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" Prácticas de gestión de proyectos y factores clave para el exito en FDA validaciones de factores humanos de dispositivos médicos y productos combinados "
Rojas, KM
Santos, Daryl
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Latin Dissertation
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| Language of Document
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English
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| Record Number
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1054049
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| Doc. No
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TL53166
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| Main Entry
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Rojas, KM
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| Title & Author
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Prácticas de gestión de proyectos y factores clave para el exito en FDA validaciones de factores humanos de dispositivos médicos y productos combinados\ Rojas, KMSantos, Daryl
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| College
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State University of New York at Binghamton
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| Date
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2020
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| Degree
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Ph.D.
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2020
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| Note
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283 p.
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| Abstract
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In 2016, the Food and Drug Administration (FDA) issued final guidance entitled “Applying Human Factors and Usability Engineering to Medical Devices” (FDA & CDRH, 2016a), as part of its comprehensive Quality System Regulation (QSR). Human Factors Engineering (HFE) is considered critical in the design of safe medical devices and its application is now a requirement for manufacturers of such products. Multiple issues and bottlenecks have emerged, involving concerns about the quality and success of the HF validations, as well as about FDA’s review process. While there is a significant amount of research looking to improve the quality of the HF validations through improving the HFE methods used, no attention has been given to other important aspects (such as understanding the needs of key stakeholders and the characteristics of FDA HF validation projects) to develop across the board solutions. Key stakeholders lack the necessary tools to adapt successfully to current and future demands of the QSR, and measures that help increase the quality and success of such projects are urgently needed. Upcoming updates to the QSR will place greater emphasis on risk-based management of suppliers of medical device manufacturers, and the FDA has launched initiatives that demand performance-based data to measure excellence. An industry-focused (human factors service providers) project management (PM) maturity assessment tool was proposed, consisting of two dimensions (HFE and PM). The research questions this work sought to answer include the following: Is PM being applied to manage FDA HF validation projects? What are the main challenges? Why do these projects fail? What are the drivers of success? What is the average PM maturity level for this industry? What is the ideal PM maturity level for HFSPs? A mixed-methods, exploratory research design was used, including Bruin’s framework for maturity models development. This work included two phases. Phase I consisted of a survey which helped to understand the specified projects and inform the design of the tool. To develop the content to populate the model, Phase II included a panel of experts (Delphi Panel). Part 2 of Phase II covered testing the beta version of the tool. Overall, participants found the tool and content useful. In addition, this work contributes to the literature research about the practices and the key factors that influence the quality and success of HF validations for medical devices and combination projects that seek approval from the FDA.
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| Descriptor
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Engineering
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Health care management
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Industrial engineering
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Santos, Daryl
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State University of New York at Binghamton
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