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

Quality assurance in agile safety-critical systems development

© 2016 IEEE. In this position paper we examine how safety could be assured when increasingly complex systems are developed using agile software development methods. We first discuss the source and nature of complexity in software systems and how a probe - sense - learn approach recommended by the Cynefin Framework is appropriate for designing complex systems and a sense - analyse - learn approach is appropriate for developing a complicated system whose design has been determined. We then examine how quality assurance is incorporated into agile software development before pointing out that those characteristics of a self-managed team that produce so many benefits for software development of complex systems whose solution evolves with problem understanding, are also vulnerable to confirmation bias. This suggests that for safety critical system development, software systems developed by agile teams will need verification and validation by independent parties. We review current quality management practices for medical device software development before discussing how our earlier findings could be adopted into safety critical software quality management

Object-oriented Tools for Distributed Computing

Distributed computing systems are proliferating, owing to the availability of powerful, affordable microcomputers and inexpensive communication networks. A critical problem in developing such systems is getting application programs to interact with one another across a computer network. Remote interprogram connectivity is particularly challenging across heterogeneous environments, where applications run on different kinds of computers and operating systems. NetWorks! (trademark) is an innovative software product that provides an object-oriented messaging solution to these problems. This paper describes the design and functionality of NetWorks! and illustrates how it is being used to build complex distributed applications for NASA and in the commercial sector

Conceptual basis for developing of trainig models in complex system software assembling generator

This paper presents conceptual basis for developing of training models of interactive assembling system for automatic building of application software systems, obtained during practical works over "Design and architecture of software systems" and "Object-oriented analysis and design" courses. The system is intended for practical demonstration of basic stages and operations in development of complex and critical software. This also includes a consideration of solutions for some substantial problems of complex systems software generation, such as: program module compatibility, formalization of computer interaction and choosing of formal model for human machine interface. In addition, several training model implementations are provided.Keywords: software generator, training models, interactive system

FAILSAFE Health Management for Embedded Systems

The FAILSAFE project is developing concepts and prototype implementations for software health management in mission- critical, real-time embedded systems. The project unites features of the industry-standard ARINC 653 Avionics Application Software Standard Interface and JPL s Mission Data System (MDS) technology (see figure). The ARINC 653 standard establishes requirements for the services provided by partitioned, real-time operating systems. The MDS technology provides a state analysis method, canonical architecture, and software framework that facilitates the design and implementation of software-intensive complex systems. The MDS technology has been used to provide the health management function for an ARINC 653 application implementation. In particular, the focus is on showing how this combination enables reasoning about, and recovering from, application software problems

The Topology ToolKit

This system paper presents the Topology ToolKit (TTK), a software platform designed for topological data analysis in scientific visualization. TTK provides a unified, generic, efficient, and robust implementation of key algorithms for the topological analysis of scalar data, including: critical points, integral lines, persistence diagrams, persistence curves, merge trees, contour trees, Morse-Smale complexes, fiber surfaces, continuous scatterplots, Jacobi sets, Reeb spaces, and more. TTK is easily accessible to end users due to a tight integration with ParaView. It is also easily accessible to developers through a variety of bindings (Python, VTK/C++) for fast prototyping or through direct, dependence-free, C++, to ease integration into pre-existing complex systems. While developing TTK, we faced several algorithmic and software engineering challenges, which we document in this paper. In particular, we present an algorithm for the construction of a discrete gradient that complies to the critical points extracted in the piecewise-linear setting. This algorithm guarantees a combinatorial consistency across the topological abstractions supported by TTK, and importantly, a unified implementation of topological data simplification for multi-scale exploration and analysis. We also present a cached triangulation data structure, that supports time efficient and generic traversals, which self-adjusts its memory usage on demand for input simplicial meshes and which implicitly emulates a triangulation for regular grids with no memory overhead. Finally, we describe an original software architecture, which guarantees memory efficient and direct accesses to TTK features, while still allowing for researchers powerful and easy bindings and extensions. TTK is open source (BSD license) and its code, online documentation and video tutorials are available on TTK's website

Teaching computational thinking to space science students

Computational thinking is a key skill for space science graduates, who must apply advanced problem-solving skills to model complex systems, analyse big data sets, and develop control software for mission-critical space systems. We describe our work using Design Thinking to understand the challenges that students face in learning these skills. In the MSc Space Science & Technology at University College Dublin, we have used insights from this process to develop new teaching strategies, including improved assessment rubrics, supported by workshops promoting collaborative programming techniques. We argue that postgraduate- level space science courses play a valuable role in developing more advanced computational skills in early-career space scientists

A theory-grounded framework of Open Source Software adoption in SMEs

This is a post-peer-review, pre-copyedit version of an article published in European Journal of Information Systems. The definitive publisher-authenticated version Macredie, RD and Mijinyawa, K (2011), "A theory-grounded framework of Open Source Software adoption in SMEs", European Journal of Informations Systems, 20(2), 237-250 is available online at: http://www.palgrave-journals.com/ejis/journal/v20/n2/abs/ejis201060a.html.The increasing popularity and use of Open Source Software (OSS) has led to significant interest from research communities and enterprise practitioners, notably in the small business sector where this type of software offers particular benefits given the financial and human capital constraints faced. However, there has been little focus on developing valid frameworks that enable critical evaluation and common understanding of factors influencing OSS adoption. This paper seeks to address this shortcoming by presenting a theory-grounded framework for exploring these factors and explaining their influence on OSS adoption, with the context of study being small- to medium-sized Information Technology (IT) businesses in the U.K. The framework has implications for this type of business – and, we will suggest, more widely – as a frame of reference for understanding, and as tool for evaluating benefits and challenges in, OSS adoption. It also offers researchers a structured way of investigating adoption issues and a base from which to develop models of OSS adoption. The study reported in this paper used the Decomposed Theory of Planned Behaviour (DTPB) as a basis for the research propositions, with the aim of: (i) developing a framework of empirical factors that influence OSS adoption; and (ii) appraising it through case study evaluation with 10 U.K. Small- to medium-sized enterprises in the IT sector. The demonstration of the capabilities of the framework suggests that it is able to provide a reliable explanation of the complex and subjective factors that influence attitudes, subjective norms and control over the use of OSS. The paper further argues that the DTPB proved useful in this research area and that it can provide a variety of situation-specific insights related to factors that influence the adoption of OSS