The Sync-Up Process to Improve the Multiple Stakeholder Communication of Requirements Analysis in Embedded Medical Software Development

The development of embedded medical software is different from ordinary software development as it needs to be coordinated with the hardware development. A typical embedded system project involves multiple stakeholders such as the business unit, software developers, hardware engineers and firmware developers. Agile methods have been successfully adopted in generic software engineering, and more recently in embedded medical software development. In this research, a systematic review has been performed to identify the challenges of embedded medical and safety-critical software development domains. From the challenges identified, this research focuses on the challenge of multiple stakeholder communication in embedded medical software development. Additionally, agile practices which have been successfully adopted in the embedded safety-critical domains have been investigated. This thesis describes the development and evaluation of a process (Sync-Up) to improve multiple stakeholder communication for embedded medical software development during requirement analysis. Through this research, the following contribution to knowledge has been made in the area of embedded medical domain. The development of the Sync-Up process to assist multiple stakeholder communication of embedded medical software development. The Sync-Up process is evaluated through both expert review by leading experts, and a case study conducted in an embedded company. Findings from the evaluations undertaken show a positive outcome during the requirement analysis phase of the Sync-Up process

Investigating the Suitability of Using Agile for Medical Embedded Software Development

Agile has been the subject of safety and critical domain in recent years. Emerging medical devices are highly relying on embedded software that runs on the specific platform in real time. The development of embedded software is different from ordinary software development due to the hardware-software dependency. Previous literature reviews discussed the challenges of bringing Agile practices to embedded software developments in general. This paper outlines the challenges and addresses the future work from medical embedded software development perspective

Supporting Embedded Medical Software Development with MDevSPICE® and Agile Practices

Emerging medical devices are highly relying on embedded software that runs on the specific platform in real time. The development of embedded software is different from ordinary software development due to the hardware-software dependency. MDevSPICE® has been developed to provide guidance to support such development. To increase the flexibility of this framework agile practices have been introduced. This paper outlines the challenges for embedded medical device software development and the structure of MDevSPICE® and suggests a suitable combination of agile practices that will help to add flexibility and address corresponding challenges of embedded medical device software development