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
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| 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.
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| Figure 1. In this example of a CFPM flowchart, an observer records notes about one hospital’s existing process for measuring a patient’s blood glucose level (click to enlarge). |
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
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| Figure 2. Using the To Be Process flowchart enables a product development team to brainstorm ways to eliminate cost-added steps through new product features (click to enlarge). |
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
