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Fergal Mccaffery - One of the best experts on this subject based on the ideXlab platform.
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EuroSPI - A Framework for Taxonomy Based Testing Using Classification of Defects in Health Software-SW91
Communications in Computer and Information Science, 2019Co-Authors: Hamsini Ketheswarasarma Rajaram, John Loane, Silvana Togneri Macmahon, Fergal MccafferyAbstract:Taxonomy based testing is an efficient approach to find Software defects at earlier phases of Medical Device Software development. It allows the creation of goal oriented test cases while brainstorming test ideas. This approach is adaptable into standard testing processes such as the ISTQB and the 29119-2. It uses a new standard, a defect taxonomy SW91 which is identified as a consensus standard by the US Food and Drug Administration (FDA). This paper presents steps to be followed in implementing taxonomy based testing at a Medical Device Software organisation which follows the Software development process explained in IEC 62304:2006+A1:2015. Finally, the future work section explains how this framework can be tailored to testing techniques and how its efficiency and benefits will be evaluated via expert reviews and implementation at Medical Device Software organisations.
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To what extent the Medical Device Software regulations can be achieved with agile Software development methods? XP—DSDM—Scrum
The Journal of Supercomputing, 2019Co-Authors: Özden Özcan-top, Fergal MccafferyAbstract:For Medical Device Software development organizations, it is very challenging to maintain both conformance to the strict regulatory requirements enforced by the safety-critical nature of the domain and achieve efficiency in Software development. Agile Software development methods provide promising solutions to overcome the efficiency issues and the challenges of traditional Software development approaches in the domain. Previously, we investigated to what extent the regulatory requirements defined in MDevSPICE^® (the Software process assessment framework for Medical Device Software development) are met through using eXtreme Programming (XP) and Scrum and what additional practices have to be performed to ensure safety and regulatory compliance in the Medical Device Software development domain. In this paper, we extended the research to include the Dynamic Systems Development Method (DSDM) which covers the whole Software development life cycle. Here, we provide a comprehensive and quantitative analysis of XP’s and DSDM’s suitability for Medical Device Software development and briefly discuss Scrum from the same perspective. We provide the coverage ratios of processes and practices defined in MDevSPICE^® when these agile Software development methods are implemented.
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A Hybrid Assessment Approach for Medical Device Software Development Companies
Journal of Software: Evolution and Process, 2017Co-Authors: Özden Özcan-top, Fergal MccafferyAbstract:Medical Device Software development organizations are bound by regulatory requirements and constraints to ensure that developed Medical Devices will not harm patients. Medical Devices have to be treated as complete systems and be evaluated in this manner. Instead of manufacturers having to ensure compliance to various regulatory standards individually, the authors previously developed a Medical Device Software process assessment framework called MDevSPICE® that integrates the regulatory requirements from all the relevant Medical Device Software standards. The MDevSPICE® was developed in a manner that suits plan‐driven Software development. To improve the usability of MDevSPICE® in agile settings, we extended the assessment approach. The hybrid assessment approach described here combines the MDevSPICE®‐based process assessment method with steps for prioritization of improvement needs through value stream mapping and enabling process improvement through the use of KATA technique. This approach integrates agile methods into the Medical Device Software development process while adhering to the requirements of the regulatory standards. This paper describes the implementation of the approach within 4 organizations that develop Software in line with Medical Device regulations.
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QUATIC - Towards Safer Medical Device Software Systems: Industry-Wide Learning from Failures and the Use of Safety-Cases to Support Process Compliance
2016 10th International Conference on the Quality of Information and Communications Technology (QUATIC), 2016Co-Authors: Marion Lepmets, Tom Mcbride, Fergal MccafferyAbstract:Software safety is checked today in regulatory audits, which verify Software development process compliance to regulatory requirements. Ensuring safety is a critical task in complex life-supporting systems and despite many existing ways of assuring it, unanticipated failure will always be possible. Checking process compliance to required standards ensures the quality of the processes by which Software is developed but does not necessarily indicate the quality of the resultant Software. Since Medical Device domain is facing an increasing amount of Device recalls due to Software failures, our goal is to explore the underlying reasons for this and suggest two improvements within this paper. First, we will introduce complicated and complex systems to illustrate why there will always be unforeseeable and unanticipated situations that could cause the failure of the entire system. We will then describe how Medical Device Software systems are reviewed for compliance and safety today, highlighting the shortcomings in the current methods adopted in the Medical Device domain and suggest the use of systems thinking. We then propose two improvements to Medical Device Software development where process compliance is supported by safety cases and industry-wide learning from experience.
