Over nine million volunteers donated about sixteen million units of whole blood in the United States in 2006 either at blood collection centers or hospitals with blood banks. Each donated unit of blood was tested for infectious diseases including hepatitis, HIV and other retroviruses using manual methods or automated testing equipment. This article shares the Human Factors research plan for designing the second generation of the automated testing equipment. Objectives, activities and deliverables are suggested for each phase of the product development life cycle. Human Factors practitioners and consultants in the healthcare industry will find this generic plan useful in designing medical devices.
Get full access to this article
View all access options for this article.
References
1.
American National Standards Institute (ANSI), Association for the Advancement of Medical Instrumentation (AAMI) (2001). Human Factors Design Process for Medical Devices (HE74). Arlington, VA: AAMI.
2.
HarmeningD. M. (2005). Modern blood banking and transfusion practices (5th Ed.). Philadelphia, PA: F. A. Davis.
3.
KuniavskyM. (2003). Observing the user experience. San Francisco, CA: Morgan Kaufmann.
PrahaladC. K.KrishnanM. S., (2008). The new age of innovation: Driving co created value through global networks. New York, NY: McGraw-Hill.
6.
U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA). (April 22, 1998). Human Factors Implications of the New GMP Rule; Overall Requirements of the New Quality System Regulation. Retrieved on February 5, 2009 from http://www.fda.gov/cdrh/humfac/hufacimp.html
7.
U.S. Department of Health and Human Services (DHHS), Food and Drug Administration (FDA). (October 14, 2008). Information for Manufacturers and Distributors. Retrieved on February 5, 2009 from http://www.fda.gov/cdrh/humanfactors/resource-manufac.htm
WiklundM. E. (2003). Is your human factors program ready for FDA scrutiny? [Electronic version]. Medical Device & Diagnostics Industry, 25(1), 100. Retrieved on January 10, 2009 from http://www.devicelink.com/mddi/archive/03/01/004.html
10.
WiklundM. E. (2006). Developing user requirements for global products. [Electronic version]. Medical Device & Diagnostics Industry, 28(2). Retrieved on January 10, 2009 from http://www.devicelink.com/mddi/archive/06/02/004.html
