HFES 2013 and Rewriting IEC 62366: Adventures in Medical Device Usability

•Medical Device Design.
•Healthcare Information Technology.
•Operating Room Arena.
•Patient and Healthcare Provider Safety.

I’ll be spending most of my time at the Medical Device Design presentations, so most of my posts will reflect that. I’ll try to focus on what’s new, different, and particularly interesting.

The first session in the Medical Device Design track focused on standards, risk analysis, and design processes.

Ed Israelski, of AbbVee, gave a talk about what’s happening in the world of human factors standards for medical devices. He should know. He’s the convener of the committees that are responsible for IEC 62366:2007 and co-chairs the AAMI Human Factors Engineering Committee that authored HE 75. 

Ed mentioned that we (I’m on the committees too and know that I can reveal what’s happening behind the scenes, if Ed talks about it) are rewriting IEC 62366 (now that everyone has digested it) by dividing it into 2 components: a normative standard and an informative technical report. The normative standard component will be streamlined, harmonized with the FDA Draft Guidance on Human Factors (which may be finalized eventually according to my sources), contain simplified terminology, and be integrated more with risk analysis. These are welcome changes (now this is me editorializing), since the present irony is that 62366 is a usability standard that isn’t particularly usable. The informative technical report component will be more of a tutorial, with examples and illustrations. All in all, despite requiring everyone to learn a new standard, the changes should be real improvements.

Dean Hooper, of Ximedica, had some interesting things to say about human error and risk analysis. His central theme was that it’s important to think of use error as a symptom, not a cause, of system failures. So use errors should be one of the starting points of risk analysis; a next step is to determine the root causes of use errors.

The third and final presentation in the session was given by Cindy Miller and Amy Gallenberg, of GE Healthcare. They compared 2 models of product development, with an emphasis on software development: an iterative, prototype/test/prototype model (the one that everyone in my world is used to using) and a “decoupled model”. The idea of the “decoupled model”, I think, is the old “concurrent engineering” from hardware development. The important advantage that I see for software development is that it pulls the prototyping out of software engineering and, instead, does it with rapid prototyping tools along a parallel track with the software-development effort—feeding information to the engineering team, but not investing engineering time in prototyping. The engineering team may find creating prototypes that don’t yield usable code unsatisfying (and this is my editorializing again), but I’m convinced that it’s faster overall and has the advantage that prototypes can be altered easily, so the team is less likely to live with mediocrity. Of course, it’s important to time the coding effort in such a way that those components that require input from the usability testing don’t get ahead of the prototyping/testing parallel track. In fact, as Cindy and Amy said, the two approaches really work together, rather than being mutually exclusive.

I participated in the second session of the Medical Device Design track at the HF Symposium.

My theme was that, as we human factors professionals have gotten more involved in regulatory affairs (doing a lot of formative and summative testing, as directed by FDA), I fear that we’re under-emphasizing early involvement—the result being that we’re developing devices via trial and error, which is notoriously inefficient and seldom yields excellence rather than adequacy. I urged my colleagues to spend more time doing contextual inquiry at the beginning of device-development projects, providing the team with technical human factors information as a project unfolds, and using our formative testing more effectively as a product-development tool, not just as a regulatory “check-off.”

My presentation was followed by one by Sara Waxberg and Pat Baird of Baxter. They gave practical advice on “selling” HF to management.

Some of their advice included:

They also suggested some information that academics might pursue to help those in industry, e.g.:

The final presentation of the session was by Rob Tannen and David Schiff of Bresslergroup. They talked about patents, something that human factors professionals don’t necessarily think that much about. As they said, increasingly in the medical-device area, the key innovations have to do with usability, so human factors can be an important driver for IP. Their advice was, when working to improve usability with medical devices, to think from the beginning about what might be patentable. They also suggested that patent research, via Google patents, makes a useful adjunct to early secondary-source research about human factors issues.

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Stephen B. Wilcox, is a principal and the founder of Design Science (Philadelphia), a 25-person firm that specializes in optimizing the human interface of products—particularly medical devices. Wilcox is a member of the Industrial Designers Society of America’s (IDSA) Academy of Fellows. He has served as a vice president and member of the IDSA Board of Directors, and for several years was chair of the IDSA Human Factors Professional Interest Section. He also serves on the human engineering committee of the Association for the Advancement of Medical Instrumentation (AAMI), which has produced the HE 74 and HE 75 Human Factors standards for medical devices.

More Adventures in Medical Device Usability

Isn’t it Time for a Better IV Pole? 

Conscious Awareness is Highly Overrated

HFES 2013 and Regulated vs. Unregulated Components of Human Factors Work: Adventures in Medical Device Usability