Publications
29 results found
Manetti S, Lettieri E, Ni M, 2023, Development of Medical Device Key Evidence Tool ('MEDKET'): an evidence-based framework to explain success in selected European and US companies, PLoS One, Vol: 18, ISSN: 1932-6203
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.
Manetti S, Cumetti M, De Benedectis A, et al., 2022, Adoption of novel biomarker test parameters with machine learning-based algorithms for the early detection of sepsis in hospital practice, JOURNAL OF NURSING MANAGEMENT, Vol: 30, Pages: 3754-3764, ISSN: 0966-0429
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- Citations: 1
Aimo A, Manetti S, Emdin M, 2021, How much is it to mend a broken heart? Results from the US Nationwide Readmission Database, INTERNATIONAL JOURNAL OF CARDIOLOGY, Vol: 329, Pages: 150-151, ISSN: 0167-5273
Vainieri M, Ferre F, Manetti S, 2021, An Integrated Framework to Measure the Performance of Inter-Organizational Programme on Health Technology Assessment, SUSTAINABILITY, Vol: 13
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- Citations: 1
Aizenberg I, Belardi R, Bindi M, et al., 2021, Failure Prevention and Malfunction Localization in Underground Medium Voltage Cables, ENERGIES, Vol: 14
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- Citations: 8
Bindi M, Garcia CI, Corti F, et al., 2021, Comparison Between PI and Neural Network Controller for Dual Active Bridge Converter, 15th International Conference on Compatibility, Power Electronics and Power Engineering (CPE-POWERENG), Publisher: IEEE, ISSN: 2166-9546
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- Citations: 5
Manetti S, Turchetti G, Fusco F, 2020, Determining the cost-effectiveness requirements of an exoskeleton preventing second hip fractures using value of information, BMC HEALTH SERVICES RESEARCH, Vol: 20
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- Citations: 5
Manetti S, Vainieri M, Guidotti E, et al., 2020, Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment, BMJ OPEN, Vol: 10, ISSN: 2044-6055
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- Citations: 3
Fontana G, Grasso F, Luchetta A, et al., 2019, A symbolic program for parameter identifiability analysis in systems modeled via equivalent linear time-invariant electrical circuits, with application to electromagnetic harvesters, 14th IEEE Workshop on Optimization and Inverse Problems in Electromagnetism (IEEE OIPE), Publisher: WILEY, ISSN: 0894-3370
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- Citations: 2
Leal J, Manetti S, Buchanan J, 2019, The Impact of Hospital Costing Methods on Cost-Effectiveness Analysis: A Case Study (vol 36, pg 1263, 2018), PHARMACOECONOMICS, Vol: 37, Pages: 867-867, ISSN: 1170-7690
Aizenberg I, Luchetta A, Manetti S, et al., 2019, A MLMVN WITH ARBITRARY COMPLEX-VALUED INPUTS AND A HYBRID TESTABILITY APPROACH FOR THE EXTRACTION OF LUMPED MODELS USING FRA, JOURNAL OF ARTIFICIAL INTELLIGENCE AND SOFT COMPUTING RESEARCH, Vol: 9, Pages: 5-19, ISSN: 2083-2567
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- Citations: 1
Bindi M, Grasso F, Luchetta A, et al., 2019, Smart Monitoring and Fault Diagnosis of Joints in High Voltage Electrical Transmission Lines, 6th International Conference on Soft Computing and Machine Intelligence (ISCMI), Publisher: IEEE, Pages: 40-44, ISSN: 2640-0154
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- Citations: 3
Leal J, Manetti S, Buchanan J, 2018, The Impact of Hospital Costing Methods on Cost-Effectiveness Analysis: A Case Study, PHARMACOECONOMICS, Vol: 36, Pages: 1263-1272, ISSN: 1170-7690
Manetti S, Orsini N, Turchetti G, 2017, Early health economic models of new ambient assisted living (AAL) devices for falls prevention, Publisher: OXFORD UNIV PRESS, ISSN: 1101-1262
