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Fergal Mccaffery - One of the best experts on this subject based on the ideXlab platform.
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agile is it suitable for Medical Device software development
International Conference on Software Process Improvement and Capability Determination, 2016Co-Authors: Fergal Mccaffery, Kitija Trektere, Ozden OzcantopAbstract:Medical Device software is typically developed through adopting a prescribed plan driven software development lifecycle approach based upon variations of the waterfall or V-Model. Organisations wishing to satisfy regulations have to define software development processes and also that these processes have been implemented throughout the complete development lifecycle. Agile development techniques report to offer solutions within other industries that would solve challenges encountered within the Medical Device industry. However, there are some concerns with using agile for Medical Device software development in relation to satisfying the regulatory bodies. In this short paper, we highlight the issues in traditional Medical Device software development. Secondly, we discuss the challenges and highlight agile practices that have been successfully adopted in the Medical Device software industry.
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an agile implementation within a Medical Device software organisation
International Conference on Software Process Improvement and Capability Determination, 2014Co-Authors: Martin Mchugh, Fergal Mccaffery, Garret CoadyAbstract:Three surveys conducted over a 6 year period revealed that Medical Device software organisations have difficulties in the area of requirements management, namely accommodating changes in requirements. Medical Device software is traditionally developed in accordance with a plan driven software development lifecycle (SDLC). These SDLCs are rigid and inflexible to changes once the requirements management stage has been completed. Agile methods are gaining momentum in non-regulated industries but as of yet, the adoption of these methods in regulated industries such as the Medical Device software domain remains low. This study presents an implementation of agile methods within a Medical Device software development organisation based in Ireland. This implementation involved integrating agile practices with a traditional plan driven SDLC. Upon completing this implementation within a Medical Device software development project, the organisation identified cost savings and a reduction in the rework required when introducing a change in requirements.
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a lightweight assessment method for Medical Device software processes
International Conference on Software Process Improvement and Capability Determination, 2014Co-Authors: Fergal Mccaffery, Paul M Clarke, Marion LepmetsAbstract:This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the Medical Device industry. MDevSPICE is a fully validated release of a Medical Device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight Medical Device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based Medical Device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed.
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mdevspice a comprehensive solution for manufacturers and assessors of safety critical Medical Device software
International Conference on Software Process Improvement and Capability Determination, 2014Co-Authors: Paul M Clarke, Fergal Mccaffery, Marion Lepmets, Anita Finnegan, Alec Dorling, Derek FloodAbstract: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.
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balancing agility and discipline in a Medical Device software organisation
International Conference on Software Process Improvement and Capability Determination, 2013Co-Authors: Martin Mchugh, Fergal Mccaffery, Valentine Casey, Brian Fitzgerald, Klaasjan Stol, Garret CoadyAbstract:Agile development techniques are becoming increasingly popular in the generic software development industry as they appear to offer solutions to the problems associated with following a plan-driven Software Development Life Cycle (SDLC). However, agile methods may not be suited to all industries or organisations. For agile methods to succeed, an organisation must be structured in a way to accommodate agile methods. Medical Device software development organisations are bound by regulatory constraints and as a result face challenges when they try to completely follow an agile methodology, but can reap significant benefits by combining both agile and plan-driven SDLC such as the Waterfall or V-Model. This paper presents an analysis of a Medical Device software development organisation based in Ireland, which is considering moving to agile software development techniques. This includes the performing of a Home-Ground Analysis to determine how agile or disciplined the organisation currently is. Upon completion of the Home-Ground Analysis recommendations were made to the organisation as to how they could tailor their existing structure to better accommodate agile development techniques. These recommendations include adopting agile practices such as self-organising teams to promote a culture of “chaos” within the organisation.
Gerry Coleman - One of the best experts on this subject based on the ideXlab platform.
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Medical Device software traceability
Software and Systems Traceability, 2012Co-Authors: Fergal Mc Caffery, Gerry Coleman, Peter Donnelly, Valentine Casey, M S Sivakumar, John BurtonAbstract:Software traceability is central to Medical Device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the Medical Device industry it is essential to have clear linkages and traceability from requirements – including risks – through the different stages of the software development and maintenance life cycles. The regulatory bodies request that Medical Device software development organizations clearly demonstrate how they follow a software development life cycle without mandating a particular life cycle. However, due to the traceability requirements of the industry most Medical Device companies adopt the V-model. Within this chapter we will discuss the importance of traceability to Medical Device software development, the current state of practice within the industry in relation to traceability and how we feel that traceability could be improved within the industry. The chapter also describes the development and implementation of a Medical Device traceability software process assessment method (Med-Trace) in two Medical Device software development organizations. We include these two case studies as one involved a Medical Device SME based in Ireland and the other a Medical Device SME based in the UK as we want to illustrate that Med-Trace can be applied within different countries.
