How GF Machining Solutions' fully integrated automated approach can help you ensure product quality, cost efficiency and traceability of key manufacturing data
Manufacturing medical instruments is both quality intensive and cost sensitive. Meeting both ISO 13485 (Medical devices QMS) and cost targets can be challenging particularly when the manufacture requires the combination of several different technologies. The production of Bone Saw Guide Blocks, used to position and guide a saw blade during hip and knee replacement surgery, is a good example of challenging medical device as it requires milling, laser marking, and wire EDM. Typically made from hardened stainless steel, these instruments must have smooth, accurate guide slots coupled with a matt exterior surface (to avoid any bright overhead lighting reflection, which could disturb the surgeon's vision).
To meet these constraints of cost and quality, GF Machining Solutions will present a unique approach using a fully integrated and automated manufacturing cell allowing efficient manufacturing of Bone Saw Guide Blocks and traceability of key manufacturing data. The cell includes System 3R's Work Shop Manager (WSM) software, robot, and pallet storage system. WSM not only ensures the active coordination of manufacturing orders to be processed, but also has the ability to "close the loop", i.e. sending confirmation back to the factory ERP that includes production data typically needed for a Device History Record (DHR). This can help meet ISO 13485 requirements.
Innovative Laser texturing technology will also be presented. The 5-axis laser machining center is able to create the exterior "matt" surface needed, but without the waste and risk of surface contamination that occurs with grit-blasting. Also key is the System 3R (S3R) pallet and zero point chuck, which positions the work piece within the machining systems, guarantees positioning repeatability within microns and allows a truly automated approach in manufacturing.
Register to learn how the integrated and automated solution from GF Machining Solutions can help you ensure that product quality and cost efficiency are all part of the package.
Medical Segment Manager, Business Development, GF Machining Solutions
Erik is the Medical Market Segment Manager at GF Machining Solutions. A mechanical engineer with an MBA, he has over 20 years of experience in providing turn-key solutions for medical device manufacturing, including process development and system qualification. With his in-depth knowledge of the regulatory and quality system requirements for this demanding industry, he has written numerous articles and been an invited speaker at different industry events.
Director Marketing Communications, GF Machining Solutions, System 3R International AB
Dick is the Marketing and communications Manager at System 3R/GF Machining Solutions. He has a electronics engineer examine, and has over 22 years of experience in the System 3R products and solutions. He has worked in several management positions over the years. From product marketing , Sales and was head of Automation and Systems department for 12 years. The knowledge in automation, software and production processes is his key strength. He is very solutions oriented and knows what value selling means in practice and in figures for the customers.