4. Process
• Current industrial design, packaging, and instructions for use were reviewed
independently by 3 Human Factors and Industrial Design experts
• Design was ranked on a scale of 1-5 for 208 different design and human factors heuristics
1 2 3 4 5
Unacceptable Below Average Average Above Average Best in Class
• The five overarching heuristics included:
– Out of Box Experience (OOBE)
– Prepare for Use
– Activate the Device
– Communicate as Needed
– Industrial Design Principles
• The team met and discussed each line item and final scores were agreed upon
• Average scores were calculated for each of five section.
• Design implications were developed for aspects of the use experience and pump design
PROJECT NAME| 4
6. Out of box experience
Exterior box
Secondary packaging
Instructions for use
Prepare for use
Activating Device
Communicate as needed
Visual Feedback and Labeling
Auditory Feedback
Tactile Feedback
Problems, alarms, warnings, and signals
Industrial Design Principles
PROJECT NAME| 6
7. Out of box experience: Exterior box
Image
Key Questions* Take Aways
Are safety warnings clear to the
user before opening the • The unboxing experience is a key touch point for the user. Consider
Are the contents of the package package increasing branding and information availability to improve overall
clear to the user before they experience.
open the package? • The current exterior box follows typical packaging conventions.
Opening the package is straightforward and does not create any
physical or cognitive challenges.
• The exterior box does not make critical information, such as what the
Does the graphic treatment of product is, what it is used for, pertinent warnings, and next steps, clear
the package utilize proper to the user before opening the package.
information architecture? Does the packaging have the
potential to cause or create user • There is a lack of information hierarchy. The most important parts are
error? not highlighted by size, placement, and/or color.
• Information layout does not follow a grid.
Does the packaging create a • Icons were not universally understood by novice users.
positive emotional response for
the user?
1 2 3 4 5 Score: 2.66
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 7
8. Out of box experience: Exterior box Opportunities
INFORMATION LAYOUT &
ICONOGRAPHY
1 2
Safety warnings should be clear to the user
before opening the package 1 Use a grid to lay out information, align visual components,
Graphic treatment should utilize proper and highlight important elements
information architecture
2
Add verbal descriptions to current icons, or update icons to
be more patient focused.
PROJECT NAME| 8
9. Out Of Box Experience: Exterior Box Opportunities
ABOVE AVERAGE EXTERIOR BOX
2
1
Safety warnings should be clear to the user
before opening the package 1 Include an image of the product on the box to indicate the
Graphic treatment should utilize proper contents of the box.
information architecture
Graphic elements and text blocks should use
a grid system
2 Update graphical treatment to make the packaging feel
more important and communicate where openings are to
the user.
PROJECT NAME| 9
10. Out Of Box Experience: Exterior Box Opportunities
BEST IN CLASS EXTERIOR BOX
1
The user should feel comfortable during the
unboxing experience 1
The package should create a positive
emotional response for the user
Use tabs to indicate openings on the box. This provides
visual indications as well as additional material to grip for
those with degraded fine motor skills.
PROJECT NAME| 10
11. Out of box experience: Interior Packaging
Image
Key Questions* Are there any challenges
Take Aways
associated with removing the • The secondary packaging should continue to guide the user through
components from the package? the process of using the pump.
After packaging is opened, is
the next step clear? • The paper flap on secondary packaging does not communicate
information effectively. It does not offer additional procedural
information.
• Offering two methods to open the package may lead the user to think
that there is a right and wrong way to open the package.
Are components labeled in a
way that makes assembly or • Users may not feel comfortable with the cartridge being unsealed.
use clear? Is the form of the secondary User testing will help verify this.
packaging conducive to
assembly or use? • The tray is not physically balanced.
• Contents felt secure inside secondary packaging, but were difficult to
remove.
• Components are not labeled for easy assembly.
1 2 3 4 5 Score: 2.25
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 11
12. Out Of Box Experience: Interior Packaging Opportunities
ABOVE AVERAGE SECONDARY
PACKAGING LABEL 1
2
3
Components should be labeled in a way that
makes assembly clear 1 Use a diagram that labels the components of the package
to help establish the terminology that will be used in the
Graphic treatment of secondary packaging instructions.
should utilize proper information architecture
Secondary packaging should help the user
orient the product Use a sticker to seal the cartridge if the cover is not sealed.
