Case study

Challenge

• Our customer, a large medical devices company in the US, received an end of life notification from their Japanese motor vendor.
• They had struggled to find a replacement part and were rapidly running out of time. They were very keen to minimise redesign and FDA re-submission. 
• They wanted a Western partner to ease communication and who was experienced in managing the complexities of manufacturing parts for a medical implant device. 
• FDA Class III required us to test, validate and certify a part for medical use that was not designed for that application.

Solution

• We took an existing brushless coin motor design and upgraded almost every sub-component.
• We also adapted the motor to contain three driving voice coils instead to two – an unusual improvement. This solved a longstanding motor starting problem experienced with the old motor.
• We built 2 custom fully-automated characterisation machines which perform an initial burn-in and then tested performance of each motor. 
• The final part was similar enough to the obsolete part that only a limited FDA submission was required, expediting it’s adoption.

Results

• Our motors were left running continuously on a longevity testing machine for over a year with minimal reduction in performance.
• We prevented the customer experiencing a serious production line stop.
• The customer received a large amount of validation and testing data. In doing so we were able to spot an error that the customer themselves were doing on inbound quality control inspection. 
• We went above and beyond to make sure that the parts were as reliable as could be, and they remain in use around the world today.

STAGE 1

Designing for application

• Our application-specific solution was a heavily modified version of an existing brushless vibration motor design.
• In addition our design contained three driving coils which fixed a start-up problem that the obsolete motor had presented.
• We supported with all the necessary documentation to enable a speedy submission to the FDA, and this prevented a production line stop for the customer’s pacemaker product line.

STAGE 2

Robust quality

• Testing, validation and very stringent quality controls, were the foundation of this project.
• We implemented extraordinary quality control and traceability of components processes.
• Full supply-chain auditing and accountability was of vital importance to our client and developed a new module in our ERP systems to meet their strict demands.
• Our advanced testing technology allowed us to thoroughly validate lifetime reliability testing.

STAGE 3

Ongoing support

• Our customer was made very confident that our motor was suitable and reliable.
• After delivering a better motor solution, on time and to spec, we provided ongoing support and communication with our customer. In doing so we improved their own product quality control processes.
• We quickly became a strong and reliable partner addressing their problems directly, and proactively managing their risk, throughout the whole project.