Bone Saw Guide Blocks are used to position and guide a saw blade during hip and knee replacement surgery. Typically made from hardened stainless steel, they have smooth, accurate guide slots and a matt exterior surface - so that the bright overhead lighting does not reflect and disturb the surgeon's vision.
Manufacturing medical instruments is both quality intensive and cost sensitive
Complying with medical quality regulations (ISO 13485, FDA, 21 CFR 820) and meeting cost targets at the same time is even more challenging when the manufacture requires several different technologies, as for a Bone Saw Guide Block.
GF Machining Solutions presents a fully integrated and automated approach allowing efficient instruments manufacturing and traceability of key manufacturing data to help you meet regulatory needs.
Product quality, cost efficiency and compliance with medical quality regulations are all part of the package.
GF Machining Solutions presents a fully integrated and automated approach allowing efficient instruments manufacturing and traceability of key manufacturing data to help you meet regulatory needs.
Product quality, cost efficiency and compliance with medical quality regulations are all part of the package.
Watch our video
The challenges and the solution
Bone Saw Guide Blocks are a good example of challenging medical devices. Traditionally, their manufacture requires milling, wire EDM, grit or sand blasting, laser marking and polishing. With many associated challenges:
- The need for a high quality surface finish and high tolerances during milling;
- the risk of wire breakage and quality problems during EDM;
- the risks and costs of manual operations – including for sand or grit blasting;
- last but not least, the challenge to track key manufacturing information to meet regulatory needs.
GF Machining Solutions' fully automated and integrated cell including milling, wire EDM, Laser texturing, automation and intelligent tooling and software, helps you meet all these challenges and ensures a better data tracking along the process, from and back to the factory resource planning system (ERP).
Automated performance with intelligent tooling and software
The automated cell includes a robot, System3R's Macro line tooling and WorkShopManager software, together with the technologies you need for the Bone saw guide block: GF Machining Solutions' 5-axis MILL X 400 U, LASER P 400 U and CUT P 550 Wire-EDM machines.
- The cell is connected to the factory ERP (Enterprise Resource Planning) network via the WorkShopManager software.
- The WorkShopManager allows scheduling of the tasks and management of the entire process chain, so that the cell can run autonomously and the human errors can be drastically reduced.
- Automated handling and cell management allow for operating efficiency and flexibility - even when the batch size is a single part.
System 3R's Macro line of zero-point chucks and pallets allows the loading of the part – by a robot or by an operator – into any machine, in seconds.
- System3R Macro pallet and zero-point chuck guarantee position repeatability at <0.002 mm.
- An integrated RFID chip provides a unique identifier for each pallet and allows data from external sources to be associated with the manufactured part.
Traceability and compliance
WorkShopManager is at the core of GF Machining Solutions' integrated solution - allowing fully digital data exchange with the site ERP.
- WSM can load manufacturing orders and CAM programs directly from the site ERP system and transfer these to each of the machines of the cell.
- Managing this data automatically avoids operator errors and the risks associated with a paper based system – saving you time, cost, and helping to ensure you pass your audits successfully.
WorkShopManager is also able to "close the loop". It can send data flows back to the site ERP, including manufacturing data typically needed for a Device History Record (DHR).
- The manufacturing data returned to the factory ERP at the completion of the job can include data related to the job order (order number, article, material, number of parts) but also job start/end date and time, machine ID, pallet ID, job events and NC program used.
- This reduces the risk of errors and can help you meet ISO 13485 and FDA requirements.
Optimized manufacturing process
Do you remember the manufacturing challenges of the Bone Saw Guide Blocks ?
With GF Machining Solutions' integrated and automated approach, you not only successfully meet all these challenges but you substitute a manufacturing process including many manual operations with a digital and fully automated one.
You get:
- Traceability and control over the process
- Reduced lead times and the possibility of "lights out" production
- Reduction of manual operations and risk of errors
- Cost per part optimization from 10 to 30%
A Bone Saw Guide Block usually has angled entrance cuts for the blade slot, requiring multiple set-ups. GF Machining Solutions' CUT P series is an ideal wire-EDM solution for this challenge thanks to:
- The Quadrax frame design, whereby the table and part remain fixed while the axis displaces the wire, allowing both straight and angled cuts - up to 45 degrees.
- Intelligent Spark Protection System (ISPS) that analyses both spark intensity and position on the wire in real time, adjusting to changing conditions and avoiding wire breakage -bringing unmatched control over product quality.
With the 5-axis MILL X 400 U from GF Machining Solutions, you can machine the complex, multiple curved surface of a vacuum hardened stainless steel Bone Saw Guide Block, with speed, high surface quality and high precision:
- Faster machining times are possible thanks to its rapid traverse (100 m/min), acceleration of 26 m/s2 and linear drives on all axis
- Excellent surface finish even in hard materials is obtained thanks to the StepTec spindle and a full +/- 110 degrees of table swivel.
- Automatic Machine Calibration (AMC) provides accurate system calibration in only minutes and ensures parts are produced "first time right".
For Laser texturing and marking, GF Machining Solutions' 5-axis Laser P 400 U is ideal. It creates the rough outer finish of the device, but also the logo, UDI, and other data – in a single step.
With Laser texturing, the manual operations of masking, grit or sand blasting and post-process cleaning can simply be avoided.
You get:
- Fully digital and repeatable process that opens up limitless design possibilities impossible to create using a traditional approach.
- Clean process – no sand residue
- Automated process without the need for manual operations
- Single set-up for texturing marking
- Anti-counterfeiting possibilities
