This paper focuses on the challenges of meeting agency requirements as it pertains to the application of human factors in the medical device development (MDD) process. Individual case studies of the design and development process for 18 medical device manufacturers located in the US and EU were analyzed and compared using a multiple case study design. The results indicate that there are four main challenges in implementing international standards. These include a lack of direct access to users for the purposes of device development; a lack of understanding by users with regards to the impact of their feedback on the development process; contract formalities limiting user exchanges; and the attitude of clinical users directly impacting on the device developer's invitation to participate in the development processes. The barriers presented in this research have the potential to be resolved but only with greater commitment by both medical device users and developers.
This paper describes methodology for determining user needs within the design process currently being used by the University of Cincinnati's Medical Device Innovation and Entrepreneurship Program. Topics such as ethnography (user observation and interviews), task analysis, and human factors for product embodiment are discussed. Specific tools for data gathering, analysis and synthesis towards determining design considerations, requirements and specifications are defined.
HALS holds promise as a surgical approach in microgravity, particularly as space travel extends beyond low earth orbit. HALS provides the benefits of MIS, facilitates MIS surgery by less surgically proficient or experienced CMOs, and contains equipment and fluid within the operative field. Simulation provides an easy, cost-effective platform to evaluate medical technology for space flight as well as a method to train CMOs on-orbit.
Knowledge of the relationship between image quality and contrast material dilution might allow a decrease in overall contrast load while maintaining appropriate image quality when using digital flat-panel detectors.
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