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

Characteristics of a medical device software development framework

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

A Cynefin based approach to process model tailoring and goal alignment

In an industrial context 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. Process models should therefore be accompanied by tailoring guidelines and approaches to assist with strategic and operational goal alignment that support their use in industry. This paper explores shortcomings of process improvement and the existing process models, suggesting that a more holistic approach should be taken to process improvement in the modern organization. The paper provides an overview of systems thinking and the Cynefin framework that organizations can use to detect the characteristics of the domain in which they are operate. Knowing their domain helps the organization realize the amount of tailoring and goal alignment necessary to benefit from implementing process model guidance

Assessing against IEC 80001-1

Medical devices are designed and produced subject to various standards. These standards are recognized by the regulatory authorities within the region in which they are going to be marketed. Traditionally medical devices were placed on a proprietary network; however emergent technology is increasingly seeing medical devices being included on to the general hospital IT network. The incorporation of a medical device into an IT network can introduce risks which can impact the safety, effectiveness & security of the medical device. 80001-1: Application of Risk Management for IT networks incorporating Medical Devices addresses the risk that healthcare can be compromised when a medical device is incorporated into an IT network. In order to address these risks, an assessment of the network against IEC 80001-1 must be performed. To perform an assessment which is compliant with ISO/IEC 15504-2 of an IT network against IEC 80001-1, a process assessment model is required. This paper examines how a process assessment model could be developed to assess against IEC 80001-1

Development of a process assessment model for assessing medical IT networks against IEC 80001-1

Increasingly medical devices are being designed to allow them to exchange information over an IT network. However incorporating a medical device into an IT network can introduce risks which can impact the safety, effectiveness and security of the medical device. Medical devices are stringently tested according to regulation during the design and manufacture process. However until the introduction of IEC 80001-1: Application of Risk Management for IT-Networks incorporating Medical Devices, no standard addressed the risks of incorporating a medical device into an IT network. In order to perform an assessment (which is compliant with ISO/IEC 15504-2) of an IT network against IEC 80001-1, a Process Assessment Model is required. Based on the relationship between IEC 80001-1 and ISO/IEC 20000-1, this paper examines how the TIPA transformation process developed by Public Research Centre Henri Tudor was used to develop a process assessment model (TIPA PAM) for ISO/IEC 20000-1. It also examines how a process assessment model can be developed following that transformation process to assess Medical IT networks against IEC 80001-1