Fully-Automated spinal screws engraving, assembling and packing
Market
Implantable Medical Device for Spine Fusion Surgery
Spinal pedical screws
FDA Device Class # 2 Customer Spinal products are distributed worldwide
The market of spinal implants is primarily driven by some of the advancements in spine surgery technologies and the increasing adoption of minimally invasive spine surgeries Customer final products are distributed worldwide
Customer
International Group specialized in Medical Devices
The machine is installed in a unit dedicated to spinal implants design and production
The facility produces à total of around 1.2 million implants per year
The delivered machine engraves, assemble and pack around 600 thousand implants per year
The customer acquired the machine to:
- Replace the existing manual production workshop
- Increase the facility capacity
- Improve and strengthen the processes repeatability
- Implement a more efficient traceability system directly linked to its ERP
- Comply with coming new rules
Project main requests and constraints
Very high batches sizes variability > from 20 up to 2 000
17 products variants in 7 "families"
- Smaller parts = Ø 5.95 x H 2.52 mm
- Bigger parts = Ø 11.30 x H 7.78 mm
Fast, simple and secure variants changes < 10 minutes
User-friendly interface for quick recipes changes
Limited floor space in an existing Cleanroom
AS.MED main requirements
Spinal parts:
- Feeding > from bulk with bowl-feeders,
- Controlling > by vision with measurement accuracy ≤ ±25 µm
- Handling,
- Orienting > by vison,
- Laser-engraving > with accuracy ≤ ±50 µm
- Engraving position, accuracy and quality control > by vision,
- Assembling by screwing > with position, force and torque control
Assembled spinal implants
Final control > by vision,
Handling,
Blistering:
- Deposition in blister with identification (UDI)
- Label printing and placing (on the blister)
- Insertion of Instruction For Use (IFU) (with control)
- Blister sealing
Unloading in boxes
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