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
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Abstract
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.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
11 Centers of Competence > KPM Center for Public Management |
UniBE Contributor: |
Blankart, Rudolf, Dams, Florian, Shatrov, Kosta Donislavov, Iskandar, Rowan |
Subjects: |
300 Social sciences, sociology & anthropology > 350 Public administration & military science |
ISSN: |
0168-8510 |
Publisher: |
Elsevier |
Funders: |
[UNSPECIFIED] European Commission Horizon 2020 |
Projects: |
Projects 779306 not found. |
Language: |
English |
Submitter: |
Carl Rudolf Berchtold Blankart |
Date Deposited: |
06 Dec 2021 10:13 |
Last Modified: |
02 Mar 2023 23:35 |
Publisher DOI: |
10.1016/j.healthpol.2021.07.010 |
PubMed ID: |
34353636 |
BORIS DOI: |
10.48350/161254 |
URI: |
https://boris.unibe.ch/id/eprint/161254 |
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