Complexity Stage Model of the Medical Device Development Based on Economic Evaluation—MedDee

Petra Marešová, Lukáš Peter, Jan Honegr, Lukáš Režný, Marek Penhaker, Martin Augustýnek, Hana Mohelská, Blanka Klímová and Kamil Kuča
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Petra Marešová: Department of Economics, University of Hradec Kralove, Rokitanskeho 62, 3 50003 Hradec Kralove, Czech Republic
Lukáš Peter: Department of Cybernetics and Biomedical Engineering, VSB—Technical University of Ostrava, FEEC, 17. Listopadu 15, 708 33 Ostrava—Poruba, Czech Republic
Jan Honegr: Biomedical Research Centre, University Hospital Hradec Králové, Sokolská 581, 500 05 Hradec Králové, Czech Republic
Lukáš Režný: Department of Economics, University of Hradec Kralove, Rokitanskeho 62, 3 50003 Hradec Kralove, Czech Republic
Marek Penhaker: Department of Cybernetics and Biomedical Engineering, VSB—Technical University of Ostrava, FEEC, 17. Listopadu 15, 708 33 Ostrava—Poruba, Czech Republic
Martin Augustýnek: Department of Cybernetics and Biomedical Engineering, VSB—Technical University of Ostrava, FEEC, 17. Listopadu 15, 708 33 Ostrava—Poruba, Czech Republic
Hana Mohelská: Department of Management, University of Hradec Kralove, Rokitanskeho 62, 3 50003 Hradec Kralove, Czech Republic
Blanka Klímová: Department of Applied Linguistics, University of Hradec Kralove, Rokitanskeho 62, 3 50003 Hradec Kralove, Czech Republic
Kamil Kuča: Department of Economics, University of Hradec Kralove, Rokitanskeho 62, 3 50003 Hradec Kralove, Czech Republic

Sustainability, 2020, vol. 12, issue 5, 1-27

Abstract: The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost–time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents’ responses, were conducted. The authors have proposed the complexity model MedDee—Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.

Keywords: medical device; development; economic evaluation; model; regulatory (search for similar items in EconPapers)
JEL-codes: O13 Q Q0 Q2 Q3 Q5 Q56 (search for similar items in EconPapers)
Date: 2020
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