Challenges experienced by medical device software development organizations while following a plan-driven software development life cycle

Medical device software organisations face challenges not faced by generic software development organisations. These challenges include the adherence to regulatory controls. Regulatory bodies require medical device software organisations to provide objective evidence that the software they are developing is safe and reliable. To produce this, regulatory bodies require a number of deliverables which must be achieved. However, they do not dictate which Software Development Life Cycle (SDLC) must be followed in order to achieve these deliverables. Despite not dictating which SDLC must be followed when developing medical device software, organisations typically develop their software in accordance with a Plan-Driven software development lifecycle. By conducting semi structured interviews with seven medical device software organisations, we gained a deeper insight into how the challenges experienced impact on the development of medical device software. The interviews also attempted to learn from the participants how they believe the challenges experienced can be overcome. The aim of this paper is to explain the methodology used to perform interviews with medical device software organisations and to present these interviews

Barriers to using agile software development practices within the medical device industry

Non-safety critical software developers have been reaping the benefits of adopting agile practices for a number of years. However, developers of safety critical software often have concerns about adopting Agile practices. Through a literature review this research identified the perceived barriers to following agile practices when developing medical device software. A questionnaire based survey was also conducted with medical device software developers in Ireland to determine what the actual barriers are to adopting agile practices. In addition a comparison is performed between the perceived and actual barriers and the results are reported

Standalone software as an active medical device

With the release of the latest European Medical Device Directive (MDD) standalone software can now be classified as an active medical device. Consequently the methods used to ensure device safety and reliability needs to be reviewed. IEC 62304 is the current software development lifecycle framework followed by medical device software developers but important processes are beyond the scope of IEC 62304. These processes are covered by additional standards. However since the MDD became mandatory these additional standards are not comprehensive enough to ensure the reliability of an active medical device consisting of only software. By employing software process improvement techniques this software can be developed and validated to ensure it performs the required task in a safe and reliable way

Software process improvement to assist medical device software development organisations to comply with the amendments to the medical device directive

A recent revision to the European Medical Device Directive (MDD) 2007/47/EC made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device and should be developed following state of the art medical device software development processes. State of the art medical device software processes is understood within the industry as developing software in accordance with IEC 62304 and standards that are aligned with it. This paper identifies how changes to the MDD affect medical device software development companies and recommendations are made as to how medical device software development companies can conform to the latest regulatory requirements. Additionally, the paper provides an overview of how Medi SPICE is currently being developed to provide organisations with a single point of reference for the practices that should be implemented in order to produce regulatory compliant medical device software

How amendments to the medical device directive affect the development of medical device software

A recent revision to the European Medical Device Directive (MDD 2007/47/EC) made fourteen amendments to the original directive (93/42/EEC). A number of these changes directly affect the development of software for use in healthcare. The most significant change in relation to medical device software development is that standalone software is now seen as an active medical device. Prior to this amendment medical device software was developed in accordance with the IEC 62304 standard. However, IEC 62304 is not sufficiently comprehensive to provide guidance in the development of standalone software as an active medical device. Medi SPICE is currently being developed to fill the gaps left by IEC 62304 in developing standalone software as an active medical device and to provide medical device software developers a single point of reference for developing software for use in healthcare

Integrating agile practices with plan-driven medical device software development

The popularity of Agile software development is growing rapidly with an increasing number of projects being developed following Agile methodologies such as Scrum and XP [1]. Research has revealed that following Agile practices when developing software can have a significantly positive impact in reducing development time, reducing cost and increasing overall quality [2-4]. Whilst Agile practices can have a positive impact on a development project there are incompatibilities between Agile methodologies and the plan driven approaches followed when developing safety critical software [5, 6]. However, it has been recognised that “formal techniques may be used in an agile way” [5]. Case studies have been performed in organisations developing safety critical software which validate this statement [7-9]. This Ph.D. is focusing on the area of medical device software development and integrating Agile software development principles into traditional plan driven lifecycles for use in developing medical device software

The significance of requirements in medical device software development

Software to be used in or as a medical device is subject to user requirements. However, unlike unregulated software, medical device software must meet both the user’s requirements and the requirements of the regulatory body of the region into which the software will be marketed. Regulatory requirements are fixed and can be planned for; unfortunately, the same is not true with user requirements. As many medical device software development organisations are following traditional sequential Software Development Life Cycles (SDLC), they are experiencing difficulties accommodating changes in requirements once development has begun. Agile methods and practices offer the ability to overcome the challenges associated with following a sequential SDLC. Whilst the regulatory requirements are fixed, this paper presents these requirements and shows how they appear to mandate the use of a sequential SDLC. This paper also explains how agile methods and practices can be successfully adopted in the development of medical device software without hindering the process of achieving regulatory approval

Integrating agile practices with a medical device software development lifecycle

The rate at which agile software development practices are being adopted is growing rapidly. Agile software development practices and methodologies appear to offer the silver bullet which can solve the problems associated with following plan driven software development lifecycles. Agile software development practices offer the possibility of achieving lower development costs, increased efficiency and improved software quality. However, there is currently a low rate of publicly available information that suggests there is widespread adoption of agile practices within the medical device software domain. This is largely due to the fact that software developed for medical devices includes challenges not faced when developing non safety critical software. As a result of these challenges, medical device software is typically developed using plan driven software development lifecycles. However, such lifecycles are quite rigid and cannot accommodate changes easily. Previous research has revealed that medical device software development projects can benefit from adopting agile practices whilst still maintaining the discipline associated with following plan driven development lifecycles. This paper outlines the challenges faced by developers when developing medical device software and how shortcomings in both agile and plan driven approaches can be resolved by following a mixed method approach to medical device software development

An agile V-model for medical device software development to overcome the challenges with plan-driven software development lifecycles

Through the use of semi structured interviews with medical device software organizations it emerged that medical device software organizations are experiencing difficulties when following plan driven Software Development Life Cycles (SDLC), particularly in the area of requirements management. To attempt to resolve these issues an examination of the non-regulated industry was performed to determine if lessons learned there could be applied to the development of medical device software. This examination revealed that agile methods are being widely adopted in the non-regulated software industry. To learn if agile methods could be adopted when developing medical device software a mapping study was performed which looked for instances of where agile methods have been used in regulated industries and where they have been adopted, to what success. This mapping study revealed that incorporating agile practices with the existing plan driven SDLC is the most favourable choice for medical device software organizations. This research aims to develop a SDLC which has a foundation of a plan driven SDLC which incorporates agile practices which can be followed when developing regulatory compliant software