The role of human factors engineering in establishing occupational fitness standards

2004 ◽  
Vol 34 (6) ◽  
pp. 451-457 ◽  
Author(s):  
U. Kuruganti ◽  
J. Rickards
Keyword(s):  
Human Factors ◽  
Human Factors Engineering

scholarly journals Considering the Dynamics of FDA Human Factors ValidationRequirement: Implications of Failure and Need to Ensure ProjectSuccess - A Conceptual Framework

2019 ◽  
Vol 8 (1) ◽  
pp. 234-247
Author(s):  
Katia M. Rojas ◽  
Nasser Sharareh ◽  
Leon Cosier ◽  
Daryl L. Santos
Keyword(s):  
Human Factors ◽  
Service Providers ◽  
Human Factors Engineering ◽  
Causal Loop Diagram ◽  
Common Goal ◽  
Product Success ◽  
Key Stakeholders ◽  
Feedback Structure

Recognizing the role of human factors engineering (HFE) in the development of medical devices and combination products that involve devices, the Food and Drug Administration (FDA) now requires human factors (HF) validations before market approval. Manufacturers are responsible for ensuring their products are safe and effective through the application of HFE. However, key stakeholders are still learning and developing capabilities to adapt to the regulatory component. Nonetheless, the lack of the corresponding HF capabilities hinders compliance with the FDA’s expectations, and though ultimate success. No known previous work has looked into FDA HF validation projects to assess the underlying factors and implications of failed submissions. Applying system dynamics (SD), a causal loop diagram (CLD) was developed. CLDs are useful for the exploration of the causal interactions among factors or variables, as well as the underlying feedback structure of a complex system. This work can serve to help manufacturers better understand the FDA’s HF requirement to enable overall product success. Further, with patient safety as a common goal, HF service providers (HFSPs) and regulators should be aware of the need to ensure the consistent quality of the HF element in premarket submissions.

The Role of Hedonomics in the Future of Industry, Service, and Product Design: Panel Overview

2005 ◽  
Vol 49 (18) ◽  
pp. 1701-1704 ◽  
Author(s):  
Tal Oron-Gilad ◽  
P.A. Hancock
Keyword(s):  
Human Computer Interaction ◽  
Human Factors ◽  
Product Design ◽  
Rapid Growth ◽  
Work Environments ◽  
User Evaluation ◽  
Human Factors Engineering ◽  
Human Factors And Ergonomics ◽  
Future Work

Hedonomics has been defined as “ the branch of science which facilitates the pleasant or enjoyable aspects of human-technology interaction.” Hedonomics in general is a fairly new area in research and it is evidently new in ergonomics, human factors, usability and human-computer interaction (HCI). During the last ten years there has been a rapid growth in research about affect and pleasure. Considering the lack of interest from the psychological community during much of the 1900's this comes as a surprise. Affective evaluations provide a new and different perspective in Human Factors Engineering. It is not how to evaluate users — it is how the user evaluates. The research on hedonic values and seductive interfaces is in fact a welcome contrast to issues of safety and productivity, which have dominated human factors and ergonomics (HF/E). In order for industry to adopt these user-evaluating principles (as opposed to user-evaluation principles) it has to be convinced of their practical effectiveness in the workplace. This panel will focus on this issue and the role of Hedonomics in future work environments and products.

AN OVERVIEW OF THE ROLE OF THE NAVSEA HUMAN FACTORS ENGINEERING PROGRAM IN SHIP DESIGN

1983 ◽  
Vol 95 (4) ◽  
pp. 139-152 ◽  
Author(s):  
NORMAN I. STEIN ◽  
RUSSELL A. BENEL ◽  
THOMAS B. MALONE
Keyword(s):  
Human Factors ◽  
Ship Design ◽  
Human Factors Engineering ◽  
Engineering Program

Human Factors Management in Systems Acquisition: Perspectives on an Applied Research and Development Success Story

1989 ◽  
Vol 33 (16) ◽  
pp. 1104-1108
Author(s):  
Jay A. Horn
Keyword(s):  
Research And Development ◽  
Human Factors ◽  
Operational Performance ◽  
Human Factors Engineering ◽  
Development Programs ◽  
Success Story ◽  
Engineering Research ◽  
Engineering Effort ◽  
The Impact

The role played by human factors engineering in the research and development of complex weapons systems is critical to satisfactory operational performance of the system. The role of the human factors engineering manager is no less critical; this individual is not only charged with designing, implementing and reviewing the human factors engineering effort, but also providing leadership in resolving conflicts, building concensus, and championing unpopular positions. This paper chronicles the impact of the human factors engineering program in a moderately-large R & D. The details of the project are analyzed using the an organizational model that focuses on the interactions among the organizational, technical and political logics prevalent at the time. Using this approach, several insights regarding the role of the HFE manager are revealed, and some guidelines for managing human factors engineering research and development programs are offered.

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