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

Political reactions in the Glasgow constituencies at the General Elections of 1885-1886

No abstract available

A software process improvement lifecycle framework for the medical device industry

This paper describes a software process improvement framework to ensure regulatory compliance for the software developed in medical devices. Software is becoming an increasingly important aspect of medical devices and medical device regulation. Medical devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) [1] (US requirement), and the European Commission under its Medical Device Directives (MDD) [2] (CE marking requirement) is achieved. Integrated into the design process of medical devices, is the requirement of the production and maintenance of a device technical file, incorporating a design history file. Design history illustrates the well documented, defined and controlled processes and outputs, undertaken in the development of medical devices and for our particular consideration with this framework - the software components

Hybrid Software Development Approaches in Practice: A European Perspective

Agile and traditional development approaches are used in combination in todays software development. To improve the understanding and to provide better guidance for selecting appropriate development approaches, it is important to analyze such combinations in practice. Results obtained from an online survey strongly confirm that hybrid development approaches are widely used in industry. Our results show that hybrid development approaches: (i) have become reality for nearly all companies; (ii) are applied to specific projects even in the presence of company-wide policies for process usage; (iii) are neither planned nor designed but emerge from the evolution of different work practices; and, (iv) are consistently used regardless of company size or industry secto

Recognizing and integrating wildlife as Elwha restoration agents

Ecosystem restoration involving large dam removal spans large spatial extents, long time scales, and diverse societal constituencies. Restoration success requires collaboration among partner organizations. Success also can be facilitated by integrating components and processes of the ecosystem itself in restoration planning and practice. We review early and future roles of wildlife in restoration of valleys flooded by Elwha dams, with implications for dam removals on other rivers. Detecting early wildlife responses depended on baseline inventories prior to dam removal, followed by monitoring during and after dam removal. Pre-removal studies revealed patterns of small and mid-sized mammal occupancy, bear movement, amphibian occupancy, and avian distributions and species composition. In the few years since dam removal, wildlife colonization of exposed reservoir beds has been rapid, dominated by early successional and mobile species. Wildlife also perform important restoration functions, and contribute to all nine attributes defining restored ecosystems. This early in Elwha restoration, conspicuous wildlife functions include native seed dispersal to restoration sites, herbivore effects on revegetation, and organic matter dispersal to nutrient-poor sediments. In future decades, diverse wildlife also will help restore terrestrial-aquatic connections by dispersing nutrients from increasing salmon runs to riparian and terrestrial areas. Each of these wildlife roles is influenced by spatial distributions of pre-dam structural legacies and structures placed during active restoration efforts, particularly large woody debris. By placing these structures in locations and configurations that support wildlife functions, restoration planning and practice more effectively integrate wildlife in restoration. Benefits include increasing the rate of restoration progress and directing it along more desirable trajectories. In this way, the collaborative interdisciplinary approach in Elwha restoration can be expanded in future restoration projects to encompass active collaboration with the ecosystem itself

Catching up with Method and Process Practice: An Industry-Informed Baseline for Researchers

Software development methods are usually not applied by the book.companies are under pressure to continuously deploy software products that meet market needs and stakeholders\u27 requests. To implement efficient and effective development processes, companies utilize multiple frameworks, methods and practices, and combine these into hybrid methods. A common combination contains a rich management framework to organize and steer projects complemented with a number of smaller practices providing the development teams with tools to complete their tasks. In this paper, based on 732 data points collected through an international survey, we study the software development process use in practice. Our results show that 76.8% of the companies implement hybrid methods.company size as well as the strategy in devising and evolving hybrid methods affect the suitability of the chosen process to reach company or project goals. Our findings show that companies that combine planned improvement programs with process evolution can increase their process\u27 suitability by up to 5%

Anti-Mullerian hormone (AMH) test information on Australian and New Zealand fertility clinic websites : A content analysis

Funding: This project was supported by a National Health and Medical Research Council (NHMRC) Program grant (APP1113532Peer reviewedPublisher PD

A test for common genetic and environmental vulnerability to depression and diabetes

Molecular genetic research has provided some evidence for the association between depression and metabolic disorders. We sought to determine if molecular findings are reflected in twin analyses testing if common genetic and environmental risk factors contribute to the co-occurrence of diabetes and depression. Data to derive depression and diabetes were collected from 1,237 male-male twins who participated in the 2005 Vietnam Era Twin Study of Aging (VETSA). The 1,237 twins were comprised of 347 MZ pairs, 3 MZ singletons, 267 DZ pairs and 6 unpaired twins. Depression was defined as a score below 46 on the Short Form-36 mental component summary score. Diabetes was defined by self report, use of anti-diabetic medications and insulin. Twin models were fit to estimate the correlation of genetic and environmental contributions to depression and diabetes. Consistent with other studies these data support the association between depression and diabetes (OR = 1.7; 95%CI: 1.1–2.7). Genetic vulnerability accounted for 50% (95%CI: 32%–65%) of the variance in risk for depression and 69% (95%CI: 52%–81%) of the variance in risk for diabetes. The genetic correlation between depression and diabetes was r = 0.19 (95%CI: 0–0.46) and the non-shared environmental correlation was r = 0.09 (95% CI: 0–0.45). Overall there is little evidence that common genetic and environmental factors account for the co-occurrence of depression and diabetes in middle aged men. Further research in female twins and larger cohorts is warranted