“Keep Your Chin Up” Verification & Validation Report

BME 401 Senior Design

Group 3 - Emma Huff, Thom Ellison, and Katelyn Miyasaki

1 March 2019
TABLE OF CONTENTS

1 Updated Scope...........................................................................................................................2
2 Updated Design Specifications...................................................................................................2
3 Updated Team Responsibilities……………………………………………………………………….3
4 Verification Testing Plan.............................................................................................................3
Figure 1………………………………………………………………………………............…..4
5 Validation Testing Plan…………................................................................................................6
6 FDA Approval ……………………………………………………………………………………….....7
7 Overall Status of the Project and Results of Proof-of-Concept Testing......................................8
Figure 2..............................................................................................................................8
8 Bibliography................................................................................................................................9
Appendix A: Updated Design Specs...........................................................................................10
Appendix B: Updated Gantt Chart...............................................................................................11
Appendix C: User Experience Survey …………………………………………………………..……12
Appendix D: Validation Survey………………………………………………………………....……..14

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1 Updated Scope

There are no reportable updates to the need statement or scope; however, the prototype

will be targeted towards a smaller age range than the finished device due to adjustability

constraints.

2 Updated Design Specifications

Several design specifications have been updated to more concrete standards for

improved testability. This will be important for verification of the device.

The aesthetics specification has been changed to the more user-centric “users feel

sufficiently comfortable with their appearance while wearing the device.” Though ideally the

device would be aesthetically pleasing to others, it is ultimately more important that the user

does not feel too self-conscious to actually wear it. This will also lend itself better to verification

testing through a simple survey of the user.

Regarding the comfort requirement, the specification originally addressed the specific

metric of pressure differential as well as the ‘softness’ of the device. These may be two

important factors for comfort; however, comfort is also ultimately a more user-centric

experience. The specification was therefore changed to “users report physical comfort while

wearing the device, even after more than four hours” (four hours is roughly eight times the

intended length of use).

The final changed specification pertains to the need for a power source. Previously, it

called for a ‘rechargeable battery’; the rechargeability alone does not guarantee that the battery

will do what it is supposed to do, so the specification has been narrowed to a “battery that can

be recharged for up to three years (or replaced if necessary).” Ideally, the original battery would

be rechargeable over a three-year period, but if necessary the user should be able to install a

new one at home.

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3 Updated Team Responsibilities

Team responsibilities are not changing significantly - Thom will continue to focus on

interpreting IMU data, and Katelyn is working on controlling feedback mechanisms through the

Raspberry Pi. Emma is focusing on the construction of the device as a whole, including the

wearable element, minimizing necessary wiring, and battery power for the device. The group will

work together to program the Raspberry Pi to take in and save data and provide the appropriate

feedback, as this will be a challenging task that involves all three group members’ focus areas.

The Gantt chart was also expanded to reflect completed tasks and to break down tasks in more

detail.

4 Verification Testing Plan

Verification testing will confirm that the device can fulfill each need according to the

design specifications. Each specification will require its own method of verification, described

below and summarized in Appendix A.

Safe: Use the online “Design Safe Analysis” tool for all involved parties (the user, caregiver, and

physician). Also, inspect the device visually and manually to check for areas of concern not

addressed by the “Design Safe Analysis” tool, and cross-check all components with lists of

flammable, toxic, and allergen-containing materials.

Unobtrusive: Calculate a rough surface area of the head based on an ellipsoid and approximate

the facial area as half of this surface. Half of the interior surface area of the device (that is, the

part that will be in contact with the face) shall not exceed 20% of the approximated facial area.

Aesthetics: Survey potential users and caretakers to assess whether they feel the device is

suitable for wearing in semi-public situations. Survey at least one user and at least one

caretaker. Questions are included in Appendix C.

