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Employing a user-centered design strategy in orthopedic device development can set a company apart from competitors.

The DNA of all product and brand experiences lives in the look, feel, sound, intuitive usability, and performance of instruments, devices, packaging, apps, and services. In the DNA of all highly successful medical products is the unrelenting pursuit of user proficiency, efficiency, comfort, and safety.

Successful design begins with detailed study of current surgical procedures--the "how"--with the goal of identifying the pressure points where tasks are too difficult, tedious, time consuming, or create unacceptable levels of stress or risk in the surgical team. These are all precursors to use errors that compromise the surgical outcome. This user-centered strategy is in direct contrast to an engineering-driven strategy that is driven by a technology, materials, or manufacturing process, alone or in combination, with very little consideration of the end user. An engineering-driven strategy results in high-tech designs with insufficient attention to fundamental human factors that directly impact surgical performance.

In this article I want to unpack the DNA of excellent design by reinterpreting three common design axioms: form follows function, high tech--high touch, and form follows emotion.

Form Follows function

Form follows function was coined by the renowned architect Louis Sullivan (1856-1924) in his Chicago, Ill.-based architectural firm. It was later hijacked by industrial designers in the 1950s and 1960s coming out of the minimalist Bauhaus movement as a fundamental principle of good design whereby a product design should be entirely driven by its intended function or purpose. Any features or design detailing that did not directly support a product's function was superfluous.

Echoing form follows function, the prevailing innovation strategy in medical products today is engineering driven. Generally, it is rooted in a unique technology, material, or manufacturing process that outperforms current engineering practices that frames future product design. Engineering teams begin their new product development journey designing from the inside out, defining motors, circuitry and materials, thereby defining product volumetrics, component layout, and product configurations that are then handed off to others to "wrap" in an external housing. Key opinion leaders (KOLs) test early breadboard designs and provide feedback on what works and what does not work. That in turn guides the engineering team on massaging the internal components and the enclosure design to appease end users' complaints.

For the KOLs, the test end users, usability is king, but their needs are chasing the design, not leading it. Early breadboards are driven by the technology package, and usability has not played a significant role in defining early design configurations, so clinicians struggle through simulations, bone labs, or cadaver labs trying to assess whether the designs have commercial value. As a result, terrific product ideas too often die on the back bench because of the lack of design sensitivity to human factors that impact usability. The product's usability issues impede the surgeon's appreciation and access to the full potency of the new idea. Engineering-driven product design strategy far too often does not consider the end user a priority or until it is too late in the design process to imbed user needs successfully in the product.

Sadly, great breakthrough technology can be sidelined by the barriers of poor usability.

An engineering-driven strategy contrasts a marketing-driven strategy that sells a lifestyle. Using experiential design techniques, each and every consumer touchpoint conveys specific lifestyle qualities the brand wants a user to associate with them. For example, Ralph Lauren Polo clothing projects to others that you believe in the brand's expressed values, and in many cases, live vicariously through the brand. Used extensively in fashion and consumer electronics, a market-driven strategy has no place in healthcare design.

From about 1980 onward, a confluence of design trends and philosophies, from psychology, linguistics, computer science, mathematics, industrial design, and human factors engineering (synonymous with ergonomics) formed the intellectual roots of user-centered design.

A user-centered design strategy is in stark contrast to an engineering-driven strategy because it begins entirely with the end user. User-centered design requires the product development team to define and study the end user in the broadest sense. For a surgical device, as an example, the end user is not just the surgeon who uses the instrumentation. The end user includes everyone in the surgical suite who touches the device during a procedure, the technical staff responsible for cleaning and sterilizing the device, and the factory floor workers that fabricate, assemble, pack, and ship the device.

Everyone and anyone who touches the product throughout its ecosystem and lifecycle have unique needs and requirements that must be considered to design a holistic design solution.

In deference to Louis Sullivan's intent of the form follows function axiom, both form and function should be interpreted as "joined in a spiritual union." This may sound fluffy to the engineering community, but in its purest form, it is a fundamental tenet where engineering and human factors respectfully intersect to create easy-to-use, intuitive design solutions that bring bona fide value to all end-users.

