A lightweight assessment method for medical device software processes

This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed

Improving Safety in Medical Devices from Concept to Retirements

As with many domains the use of software within the healthcare industry is on the rise [1, 2] within the last 20 years

How Can Software SMEs Become Medical Device

The amount of software content within medical devices has grown considerably over recent years and will continue to do so as the level of complexity of medical devices increase. This is driven by the fact that software is introduced to produce sophisticated medical devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become medical device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a medical device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transitio

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

Automotive Systems Engineering und Functional Safety: The Way Forward

International audienceThe increasing of complexity of safety relevant functions, as well as their implementation on distributed components is one of the major issues in automotive engineering. The situation is additionally tightened by challenges arising from the introduction of ISO26262 standard. It is discussed how a model based systems engineering approach enables the integration of the safety activities into the development process to deal with growing complexity and to improve efficiency as well. Finally the extension of the product line engineering approach to work products of safety activities can lead to the step change required to match the capabilities of engineering departments to the complexities of the task at hand

Proceedings of the 1st international workshop on software process education, training and professionalism (SPETP 2015)

These Proceedings contain the papers accepted for publication and presentation at the first 1st International Workshop on Software Process Education, Training and Professionalism (SPETP 2015) held in conjunction with the 15th International Conference on Software Process Improvement and Capability dEtermination (SPICE 2015), Gothenburg, Sweden, during June 15-17, 2015. During the 14th International Conference on Software Process Improvement and Capability dEtermination (SPICE 2014) held in Vilnius, Lithuania, at a post conference dinner, a group of key individuals from education and industry started to discuss the challenges faced for software process education, training and professionalism, especially with the background of the new modes of learning and teaching in higher education. Further discussions held post conference with key players in the relevant professional and personal certification fields led to a consensus that it is time for the industry to rise to the new challenges and set out in a manifesto a common vision for educators and trainers together with a set of recommendations to address the challenges faced. It was therefore agreed co-located the 1st International Workshop on Software Process Education, Training and Professionalism with the 15th International Conference on Software Process Improvement and Capability dEtermination. This workshop focused on the new challenges for and best practices in software process education, training and professionalism. The foundation for learning of software process should be part of a university or college education however software process is often treated as ‘add one’ module to the core curriculum. In a professional context, whilst there have been a number of initiatives focused on the certification related to the software process professional these have had little success for numerous reasons. Cooperation in education between industry, academia and professional bodies is paramount, together with the recognition of how the education world is changing and how education is resourced, delivered (with online and open learning) and taken up. Over the next 10 years on-line learning is projected to grow fifteen fold, accounting for 30% of all education provision, according to the recent report to the European Commission on New modes of learning and teaching in higher education. It is a great pleasure to see the varied contributions to this 1st International Workshop on Software Process Education, Training and Professionalism and we hope that our joint dedication, passion and innovation will lead to success for the profession through the publication of the manifesto as a key outcome from the workshop. On behalf of the SPETP 2015 conference Organizing Committee, we would like to thank all participants. Firstly all the authors, whose quality work is the essence of the conference, and the members of the Program Committee, who helped us with their expertise and diligence in reviewing all of the submissions. As we all know, organizing a conference requires the effort of many individuals. We wish to thank also all the members of our Organizing Committee, whose work and commitment were invaluable

A Management Maturity Model (MMM) for project-based organisational performance assessment

Common sense suggests that organisations are more likely to deliver successful projects if they have systems in place that reflect a mature project environment based on a culture of continuous improvement. This paper develops and discusses a Management Maturity Model (MMM) to assess the maturity of project management organisations through a customisable, systematic, strategic and practical methodology inspired from the seminal work of Darwin, Deming, Drucker and Daniel. The model presented is relevant to organisations, such as construction and engineering companies, that prefer to use the Project Management Body of Knowledge (PMBOK™ Guide) published by the Project Management Institute (PMI), but without the disadvantages of excessive time and cost commitments and a ‘one size fits all’ approach linked to rigid increments of maturity. It offers a game-changing advance in the application of project-based organisational performance assessment compared to existing market solutions that are unnecessarily complex. The feasibility of MMM is field-tested using a medium-sized data centre infrastructure firm in Tehran