Turchetti G, Pierotti F, Palla I, et al., 2017, Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study, SURGICAL ENDOSCOPY AND OTHER INTERVENTIONAL TECHNIQUES, Vol: 31, Pages: 543-551, ISSN: 0930-2794
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- Citations: 11
Manetti S, Burns RM, Turchetti G, 2017, Evidence-gathering across industry and academia on early health technology assessment (HTA) of medical devices: Survey design and piloting, IFMBE Conference, Pages: 631-634, ISSN: 1680-0737
© Springer Nature Singapore Pte Ltd. 2018. The adoption and reimbursement of a new or novel medical device frequently occurs after an economic evaluation of the innovation. One important factor for reimbursement rejections by the English National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) appears to be the scarce or no attention to early assessment. This protocol describes a mixed methods research strategy employed to develop and test the quality, validity and consistency of two survey questionnaires aiming to explore the early Health Technology Assessment (HTA) level of adoption, and potential barriers to its adoption, across industry and academia. Qualitative interviews involved two types of key stakeholders: people working in the R&D or market access departments of small and medium enterprises, and academics working in the field of health economics, across England and Italy. We analysed the content of 25 informant interviews, constructed, and piloted two different academia and industry-tailored questionnaires. We then piloted the revised questionnaires with 15 professionals (5 developers and 10 academics) and re-piloted both a month later. To our knowledge, this study is the first to develop and test a survey that investigates the views in academia and in private companies on how conducting early HTA might affect the introduction of new medical devices to the market. Due to few original research papers on early HTA in the published literature and limited application of the guidance for early HTA in reimbursement claims, the incorporation of a more robust analytical framework including a societal perspective is necessary to understand whether early assessment can be effectively embedded into all aspects of the development process.
Manetti S, Leal J, 2017, VP136 The Impact Of Hospital Costing Methods On Economic Evaluations, International Journal of Technology Assessment in Health Care, Vol: 33, Pages: 211-212, ISSN: 0266-4623
<jats:sec><jats:title>INTRODUCTION:</jats:title><jats:p>There are several methods to cost hospital contacts when estimating the cost effectiveness of a new intervention. In England, the National Insitute for Health and Care Excellence (NICE) recommends the use of diagnosis-related group (DRG)-based costs as a valuable way of costing hospital resource use. There are three main sources of unit costs of a DRG: (i) tariffs as used for reimbursement purposes, (ii) benchmarking finished consultant episode (FCE)-level reference costs and (iii) benchmarking spell-level reference costs.</jats:p><jats:p>The purpose of this work is to compare the implications of choosing a particular source of DRG-based unit costs when conducting an economic evaluation.</jats:p></jats:sec><jats:sec><jats:title>METHODS:</jats:title><jats:p>As a case study, we used a cost-utility model developed to compare secondary fracture prevention models of care for hip fracture patients (1). A Markov model was derived from large primary and hospital care administrative datasets in England. Utilities were informed by a meta-regression of thirty-two studies. Hospital resource use (inpatient, outpatient, critical care and emergency care) was valued using the three different 2014–15 DRG-based unit costs and regression-based costing models were derived from 33,000 hip fracture patients to inform the health states of the model (2). For each source of DRG-based costs, we calculated mean life years, Quality-Adjusted Life Years (QALYs) and costs for a representative male and female associated with three models of care: (i) orthogeriatrician (OG)-led, (ii) nurse-led fracture liaison services and (iii) usual care.