As a medical product development firm, we have visited an extensive list of hospitals, labs, and operating rooms. We do this to understand the products we are designing in their natural environments, watching and interacting with the patients and users of the products. This is included in typical “user-centered product development” research. During these site visits, I always take time to get a first impression of the hospital or lab, starting at the main entrance. I note cleanliness, signage, lighting, and the collective personality of the staff. Does the landscape look friendly, organized, efficient, and safe? Does the staff seem energetic, helpful, and knowledgeable? I use this first impression as the baseline for the visit. In some cases my first impression remains unchanged throughout the visit. However, sometimes my impressions change for better or worse, but the important fact is to determine how long it took me to disassociate my first impression. Next time you visit a hospital, try associating words to what your ideal qualities are for the environment. Did your words match your perception? The first impression is what most visitors use to challenge their actual expectations and affect their emotions throughout their stay. This first impression experience holds true for the hospital staff. How doctors, nurses, and technicians establish trust in a product is carried over to the impression of the company. This is why brand identity is so valuable.

Past experiences and associations form our perceptions. Perception is learned and affected by multiple sense modalities; sight, hearing, taste, touch, and smell. “What is necessary is for the first impression to be challenged in multiple different contexts. In this case, new experiences become decontextualized and the first impression will slowly lose its power. But, as long as a first impression is challenged only within the same context, you can do whatever you want. The first impression will dominate regardless of how often it is contradicted by new experiences.

”The idea of creating a good “first impression” is an integral component of front-end research. If you have a product that is not designed with the characteristics users expect, the product has to overcome its first impression. An example of this can be found in user interface design. When a user approaches a device it should be intuitive to operate, service, or move. If not, the first impression will be negative and the device, no matter how brilliant, will suffer an uphill battle of user acceptance. Additionally, how people treat their products directly correlates with their past experiences or perception of use. Products are often treated in a manner reflective of the user’s perception of value.

This is the main reason that some products are misused or disregarded while others are protected, babied, and treated with care. For example, what do Ms. Piggy, Underdog, Superman, Batman, and Homer have in common? Yes, they are all animated characters, but they also have something else in common. They are nicknames that were given by technicians at world-class hospitals to “personalize” instruments in clinical laboratories. Lab clinicians, known for having tough schedules and demanding workloads, find the time to name the instruments they use. Walking into a clinical lab you see post-it notes attached to each instrument talking about when they were calibrated, serviced, etc. But you will also see handwritten nicknames attached to the instruments. If a machine is named Ms. Piggy or Homer, chances are it’s slow, bulky, difficulty to operate, or just plain fickle. Equally said, devices with the names like Superman or Batman probably indicate these are the “go to” instruments that have high throughput, function reliably, and operate with intuitiveness. Underdog may very well be that instrument that had a bad first impression, but has consistently proved those impressions wrong.

Improving the development process

Combining front-end research and system architecture significantly improves the chance to develop a successful product by first understanding the context of use and the environment it is designed for, and then defining the appropriate relationship of its components. This ideal combination of activities provides the foundation for the product’s form throughout its development cycle. To derive the appropriate aesthetic, the system architecture needs to be addressed at the same time as research, prior to conceptual design. Achieving an “appropriate aesthetic” highly depends on the integration of firsthand environmental knowledge and system architecture. This is another integral component, often equated to problem solving in front-end research.

System architecture, as discussed here, is the systematic approach to creating the foundation of the internal components that will provide the skeleton of the product form and function. The decision to make the medical device pole ceiling and wall mounted, free standing, bench top or handheld is based on the integration of system architecture and front-end research. This combined effort helps define the market and user specification, ultimately affecting the entire product development path.

In product development, whether based in software or hardware, system architecture is based upon the idea that a structure of a product matters. This is similar to a foundation, and getting the structure right is critical to the success of the product. In hardware or product design, the system architecture is sometimes overlooked or devalued. This leads to either prolonged development plans or products that do not meet the needs of the users. The combination of front-end research and system architecture allows for early immersion into engineering challenges and allows for quick visual choices for the team to articulate.

