A primer on Design Thinking and how it can be used in regulated industries to design Quality Systems.

1. Optimizing Quality Systems with
Design Thinking
Michael Plishka, ZenStorming Solutions, LLC
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2. Who Designs?
“Everyone designs who devises courses of
action aimed at changing existing
situations into preferred ones.”
-Herb Simon
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The good news is that it means that much of what we
do in corporations is actually design. Whether we
make products, provide services or develop quality
systems, we're already in the business of Design.
The bad news is that often we don't design well. It's
like we know the words to a language but we haven't
gotten all the grammar down yet.
The goal is to become design literate.

3. Design is More Than Style...
“Good design is a catalyst for creating total experiences that
transcend functional benefits alone and delight consumers. It is
a catalyst for moving a business from being technology-
centered or product-myopic to one that is more consumer-
experience-centered”
-A.G. Lafley, CEO of P&G
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By becoming design literate we become more
effective at changing and modifying systems and
products to bring value.
“Good design is a catalyst for creating total
experiences that transcend functional benefits
alone. It is a catalyst for moving a business from
being technology-centered or product-myopic to
one that is more consumer-experience-centered”
That consumer can be outside the company or
within the company walls.

4. A Detailed Design Process Model...
Define
Research
Ideate
Prototype
Choose
Implement
Learn
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One model for the design process follows these
essential steps, though there can often be feedback
loops within it.
Define is the stage in which we state that something
needs to be done.
Research is the process of learning what the current
situation is – where the issues are.
Ideate is the process of brainstorming solutions.
Prototyping is the process of trying out the best of the
ideas.
We then Choose the best solution and Implement it.
As time progresses we assess the system, we Learn
and start the process over again.

5. A Simplified Model of Design Thinking
From:
Evolution of the Mind: A Case for Design Literacy by Chris Pacione; XVII.2 - March / April, 2010
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This model provides additional insights into DT.
Usually understanding is thought of as the result of
observation. This is true, but understanding also
comes from the process of making something, testing
it and seeing what happens. We understand by
looking and by doing/making.

6. Learning by Observing AND Making...
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Image Courtesy of the BBC
Remember, we're all designers so this process
shouldn't be foreign to us. Think back to when you
were making sandcastles using a bucket. At first you
put sand in the bucket and turned it over. It came
together but not that great. So you compacted the
sand into the bucket and then turned it over. Better,
but still not the best.
You remember the time you put your hand into the
moist sand at the edge of the sandbox and how it took
an impression of your hand. You scoop the moist sand
into the bucket, pat it down, turn it over, and voila!
You built a thing of beauty out of sand!

7. Design Thinking is About Beauty...
“Remember that beauty breeds loyalty
when it comes to organizational systems.”
-Scott Belsky, Author and Founder of Behance.com
Beauty = Elegant, Pleasing
Loyalty = Faithfulness= Compliance!
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Yes, beauty.
Why the emphasis on beauty?
Because, as Scott Belsky points out, beautiful systems
breed loyalty and loyalty equals faithfulness to the
system, which equals compliance!
We want our systems to be compliant, we want people
to want to follow them.

8. What Are Some Traits of a Beautiful System?
It makes sense
It has balance
It has form
It is clear
It is useful 8
So what are some traits of a beautiful system?
This is just a partial list, and I'm sure you could come
up with other definitions.
It makes sense, it has balance, it has form, is clear
and it's useful. These are just a few traits, but we all
know that ...

9. Subjectiveness of Beauty...
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Beauty is in the eye of the beholder. Or in the case of
system design, beauty is in the eyes of every person in
each department who is touched by the system.
So the challenge becomes, how do we meet
everyone's needs? How do we design and develop
systems that everyone, including regulatory bodies like
the FDA, see as beautiful?

10. The Beginnings of a Beautiful System...
It's human centered – not system
centered. A beautiful system exists
for you, not vice-versa.
It starts with the premise of asking,
“What is possible?”
It asks “Why are we doing this?”
It is an extension of your brand, it
reflects who you are and what you
do.
It fosters conversation and
conversation leads to understanding
of yourselves, your customers, your
systems and your goals.
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We start with a focus on people.
At its core, a properly designed system will be human centered – not
system centered. A beautiful system exists for you, not vice-versa.
How many times have we felt at the mercy of our systems? (That's a
sure sign that things aren't right). And, when the system stresses
people, there's a temptation towards non-compliance.
So, start with the premise of asking, “What is possible?” not “we
need to fix xyz.” To answer that question look to the people, the
culture, and the technology available.
Ask, “why are we doing this?”
The system is an extension of your brand, it reflects who you are and
what you do. The output of your system should reflect who you are
as a company.
The system fosters conversation and conversation leads to
understanding of yourselves, your customers, your systems and your
goals.

