I recently attended the Human Factors and Ergonomics in Health Care event in New Orleans, which offered cutting-edge presentations and workshops on emerging issues in healthcare human factors and the challenges facing us in the near future. It was sponsored by the Human Factors and Ergonomics Society (HFES), whose mission is, “To promote the discovery and exchange of knowledge concerning the characteristics of human beings that are applicable to the design of systems and devices of all kinds.”

The conference highlighted the increased importance of human factors in designing medical devices and the challenges to apply them in healthcare. I came away from the show with the following conclusions:

  1. It’s crucial for device designers to understand the context in which clinicians operate. There are unique elements of clinical workflows that are very different than workflows in every other industry. These workflows are complex and are heavily engrained in hospital procedures and clinical training, so a major challenge facing device manufacturers is to reimagine clinical workflows in a way that overcomes barriers to adoption. This is particularly challenging because clinicians naturally are conservative in changing their methods and processes because of the impact existing systems have on patient health and safety.
  2. Vendors need to adopt agile software development principles so device functionality can be continuously iterated by new software releases. While electronic medical record (EMR) solutions are not regulated by the FDA, regulated medical devices must find a way that both addresses regulatory requirements and the evolving feedback from their users.

As CTO of Etiometry, I pay close attention to human factors and have developed software development policies and procedures based on the underlying principles of human factor design. We’ve developed our business model based on shipping at least four major software releases each year, and will continue to embrace both agile development principles and working closely with customers and prospects to fully understand the context and requirements of clinical workflows.

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