Integrating Agile Practices with Plan-Driven Medical Device Software Development

The popularity of Agile software development is growing rapidly with an increasing number of projects being developed following Agile methodologies such as Scrum and XP [1]. Research has revealed that following Agile practices when developing software can have a significantly positive impact in reducing development time, reducing cost and increasing overall quality [2-4]. Whilst Agile practices can have a positive impact on a development project there are incompatibilities between Agile methodologies and the plan driven approaches followed when developing safety critical software [5, 6]. However, it has been recognised that “formal techniques may be used in an agile way” [5]. Case studies have been performed in organisations developing safety critical software which validate this statement [7-9]. This Ph.D. is focusing on the area of medical device software development and integrating Agile software development principles into traditional plan driven lifecycles for use in developing medical device software

A safety-centric change management framework by tailoring agile and V-Model processes

Safety critical systems are evolutionary and subject to preventive, perfective, corrective or adaptive changes during their lifecycle. Changes to any part of those systems can undermine the confidence in safety since changes can refute articulated claims about safety or challenge the supporting evidence on which this confidence relies. Changes to the software components are no exception. In order to maintain the confidence in the safety performance, developers must update their system and its safety case. Agile methodologies are known to embrace changes to software where agilists strive to manage changes, not to prevent them. In this paper, we introduce a novel framework in which we tailor a hybrid process of agile software development and the traditional V-model. The tailored process aims to facilitate the accommodation of non-structural changes to the software parts of safety critical systems. We illustrate our framework in the context of ISO 26262 safety standard

Remote and agile improvement of industrial control and safety systems processes

Digitalization and remote operations introduce new possibilities for continuous and agile improvements of products in operation by exploiting inherent possibilities in software which is easily changeable and deployable. This approach is driven by data analysis, customer expectations and the possibility of frequent deployment over the air of improved software. Adding functionality into software, combined with connectivity to products, opens possibilities for manufacturers and operators, enabling new features and new operational models. This has also become relevant for regulated environments like industrial control and safety systems used in critical infrastructures. Adapted agile processes like SafeScrum and DevOps may be used to achieve continuous improvement. They enable speed and a continuum between development, maintenance and operation. For instance, experience and data from operation on new cybersecurity threats, must be fed back to the maintenance process to be resolved fast. Hence, the DevOps concept, which is imperative in non-safety domains, is now highly relevant in regulated environments as well. The speed of this process is vital where in particular cybersecurity threats must be resolved fast to avoid safety threats. The Agile Safety Case is an enabler of ensuring structured proof of compliance of safety performance for the involved stakeholders. This paper proposes a solution for a safety case which may be applied for continuous product improvements during operation considering safety as well as security. The solution involves the relevant stakeholders and results in a shift in responsibilities.publishedVersio

Requirements Engineering that Balances Agility of Teams and System-level Information Needs at Scale

Context: Motivated by their success in software development, large-scale systems development companies are increasingly adopting agile methods and their practices. Such companies need to accommodate different development cycles of hardware and software and are usually subject to regulation and safety concerns. Also, for such companies, requirements engineering is an essential activity that involves upfront and detailed analysis which can be at odds with agile development methods. Objective: The overall aim of this thesis is to investigate the challenges and solution candidates of performing effective requirements engineering in an agile environment, based on empirical evidence. Illustrated with studies on safety and system-level information needs, we explore RE challenges and solutions in large-scale agile development, both in general and from the teams’ perspectives. Method: To meet our aim, we performed a secondary study and a series of empirical studies based on case studies. We collected qualitative data using interviews, focus groups and workshops to derive challenges and potential solutions from industry. Findings: Our findings show that there are numerous challenges of conducting requirements engineering in agile development especially where systems development is concerned. The challenges discovered sprout from an integration problem of working with agile methods while relying on established plan-driven processes for the overall system. We highlight the communication challenge of crossing the boundary of agile methods and system-level (or plan-driven) development, which also proves the coexistence of both methods. Conclusions: Our results highlight the painful areas of requirements engineering in agile development and propose solutions that can be explored further. This thesis contributes to future research, by establishing a holistic map of challenges and candidate solutions that can be further developed to make RE more efficient within agile environments

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

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

Rethinking Security Incident Response: The Integration of Agile Principles

In today's globally networked environment, information security incidents can inflict staggering financial losses on organizations. Industry reports indicate that fundamental problems exist with the application of current linear plan-driven security incident response approaches being applied in many organizations. Researchers argue that traditional approaches value containment and eradication over incident learning. While previous security incident response research focused on best practice development, linear plan-driven approaches and the technical aspects of security incident response, very little research investigates the integration of agile principles and practices into the security incident response process. This paper proposes that the integration of disciplined agile principles and practices into the security incident response process is a practical solution to strengthening an organization's security incident response posture.Comment: Paper presented at the 20th Americas Conference on Information Systems (AMCIS 2014), Savannah, Georgi

Addressing the Quality and Safety Gap Part I: Case Studies in Transforming Hospital Nursing and Building Cultures of Safety

Presents case studies of strategies four healthcare systems and a state government are using to address underlying causes in flawed systems: strengthening care processes, optimizing staffing, and promoting safe work habits. Lists policy recommendations

Boundary Objects and their Use in Agile Systems Engineering

Agile methods are increasingly introduced in automotive companies in the attempt to become more efficient and flexible in the system development. The adoption of agile practices influences communication between stakeholders, but also makes companies rethink the management of artifacts and documentation like requirements, safety compliance documents, and architecture models. Practitioners aim to reduce irrelevant documentation, but face a lack of guidance to determine what artifacts are needed and how they should be managed. This paper presents artifacts, challenges, guidelines, and practices for the continuous management of systems engineering artifacts in automotive based on a theoretical and empirical understanding of the topic. In collaboration with 53 practitioners from six automotive companies, we conducted a design-science study involving interviews, a questionnaire, focus groups, and practical data analysis of a systems engineering tool. The guidelines suggest the distinction between artifacts that are shared among different actors in a company (boundary objects) and those that are used within a team (locally relevant artifacts). We propose an analysis approach to identify boundary objects and three practices to manage systems engineering artifacts in industry