The role of regulators in mitigating uncertainty within the Valley of Death

Roca, Jaime Bonnín; O’Sullivan, Eoin

doi:10.1016/j.technovation.2020.102157

Cited by 25 publications

(14 citation statements)

References 114 publications

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“…18,19 In addition, public policy plays a vital role in supporting the transition to higher TRL. 20 Rapidly developing and deploying CO 2 utilization technologies in a responsible manner requires an accelerated process to translate inventions from research laboratories to the market. Connecting and coordinating communities in academia, business, and government will be essential to address technical, nancial, and societal questions in a responsible and impactful manner.…”

Section: Papermentioning

confidence: 99%

Spiers Memorial Lecture: CO₂ utilization: why, why now, and how?

Sick

2021

Faraday Discuss.

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Section: Papermentioning

confidence: 99%

Spiers Memorial Lecture: CO₂ utilization: why, why now, and how?

Sick

2021

Faraday Discuss.

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“…Furthermore, these systems require an effective approach to incorporating stakeholders, such as diagnostic test manufacturers and medical professionals, in rulemaking. 9 In the context of pandemics, existing approaches to involving stakeholders may not always be inclusive enough.…”

Section: Preparing For Future Pandemicsmentioning

confidence: 99%

Balancing Quality and Speed in the Market Approval of Diagnostic Tests

Wiegmann

Roca

2021

JAMA Health Forum

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Mass testing has proven to be a critical pillar in the fight against a pandemic. 1 The COVID-19 crisis has demonstrated, especially in the early months of the pandemic, how a lack of reliable data regarding the number and distribution of infections led to an underestimation of the health risks and late and erratic containment policies. 2 Countries that deployed early mass testing, such as the Republic of Korea (South Korea) did, have been the most successful in dealing with the pandemic. Mass testing

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“…Examples of push and pull schemes or models are shown in Rothwell’s diagram. 6 Regulation also plays an important role in the innovative field of medical devices, and as Bonnin Roca and O’Sullivan 7 observe, regulatory agencies in this sector focus on ensuring patient safety rather than promoting innovation. According to Johnson, 8 this affects variables such as costs, quality, and availability in the healthcare system, but also financing options as shown by his observation about the venture capital outflow due to a regulation favouring “sure bets.” 9 …”

Section: Introductionmentioning

confidence: 99%

Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

Mačí¹

2022

RMHP

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Introduction The regulatory area is one that restricts human behaviour and opportunities, but it also allows the prevention of loss of property, health, or even life in various fields. Regulations provide the market with public confidence, which is extremely important in the field of innovative medical devices. The aim of this article is to analyse critical factors and economic methods for regulatory impact assessment in the medical device industry, to focus on the finances, processes, or innovation activity of organisations operating in the medical device sector. Methods The paper consists of a scoping review according to the PRISMA methodology of the available literature in Web of Science and Scopus database, whereby combing the keywords “regulation” AND “innovation” AND “medical device” AND “economic impact,” we obtained a set of 156 results in the form of English-written articles. The output was then limited to the period between 2011 and 2020. Finally, 23 papers were used based on the exclusion and inclusion criteria. Results The resulting challenges of the identified problems in particular are the amount of high-quality data available at an appropriate cost and the availability of a flexible notified body. There are also challenges specific to the situation, such as demands on the safety of medical devices for children. From a public expectations point of view, there is a continuing need to maintain the urgency of the balance between available innovation and safety. Discussion As for the methods of economic assessment in general, or methods for assessing the economic impact of regulations in particular, cost-effectiveness analysis is the most commonly used method for research and development, while internal rate of return is frequently used for the producers, and budget impact analysis is typically used for healthcare service providers. A non-financial indicator that is often discussed is the time demands associated with meeting compliance requirements. The time-to-market indicator is also often mentioned. Economic and financial topics are not discussed in depth, as the reviewed articles simply mention the generally high costs attendant on complying with regulations and obtaining certificates.

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The role of regulators in mitigating uncertainty within the Valley of Death

Cited by 25 publications

References 114 publications

Spiers Memorial Lecture: CO₂ utilization: why, why now, and how?

Spiers Memorial Lecture: CO₂ utilization: why, why now, and how?

Balancing Quality and Speed in the Market Approval of Diagnostic Tests

Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

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The role of regulators in mitigating uncertainty within the Valley of Death

Cited by 25 publications

References 114 publications

Spiers Memorial Lecture: CO2 utilization: why, why now, and how?

Spiers Memorial Lecture: CO2 utilization: why, why now, and how?

Balancing Quality and Speed in the Market Approval of Diagnostic Tests

Critical Factors and Economic Methods for Regulatory Impact Assessment in the Medical Device Industry

Contact Info

Product

Resources

About

Spiers Memorial Lecture: CO₂ utilization: why, why now, and how?

Spiers Memorial Lecture: CO₂ utilization: why, why now, and how?