Method for opening the secondary packaging
2 The sticker can provide information about which medicine
that cartridge holds.
should be clear to the user
Provide visual indications of where the user can pull off the
3 cover create a higher quality experience.
PROJECT NAME| 12
13. Out Of Box Experience: Interior Packaging Opportunities
BEST IN CLASS SECONDARY
PACKAGING LABEL
1
Components should be labeled in a way that
makes assembly clear 1
Graphic treatment of secondary packaging
should utilize proper information architecture
Use a clear package cover with printed graphics. This lets
Secondary packaging should help the user
orient the product the users know what to expect when they open the
package and starts to build familiarity with the assembly
Method for opening the secondary packaging
should be clear to the user process.
Secondary packaging should start to give
users additional information to guide “next
steps”
PROJECT NAME| 13
14. Out Of Box Experience: Interior Packaging Opportunities
BEST IN CLASS TRAY 1
3 2
4
Components should be labeled in a way that Mold Labeling into plastic shell to provide additional
makes assembly clear 1 orientation and guidance
Secondary packaging should help the user
orient the product Offer multiple access points for both fingers to make
Method for removing the secondary 2 removing the device easier
packaging should be clear to the user
The form of the secondary packaging should Create side contours to help users remove the interior
be conducive to assembly or use 3 packaging from the box.
Create feet under the cartridge allow the package to stand
4 without tipping.
PROJECT NAME| 14
15. Out of box experience: Interior Packaging Opportunities
BEST IN CLASS INTERIOR
PACKAGING EXPERIENCE
2
1
Secondary packaging should start to give
users additional information to guide “next 1 Create a system that gives the user everything they will
steps”
need to carry out the procedure: the product, instructions
Secondary packaging system should make for use, alcohol swab, and possibly a return address label.
the user feel comfortable and confident
2
Start to orient the user right away and continue to offer
more detailed and useful information at each touch point.
PROJECT NAME| 15
16. Out of box experience: Instructions for Use (IFU)
Key Questions* Does IFU provide information
Take Aways
as to all the pertinent • Overall, the instructions for use lack context and are slightly confusing.
components and controls? • The instructions do not explain what the pump is for, how it works,
Does IFU provide orienting
information about device? where it should be placed on the body, how long it will take and if the
user can move around while receiving treatment.
• The assembly instructions do not map to the images.
• The IFU talks about orientating the pump with LED on the top, but it is
Does IFU provide information not clear if the pump should be horizontal or vertical.
as to what this device is to be
used for? Does IFU provide adequate
steps for walking patient
through use?
Does IFU indicate if individual
can move around during and/or
after administration?
1 2 3 4 5 Score: 1.75
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 16
17. Out Of Box Experience: Instructions For Use (IFU) Opportunities
INSTRUCTIONS FOR USE
OVERVIEW
IFU should guide the user through the
process in an easy to understand and straight 1 Include a small instruction packet that folds accordion style
forward manner
allowing users to see the entire process of setting up and
using the device at the same time.
2 Step by step instructions should each be supported with in
context graphics or photos, making them easy to
understand.
PROJECT NAME| 17
18. Out Of Box Experience: Instructions For Use (IFU) Opportunities
INSTRUCTIONS FOR USE DETAILS
2
1
IFU should provide orienting information about
the device 1
Give users context by explaining device components
IFU should provide information about what the
device is used for before showing assembly instructions
IFU should provide information regarding
patient type, drug, etc.
IFU should provide information as to which
position is appropriate 2 Explain what the pump is for, how it works, where it should
IFU should indicate if the user can move be placed on the body, how long it will take and if the user
around during and/or after administration can move around while receiving treatment.
PROJECT NAME| 18
19. Out Of Box Experience: Instructions For Use (IFU) Opportunities
INSTRUCTIONS FOR USE DETAILS
The assembly process should be clear to the
user 1
Instructions should be presented in a linear fashion. Each
sub-step should be presented in a clear and logical
manner.
