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VEXTEC Reliability Analysis of Above-the-Knee Leg Prosthesis

VEXTEC Reliability Analysis of Above-the-Knee Leg Prosthesis. Group 11 Aashish Bapat, April Boldt, Jason Deaner, Grainger Greene, Dani Shuck. Project Need. VEXTEC (Sponsor Company) Fatigue failure and reliability analysis Automobile and Aerospace Industry

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VEXTEC Reliability Analysis of Above-the-Knee Leg Prosthesis

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  1. VEXTECReliability Analysis of Above-the-Knee Leg Prosthesis Group 11 Aashish Bapat, April Boldt, Jason Deaner, Grainger Greene, Dani Shuck

  2. Project Need • VEXTEC (Sponsor Company) • Fatigue failure and reliability analysis • Automobile and Aerospace Industry • Market Potential in Medical Device Sector • Project Overview • Re-Design the existing reliability analysis protocol to cater the needs of the medical device manufactures A) Cost B) Time C) Quality

  3. Project Goals • Predict reliability of above-the-knee prosthetic leg (Finite element analysis) • Material • Geometrical • Loading • Available data on failure • Modify the design of Reliability analysis software for the prosthetic leg

  4. Project Goals (contd..) 3) Market Analysis • Potential Medical device manufactures • Testing cost and time reduction analysis • Meetings with the medical device industry to identify specific market needs • Aid for FDA approval

  5. Prosthesis Hardware • Socket • Knee system • Shank • Foot-ankle system

  6. Design System and Weaknesses • Inherent Weaknesses in Prosthetic Design: • Longevity of Prosthesis • Fracture vs. hardness • Material friction vs. debonding • Cyclic loading vs. corrosion • Strength of bone tissue surrounding • Method of fixation/integration into bone matrix • stress shielding dissolved tissue • Misalignment and loosening BIOCOMPATIBILITY

  7. Market Analysis • Approximately 50% of all medical device recalls are due to design errors that could have been prevented by adequate design controls • FDA Quality System Regulation requires risk analysis as a portion of its Design Control requirements. • November 9, 2006 – FDA announced it is strengthening its postmarket approval program for medical devices

  8. Competitors • Relex • Uses fault tree analysis, reliability predictions and block diagrams, FMEA/FMECA software modules • Clients for medical device software/consulting include Abbott Laboratories, GE Medical Systems, Siemens Medical • Other non medical device clients include Boeing, Northropp Grumman, Motorola • ReliaSoft • Similar products to Relex, including fault tree analysis and MTBF calculations • Weibull++ goes for approx. $1000 for individual customer

  9. Work Completed • Visited VEXTEC on October 19 to discuss design project goals with Dr. Curtin • Submitted preliminary proposal on November 2 • Talked with Dr. Collins to obtain alumni contacts in the FDA • Contacted Dr. Goldfarb for future assistance in finite element analysis techniques • Talked with Dr. Bers to discuss market potential and obtain permission to participate in the Technology Marketing course

  10. Current Work • Tuesday, Nov. 28 • Meeting with Dr. Bers on Market Analysis • Background Research completed by December 15 • Technology • Prosthesis development since WWII • Current technologies • Prediction of future development • Market • SBIRs • Need

  11. Future Work • Development of MATLAB code by February 27 • Development of MATLAB reliability analysis by March 30 • Selection of most likely site of failure • Finite Element Analysis – ProE • Manufacturing parameters • MATLAB simulation • Poster and Design Report by April 26th

  12. Roles Sponsors • Dr. Curtin • Dr. King Advisors • Dr. Collins • Dr. Goldfarb

  13. Questions?

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