<p>    </p> <p>Healthcare is one of the most critical and valuable industries. This report is a systematic literature review of the usability and safety of medical devices used extensively for patient care. Safety has been broadly considered to mean in-patient safety and improving patient care. As part of the literature review and bibliometric analysis, a search of all the articles containing the keywords “medical device” AND “usability” AND “safety” was conducted on both Web of Science and Google Scholar (through Harzing’s Publish or Perish). The results that also contained the metadata were exported to VOS Viewer for cluster generation and co-citation analyses. As part of data mining, statistical tests such as regression analysis were conducted to find the causal relationship and significance between the variables. Following this, a core set of articles, some of which demonstrated strong ties to the topic at hand, were chosen from various databases and co-citation analyses. The core set also included a relevant chapter from the <em>Handbook of Human Factors and Ergonomics, Fourth Edition </em>by Salvendy. The articles were added to Mendeley and then exported to MAXQDA for the word-cloud generation. As part of the lexical search, Springer’s AuthorMapper and Digital Science’s Dimensions were used to extract trending keywords, author information, and metadata of relevant contributions made to the topic by institutions worldwide. The regression analysis revealed a significant tie between the database and the number of articles. Additionally, the regression showed that cites per year in Google Scholar had a significant effect on g-index. Finally, the discussion section included a case study of three different drug delivery systems. This aimed to perform a risk assessment of pre-existing “smart” medical devices. The analysis revealed that there is a high risk of malfunction in all the devices due to pre-programmed dose error. None of the devices were capable of “learning’ from patient behavior and adapting accordingly. Finally, the paper discusses Human-Computer Interaction and Human Factors Problems that exist in software medical devices that utilize AI/ML methodologies. Overall, the main keywords of human cognition, health informatics, precision medicine, applied ergonomics, and design safety showed high relevance within all the chosen articles. These keywords are highly reflective of the fields that are currently disrupting the conventional governance of healthcare. </p>

Este trabalho descreve a definição e institucionalização de um processo de engenharia de requisitos que está em conformidade com as áreas de processo do CMMI (Capability Maturity Model) de Gerência de Requisitos e Desenvolvimento de Requisitos e cujos componentes (atividades, papéis, produtos de trabalho) são baseados em RUP (Rational Unified Process). A principal contribuição deste estudo é a definição de um processo de engenharia de requisitos baseado em abordagens de desenvolvimento diferenciadas, que foi implantado em uma organização específica, com foco em praticidade, eficiência e retorno do investimento. A implantação do processo em projetos reais permitiu sua experimentação, avaliação e refinamento, validando as alternativas de integração utilizadas para empregar as abordagens de desenvolvimento escolhidas. Complementando o processo proposto, como decorrência do foco em eficiência, são consideradas possibilidades de emprego de práticas de métodos ágeis na execução do processo, com o intuito de aumentar a produtividade do mesmo, sustentando sua garantia de qualidade. O processo proposto é descrito, do método de concepção aos passos envolvidos e artefatos gerados em cada atividade. Também são comentadas as etapas e áreas de trabalho envolvidas na institucionalização do trabalho. / This research depicts the definition and institutionalization of a requirements engineering process which is in conformance to CMMI (Capability Maturity Model) Requirements Management and Requirements Development process areas. The proposed process components (activities, roles, work products) are based on Rational Unified Process (RUP) process framework. The proposed process main contribution is the definition of a requirements engineering process, leveraging such diverse development approaches, which was implemented in a specific organization, focusing on practicality, efficiency and return on investment. Implementing such process in real projects has promoted its experimentation, evaluation and refinement, validating the integration alternatives used to bring together the chosen development approaches. The possibility of employing agile methods practices through the process execution is discussed, aiming at increasing the process productivity, while assuring product quality. The proposed process details are described, from method conception to each activity steps and generated artifacts. The process institutionalization phases and work areas are also commented.

