Since 1989 when the FDA completed their study on device recalls that “demonstrated that 45 to 50 percent … stemmed from poor product design” (1), design companies and the FDA have taken more seriously how humans interact with machines and software. Additionally, the Occupational Safety and Health Administration (OSHA) focuses on the effect products have on the product’s relation to the physical person and their anatomy. OSHA not only discovered the importance of these human factors/ergonomics studies to protect workers; they also found that investing in the development of safe products can cut worker’s compensation costs. What some might consider ‘common sense’ is not so common, especially if the product isn’t commonly used or the user isn’t naturally adapted to using it. Over fifty percent of recalls involve issues with general manufacturing process (GMP) issues. As a result, there are now internationally held standards for product development. (For the latest information on International Standards of Operations, check out our article: ISO 13485: 2016 and What It Means for Product Development in the Medical Field). Even with consistently updated regulations on operations, no software or machine can do what humans can, and that is why research into human factors engineering (HFE) done by humans is so important.
Some might assume that these tests could be automated; that you could collect data from machines that have gathered information. However, the role of HFE is more than just a collection of information that is sent to the FDA for evaluation. If you ask the engineers and user experience testers in the industry, they will tell you that to be successful in creating a product that is resilient, safe and effectively does its job, you need humans to understand human behavior. Software is used mostly to track what is happening or to simulate, but doesn’t replace the feedback and deduction that a human has.
So the question remains, why is human factors engineering in product design so important?
Here’s the breakdown:
The primary objective of GMP is to design products that won’t harm the user. The product must not only do what it is supposed to, but it must be done in a way that protects all those involved. When it comes to medical devices, the stakes are even higher; it is literally life or death. Even with minor injuries caused by a badly made product, due to consumer protection laws, the cost of reparations is the responsibility of the manufacturer and suppliers.
Everyone involved in product design takes the process seriously and wants a great end result, but no one has a stake higher than the investor. Unfortunately, when the investor or client is too close to the problem to see it objectively, they can miss certain flaws or unknowingly lead the test user on during panel testing. An experienced User Experience (UX) team will have the skillset to listen equally to negative and positive feedback from the users and turn that information into constructive data.
Evan Ross, Experience Manager at NectarPD, comments on testing products and avoiding bias. “I think of it as similar to a lawyer in court; you don’t want to lead a witness or ask yes or no questions, so you try and keep it really open-ended and err on the side of caution.” To not push them towards a particular design and skew the data requires a certain level of self-awareness. “You have to give bad ideas the same attention as you would good ideas, early on.”
3. Effective Design
Have you ever bought a car before driving it, even if it’s similar to many other cars you’ve driven before? Even a subtle change in the seat or the position of the controls may factor into your decision to buy or not. There’s something about hands-on experience that helps with the final assessment and decision about a product. When it comes to design, creating a tangible prototype early on is key.
“When we’re in development and making the product, we use a lot of software to simulate the use… It’s very visualized, but it isn’t really until you have the thing in your hand, and that’s where the rubber meets the road.” James Wilkin, Industrial Design Manager at NectarPD, stresses that the effectiveness of the design is in its use, and the product simply cannot be assessed efficiently until a human can interact with it. “About 95% of testing on how human anatomy works with the design is when you actually get it and feel it and figure out if it’s a deal breaker or not. What’s key is to get a physical representation early. Out of clay, foam, paper, etc… any way to get something physical that people interact with.”
4. Product Assessment
When assessing and evaluating a design, there are products that are entirely new and others that are new evolutions of a previous one. According to Ross, the first step is to “look at what the product is supposed to do and come up with success criteria and pain-points.” Additionally, you have to take into account who you are designing for, meaning that the design team needs to know the demographic and understand the purpose, application, and setting of the product. A specialty that NectarPD has is in creating medical devices. In this sector of design, there is a whole new level of risk assessment. These products can’t afford errors that cause harm to the user. Ross explains why this is so important.
“If you have a surgeon who’s using the tool for spinal surgery and he can’t properly grip it, and it falls, there’s potentially a serious problem. There can be pretty severe consequences.” Everything down to the amount of grip required by the hand is factored in during R&D. Human factors are about “preventing deaths.”
In the case of the NuVasive Limb Lengthener, a device for juveniles that helped lengthen their limbs if their limbs had trouble growing, the previous design made it difficult on the user to operate alone, caused stress to the user, and the design was not intuitive. The criteria for the new design was that it would “not be too invasive or painful… and had to be non-threatening to children” (Wilkin). Considering who is using your product, in what circumstances, and what their physical limits and requirements already are, all factor into the end design.
Collectively, the explanation of HFE seems so simple it almost seems obvious. Yet, there is a certain skill in seeing beyond our own perspective and being able to step into the mind and behaviors of a complete stranger. What works for one person, or one group, will not always apply to other demographics. Even though there may not be any such thing as a ‘perfect design’ that will include the outliers, the importance of HFE goes beyond saving money for the investor by keeping products from being recalled. Neither does the fiscal benefit of a higher profit made from a product that truly considers its target audience outshine the end result. No, the most impressive reason why HFE is essential is simply that it protects the user and may even result in saving lives.