It’s not enough to bring to market state-of-the-art medical innovations if their designs do not take into account how users think, feel, behave and respond. That is, if the design lacks attention to ergonomics, the product may cause users to make errors that impact patient outcomes, as well as a company’s balance sheet and brand integrity. Ergonomics is not something you sprinkle on a design in the conceptual phase of development, but rather it is a way of thinking and frames a development strategy that is founded on the human factor—a user-centered innovation strategy. It’s this strategy that leads to world-class designs. What is world-class design?

We all know what bad design is. These are the products that we complain about, that make us feel stupid, and do little to enhance our user experience. These include mobile phones that make it difficult to type e-mails without keystroke errors; automotive navigation systems that take longer to program than it does to to drive to the destination; and medical devices that cause clinicians to use them the wrong way, resulting in tragic errors.

But what is a world-class design? Intuitively one would say it is a product that looks great and functions well. But what separates world-class design from everyday design is a higher level of fidelity between the product and the user. World-class designs provide seamless extensions of our bodies, allow us to execute tasks more adroitly, and bring emotional content to the consumer product experience that consciously and unconsciously deliver a higher level of value to the user.

The DNA of world-class designs is based on a clear and concise understanding of how users think, feel, and behave. They are intuitive because through the articulation of the product’s form, colors, textures, materials, and on-product nomenclature, they speak to us and tell a story of interaction. When we use them they work the way we expect—there is a cognitive fit. When we physically interact with them they enhance our performance to new levels—there is a physical fit. When we use them, the experience is meaningful and enhances our state of mind—there is an emotional fit. Collectively this perfection of fit defines world-class design and causes users to return time after time to seek out not only the same product when replacement is necessary, but also to live within a singular brand family because of trust.

World-class design builds unprecedented customer loyalty, clearly establishes a company’s leadership position, and defines the integrity of the brand. When this happens companies enjoy category leadership and can focus their attention and financial horsepower on continued innovation.

What is ergonomics?

For decades ergonomics brought to mind control rooms, cockpits, adjustable keyboard surfaces, and office task chairs. Historically ergonomics was introduced to the design process through academic ergonomic experts who unfortunately knew little about design and were not sufficiently adroit in balancing compromises between often conflicting constraints between design, ergonomics, manufacturing, and branding. This shortcoming resulted far too often in ergonomically designed products that were difficult to manufacture, were unappealing, and were inconsistent in terms of brand strategy. More recently we have seen designers embrace ergonomics and attempt to integrate it themselves. It should come as no surprise that this is not a good formula for success inasmuch as designers have little to no understanding about how our bodies are built and what our body’s limits and capabilities are. This old school ergonomics as a strategy simply does not work anymore.

Ergonomics provides a strategic framework for thinking. Ergonomic thinking—thinking about the user—shapes and informs each and every step throughout the development process. In the beginning it prescribes a set of tools that allow you to study and explore white spaces to identify innovation opportunities, providing formative inputs for design. Then using these formative inputs, you build-out human performance and user interface specifications—generative inputs for design—that shape and inform the industrial design process. These same inputs are then used systematically as metrics evaluating designs further downstream in the development process—summative research testing.

Ergonomics is about designing products that fit people. It is about finding ways to enhance the physical, cognitive, and emotional interaction with the product. It is all about designing products that we simply enjoy using because each and every aspect of the person—product interface is perceived by the user to be custom… it’s made just for them.

This new ergonomics is all about you—how you think, feel, behave, and perceive. It takes into account variability between users, cultural differences, variations in global protocols, and the level of sophistication of the targeted users themselves. And it takes into account that our thinking and behaviors cannot be reduced to two-dimensional representations but in fact are dynamic and change over time, and the way in which we use a product is directly influenced by the context of use and our state of mind. World-class design is driven by a user-centered philosophy that puts the user first.

A user-centered design strategy

A user-centered design strategy begins with a broad and deep understanding of who the user is, the tasks they will be executing, how current similar products are used, and identification of new paradigms that offer a higher level of clinical efficacy, human efficiency, and economic success. This strategy shapes the earliest stage of the development process and creates necessary foundational knowledge upon which the entire development program will rest. It requires all project team members to bring an unadulterated point of view of what the final design will be when it grows up and a requirement to park all legacy experiences and expectations that can confound creativity because without an open mind, the outcome will be nothing more than a reskinning of the current design. Exploring early-stage white-space opportunities is the frontier of design innovation and creating new ownable intellectual property. Without a doubt these early-stage efforts are also the hardest part in any new product development program, so let’s take a moment to highlight common challenges in this most difficult phase of work.