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Upright: Using a goniometer, find

and mark on a wall the various

degrees of head tilt for a human

subject (see Fig. 1). The subject

will then sit in front of the wall and

slowly tilt their head forward and

backward, reporting when

feedback is given. Positive

feedback should only be offered at

Figure 1: Testing setup, to be used for ‘Upright’,
less than 25° from the vertical, and
‘Adjustable/Adaptable’, ‘Response Time’, ‘Multiple
negative feedback should only be Forms of Feedback, and ‘Data Output’.

given at greater than 45° from the vertical, although these values may vary based on how close

to vertical each individual user can get. Ideally, the device will be accurate to within 5°.

Comfortable: Survey wearers about the comfort of the device when it is worn for thirty minutes,

one hour, and four hours. Questions are included in Appendix C.

Lightweight: Use a scale to weigh the parts of the device which will be on the user’s head. For

different head positions, calculate axial loads on the neck. Less than 0.2kg of axial load should

rest on the neck in any head position.

Clean: Research the wicking properties and washability of the fabric in contact with the skin.

The fabric should be fully washable and not retain dirt or smells after being washed. Wear the

fabric on skin during vigorous exercise, then wash it. Survey both men and women to find out if

they think it smells bad after a wash.

Expandable: Measure the headband while it is taut but unstretched to find the smallest possible

fit. On a volunteer, tighten the headband to determine the approximate amount of

circumferential tension on the headband that is unpleasant to wear. Using a force gauge, stretch

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the band out from end to end with 90% of this force; the length between fasteners is the

maximum band circumference.

Adjustable/Adaptable: With the same setup used to determine ‘Upright’ (see Fig. 1), have a

wearer experiment with different directions of head tilt (left/right forward, left/right backward,

fast/slow, etc.). In each scenario, positive feedback should only be offered at less than 25° from

the vertical and negative feedback should only be given at greater than 45° from the vertical.

Easy to put on: Ask an adult untrained in the device to put the device on a volunteer five

consecutive times. After five tries, they should be able to put it on in under two minutes.

Power source: Run the device with no part connected to an outlet. The power source should be

able to independently drive all necessary components.

Battery charge method: Charge the power source using a standard outlet and any necessary

charging device. It should charge fully in the factory-recommended charging time.

Length of use: Keep the device and power source turned on until the power source depletes or

for eight hours (whichever comes first). The device should continue functioning without charging

the power source for at least four times the intended duration of use.

Durability: Perform a three-meter drop test on the head unit five times; it should not have

noticeable differences in functionality after these drops as compared to before. (This will not be

performed on the prototype since there is only one version.) Any wires subject to bending during

use will be flexed 10,000 times up to 60° using a mechanical bending device. No significant

breakage or degradation of signal transmission should be observed.

Response time: With the same setup used to determine ‘Upright’ and ‘Adaptability’, have a

volunteer move their head to three ‘zones’ (<25° from vertical, >25° and <45° from vertical, and

>45° from vertical) at varying speeds. The user should keep their head inside each zone until

feedback begins, or in the case of the middle zone, for ten seconds to ensure no feedback

begins. An individual observing will record the difference in time between when the user enters

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each feedback zone and when they report feedback initiation; delay should not exceed two

seconds.

Multiple forms of feedback: With the same setup used to determine ‘Upright’, ‘Adaptability’, and

‘Response Time’ (see Fig. 1), record the forms of feedback reported by a user in each of the

three ‘zones’ (<25° from vertical, >25° and <45° from vertical, and >45° from vertical). With 15%

error rate tolerance, only auditory feedback should be reported in the <25° zone, nothing should

be reported in the 25° to 45° zone, and only haptic feedback should be reported in the >45°

zone.

Data output: As the user moves their head according to a predetermined protocol, manually

record data such as time in each ‘zone’ (as determined by using the setup shown in Fig. 1),

overall use time, and amount of each feedback type delivered. Device output should be within

15% of manual calculations.

Connectivity: Visually inspect the device as it is worn on the human head and measure the

length of wired connections with a measuring tape. Ideally, no wires should connect the head

unit to anything more than one foot away from it; however, this may not be practical in the

prototype.