It's always important to note that all successful designs are delivered at a manufacturing cost that allows for financial success.

Form Follows Emotion

In 1969, Hartmut Esslinger, founder of the design/strategy firm frog, expanded the concept of form follows function into form follows emotion. To him, the emotional relationship between a person and a product ultimately defines the product's design success. Product function and performance are measurable in an engineering world, but emotional performance requirements are more elusive. They cut across all sensory capabilities, coming together to deliver a singular emotional product experience.

User-centered design teams commonly use three of the five senses--touch, sight, and hearing. By manipulating a product's form, color, texture, and all related touch points in the product's ecosystem and lifecycle, designers can create intentional user experiences that shape behavior by placing the user in an optimal relationship with the product. This applies to all stages of the products' life, from IFUs to packaging to apps and website through each active use of the product.

Touch

For example, designing an instrument with a grip shape and finger configuration that will solicit a specific grip architecture by the user is a premeditated design decision based in usability. In hand function, the thumb, index, and middle fingers are the three smartest fingers in the dominant hand. These digits are biologically designed for highly precise movements and through ~30,000 sensory receptors in these three fingertips feedback on pressure, temperature, sheer, and other tactile elements are provided. Thus, the design of the instrument's grip will result in the most biomechanically efficient grip with the highest level of coordination, control, and skill for the task at hand.

This design premeditation to elicit emotion in the user extends well beyond grip architecture to include a premeditated placement of the instrument's center of gravity, switches, and controls that are compatible with finger strength and range of motion across the 5th to 95th percentiles in hand size. For tethered handpieces, a successful design geometry minimizes the "whiplash" users experience from cables and tubes exiting the tail of the handpiece. Collectively, these factors define an instrument's haptic signature and when executed properly, naturally elicit the most efficient hand function capability from the surgeon, as well as the greatest emotional sense of ownership.

Sight

Working with the haptics are the product's visual cues that signal to the user how to pick it up, the best way to hold it, and how to use the device most effectively. In 1966, the renowned ecological psychologist JJ Gibson referred to these visual cues as affordances. These affordances possess intrinsic information that prescribes a user's behavioral outcome. Intrinsic in this visual information we receive is an interior dialogue about all characteristics of the product a user will interact with and a comparison of this information to the size, strength, and capability of the user's body. That dialogue is essential to understanding how to use a product. A common example is the decision to hop over a puddle in a parking lot or walk around it. Intuitively, unconsciously, and almost immediately an individual decides the preferred action. This phenomenon is referred to as body scaling, where each person has an intrinsic ruler to measure the environment to determine the most biomechanically efficient and safe behavior.

The body scaling phenomenon is true in grasping, where a user perceives an object's size and form and unconsciously selects the best grip architecture to use in advance of touching it. Research has also shown that the selected grip will also be the most biomechanically efficient grip. World-class design leverages this scientific fact by using functional aesthetics, not styling, to create visual signatures that direct user behavior deemed to be the most effective, biomechanically efficient, and comfortable for the specific task.

Sound

The third key sense that completes the emotional quotient of any product is how it sounds. We have all heard products that sound cheap, irritating, or perhaps sensuous or high quality. In the world of orthopedic surgery, the auditory signature can be something as simple as a decisive "snap" sound so sliding a battery on a bone saw confirms proper connection, or the sound of crisp "clicks" to validate the rotation of a micro adjuster to the height of the femoral cutting block. The key design factor for dialing in the most effective auditory signature is to provide for the ambient noise level and the signal-to-noise ratio that will penetrate the typical cacophony of noise in surgery by selecting the most effective combination of sound frequency and decibel level.

Anyone who has been involved in user research knows what people say they do and how they really behave is never the same. People do not intentionally lie about their behavior; they simply have no trained skill or ability to step back and look at themselves objectively so they can parse their perceptions from their behaviors. A foundational concept of user-centered design is to watch what users do and listen to how they describe their behavior. The former allows you to study human performance and the latter allows you to drill into emotional and behavioral outcomes that are shaped by the visual, haptic, and auditory signatures of the product.

