Reading HE-75, you will note that this document continually discusses risk management and reducing risk. In fact, the entire document is fundamentally about reducing risk, the risks associated with a poor or inappropriate design.
If you drive a car, especially if you have been driving cars for more than a decade or two, you will note that a driving a car with well-designed controls and well-laid out and designed displays seems inherently easier than one that is poorly designed. Furthermore, it has been demonstrated time and again that driving safety increases when a driver has been provided well-designed controls and displays, driving become less risky for everyone concerned.
Car makers now see safety as selling point. (Look at a car that was built in the 40s, 50s or 60s and you'll note how few safety features the car included.) Manufacturers are beginning to include in their luxury models driver-error detection systems. For example, one manufacturer has a system that signals the driver of the existence of an other vehicle the space the driver wants to move to. One of the qualities of a well-designed user interface is the ability to anticipate the user and identify and trap errors or potential user errors, and provide a means or path for preventing or correcting the error without serious consequences. Car manufacturers have been moving in this direction. I suggest that the adoption of HE-75 will be the FDA's way of pushing medical manufacturers in the same direction.
Risk Management: Creating a Good Design and Verifying It
My many blog postings on HE-75 will address the specifics of how to create a good design and verify it, and the process of incorporating these design and verification processes in the a company's risk management processes. In this posting I want to address a two issues at a high level.
First, I want to address "what is a good design and how to do to create it." Creating a good design requires a process such as one outlined by HE-75. I am often amused at hiring managers and HR people who want to see a designer's portfolio having no conception regarding how the design were created. A good design for a user interface is not artistry, it is a result of an effective process. It should not only look good, but it should enable users to perform their tasks effectively and with a minimum of errors. Furthermore, it should anticipate users and trap errors and prevent serious errors occurring. And finally, it should provide users with paths or instructions on how to correct the error. This is what HE-75 teaches in that it instructs researchers and designs And to that end, the design process should reduce risk. Think this is not possible? Then I suggest you spend some time in the cockpit of a commercial airline. It is possible.
Second, HE-75 teaches that design verification should be empirical and practiced often throughout the design process. This is an adjunct to classic risk management that tends to be speculative or theoretical in that it relies on brainstorming and rational analysis. HE-75 teaches that medical device and system manufacturers should not rely just on opinions - although opinions provided by subject-matter experts can provide valuable guidance. HE-75 instructs subjects drawn from the targeted population(s) should be used to guide and test the design at each stage of the process. This becomes the essence of risk management and risk reduction in the design of user interfaces.
Additional Resources
I have this book in my library. It provides some good information, but it's not comprehensive. Unfortunately, it's the only book I know of in this field.
These books I do not owe, but provide you with the links for information purposes. I am surprised at how few books in the field of medical risk management there are. It may go a long ways to explain the large number medical errors, especially the ones that injure or kill patients.
Risk Management Handbook for Health Care Organizations, Student Edition (J-B Public Health/Health Services Text)
Medical Malpractice Risk Management
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