Cost: Prices of each component will continue to be tracked throughout the prototyping process.

The cost of each part used in the final device will be tallied; this total should be less than $200.

5 Validation Testing Plan

While verification of the device confirms whether the specifications have been fulfilled,

validation determines whether those specs conform with user needs and intended use. To

assess this objectively, there is a testing plan that addresses what the device needs to

accomplish, who must be able to use it, and why it would be used.

Users: There are three primary user groups for this device: wearers, caretakers, and physical

therapists. Each group must be able to use the device safely and somewhat easily. A survey will

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be administered to each group to assess ease of use, perceived benefits, and perceived

drawbacks. This survey is shown in Appendix D.

Device Function: The ultimate goal of this device is to improve head position in children with

cerebral palsy. Though it is still advantageous if the user improves their head position only while

wearing the device, an ideal outcome would result in an improved head position even when

feedback is removed. Long-term effects of device use will require months to years of testing,

and thus will not be completed within the duration of this class. In an ideal situation with a longer

period for assessment, more devices, and candidates willing to use the device, validation of

device function would be done over the course of one year for fifty users. Each user would wear

the device with feedback in use as directed by a physical therapist during that time; for one day

a week (chosen by the user/caretaker based on convenience), the user would wear the device

from morning to night in ‘recording’ mode. No feedback will be delivered during this time, and

the device would output only user data. Based on the changes in user head position over time,

the device will be validated if a significant trend exists showing more time spent in the ‘upright’

zone as the user continues to use the ‘feedback’ feature of the device.

6 FDA Approval

This device would most likely be a Class 1 device, as the sensor unit will act just like a

normal headband and the feedback will be solely in the form of haptics and audio at a

comfortable listening volume. None of the interactions with the user will be of greater intensity

than wearing normal clothing or using a cell phone with haptic feedback/Bluetooth audio. As a

Class 1 device, it would have to go through the 510(k) process to establish Substantial

Equivalence (SE) to “a legally marketed device that is not subject to Premarket Approval

(PMA).”2 Since each function of the device (haptic feedback, audio feedback, wearable sensor

that does not electronically interact with user) appears in many existing devices, the 510(k)

process should be sufficient to establish this as a marketable Class 1 device.

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7 Overall Status of the Project and Results of Proof-of-Concept Testing

IMU

The device measures head position with

an inertial measurement unit (IMU). The

physical device is currently an elastic

headband with a sewed-on pocket

which holds the IMU against the side of

the user’s head. The IMU’s position is

shown in Fig. 2. The IMU is wired to an

Arduino, and Arduino code from Maker Figure 2: Head unit, shown with Arduino (left) and
in intended usage position (right).
Pro interprets the raw IMU output to

calculate values for the yaw, pitch, and roll of the IMU board in degrees, then sends this data to

the Arduino’s serial monitor1. With the current position of the IMU on the side of the head, yaw is

the most useful dimension for measurements. However, if it is better for standardizing IMU

position, the IMU may be moved to the top of the head, in which case pitch would be a more

useful metric. Ideally, the Arduino would be replaced by a microchip and would send data to a

computer wirelessly, but this may not be feasible for the prototype.

Currently, work is focused on determining the best way to interpret the data and determine a

binary value for head drop, i.e. “up” or “down.” The Arduino program has been modified to

display text reading “Head is UP” if the yaw angle is below 65° or “Head is DOWN” if it is below

65°. Initial proof-of-concept testing has shown that the message successfully changes from “UP”

to “DOWN” when the user drops their head; however, this response needs to be refined by

adding a calibration program. The IMU/headband unit will fit each user’s head differently and will

be positioned differently each time the device is put on, so a calibration will determine what

angles should trigger feedback. Over the next few months, a calibration method will be added,

most likely a button to press in order to zero out the values for pitch, yaw, and roll when the

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head is upright; therefore, the angles of head drop that trigger each type of feedback may be

adjusted.

