Regulatory and HTA early dialogues in medical devices

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 and 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:

06 Dec 2021 10:13

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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