PROJECT NAME| 19
20. Out Of Box Experience: Instructions For Use (IFU) Opportunities
INSTRUCTIONS FOR USE DETAILS
The IFU should provide information to all
pertinent components and controls 1
The IFU should provide information about
display meaning
The IFU should provide adequate steps for Instructions should explain how controls work and what to
walking the patient through use expect from the procedure. Additionally the device should
The IFU should show the product in context be shown on the body when possible.
where applicable
PROJECT NAME| 20
21. Out Of Box Experience: Instructions For Use (IFU) Opportunities
INSTRUCTIONS FOR USE DETAILS
The IFU should provide more detailed
information about disposal possibly creating a 1
product return program
Removal and disposal instructions should address how to
safely dispose of the device.
PROJECT NAME| 21
22. Out of box experience: Overall
Secondary Packaging
IFU Score: 1.75 Exterior Box Score: 2.66
Score: 2.25
1 2 3 4 5
Unacceptable Below Average Average Above Average Best in Class
Out of Box Experience Average Overall: 2.22
PROJECT NAME| 22
23. Out Of Box Experience: Overall
Current Above Average Best in Class
Exterior
Box
2.66 4 5
Secondary
Packaging
2.25 4 5
IFU
1.75 5
PROJECT NAME| 23
24. Out of box experience
Exterior box
Secondary packaging
Instructions for use
Prepare for use
Activating Device
Communicate as needed
Visual Feedback and Labeling
Auditory Feedback
Tactile Feedback
Problems, alarms, warnings, and signals
Industrial Design Principles
PROJECT NAME| 24
25. Prepare for Use
Image
Key Questions* Take Aways
Do components require 2 or After the user determines the orientation of the components, assembly
fewer steps to assemble? is fairly straight forward.
Is the device easy to setup with It is unclear which part of the vial should be swabbed, and with what.
minimal effort?
The vial insertion did not make an audible click.
The lid was difficult to open and close.
There were no affordances or visual clues on the pump to guide the
user on how to hold or orient the device.
Does device provide information
as to how to grab/approach
device? Does the device pose any
issues when sitting, standing, or
bending?
1 2 3 4 5 Score: 2.91
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 25
26. Prepare for Use: Opportunities
OREINTATION METHODS
1 2
The device should provide information
regarding proper orientation 1
The device should provide information as to Provide orientation information in the IFU
how to grab/approach the device
2
Offer affordances and grips to help the user orient the
product
PROJECT NAME| 26
27. Prepare for Use: Opportunities
LID OPENING & CLOSING
1 2
The lid should be easier to identify, open, and
close securely 1
Create more pronounced arrows to guide the user
2
xx Increase the size of the lid to make it easier to manipulate
PROJECT NAME| 27
28. Prepare for Use: Opportunities
SWABBING
1 2 3
Average Above average Best in class
All components needed to carry out the
procedure should be included in the package 1 Provide wipe in box
2 Attach wipe to IFU
3 Create a place in the tray for a swab
PROJECT NAME| 28
29. Prepare for Use: Opportunities
INSERTING VIAL
When the vial is inserted the click should be
more pronounced 1
Create a more pronounced “click” when vial is inserted and
when lid closes
PROJECT NAME| 29
30. Prepare for use: Overall
Prepare for Use Score:
2.91
1 2 3 4 5
Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 30
31. Prepare for Use: Overall
Current Above Average Best in Class
Orientation
2.91 4 5
Lid Opening
2.91 4 5
Swabbing
3 4 5
PROJECT NAME| 31
32. Out of box experience
Exterior box
Secondary packaging
Instructions for use
Prepare for use
Activating Device
Communicate as needed
Visual Feedback and Labeling
Auditory Feedback
Tactile Feedback
Problems, alarms, warnings, and signals
Industrial Design Principles
PROJECT NAME| 32
33. Activating Device
Image
Key Questions* Take Aways
Does the user have to rotate or • Operating the device on the body is simple and straightforward.
move controls in any direction?
Is that direction intuitive? • Color breaks help delineate interaction points.
Does device make it easy to
• The one control is clear and easy to find and use.
find controls?
• It is not clear if the button has been depressed or not.
