As Grace Medical added other new manufacturing technologies, its measuring needs evolved, creating new priorities for its metrology system. QA/Regulatory vice president Jeff Cobb supervised the project.Įvolving Needs Medical device manufacturing has ever-increasing demands for new materials with tighter specifications. The implementation team at Grace Medical included validation engineer Joe Miller, programmer Lucas Hines, Holton and Prescott. Harvey Rath of D&H subsequently served as programming, trainer and setup consultant for implementation of the system into the manufacturing process at Grace Medical. The SmartScope Flash 200, a compact measuring system with an 8 by 8 by 6 inch measuring range, was chosen based on a review of system capabilities by local OGP representative D&H Metrology (LaVergne, TN). The titanium implants made by Grace Medical have complex shaft geometries on surfaces as small as 0.008 inch in diameter. Grace Medical has the ability to produce precision-molded, flash-free silicone parts-free of excess material attached to the molded product-with core pins as small as 0.002 inch and overall lengths as small as 0.01 inch that require accurate measurement. The Need The medical devices Grace Medical produces are made of a broad range of materials from soft, malleable silicone compounds to strong alloys such as titanium. Grace Medical employs approximately 25 people in a 20,000-square-foot facility that is certified to ISO 13485, a quality management standard for medical devices. Its otolaryngology products are sold under the Grace Medical brand name, while precision miniature devices called punctum plugs-silicone plugs for treatment of dry eye that keep tears from draining away as quickly-are manufactured for its sister company, EagleVision. Founded in 1996, Grace Medical manufactures devices that are used in the disciplines of ophthalmology-the diagnosis and treatment of disorders of the eye-and otolaryngology-treating the ear, nose and throat.
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