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

Process of designing robust, dependable, safe and secure software for medical devices: Point of care testing device as a case study

This article has been made available through the Brunel Open Access Publishing Fund.Copyright © 2013 Sivanesan Tulasidas et al. This paper presents a holistic methodology for the design of medical device software, which encompasses of a new way of eliciting requirements, system design process, security design guideline, cloud architecture design, combinatorial testing process and agile project management. The paper uses point of care diagnostics as a case study where the software and hardware must be robust, reliable to provide accurate diagnosis of diseases. As software and software intensive systems are becoming increasingly complex, the impact of failures can lead to significant property damage, or damage to the environment. Within the medical diagnostic device software domain such failures can result in misdiagnosis leading to clinical complications and in some cases death. Software faults can arise due to the interaction among the software, the hardware, third party software and the operating environment. Unanticipated environmental changes and latent coding errors lead to operation faults despite of the fact that usually a significant effort has been expended in the design, verification and validation of the software system. It is becoming increasingly more apparent that one needs to adopt different approaches, which will guarantee that a complex software system meets all safety, security, and reliability requirements, in addition to complying with standards such as IEC 62304. There are many initiatives taken to develop safety and security critical systems, at different development phases and in different contexts, ranging from infrastructure design to device design. Different approaches are implemented to design error free software for safety critical systems. By adopting the strategies and processes presented in this paper one can overcome the challenges in developing error free software for medical devices (or safety critical systems).Brunel Open Access Publishing Fund

Implementation of Risk Management in the Medical Device Industry

This study looks at the implementation and effectiveness of risk management (RM) activities in the medical device industry. An online survey was distributed to medical device professionals who were asked to identify RM-related activities performed during the device life cycle. RM activities and techniques included Establishing Risk Acceptance Criteria, Hazard Identification, Human Factors/Usability, Fault Tree Analysis (FTA), Design Failure Mode and Effects Analysis (DFMEA), Process Failure Mode and Effects Analysis (PFMEA), Hazard and Operability Study (HAZOP), Hazard Analysis and Critical Control Point (HACCP), Risk Benefit Analysis, and Risk Assessment of Customer Complaint. Devices were identified by type (therapeutic, surgical/clinical tools, diagnostic, instrument disposable, implantable, etc.), development history (new, second, third or later generation device), and time since market release. Respondents were also asked to indicate the degree of change made to the device as a result of RM activities and to rate the effectiveness of associated RM activities for the device. Survey results indicated that RM\u27s impact and level of effectiveness on a medical device are dependent primarily on the device type and life-cycle stage (i.e., pre-market versus post-market). There is also some impact of development history and the time since the device was released to market

Safety-Critical Systems and Agile Development: A Mapping Study

In the last decades, agile methods had a huge impact on how software is developed. In many cases, this has led to significant benefits, such as quality and speed of software deliveries to customers. However, safety-critical systems have widely been dismissed from benefiting from agile methods. Products that include safety critical aspects are therefore faced with a situation in which the development of safety-critical parts can significantly limit the potential speed-up through agile methods, for the full product, but also in the non-safety critical parts. For such products, the ability to develop safety-critical software in an agile way will generate a competitive advantage. In order to enable future research in this important area, we present in this paper a mapping of the current state of practice based on {a mixed method approach}. Starting from a workshop with experts from six large Swedish product development companies we develop a lens for our analysis. We then present a systematic mapping study on safety-critical systems and agile development through this lens in order to map potential benefits, challenges, and solution candidates for guiding future research.Comment: Accepted at Euromicro Conf. on Software Engineering and Advanced Applications 2018, Prague, Czech Republi

Space biology initiative program definition review. Trade study 2: Prototype utilization in the development of space biology hardware

The objective was to define the factors which space flight hardware developers and planners should consider when determining: (1) the number of hardware units required to support program; (2) design level of the units; and (3) most efficient means of utilization of the units. The analysis considered technology risk, maintainability, reliability, and safety design requirements for achieving the delivery of highest quality flight hardware. Relative cost impacts of the utilization of prototyping were identified. The development of Space Biology Initiative research hardware will involve intertwined hardware/software activities. Experience has shown that software development can be an expensive portion of a system design program. While software prototyping could imply the development of a significantly different end item, an operational system prototype must be considered to be a combination of software and hardware. Hundreds of factors were identified that could be considered in determining the quantity and types of prototypes that should be constructed. In developing the decision models, these factors were combined and reduced by approximately ten-to-one in order to develop a manageable structure based on the major determining factors. The Baseline SBI hardware list of Appendix D was examined and reviewed in detail; however, from the facts available it was impossible to identify the exact types and quantities of prototypes required for each of these items. Although the factors that must be considered could be enumerated for each of these pieces of equipment, the exact status and state of development of the equipment is variable and uncertain at this time

