The 2nd Annual Human Factors Engineering and Usability Study Summit was held in San Francisco, CA on February 7 – 8, 2017. Kaleidoscope served as event sponsor, with Chris Carles, Director of Research and Insights, and Larry Schwarz, Ph.D., Marketing Research Specialist, in attendance.

At its core, human factors engineering and usability testing is about more than just satisfying FDA regulations. Maximizing outcomes through appropriate equipment and drug use drives human factors and usability activities. By minimizing opportunities for mistakes (i.e. risk mitigation), many of which have the potential for serious clinical consequences, outcomes are maximized. By evaluating how end users perceive, interpret and operationalize medical devices and their Instructions for Use (IFU), potential product usage errors can be understood, anticipated and successively designed out.

The Summit focused on the importance of and strategies for incorporating human factors and usability testing experts from the outset of a product design plan. This earlier integration not only facilitates product development, it also ensures proper documentation required by the FDA will be available and in good order at the end of the design and development process.

From a business perspective, including human factors and usability testing from the earliest phases of product development is cost-effective. While traditionally there has been reluctance to spend money up front for such activities, experience has shown that the costs of NOT evaluating usability issues at the outset – notably delayed approval and launch, reduced product life cycle and missed sales opportunities – more than offset the time, effort and money spent to ensure that devices are usable in the real world.

Early human factors and usability evaluations – including both exploratory and iterative formative research waves – allow for problems to be designed out before it is too late or too expensive to alter product design. Less time spent focused on the wrong features yields devices and instrumentation that work as intended in the expected environment by anticipated end users. Later summative research and design validation serves as a product’s “final exam” and both demonstrates and documents that a device or drug delivery system can be employed by intended users in anticipated usage environments without significant errors or problems while accomplishing the intended clinical tasks.

We, at Kaleidoscope, understand and stand ready to facilitate the inclusion of human factors engineering and usability testing into the design and implementation of our clients’ product development efforts. We do not stop at providing design solutions. Kaleidoscope maintains both the attitude and the experience necessary to be part of the HFE/usability solution.




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