Medi­cal Device Assem­bly and Test System

InvotecCase Study, Complex Assembly Equipment, Machine Vision Systems, Micro Laser Processing, Test Systems

medical device assembly line
The Chal­len­ge

Our cus­to­mer nee­ded a sys­tem that would assem­ble, test, and label their medi­cal device. Using in-pro­cess checks, they wan­ted to veri­fy that all com­pon­ents in the assem­bly com­plied with rigid qua­li­ty stan­dards; addi­tio­nal­ly recor­ded data from post-pro­cess tes­ting ope­ra­ti­ons was requi­red on all of the devices.

The Solu­ti­on

Invo­tec deve­lo­ped a sys­tem that employ­ed lean cell tech­no­lo­gy in an assem­bly line approach— incor­po­ra­ting a manu­al­ly index­ing, pal­let con­veyor to trans­fer assem­bled com­pon­ents bet­ween operations.

Machi­ne visi­on sys­tems were used to veri­fy that the cor­rect com­pon­ents were loa­ded and assem­bled pro­per­ly. The assem­bly pro­cess con­clu­ded with the machi­ne-con­trol­led pres­sing ope­ra­ti­ons that were moni­to­red to ensu­re the for­ces and distan­ces the too­ling tra­vel­led were wit­hin the pro­cess limits. Sub­se­quent visi­on inspec­tions veri­fied the device was wit­hin dimen­sio­nal specifications.

Func­tio­n­al tes­ting then veri­fied that resul­tant for­ces, from a varia­ble input load, met the design cri­te­ria. The device was electri­cal­ly tes­ted in a sys­tem that auto­ma­ti­cal­ly con­nec­ted, tes­ted, and dis­con­nec­ted the device. Final­ly, accep­ted devices were batch num­be­red with a laser marker.

This cus­tom machi­ne inclu­ded the­se technologies:

  • Inte­gra­ted visi­on dimen­sio­nal & pro­fi­le inspections
  • Laser mar­king system
  • Press sys­tem for­ce & distance trans­du­cers with auto­ma­tic calibration
  • Reac­tion for­ce & electri­cal testing
The Results

Ori­gi­nal­ly, the manu­al assem­bly of this device was pro­ne to ope­ra­tor errors. Due to the cri­ti­cal-to-func­tion cha­rac­te­ris­tics of this pro­ject, this new sys­tem inspec­ted com­pon­ents throughout the assem­bly pro­cess while the device was being held in dedi­ca­ted fixtures.

The pre­vious tes­ting sys­tem for this device was also unre­li­able and incon­sis­tent. The new sys­tem offe­red a self-cali­bra­ti­on rou­ti­ne that auto­ma­ti­cal­ly cali­bra­ted the moni­to­ring equip­ment during sche­du­led inter­vals. Post-pro­cess tes­ting was inclu­ded in the assem­bly cell to veri­fy that the device was com­plied with rigid qua­li­ty standards.


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