Observing what users do and asking them what they did is essential. However, what people say they do and how they really behave is rarely identical, so it is important to understand the perceptions of users and the reality of their behavior. What they say represents their perception of reality, which can provide valuable insights into how sales and marketing strategies need to be tailored to make meaningful connections. In contrast, watching what people do shows us how users adapt the shortcomings of current designs and provides guidance for defining relevant human performance attributes that will enhance user performance.

A common error in early-stage discovery, ergonomics, and design research is the assumption that how people are using the product today prescribes how we should be designing the new product. As an example, consider the challenge of designing a new surgical scalpel. If we base our redesign on what we observed, this would mean that the grips that are used by surgeons today are in fact the best grips and the ones we need to design toward, which is simply not the case. The design of the product directly constrains how that product can be used and in the case of our scalpel, which has not evolved in decades, what we observe are suboptimal grips that have been driven by manufacturing efficiencies rather than user needs. Scalpel designs today are no more sophisticated than kitchen flatware with a well honed edge and do not take into account hand function, ergonomic, and design factors that can increase a surgeon’s performance and comfort.

In contrast, applying a user-centered design strategy would require that we study and understand all aspects of how a scalpel is used and how it varies across the cohort of users and surgical procedures. This includes developing a taxonomy of cuts (length, curvilinear, straight, depth, etc.); defining the type and amplitude of feedback the surgeon wants to best understand the biological nature of the tissue being cut; taking into account for variations in hand size, finger strength, range of joint motion; and from a motor control and biomechanics perspective defining digital grip architectures that promote the highest degree of dexterous control and precision with the least amount stress and strain on the surgeon’s hand. This confluence of human factors immediately defines the sandbox within which designers must play, and in so doing will result in design concept options that are all viable.

The importance of a user-centered design strategy will be felt by all medical device manufacturers immediately with the Association for the Advancement of Medical Instrumentation’s (AAMI) comprehensive human factors standard HE75, formally recognized by the FDA. It provides guidelines and best practices on ways to integrate human factors in device design and development. And the expectation of many in the industry is that this serves as a precursor to mandated requirements in the not too distant future.

User error or use error?

Of particular note in AAMI’s HE75 human factors standard is the difference between user errors and use errors. On far too many occasions we as users have at one time or another felt stupid when we could not figure out how to use a product, or assumed it was to be used one-way when in fact it was not. In some cases our post hoc rationalization is because we did not read the instructions carefully. In other cases we write these errors off to inexperience or carelessness. We think that we made an error—a user error.

When a product misleads users, causing them to use the product incorrectly, it is the product that is at fault, not the users. These are use errors. Use errors are a direct outcome of bad design. They can result in massive recalls and frightening clinical outcomes, and overnight they can take a category leading brand to the basement for a lifetime of litigation. Today there is no brand that can afford bad design. There is no brand that can create any meaningful rationale for ignoring the human factor.

World-class designs don’t lie or pretend. They provide clear and unambiguous cues to our senses on how we should be interacting with the product. World-class designers adroitly use form, color, textures, materials, and design detailing to tell the story of use. When done properly, a design explicitly and immediately communicates to the user. It tells how to properly interact with it and when critical decisions or actions need to be made, the design requires users to double check their decisions before acting to ensure the correct outcome.

Designing the complete user experience

But why is it that we all have seen well-designed products that still fail in the market? The product alone is only one piece to the overall consumer experience. The instructions for use (IFUs), secondary packaging, associated disposables, shipper cartons, training materials, and the Web experience all play an important role in developing world-class designs. Non-nintuitive or poorly designed IFUs or secondary packaging can immediately undermine even the best design. Each and every touch point of the consumer experience provides an opportunity to inform the user. From an ergonomic perspective, how we physically interact with the package and the visual cues that tell us how to interact with the package and how IFUs are designed collectively impact the efficacy of a design.

This does not mean that use errors can be prevented or effectively reduced by simply increasing instructional materials. In fact there is a direct correlation between the quality of a design and the amount of instructions that are needed to support—good designs are intuitive, speak for themselves, and need a minimum of instructional materials whereas bad designs have to tell you in great detail how they are to be used.

Each and every touch point presents an opportunity to make an impression on your customer, enhance their experience, and define the integrity of your brand.

Product and brand integrity

Think about the best designed product you own. You love this product is because of its overall integrity. It feels right when you use it. You love the way it sounds. It allows you to perform at your highest level. Aesthetically it is appropriate and does not add visual noise. It personifies who you are and what you stand for. It is through the products that we use at work, at home, and in play that all of us express what we stand for and what is important to us. I have yet to find anyone who seeks out bad design. And I have yet to find anyone who turned their nose up at good design. Brands that sell quality products build loyalty with their customers and create advocates in the field that extend internal sales and marketing efforts by creating an unending viral marketing campaign.