11. The Beginnings of a Beautiful System...
It's human centered – not
system centered. A beautiful
Design Thinking system exists for you, not vice-
versa.
isn't about It starts with the premise of
asking, “What is possible?”
solving problems It asks “Why are we doing
as much as it is this?”
It is an extension of your brand,
about exploring it reflects who you are and
what you do.
possible It fosters conversation and
conversation leads to
solutions understanding of yourselves,
your customers, your systems
and your goals.
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Design thinking is less about solving problems and
more about exploring possible solutions. It's about
coming together to make dreams reality, to inspire and
build to meet the needs of everyone that the system
will touch, including regulatory bodies.
It's not about one person or one group's idea of a
system foisted upon the entire company.
So what tools are needed?
Let's return to our diagram from earlier.

12. What Basic Skills Are Needed?
From: Evolution of the Mind: A Case for Design Literacy by Chris Pacione;
XVII.2 - March / April, 2010
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For purposes of designing systems, I've highlighted
some of the key tools that could be used. On the
Look side we have things like interviews, task
analyses, questionnaires and usability testing.
On the Make side we have things like storyboarding,
ideation, prototyping, persona development,
sketching, and stakeholder mapping.
While these specific tools are extremely helpful at
helping us understand what our system needs to be,
we can further simplify this approach and boil the
design of systems down two fundamental skills: By
using these two skills, you will be well on your way to
being design literate and using design thinking. They
are:

13. What TWO Basic Skills Needed for Designing
Quality Systems?
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Image Sources: http://blogs.intland.com/main/entry/15 and M.C. Escher
Collaboration and Drawing
Collaboration is essential to making sure that all the pieces of the puzzle in the system
are looked at. A puzzle that's missing pieces is interesting in that by nature it draws
attention to those pieces that are missing. With systems, auditors and those that use
your systems, find the gaps with little effort. Each person expects a certain picture
and pain, friction, frustration are all indicators of missing pieces in the puzzle. Without
all the pieces in the puzzle present, the system, and your people, suffer. It is
absolutely essential that representatives from every group being touched by the
system be a part of the process of developing the system. Their input needs to be
taken seriously. Systems should not be cobbled together by one person who floats it
out to everyone. For it to be designed it needs to be a collaborative effort.
Drawing is essential to diagramming and communication. We don't have to be able to
sketch like Leonardo da Vinci, but we need to feel comfortable with making pictures,
with making our problems and solutions visible to others. Our brains engage with
pictures differently than they do words. Look at the two pictures on this slide, They're
provocative. They mean more than words.. Simple Pictures, even stick figures, will
often convey problems more effectively than a 10 page report. Tools like Visio are
great, but if we really want the magic to happen, we need to feel comfortable with
markers and pencils in our hands. I can't stress how much more powerful design can
be when everyone is collaborating on a giant piece of paper or a white board as
opposed to reading emails..

16. 16

18. 18

20. 20

22. 22

23. What's the Difference?
Reg
Strategy
Reqmt's
System
Use System
Dev
Roll-out
Typical Process Design Thinking Process
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How is this different from what is usually done?
The typical process on the upper left starts with the
statement of what the regulatory strategy is. The
requirements are determined and a system is created,
written and disseminated. While there is some
interaction during the process development phase
between departments, it is not always intentional and
collaborative.
When processes are finally penned they are rolled out,
used and perhaps modified at yearly or semi-annual
reviews.
The Design Thinking process, on the other hand,
brings advantages through more robust needs
determination, accelerated learning using visualization,
hands on experimenting, and quick prototyping.

24. How Does it Map?
The Define and Research Phases Include:
Constraints Set by Regulatory Bodies
Understanding Needs of Various
Departments
Empathy for Those in Various Depts.
The Ideate, Prototype and Choose Phases
Include:
Synthesis of Define and Research Phases
Hands on Collaboration and Development
Small Scale Testing/Dry Runs of Various
Solutions
Group Ownership of Processes
Design Thinking Process
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In other words, as opposed to the typical process
that includes requirements and perhaps some of
the various needs, Design Thinking will include
an empathic appreciation of what various
departments and team members go through.
In addition, the process will contain multiple
iterations and testing of processes in a
collaborative manner before roll out takes place.
This creates communal ownership and agreement
of the usability of the system.
The result is a beautiful, more elegant, and useful
system. This system will be more useful
immediately at launch and usually there will be
fewer changes after launch.

25. through doing.
Processes then become living, vibrant and interactive; beautiful,
useful and perhaps even innovative.

26. Contact Information
Michael Plishka
ZenStorming Solutions, LLC
PO Box 6158
Lindenhurst, IL 60046
michael@zenstorming.com
1-866-801-6737
Skype: callmeplish
Twitter: @Plish
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