Imperial College London
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DrStefaniaManetti

Faculty of Medicine, Department of Surgery & Cancer

Honorary Research Associate
 
 
 
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Contact

 

s.manetti

 
 
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Location

 

Queen Elizabeth the Queen Mother Wing (QEQM)St Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Manetti:2023:10.1371/journal.pone.0288126,
author = {Manetti, S and Lettieri, E and Ni, M},
doi = {10.1371/journal.pone.0288126},
journal = {PLoS One},
title = {Development of Medical Device Key Evidence Tool ('MEDKET'): an evidence-based framework to explain success in selected European and US companies},
url = {http://dx.doi.org/10.1371/journal.pone.0288126},
volume = {18},
year = {2023}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - Innovating in Medical Device (MD) industry is challenging. This study aims to develop and validate an evidence-based framework that helps innovators of small and large enterprises (SEs and LEs) assess their readiness for successful MD development and deployment. We conducted a key-informant process (stage 1) where 25 international experts identified a list of emergent Health Technology Assessment (HTA) themes they believed were essential to company success. A sample of 22 European and US selected companies (13 SEs and 9 LEs) then reached a consensus on a list of key themes through a robust Delphi process (stage 2). Finally, we constructed (stage 3) and validated (stage 4) the checklist for SEs and LEs. The checklist for SEs and LEs included 21 and 15 items (i.e., fundamental Yes/No questions) with nine overlapping criteria for both SEs and LEs. In both groups, MD success was driven by three major item categories: (i) R&D assessment strategy; (ii) device-outcome measures; (iii) company profiling. Alongside the retrospective validation study, we collected 40 case studies on MDs (23 successes and 17 failures) across the selected enterprises. The retrospective validation provided the proportion of successful and failed case studies that met the ’MeDKET’ criteria. We discovered that early HTA plays a pivotal role in MD industry success with different implications based on enterprise size. This study is the first of its kind to provide a holistic picture of the perceived role of early-stage HTA in MD industry success.
AU  - Manetti,S
AU  - Lettieri,E
AU  - Ni,M
DO  - 10.1371/journal.pone.0288126
PY  - 2023///
SN  - 1932-6203
TI  - Development of Medical Device Key Evidence Tool ('MEDKET'): an evidence-based framework to explain success in selected European and US companies
T2  - PLoS One
UR  - http://dx.doi.org/10.1371/journal.pone.0288126
UR  - http://hdl.handle.net/10044/1/105570
VL  - 18
ER  -
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