Safety-Critical Systems and Agile Development: A Mapping Study

In the last decades, agile methods had a huge impact on how software is developed. In many cases, this has led to significant benefits, such as quality and speed of software deliveries to customers. However, safety-critical systems have widely been dismissed from benefiting from agile methods. Products that include safety critical aspects are therefore faced with a situation in which the development of safety-critical parts can significantly limit the potential speed-up through agile methods, for the full product, but also in the non-safety critical parts. For such products, the ability to develop safety-critical software in an agile way will generate a competitive advantage. In order to enable future research in this important area, we present in this paper a mapping of the current state of practice based on {a mixed method approach}. Starting from a workshop with experts from six large Swedish product development companies we develop a lens for our analysis. We then present a systematic mapping study on safety-critical systems and agile development through this lens in order to map potential benefits, challenges, and solution candidates for guiding future research.Comment: Accepted at Euromicro Conf. on Software Engineering and Advanced Applications 2018, Prague, Czech Republi

An audit model for safety-critical software

Atualmente o uso de software considerados complexos e críticos está crescendo em diversos setores da indústria como a aeronáutica com seus diversos sistemas embarcados em aeronaves e a médica com seus dispositivos médicos cada vez mais avançados. Devido a isso, a quantidade de standards dedicados a esse tipo de desenvolvimento está crescendo nos últimos anos e autoridades regulamentadoras estão reconhecendo a sua aplicabilidade e, em alguns casos, tornando como parte dos requisitos obrigatórios de certificação ou aprovação. O intuito de uma auditoria de software é verificar que o software desenvolvido está de acordo com a norma aplicável, no entanto os modelos existentes não permitem o auditor ter a flexibilidade de adequar o modelo de auditoria às suas necessidades. Como parte dessa pesquisa, diferentes modelos de desenvolvimento software foram considerados, bem como standards da área aeronáutica (RTCA DO-178C) e área médica (IEC 62304) foram estudados quanto as suas recomendações e requisitos para desenvolvimento de software safety-crítico. Como objetivo dessa dissertação, um modelo de auditoria de software foi proposto com as atividades que são necessárias para a condução de auditoria de software safety-crítico, permitindo ao auditor aplicar o modelo de acordo com as atividades que precisam ser auditadas, dando a flexibilidade necessária para o escopo da auditoria, bem como um conjunto de perguntas para a auditoria de software desenvolvido utilizando RTCA DO-178C e IEC 62304 foi sugerido e avaliado por especialistas de software para garantir a maturidade e eficiência das perguntas propostas. Além da avaliação das perguntas, também foi conduzido um estudo de caso, em uma empresa aeroespacial, com duas instanciações para avaliar a maturidade do modelo de auditoria de software proposto.Nowadays, the use of software considered complex and critical is growing in several industry sectors, such as aeronautics with its various systems embedded in aircraft and the medical one with its increasingly advanced medical devices. Because of this, the number of standards dedicated to this type of development is growing in recent years, and regulatory authorities are recognizing its applicability and, in some cases, making it part of the mandatory certification requirements or approval. The software audit intent is to verify that the software developed complies with the applicable standard. However, the existing audit models do not allow the auditor to tailor the audit model to its audit necessities. As part of this research, the various software development models were considered, and standards in the aeronautical (RTCA DO-178C) and medical (IEC/ISO 62304) areas were studied regarding their guidelines and requirements for safety-critical software development. This thesis aims to propose a software audit model with the activities necessary for conducting a safety-critical software audit, giving the auditor the necessary flexibility in the audit execution without the need to achieve specific predetermined milestones. Additionally, a set of questions for software auditing developed using RTCA DO-178C and IEC 62304 has been suggested and evaluated by software experts to ensure the maturity and efficiency of the proposed questions. In addition to evaluating the questions, a case study was also conducted in an aerospace company, with two instances to evaluate the proposed software audit model’s maturity.Não recebi financiament