High Tech - High Touch

Author John Naisbitt first developed the concept of high tech - high touch in his classic 1982 bestseller "Megatrends," in which he theorized that as technology increased, people would long for more personal, human contact. Over the last 30-plus years, an unfortunate design trend that contradicts this tenet is to consistently reduce the amount of tactile feedback as technology increases. Furthermore, it is not just touch that high-tech has hijacked. A typical example is Baby Boomers baffled by their children and grandchildren's preference to send a text from the backseat of the car or the far end of the dining room table rather than speak.

Many can remember and grieve for the Blackberry device that remained highly competitive throughout the early years of the introduction of the smart phone. Millions of users loved it, specifically because of its keypad. It had real keys compared to smart phones where the user presses on a sheet of glass, with no haptic feedback. So much for "touch typing!" Blackberry users hung on as long as they could until the manufacturer left them behind by not keeping software up to date. This same migration to less touch is in today's surgical environments, where consoles and instrument controls have gone to high-tech touch screen interfaces that have eliminated valuable tactile feedback to the user.

Lower cost, cleanability between surgeries, simplicity, and small footprint are the drivers for touch screen controls and interfaces in the surgical suite. But these "glass" designs have a direct impact on human performance, effectively slowing users by eliminating rich tactile feedback and leaving control to visually guided action with acoustical feedback. Gone is the richness of tactile feedback provided by the 10,000 sensory receptors we have in each of our 10 fingertips.

Another unintended design consequence from glass interfaces is that touch keys and keypads are larger to mitigate accidental button presses, as compared to smaller, denser three-dimensional keypad designs. Interestingly, Blackberry recently introduced a smart phone with a real keypad that has reignited interest and demand. That response is driven by consumers' desires for real high-tech - high touch products. While smartphone manufacturers have brought back varying levels of haptic feedback to touch interfaces, it remains puzzling why medical manufacturers continue to use low or no feedback touch interfaces.

Why Good Design Matters

Medical device manufacturers 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. That often results in a revival or mimic of what is currently in the market. Others have simply watched their businesses erode and manufacturing lines go quiet while sales go to lower cost, offshore knock-offs.

There are, however, a few businesses that recognize the strategic power of user-centered 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 are directly linked to their ability to make a meaningful connection with their customer. They have studied and designed each aspect of the user experience, from product to packaging to web through to instructions for use and secondary packaging. Notable are the few examples of such brands in the healthcare market.

Human factors is not something you sprinkle on the front end of the design project. Human factors as a design strategy is fundamentally based on bringing science to design to create products that are intuitive, easy-to-use, fit the user physically and cognitively, and are seamless extensions of mind and body. A human factors strategy produces products that do not require extensive and complicated IFUs or expensive in-service training. In fact, there is a direct correlation between the integrity of the design and the need for these crutches for use.

Good design for good design's sake goes beyond aesthetics and can have a profound impact on a company's brand and bottom line. Good design drives profits and market share, and generates new intellectual property. Good ergonomic design creates unique and ownable brand experiences that effectively extricate a company from a commodity market through designs that are sought out, provide rewarding profit margins, advance the state-of-the-art, and place the company as the undisputed category leader.

Dr. Bryce Rutter * Founder and CEO, Metaphase Design Group Inc.

Dr. Bryce Rutter, founder and CEO of Metaphase Design Group Inc., is a specialist in innovation and business strategy with the integration of usability research, human factors engineering, and ergonomic design of hand-intensive products and packaging. His work includes collaborations with numerous global prestigious brands and high-profile startups on products ranging from robotic surgical systems, powered and manual instrument design, and drug delivery systems to disposables, mobile, and wearable devices to personal care products, IFUs, and usability and contextual inquiry research programs. Metaphase delivers innovative designs that redefine industry standards, invigorate sleepy brands, and create new product categories. Under Dr. Rutter's leadership, Metaphase has received more than 120 international design excellence awards and 117 patents. Email him at bryce@metaphase.com.
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Title Annotation:Design Excellence Drives Market Performance
Author:Rutter, Bryce
Publication:Orthopedic Design & Technology
Date:Nov 1, 2018
Words:2554
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