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The Need for a Software Process Improvement Model for the Medical Device Industry
2007Co-Authors: Fergal Mc Caffery, Gerry ColemanAbstract:Software is becoming an increasingly important aspect of Medical Devices and Medical Device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of Medical Device software. Medical Devices can only be marketed if compliance and approval from the appropriate regulatory bodies (e.g. the Food and Drug Administration (FDA)) is achieved. This paper outlines the development of a software process improvement (SPI) model specifically for the Medical Device industry. The paper details how Medical Device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration ( CMMI®). Copyright © 2006 Praise Worthy Prize - All rights reserved.
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developing a configuration management model for use in the Medical Device industry
International Conference on Software and Data Technologies, 2006Co-Authors: Fergal Mccaffery, Rory V Oconnor, Gerry ColemanAbstract:Software is becoming an increasingly important aspect of Medical Devices and Medical Device regulation. Software enables highly complex systems to be built. However, complexity is the enemy of safety, therefore strict adherence to well documented processes is important within the domain of Medical Device software. Medical Devices can only be marketed if compliance and approval from the appropriate regulatory bodies of the Food and Drug Administration (FDA) is achieved. This paper outlines the development of a Configuration Management Capability Model (CMCM). The CMCM is a Software Process Improvement (SPI) model specifically dedicated to Configuration Management (CM) for the Medical Device industry. This paper details how Medical Device regulations may be satisfied by adopting relevant practices from the Capability Maturity Model Integration (CMMI®) CM process area. It also investigates how the CMMI® CM process area may be extended with additional practices that are outside the remit of the CMMI®, but are required in order to satisfy Medical Device Regulatory (MDR) guidelines.
Fergal Mc Caffery - One of the best experts on this subject based on the ideXlab platform.
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piloting mdevspice the Medical Device software process assessment framework
International Conference on Software and System Process, 2015Co-Authors: Marion Lepmets, Fergal Mc Caffery, Paul M ClarkeAbstract: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.
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Medical Device standards requirements for traceability during the software development lifecycle and implementation of a traceability assessment model
Computer Standards & Interfaces, 2013Co-Authors: Gilbert Regan, Kevin Mc Daid, Fergal Mc Caffery, Derek FloodAbstract:Developing safety critical software is a complex process. Due to the fact that Medical Device software failure can lead to catastrophic consequences, numerous standards have been developed which govern software development in the Medical Device domain. Risk management has an important role in Medical Device software development as it is important to ensure that safe software is developed. Demonstrating traceability of requirements right throughout the Medical Device software development and maintenance lifecycles is an important part of demonstrating that 'safe' software has been produced through adopting defined processes. Consequently, Medical Device standards and guidelines emphasise the need for traceability. This paper outlines the extent and diversity of traceability requirements within Medical Device standards and guidelines, and identifies the requirements for traceability through each phase of the software development lifecycle. The paper also summarises the findings obtained when a lightweight assessment method (Med-Trace), which we created, based upon the traceability practices within these standards, was implemented in two SME organisations. Finally we highlight how the findings indicate a lack of guidance as to what is required when implementing and maintaining a traceability process.
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barriers to using agile software development practices within the Medical Device industry
2012Co-Authors: Martin Mc Hugh, Fergal Mc Caffery, Valentine CaseyAbstract: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.
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Medical Device software traceability
Software and Systems Traceability, 2012Co-Authors: Fergal Mc Caffery, Gerry Coleman, Peter Donnelly, Valentine Casey, M S Sivakumar, John BurtonAbstract:Software traceability is central to Medical Device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the Medical Device industry it is essential to have clear linkages and traceability from requirements – including risks – through the different stages of the software development and maintenance life cycles. The regulatory bodies request that Medical Device software development organizations clearly demonstrate how they follow a software development life cycle without mandating a particular life cycle. However, due to the traceability requirements of the industry most Medical Device companies adopt the V-model. Within this chapter we will discuss the importance of traceability to Medical Device software development, the current state of practice within the industry in relation to traceability and how we feel that traceability could be improved within the industry. The chapter also describes the development and implementation of a Medical Device traceability software process assessment method (Med-Trace) in two Medical Device software development organizations. We include these two case studies as one involved a Medical Device SME based in Ireland and the other a Medical Device SME based in the UK as we want to illustrate that Med-Trace can be applied within different countries.
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Integrating Agile Practices with a Medical Device Software Development Lifecycle
2012Co-Authors: Martin Mc Hugh, Fergal Mc Caffery, Valentine Casey, Minna PikkarainenAbstract: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.
Julian M Goldman - One of the best experts on this subject based on the ideXlab platform.
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openice Medical Device interoperability platform overview and requirement analysis
Biomedizinische Technik, 2018Co-Authors: David Arney, Jeffrey Plourde, Julian M GoldmanAbstract:We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages Medical Device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.
