Originally Published MDDI January 2005

Product Development Insight

Process Mapping as a Route to Innovative New Products

Identifying customer needs and creating a product that addresses them is difficult. Cross-functional process mapping provides one way to approach the problem.

David Warburton

Where is the next great new product idea going to come from? It is a question every company faces at some point in its life. For a start-up company, the answer can mean the difference between growth and failure. Start-ups must try to grow beyond the one product idea around which the company was founded. For a large multinational company, the question becomes the focus of entire departments. Because of the relentless demands of earnings growth, large companies require a constant and regular supply of new product introductions.

The new product idea or innovation is the initiating spark of the new-product development process. Everything beyond that is execution, from customer requirements definitions through process validation and market release. Yet, despite the importance of innovation to the new-product development process, the act of innovation itself often appears to be left to chance.

Innovation can be subdivided into three categories: research driven, technology driven, or marketing driven.

Research-driven innovations come from the advancing knowledge of physiology. As knowledge about the human body increases, it creates new avenues for medical device innovation. Recent advances applying drug coatings to stents are an example of this kind of innovation.

Technology-driven innovation occurs because the advancing technical state of device development enables something new. This innovation occurs either directly through a new invention or through indirect innovation. For example, the original computed axial tomography (CAT) scanner was a new invention. Many subsequent improvements to the CAT scanner were developed because smaller, more-powerful computers became available. The evolving CAT scanner, then, is an example of indirect innovation.

Market-driven innovation is the most common type. Breakthrough research- or technology-driven innovations, like the coated stent or the CAT scanner, do not come along every day. These kinds of innovations may require years of research and development before they are ready for the marketplace. Consequently, most medical device innovation comes, like most other products, through market research. A company discovers or creates a customer need, then develops a product based on an existing technology that it tailors to fill that need. This sounds simple enough, but that does not mean it should be taken lightly.

A company's success often hinges upon its ability to discern the needs of its customers and to define a product with the features that meet those needs. Despite the importance of this process, many companies' approach to discovering or creating customer needs is haphazard. Some of the most common methods include

• Luck.
• Genius, which is often luck combined with experience.
• Suggestions from the sales force or directly from customers.
• Ideas from senior management.

CFPM

A more-formal method of generating new product ideas in the medical device industry is cross-functional process mapping (CFPM). CFPM is a six-sigma methodology used to flowchart virtually any type of business process. The process was developed as a visualization tool to help a process improvement team identify the wasteful or redundant steps in a process.

CFPM can also be used to identify new product opportunities. Medical devices are often used in a highly complex environment, such as a hospital, where they are part of a process involving patients, caregivers, and administrative staff. But looking for a product opportunity in this web of interrelated processes can be challenging. CFPM can provide a structured way for observers to make sense of these processes and graphically depict points of opportunity.

A cross-functional process map of a process, like the prepping of an operating suite for surgery, may identify the features of a company's product that add value. Then those features can be highlighted in a company's advertising. The map may also identify places where a company's product creates waste. For example, a drape may have to be taped up to fit properly because the snaps are in the wrong places. At its best, CFPM can help to identify the not-yet-invented product that could eliminate a major cost-adding step in the process.

Identifying Customer Needs

The following hypothetical example illustrates how a company can use CFPM to identify the market need for an entirely new product. A medical device company makes handheld blood glucose monitors for the over-the-counter retail market. The company begins to notice that some of its customer service calls and returns are coming from hospitals. Follow-up calls reveal that the product is being used in the hospital as an adjunct to the laboratory blood analyzers.

Because the product's features are tailored primarily for the home user, the marketing team is eager to find out what made the product attractive in the hospital. They wonder if a product designed specifically for hospital use would be well received. So, they send an observer into one of the hospitals that is using the glucose monitor.

The observer uses a CFPM flowchart called an opportunity flowchart to record observations about this hospital's process for measuring a patient's blood glucose level (see Figure 1). The opportunity flowchart is divided into two columns: “Value Added” and “Cost Added Only.” The “Value Added” column is for tasks which contribute to the end goal of the process. The “Cost Added Only” column is for tasks which do nothing to contribute to the end goal but add cost. Some examples of time-wasting, cost-added tasks are

• Looking for a tool or information required to complete a task.
• Long periods spent moving between remotely linked tools or information and the point of use.
• Correcting errors from previous steps in the process.
• Waiting for approvals that do not add value.

The most important telltale process for the marketing observer looking for new product ideas, however, is the jury-rig, or as some call it, the hack. The hack is a nonfactory modification made to an ill-designed product just to get it to work properly. Alternately, a hack can be a nonfactory modification made to a product so it can be used in on off-label way.

Customers hack products because the manufacturer is not providing features that the customer needs. If a manufacturer can identify those needs, it can develop a product for a receptive customer base.

While observing the use of the handheld glucose monitor, the observer finds several hacks. The nurses love the handheld monitor's ability to obtain a reasonably accurate blood glucose level in 30 seconds. But the features of the handheld monitor do not allow it to comply with the hospital's laboratory quality system requirements. So the nurse still has to take an official blood sample to send to the lab, but starts therapy based on the results from the handheld glucose monitor. The completed opportunity flowchart illustrates these findings.

