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New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?

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  • Petra Maresova

    (Department of Economy, Faculty of Informatics and Management, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech Republic)

  • Ladislav Hajek

    (Department of Economy, Faculty of Informatics and Management, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech Republic)

  • Ondrej Krejcar

    (Center for Basic and Applied Research, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech Republic)

  • Michael Storek

    (Admirx, Inc., Cambridge, MA 02139, USA)

  • Kamil Kuca

    (Center for Basic and Applied Research, University of Hradec Kralove, Rokitanskeho 62, 500 03 Hradec Kralove, Czech Republic)

Abstract

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.

Suggested Citation

  • Petra Maresova & Ladislav Hajek & Ondrej Krejcar & Michael Storek & Kamil Kuca, 2020. "New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?," Administrative Sciences, MDPI, vol. 10(1), pages 1-18, March.
    • Handle: RePEc:gam:jadmsc:v:10:y:2020:i:1:p:16-:d:331577
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    References listed on IDEAS

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    1. Anne P. M. Velenturf & Paul D. Jensen & Phil Purnell & Juliet Jopson & Norman Ebner, 2019. "A Call to Integrate Economic, Social and Environmental Motives into Guidance for Business Support for the Transition to a Circular Economy," Administrative Sciences, MDPI, vol. 9(4), pages 1-13, November.
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    Cited by:

    1. Lim, Chulmin & Rowsell, Joe & Kim, Seongcheol, 2024. "Exploring killer domains to create new value: A comparative case study of Canadian and Korean telcos," Telecommunications Policy, Elsevier, vol. 48(4).
    2. Lim, Chulmin & Rowsell, Joe & Kim, Seongcheol, 2023. "Exploring the killer domains to create new value: A Comparative case study of Canadian and Korean telcos," 32nd European Regional ITS Conference, Madrid 2023: Realising the digital decade in the European Union – Easier said than done? 277998, International Telecommunications Society (ITS).
    3. Allers, Sanne & Eijkenaar, Frank & van Raaij, Erik M. & Schut, Frederik T., 2023. "The long and winding road towards payment for healthcare innovation with high societal value but limited commercial value: A comparative case study of devices and health information technologies," Technology in Society, Elsevier, vol. 75(C).
    4. Nicolas Haber & Mario Fargnoli, 2021. "Sustainable Product-Service Systems Customization: A Case Study Research in the Medical Equipment Sector," Sustainability, MDPI, vol. 13(12), pages 1-20, June.

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