Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

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.

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Medical Devices: Regulation, Risk Classification, and Open Innovation

Journal of Open Innovation Technology Market and Complexity ◽

10.3390/joitmc6020042 ◽

2020 ◽

Vol 6 (2) ◽

pp. 42 ◽

Cited By ~ 1

Author(s):

Lukas Peter ◽

Ladislav Hajek ◽

Petra Maresova ◽

Martin Augustynek ◽

Marek Penhaker

Keyword(s):

Medical Device ◽

Medical Devices ◽

Social Structures ◽

Added Value ◽

Strategic Decisions ◽

The Czech Republic ◽

Risk Class ◽

Medical Device Manufacturers ◽

Legislative Changes ◽

Medical Device Regulation

In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly.

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A Platform and Multi-sided Market for Translational, Software-defined Medical Research in the Operation Room: OP 4.1 (Preprint)

10.2196/preprints.27743 ◽

2021 ◽

Author(s):

Magdalena Görtz ◽

Michael Byczkowski ◽

Mathias Rath ◽

Viktoria Schütz ◽

Philipp Reimold ◽

...

Keyword(s):

Medical Device ◽

Medical Devices ◽

Heterogeneous Data ◽

Healthcare Sector ◽

Successful Development ◽

Software Developers ◽

Intelligent Support ◽

Operation Room ◽

Central Platform ◽

Medical Device Manufacturers

BACKGROUND While digital and data-based technologies are widespread in various industries in the context of Industry 4.0, the use of smart, connected devices in healthcare is still in its beginnings. Innovative solutions for the medical environment suffer from difficult access to medical device data and high barriers for market entry due to proprietary systems. OBJECTIVE In the proof-of-concept project OP 4.1, we show the business viability of connecting and augmenting medical devices and data through software add-ons by giving companies a technical and commercial platform for the development, implementation, distribution, and billing of innovative software solutions. METHODS The creation of a central platform prototype requires the collaboration of several independent market contenders, amongst them medical users, software developers, medical device manufacturers, and platform providers. A dedicated consortium of clinical and scientific partners as well as industry partners was established. RESULTS We demonstrate the successful development of the prototype of a user-centric, open, and extensible platform for the intelligent support of processes starting with the operation room. By connecting heterogeneous data sources and medical devices from different manufacturers and making them accessible for software developers and medical users, the cloud-based platform OP 4.1 enables the augmentation of medical devices and procedures through software-based solutions. The platform also allows for the demand-oriented billing of applications and medical devices, thus permitting software-based solutions to fast-track their economic development and become commercially successful. CONCLUSIONS The technology and business platform OP 4.1 creates a multi-sided market for the successful development, implementation, distribution, and billing of new software solutions in the operation room and in the healthcare sector in general. Consequently, software-based medical innovation can be translated into clinical routine fast, efficiently, and cost-effectively, optimizing the treatment of patients through smartly assisted procedures.

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Adopting Identification Standards in the Medical Device Supply Chain

International Journal of Information Systems and Supply Chain Management ◽

10.4018/ijisscm.2020010101 ◽

2020 ◽

Vol 13 (1) ◽

pp. 1-14 ◽

Cited By ~ 1

Author(s):

Yousef Abdulsalam ◽

Dari Alhuwail ◽

Eugene S. Schneller

Keyword(s):

Supply Chain ◽

Medical Device ◽

Medical Devices ◽

Business Intelligence ◽

Return On Investment ◽

Survey Methods ◽

Device Identification ◽

Medical Device Manufacturers ◽

High Level ◽

The U.S

The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.

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A survey of feline trichomonosis suggests a low incidence of Tritrichomonas blagburni among cats in the Czech Republic

Veterinární Medicína ◽

10.17221/106/2016-vetmed ◽

2017 ◽

Vol 62 (No. 5) ◽

pp. 269-273 ◽

Cited By ~ 2

Author(s):

V. Ceplecha ◽

V. Svobodova ◽

C. Lendon ◽

R. Husnik ◽

K. Horackova ◽

...

Keyword(s):

Czech Republic ◽

Single Case ◽

Risk Groups ◽

Species Differentiation ◽

Culture Methods ◽

The Czech Republic ◽

Pcr Screening ◽

Low Incidence ◽

Medium Method

Tritrichomonas blagburni (previously called T. foetus) has been implicated as an aetiological agent of long-term large-bowel diarrhoea in cats in many countries worldwide. The aim of this study was to determine the presence of, and risk factors for T. blagburni among a cohort of cats living in different conditions in the Czech Republic. Samples were collected from 170 cats living in different environments. The InPouch™ TF-Feline medium method was used for diagnosis of feline trichomonosis. A single case (0.6%) with motile trichomonads identified as Pentatrichomonas hominis was found in a cat from a multi-cat household. Our study suggests that trichomonads and in particular, T. blagburni, infection may be much less common in the Czech Republic than in neighbouring countries, despite the inclusion of cats that were likely to be from higher-risk groups. A review of studies of the association of trichomonads and feline diarrhoea carried out in different countries revealed variation in the frequency of trichomonads detected. Different combinations of PCR or culture methods for screening or confirmation have been utilised, with or without species differentiation; however, this could not solely account for the variation in the occurrence between countries. From those studies where differentiation was performed, we calculated from the combined studies that T. blagburni occurred in six cats without diarrhoea (1.1%) and 47 cases with diarrhoea (5%). This finding supports an association with diarrhoea as well as the occurrence of asymptomatic cases. We note that in many studies, including our own, the occurrence of T. blagburni may well be underestimated and suggest that future studies use a combination of PCR screening of both faeces and faecal cultures, with differentiation of trichomonad species.

