On August 27, 2010 the first internally generated inventory of the company’s medically approved LED light source was logged in, formally marking the start of electronic manufacturing at FTI.
“Our new competence will allow us to better serve our customers, control price, and manage innovation; attributes which optimize the value proposition we offer to the marketplace” said Steve Giamundo, the company’s President.
The first units have undergone rigorous testing, having passed 60601 and 60601-2. The units are also certified for sale in Europe (CE marked) and have been granted a 510K certificate by the FDA to be used as a FDA Class 2 medical device for endoscopy, surgery, and general examination applications.
The product’s performance specifications exceed those of traditional halogen lamps. The company has applied for a patent related to light collection, and plans to manufacture and sell a finished product as well as the light engine component for OEM and custom applications.
Documentation submittal, program development, cell implementation was managed by Walter Seagrave, a 20 year veteran Mechanical Engineer who has previous fiber optic light source design, manufacturing and program management experience developed at Luxtec Integra.
“FTI has invested to build a first class electronics assembly cell, which includes all test equipment to comply with the medical device directive. As many as 2000 units can be manufactured per year without additional capital investment. Private label and customized options are now available”, said Seagrave.
For more information about the new light source or FTI’s electronics manufacturing capability, contact Tim Beeman at 800.433.5248.