like others in the field, needs to comply with both the FDA 21 CFR Part 820 Quality System Regulation and the SO 13485 Medical Device Standard. The right metrology equip- ment used well is vital.
Investing in machines that deliver quality has been a corner- stone of the company’s strategy since its founding in a garage in 1969. It has grown since into four manufacturing locations totaling 750,000 ft² (69,675 m²), employing more than 500. Industries it serves includes aerospace, defense, and automotive as well as medi- cal. Jobs range from prototype compo- nents to complete assemblies. “For medical, we specialize in surgical tools and implants,” explains Marr. These in- clude orthopedic chisels, tibia alignment guides, patella clamps, and acetabular shells and inserters. “We developed an important niche in spinal implants, such as replacements for discs,” says Marr. As a contract manufacturer serving many industries, they found they need- ed to organize their facilities differently than a dedicated manufacturer. Each portion of the plant, or pod, is dedicated to machine types—grinding, milling, or lathe/mill-turn. The company’s South Building, for example, is shaped like an “H”—180,000 ft² (16,722 m²) on 46 acres—with each leg containing four pods of over 20,000 ft² (1858 m²). “Our volume is not high enough in most cases in any one part to make dedicated workcells attractive for us,” says Marr. This means a lot of material flowing around their plant as each job moves from operation to operation.
Each pod contains its own metrology
laboratory, typically outfitted with one or two Contura CMMs from Carl Zeiss Industrial Metrology, LLC (Brighton, MI), and optical comparators from Optical Gaging Products (OGP, Rochester, NY). They use Zeiss CALYPSO software for programming their CMMs. Each CMM is equipped with touch probes and scan- ning analog probes. “We are looking into nonontact sensing, like laser scanning, for our CMMs, but have not made that decision yet,” says Marr. Their noncon-