A Traceability Process Assessment Model for the Medical Device Domain

Regulation normally requires critical systems to be certified before entering service. This involves submission of a safety case - a reasoned argument and supporting evidence that stringent requirements have been met and that the system is acceptably safe. A good safety case encompasses an effective risk mitigation process which is highly dependent on requirements traceability. However despite its many benefits and regulatory requirements, most existing software systems lack explicit traceability links between artefacts. Reasons for the lack of traceability include cost, complexity and lack of guidance on how to implement traceability.To assist medical device organisations in addressing the lack of guidance on how to implement effective traceability, this paper aims to present the development and validation of a traceability process assessment model and the actions to be taken as a result of the validation. The process assessment model will allow organisations to identify strengths and weaknesses in their existing traceability process and pinpoint areas for improvement.

We present a requirement-centered analysis and testing framework that integrates methods and tools for capturing and formalizing textual customer requirements, analyzing requirements consistency, generating test cases from formalized requirements and executing them on the implementation model. The framework preserves a fine grained traceability of informal and formal requirements, test cases and implementation models throughout every step of the workflow. We instantiate the framework with concrete tools that we integrate via a file repository and Open Services for Lifecycle Collaboration (OSLC). The standardized integration ensures that the framework remains generic -- any specific tool used in our instantiation can be replaced by another one with compatible functionality. We apply our framework on an industrial airbag control chip case study that we use to illustrate step-by-step our requirements-driven analysis and test methodology.

Apart from the different formats of software process descriptions and life cycle models as discussed in the previous chapter, there are many different types of such models. The basis for these models is formed by several fundamental life cycles, in particular sequential models such as the waterfall model or the V-shaped model, and iterative-incremental models such as the spiral model or Scrum. These fundamental life cycles can be varied in many forms, or extended by adding information leading to detailed process models such as the (Rational) Unified Process. The models can also include different sets of processes, where at one end of the spectrum, software processes support software development by structuring the different development-related activities. At the other end of the spectrum, software processes also provide a more comprehensive perspective, e.g. including operation and IT service management, or interfacing with organisational and administrative tasks. Depending on the purpose of the model, there are some very different types of process reference models available, including for example method-driven life cycle models, agile methodologies, process assessment models. In this chapter, we survey these different types of software processes and their role in the software life cycle. We provide a categorization of software processes, introduce the basic life cycle models, and present some selected reference models.

The application of software in the medical device domain has become central to improve diagnoses and treatments. The introduction of new regulations poses issues for the qualification and classification of MD software and requires complex procedures to make them complaint with safety requirements. The paper focuses on EU, Canada and US regulations, standards and guidelines and in particular highlights the integration of the risk management process with the software lifecycle.

Traceability is central to medical device software development and is an essential requirement for regulatory approval. To achieve compliance an effective traceability process needs to be in place. This process must ensure the need for clear linkages and traceability from software requirements - including risks - through the different stages of the software development and maintenance lifecycles. This is difficult to achieve due to the lack of specific guidance which the medical device standards and documentation provide. This has resulted in many medical device companies employing inefficient software traceability processes. In this paper we outline the development and implementation of Med-Trace a lightweight software traceability process assessment and improvement method for the medical device industry. We also present and discuss our findings from two industry based Med-Trace assessments.

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.

Requirements Traceability (RT) refers to the process of tracing requirements through the software development life-cycle. It is essential for the software development process because a lot of information is used and produced and it should be kept related or traceable. Nevertheless, as the complexity of a system increases, the myriad of related artifacts also increases. Therefore, one is encumbered of tracing requirements through different abstraction levels. Proposing a common abstraction to the requirements traceability process and also providing query mechanisms to retrieve trace links has been recognized as one of the grand challenges of RT. Hence, in this paper, we propose a Traceability Representation Language (TRL), which provides abstractions to requirements, artifacts and trace links as well as queries, through which trace links can be searched, retrieved and filtered. To evaluate the proposed language, we have conducted an empirical experiment comparing TRL with other traceability languages, namely TracQL and TQL. We observed the readability and writability of the languages as well as their trace links representations and query declarations and concluded that the proposed TRL language is a feasible abstraction to the RT process. As a final remark, we discuss how the proposed language contributes towards portable and scalable traceability.

