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Sterilizable Motors Design Approach

Sterilizable Motor Design Process

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)

StepsDetails
Define Motor Specifications & NeedsInitial 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 PlanCustomer 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/TestingEngineering 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 TestingMotor 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-productionProduction 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 ProductionIncoming quality plan
Develop and release manufacturing procedures
Quality records plan development
Supplier performance tracking in place
pFMEA
Production ramp up