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

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

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%

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

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

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

Background - HOQ Kevin

Functional Decomposition Why? How? Dan

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

Concept Development 2 - Faceplate Kevin

Concept Development 3 - ClaRITy Tom

Concept Development 4 - iPad Case Kyle

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

Concept Development 6 - iPhun Dan

Concept Development 7 - Fundus Gun Ian

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

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

Engineering Analysis - Budget Kevin

Engineering Analysis - Lighting Light Spectrum UV: 10-380nm Visible: 380-800nm 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 825-895nm Show details Low risk of damage Ian

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

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: 4.36-4.41mm FOV dimensions determined from interpolated sensor size 68.6x51.4mm Much larger than eyeball diameter Need additional magnification/zoom Tom

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

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

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

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

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

Risk Assessment Quang - alex leaving after first semester

Test Plan Dan

Updated Project Plan Next 3 weeks: Kyle

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

Questions