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New medical device regulations: the regulator’s view

EFORT Open Reviews ◽

10.1302/2058-5241.4.180061 ◽

2019 ◽

Vol 4 (6) ◽

pp. 351-356 ◽

Cited By ~ 8

Author(s):

Tom Melvin ◽

Marina Torre

Keyword(s):

Medical Device ◽

Medical Devices ◽

Clinical Investigation ◽

Pool Data ◽

Critical Function ◽

Core Dataset ◽

Medical Device Manufacturers ◽

In Vitro Diagnostic ◽

And Performance

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries. Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance. Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061

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Medical Device Regulation from a Health Service Provider’s Perspective

Prosthesis ◽

10.3390/prosthesis3030025 ◽

2021 ◽

Vol 3 (3) ◽

pp. 261-266

Author(s):

Man Ting Kwong ◽

David Stell ◽

Emmanuel Akinluyi

Keyword(s):

Health Service ◽

Medical Device ◽

Medical Devices ◽

Clinical Setting ◽

Service Providers ◽

Healthcare Providers ◽

Current Trends ◽

Health Service Providers ◽

The Uk ◽

Medical Device Regulation

Unfamiliarity with medical device regulations can sometimes be a barrier to deploying technology in a clinical setting for researchers and innovators. Health service providers recognise that innovation can happen within smaller organisations, where regulatory support may be limited. This article sets out to increase transparency and outline key considerations on medical device regulations from a UK healthcare provider’s perspective. The framework used by Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) for assessing research devices is presented to give an overview of the routes that R&D medical devices take to enter a clinical setting. Furthermore, current trends on research studies involving medical devices were extracted from the GSTFT internal R&D database and presented as the following categories (i) commercial vs. non-commercial, (ii) assessment type and (iii) software vs. non-software. New medical devices legislation will be introduced within the UK in July 2023. It is anticipated regulating software as a medical device may become more challenging for healthcare providers and device manufacturers alike. It is therefore important for different stakeholders involved to work together to ensure this does not become a barrier to innovation.

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Biocompatibility of Medical Devices - A Review

Journal of Evolution of Medical and Dental Sciences ◽

10.14260/jemds/2021/641 ◽

2021 ◽

Vol 10 (36) ◽

pp. 3152-3158

Author(s):

Ramya Shree Gangadhar ◽

Balamuralidhara V ◽

Rajeshwari S.R.

Keyword(s):

Medical Device ◽

Medical Devices ◽

Human Body ◽

The Body ◽

Biological Responses ◽

Medical Device Manufacturers ◽

Biocompatibility Testing ◽

Biological Environment ◽

Key Words Biocompatibility

BACKGROUND Biomaterial is defined as "any substance or combination of medicine, artificial or natural origin, which can be used at any time, in whole or part by a system that controls, adds to, or restores any tissue, organ or function". ISO 10993-1: 2018 standard defines bio compliance law as "the ability of a medical device or tool to perform a selected program with the acceptable response of experts". Incompatible factors cause chemical reactions in patients, with little or no side effects. The body can respond in a sort of way after the installation of medical devices, so testing and improvement is important here. Therefore, testing and improvement in this field are important. Biocompatibility is required for any significant use of components or materials in medical devices. Inconsistent factors create negative biological responses in patients, which may have serious consequences. Biomaterials are substances utilized in medical devices, especially in applications where the device is touched, temporarily embedded, or permanently implanted within the body. Because of the significant impact of biocompatibility, many countries have imposed regulations on medical device manufacturers to meet biocompatibility specifications. Here is a brief explanation about the biocompatibility and incompatibility parameters of medical devices with a human body and its need for biocompatibility of medical devices with the human body. Medical devices have improved doctors' ability to diagnose and treat disease, which has led to significant improvements in health and quality of life. Thus, medical devices are prone to various incompatibility issues and procedures that affect the biological environment must be followed. KEY WORDS Biocompatibility, Material Interactions, Sterilization, Medical devices, Biocompatibility Testing, Incompatibility Factors.

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Too Limited, Too Late: Evaluating the Czech Republic's Performance as a Small-State Lobbyist in EU External Policy

New Perspectives ◽

10.1177/2336825x1602400103 ◽

2016 ◽

Vol 24 (1) ◽

pp. 53-78

Author(s):

Tomáš Weiss

Keyword(s):

Czech Republic ◽

Single Case ◽

Small States ◽

Original Research ◽

The Czech Republic ◽

Eu Member States ◽

Research Interviews ◽

Small Member

The article proposes a classification of interest promotion methods used by small EU member states which draws on lobbying literature in order for us to better understand how small states pursue their preferences in Council negotiations. It explores a single case study of the Czech Republic's efforts to influence the 2012 revision of the European Union's Generalised System of Preferences scheme through the lenses of this classification. The empirical part of the paper is based on original research interviews with European and Czech stakeholders who participated in the studied negotiations. While the dossier was considered important, the Czech Republic failed to employ more elaborate methods of interest promotion and thus came away with a sub-optimal outcome. Rather than explaining this by pointing to a lack of socialization of Czech representatives (and thus a lack of effective competence), this deficiency can be better explained by the low salience of the general policy area for the Czech Republic, which prevented the country from developing a favourable position from which to react promptly to the related developments and deploy the lobbying tools at its disposal. The article suggests that the lobbyist-like character of a small member state's performance in the Council may have wider consequences for the flexibility of the country's EU policy and the ability of its governments to pursue specific European policies.

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