Integrity is critical into a brand’s success. In fact, the initial lack of success of generic brands was largely due to a lack of brand integrity that defined what the consumer could expect when buying a cheaper unadorned product. The bland and generic appearance and brand messaging conveyed to consumers was that they would get low cost but also low quality. Once this concept was understood by brand experts, there was a sea change in the brand messaging and graphic design of the packaging of these products. They quickly migrated from being simple and plain to possessing the same caliber of on-the-shelf presence and brand promise as longstanding core brands. At a recent conference I attended, a P&G executive noted that historically they did not worry about a generic brand’s competitiveness; however, today because of the sophistication of generic brands, they are as much of a competitive threat as established brands.

Why good design matters

Brands around the world, in all product categories, invest in detailed and costly market research studies to define the right feature sets to be combined with the best styling options only to consistently experience disappointing financial results. Similarly, many global brands rely on engineering development or their manufacturing vendors to create breakthrough designs, which results in nothing more than a redux or mimicry of what is currently in the market today. Others have simply watched their business erode and manufacturing lines go quietly to lower cost off-shore knock-offs.

There are, however, a smaller number of businesses that recognize the strategic potency of good ergonomic design and its direct impact on financial success. These companies have created new product categories, redefined industry standards, built cult-like brand loyalty, exceeded all financial projections, and changed markets forever. The successes of this exclusive club of highly successful brands, such as Johnson & Johnson, Apple, BMW, and Coach, are directly linked to their ability to make a meaningful connection with their customer. They have studied and designed each and every aspect of the user experience, from product to packaging to instructions to Web. How your product or service looks, feels, sounds, combined with intuitive usability and performance excellence defines the DNA of world-class designs.

A design that does not take into account the human factor—ergonomics—is sculpture. Ergonomically designed products can have an immediate and direct impact on a company’s market share, profitability, and brand reputation. They can create unprecedented demand by leapfrogging the competition and provide a unique and ownable consumer brand experience.

The journey to world-class design, not unlike the famous Chinese proverb, begins with the first step. The most effective way to transform your company is to truly believe that a user-centric strategy is fundamentally more productive and in the end more profitable than carrying forward traditional engineering-centric and or marketing-centric business models.

For traditional technology-driven companies, this strategy means not abandoning technology innovations but rather focusing technology explorations based on the unmet and unarticulated needs of users and ways of reinventing the treatment of disease states and procedures that increase efficacy and enhance the user experience. It also means humanizing the technology and stripping out any and all extraneous features and functionality qualities of the product that do not have direct and meaningful value to the user.

For corporations that are marketing-centric, this means spending less time worrying about the features and price points of your competitors, or basing new product introductions on incremental features that may or may not have any impact on the end-user but simply are adopted out of a fear of falling behind on the competitive product matrix.

A company cannot migrate to a user-centered innovation strategy with a few tactical hirings of researchers and ergonomists. Unlike the classic stage-gate new product development processes, a user-centered innovation strategy affords considerably greater freedom to explore new paradigms and to develop a deeper and broader understanding of the users within the markets your company sells into to discover shortcomings, tactical and strategic differences between competitors, and where new technology innovations can have the greatest impact to advance the state-of-the-art.

I have yet to see the transformation of a company to one that consistently produces world-class design take root in any other way than with a top-down corporate culture change. However, a cultural change without adequate funding will be nothing more than an unloaded weapon. The executive office not only has to believe that this is the best business strategy for innovation, but they must adequately fund it to allow it to take seed and flourish. They must also understand that funding a user-centered design strategy differs from traditional stage-gate funded projects. The latter begins with seed money to gain a proof of concept then as successive toll gates are passed funding increases. It is a simple bell curve function (see Figure 1 on page 34).

A user-centered strategy funding model is quite different. It begins with significant funding to develop a broad and deep understanding and to define where innovation opportunities exist, then recedes as designs are explored, then increases again when designs are brought back to the user population for ergonomic and design testing, from which a final design direction is developed. A third wave of investment occurs after the final design direction is prototyped then tested again with users as a final sanity check, followed by the traditional high costs of commercialization. This multimodal funding model is front-end loaded, and without proper funding you simply cannot expect to be as thorough as needed to consistently produce world-class designs. Successful companies are those that view this strategy not just as a necessary cost to be competitive, but instead as an investment in the company’s future health to be the category leader and to fuel long-term innovation.

It’s about getting it consistently right, time after time, with thoughtful design solutions that look great, fit perfectly, and perform flawlessly to make an emotional connection between the brand and its consumers that define your company as the undisputed category leader with world-class design solutions that drive shareholder value.

It’s about achieving world-class ergonomics design!