Technology in Parkinson's disease:challenges and opportunities

The miniaturization, sophistication, proliferation, and accessibility of technologies are enabling the capture of more and previously inaccessible phenomena in Parkinson's disease (PD). However, more information has not translated into a greater understanding of disease complexity to satisfy diagnostic and therapeutic needs. Challenges include noncompatible technology platforms, the need for wide-scale and long-term deployment of sensor technology (among vulnerable elderly patients in particular), and the gap between the "big data" acquired with sensitive measurement technologies and their limited clinical application. Major opportunities could be realized if new technologies are developed as part of open-source and/or open-hardware platforms that enable multichannel data capture sensitive to the broad range of motor and nonmotor problems that characterize PD and are adaptable into self-adjusting, individualized treatment delivery systems. The International Parkinson and Movement Disorders Society Task Force on Technology is entrusted to convene engineers, clinicians, researchers, and patients to promote the development of integrated measurement and closed-loop therapeutic systems with high patient adherence that also serve to (1) encourage the adoption of clinico-pathophysiologic phenotyping and early detection of critical disease milestones, (2) enhance the tailoring of symptomatic therapy, (3) improve subgroup targeting of patients for future testing of disease-modifying treatments, and (4) identify objective biomarkers to improve the longitudinal tracking of impairments in clinical care and research. This article summarizes the work carried out by the task force toward identifying challenges and opportunities in the development of technologies with potential for improving the clinical management and the quality of life of individuals with PD. © 2016 International Parkinson and Movement Disorder Society

Emergence of 3D Printed Dosage Forms: Opportunities and Challenges

The recent introduction of the first FDA approved 3D-printed drug has fuelled interest in 3D printing technology, which is set to revolutionize healthcare. Since its initial use, this rapid prototyping (RP) technology has evolved to such as extent that it is currently being used in a wide range of applications including in tissue engineering, dentistry, construction, automotive and aerospace. However, in the pharmaceutical industry this technology is still in its infancy and its potential yet to be fully explored. This paper presents various 3D printing technologies such as stereolithographic, powder based, selective laser sintering, fused deposition modelling and semi-solid extrusion 3D printing. It also provides a comprehensive review of previous attempts at using 3D printing technologies on the manufacturing dosage forms with a particular focus on oral tablets. Their advantages particularly with adaptability in the pharmaceutical field have been highlighted, including design flexibility and control and manufacture which enables the preparation of dosage forms with complex designs and geometries, multiple actives and tailored release profiles. An insight into the technical challenges facing the different 3D printing technologies such as the formulation and processing parameters is provided. Light is also shed on the different regulatory challenges that need to be overcome for 3D printing to fulfil its real potential in the pharmaceutical industry

Rhinology future debates, an EUFOREA report

The first Rhinology Future Debates was held in Brussels in December 2016, organized by EUFOREA (European Forum for Research and Education in Allergy and Airways diseases). The purpose of these debates is to bring novel developments in the field of Rhinology to the attention of the medical, paramedical and patient community, in a highly credible and balanced context. For the first time in Rhinology, a peer to peer scientific exchange with key experts in the field of rhinology and key medical colleagues from leading industries let to a brainstorming and discussion event on a number of hot issues in Rhinology. Novel developments are presented by key experts from industry and/or key thought leaders in Rhinology, and then followed by a lively debate on the potential positioning of new developments in care pathways, the strengths and weaknesses of the novel development(s), and comparisons with existing and/or competing products, devices, and/or molecules. As all debates are recorded and distributed on-line with limited editing (www.rhinology-future.com), EUFOREA aims at maximizing the education of the target groups on novel developments, allowing a critical appraisal of the future and a more rapid implementation of promising novel tools, techniques and/or molecules in clinical practise in Europe. The next Rhinology Future debate will be held in Brussels in December 2017

Administrative Law\u27s Extraordinary Cases

The Supreme Court\u27s major questions doctrine is grounded in the Chevron framework. Reconstituting it as a major rules exception to Chevron or as a non-delegation principle are misguided and create greater uncertainty