1,720,983 research outputs found
R&D and innovative health technologies: towards the definition of a methodology for an Early Assessment
No full textDevelopment and validation of Medical Device Key Evidence Tool (‘MeDKET’): An evidence-based framework to explain success in selected European and US companies
Full text linkInnovating 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
Model-Based Techniques In The Early Phases of The Medical Device Development: A Systematic Literature Review
No full textAssessing the Social and Environmental Impact of Healthcare Technologies: Towards an Extended Social Return on Investment
Full text linkStroke is the third leading cause of death and disability overall worldwide. Upper limb impairment is a common consequence for stroke survivors, having negative impact on their quality of life. Robotic rehabilitation, through repetitive and monitored movements, can improve their status. Developed by a team of researchers at Politecnico di Milano, AGREE is an exoskeleton for upper limb rehabilitation at the stage gate between translational research and clinical validation. Since the cost of this device is particularly high, the present study aimed to provide a framework for assessing its value. The Social Return on Investment (SROI) method, able to grasp the economic, social and environmental impact of an activity, was applied, using expert opinions of a pool of clinical engineers and healthcare professionals from different Italian hospitals to obtain information. Environmental impacts were estimated through Life Cycle Assessment in terms of CO2 emissions and incorporated in the analysis. Considering a 5-year period, the SROI for a single exoskeleton was 3.75:1, and the SROI for the number of exoskeletons projected to be sold was 2.868:1, thus resulting largely in value for money. This study provides a model for combining economic, social and environmental outcomes that, besides contributing to theory, could be useful for decision-making
Rewiring care delivery through Digital Therapeutics (DTx): a machine learning-enhanced assessment and development (M-LEAD) framework
Full text linkAbstract Background Digital transformation has sparked profound change in the healthcare sector through the development of innovative digital technologies. Digital Therapeutics offer an innovative approach to disease management and treatment. Care delivery is increasingly patient-centered, data-driven, and based on real-time information. These technological innovations can lead to better patient outcomes and support for healthcare professionals, also considering resource scarcity. As these digital technologies continue to evolve, the healthcare field must be ready to integrate them into processes to take advantage of their benefits. This study aims to develop a framework for the development and assessment of Digital Therapeutics. Methods The study was conducted relying on a mixed methodology. 338 studies about Digital Therapeutics resulting from a systematic literature review were analyzed using descriptive statistics through RStudio. Machine learning algorithms were applied to analyze variables and find patterns in the data. The results of these analytical analyses were summarized in a framework qualitatively tested and validated through expert opinion elicitation. Results The research provides M-LEAD, a Machine Learning-Enhanced Assessment and Development framework that recommends best practices for developing and assessing Digital Therapeutics. The framework takes as input Digital Therapeutics characteristics, regulatory aspects, study purpose, and assessment domains. The framework produces as outputs recommendations to design the Digital Therapeutics study characteristics. Conclusions The framework constitutes the first step toward standardized guidelines for the development and assessment of Digital Therapeutics. The results may support manufacturers and inform decision-makers of the relevant results of the Digital Therapeutics assessment
Health Technology Assessment Needs Information Technology: The Experience From The First Italian Study On The Da Vinci Surgical Robot
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Seventy-two shades of environmental sustainability in healthcare: A holistic framework proposal
No full textSustainability is emerging as a critical research domain, transcending industrial applications to also address healthcare issues. This necessitates the adoption of an all-encompassing holistic, multidimensional, and multi- stakeholder approach. In an era where economic growth has predominantly driven all industries, integrating environmental sustainability into business strategies and, subsequently, into daily operations is increasingly emerging. Different levels (macro, considering the national healthcare system; meso, focusing on a single hospital or healthcare facility; and micro, concerning the single process) might be considered to address the unmet need to transform the healthcare sector towards a net-zero emissions approach, especially for the environmental impacts and carbon footprint generated by this industry. A more comprehensive framework emerges as a priority for both scholars and practitioners, to manage and synthesize these aspects. To achieve this objective, a scoping literature review was conducted, including 72 articles, as the starting point for the development of a holistic framework, and then the Nominal Group Technique was applied to perform the validation phase, measuring the experts' agreement on the framework proposed. The latter comprises three principal dimensions: i) infrastructure, ii) organisation, and iii) technology, emerging as the primary units of analysis for evaluating environmental sustainability within the healthcare sector. By assessing these three main outlined dimensions, decision-makers and healthcare professionals can gain a comprehensive understanding of sustainability performance. This will guide the evaluation process and provide a structured approach to assess current and future practices, set targets, implement actions, and monitor progress towards environmentally sustainable goals. This is also important in relation to international and national policies, such as the 2030 Agenda. The present research aims to investigate the available evidence on the topic and suggest a new framework. This proposed model aims to overcome the existing limitations, related to already proposed one-dimensional framework or models concerning only limited and not integrated aspects (building, supply chain or HR management). It also aims to provide guidance to healthcare professionals and policymakers in making informed decisions and prioritising interventions that comply with environmentally sustainable principles
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