The Experts below are selected from a list of 527718 Experts worldwide ranked by ideXlab platform

Richard A Wysk - One of the best experts on this subject based on the ideXlab platform.

  • supporting medical device development a standard product Design Process Model
    Journal of Engineering Design, 2013
    Co-Authors: Lourdes A Medina, Gul Okudan E Kremer, Richard A Wysk
    Abstract:

    This article describes the complex nature of the medical device development (MDD) Process and presents a product Design Process Model to aid Designers engaged in MDD. Basically, the Model serves as a conceptual framework and provides a set of formalisms to define the development landscape for medical devices. Specifically, the Model describes the phases of MDD and their relationships, including the testing and approval environment that impacts this Process. The Food and Drug Administration (FDA) is an essential part of this environment, acting as the regulatory agency for medical devices in the USA. FDA approval is a significant milestone which industry developers must achieve before the actual release of their devices in the US market. In this article, the relevant literature addressing the regulations and the MDD Process Models are reviewed. The development and organisation of the Model are discussed in detail with descriptions of the building Process, concepts, granularity, utility and overall contribution. The Model is the result of a documentation analysis and is supported by a content validation survey and a case study. The Model is proposed as an aid for Designers to proactively use in handling the complexities of MDD.

Lourdes A Medina - One of the best experts on this subject based on the ideXlab platform.

  • supporting medical device development a standard product Design Process Model
    Journal of Engineering Design, 2013
    Co-Authors: Lourdes A Medina, Gul Okudan E Kremer, Richard A Wysk
    Abstract:

    This article describes the complex nature of the medical device development (MDD) Process and presents a product Design Process Model to aid Designers engaged in MDD. Basically, the Model serves as a conceptual framework and provides a set of formalisms to define the development landscape for medical devices. Specifically, the Model describes the phases of MDD and their relationships, including the testing and approval environment that impacts this Process. The Food and Drug Administration (FDA) is an essential part of this environment, acting as the regulatory agency for medical devices in the USA. FDA approval is a significant milestone which industry developers must achieve before the actual release of their devices in the US market. In this article, the relevant literature addressing the regulations and the MDD Process Models are reviewed. The development and organisation of the Model are discussed in detail with descriptions of the building Process, concepts, granularity, utility and overall contribution. The Model is the result of a documentation analysis and is supported by a content validation survey and a case study. The Model is proposed as an aid for Designers to proactively use in handling the complexities of MDD.

Gul Okudan E Kremer - One of the best experts on this subject based on the ideXlab platform.

  • supporting medical device development a standard product Design Process Model
    Journal of Engineering Design, 2013
    Co-Authors: Lourdes A Medina, Gul Okudan E Kremer, Richard A Wysk
    Abstract:

    This article describes the complex nature of the medical device development (MDD) Process and presents a product Design Process Model to aid Designers engaged in MDD. Basically, the Model serves as a conceptual framework and provides a set of formalisms to define the development landscape for medical devices. Specifically, the Model describes the phases of MDD and their relationships, including the testing and approval environment that impacts this Process. The Food and Drug Administration (FDA) is an essential part of this environment, acting as the regulatory agency for medical devices in the USA. FDA approval is a significant milestone which industry developers must achieve before the actual release of their devices in the US market. In this article, the relevant literature addressing the regulations and the MDD Process Models are reviewed. The development and organisation of the Model are discussed in detail with descriptions of the building Process, concepts, granularity, utility and overall contribution. The Model is the result of a documentation analysis and is supported by a content validation survey and a case study. The Model is proposed as an aid for Designers to proactively use in handling the complexities of MDD.

Steven D Eppinger - One of the best experts on this subject based on the ideXlab platform.

  • Model based approaches to managing concurrent engineering
    Journal of Engineering Design, 1991
    Co-Authors: Steven D Eppinger
    Abstract:

    SUMMARY As Design managers begin to implement concurrent engineering in order to reduce development time, Design procedures can become more complex, potentially taking even greater time to complete. This paper discusses the basis for such Design task complexity and presents a method for representing these constraints within a Design Process Model. These Models are used to explore several approaches for Design Process management. It is shown that while the feedback characteristic of concurrent engineering is essential to enhance Design quality, this feedback causes iteration which can use up valuable engineering time. For concurrent engineering to save time, we require a framework for evaluating which tasks are vital to begin early in the development cycle, and which tasks should be left for later.

Cetin Tuker - One of the best experts on this subject based on the ideXlab platform.

  • A proposal for a computational Design and ecology based approach to architectural Design studio
    International Journal of Technology and Design Education, 2020
    Co-Authors: Derya Karadağ, Cetin Tuker
    Abstract:

    Using computational Design methods, this study aims to analyze the effects of an integrated Design Process Model on the ecological awareness of architectural students, and on their ability to incorporate ecological issues in their Design work. To this end, two studies have been carried out. The first one involves a survey about how ecology-related and computational Design courses complement the architectural Design studio at different universities in Turkey. The second one, which is the main study of this paper, presents the results of an ecology-based computational Design workshop. According to the results of the first study, computer-based Design courses in Turkey usually lack the dimension of “computational thinking”, focusing only on computer-aided Design tools. Moreover, we have also found out that ecology courses in Turkish architectural education are mostly elective, and hence, have only very indirect connection to the architectural Design studio. In the second study, we have demonstrated how incorporating computational thinking into the Design Process increase students’ awareness of the ecological dimension and their ability to make this dimension an integral part of their projects. The paper concludes by elaborating on the importance of computational methods in architectural education.