</jats:p></jats:sec><jats:sec><jats:title>RESULTS:</jats:title><jats:p>Using the benchmarking FCE-level DRG-based costs, the OG-led model was estimated to be the most effective model of care (1.7
Palla I, Lorenzoni V, D'Isidoro C, et al., 2016, A NEW ORGANIZATIONAL INTEGRATED HOME-CARE MODEL: AN ITALIAN PILOT STUDY, Publisher: ELSEVIER SCIENCE INC, Pages: A747-A747, ISSN: 1098-3015
Manetti S, Turchetti G, 2015, MODEL-BASED TECHNIQUES IN THE EARLY PHASES OF THE MEDICAL DEVICE DEVELOPMENT: A SYSTEMATIC LITERATURE REVIEW, VALUE IN HEALTH, Vol: 18, Pages: A703-A704, ISSN: 1098-3015
Manetti S, Palla L, Freschi C, et al., 2015, HEALTH TECHNOLOGY ASSESSMENT NEEDS INFORMATION TECHNOLOGY: THE EXPERIENCE FROM THE FIRST ITALIAN STUDY ON THE DA VINCI SURGICAL ROBOT, VALUE IN HEALTH, Vol: 18, Pages: A693-A693, ISSN: 1098-3015
Manetti S, Cecchi F, Sgandurra G, et al., 2015, EARLY STAGE ECONOMIC EVALUATION OF CARETOY SYSTEM FOR EARLY INTERVENTION IN PRETERM INFANTS AT RISK OF NEURODEVELOPMENTAL DISORDERS, VALUE IN HEALTH, Vol: 18, Pages: A358-A358, ISSN: 1098-3015
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- Citations: 4
Turchetti G, Pierotti F, Palla I, et al., 2014, COST ANALYSIS OF THE ROBOTIC SURGERY IN ITALY, Publisher: ELSEVIER SCIENCE INC, Pages: A157-A157, ISSN: 1098-3015
Volandri G, Di Puccio F, Forte P, et al., 2012, Model-oriented review and multi-body simulation of the ossicular chain of the human middle ear, MEDICAL ENGINEERING & PHYSICS, Vol: 34, Pages: 1339-1355, ISSN: 1350-4533
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- Citations: 23
Grasso F, Luchetta A, Manetti S, et al., 2012, Symbolic Analysis Techniques for Fault Diagnosis and Automatic Design of Analog Circuits, DESIGN OF ANALOG CIRCUITS THROUGH SYMBOLIC ANALYSIS, Editors: Fakhfakh, TleloCuautle, Fernandez, Publisher: BENTHAM SCIENCE PUBL, Pages: 361-398, ISBN: 978-1-60805-425-1
Luchetta A, Manetti S, Reatti A, 2001, SAPWIN-A Symbolic Simulator as a Support in Electrical Engineering Education, IEEE TRANSACTIONS ON EDUCATION, Vol: 44, Pages: 213-213, ISSN: 0018-9359
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- Citations: 29
Leoni P, Manetti S, Pasquali M, et al., 1996, CO-induced reductive elimination of P(t-Bu)(2)H from the platinum(II) dinuclear derivative Pt2Cu[mu-P(t-BU)(2)](2)(H)(2)[P(t-BU)(2)H](2), affording mononuclear platinum(0) or triangulo triplatinum(I,I,II) derivatives, INORGANIC CHEMISTRY, Vol: 35, Pages: 6045-6052, ISSN: 0020-1669
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- Citations: 42
LEONI P, MANETTI S, PASQUALI M, 1995, SYNTHESIS OF NEW NEUTRAL AND CATIONIC PHOSPHIDO-BRIDGED DINUCLEAR PLATINUM(II) HYDRIDES, INORGANIC CHEMISTRY, Vol: 34, Pages: 749-752, ISSN: 0020-1669
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- Citations: 46
GRECO L, MUSMARRA F, AMATO L, et al., 1992, GROWTH EVALUATION FROM A TODDLERS POPULATION WITH CONTROLLED NUTRITIONAL INPUT - OPTIMAL-POPULATION STANDARDS, RIVISTA ITALIANA DI PEDIATRIA-ITALIAN JOURNAL OF PEDIATRICS, Vol: 18, Pages: 443-449, ISSN: 0390-671X
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- Citations: 1
LIBERATORE A, MANETTI S, 1984, COMMUTED CONDENSERS AND THEIR USAGE IN MODERN INTEGRATED-CIRCUITS, ELETTROTECNICA, Vol: 71, Pages: 1031-1041, ISSN: 0013-6131
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