Complex systems are designed using set of norms, like EIA-632, IEEE-15288. The requirement traceability is one of the suggested activities to carry out during product life cycle. Currently, most of the requirement traceability processes are defined for software intensive systems. However, it is not specified how to carry out requirement traceability for non-software intensive systems or complex systems. It is very difficult to determine the level of granularity in traceability for complex systems. Traceability is seen as separate process, apart from designing and decision-making. We present in our work here a system design paradigm, which integrates requirement traceability with multi-view modeling and an integrated system of decision-making. We show how an integrated traceability process can become fuel for design and decision engine, which is in accordance with EIA-632 and IEEE-15288. We are developing a tool called ISDT, which shows the effectiveness of our methodology.

In the healthcare industry, safety and efficacy of medical devices is crucial for the protection of patients and practitioners. Medical device development is a complex process dominated by different guidelines and regulatory demands. A systematic and continuous verification and validation is central to the development process, as it provides a structured approach to ensure that medical devices comply with regulatory requirements and fulfill their intended use. There is a great need for methodological support in medical technology product development. In co-operation Getinge AB a framework for the verification and validation of blood temperature control devices at an early stage of development is being drafted and compared with frameworks identified through a systematic literature review. This paper outlines the need for and key aspects of a general validation framework and introduces the X-in-the-loop (XiL) approach known from the automotive industry as a possible framework to be applied and adapted to the medical engineering sector. It recognizes the strengths of IPEK -XiL for system of systems development and validation and transfers these to the equally complex cyber-physical or single hardware/software medical device domain. With the transfer of the XiL framework to medical engineering a focus on applicability and credibility compliments the iterative development process in the highly regulated marked, thereby encouraging medical device innovation.

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Global software development (GSD) organizations encouraged to improve software quality of products. The GSD used highly skilled and advance technology at one place through the internet. The main challenges face in GSD with benefits are communication, coordination and control. These issues create ambiguities and incompleteness in requirements prioritization and traceability process due to lots of stakeholders and human efforts involved. Therefore, we proposed a framework to improve requirements prioritization and traceability process using artificial intelligent technique. The framework was evaluated using experiment and compared with existing solutions. Results described that proposed framework significantly improved requirements prioritization and traceability with less human interaction to reduce GSD challenges.

Human beings make errors and that is nothing that we can avoid completely. We can however lower the risk of people doing wrong in situations where, for example, medical devices are used. The overall objective of the research presented in this paper is to investigate how usability testing can contribute to software risk management process in the medical device domain. Experience has been collected from both the risk management process and usability testing in a development project of a medical device. It can be concluded that usability tests can give valuable input to the risk management process. Usability tests can indicate risks that are not identified in the risk management process and render the possibility to verify if risks with high risk value actually cause the presumed problems.

Formal modeling can be used as an effective technique to improve the quality and reliability of software-intensive systems in general, and medical devices in particular. However, for formal modeling to be accessible to practicing engineers and domain specialists, suitable educational materials need to be developed. We report on the development of educational materials designed to give students the necessary experience to infuse formal modeling into practice. A core component of this effort is a set of modeling tasks drawn from the medical device domain.

Effective verification and validation are central to medical device software development and are essential for regulatory approval. Although guidance is available in multiple standards in the medical device software domain, it is difficult for the manufacturer to implement as there is no consolidated view of this information. Likewise, the standards and guidance documents do not consider process improvement initiatives. This paper assists in relation to both these aspects and introduces the development of processes for verification and validation in the medical device domain.

This article aims to present an experience report on the configuration of an automated management tool, Jira Confluence, for documentation and requirements management, throughout the software lifecycle using agile teams, in addition to clarifying concepts about the Traceability of requirements and situate through examples why standardize and centralize them, Especially when we're talking about distributed teams.