The definition of architecture can be described as both the process and product of planning, designing, and constructing form, space, and ambience that reflects functional, technical, social, and aesthetic considerations. Architecture is further based on establishing guidelines that must be observed in making choices. An architect will design each room by function and place structural items within those rooms according to their best utility. This is not an arbitrary process—it is architecture. Similar to buildings, products use system architects to respond to user needs, define and allocate functionality, decompose the system, and define interfaces.

FERSA, a term our office uses to describe the combined effort of front-end research and system architecture, can also increase a product’s value in hidden ways (see Figure 1). Understanding a device through its lifespan allows for the consideration of environmental, social, and economic issues. It addresses the placement of components that lead to increased serviceability, reclamation, and separation of disposable and reusables, ultimately increasing sustainability. Seamless integration is accomplished by knowing how a device integrates into other systems or future expansion, allowing for a longer life and better customer acceptance. Products that seem to naturally fit in the environment, almost transparent to the user, are examples of products that integrated user needs, the environment in which they work, and its component layout.

Changing workflow with new technologies

New emerging technologies have the most to gain with FERSA. By understanding the existing system in place, the design team can integrate new technology directly into the existing workflow. By keeping the process or workflow the same, but by adding technology, users are more willing to embrace change. This enables rapid evolution of new technologies. A great example of this is the transformation happening today in pathology. Due to the extreme visual nature of slide reading, pathologists have to visually read and assess each slide. Based on the case, this could mean up to 20 slides per patient (see Figure 2). If a consult is necessary, the physical slides need to be couriered to that location, risking loss or damage. These slides need to be stored onsite for many years, creating an enormous storage and logistics problem. Technology using a digitized approach is now in a place to challenge the current methods of analog visualization of tissues through microscopes. Going from analog to digital workflow in a histology laboratory is a huge technological disruption, similar to how radiology went from film to digital technology. For companies developing products using this emerging technology to be successful, they need to humanize technology and have it integrated into the existing workflow. They need to not only solve the technical problems, but to also understand the entire system, including people that process the slides, the space available within the lab, and how it fits in with the existing system (see Figures 3 and 4). A lot can be learned from shadowing users and even more by documenting the surroundings. Noting what is not there is as important as noting what is.

Validating the voice of the customer

FERSA also helps in validating and challenging voice of customer (VOC) data. VOC captures the appropriate design specifications and the customers’ needs and desires organized into a hierarchical structure. The difference between VOC and up-front research is twofold. The first difference is how it connects to the customers’ user groups. FERSA enables firsthand feedback from the user, allowing the development team to engage with the user, rather than input filtered through a marketing layer. In VOC, the feedback is often two or three times removed before it reaches the development team, and small points can get dropped. Second, up-front research is based on observation. Videos and photos help tell the story or a “day in the life” of the user. It is important to realize VOC collects the information from the user in a way the user believes they are working. Sometimes the way they work is different from the way they think they work. This is extremely true when talking to surgeons. They describe what they do as they actually believe they should be doing. Not until observation can one find differences in what they say and what they do, ultimately creating opportunities for breakthrough features. FERSA takes theses observations and discusses them with the user, providing feedback. Selected users will continue to provide feedback throughout concept development. This feedback allows the team to test the assumptions prior to final development, keeping the users in the design loop throughout development. VOC is a must to identify and prioritize customers’ needs, but does not always illuminate the unmet needs of the user. After all, VOC can only capture what a customer thinks they want, not necessarily realizing there may be new ideas they might desire even more.

Conclusion

Front-end research and system architecture analysis decreases cost and time to market by developing a vetted solution. Opposing constraints are typical with developing medical products. Marketing’s specifications are often in direct conflict with engineering specifications. By taking time to understand user needs and engineering challenges, the team can determine the most desirable attributes, balancing and trading off features that are in direct conflict with another. Complex medical products can have multiple scenarios and multiple solutions. Testing and evaluating different solutions helps optimize the throughput and user interaction. In the past, the system architecture was typically left to engineering. However, FERSA integrates the usability, environmental awareness, system architecture, and rapid visualization mapping techniques that create an effective means to communicate with the user during the front-end of the product development process.

The goal of up-front user research and system architecture is to understand the user needs and requirements to effectively establish appropriate component organization, ultimately making the product more robust and easier to use. Understanding the complexities of the system and identifying the primary, secondary, and unmet needs of the user is paramount for achieving breakthrough products.