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towards safer Medical Device Software systems industry wide learning from failures and the use of safety cases to support process compliance
Quality of Information and Communications Technology, 2016Co-Authors: Marion Lepmets, Tom Mcbride, Fergal MccafferyAbstract:Software safety is checked today in regulatory audits, which verify Software development process compliance to regulatory requirements. Ensuring safety is a critical task in complex life-supporting systems and despite many existing ways of assuring it, unanticipated failure will always be possible. Checking process compliance to required standards ensures the quality of the processes by which Software is developed but does not necessarily indicate the quality of the resultant Software. Since Medical Device domain is facing an increasing amount of Device recalls due to Software failures, our goal is to explore the underlying reasons for this and suggest two improvements within this paper. First, we will introduce complicated and complex systems to illustrate why there will always be unforeseeable and unanticipated situations that could cause the failure of the entire system. We will then describe how Medical Device Software systems are reviewed for compliance and safety today, highlighting the shortcomings in the current methods adopted in the Medical Device domain and suggest the use of systems thinking. We then propose two improvements to Medical Device Software development where process compliance is supported by safety cases and industry-wide learning from experience.
Oliver Jakel - One of the best experts on this subject based on the ideXlab platform.
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first experiences with the implementation of the european standard en 62304 on Medical Device Software for the quality assurance of a radiotherapy unit
Radiation Oncology, 2014Co-Authors: Angelika Hoss, Christian Lampe, Ralf Panse, Benjamin Ackermann, Jakob Naumann, Oliver JakelAbstract:According to the latest amendment of the Medical Device Directive standalone Software qualifies as a Medical Device when intended by the manufacturer to be used for Medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of Medical Device Software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). The EN 62304 standard outlines minimum requirements for each stage of the Software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support Software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to Medical Devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. The EN 62304 standard is difficult to implement without proper tools, thus open-source Software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all Software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized Medical Software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.
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First experiences with the implementation of the European standard EN 62304 on Medical Device Software for the quality assurance of a radiotherapy unit
Radiation Oncology, 2014Co-Authors: Angelika Hoss, Christian Lampe, Ralf Panse, Benjamin Ackermann, Jakob Naumann, Oliver JakelAbstract:Background According to the latest amendment of the Medical Device Directive standalone Software qualifies as a Medical Device when intended by the manufacturer to be used for Medical purposes. In this context, the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of Medical Device Software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture). Methods The EN 62304 standard outlines minimum requirements for each stage of the Software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support Software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to Medical Devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels. Results The EN 62304 standard is difficult to implement without proper tools, thus open-source Software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility. Conclusions The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all Software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized Medical Software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.
Marion Lepmets - One of the best experts on this subject based on the ideXlab platform.
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QUATIC - Towards Safer Medical Device Software Systems: Industry-Wide Learning from Failures and the Use of Safety-Cases to Support Process Compliance
2016 10th International Conference on the Quality of Information and Communications Technology (QUATIC), 2016Co-Authors: Marion Lepmets, Tom Mcbride, Fergal MccafferyAbstract:Software safety is checked today in regulatory audits, which verify Software development process compliance to regulatory requirements. Ensuring safety is a critical task in complex life-supporting systems and despite many existing ways of assuring it, unanticipated failure will always be possible. Checking process compliance to required standards ensures the quality of the processes by which Software is developed but does not necessarily indicate the quality of the resultant Software. Since Medical Device domain is facing an increasing amount of Device recalls due to Software failures, our goal is to explore the underlying reasons for this and suggest two improvements within this paper. First, we will introduce complicated and complex systems to illustrate why there will always be unforeseeable and unanticipated situations that could cause the failure of the entire system. We will then describe how Medical Device Software systems are reviewed for compliance and safety today, highlighting the shortcomings in the current methods adopted in the Medical Device domain and suggest the use of systems thinking. We then propose two improvements to Medical Device Software development where process compliance is supported by safety cases and industry-wide learning from experience.
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towards safer Medical Device Software systems industry wide learning from failures and the use of safety cases to support process compliance
Quality of Information and Communications Technology, 2016Co-Authors: Marion Lepmets, Tom Mcbride, Fergal MccafferyAbstract:Software safety is checked today in regulatory audits, which verify Software development process compliance to regulatory requirements. Ensuring safety is a critical task in complex life-supporting systems and despite many existing ways of assuring it, unanticipated failure will always be possible. Checking process compliance to required standards ensures the quality of the processes by which Software is developed but does not necessarily indicate the quality of the resultant Software. Since Medical Device domain is facing an increasing amount of Device recalls due to Software failures, our goal is to explore the underlying reasons for this and suggest two improvements within this paper. First, we will introduce complicated and complex systems to illustrate why there will always be unforeseeable and unanticipated situations that could cause the failure of the entire system. We will then describe how Medical Device Software systems are reviewed for compliance and safety today, highlighting the shortcomings in the current methods adopted in the Medical Device domain and suggest the use of systems thinking. We then propose two improvements to Medical Device Software development where process compliance is supported by safety cases and industry-wide learning from experience.
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Development and benefits of MDevSPICE®, the Medical Device Software process assessment framework
Journal of Software: Evolution and Process, 2016Co-Authors: Marion Lepmets, Fergal Mccaffery, Paul 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 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.
