Exploring the use of the Cynefin Framework to inform software development approach decisions

Choosing an appropriate software development process is a complex and challenging task, exacerbated by the fact that all process models require a certain amount of tailoring to fit to the business environment of any specific organization in which the model is to be deployed. This position paper proposes that one of the potentially most significant factors impacting how a team should structure their software development process is domain (contexts defined by the nature of the relationship between cause and effect) the team is in, an approach pioneered by Snowden with The Cynefin Framework. Cynefin (pronounced Ku-nev-in) is a decision framework that recognizes the causal differences that exist between different types of systems and proposes new approaches to decision making in complex social environments and new mechanisms of understanding levels of complexity as decisions are made. It is argued that using the Cynefin framework for classifying important software process selection decisions assists in choosing the right process for the given situational context. This position paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the significant characteristics of the domain in which they operate which has a direct and significant affect on the software process approach (model / methodology) chosen

Piloting MDevSPICE: the medical device software process assessment framework

Software development companies moving into the medical device domain often find themselves overwhelmed by the number of regulatory requirements they need to satisfy before they can market their device. Several international standards and guidance documents have been developed to help companies on their road to regulatory compliance but working their way through the various standards is a challenge in itself. In order to help software companies in the medical device domain, we have developed an integrated framework of medical device software development best practices called MDevSPICE®. This framework integrates generic software development best practices with medical device standards’ requirements enabling consistent and thorough assessment of medical device processes. MDevSPICE® can be used by software companies evaluating their readiness for regulatory audits as well as by large medical device manufacturers for selecting suitable software suppliers. The MDevSPICE® framework consists of a process reference model, a process assessment model, an assessment method, and training and certification schemes. The framework has been validated using expert reviews and through MDevSPICE® assessments in industry. In this paper, we describe the MDevSPICE® process assessment framework focusing on its benefits and significance for the medical device manufacturing community as learned from MDevSPICE® assessments conducted to date

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

Characteristics of medical device software development

This paper aims to describe the software development settings of medical device domain focusing on the demands of the safety critical software processes. Medical device software developers have to adhere to a number of regulations and standards. This paper addresses the most important characteristics of a software development framework that could support medical device software developers in their efforts to comply with these regulations as well as to improve their software development processes

MDevSPICE - A comprehensive solution for manufacturers and assessors of safety-critical medical device software

Software development is frequently challenged with quality concerns. One of the primary reasons for such issues is the very nature of the software development process. First, it can be difficult to accurately and completely identify the requirements for a software development product. Also, the implementation on various platforms and the need to integrate with sometimes unforeseeable additional systems adds complexity. For safety critical domains, such as the medical device and healthcare sectors, these hurdles are amplified. Whereas a failure in a desktop application may be resolved through a restart with no harm incurred, a failure in a medical device can have life threatening consequences. Our work in the Regulated Software Research Centre (RSRC) aims to support medical device producers in the production of safer medical device software. In this paper, we describe the MDevSPICE framework and how it addresses the safety concerns faced by medical device producers

Safety critical software process assessment: how MDevSPICE® addresses the challenge of integrating compliance and capability

One of the primary outcomes of a software process assessment is visibility of the capability of a software process which among other things, informs us of the ability of a process to deliver consistent product quality levels. In safety critical domains, such as the medical device sector, high product quality – and particularly high product safety - is an important consideration. To address this safety concern, the medical device sector traditionally employs audits to determine compliance to software process standards and guidance. Unlike an audit which results in a pass/fail outcome, an assessment provides a process capability profile which identifies areas for improvement and enables a comparison with broader best practice. MDevSPICE® integrates the various medical device software standards and guidance within the infrastructure of a SPICE assessment model, thus encompassing aspects of compliance and capability. This paper describes some of the key enablers of this integration

Harnessing software development contexts to inform software process selection decisions

Software development is a complex process for which numerous approaches have been suggested. However, no single approach to software development has been met with universal acceptance, which is not surprising, as there are many different software development concerns. In addition, there are a multitude of other contextual factors that influence the choice of software development process and process management decisions. The authors believe it is important to develop a robust mechanism for relating software process decisions and software development contexts. Such an approach supports industry practitioners in their efforts to implement the software development processes vital for a particular set of contextual factors. In this paper, the authors outline a new tool-based framework for relating the complexity of software settings with the various aspects of software processes. This framework can extract the key software process concepts from process repositories, for example, from CMMI-DEV or ISO/IEC 15504-5 (a.k.a. SPICE – Software Process Improvement and Capability dEtermination). A team of software development experts then collaborates in order to identify and validate the strength and nature of the relationship between the key process concepts and the contextual factors that are known to affect the software development process. The result of this collaboration is a prototype of a flexible model, which can be extended over time into a broader process consideration, for example, where agile processes or further specific situational factors could be added to the framework. The authors contend that a model such as the one proposed in this paper can serve as a valuable tool, assisting software developers in making decisions regarding the selection of software best practices, as well as providing general guidance for process improvement initiatives

Evaluation of Basic Project Management Activities - Study in Software Industry

In this research the relevance of the guidance of software process models to industry is studied - more precisely, how relevant the basic project management activities are to the industry projects and to the success of these projects.To attain the research aim, a model of basic project management activities was constructed where model elements were derived mostly from the CMMI and ISO/IEC IS 15504, and the relevant ones from various project management literature sources. The model was then provided with metrics and evaluated against the industry data. The data was gathered using a survey questionnaire from 29 software project managers from Finland and Estonia who described the project management activities implemented in the projects they managed.The model was evaluated by triangulating the data three data analysis methods were used. We looked for the relationship between the implementation of the basic project management activities and the project success. Also, we aimed to find whether the characteristics of the project, the project manager and the company affect the intensity with which the basic project management activities are implemented in the industry projects.The findings of the research suggest that the organizations improving their processes with the help of process models may not experience much benefit to their improvement work at the beginning, i.e. not until the processes reach higher capability levels than level 2. The results also indicate that successful software process improvement relies heavily on human factors, skills and teamwork competencies. A project manager has to motivate the team members, coordinate their interactions and supervise them when necessary to create a positive environment for the software development that supports the overall project success

Measuring IT service quality: evaluation of IT service quality measurement framework in industry

IT service quality is determined by the value that the IT service brings to both the IT service provider and its customers, but service value is not measured in most IT service organizations today. We describe the fourth iteration of our IT service quality measurement framework and report on the evaluation of the framework in the Australian IT service industry. The data was gathered from 63 IT service providers through an online survey. The paper focuses on the application of the proposed IT service quality measurement framework in industry as well as the importance and feasibility of measuring and interlinking various IT service quality aspects. An important finding is that although the majority of respondents recognize the importance of IT service value, very few providers actually measure the value of their IT services. The findings also support the importance of taking a systemic approach to IT service measurement. It is clear that various service areas are inter-linked: IT service stability impacts on customer satisfaction, and process performance affects IT service stability. With the exception of three indicators, all the proposed indicators and measures were applied in the surveyed IT service organizations. Further efforts to confirm these findings will be undertaken within the global IT service industry