Client News: OR System Meets FDA UX Requirements!

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Pictured from left: Dr. Bagian, Dr. Tremper, and Justin Adams

AlertWatch, Inc. In the News

Occasionally, the usability of a client’s application is directly involved in life-or-death situations, as is the case with University of Michigan startup company AlertWatch, Inc.

The AlertWatch:OR system helps attending physicians, Certified Registered Nurse Anesthetists (CRNAs), and residents in anesthesiology to monitor patients in the operating room (OR) by aggregating data from primary physiological monitors, health records, and lab results to produce an at-a-glance, real-time display of a patient’s condition. The system produces data and visual displays that indicate whether conditions are normal, marginal, or abnormal. (Because AlertWatch:OR is a secondary monitoring system, personnel need to confirm conditions using primary sources.)

As with any software application, AlertWatch:OR users need to understand how to use the system, especially in a high-pressure environment such as the OR.  In fact, the U.S. Food and Drug Administration required usability testing with users before approving AlertWatch:OR for the U. S. market.  We were pleased that AlertWatch turned to TecEd to partner with them to design and execute this validation usability testing to meet FDA requirements.

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AlertWatch:OR Screen

Challenges

AlertWatch asked physicians/anesthesiologists, who typically have full and busy schedules, to attend an AlertWatch:OR training session, and then visit the TecEd lab days later to participate in a one-hour usability test.  Fortunately, we were very happy to meet our goal of recruiting 15 medical personnel for the testing.

Although usability testing in an actual OR was not feasible, TecEd attempted to simulate the environment using OR background audio and images of primary monitoring equipment.

The result is that AlertWatch has obtained Federal clearance to sell the OR version of its patient monitoring software to U. S. clients.  Congratulations to our friends at AlertWatch – we are thrilled to have played a role in this achievement!  Read press release and look for a case study to be published.

About the Author

TecEd’s Vice President of Business Development, Cynthia Zimber, has more than thirty years of experience in Fortune 1000 technology and software channel sales management, as well as marketing and business development for both established and startup companies.