The flowchart also illustrates that, although the handheld monitor gives much faster results than the lab, the assay process still has a number of cost-added steps. Many of the steps could be addressed with a new or improved product. Because the device is small, it is easily lost. On one occasion, the observer finds the small, credit-card–sized glucose monitors taped to clipboards and hung on walls. The nurse explains that the monitors are taped there so they don't get lost.

Observation and interviews also reveal that the method used to calibrate the monitor in the home does not work in the hospital. In the home, the device is calibrated once when a new box of 50 test strips is opened. In the hospital, several caregivers use the same device, and more than one box of test strips is often open at the same time. Consequently, a caregiver has to check the calibration each time the device is used.

Figure 1 illustrates the findings at one hospital. Typically, once the opportunity chart is developed for one observation site, the CFPM process is repeated at other sites and the flowcharts compared. It is important to get the feedback from multiple sites. If the product is to be successful, it needs to solve problems that are common to a community of users, rather than to just one customer.

This example highlights some of the weaknesses of relying exclusively on focus groups as a methodology for discovering customer needs. While focus groups are a powerful tool for developing user needs, they have limitations.

First, focus groups may be unintentionally guided by a set of questions that is framed by the biases of a marketing team and by a focus on a specific product. Consequently, the scope of the resulting discussion process may be unconsciously and artificially circumscribed. Process mapping relies on a combination of direct observation and interviews focusing on the process rather than the product. This opens the door for unexpected insight, which can lead to real innovation.

Second, the participants in a study are limited by their own biases and often cannot see beyond a linear extension of what they are currently doing. For example, a focus group may generate comments like “Make calibration faster,” or “Make the device easier to calibrate.” These kinds of comments are often transcribed directly into the requirements as a user need without further investigation. Soon the development team is benchmarking calibration time against three other competitors, and the next generation of meter calibrates 25% faster than before.

What these comments do not reveal, but direct observation and process mapping do show, is that the root cause of the problem in the hospital setting is not that calibration time is too slow. Rather, there are always two or three opened boxes of test strips in use. Consequently, the nurse can never tell which lot of strips goes with which calibration strip. This lack of knowledge forces the nurse to confirm the calibration manually each time the meter is used. Furthermore, the calibration strips themselves often go missing. The real problem has nothing to do with the actual speed of calibration.

Third, people often describe how they perform a task differently from the way they actually perform the task. In the case of the glucose monitor, the nurse practitioner might say, “We keep the device near the nurse's station, where it is convenient.” However, direct observation might reveal that the device is thrown into a drawer, and that three people over an eight-hour shift spend more than five minutes looking for it.

Addressing Customer Needs

Once an opportunity flowchart has been created for each of the sites visited and the common observations have been consolidated into a master opportunity flowchart, the chart is taken back to the new-product development team. The team then creates a To Be Process flowchart, in which they brainstorm ways to eliminate the cost-added steps, preferably through new product features. The new product development team comes up with the flowchart shown in Figure 2. The text clouds represent product features that would eliminate the cost-added steps.

Comparing the charts side by side allowed the team to map out a set of customer needs. The text clouds on the chart need not map directly to the customer needs, but they should be closely correlated. In this example, the following customer needs are identified:

• The device must be difficult to misplace.
• The device needs to show whether it is calibrated to the strip at hand.
• The device must be able to be calibrated to the test strip at hand even if the calibration strip is lost.
• The device must be able to match the patient to the assay.
• The device must be able to download data into the hospital's data management system.
• The device must meet hospital laboratory quality system requirements to eliminate the need for an official test result.

Comparing the two charts also allows the team to come up with a concise set of questions for a second round of interviews with the hospital caregivers. In this example, inquiries focus on what features the device needs to have to meet the hospital's laboratory quality standards. A second line of inquiry focuses on the data management needs of the hospital setting. These interviews are effective because the CFPM exercise has framed the problem correctly, enabling the interviewers to ask questions that elicit meaningful answers.

This second round of interviews sufficiently defines the customer requirements for the product, and the development proceeds to a successful launch into the marketplace.

The new hospital glucose monitor is larger and incorporates an integral bar code reader that reads a calibration bar code on each individual strip package. That feature ensures that the device is correctly calibrated. The bar code reader can also read the patient's and caregiver's ID bracelets, allowing each assay to be matched to a patient. Finally, the device comes with a wall-mounted docking station, which gives the device a permanent, highly visible storage location, and enables the device to be charged and download data at the same time.

The original opportunity flowchart provides a clear illustration of the features and benefits of the product, and provides a basis for the marketing department to describe the features and benefits of the product.

Conclusion

CFPM is not a panacea for discovering new product opportunities. It is one of many tactics for generating innovation in the new product development process. Like other tools for brainstorming, such as Pugh charts, it provides a way to distill the volume of disparate data coming from observation in the field down into actionable customer needs.

Copyright ©2005 Medical Device & Diagnostic Industry