DevOps in an ISO 13485 Regulated Environment: A Multivocal Literature Review

Background: Medical device development projects must follow proper directives and regulations to be able to market and sell the end-product in their respective territories. The regulations describe requirements that seem to be opposite to efficient software development and short time-to-market. As agile approaches, like DevOps, are becoming more and more popular in software industry, a discrepancy between these modern methods and traditional regulated development has been reported. Although examples of successful adoption in this context exist, the research is sparse. Aims: The objective of this study is twofold: to review the current state of DevOps adoption in regulated medical device environment; and to propose a checklist based on that review for introducing DevOps in that context. Method: A multivocal literature review is performed and evidence is synthesized from sources published between 2015 to March of 2020 to capture the opinions of experts and community in this field. Results: Our findings reveal that adoption of DevOps in a regulated medical device environment such as ISO 13485 has its challenges, but potential benefits may outweigh those in areas such as regulatory, compliance, security, organizational and technical. Conclusion: DevOps for regulated medical device environments is a highly appealing approach as compared to traditional methods and could be particularly suited for regulated medical development. However, an organization must properly anchor a transition to DevOps in top-level management and be supportive in the initial phase utilizing professional coaching and space for iterative learning; as such an initiative is a complex organizational and technical task.Comment: ACM / IEEE International Symposium on Empirical Software Engineering and Measurement (ESEM '20), October 8--9, 2020, Bari, Ital

The Role of Value Stream Mapping in Healthcare Services: A Scoping Review

[EN] Lean healthcare aims to manage and improve the processes in the healthcare sector by eliminating everything that adds no value by improving quality of services, ensuring patient safety and facilitating health professionals' work to achieve a flexible and reliable organization. Value Stream Mapping (VSM) is considered the starting point of any lean implementation. Some papers report applications of VSM in healthcare services, but there has been less attention paid to their contribution on sustainability indicators. The purpose of this work is to analyze the role of VSM in this context. To do so, a scoping review of works from recent years (2015 to 2019) was done. The results show that most applications of VSM reported are in the tertiary level of care, and the United States of America (USA) is the country which leads most of the applications published. In relation with the development of VSM, a heterogeneity in the maps and the sustainability indicators is remarkable. Moreover, only operational and social sustainability indicators are commonly included. We can conclude that more standardization is required in the development of the VSM in the healthcare sector, also including the environmental indicators.Marin-Garcia, JA.; Vidal-Carreras, PI.; García Sabater, JJ. (2021). The Role of Value Stream Mapping in Healthcare Services: A Scoping Review. International Journal of Environmental research and Public Health (Online). 18(3):1-25. https://doi.org/10.3390/ijerph18030951S12518

Integração de usabilidade no paradigma de IoT em telesaúde: Automatização ao serviço da usabilidade

Durante os últimos anos os países desenvolvidos têm sofrido um shift demográfico fomentado pelo aumento da população idosa e pela redução da taxa de natalidade. A proeminência destes fatores nas sociedades atuais despoletou desafios de natureza societal, técnica e económica em várias áreas de atuação. Nessas áreas, destaca-se a área de saúde pela sua sensibilidade e relevância para o quotidiano de utilizadores com necessidades especiais (pessoas idosas, deficientes motores, entre outros). Nesse sentido, para mitigar os desafios impostos nos sistemas de saúde, têm-se adotado tecnologias de informação e comunicação para o dimensionamento de soluções dedicadas, que visam satisfazer necessidades específicas – os ecossistemas AAL (Ambiente de Vida Assistida). Apesar do seu atual estado de desenvolvimento, enfrentam múltiplos desafios relacionados com a autonomia, robustez, segurança, integração, interação humano-computador, armazenamento de dados e usabilidade, que condicionam a sua aceitação junto dos principais intervenientes [1][2][3][4]. O foco do desenvolvimento desta tipologia de ecossistemas sobre o paradigma tecnológico fomentou o desenvolvimento de aplicações específicas centralizadas sobre a mitigação de lacunas técnico-científicas [5][6][7][8], e é apontado como um dos motivos para os seus atuais níveis de adesão. A maximização da sua introdução no mercado impõe que o seu dimensionamento se centralize sobre o utilizador final, em termos de design, requisitos funcionais e não funcionais; e contemple o contexto de integração e continuidade de cuidados inseridos num sistema complexo, por contabilização da diversidade multidimensional dos utilizadores, da natureza das tarefas, do contexto de utilização e das plataformas tecnológicas [5]. Neste contexto, a usabilidade e a utilidade percecionada adquirem um papel de destaque, devido à sua estreita relação com o público-alvo. A necessidade crescente a nível empresarial de minimização do tempo necessário à colocação de produtos no mercado tem motivado a colocação da usabilidade do produto dimensionado em segundo plano [9][10][11]. Fator que aliado à morosidade do processo de análise e ao número de dependências, existência de profissionais na área, de utilizadores finais disponíveis para testar os protótipos dimensionados, entre outras, inviabiliza um estudo extensivo da usabilidade do produto antes, durante e após o seu desenvolvimento. No sentido de mitigar as lacunas identificadas no processo em termos de tempo de execução e dependências explícitas, visar-se-á dotar equipas de desenvolvimento de uma ferramenta que analise o produto dimensionado em tempo real ao nível das linhas orientadoras definidas na literatura. Para quantificar as linhas orientadoras especificadas, impor-se-á a sua parametrização baseada na informação existente na literatura. Nesse sentido, a tese visa compilar os parâmetros necessários a quantificar as linhas orientadoras definidas na literatura: Jakob Nielsen, Gerhardt‐Powals, Shneiderman, Weinschenk e Barker, e Tognazzini. Através da parametrização definir-se-á a base para traduzir linhas orientadoras em lógica a utilizar no dimensionamento de uma ferramenta de análise de usabilidade em tempo real das interfaces. Ferramenta que conferirá aos intervenientes diretos no ciclo de desenvolvimento, os programadores, uma forma objetiva de analisar a usabilidade do produto dimensionado sem requerer a intervenção de entidades externas a título inicial.In the past few years there has been a significant growth of the elderly population in both developing and developed countries. This event provided new economic, technical and demographic challenges to current societies in several areas and services. Among them the healthcare services can be highlighted, due to its impact in people daily lives. As a natural response an effort has been made by both the scientific and industrial community to develop alternatives, which could mitigate the current healthcare services bottlenecks and provide means in aiding and improve the end-user life quality. Through a combination of information and communication technologies specialized ecosystems have been developed, however multiple challenges arose, which compromise their adoption and acceptance among the main stakeholders, such as their autonomy, robustness, security, integration, human-computer interactions, and usability. As consequence an effort has been made to deal with the technical related bottlenecks, which shifted the development process focus from the end-user to the ecosystem’s technological impairments. Despite there being user related issues, such as usability, which remains to be addressed. Therefore, this thesis focuses over the ecosystem’s usability through the analysis of the process used to check the ecosystem’s compliance level with the usability guidelines subset from Jakob Nielsen and Rolf Molich, from Ben Shneiderman, from Weinschenk and Barker and from Tognazzini; and the identification of the quantifiable parameters for each principle that could aid in the heuristics evaluation process by maximizing its objectivity improve its overall accuracy. Through this quantification the base ground is set up to translate the broad guidelines defined in the literature to business rules that can be used to create a tool to check an interface usability overall status in real time. Tool which will provide the main entities in the development cycle an objective approach to check the usability of the product/service created without the intervention of real users in the initial stage of the project

A Hybrid Assessment Approach for Medical Device Software Development Companies

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