“User Centered Participatory Design and Medical Devices: The Good, the Bad, and the Ugly”
User Centered Participatory Design (UCD/UCPD) is no longer a luxury, it is a requirement. The various regulatory bodies, e.g., ISO, FDA, etc. have incorporated the processes and principles of UCD into their standards. The incorporation of Usability Testing into the Product Lifecycle is only one part of these requirements.
Companies are finding Usability Testing to be very expensive and time consuming and that is because they are not incorporating UCD/UCPD processes and principles from the beginning of their product cycle. And the largest factor is the U, or the USER that is not being integrated in those early stages. This talk will outline some of the very simple and efficient processes and methods that when used in the beginning of the product cycle can assist in cutting the time line and costs of products. Examples of what to do and not to do will be illustrated by real life experiences.
In addition, it will be shown how these processes and methods can actually cut the costs of the required Usability Testing, namely, summative testing. In summary, products that use UCD/UCPD methods and processes assure safe, effective, usable, and profitable products entering the medical device market.
Virginia is both a Principal and founder of HirLan, Inc. Virginia is the primary consultant on Human Factors research projects. Virginia started in the medical research field as a Coordinator of Research at the Clinical Research Unit Kennedy Institute of Johns Hopkins Medical Center. She was responsible for the initiation, coordination, and management and/or analysis of research projects in the Clinical Research Unit. These projects were funded by various Federal Government Agencies, for example NIH. Subsequent to that experience Virginia entered the field of Human Factors through her doctoral graduate training at SUNY Binghamton. Virginia held a fellowship at the Aeromedical Research Laboratory of the United States Air Force at Wright-Patterson AFB, Dayton, Ohio and a fellowship at NASA. Her research dealt with cognitive factors that differentially affect the characteristics of visual displays. Applications of this research are directly related to various medical devices and software applications.
In addition, Virginia has extensive experience in the areas of product design, User Centered Participatory Design processes, and product lifecycle management. She has held management levels positions in User Experience, Web Services and Infrastructure, UI Design, and User Research at HandsOn Mobile, DivX, DirecTV, Microsoft, AIG SunAmerica, RemoteNet, AOL, Symantec, Motorola, and Bellcore. These positions have provided her with both product and IT experiences that have created products that differentiate themselves from the competition. She is also known in the Human Computer Interaction and Usability Communities for her innovative techniques for collecting and incorporating user/customer feedback throughout the product lifecycle.
Virginia holds a PhD in Psychology from SUNY Binghamton, a MS (ABT) in Applied Technology, Systems Science from SUNY Binghamton, a MA in Psychology from Towson State University and a BA in English from SUNY College at New Paltz.