Este trabalho descreve a definição e institucionalização de um processo de engenharia de requisitos que está em conformidade com as áreas de processo do CMMI (Capability Maturity Model) de Gerência de Requisitos e Desenvolvimento de Requisitos e cujos componentes (atividades, papéis, produtos de trabalho) são baseados em RUP (Rational Unified Process). A principal contribuição deste estudo é a definição de um processo de engenharia de requisitos baseado em abordagens de desenvolvimento diferenciadas, que foi implantado em uma organização específica, com foco em praticidade, eficiência e retorno do investimento. A implantação do processo em projetos reais permitiu sua experimentação, avaliação e refinamento, validando as alternativas de integração utilizadas para empregar as abordagens de desenvolvimento escolhidas. Complementando o processo proposto, como decorrência do foco em eficiência, são consideradas possibilidades de emprego de práticas de métodos ágeis na execução do processo, com o intuito de aumentar a produtividade do mesmo, sustentando sua garantia de qualidade. O processo proposto é descrito, do método de concepção aos passos envolvidos e artefatos gerados em cada atividade. Também são comentadas as etapas e áreas de trabalho envolvidas na institucionalização do trabalho. / This research depicts the definition and institutionalization of a requirements engineering process which is in conformance to CMMI (Capability Maturity Model) Requirements Management and Requirements Development process areas. The proposed process components (activities, roles, work products) are based on Rational Unified Process (RUP) process framework. The proposed process main contribution is the definition of a requirements engineering process, leveraging such diverse development approaches, which was implemented in a specific organization, focusing on practicality, efficiency and return on investment. Implementing such process in real projects has promoted its experimentation, evaluation and refinement, validating the integration alternatives used to bring together the chosen development approaches. The possibility of employing agile methods practices through the process execution is discussed, aiming at increasing the process productivity, while assuring product quality. The proposed process details are described, from method conception to each activity steps and generated artifacts. The process institutionalization phases and work areas are also commented.

Este trabalho descreve a definição e institucionalização de um processo de engenharia de requisitos que está em conformidade com as áreas de processo do CMMI (Capability Maturity Model) de Gerência de Requisitos e Desenvolvimento de Requisitos e cujos componentes (atividades, papéis, produtos de trabalho) são baseados em RUP (Rational Unified Process). A principal contribuição deste estudo é a definição de um processo de engenharia de requisitos baseado em abordagens de desenvolvimento diferenciadas, que foi implantado em uma organização específica, com foco em praticidade, eficiência e retorno do investimento. A implantação do processo em projetos reais permitiu sua experimentação, avaliação e refinamento, validando as alternativas de integração utilizadas para empregar as abordagens de desenvolvimento escolhidas. Complementando o processo proposto, como decorrência do foco em eficiência, são consideradas possibilidades de emprego de práticas de métodos ágeis na execução do processo, com o intuito de aumentar a produtividade do mesmo, sustentando sua garantia de qualidade. O processo proposto é descrito, do método de concepção aos passos envolvidos e artefatos gerados em cada atividade. Também são comentadas as etapas e áreas de trabalho envolvidas na institucionalização do trabalho. / This research depicts the definition and institutionalization of a requirements engineering process which is in conformance to CMMI (Capability Maturity Model) Requirements Management and Requirements Development process areas. The proposed process components (activities, roles, work products) are based on Rational Unified Process (RUP) process framework. The proposed process main contribution is the definition of a requirements engineering process, leveraging such diverse development approaches, which was implemented in a specific organization, focusing on practicality, efficiency and return on investment. Implementing such process in real projects has promoted its experimentation, evaluation and refinement, validating the integration alternatives used to bring together the chosen development approaches. The possibility of employing agile methods practices through the process execution is discussed, aiming at increasing the process productivity, while assuring product quality. The proposed process details are described, from method conception to each activity steps and generated artifacts. The process institutionalization phases and work areas are also commented.