Development of New Medical Device – Investment Evaluation

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F20%3A50018044" target="_blank" >RIV/62690094:18450/20:50018044 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Development of New Medical Device – Investment Evaluation

Popis výsledku v původním jazyce

The entrance of company into the regulated market for medical devices is associated with compliance with many regulations, ordinances and laws. On the other hand, the production and sale of medical devices is very promising, in all economic periods. In May 2021, Europe is facing a major change in the legislation on medical devices in the form of MDR Directive 2017/745, which has been developed to protect patients in order to increase their safety. This is undoubtedly the right and proportionate situation for society, but it involves high costs and investments for manufacturers. Companies are now faced with the question of what future economic result can be expected and what strategy to follow. The goal of this study is to suggest and specfify steps of medical device development for economic evaluation and calculation of economic efficiency. For these purposes, a calculator that calculates economic efficiency indicators such as Return on Investment, Net Present Value and Breakeven Point, was made. It takes into account the new legislative conditions, and it also allows its users to set the risk class and other characteristics of the medical device. The study also contains demonstrated calculation of economic efficiency indicators for one case study.

Název v anglickém jazyce

Development of New Medical Device – Investment Evaluation

Popis výsledku anglicky

The entrance of company into the regulated market for medical devices is associated with compliance with many regulations, ordinances and laws. On the other hand, the production and sale of medical devices is very promising, in all economic periods. In May 2021, Europe is facing a major change in the legislation on medical devices in the form of MDR Directive 2017/745, which has been developed to protect patients in order to increase their safety. This is undoubtedly the right and proportionate situation for society, but it involves high costs and investments for manufacturers. Companies are now faced with the question of what future economic result can be expected and what strategy to follow. The goal of this study is to suggest and specfify steps of medical device development for economic evaluation and calculation of economic efficiency. For these purposes, a calculator that calculates economic efficiency indicators such as Return on Investment, Net Present Value and Breakeven Point, was made. It takes into account the new legislative conditions, and it also allows its users to set the risk class and other characteristics of the medical device. The study also contains demonstrated calculation of economic efficiency indicators for one case study.

Druh

D - Stať ve sborníku

CEP obor

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OECD FORD obor

50202 - Applied Economics, Econometrics

Projekt

<a href="/cs/project/TL01000302" target="_blank" >TL01000302: Vývoj zdravotních prostředků jako efektivní investice pro veřejné i soukromé subjekty</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2020

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název statě ve sborníku

Sustainable Economic Development and Advancing Education Excellence in the era of Global Pandemic

ISBN

978-0-9998551-5-7

ISSN

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e-ISSN

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Počet stran výsledku

12

Strana od-do

1-12

Název nakladatele

International Business Information Management Association, IBIMA

Místo vydání

Neuveden

Místo konání akce

Granada, Spain

Datum konání akce

4. 11. 2020

Typ akce podle státní příslušnosti

WRD - Celosvětová akce

Kód UT WoS článku

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