Whole device

As of now, little work has been done with the device as a complete unit, so the next major step

is to integrate the IMU/Arduino unit into the device as a whole. A Raspberry Pi, which will be

used to trigger feedback, has been obtained and set up to run the Raspbian OS using a USB

mouse/keyboard and a small HDMI monitor. It has also been configured to play audio output

using the VLC media player through Bluetooth headphones. However, there is still a lot of work

to do with the Pi. The Pi connects the IMU and the feedback devices, so it needs to be

programmed to receive input from the IMU/Arduino unit, to activate the appropriate audio/haptic

feedback, and to save head position data over time in an Excel sheet or another simple format.

The head position data will then be available for use by the clinician. Haptic motors must be

obtained and set up for operation through the Pi. Also, at this point it is unclear what data will be

sent from the IMU/Arduino unit to the Pi. The final step will be to refine the housing and

positioning of the whole device, including a more visually appealing headband to hold the IMU

and an optimization of the location of the Arduino, Pi, and haptic motor on or around the user’s

wheelchair.

8 Bibliography

1. Sanjeev, Arvind. “How to Interface Arduino and the MPU 6050 Sensor.” Maker Pro, EETech

Media, LLC. 21 March 2018, https://maker.pro/arduino/tutorial/how-to-interface-Arduino-

and-the-mpu-6050-sensor

2. “The Device Development Process.” U.S. Food and Drug Administration, U.S. Department of

Health and Human Services, 4 January 2018,

fda.gov/ForPatients/Approvals/Devices/ucm405378.htm

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Appendix A: Updated Design Specifications. Shading indicates a specification update.

Need Specification Testing Protocol

Non-flammable, non-toxic, hypoallergenic,
Use online "Design Safe Analysis" tool for the user, caregiver, and physician.
no electrical components adjacent to skin,
Manually and visually inspect all areas; cross-check each component with lists of
does not apply pressure to sensitive areas
flammable, toxic, and allergen-containing materials.
Safe like the throat

Does not cover more than 20% of face, does Calculate a rough surface area approximation of the head based on an ellipsoid.
not inhibit head movement or affect head Approximate the face as half of this surface area. Half of the surface area of the
Unobtrusive position device (that will be in contact with the head) should not exceed 20% of this value.

Users feel sufficiently comfortable with their

appearance while wearing the device (to use User/caretaker survey.
Aesthetics it as recommended)

Allows user to have eyeline < 30 degrees Use marked angles to determine zones of head position. Positive feedback: <25
Upright from parallel in either direction degrees from vertical. Negative feedback: >45 degrees from vertical.

Users report physical comfort while wearing

the device, even after >4 hours (8x the User survey.
Comfortable probable length of use)

<0.2 kg of load on neck Weight, then calculate loads based on various head positions using Matlab.
Lightweight

Research the wicking properties and washability of the fabric in contact with the skin.
Exterior is fully washable Wear the fabric on skin during vigorous exercise, then wash it; wash, then survey
both men and women as to whether it smells bad.
Clean

45.1-57.5 cm circumference (based on 5th Measure fully tightened, unstretched device for minimum size. Determine the
percentile female 2-year-old and 95th amount of circumferential tension that is unpleasant to head, and exert 90% less
Expandable percentile male 18-year-old)45 than this force amount as measured by a force gauge to get max circumference.

Must be able to accommodate for a range of With angle ranges marked, have a volunteer user experiment with different speeds
head angles, sensory abilities, and ages. and directions of head tilt. Feedback should only be offered when forward head tilt is
Adjustable Goal is to be usable for children at GMFCS within the specified zones (Positive feedback: <25 degrees from vertical. Negative
/Adaptable levels 3 through 5. feedback: >45 degrees from vertical).

Takes less than 2 minutes for a typical adult

After 5 tries, an adult previously untrained in the device should be able to put it onto
to put on and turn on (assuming caretaker
the user in under 2 minutes.
Easy to put on puts device on the user)
Battery that can be recharged (or replaced if
Run the device without being connected to an outlet.
Power source necessary) for up to three years of use.

