IMPACTS OF THE SCHEDULED LEGISLATION CHANGE IN EUROPE FOR MEDICAL DEVICE PRODUCERS - SYSTEM DYNAMICS MODEL OF A FIRM
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F21%3A50018203" target="_blank" >RIV/62690094:18450/21:50018203 - isvavai.cz</a>
Výsledek na webu
<a href="https://eds.p.ebscohost.com/abstract?site=eds&scope=site&jrnl=16484460&AN=153885459&h=6HyLuLiGwVEOIJzsIoCinkO3tEbp1lVZcwBWkD05Ep0xEn9tyI0GUNSpktgZLTUTnv3bjwbvUrWsvwsQkRJoDQ%3d%3d&crl=c&resultLocal=ErrCrlNoResults&resultNs=Ehost&crlhashurl=login.aspx%3fdirect%3dtrue%26profile%3dehost%26scope%3dsite%26authtype%3dcrawler%26jrnl%3d16484460%26AN%3d153885459" target="_blank" >https://eds.p.ebscohost.com/abstract?site=eds&scope=site&jrnl=16484460&AN=153885459&h=6HyLuLiGwVEOIJzsIoCinkO3tEbp1lVZcwBWkD05Ep0xEn9tyI0GUNSpktgZLTUTnv3bjwbvUrWsvwsQkRJoDQ%3d%3d&crl=c&resultLocal=ErrCrlNoResults&resultNs=Ehost&crlhashurl=login.aspx%3fdirect%3dtrue%26profile%3dehost%26scope%3dsite%26authtype%3dcrawler%26jrnl%3d16484460%26AN%3d153885459</a>
DOI - Digital Object Identifier
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Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
IMPACTS OF THE SCHEDULED LEGISLATION CHANGE IN EUROPE FOR MEDICAL DEVICE PRODUCERS - SYSTEM DYNAMICS MODEL OF A FIRM
Popis výsledku v původním jazyce
In 2021, Europe will face a fundamental change in medical device (MD) legislation with the introduction of obligatory clinical trials in lower-risk classes post-entry to the market. This change raises questions for future economic results of MD companies. We present a system dynamics (SD) model of a small company based on explicit representation of a new MD development, emphasizing the importance of the imposed legislation on otherwise intuitive management decision making. The model projections show that for small companies, the new legislation would result in almost doubling certification costs. Though the implementation of the MDR 2017/745 directive aims to increase patient safety, in the context of market development, such measures may lead to increased pressure on the horizontal integration of companies, with the exit of small firms from the market and the related decline in R&D activities at the SME level.
Název v anglickém jazyce
IMPACTS OF THE SCHEDULED LEGISLATION CHANGE IN EUROPE FOR MEDICAL DEVICE PRODUCERS - SYSTEM DYNAMICS MODEL OF A FIRM
Popis výsledku anglicky
In 2021, Europe will face a fundamental change in medical device (MD) legislation with the introduction of obligatory clinical trials in lower-risk classes post-entry to the market. This change raises questions for future economic results of MD companies. We present a system dynamics (SD) model of a small company based on explicit representation of a new MD development, emphasizing the importance of the imposed legislation on otherwise intuitive management decision making. The model projections show that for small companies, the new legislation would result in almost doubling certification costs. Though the implementation of the MDR 2017/745 directive aims to increase patient safety, in the context of market development, such measures may lead to increased pressure on the horizontal integration of companies, with the exit of small firms from the market and the related decline in R&D activities at the SME level.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
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OECD FORD obor
50204 - Business and management
Návaznosti výsledku
Projekt
<a href="/cs/project/GA17-03037S" target="_blank" >GA17-03037S: Hodnocení investic do vývoje zdravotních prostředků</a><br>
Návaznosti
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Ostatní
Rok uplatnění
2021
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
Transformations in business and economics
ISSN
1648-4460
e-ISSN
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Svazek periodika
20
Číslo periodika v rámci svazku
2A
Stát vydavatele periodika
LT - Litevská republika
Počet stran výsledku
24
Strana od-do
450-473
Kód UT WoS článku
000726731500004
EID výsledku v databázi Scopus
2-s2.0-85120833627