1. Low Cost Fundus Camera P15590 September 30th, 2014
Presented by: Daniel Sui, Ian Morency, Kevin Labourdette, Kyle Burden, Thomas Casero, Quang Huynh
September 30th, 2014
Kyle

2. Overview Background Functional Decomposition Concept Development
Problem Statement
Current Product
House of Quality
Functional Decomposition
Concept Development
Engineering Analysis
System Level Proposal
Risk Assessment
Test Plan
Updated Project Plan
Kyle

3. Background Diabetic Retinopathy Fundus Camera Our Goals Vein Damage
Reduce Risk
Many drawbacks
Our Goals
Low Cost
No Medical Dilation
Ian
High-power camera
Inner Eye
Diabetic Retinopathy
40% mild to moderate risk
Severe risk ~40% chance of blindness (4 years)
Risk can be reduced ~35%

4. Background - Problem Statement
Current State
Only in Optometrist offices
Expensive
Complicated
Desired State
Easily Accessible
Inexpensive
Intuitive to use
Project Goals
Research current systems and patents
Develop Working Prototype
Constraints
FDA Requirements
Ian

5. Background - Current Product
Device Issues:
Prohibitively expensive
Pupil dilation required
Requires specialized medical personnel
Heavy and large
Difficult setup
Tom
Leads to:
Inconvenient regular screenings
Low patient compliance
Vision loss

6. Background - HOQ Engineering Requirements Customer Requirements
Correlation
Kevin
Customer reqmts - voice of customer:
what do they want or need? desired attributes
Engineering reqmts - voice of engineer:
what are the tech needs? often called specifications
How do they correlate? - House of Quality
CRs - rows, ERs - columns, CR v. ER - middle, ER targets & benchmarking - bottom, CR benchmarking - right
Our focus is ER vs CR & ER targets/benchmarking
Fundamental Question: If the ER is successfully achieved will the customer be satisfied?
Assessment: 9- Strong Corr., 3- Med. Corr., 1- Weak Corr., 0- Not Corr.
(empty rows = customer need not addressed, empty columns = superfluous EM, too many relationships = EM too broadly defined)
TAKEAWAYS:
Too broad: ease of use, consistent alignment system, non invasive
Importance:
High - Reduce alignment time, high quality photo (I thought cost (19) & portability (16))
Low - Measure patients refractive error (recording aberration adjustment), image display preview 8 6 7 4 13 2 12 5 10 11 3 9

7. Background - HOQ
Kevin

8. Functional Decomposition
Why?
How?
Dan

9. Concept Development 1 - Table Top
Quang - talk about morph table
Include morph table selection process
pros and cons

10. Concept Development 2 - Faceplate
Kevin

11. Concept Development 3 - ClaRITy
Tom

12. Concept Development 4 - iPad Case
Kyle

13. Concept Development 5 - Goggles
IanMask face support
Blocks out ambient light
Consistent
Takes Two pictures simultaneously
L/R Picture of equal quality
Much more expensive
Lightweight
Easy to transport
Usable by all ages
More difficult to engineer
Controlled via computer
Requires external software
Easy to use/design controls
Requires doctor to have computer

14. Concept Development 6 - iPhun
Dan

15. Concept Development 7 - Fundus Gun
Ian

16. Engineering Analysis - Lens Material
Glass
High optical quality
Cheap
Plastic
Lightweight
Good optical quality
Shatter resistant
Easily processed
Polycarbonate
Impact resistant
Thin
3D Printed Lens
UV light curing
Lighting fixtures
Heavy
Thick
Shatters easily
Scratches easily
Poor optical quality
Expensive
Not designed for optical lenses
Quang

17. Engineering Analysis - System Power
Faceplate
Component
Make/Model mA V W
Cost
Comments
SLR Camera
Nikon D3300
$550
410 gram weight
Servo motor
HS-311
160
4.8
0.768 $8
Torque 3.7 kg-cm
850 nm IR lamp
COM-09469 50
1.6
0.08
$0.95
LED flash lamp
COM-11118 80
3.4
0.272
$1.50
16-20 candela
LED indicator
COM-09592 20 2
0.04
$0.35
Controller
Arduino Uno
500 5
2.5
$50
via USB power
Dan

18. Engineering Analysis - Budget
Kevin

19. Engineering Analysis - Lighting
Light Spectrum
UV: nm
Visible: nm
IR: 800nm-1mm
Long Wavelengths - Low Energy
“Infrared Imaging of Sub-Retinal Structures in the Human Occular Fundus”
Visibility of Fundus Features
Need to see
Retinal Vessels
Sub-retinal Hemorrhage
Sub-retinal Deposits nm
Show details
Low risk of damage
Ian

20. Engineering Analysis - Data Transfer
Question: Feasibility of data transfer methods for Ophthalmic images
Options:
Wi-Fi
Bluetooth
Wired
USB
Picture Archiving and Communication System
(PACS)
DICOM standard
Health Insurance Portability and Accountability Act (HIPPA)
Health Information for Economic and Clinical Health Act (HITECH)
FDA Federal Food, Drug, and Cosmetic Act Class II
510(k) process
Kyle

21. Engineering Analysis - iDevice
Question: Feasibility of iPhone/iDevice camera use
Basis:
iPhone 5 back camera
4.12mm focal length
1/3.2” sensor size
Given working distance 1.5-2”, ~38-50mm
Average eyeball diameter 24mm
Real working distance: 62-74mm
Calculated image distance: mm
FOV dimensions determined from interpolated sensor size
68.6x51.4mm
Much larger than eyeball diameter
Need additional magnification/zoom
Tom

22. Selection Criteria Low Cost Adheres to FDA/Safety Regulations
Portability
Usability
Reliability
Diagnosable Image
Adheres to FDA/Safety Regulations
Patient Comfort
Plausibility
Cost
Time
Engineering
Ian

23. Pugh Table - Datum 1
Highest (+) Rating
Kevin
Lowest (-) Rating

24. Pugh Table - Datum 2
Highest (+) Rating
Kevin
Lowest (-) Rating

25. Pugh Table - Datum 3
Highest (+) Rating
Kevin
Lowest (-) Rating

26. System Level Proposal System Power - Wall Plug
Illuminate Retina - IR then LED Flash
Capture Video - Camera
Display Video - External Monitor
Support Head - Face down
Direct Eye - Internal target
Position Camera - Controlled on GUI
Focus Image - Auto / on GUI
Metadata - Input to GUI
Connect to comp - Network/USB
Package File - DICOM
Kyle
Some Whys:
Stability
Consistency
Comfort

27. Risk Assessment
Quang - alex leaving after first semester

28. Test Plan
Dan

29. Updated Project Plan
Next 3 weeks:
Kyle

30. Summary Background Functional Decomposition Concept Development
Problem Statement
Current Product
House of Quality
Functional Decomposition
Concept Development
Engineering Analysis
System Level Proposal
Risk Assessment
Test Plan
Updated Project Plan
Kyle

31. Questions