Are their appropriate color
breaks to delineate interaction
touch points Does the user have to sustain
motion or pressure to any of the
controls to operate?
1 2 3 4 5 Score: 4.16
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 33
34. Activating Device: Opportunities
DEPRESSED BUTTON GUIDANCE
Before use During use
It should be obvious to the user if the button
has been depressed 1
xx
Attach the membrane of the button to the injector so the
state of the button is obvious
xx
PROJECT NAME| 34
35. Activating Device : Overall
Activating Device Score:
4.19
1 2 3 4 5
Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 35
36. Activating Device : Overall
Current Best in Class
Activating
Device
4.16 5
PROJECT NAME| 36
37. Out of box experience
Exterior box
Secondary packaging
Instructions for use
Prepare for use
Activating Device
Communicate as needed
Visual Feedback and Labeling
Auditory Feedback
Tactile Feedback
Problems, alarms, warnings, and signals
Industrial Design Principles
PROJECT NAME| 37
38. Visual Feedback & Control
Image
Key Questions* Take Aways
Are depressed and un- • The button does not offer feedback about its state (depressed/un-
depressed conditions of depressed).
Are colors are used to convey
pushbuttons are indicated? • LED is difficult to see from some angles.
information to the user? • LED and vial window both offer visual feedback, but can not be viewed
at the same time.
• The device changes modes from active to finished, but the LED color
Do visual indicator displays use stays the same and the blink rate is very similar.
proper blink coding (Used
• Vial window is difficult to interpret.
sparingly, conveys well-defined
Do auditory displays have messages & uses only 2 • The product does not have any labels.
proper sound type (Uses identifiable blink rates (blink/
sounds that contrast with the not)?
sound of the environment)?
Are status indicators properly
labeled and coded?
1 2 3 4 5 Score: 2.58
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 38
39. Visual Feedback & Control: Opportunities
LED
1 2 3
or
Off In use Finished
LED should be elevated off of the surface of
the pump to offer additional visibility 1 Elevate the LED so it is visible form multiple angles
LED and Vial window should both be visible to
the user while the product is in use
LED should switch to red when process is 2 Orient the LED and Vial window so they are visible at the
finished same time
Avoid using multiple blink rates, color change
is preferred
3 Avoid using multiple blink patterns. Ideally the LED will
change color when procedure is finished. Green to red is a
popular convention.
PROJECT NAME| 39
40. Visual Feedback & Control: Opportunities
ABOVE AVERAGE VIAL WINDOW
Window with background color During After
Vial window should offer additional
visualization to enhance the viewing of the vial 1
delivery
Vial window should make it clear where the
user is in the process and when the process is
finished Coloring the background of the vial window creates a visual
indicator as the plunger moves
PROJECT NAME| 40
41. Visual Feedback & Control: Opportunities
BEST IN CLASS VIAL WINDOW
Vial with colored plunger During After
Vial window should offer additional
visualization to enhance the viewing of the vial 1
delivery
Vial window should make it clear where the
user is in the process and when the process is Coloring the plunger creates a visual indicator as the
finished
plunger moves. This method would better support the
user’s mental model of how the device is working.
PROJECT NAME| 41
42. Auditory Feedback
Image
Key Questions* Take Aways
Can auditory display frequency • The pump provides auditory feedback through the crunch of the
be adjusted for a wide range of button, the sound of the motor, and procedural beeps.
users?
Does pushbutton have auditory • Beep pattern was not loud enough to be heard through clothes.
feedback when activated? • Beep pattern was not long enough in duration to be heard through
ambient environmental noise.
• Initial beep pattern was not obviously different from final beep pattern
(we did not hear initial beep pattern).
Do auditory displays have • Auditory feedback does not have adjustable volume and frequency for
proper sound type (Uses hearing impaired users.
sounds that contrast with the Is important auditory information
sound of the environment)? is also provided in visual or
tactile form?
1 2 3 4 5 Score: 2.27
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 42
43. Auditory Feedback: Opportunities
AUDITORY FEEDBACK 1
1
Offer volume control
Increase the volume and duration of auditory 1
feedback
Provide adjustable auditory feedback.