The future of Cybersecurity in Italy: Strategic focus area

This volume has been created as a continuation of the previous one, with the aim of outlining a set of focus areas and actions that the Italian Nation research community considers essential. The book touches many aspects of cyber security, ranging from the definition of the infrastructure and controls needed to organize cyberdefence to the actions and technologies to be developed to be better protected, from the identification of the main technologies to be defended to the proposal of a set of horizontal actions for training, awareness raising, and risk management

Determining the reliability of critical controls in construction projects

Across the global construction industry, fatalities continue to occur from high-risk activities, where the risk controls have been defined; however, these were unreliable. In the mining industry, Critical Control Risk Management has provided positive results in reducing major accidents, which raises the question, could the Critical Control approach reduce the fatality rate in the construction industry? This study analyzed 10 years of serious and fatal incident investigation reports from four international construction companies to (i) assess the reliability of their Critical Controls (CCs) and (ii) assess the factors that affect the reliability of CCs. The results show the reliability of CCs, measured by implementation and effectiveness, averaged just 42%. Insight into human performance and organizational factors, including risk identification, decision-making and competency, together with supervision, job planning and communication, were identified as opportunities to improve the reliability of CCs. The study used bowtie diagrams with real event data to find the actual CC reliability. This appears to be the first published study that reports on the reliability of critical risk controls in construction. It demonstrates a feasible method for determining and communicating control effectiveness that can be used to deliver meaningful insights to industry practitioners on actual control performance and focus areas for improvement. In addition, actionable findings directly related to individual CCs can be derived that enable the participating organization to focus resources on improving specific verification processes. The results confirm the applicability of CCs for the Major Accident Event hazards analyzed and highlights that further reviews are required on the factors that need to be considered when implementing a CC program. This paper details our methodology and results, to assist others applying CCs as a risk management tool

Medical devices with embedded electronics: design and development methodology for start-ups

358 p.El sector de la biotecnología demanda innovación constante para hacer frente a los retos del sector sanitario. Hechos como la reciente pandemia COVID-19, el envejecimiento de la población, el aumento de las tasas de dependencia o la necesidad de promover la asistencia sanitaria personalizada tanto en entorno hospitalario como domiciliario, ponen de manifiesto la necesidad de desarrollar dispositivos médicos de monitorización y diagnostico cada vez más sofisticados, fiables y conectados de forma rápida y eficaz. En este escenario, los sistemas embebidos se han convertido en tecnología clave para el diseño de soluciones innovadoras de bajo coste y de forma rápida. Conscientes de la oportunidad que existe en el sector, cada vez son más las denominadas "biotech start-ups" las que se embarcan en el negocio de los dispositivos médicos. Pese a tener grandes ideas y soluciones técnicas, muchas terminan fracasando por desconocimiento del sector sanitario y de los requisitos regulatorios que se deben cumplir. La gran cantidad de requisitos técnicos y regulatorios hace que sea necesario disponer de una metodología procedimental para ejecutar dichos desarrollos. Por ello, esta tesis define y valida una metodología para el diseño y desarrollo de dispositivos médicos embebidos

Towards safer medical device software systems: Industry-wide learning from failures and the use of safety-cases to support process compliance

© 2016 IEEE. Software safety is checked today in regulatory audits, which verify software development process compliance to regulatory requirements. Ensuring safety is a critical task in complex life-supporting systems and despite many existing ways of assuring it, unanticipated failure will always be possible. Checking process compliance to required standards ensures the quality of the processes by which software is developed but does not necessarily indicate the quality of the resultant software. Since medical device domain is facing an increasing amount of device recalls due to software failures, our goal is to explore the underlying reasons for this and suggest two improvements within this paper. First, we will introduce complicated and complex systems to illustrate why there will always be unforeseeable and unanticipated situations that could cause the failure of the entire system. We will then describe how medical device software systems are reviewed for compliance and safety today, highlighting the shortcomings in the current methods adopted in the medical device domain and suggest the use of systems thinking. We then propose two improvements to medical device software development where process compliance is supported by safety cases and industry-wide learning from experience