The Birth of a Power Wheelchair. What Will Be Covered Today 2/20/2015. Common Questions All Manufacturer s Hear

Transcription

1 The Birth of a Power Wheelchair Jay Doherty, OTR, ATP/SMS Senior Clinical Education Manager Eastern US John Storie National Director of Quantum Field Sales What Will Be Covered Today A shortened version of the entire process of developing a new power base from start to Launch. Concept and Planning The Development Phase The Testing Phase The Beta Test Phase The Launch Common Questions All Manufacturer s Hear I need your Power wheelchair to do this! Can t you just change this one thing? This typically works well for most people but I have a couple of people that need it to do this. Can t you just change this? Not with everything but many things on a power wheelchair can t just be changed quickly. It is a process! 1

2 How do power chairs come to be? How do power chairs come to be? How do power chairs come to be? A Long Process? YES!!!!!!!!!! 2

3 Concept and Planning Project Concept Design Input 510(k) Submission Design Planning Quality Goals/Reliability Conceptualization /Renderings Design Gather the information from the therapists and ATP s who have experience recommending the equipment in the field. Project concept Project Concept Gather information from end-users who use the equipment everyday. 3

4 Preliminary Design The power base starts with drawings then is reviewed and changed accordingly. Preliminary Design The power base starts with drawings Then it is reviewed by leaders in the sales department. Then it is redesigned and reviewed again. This occurs until the concept is agreed upon by all involved. Development Phase 4

5 Preliminary Design After many review sessions the design team will use 3D software to give better perspective on the design before an actual model or beta unit is designed and fabricated. Preliminary Design Once the 3D computer image is completed the team will decide if an actual printed design is needed. This allows the review team to hold and manipulate the actual object in their hand itself. Design approval Now that Sales and Research and development have agreed on an actual design the design starts to be finalized. This includes: Final drawings which will show actual parts Shrouding/plastics designs Mechanical parts The framing of the power base How batteries fit Etc. 5

6 Edge HD Shroud Design Edge HD Shroud Design Edge HD Shroud Design 6

7 Edge HD final design Building Prototypes R&D work with Vendors to get parts produced. R&D work with Vendors on pricing. Provide drawings and measurements of parts needed. Get parts in; the parts must go through first article. Communicate problems and work with vendor to rectify problems. If no problems build prototype units. Preliminary Production Supplier Kick Off Tooling Review Supplier Control Plan First Article Inspection Release drawings to production life cycle Design verification testing complete 510 (k) Application Submission BOM Breakdown 7

8 Requirements and Test Methods for Wheelchairs Determination of Static Stability Determination of Dimensions, Mass and Maneuvering space Method of Measurement of seating and Wheel Dimensions Requirements and test methods for static, impact and fatigue strengths Test dummies Determination of coefficient of friction of test surfaces Requirements for information disclosure, documentation and labeling Resistance to ignition of upholstery parts Determination of the performance of stand-up type wheelchairs Setup procedures RESNA WC-1:2009 Additional Requirements for Wheelchairs with Electrical Systems Determination of dynamic stability of electrically powered wheelchairs Determination of effectiveness of brakes Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical distance range Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs Climatic tests for electrically powered wheelchairs Determination of obstacle-climbing ability of electrically powered wheelchairs Power and control systems for electrically powered wheelchairs Requirements and test methods Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and motorized scooters RESNA WC-1:2009 Testing 2 drum test: This is a fatigue strength test which runs a unit over two drums for 200,000 revolutions. Each drum has slats that are located on it which causes significant jarring to the power wheelchair unit that is being tested. If ay part that is considered permanent loosens or breaks the unit fails the test. 8

9 Two Drum Test Drop Test The drop test requires that a unit be dropped (complete freefall) from a height of 2. This test is performed 6666 times. Drop Test 9

10 Impact Durability Test Static Stability Test This test uses a ramp that increases in pitch slowly. When the front caster wheels lift off of the surface (not the unit tipping over backwards) the test is completed and that is the angle recorded Dynamic Stability Test This test utilizes a ramp at a set angle (for group 3 it is a 7.5% grade). The unit is loaded with the maximum weight capacity and then driven backwards and stopped abruptly and then driven forward and stopped abruptly. A unit passes as long as it does not tip over. 10

11 Environmental Water Test The test simulates rain for a period of 10 minutes. Once completed the power wheelchair must function properly after the test. Quantum actually does this two more times for 20 minute cycles with 2 hours between each cycle. Environmental Test: Extreme Heat and Cold Storage test The unit is subjected to -40⁰F or 149⁰F The unit is removed and left at ambient temperature for 1 hour. The unit is then turned on and must run properly. Operational Test The unit is placed in -13⁰F or 122⁰F for 3 hours. Removed and after 5 minutes it,must run until the frost and ice is melted. Placed back in for 3 hours Then removed and after 5 minutes run again. Maneuverability Test The unit is driven through a hallway and makes a 90⁰ turn. This test helps to identify the environmental barriers the unit can handle. 11

12 Obstacle Climb For group 3 power wheelchair they must climb a 60mm obstacle while traveling forward. Effectiveness of Braking standards Must drive the power chair maximum speed forward and brake in three different ways: Letting go of joystick Shutting the unit off Pulling the joystick into reverse. Environmental Test: Salt Water Testing (Not a required test) In this test the unit is sprayed down with salt water especially the electrical components. Turn the unit on and run it until the battery discharges itself. Charge the battery up and do it again. This battery runs for at least 8 hours a day. 12

13 Transaxle Testing (Not a required test) We test our motors by running the units forward and reverse continuously for a length of time depending on the type of motor used. Durability Testing (these tests are not required) Durability of the power positioning system Quantum Rehab runs this test so that every actuator runs 15,000 times while loaded with the maximum weight capacity Durability of Seating System We run this test so that we can simulate everyday forces that are placed on the seating system. This is a Quantum Rehab test not required by PDAC. 13

14 Launch Documentation Ready Order Entry rules design review Release PO for Production Product and Vendor Serialization Serial Numbers released for production Design output BETA testing (if applicable) Government Regulation Submission (if applicable) Software Validation Data on File Phase 3 Design Review Production and Release (Transfer) ECO Release Production Ready IT Development Complete Final Illustrated Breakdown (IPB) Training Test Order Confirmed and Fulfilled Launch Packet Design Validation Regulatory Approvals Declaration of Conformity and/or Health Canada Forms Complete Device Master Record and/or Technical Dossier 14

15 Preliminary Order Form Completed Preliminary Rules Established for Order Entry Preliminary Owner s Manual Complete Release Drawings to tooling lifecycle Market Activities Putting together Marketing posters. Putting together Marketing/Sales Slicks. Review What works from a marketing perspective. Sales Education We must educate the field sales staff for them to provide in-services to ATP s and Therapists. Provide demos to field sales staff. Provide field sales staff with pricing. Provide field sales staff with launch dates 15

16 Production The R&D team and production management team review how the unit can best fit into the current production process. The team will look at changes to production process if needed. The R&D team and production management team train production staff on how to properly setup the new product. Quality Quality is taken very seriously. We document the quality of the order and device before it leaves the facility. Our Quality management is never entirely completed. We follow chairs throughout their lifetime. Watching and addressing any quality failures that possibly may occur. Of course we always strive for the highest level of quality at launch! Final Documentation Through the entire process of development to launch every part of the process is thoroughly documented. Any changes made to the original design must be documented. The manufacturing process must be documented The marketing process is documented. Every part of this process is documented and it is all put into one document which is kept on hand. Any problems in the field at any time after launch is documented in this book as well as any changes that are made to the unit. 16

17 Any Questions? 17