SOURCE: marcus evans

marcus evans

November 06, 2015 11:31 ET

Design Safer Medical Devices by Factoring in the Human Risk

Interview With Eric Bergman, Director of Human Factors Engineering, Fresenius Medical Care North America

SAN DIEGO, CA--(Marketwired - November 06, 2015) - A top priority of medical device manufacturing is to develop and market a functional product that is safe and easy to use. Human factors and usability engineering are integral components of safe and effective device development. A robust human factors strategy is absolutely necessary to maintain customer safety and sustain a competitive edge in the medical device industry.

Eric Bergman, Director of Human Factors Engineering at Fresenius Medical Care North America, recently shared with marcus evans how usability engineering affects the design and development of medical devices:

How does "Human Factors Engineering" differ from "Usability Engineering"?

EB: In the medical device domain, these are different terms for the same process. In the US, we tend to favor "Human Factors Engineering" over "Usability Engineering," but there isn't a difference in meaning.

In fact, the 62366-1 usability engineering standard revised earlier this year states that for the purposes of the standard, the terms should be considered interchangeable. I've been known to use both terms in the same sentence, so don't be surprised if I do that here.

How would you describe the role of usability engineering in the medical device space, and how does it (or should it) influence the design and development process?

EB: Usability engineering is most effective if applied across the development lifecycle. It should influence design and development from the earliest stages of identifying user requirements and developing and evaluating product concepts. It should continue iteratively across development. In this way, usability considerations contribute a series of smaller and smaller course corrections cumulatively lowering the likelihood of surprise findings in validation that could derail your project.

What are the main benefits of performing comprehensive early formative usability evaluations?

EB: The primary benefit of early testing is improved quality of the system under development -- meaning a safer more usable product; and likely more satisfied users.

I once read that if we detect even a huge meteorite that will strike the Earth, if we find it far enough in advance, then it can take a small push to deflect it. On the other hand, if we detect an object when it is close, the cost and effort to change its course becomes enormous or even impossible. Performing early usability testing has a lot in common with that scenario.

If you think of formatives as helping "form" the design by identifying needed course corrections, then you can see that the earlier you address human factors considerations, the better.

What specific tests do you perform to assess device safety?

EB: The joke about asking a human factors engineer a question is that the answer is always "it depends." That's because so much of human behavior is a matter of context. Who is the user? What is the environment? What is the training? Who is performing what tasks in what conditions? That's all before we get to the question of the device design itself!

So my answer to the question of "specific tests" is that there is no answer. Usability testing is an important tool, but it is just one of many. So the best answer to your question is that it is critical to identify users, their environment, and their tasks as early as possible. Identify the tasks and assess use safety in the context of use through task analysis or similar methods. If you don't lay out that analysis first, then you may be asking the wrong questions.

What is your advice for companies looking to develop usability engineering capabilities?

EB: It won't surprise you to hear me recommend that they start by hiring a subject matter expert with medical device human factors experience! However, this is easier said than done, so they may need to engage a human factors engineering consulting firm in the early stages of developing internal competency. There are a number of excellent small firms that focus exclusively on medical device human factors.

Note that experience with market research and focus groups is not a primary qualification. Similarly, make sure that anybody you hire has experience with successful summative usability testing, not only formative testing during design/development.

It is also important to develop a human factors process that integrates with your design control and risk management procedures. We all know this as medical device professionals, but it is especially important in the human factors domain where activities touch aspects of development ranging from requirements to design of the interface to risk analysis to validation and more.

Join Eric at the Human Factors Excellence for Medical Device Design Conference, November 18-19, 2015 in San Diego, CA. For any questions, read through the conference agenda or contact Tyler Kelch, Digital Marketing Manager, marcus evans at 312.894.6310 or

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