Frequently Asked Questions (FAQs)

Question: We design, test and build high-quality products. Aren’t users responsible for their mistakes?

Agilis Answer: The FDA's short answer is "no." The FDA sees its regulatory mission is to: o Ensure that manufacturers produce safe and effective medical devices. o Ensure that a safe product includes reasonable protection against dangerous use error. As we work with the FDA and are contributors to its standards and guidelines, we help you understand and anticipate what FDA might be looking from your 510(k) or PMA submission.

Question: We conduct FMEAs. Isn’t that sufficient?

Agilis Answer: Perhaps. FMEAs don’t typically address use errors that may possibly occur when users interact with the device, nor do they address the perceptual, cognitive and behavioral demands that the device places on the user. We can help you develop a customized human factors FMEA that works within your existing processes.

Question: We already have human factors and industrial designers looking at our products. Isn’t this the same thing?

Agilis Answer: Perhaps. Having in-house human factors professionals involved in your research is a real plus. However, human factors for medical products require different skills and a different emphasis on use errors than do traditional human factors. The same applies with industrial designers who typically examine the ‘look and feel ’of a product with an emphasis on aesthetics. It’s important to be prepared when the FDA asks for hard use-related data that neither of these two professionals is familiar with producing. We can train your internal staff to do this work.

Question: We know there are some problems. Can’t we handle them in the instructions?

Agilis Answer: The FDA considers handling use errors in the instructions as the least effective method for mitigation. This is why we work with clients throughout the product development process to help identify problems as they arise and when mitigation efforts are most cost effective. This approach also ensures that your design takes advantage of human factors and performance-based techniques that will enhance your device’s elegance and ease-of-use.

Question: Can’t we wait either until or unless the FDA makes us address human factors?

Agilis Answer: Yes. But by then, you may either be in jeopardy of meeting your launch goals, or, as some companies have unfortunately discovered, you may see your company’s name on the front page of The Wall Street Journal or hear it mentioned on the 6 p.m. news.

Question: Our technology is state-of-the-art. Doesn’t this illustrate how obvious it is to use?

Agilis Answer: In many cases, the smart, technical people who are responsible for delivering this wonderful technology do not represent your users. Education, work environment and age are factors that make it difficult if not impossible for them to truly understand users. If making your product available to the widest possible market to maximize both its value and revenue reflects your goals, then consider how human factors can help accomplish this.

Question: Our users are educated, smart people. Won’t they figure it out?

Agilis Answer: Perhaps. However, from a business perspective, it might make more economic sense for you to ensure that people who use your medical device experience a positive, not frustrating initial experience. Also, with devices in the home environment, it’s important to remember that home users, regardless of their education, can often be under unique stress levels. Also, recent research in the area of cognition suggests that products that place high cognitive demands on users will encounter more (and costly) problems. Given the slim profit margins most manufacturers operate within, this could present devastating consequences.

Question: Shouldn’t we deal with the instructions when we know how everything works?

Agilis Answer: You can. However, performance-based labeling and training are derived from the way you intend the users to interact with your device. This means that the instructions can shed a light on user interaction that may be missed by other analytical techniques. Clients have discovered small but critical user information from this training approach that may have easily gone unnoticed until post market.

Question: We think our training seems to work just fine. Isn’t this enough?

Agilis Answer: How do you know this? Training, whether it’s effective or ineffective can have economic consequences. Ineffective training in clinical studies can lead to poor study outcomes and bad business decisions. Ineffective training in launch cuts profits from your bottom line. If you don’t validate your training, you’re operating in the dark. We can show you how to validate your training.

Question: Human factors is an evaluative tool we do during verification. Isn’t this OK?

Agilis Answer: OK. However, you might be missing critical data about user interaction that would inform your design long before verification. Delaying human factors until verification can mean missed opportunities to differentiate your product from the competition.

Question: We’re just doing a redesign on an existing product. Can’t we skip human factors?

Agilis Answer: Perhaps. Before making this decision, examine other data, including examples of any adverse events, CAPA letters and Customer Support calls. It’s possible that the application of certain human factors and performance-based labeling and training methods, even in a redesign, can provide tangible outcomes.

Question: We can’t do human factors until we have a product that someone can actually use. Right?

Agilis Answer: Many people think that. Actually, the best time to begin to integrate human factors is during product concept. During this time period, a very quick and simple ‘heuristic’ analysis, using nothing more than a flash presentation of how your device might look and work, can produce measurable benefits that will inform your design.

Question: Can’t we find the source of human factors issues with market research and focus groups?

Agilis Answer: There may appear to be some overlap. The major difference between marketing data and human factors is that marketing tends to focus on how people feel about a product; human factors focuses on how people interact with it. We’ve seen clients literally shocked when, for the first time, they see a potential user simply interact — hands on with their device, having no direction or instructions. It’s a real eye-opener… better done before launch than after!