Practical Use of Early Stage Health Technology Assessment of Medical Devices: Systematic Literature Review

Simonova, M.; Rogalewicz, V.; Donin, G.; Kneppo, P.

In: XV Mediterranean Conference on Medical and Biological Engineering and Computing MEDICON 2019. Basel: Springer Nature Switzerland AG, 2020. p. 1047-1056. IFMBE Proceedings. vol. 76. ISSN 1680-0737. ISBN 978-3-030-31634-1.

Abstract. The early stage HTA (eHTA) is a commonly used tool for identifying
economic indicators of health technology in early phases of research and
development. It provides powerful influence instruments to manage the manufacturer’s
investment risks and to improve the device design.
There is no uniform generally accepted standard of eHTA implementation,
but an analysis of several large-scale theoretical studies showed that, in general,
the eHTA process for medical devices consists of three stages: conceptual
modelling of the new medical technology, determination of new technology
parameters by expert elicitation methods, and simulation allowing for an analysis
of commercial options.
The aim of this study is a systematic review of studies published from 2014
till 2019 and an analysis of selected articles in terms of the methods used in each
step of the early stage health technology assessment.
Most of the analyzed case studies deal only with a part of the early stage
medical device assessment, probably because of its confidential character. But
we have found the popularity of decision-making models, the applicability of
AHP (the analytic hierarchy process) methods to the elicitation process, and
information on the use of CEA (cost-effectiveness analysis) methods and
headroom methods as economic analysis tools.

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