Do regulatory changes seriously affect the medical devices industry? Evidence from the Czech Republic
| Autor: | Lukas Peter, Frank Lefley, Lukas Rezny, Petra Maresova, Ladislav Hájek |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Czech
Context (language use) Legislation 030204 cardiovascular system & hematology Single-subject design medical devices 03 medical and health sciences Patient safety 0302 clinical medicine patient safety Humans Industry 030212 general & internal medicine Marketing Czech Republic Original Research risk business.industry SME Public Health Environmental and Occupational Health Health technology regulation language.human_language innovation Product (business) language Public Health Public aspects of medicine RA1-1270 business Quality assurance |
| Zdroj: | Frontiers in Public Health Frontiers in Public Health, Vol 9 (2021) |
| Popis: | Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations.Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation?Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic.Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to “non-medical” products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers. |
| Databáze: | OpenAIRE |
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