New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?
Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2020-03-01
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| Series: | Administrative Sciences |
| Subjects: | |
| Online Access: | https://www.mdpi.com/2076-3387/10/1/16 |
| _version_ | 1818450940223553536 |
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| author | Petra Maresova Ladislav Hajek Ondrej Krejcar Michael Storek Kamil Kuca |
| author_facet | Petra Maresova Ladislav Hajek Ondrej Krejcar Michael Storek Kamil Kuca |
| author_sort | Petra Maresova |
| collection | DOAJ |
| description | Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is to analyze patent activity based on the example of the selected country (Czech Republic), compare it with selected foreign countries, and discuss the development of this industry in the context of new medical device regulation (MDR) implementation. The paper is based on the theoretical concept of the relationship between regulation and innovation. The main challenge in the implementation of the new medical device regulations lies in the area of innovation. This is because most innovative research in the medical device sector is undertaken by small to medium enterprises (SMEs) rather than by large companies. SMEs are more vulnerable than big companies when it comes to development because the accompanying administrative costs can be so high that it may force the company to leave the market. Given that the main reason for the existence of economic regulations are various forms of market failure, which occurs when market mechanisms do not lead to results that benefit society, any attempts to redress this situation should naturally lead to greater benefits for society and hence benefits for the given industry as well. |
| first_indexed | 2024-12-14T20:59:17Z |
| format | Article |
| id | doaj.art-d8fa0d50dbec48a3861525b265dbcc04 |
| institution | Directory Open Access Journal |
| issn | 2076-3387 |
| language | English |
| last_indexed | 2024-12-14T20:59:17Z |
| publishDate | 2020-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Administrative Sciences |
| spelling | doaj.art-d8fa0d50dbec48a3861525b265dbcc042022-12-21T22:47:37ZengMDPI AGAdministrative Sciences2076-33872020-03-011011610.3390/admsci10010016admsci10010016New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?Petra Maresova0Ladislav Hajek1Ondrej Krejcar2Michael Storek3Kamil Kuca4Department of Economy, Faculty of Informatics and Management, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech RepublicDepartment of Economy, Faculty of Informatics and Management, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech RepublicCenter for Basic and Applied Research, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech RepublicAdmirx, Inc., Cambridge, MA 02139, USACenter for Basic and Applied Research, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech RepublicIncreasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is to analyze patent activity based on the example of the selected country (Czech Republic), compare it with selected foreign countries, and discuss the development of this industry in the context of new medical device regulation (MDR) implementation. The paper is based on the theoretical concept of the relationship between regulation and innovation. The main challenge in the implementation of the new medical device regulations lies in the area of innovation. This is because most innovative research in the medical device sector is undertaken by small to medium enterprises (SMEs) rather than by large companies. SMEs are more vulnerable than big companies when it comes to development because the accompanying administrative costs can be so high that it may force the company to leave the market. Given that the main reason for the existence of economic regulations are various forms of market failure, which occurs when market mechanisms do not lead to results that benefit society, any attempts to redress this situation should naturally lead to greater benefits for society and hence benefits for the given industry as well.https://www.mdpi.com/2076-3387/10/1/16medical device industryinnovationpatent analysisregulatorymarket potential |
| spellingShingle | Petra Maresova Ladislav Hajek Ondrej Krejcar Michael Storek Kamil Kuca New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth? Administrative Sciences medical device industry innovation patent analysis regulatory market potential |
| title | New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth? |
| title_full | New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth? |
| title_fullStr | New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth? |
| title_full_unstemmed | New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth? |
| title_short | New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth? |
| title_sort | new regulations on medical devices in europe are they an opportunity for growth |
| topic | medical device industry innovation patent analysis regulatory market potential |
| url | https://www.mdpi.com/2076-3387/10/1/16 |
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