Battery charge Charge power source using a standard outlet and any necessary charging device;
Standard wall outlet (120V, 60Hz)
method should lead to a full battery charge that meets the requirements for ‘power source’.

Use the device and power source until the point of power source depletion or eight
hours. The device should continue functioning without cords for at least four times
>8 hours on a single charge
the intended duration of use.
Length of use .
Head unit survives 3m drop test > 5 times and maintains functionality; any wires
Doesn’t break easily if jostled, bumped, or
should survive >10,000 flexes up to 60 degrees without noticeable signal
otherwise disturbed
Durability degradation.

Device must respond quickly to the user’s
head moving out of proper position
Response time
Move the head to set positions within each feedback zone, staying longer in 'no
feedback' areas to ensure none is delivered. Reading should adapt to these
locations, and device must respond within 2 seconds to the user’s head moving into
a feedback zone (Positive feedback: <25 degrees from vertical. Negative feedback:
>45 degrees from vertical).

Record the forms of feedback reported by a user in each of the three ‘zones’ (<25°
from vertical, >25° and <45° from vertical, and >45° from vertical). Only auditory
Device should provide feedback in multiple
feedback should be reported in the <25° zone, nothing should be reported in the 25°
ways
Multiple forms to 45° zone, and only haptic feedback should be reported in the >45° zone. 15%
of feedback error is within the zone of acceptability.

Outputs the total amount of time used and Use the device according to a specified plan, and manually measure the user
Data output the successful use percentage statistics. Device output should be within 15% of manual calculations.

Wireless while in use, delivers data to a

Visually inspect device on human head: no cords should connect the head unit to
phone, computer, or other device with a user
anything more than 1 foot away from the head.
Connectivity interface

Less than $200 in parts Tally of parts actually used in the final device amounts to less than $200.
Cost

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Appendix B: Updated Gantt Chart. This Gantt chart shows the proposed schedule. Full-team
tasks are shown in teal, Katelyn’s tasks are shown in purple, Thom’s tasks are shown in green,
and Emma’s tasks are shown in red.

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Appendix C: User Experience Survey
For wearer:----------------------------------------------------------------------------------------------------------------
1. How easy was it to put on the device?
a. Very easy
b. Somewhat easy
c. Neither easy nor difficult
d. Somewhat difficult
e. Very difficult

2. How comfortable was the device after thirty (30) minutes of use?
a. Very comfortable
b. Somewhat comfortable
c. Neither comfortable not uncomfortable
d. Somewhat uncomfortable
e. Very uncomfortable

3. How comfortable was the device after one (1) hour of use?
a. Very comfortable
b. Somewhat comfortable
c. Neither comfortable not uncomfortable
d. Somewhat uncomfortable
e. Very uncomfortable

4. How comfortable was the device after four (4) hours of use?
a. Very comfortable
b. Somewhat comfortable
c. Neither comfortable not uncomfortable
d. Somewhat uncomfortable
e. Very uncomfortable

5. Did wearing the device make you feel conspicuous?

a. Very inconspicuous
b. Somewhat inconspicuous
c. Neither inconspicuous nor conspicuous
d. Somewhat conspicuous
e. Very conspicuous

6. How likely would you be to wear this device in front of a small group of friends or family?
a. Very likely
b. Somewhat likely
c. Neither likely nor unlikely
d. Somewhat unlikely
e. Very unlikely

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 7. How likely would you be to wear this device in front of a small group of strangers?
a. Very likely
b. Somewhat likely
c. Neither likely nor unlikely
d. Somewhat unlikely
e. Very unlikely

8. How likely would you be to wear this device in public?

a. Very likely
b. Somewhat likely
c. Neither likely nor unlikely
d. Somewhat unlikely
e. Very unlikely

