MMSL 2020, 89(2):99-107 | DOI: 10.31482/mmsl.2020.003

DEFINITION OF THE TARGET POPULATION FOR EXTERNAL PACEMAKER AS A KEY ASPECT IN SUCCESSFUL MEDICAL DEVICE HTA PROCESSReview article

Jan Honegr ORCID...1*, Daniel Jun ORCID...1, Kamil Kuca ORCID...2, Petra Maresova ORCID...2
1 Biomedical Research Centre, University Hospital Hradec Kralove, Sokolska 581, 500 12 Hradec Kralove, Czech Republic
2 Faculty of Informatics and Management, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech Republic

In this paper we have compiled and summarized the steps which manufacturers and clinical investigators need to undertake to perform a target population definition during the Health technology assessment process of medical device, namely external cardio stimulator (pacemaker). Based on available data using top-down approach we have defined target population for external cardiostimulator and estimated, that the size of the target population for external pacing will not exceed 16000 patients per year in the Czech Republic and is of comparable size with other states in the region.

Keywords: HTA; Medical Devices; target population; external pacemaker; policymaking

Received: December 30, 2019; Revised: January 28, 2020; Accepted: January 28, 2020; Prepublished online: February 10, 2020; Published: June 5, 2020  Show citation

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Honegr, J., Jun, D., Kuca, K., & Maresova, P. (2020). DEFINITION OF THE TARGET POPULATION FOR EXTERNAL PACEMAKER AS A KEY ASPECT IN SUCCESSFUL MEDICAL DEVICE HTA PROCESS. MMSL, 89(2), 99-107. doi: 10.31482/mmsl.2020.003
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