Assessment of the added value of the Twente Photoacoustic Mammoscope in breast cancer diagnosis\ud

Purpose: Photoacoustic (PA) imaging is a recently developed breast cancer imaging technique. In order to enhance successful clinical implementation, we quantified the potential clinical value of different scenarios incorporating PA imaging by means of multi-criteria analysis. From this analysis, the most promising area of application for PA imaging in breast cancer diagnosis is determined, and recommendations are provided to optimize the design of PA imaging. - \ud Methods: The added value of PA imaging was assessed in two areas of application in the diagnostic track. These areas include PA imaging as an alternative to x-ray mammography and ultrasonography in early stage diagnosis, and PA imaging as an alternative to Magnetic Resonance Imaging (MRI) in later stage diagnosis. The added value of PA imaging was assessed with respect to four main criteria (costs, diagnostic performance, patient comfort and risks). An expert panel composed of medical, technical and management experts was asked to assess the relative importance of the criteria in comparing the alternative diagnostic devices. The judgments of the experts were quantified based on the validated pairwise comparison technique of the Analytic Hierarchy Process, a technique for multi-criteria analysis. Sensitivity analysis was applied to account for the uncertainty of the outcomes. - \ud Results: Among the considered alternatives, PA imaging is the preferred technique due to its non-invasiveness, low cost and low risks. However, the experts do not expect large differences in diagnostic performance. The outcomes suggest that design changes to improve the diagnostic performance of PA imaging should focus on the quality of the reconstruction algorithm, detector sensitivity, detector bandwidth and the number of wavelengths used. - \ud Conclusion: The AHP method was useful in recommending the most promising area of application in the diagnostic track for which PA imaging can be implemented, this being early diagnosis, as a substitute for the combined use of x-ray mammography and ultrasonography

The online multi-agency support barometer

This report presents the findings of a small feasibility study which sought to investigate the use of an online risk management Barometer. The barometer was developed with a view to helping multiple agencies communicate about vulnerable and 'at risk' patients within mental health settings.The Barometer is an online tool which allows staff from multiple agencies to access and share information with other staff if a patient is at risk.The key aims and objectives of this small research project were i) to evaluating how professionals felt about their current risk assessment tools, ii) to assess the ease of use and the relevance of questions within the Barometer tool and iii) to discuss some potential modifications/problem areas of incorporating the Barometer tool within mental health services and across a multi-disciplinary perspective.The research was conducted in three mental services within the South Essex Partnership Trust (2 x CAMHS and 2 x Adult Services) using a mixed-methods approach

BioMeT and algorithm challenges: A proposed digital standardized evaluation framework

Technology is advancing at an extraordinary rate. Continuous flows of novel data are being generated with the potential to revolutionize how we better identify, treat, manage, and prevent disease across therapeutic areas. However, lack of security of confidence in digital health technologies is hampering adoption, particularly for biometric monitoring technologies (BioMeTs) where frontline healthcare professionals are struggling to determine which BioMeTs are fit-for-purpose and in which context. Here, we discuss the challenges to adoption and offer pragmatic guidance regarding BioMeTs, cumulating in a proposed framework to advance their development and deployment in healthcare, health research, and health promotion. Furthermore, the framework proposes a process to establish an audit trail of BioMeTs (hardware and algorithms), to instill trust amongst multidisciplinary users

Identifying, Monitoring, and Assessing Promising Innovations: Using Evaluation to Support Rapid-Cycle Change

Examines the new Center for Medicare and Medicaid Innovation's mission, critical issues, and challenges in finding effective ways to raise healthcare quality and lower costs, documenting innovation, and providing evidence to support broad policy change

Complexity stage model of the medical device development based on economic evaluation-MedDee

The development of a new product is essential for the progress and success of any company. The medical device market is very specific, which is challenging. Therefore, this paper assesses an economic model for medical device evaluation using the economic, health, technology regulatory, and present market knowledge to enable the cost-time conception for any applicant. The purpose of this study is to propose a comprehensive stage model of the medical device development to subsequently describe the financial expenditure of the entire development process. The identification of critical steps was based on the literature review, and analysis, and a comparison of the available medical device development stages and directives. Furthermore, a preliminary assessment of the medical device development steps and procedures on the basis of the interviews was performed. Six interviews were conducted with an average duration of one hour, focusing on areas: relevance and level of detail of the medical device development stages, involvement of economic methods, and applicability of the proposed model. Subsequently, the improvement and modification of the medical device investment process, based on respondents' responses, were conducted. The authors have proposed the complexity model MedDee-Medical Devices Development by Economic Evaluation. This model is comprised of six phases: initiation, concept, design, production, final verification, and market disposition in which the economic methods are incorporated.Web of Science125art. no. 175

From laboratory bench to benchmark: technology transfer in laboratory medicine

Background: Life Sciences research, enhancing the occurrence of innovation, is able to impact clinical decision-making, both at diagnosis and therapy. Indeed, starting from the knowledge of specific needs and of technical-scientific demands, researchers can conceive and experiment innovative solutions. Despite these strengths, transferring research to the market in Life Sciences shows considerable criticalities. The aim of this paper is to provide concrete evidences on the processes of technology transfer based on the exploitation of the results obtained by KronosDNAsrl, an academic spin-off focused on reproductive medicine. Methods: Different tools were used to evaluate the technical feasibility (validation of the results obtained with the prototype) and to manage the technology transfer process of One4Two®. Results: The different analyses we carried out showed the feasibility of the proposed solution. As a result, the One4Two® prototype has been developed and validated. Conclusions: Here, we provide a strength of evidences on how knowledge obtained by translational research on "bench" can be used to be transferred to the market on "benchmark" enabling innovation in Laboratory Medicine. In addition, the model described for One4Two® can be easily transferred to other products