• Where is the next breakthrough product idea going to come from? All companies face this question, whether you are running a start-up and the success of your company is relying on the success of your first product or running an R&D department of a large, multinational medical device company.

September 13, 2013 — Where is the next breakthrough product idea going to come from? All companies face this question, whether you are running a start-up and the success of your company is relying on the success of your first product or running an R&D department of a large, multinational medical device company. Breakthroughs, whether technical or conceptual that fail to meet the needs and values of people, are typically ignored by the user and ultimately fail in the marketplace. Identifying customer needs and creating a product that addresses them is difficult. The use of Process Mapping is one way to identify problems, turn them into opportunities and create the spark for the development of innovative new products.

What is Process Mapping?

The concept of process mapping has its origins in the development of Scientific Management in the early 20th century. In this system, elements of work were broken down and carefully studied, then reassembled into the most efficient way possible. It was the process that helped define the Industrial Revolution and create the assembly line. From these early beginnings, Process Mapping has expanded into a much broader range of activities, applications and evolved into a six-sigma process used to flowchart any type of business process.

Process Mapping can also be used to identify new product opportunities and can be most valuable when developing new medical devices. Medical devices are often used in a very complex environment such as a hospital or operating room and are part of a process with multiple participants involving patients, caregivers, physicians, administrative staff, nurses, etc. Finding a new product idea or innovation in this web of people and processes can be challenging. Process Mapping is a structured way for observers to make sense of the process from different perspectives and graphically depict points of opportunity.

We are all Designers

The most important moment for observational research is when they witness “the work-around” or “jury-rig”. We are all designers and we all design solutions to help us get through our everyday life. This is the “Ah-Ha” moment for designers and serves as the inspiration we need that could never be accomplished with market research. It is one thing when a consumer modifies a remote control with hand-written tape labels so their mother can use it when they watch the kids. It is another when a surgeon modifies an endoscopic hand tool in order to provide a “work-around” to an ill-designed product. This on-the-fly modification interrupts the normally smooth flow of the surgical team, introduces new risk, creates a distraction, reduces the focus on the procedure and ultimately could compromise the health of the patient.

Problems = Opportunities >>> Innovation

People “design” fixes to products because the manufacturer is not providing the features that they need. By identifying those needs, they can develop a product for a very receptive user base. As a hypothetical example, a medical device company produces handheld glucose monitors that are intended for diabetes patients and are primarily sold as over-the-counter retail products. Someone from customer service notices that a large number of units were purchased by a local hospital through the company’s online store. The information is forwarded onto the Marketing department and they wonder why a hospital would want to use so many monitors with simple features tailored for a home user. Could a new glucose monitor with features specifically designed for a hospital environment be successful?

At the start of the design program, an observation team is sent to the hospital to understand how/why/where the product is being used and uncover additional areas of opportunity. During the observations, it is discovered that the nurses love the handheld units because it gives them a reasonably accurate blood glucose level in less than 10 seconds as compared to the hospital’s system, which requires all samples to be sent to the laboratory, which can take 30 minutes or more. The nurses have created a “design fix”: use the handheld monitor, start the treatment then take the “official” sample and have it sent to the lab. By the time, the “official” results are back, the therapy has been completed. Even though a work-around has been created, an opportunity to create a new product has been discovered.

User Centered Design

Now that the need for a new blood glucose monitor has been identified, the team can begin understanding the device in a much larger context, by mapping actions, environments and users. The device is small and can be easily lost, so many of them are taped to clipboards and attached to nurse’s stations using retractable cords, like at a bank. There is also a problem with calibration. In a home setting, the glucose monitor is calibrated every time a new box of test strips is opened. In the hospital, several test strip boxes are open at one time and more than one nurse uses the same device. In order to provide accurate results, the blood glucose monitor needs to be calibrated to a test strip each time it is used. Even though this method is still faster than the lab test, it is another opportunity for improvement.

After several days of observations, watching a number of different caregivers using the blood glucose monitor, discovering their work-a-rounds and documenting how the device is actually used; the team begins to layout a process map of the blood glucose monitor. The mapping begins to take shape with a “Swim Lane Map” with users as “swimmers” and the process (time & activities) are the “lanes”. To understand the product in its complete context, the process map begins when the need for the blood glucose monitor begins, not when a nurse first picks it up to use. In the same way, the mapping includes stakeholders that don’t come into direct contact with the device such as lab technicians, administration and physicians.

What about Focus Groups? Isn’t that Observational Research?

Focus groups can be beneficial for developing user needs, but they can be very limiting. Focus groups may be unintentionally guided by a set of questions provided by Sales, Marketing, Engineering or some other department with a focus on a specific product or competitor. As a result, the scope of the discussion can be artificially limited. Process Mapping relies on a combination of the direct observation and interviews focusing on the Process, rather than the Product. This allows for open, honest discussion, which can lead to the unexpected insight, the “AH-HA moment” that is the spark for real innovation.

Participants in a Focus Group know that they are being observed, and they tend to act differently. They read instructions, when normally, they wouldn’t. They describe how they perform a task, which tends to be very different from how they actually do it. Most importantly, they are influenced by their own biases. Comments from a Focus Group would be things like, “make it easier to calibrate” or “speed up the calibration time”. Given this input, the Design team begins to develop a product that calibrates twice as fast as their competition. Calibration speed isn’t the problem, it’s because multiple boxes of test strips are open at the same time that the monitor needs to be calibrated. A Focus Group would reveal that most of the glucose monitors are taped to clipboards, but observational research would uncover that many of them are thrown into drawers and it can take 5-10 minutes to find them.

Critical Path leads to Revolutionary Design

After the process map is completed, the team then looks to uncover the critical path of process decisions and interactions, which creates a Blood Glucose Monitor (BGM) Product Definition focused on the user experience:

  • BGM must be difficult to lose
  • BGM must be able to identify calibrated test strips
  • BGM must be able to quickly calibrate to any new test strip
  • BGM must be able to download data into the hospital’s electronic records
  • BGM must be able to meet the hospital laboratory quality system requirements

These requirements identified using process mapping, provide the inspiration for a new hospital-specific Blood Glucose Monitor that is larger than the home version, with an integrated bar code reader that reads a calibration strip on each test strip box. The bar code reader can also read a patient’s ID, allowing their information to be linked to the test results. The Hospital BGM has a dedicated docking station that downloads data into the hospital’s electronic records, while also getting charged at the same time.

About Robert:

Robert has more than 20 years experience creating innovative solutions for clients in the Consumer Products, Industrial Equipment and Medical Device Industries.

Robert is responsible for Business Development efforts at ROBRADY design, consulting with clients on innovation approaches, user research, industrial and interaction design, engineering and all other phases of the product development process. He holds 6 patents in diverse industries such as Semiconductors, Children’s toys, Transportation and Medical Devices. He has won numerous design awards, including the IDSA Design Excellence, Red Dot and Medical Design Excellence Award for his work with clients such as Philips, Home Depot, IBM, General Motors and Coca-Cola.

Robert has a Bachelor’s degree in Industrial Design from Auburn University.