12 research outputs found
Mobile medical app development with a focus on traceability
No full textToday, the growth of medical devices and mobile medical applications is increasing enormously, thanks to the efficiency and enhancement of new technology. When it comes to mobile medical apps, developers 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 in a manner that will also ensure the production of regulatory documentation that is essential to market such devices. In this paper, we identify the need for a mobile medical application development framework, the key criteria for such a framework, and describe how the results were collected through performing a Medical Device Software Development workshop. Furthermore, we describe how MDevSPICE together with an agile software development approach can be tailored to support a mobile medical applications development framework. We detail one of the key criteria for mobile medical application development framework—traceability
Hybrid software and system development in practice: waterfall, scrum, and beyond
No full textSoftware and system development faces numerous challenges of rapidly changing markets. To address such challenges, companies and projects design and adopt specific development approaches by combining well-structured methods and flexible agile practices. Yet, the number of methods and practices is large and the actual process composition is often carried out in an ad-hoc manner. This paper reports on a survey on hybrid software development approaches. We study which approaches are used in practice, how different approaches are combined, and what contextual factors influence the use and combination of hybrid software development approaches
Agile Medical Device Software Development: Introducing Agile Practices into MDevSPICE®
No full textMedical 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
Hybrid Software and System Development in Practice
No full textThis paper was accepted and presented in 2017 as a Full Research Paper at the International Conference on Software and Systems Process (ICSSP). This paper examines the question of which software and system development approaches are used in practice. The underlying HELENA study (hybrid dEveLPmENt approaches in software systems development) breaks away from the discussion of "traditional" versus "agile" development and examines actual combinations of processes and methods in so-called hybrid development approaches. This paper reports on the results of the first stage of the HELENA study, in which 69 participants, mainly European, participated in an online survey. Participants were asked to rate and present 40 different development approaches how and why the approaches are used in their companies / projects. The results show that in practice, a structured traditional process often forms the organizational framework for a project, while fine-grained tasks are addressed through individually introduced agile practices. This combination can be found in almost all companies, regardless of company size and industry. In addition, using affinity propagation clustering and spectral clustering, different combination patterns were derived from the data, which were successfully tested for realism with other external studies. Our study shows the widespread use of hybrid development processes and that they usually arise through an individual learning process
Hybrid Software and System Development in Practice: Waterfall, Scrum, and Beyond
No full textSoftware and system development faces numerous challenges of rapidly changing markets.
To address such challenges, companies and projects design and adopt speciĄc development approaches
by combining well-structured methods and Ćexible agile practices. Yet, the number of methods and
practices is large and the actual process composition is often carried out in an ad-hoc manner. This
paper reports on a survey on hybrid software development approaches. We study which approaches
are used in practice, how diferent approaches are combined, and what contextual factors inĆuence the
use and combination of hybrid software development approaches.
This summary refers to the paper Hybrid Software and System Development in Practice: Waterfall,
Scrum, and Beyond [Ku17]. This paper was published as full research paper in the proceedings of the
International Conference on Software System Process
Hybrid Software and System Development in Practice
No full textThis paper was accepted and presented in 2017 as a Full Research Paper at the International Conference on Software and Systems Process (ICSSP). This paper examines the question of which software and system development approaches are used in practice. The underlying HELENA study (hybrid dEveLPmENt approaches in software systems development) breaks away from the discussion of "traditional" versus "agile" development and examines actual combinations of processes and methods in so-called hybrid development approaches. This paper reports on the results of the first stage of the HELENA study, in which 69 participants, mainly European, participated in an online survey. Participants were asked to rate and present 40 different development approaches how and why the approaches are used in their companies / projects. The results show that in practice, a structured traditional process often forms the organizational framework for a project, while fine-grained tasks are addressed through individually introduced agile practices. This combination can be found in almost all companies, regardless of company size and industry. In addition, using affinity propagation clustering and spectral clustering, different combination patterns were derived from the data, which were successfully tested for realism with other external studies. Our study shows the widespread use of hybrid development processes and that they usually arise through an individual learning process
Hybrid Software and System Development in Practice
No full textAbstract: Das vorliegende Paper wurde 2017 auf International Conference on Software and Systems Process (ICSSP) als Full Research Paper akzeptiert und präsentiert. Im vorliegenden Paper wird die Frage untersucht, welche Software-und Systementwicklungsansätze in der Praxis eingesetzt werden. Die zugrundeliegende HELENA-Studie (Hybrid dEveLopmENt Approaches in software systems development) löst sich von der Diskussion „traditioneller“ verus „agiler“ Entwicklung und untersucht tatsächliche Kombinationen von Prozessen und Methoden in sog. Hybriden Entwicklungsansätzen. Das vorliegende Paper berichtet über die Ergebnisse der ersten Stufe der HELENA-Studie, in der 69, vornehmlich europäische, Teilnehmer an einer Onlineumfrage teilnahmen. Die Teilnehmer wurden gebeten, 40 unterschiedliche Entwicklungsansätze zu bewerten und darzustellen, wie und warum die Ansätze in ihren Unternehmen/Projekten eingesetzt werden. Die Ergebnisse zeigen, dass in der Praxis häufig ein strukturierter traditioneller Prozess den organisatorischen Rahmen für ein Projekt bildet, während feingranulare Aufgaben durch individuell eingebrachte agile Praktiken adressiert werden. Diese Kombination findet sich bei fast allen Unternehmen, und zwar unabhängig von Unternehmensgröße und Branche. Darüber hinaus wurden durch Anwendung von Affinity Propagation Clustering und Spectral Clustering unterschiedliche Kombinationsmuster aus den Daten abgeleitet, welche mit weiteren externen Studien erfolgreich auf Realitätsnähe geprüft wurden. Unsere Studie zeigt die weite Verbreitung hybrider Entwicklungsprozesse und dass sie i.d.R. durch einen individuellen Lernprozess entstehen
Hybrid Software and System Development in Practice: Waterfall, Scrum, and Beyond
No full textS.30-39Software and system development faces numerous challenges of rapidly changing markets. To address such challenges, companies and projects design and adopt specific development approaches by combining well-structured comprehensive methods and flexible agile practices. Yet, the number of methods and practices is large, and available studies argue that the actual process composition is carried out in a fairly ad-hoc manner. The present paper reports on a survey on hybrid software development approaches. We study which approaches are used in practice, how different approaches are combined, and what contextual factors influence the use and combination of hybrid software development approaches. Our results from 69 study participants show a variety of development approaches used and combined in practice. We show that most combinations follow a pattern in which a traditional process model serves as framework in which several fine-grained (agile) practices are plugged in. We further show that hybrid software development approaches are independent from the company size and external triggers. We conclude that such approaches are the results of a natural process evolution, which is mainly driven by experience, learning, and pragmatism
