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.
Highlights
Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development
This study explores the different perceptions on EDs by manufacturers, competent authorities (CA), and HTA agencies and investigates how EDs should be designed and implemented to accelerate patient access to potentially life-saving and health-improving Medical Device (MD)
To identify whether EDs between manufacturers, CAs, and HTA agencies have the potential to shorten the time to a reimbursement decision and to enable faster patient access, we developed three surveys that we disseminated to experts affiliated with HTA agencies, CAs, as well as manufacturers of MDs
Summary
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. Awareness of regulatory requirements, such as HTA, at an early stage in a product lifecycle, will assist manufacturers in identifying key evidentiary needs and potentially shortening the delay in patient access to life-saving MDs. In particular, guidance on study design, accepted clinical endpoints, budget impact, and relative effectiveness help manufactures address the HTA agencies’ requirements. Guidance on study design, accepted clinical endpoints, budget impact, and relative effectiveness help manufactures address the HTA agencies’ requirements The lack of such evidence may delay reimbursement or create an inaccurate perception of the benefits and harms of an MD, which usually leads to a denial of reimbursement and a delay in patient access
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
