of cemented and uncemented implant fixation modalities, we pooled treatment effect estim...
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#1Devidas Menon (U of A: University of Alberta)H-Index: 28
#2Tania Stafinski (U of A: University of Alberta)H-Index: 20
Last. Alun L. Edwards (AHS: Alberta Health Services)H-Index: 14
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Decisions on the introduction of new non-drug health technologies into healthcare are challenging. This article describes the introduction of insulin pump therapy for type 1 diabetes in Alberta, using an Access with Evidence Development (AED) approach. The organization and implementation of the AED, its current status, and lessons learned are described.
Regulation criteria for licensing pharmaceuticals and medical devices (MDs) are asymmetric. This has affected the type, quantity and quality of the evidence produced in support of MDs. This paper has three objectives: to examine the reasons behind the current licensing criteria for MDs; to identify key methodological challenges associated with pre- and post-market evaluation of MDs and to assess the extent to which existing methods for the economic evaluation of pharmaceuticals can be applied to...
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