Defining innovativeness of high-technology medical devices in an Italian region

In more detail, a retrospective evaluation has been made of 45 innovative devices approved consecutively by GRDM from its inception to October 2021.4 A Health Technology Assessment (HTA) report has accompanied each of these decisions.5 According to these data, innovativeness of a new medical device...

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Bibliographic Details
Published in:European journal of hospital pharmacy. Science and practice 2023-03, Vol.30 (2), p.e10-e10
Main Authors: Messori, Andrea, Trippoli, Sabrina, Bartoli, Laura, Marinai, Claudio
Format: Article
Language:English
Subjects:
Equipment and Supplies
evidence-based medicine
health care economics and organizations
Health technology assessment
hospital
Innovations
Italy
Medical equipment
Medical technology
organization and administration
Pharmaceuticals
pharmacy service
PostScript
public health
Technology
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Summary:In more detail, a retrospective evaluation has been made of 45 innovative devices approved consecutively by GRDM from its inception to October 2021.4 A Health Technology Assessment (HTA) report has accompanied each of these decisions.5 According to these data, innovativeness of a new medical device compared with devices already in use was related in 60% of cases (26/45) to a ‘documented advantage‘ of clinical, economic or organisational nature, and in 35% of cases (15/45) to covering an ‘unmet clinical need‘. [...]innovative devices are directed towards a rapid procurement without any competitive tender, whereas all other devices undergo the usual procurement paths (in most cases a competitive tender). [...]our expectation is that this proposal focused on these criteria of innovativeness can improve the decision-making process on medical devices in the Tuscany region and hopefully in other Italian regions.
ISSN:2047-9956
2047-9964
DOI:10.1136/ejhpharm-2021-003204