Assessing risk by analogy: a case study of us medical device risk management policy

White, Shelley K.; Walters, Abigail N.

doi:10.1080/13698575.2018.1554802

Cited by 13 publications

(13 citation statements)

References 33 publications

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“…Previous studies [see, for example, ( 7 )] highlight the need for regulatory change. The current regime appears to be biased toward MD producers and not the end users' safety and risk assessment.…”

Section: Discussionmentioning

confidence: 99%

“…Attitudes toward regulations are perceived differently. Concern has been expressed in the literature that the current regulatory regime for medical devices (MDs) is inadequate, biased toward commercial interests, that innovation outpaces the development of regulatory controls, resulting in social and patient risk implications ( 5 – 7 ). de Mol ( 8 ) argues (p. 735) that “medical devices are considered to be a cornerstone of medical technology and to enable progress in healthcare for millions of patients.” The current regulatory regime may, however, be putting patients at risk ( 9 ).…”

Section: Introductionmentioning

confidence: 99%

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

Režný

Peter

Hájek

et al. 2021

Front. Public Health

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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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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Režný

Peter

Hájek

et al. 2021

Front. Public Health

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“…The need for a change in regulations has been emphasized in numerous studies (White and Walters 2018) which drew attention to the fact that the current legislation favors the medical device manufacturers at the expense of the patients. Kent and Faulkner (2002) pointed out that the safety of end users is backgrounded, while "commercial interests have dominated regulatory policy".…”

Section: Discussionmentioning

confidence: 99%

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

Hájek

Krejcar

Storek³

et al. 2020

Administrative Sciences

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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.

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“…The agency has a crucial gatekeeper power, as these products can only be marketed after having received approval from the FDA (Carpenter 2010 ). Although its gatekeeping function is only applicable on US soil, FDA policy initiatives carry extensive global weight because the US are among the world’s major players in the production of medical devices, representing 45 percent of this market in 2011 (Carpenter 2010 ; White and Walters 2018 ; Davis and Abraham 2011 ). Moreover, other major national regulators (e.g.…”

Section: Studying the Us Food And Drug Administration (Fda)mentioning

confidence: 99%

“…Since its inception, however, and ever increasingly since the late 1970s (Hilts 2003 ; Maschke and Gusmano 2018 ; Abraham 1995 ), the agency has had to address the tension between ensuring the quality and safety of products in order to protect American citizens and supporting companies to spur technological innovation. As such, the agency’s policy actions are driven by its self-understanding as an entity at once acting as a ‘safety watchdog’ (Cortez 2015 ) and as an ‘innovation enabler’ (Abraham 1995 ; Davis and Abraham 2011 ; White and Walters 2018 ).…”

Section: Studying the Us Food And Drug Administration (Fda)mentioning

confidence: 99%

The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation

2021

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As digital health technologies (DHT) have been embraced as a ‘panacea’ for health care systems, they have evolved from a buzzword into a high priority objective for health policy across the globe. In the realm of quality and safety standards for medical devices, the US Food and Drug Administration (FDA) has been a frontrunner in adapting its regulatory framework to DHT. However, despite the utmost relevance of quality and safety standards and their role for sustaining the innovation pathway of DHT, their actual making has not yet been subjected to in-depth social-science scrutiny. Drawing on the conceptual repertoires of Science and Technology Studies (STS), this article investigates how digital health evolved from a buzzword into an ‘object of government’, or gained material meaning and transformed into a regulatable object, by charting the standard-making process of FDA’s medical digital health policy between 2008 and 2018. From this, we reflect on the mutually sustaining dynamics between technological and organizational innovation, as the FDA’s attempts to standardize medical DHT not only shaped the lifestyle/medical boundary for DHT. It also led to significant reconfigurations within the FDA itself, while fostering a broader shift toward the uptake of alternative forms of evidence in regulatory science.

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Assessing risk by analogy: a case study of us medical device risk management policy

Cited by 13 publications

References 33 publications

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

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

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

The FDA’s standard-making process for medical digital health technologies: co-producing technological and organizational innovation

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