Software and systems traceability for safety-critical projects: report from Dagstuhl Seminar 15162

This report documents the program and the outcomes of Dagstuhl Seminar 15162 on “Software and Systems Traceability for Safety-Critical Projects”. The event brought together researchers and industrial practitioners working in the field of safety critical software to explore the needs, challenges, and solutions for Software and Systems Traceability in this domain. The goal was to explore the gap between the traceability prescribed by guidelines and that delivered by manufacturers, and starting from a clean slate, to clearly articulate traceability needs for safety-critical software systems, to identify challenges, explore solutions, and to propose a set of principles and domain-specific exemplars for achieving traceability in safety critical systems

Medical device software as a subsystem of an overall medical device

Embedded software is a sub-system that needs to be integrated with the electrical and mechanical subsystems for a functional medical device to be developed and marketed. In order to be able to develop a medical device system through integrating its sub-systems, the complete system requirements should be known at the start of the project and managed throughout development. Software requirements are then derived from the systems requirements. We have developed and piloted a medical device software process assessment framework called MDevSPICE® that integrates processes from various medical device software standards as well as generic software development standards. This paper describes how the MDevSPICE® framework has been designed so as to enable medical device software developers to produce software that will be safe and easily integrated with other sub-systems of the overall medical device. We also describe the lessons learned from piloting MDevSPICE® in the medical device industry and challenges medical device software developers meet in tracing requirements and risks to and from the system level

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

Integrating Agile Practices with a Medical Device SDLC.

The rate at which agile software development practices are being adopted is growing rapidly. Agile software development practices and methodologies appear to offer the silver bullet which can solve the problems associated with following plan driven software development lifecycles. Agile software development practices offer the possibility of achieving lower development costs, increased efficiency and improved software quality. However, there is currently a low rate of publicly available information that suggests there is widespread adoption of agile practices within the medical device software domain. This is largely due to the fact that software developed for medical devices includes challenges not faced when developing non safety critical software. As a result of these challenges, medical device software is typically developed using plan driven software development lifecycles. However, such lifecycles are quite rigid and cannot accommodate changes easily. Previous research has revealed that medical device software development projects can benefit from adopting agile practices whilst still maintaining the discipline associated with following plan driven development lifecycles. This paper outlines the challenges faced by developers when developing medical device software and how shortcomings in both agile and plan driven approaches can be resolved by following a mixed method approach to medical device software developmen

What have we learnt from the challenges of (semi-) automated requirements traceability? A discussion on blockchain applicability.

Over the last 3 decades, researchers have attempted to shed light into the requirements traceability problem by introducing tracing tools, techniques, and methods with the vision of achieving ubiquitous traceability. Despite the technological advances, requirements traceability remains problematic for researchers and practitioners. This study aims to identify and investigate the main challenges in implementing (semi-)automated requirements traceability, as reported in the recent literature. A systematic literature review was carried out based on the guidelines for systematic literature reviews in software engineering, proposed by Kitchenham. We retrieved 4530 studies by searching five major bibliographic databases and selected 70 primary studies. These studies were analysed and classified according to the challenges they present and/or address. Twenty-one challenges were identified and were classified into five categories. Findings reveal that the most frequent challenges are technological challenges, in particular, low accuracy of traceability recovery methods. Findings also suggest that future research efforts should be devoted to the human facet of tracing, to explore traceability practices in organisational settings, and to develop traceability approaches that support agile and DevOps practices. Finally, it is recommended that researchers leverage blockchain technology as a suitable technical solution to ensure the trustworthiness of traceability information in interorganisational software projects.publishedVersio

An Agile V-Model for Medical Device Software Development to Overcome the Challenges with Plan Driven SDLCs

Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software