PROJECT NAME| 43
44. Tactile Feedback
Image
Key Questions* Take Aways
• Color, material, and height change makes the main button easy to find.
Do pushbutton controls have
proper travel distance? • The button is appropriately sized to accommodate most hands.
Are there tactile difference
between the pushbutton and • The button has too much travel. This could be problematic for an older
population.
main surfaces?
• The button does not give feedback that it has been depressed.
• It is unclear if the button offers a delay before activation.
Does pushbutton has adequate • It is unclear if the user is able to stop delivery if necessary.
delay before activation (1-2
Is pushbutton an adequate seconds)?
diameter for finger activation
(0.5-1'')?
Are cues perceptible to touch
produced to display decision
support and interpretive
features to the user?
1 2 3 4 5 Score: 2.27
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 44
45. Tactile Feedback: Opportunities
TACTILE FEEDBACK
1 2
Reduce the travel distance of the button
Add more tactile different to the button surface
1
Molded ridges on button makes it easier to find
2
Rough surface texture makes button easier to find
PROJECT NAME| 45
46. Problems, Alarms, Warnings & Signals
Key Questions* Are umber of alarms/warning
signals is few enough to be
Take Aways
• It is unclear if the device signals problems or alerts.
!
clear to the user? • It is critical for the user to know if the pump is working properly and if
they are receiving medication.
Do prompts point out the
presence of a problem?
Can action be reversed & are
prevention methods used if
activation is serious?
1 2 3 4 5 Score: 1.25
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 46
47. Communicate as needed: Overall
! Auditory Feedback Tactile Feedback Score: Visual Feedback Score:
Warnings Score: 1.25
Score: 2.27 2.27 2.58
1 2 3 4 5
Unacceptable Below Average Average Above Average Best in Class
Communicate as Needed Average Overall: 2.09
PROJECT NAME| 47
48. Communicate as needed: Overall
Current Above Average Best in Class
Visual
Feedback
2.58 4 5
Auditory
Feedback
2.27 4 5
Tactile
Feedback
2.27 4
Alarms
and
Warnings !
1.25
Offer Alarms and Warnings
5
PROJECT NAME| 48
49. Out of box experience
Exterior box
Secondary packaging
Instructions for use
Prepare for use
Activating Device
Communicate as needed
Visual Feedback and Labeling
Auditory Feedback
Tactile Feedback
Problems, alarms, warnings, and signals
Industrial Design Principles
PROJECT NAME| 49
50. Design Principles
Image
Key Questions* Is a consistent design language
Take Aways
used to tie together separate • The overall aesthetic is balanced, but individual elements lacked unity.
elements? Contour lines emphasize the button and window, but not the LED,
Is there a sense that every which is on the opposite side from the window.
element "belongs" there?
• The form of the device does not look as though it belongs on
someone’s body. Its bulky and inorganic shape looks heavy and
uncomfortable, and hard edges make pulling clothes over the device
difficult.
Does your eye move in a • Overall, a user should have a general idea of what the device is going
connected and flowing way? to do and how to make that happen just by looking at it.
Does design indicate how the
device is used?
1 2 3 4 5 Score: 2.22
* This is a small subset of the heuristics used for this section Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 50
51. Design Principles: Opportunities
DESIGN OPPORTUNITIES
3
1 2
4
Current Design Above Average Design Best in Class Design
There should be a sense that every element Flowing contour lines tie the separate elements together,
“belongs” and that the whole is more than the 1 indicates touch points and creates a more organic object.
sum of its parts.
There should be a focal point to which your
eye is drawn. 2 A raised LED increases visibility.
The design should indicate how the device
and it’s parts work. Increasing the touch point on the cap with texture that
Your eye should move in a connected and 3 indicates its motion will make it easier to open.
flowing way.
Center-aligning the LED with the button makes it visible
4 from all angles and helps create a more organic form.
PROJECT NAME| 51
52. Design Principles : Overall
Design Principles Score:
2.22
1 2 3 4 5
Unacceptable Below Average Average Above Average Best in Class
PROJECT NAME| 52
53. Design Principles: Overall
Current Above Average Best in Class
Design
Principles
2.22 4 5
PROJECT NAME| 53