Design Realization/Detailed Design - Medical Device Design: Innovation from Concept to Market - page 194

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Is the device going to be moved? If so, can it be moved with ease?

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Where will the device be stored when not in use?

Do you remember the “5 Whys” I introduced earlier? Perhaps now is the time to introduce the
“5 Whos”:

1. Who is going to use it?

2. Who is going to provide training?

3. Who is going to assemble the device?

4. Who is going to transport the device?

5. Who is going to store the device?

Let us look at the first “who” in detail. Who is going to use it? Who is (or are) the end-user(s)?
Once you have identified these then you can consider all of the human interaction that will occur.

Let me give you an anecdote that may or may not be true, but is totally imaginable. On a
visit to a nuclear power station an inspector noticed a handle from a public house attached
to the main control desk. “What is that?” he asked in alarm. “That,” said the technician “is
the emergency shutdown button.” The technician then proceeded to remove the handle to
reveal two identical rocker switches next to each other. Apart from a small sign they were
indistinguishable - and in the heat of a shutdown a mistake could easily be made leading to
catastrophe. The technical team added the beer-pull so that they could never hit the wrong
switch. The designer of the panel had got it wrong!

Table 8.13: 6 σ Seven Wastes Applied to DFU

Waste Description/Question

1. Waste of overproduction

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Are there lots of spare items that will not be used?

2. Waste of waiting

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Are the users waiting for things to happen without any information about
what is happening?

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Do the end-users need to order anything specific?

3. Waste of transporting

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Does the device require significant transport for calibration,
sterilization, etc.?

4. Waste of inappropriate
processing

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Have you thought about the MMI?

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Are there numerous subtasks to achieve an overall goal?

5. Waste of unnecessary
inventory

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Do your operating/procedure packs come with overly numerous spare items?

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Have you discussed inventory with the end-user?

6. Waste of unnecessary
motion

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Are the end-users' eyes having to dart all over the place?

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Are the end-users' hands, eyes, and arms involved? If so have you considered
the ergonomics?

7. Waste of defects

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Is your process complex enough to cause procedural mistakes that do not
cause harm but create waste that will annoy your end-user?

“New” Waste
7(c) Waste of untapped
human potential

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Have you sought advice from those who may understand the usual
processes in situ?