Portescap works with customers through the design & development processes that are exclusive to the medical device field including helping support 510K, CE Mark, PMA, or other regulatory activities as they pertain to the motor design. Portescap is thinking about the customer end product from the initial engineer to engineer conversations through the full production phase.
Design Approach (BLDC Slotted Motors)
| Steps | Details |
|---|---|
| Define Motor Specifications & Needs | Initial customer contact with Portescap Portescap Engineer to Customer Engineer collaborations Understanding of customer motor needs, qualifications and testing cycles. |
| Design Proposal (multiple iterations if needed) | Preliminary design to performance specs. Continued engineer to engineer contact Design Lamination (if needed custom), stack, stator, magnet, design, shaft and rotor configuration Optimize efficiency to customer specified operating point Software analyzing of electrical, magnetic and thermal losses Produce mechanical/electrical outline drawing and performance curves |
| Design Plan | Customer Signoff and Motor Prototype Order Received CAD models created BOMs created Motor Design Reviews Procurement of parts and fixtures and mold tools if necessary Supply chain plan developed |
| Prototypes (multiple iterations if needed) | Inspection and analyses of motor components Building of Prototype motors Joint testing and analysis of motors with customer if needed |
| Validation/Testing | Engineering design validation and test data generated First Article inspection performed to ensure motor quality Additional testing in medical washer or autoclave available if required |
| Customer Internal Evaluation and Testing | Motor Prototype shipped to customer Portescap continues to provide support to customer medical device testing efforts such as verification and validation and other design stages. Portescap will also work to support documentation needed for regulatory approvals (e.g. 510k, PMA or CE mark) as it pertains to the device motor |
| Motor Pre-production | Production order received from customer Supplier selection & qualification Design & source fixtures Identify component CTQs Full product validation test plan established and testing completedGages identified and ordered Process validation plan |
| Motor Production | Incoming quality plan Develop and release manufacturing procedures Quality records plan development Supplier performance tracking in place pFMEA Production ramp up |