9. Does using the device cause any nervousness or anxiety?

a. Not at all nervous
b. Slightly nervous
c. Noticeable anxiety
d. Significant anxiety
e. Too much anxiety to use

For caretaker:-------------------------------------------------------------------------------------------------------------
1. How likely would you be to facilitate use of this device in front of a small group of the
user’s friends or family?
a. Very likely
b. Somewhat likely
c. Neither likely nor unlikely
d. Somewhat unlikely
e. Very unlikely

2. How likely would you be to facilitate use of this device in front of a small group of
strangers?
a. Very likely
b. Somewhat likely
c. Neither likely nor unlikely
d. Somewhat unlikely
e. Very unlikely

3. How likely would you be to facilitate use of this device in public?

a. Very likely
b. Somewhat likely
c. Neither likely nor unlikely
d. Somewhat unlikely
e. Very unlikely

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Appendix D: Validation Survey
For physical therapist:--------------------------------------------------------------------------------------------------
1. Was it straightforward to prescribe device usage?
a. Very straightforward
b. Somewhat straightforward
c. Neither straightforward nor complicated
d. Somewhat complicated
e. Very complicated

2. Is it easy to explain and demonstrate usage to a caretaker?

a. Very easy
b. Somewhat easy
c. Neither easy nor difficult
d. Somewhat difficult
e. Very difficult

3. How well-suited is the device for regular use?

a. Very well-suited
b. Somewhat well-suited
c. Neither well-suited nor poorly-suited
d. Somewhat poorly-suited
e. Very poorly-suited

4. How comfortable are you recommending this device?

a. Very comfortable
b. Somewhat comfortable
c. Neither comfortable not uncomfortable
d. Somewhat uncomfortable
e. Very uncomfortable

5. To what extent do you believe the device is helpful in improving posture during use?
a. Very helpful
b. Somewhat helpful
c. Neither helpful nor unhelpful
d. Somewhat unhelpful
e. Very unhelpful

6. To what extent do you believe the device is helpful in improving posture outside of use?
a. Very helpful
b. Somewhat helpful
c. Neither helpful nor unhelpful
d. Somewhat unhelpful
e. Very unhelpful

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 7. How likely would you be to recommend this device?
a. Very likely
b. Somewhat likely
c. Neither likely nor unlikely
d. Somewhat unlikely
e. Very unlikely

For caretaker:-------------------------------------------------------------------------------------------------------------
1. How easy was the device to put onto the user?
a. Very easy
b. Somewhat easy
c. Neither easy nor difficult
d. Somewhat difficult
e. Very difficult

2. How easy was it to learn how to operate the device?

a. Very easy
b. Somewhat easy
c. Neither easy nor difficult
d. Somewhat difficult
e. Very difficult

3. How easy was it to operate the device (once taught)?

a. Very easy
b. Somewhat easy
c. Neither easy nor difficult
d. Somewhat difficult
e. Very difficult

4. Does the device appear to encourage upright head position during use?
a. Significant improvement
b. Some improvement
c. No change
d. Some decline
e. Significant decline

5. Does the device appear to encourage upright head position, even when not in use?
a. Significant improvement
b. Some improvement
c. No change
d. Some decline
e. Significant decline

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 6. Did the device irritate the user?
a. No irritation
b. Some irritation
c. Moderate irritation
d. Significant irritation
e. User refuses to wear device

For wearer:----------------------------------------------------------------------------------------------------------------
1. How easy was the device to use?
a. Very easy
b. Somewhat easy
c. Neither easy nor difficult
d. Somewhat difficult
e. Very difficult

2. Do you feel that your head position improves while using the device?
a. Significant improvement
b. Some improvement
c. No change
d. Some decline
e. Significant decline

3. Do you feel that your head position improves even while no longer using the device?
a. Significant improvement
b. Some improvement
c. No change
d. Some decline
e. Significant decline

4. Is the device irritating to wear?

a. No irritation
b. Some irritation
c. Moderate irritation
d. Significant irritation
e. Will not wear

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