Skip to Main Content
 

Global Search Box

 
 
 
 

Files

File List

ETD Abstract Container

Abstract Header

Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard

Alley, Krista I

Abstract Details

2014, MDES, University of Cincinnati, Design, Architecture, Art and Planning: Design.
In recent years, the medical device industry has revised its development practices by incorporating the ISO/IEC 62366 (Usability Engineering Process) standard. The standard, purposed to guide industry toward achieving reasonable usability in all medical devices and reduce use errors, heavily emphasizes risk management and has created a large need for usability research and an in-depth understanding of human factors. A common misconception exists that the complexity of identifying, mitigating, and testing for such risk is beyond the usability and human factors components of tradition industrial design. As a result, medical device design teams typically rely on human factors engineers, and in many cases where both disciplines are present, have consequently grayed the understanding of team roles concerning usability engineering. By surveying and performing case studies on design processes used in medical device design, this thesis examines the role of the industrial designer and suggests the best practices for industrial design within the ISO/IEC 62366 standard.
Steven Doehler, M.A. (Committee Chair)
Edwin Bills, M.Ed. (Committee Member)
Soo-Shin Choi, M.F.A. (Committee Member)
Tony Kawanari, M.A. I.D. (Committee Member)
50 p.

Recommended Citations

Citations

  • Alley, K. I. (2014). Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard [Master's thesis, University of Cincinnati]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614

    APA Style (7th edition)

  • Alley, Krista. Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard. 2014. University of Cincinnati, Master's thesis. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614.

    MLA Style (8th edition)

  • Alley, Krista. "Defining the Industrial Designer's Role in the ISO/IEC 62366 Standard." Master's thesis, University of Cincinnati, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1397235614

    Chicago Manual of Style (17th edition)