1. ACTIVE ANKLE FOOT ORTHOTIC (AFO) VOICE OF THE ENGINEER Design Project Management

2. Introduction to the Team Shane Reardon - (ME) Travis Blais - (ME) Diane Kang - (IE) Austin Frazer – (ME) Gerald Garavuso Team Members Mentor Stakeholders Dr. Lamkin-Kennard Dr. DeBartolo Christopher Sullivan

3. Table of Contents Functional Decomposition Benchmarks Specifications House of Quality Family Roadmap Potential Concepts Staffing Feedback

4. Overview  Lay out roadmap for air muscle-driven active Ankle- Foot Orthotic  Eliminate the condition known as “foot drop” Midstance Foot Drop (Between Propulsive and Contact Phase)

5. Functional Decomposition

6. Functional Decomposition Cont. The active ankle foot orthotic must mitigate the effects of foot drop. Allows adequate motion Modifies Foot Behavoir Interprets sensor data Allows plantar flexion and dorsiifle- xion Identifies phase of gait Utilizes terrain sensing system Compares current and ideal states Determin es foot position Senses Terrain Utilizes terrain sensing system Identifies phase of gait Controls Foot Position Applies force to foot Support Portability Safely store Energy Safely Receive Energy Safely Regulate Energy Accomodates Range of Users Easily Adjustable Reduce/ eliminate custom fitting process Removable Determine Current State Determine Ideal State

8. Engineering Specification Number Engineering Specification Description Units of Measure Preferred Direction Nominal Value Method of Validation Stems From Customer Need Notes s1Torque on FootN-mUp ≥ ±1.5 TestFT1,2,4,ST1,5 s2 System response time (sensing terrain to actuating device) msdown<150TestST3 s10 allowable range of motion between foot and shin degreesrange 94.5 to 137.7 TestFT1,3,CF8,9,ST1 s12untethered usage timehrs/stepsup>3000 steps P1,2,D1project dependant s14fits calf (diameter)mmrange292 to 433MeasurementCF1,3,5user dependent s15fits foot (length)mmrange212 to 317MeasurementCF1,3,5user dependent s17force to secure constraintsNdown< 80 NTestC4 s18force to remove constraintsNdown< 80 NTestC3 s24weight of entire devicekgdown ≤2 or ≤3 weighFT6 s31Minimum life until failurestepsup5.5 milliontestD1 s32Allowable toe extension/flexiondegreesrange0-50testCF8, CF9 Specifications

9. Engineering Specifications Spec s27s31s32s33 Stakeholders need a convenient active ankle foot orthotic to mitigate the effects of foot drop while not constraining user's motion in ways that force unnatural gait Customer Weights Has housing around electronic components Minimum life until failure Allowable toe extension/flexion Fits with users regular shoe size VOC - Affinity GroupsCO #VOC - Customer Objectives Preferred Direction - up - Comfort CF8allow toes to flex up 12.0% 9 CF9keep toes from curling down 9 CF10aesthetically pleasing CF11low noise Durability D1reliable for day to day usasge 10.0% 99 D2sensors/controls withstand elements 9 D3usable in rain/shower 9 D4washable 9 Convenient C1fit into normal shoe size 5.0% 9 C2reduce time and cost of custom fitting process C3easy to take off C4easy to put on C5easy patient interface with sensing system C6easily adjustable House of Quality

10. Family Roadmap

11. Potential Concepts  Ratchet and flexible air muscle pictures

12. Staffing

13. Feedback  Family roadmap and individual project definitions were all approved.  Dr. DeBartolo requested project submission into ASME summer bioengineering competition

14. Questions?