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ICSSP - Tailoring MDevSPICE® for mobile Medical apps
Proceedings of the International Workshop on Software and Systems Process - ICSSP '16, 2016Co-Authors: Kitija Trektere, Fergal Mccaffery, Marion Lepmets, Grainne BarryAbstract:Mobile Medical apps play an important role within the healthcare industry. Developers of mobile Medical apps need to understand what is required when a mobile application fulfils the definition of a Medical Device. Such applications have to be developed in compliance with Medical Device regulations. This can be a challenge for mobile Medical application developers as Medical Device Software is normally developed with a focus upon producing the regulatory documentation that is essential to market such Devices. Regulatory compliance is usually achieved by adopting a plan-driven Software development approach, which is not typically the method used to develop mobile applications. MDevSPICE® is a Medical Device Software process framework that integrates processes from various Medical Device Software and generic Software development best practice standards. In this paper the authors describe how the MDevSPICE® framework can be tailored to support mobile Medical applications development by introducing agile practices into the framework.
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Agile Medical Device Software development: Introducing agile practices into MDevSPICE
Advances in life sciences, 2016Co-Authors: Fergal Mccaffery, Özden Özcan-top, Marion Lepmets, Kitija Trektere, Minna PikkarainenAbstract:Medical Device Software is usually embedded within the overall system as one of the sub-systems. It needs to be integrated with other sub-systems such as the electrical and mechanical for a functional Medical Device to be developed. In order to develop a working Medical Device system through integrating its sub-systems, the sub-systems’ requirements have to be derived from the overall Medical Device system requirements. The system requirements are continuously collected, analysed and built from the needs of different stakeholders such as patients, health professionals and other companies offering relevant Devices, interfaces and Software related to the Medical Device system under development. Various regulatory requirements have to be achieved for a Medical Device to be allowed market access. We have developed and piloted a Medical Device Software process assessment framework called MDevSPICE® that integrates the regulatory requirements from the relevant Medical Device Software standards. This paper describes how the MDevSPICE® framework has been designed to enable Medical Device Software developers to produce Software that will be safe and easily integrated with other sub-systems of the overall Medical Device. We also describe the lessons learned from piloting MDevSPICE® in the Medical Device industry and introduce an agile methodology together with its benefits and challenges. This paper outlines how MDevSPICE® can be extended to include agile practices to enable Medical Device Software development to be performed in a more flexible manner.
Alan Wassyng - One of the best experts on this subject based on the ideXlab platform.
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envisioning a requirements specification template for Medical Device Software
Product Focused Software Process Improvement, 2014Co-Authors: Hao Wang, Yihai Chen, Ridha Khedri, Alan WassyngAbstract:In many health jurisdictions, Software is considered to be Medical Device Software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient’s health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a Medical Device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of Medical Device Software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a ‘good’ MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.
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PROFES - Envisioning a Requirements Specification Template for Medical Device Software
Product-Focused Software Process Improvement, 2014Co-Authors: Hao Wang, Yihai Chen, Ridha Khedri, Alan WassyngAbstract:In many health jurisdictions, Software is considered to be Medical Device Software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient’s health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a Medical Device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of Medical Device Software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a ‘good’ MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.
Hao Wang - One of the best experts on this subject based on the ideXlab platform.
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envisioning a requirements specification template for Medical Device Software
Product Focused Software Process Improvement, 2014Co-Authors: Hao Wang, Yihai Chen, Ridha Khedri, Alan WassyngAbstract:In many health jurisdictions, Software is considered to be Medical Device Software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient’s health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a Medical Device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of Medical Device Software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a ‘good’ MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.
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PROFES - Envisioning a Requirements Specification Template for Medical Device Software
Product-Focused Software Process Improvement, 2014Co-Authors: Hao Wang, Yihai Chen, Ridha Khedri, Alan WassyngAbstract:In many health jurisdictions, Software is considered to be Medical Device Software (MDS), when it is used to analyze patient data in order to render a diagnosis or monitor the patient’s health; when it is to be used by a patient to diagnose an ailment; or when it is used to deliver functionality for a Medical Device. Flaws in MDS can result in patient harm, including death. Legislators and regulatory agencies publish guidelines and regulatory standards that are aimed at ensuring the safety, security and dependability of MDS. These guidelines and standards universally agree that a complete and consistent requirement specification is vital to the success of Medical Device Software. Moreover, we observe that regulators are shifting from being process focused to being product focused in their approval guidance. In this paper, we review challenges associated with requirements used in the development of MDS, current standards and guidelines relevant to MDS, and existing templates for requirement specifications. We then propose a set of design objectives for a ‘good’ MDS requirements template and propose a template structure for MDS requirement specification fulfilling all the design objectives. Our template is, by design, tailored to facilitate the gathering and documenting of high quality requirements for MDS.