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the need to apply Medical Device informatics in developing standards for safe interoperable Medical systems
Anesthesia & Analgesia, 2017Co-Authors: Sandy Weininger, Michael B Jaffe, Julian M GoldmanAbstract:: Medical Device and health information technology systems are increasingly interdependent with users demanding increased interoperability. Related safety standards must be developed taking into account these systems' perspective. In this article, we describe the current development of Medical Device standards and the need for these standards to address Medical Device informatics. Medical Device information should be gathered from a broad range of clinical scenarios to lay the foundation for safe Medical Device interoperability. Five clinical examples show how Medical Device informatics principles, if applied in the development of Medical Device standards, could help facilitate the development of safe interoperable Medical Device systems. These examples illustrate the clinical implications of the failure to capture important signals and Device attributes. We provide recommendations relating to the coordination between historically separate standards development groups, some of which focus on safety and effectiveness and others focus on health informatics. We identify the need for a shared understanding among stakeholders and describe organizational structures to promote cooperation such that Device-to-Device interactions and related safety information are considered during standards development.
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synchronizing an x ray and anesthesia machine ventilator a Medical Device interoperability case study
International Conference on Biomedical Electronics and Devices, 2009Co-Authors: David Arney, Julian M Goldman, Susan F WhiteheadAbstract:When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play Medical Device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable Medical Device systems by implementing a solution to a clinical use case requiring interoper-
Valentine Casey - One of the best experts on this subject based on the ideXlab platform.
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balancing agility and discipline in a Medical Device software organisation
International Conference on Software Process Improvement and Capability Determination, 2013Co-Authors: Martin Mchugh, Fergal Mccaffery, Valentine Casey, Brian Fitzgerald, Klaasjan Stol, Garret CoadyAbstract:Agile development techniques are becoming increasingly popular in the generic software development industry as they appear to offer solutions to the problems associated with following a plan-driven Software Development Life Cycle (SDLC). However, agile methods may not be suited to all industries or organisations. For agile methods to succeed, an organisation must be structured in a way to accommodate agile methods. Medical Device software development organisations are bound by regulatory constraints and as a result face challenges when they try to completely follow an agile methodology, but can reap significant benefits by combining both agile and plan-driven SDLC such as the Waterfall or V-Model. This paper presents an analysis of a Medical Device software development organisation based in Ireland, which is considering moving to agile software development techniques. This includes the performing of a Home-Ground Analysis to determine how agile or disciplined the organisation currently is. Upon completion of the Home-Ground Analysis recommendations were made to the organisation as to how they could tailor their existing structure to better accommodate agile development techniques. These recommendations include adopting agile practices such as self-organising teams to promote a culture of “chaos” within the organisation.
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barriers to using agile software development practices within the Medical Device industry
2012Co-Authors: Martin Mc Hugh, Fergal Mc Caffery, Valentine CaseyAbstract: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.
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Medical Device software traceability
Software and Systems Traceability, 2012Co-Authors: Fergal Mc Caffery, Gerry Coleman, Peter Donnelly, Valentine Casey, M S Sivakumar, John BurtonAbstract:Software traceability is central to Medical Device software development and essential for regulatory approval. In order to comply with the regulatory requirements of the Medical Device industry it is essential to have clear linkages and traceability from requirements – including risks – through the different stages of the software development and maintenance life cycles. The regulatory bodies request that Medical Device software development organizations clearly demonstrate how they follow a software development life cycle without mandating a particular life cycle. However, due to the traceability requirements of the industry most Medical Device companies adopt the V-model. Within this chapter we will discuss the importance of traceability to Medical Device software development, the current state of practice within the industry in relation to traceability and how we feel that traceability could be improved within the industry. The chapter also describes the development and implementation of a Medical Device traceability software process assessment method (Med-Trace) in two Medical Device software development organizations. We include these two case studies as one involved a Medical Device SME based in Ireland and the other a Medical Device SME based in the UK as we want to illustrate that Med-Trace can be applied within different countries.
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Integrating Agile Practices with a Medical Device Software Development Lifecycle
2012Co-Authors: Martin Mc Hugh, Fergal Mc Caffery, Valentine Casey, Minna PikkarainenAbstract: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.
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how can software smes become Medical Device software smes
European conference on Software Process Improvement, 2011Co-Authors: Fergal Mccaffery, Valentine Casey, Martin MchughAbstract:The amount of software content within Medical Devices has grown considerably over recent years and will continue to do so as the level of complexity of Medical Devices increase. This is driven by the fact that software is introduced to produce sophisticated Medical Devices that would not be possible using only hardware. This therefore presents opportunities for software development SMEs to become Medical Device software development organisations. However, some obstacles need to be addressed and overcome in order to make the transition from being a generic software development organisation to becoming a Medical Device software development organisation. This paper describes these obstacles and how research that is currently being performed within the Regulated Software Research Group in Dundalk Institute of Technology may be used to assist with this transition.
