Regulatory and HTA early dialogues in medical devices
| Autor: | Carl Rudolf Blankart, Hannah Penton, Carlo Federici, Zoltán Kaló, Florian Dams, Rowan Iskandar, Antal Zemplényi, Kosta Shatrov |
|---|---|
| Přispěvatelé: | Health Technology Assessment (HTA) |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Technology Assessment
Biomedical Medical device Process (engineering) Cost-Benefit Analysis education 03 medical and health sciences Government Agencies 0302 clinical medicine SDG 3 - Good Health and Well-being Humans 030212 general & internal medicine Product (category theory) BIOMEDICAL 350 Public administration & military science business.industry 030503 health policy & services Health Policy COST-BENEFIT ANALYSIS EUROPE HEALTH POLICY HUMANS GOVERNMENT AGENCIES TECHNOLOGY ASSESSMENT BIOMEDICAL Health technology Public relations Europe Incentive Clinical evidence TECHNOLOGY ASSESSMENT Business 0305 other medical science Legislator |
| Zdroj: | Blankart, Carl Rudolf; Dams, Florian; Penton, Hannah; Kaló, Zoltán; Zemplényi, Antal; Shatrov, Kosta; Iskandar, Rowan; Federici, Carlo (2021). Regulatory and HTA early dialogues in medical devices. Health Policy, 125(10), pp. 1322-1329. Elsevier 10.1016/j.healthpol.2021.07.010 Health Policy Health Policy, 125(10), 1322-1329. Elsevier Ireland Ltd |
| ISSN: | 0168-8510 |
| DOI: | 10.1016/j.healthpol.2021.07.010 |
| Popis: | Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence. Methods: We explore the perceptions of manufacturers, competent authorities, and HTA agencies towards such dialogues and investigate how they should be designed to accelerate the translational process from development to patient access using semi-structured interviews. We synthesized the evidence from manufacturers, competent authorities, and HTA agencies from 14 different jurisdictions across Europe. Results: Eleven HTA agencies, four competent authorities, and eight manufacturers of high-risk devices expressed perceptions on the current situation and the expected development of three types of early dialogues. Discussion: The MDR has to be taken into account when designing the early dialogue processes. Transferring insights from medicinal product regulation is limited as the regulatory pathways differ substantially. Conclusion: Early dialogues promise to accelerate the translational process and to provide faster access to innovative medical devices. However, health policy-makers should promote and fully establish regulatory and HTA early dialogues before introducing parallel early dialogues of regulatory, HTA agencies, and manufacturers. For initiating change, the legislator must create the legal basis and set the appropriate incentives for manufacturers. |
| Databáze: | OpenAIRE |
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