Department of Economics, University of Hradec Kralove, Hradec Kralove, Czechia.
Department of Cybernetics and Biomedical Engineering, Technical University of Ostrava, Ostrava, Czechia.
Front Public Health. 2021 Apr 28;9:666453. doi: 10.3389/fpubh.2021.666453. eCollection 2021.
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. 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? 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. 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.
在欧盟内部，一些医疗设备 (MD) 开发商现在面临的挑战和感知到的风险源于监管框架的变化，强调安全。因此，医疗技术公司必须采取更严格的质量保证措施，以便在紧急情况下能够迅速追踪和检索个别设备。 我们强调了欧洲医疗器械行业面临的挑战和风险，特别是捷克中小企业面临的挑战和风险。我们解决了两个重要的研究问题：Q1. 增加监管带来的优势是否超过了额外的费用？Q2. 由于许多 MD 开发商都是中小企业，新的监管制度是否会导致其中一些公司倒闭，从而阻碍未来的创新？ 本文专注于单一案例研究，讨论情况和结果是在捷克共和国营销的另外 50 家医疗器械制造商的财务结果的背景下进行的。 我们的研究结果表明，新法规将提高安全性，促进产品召回，但成本和行政负担可能很高。证据还表明，一些中小企业可能被迫转向“非医疗”产品，从而不可避免地减少了向患者和医疗保健提供者提供创新的 MD。
