Developing an Agile-Based Model for Addressing Defects in Medical Device Software Development

Nyirenda, Misheck (0020) Developing an Agile-Based Model for Addressing Defects in Medical Device Software Development. Doctoral thesis, Dundalk Institute of Technology.

PDF Download (5MB)

Abstract

Medical Device Software (MDS) plays an important role in modern healthcare by enabling complex tasks that would otherwise be impossible to perform. However, defects in MDS result in patient injuries, deaths, and recalls of numerous medical devices. These incidents ultimately lead to reputational damage and financial losses for MDS organisations. This research focuses on addressing defects in MDS to avoid these costly incidents. In software development projects, defects can be addressed through prevention in the early stages of the development lifecycle and identification in later stages. While prevention reduces the risk of defects in later stages and the final release, it is often overlooked or inadequately implemented. MDS organisations emphasise defect identification through software testing when coding is completed. Various software testing techniques such as taxonomy-based testing like IBM’s Orthogonal Defect Classification (ODC) are used. However, given the safety-critical nature of MDS, it is essential to address defects throughout the development lifecycle by emphasising on both prevention and identification. To address this need, this research developed the Agile V-Model for Addressing Defects (AV4AD) model, drawing insights from the literature review and a survey of MDS organisations. The AV4AD model was developed by integrating agile practices that address defects with the V-Model. It is designed for use by any MDS organisation regardless of organisational size and MDS classification or associated risk level. The model was evaluated through semi-structured interviews conducted with eight developers from different MDS organisations in Ireland. Thereafter, the model underwent validation through desk-based implementation in four MDS organisations in Ireland. Findings from both the evaluation and validation indicate that the AV4AD model can assist MDS organisations in addressing defects throughout the MDS development lifecycle, thereby improving overall software quality and reducing the risk of defects slipping to the final release. The findings further indicate the AV4AD model’s suitability for adoption in MDS development projects, particularly given its potential to minimise the likelihood of defects that could lead to patient injuries, deaths, financial loss, and reputational damage for MDS organisations.

Item Type:	Thesis (Doctoral)
Subjects:	Computer Science Computer Science > Computer Software
Research Centres:	UNSPECIFIED
Depositing User:	Martin McHugh
Date Deposited:	01 Sep 2026 08:11
Last Modified:	01 Sep 2026 08:11
License:	Creative Commons: Attribution-Noncommercial-Share Alike 4.0
URI:	https://eprints.dkit.ie/id/eprint/1095

Actions (login required)

View Item

Downloads