Plastics News correspondent Roger Renstrom reported these items from the Medical Device & Manufacturing West conference and exposition, held Jan. 20-22 in Anaheim, Calif.
VPI Medical Products to add fifth extruder
The Sheboygan, Wis., medical products division of Vinyl Plastics Inc. is adding a Davis-Standard 2-inch extrusion-process unit this month, bringing the division's number of extruders to five.
The operation extrudes close-tolerance tubing and provides contract assemblies, Deborah Wente, the division's general manager, said in an interview.
In addition, VPI Medical Products is converting Cryovac M312 film into bags for pharmaceutical products under a technology licensing agreement with W.R. Grace & Co.'s Cryovac division of Duncan, S.C. The film is suitable for autoclaving.
VPI established its medical-related capabilities with the March 1996 acquisition of Complex Medical Products Inc. and relocation of the business to Sheboygan from Exeter, N.H.
``That acquisition gave us the opportunity to put in a Class 100,000 clean room,'' subsequently upgraded to Class 10,000, Wente said.
VPI Medical Products relocated to a new 18,000-square-foot building in April 1996, employing 15. Now, the division employs 45 and uses 10-15 temporary workers as needed for contract assembly, Wente said.
Software firms aid in ISO 9000 compliance
Software manufacturers Fourth Shift Corp. and LumenSoft Corp. have formed a partnership to help manufacturers, including polymer processors, comply with ISO 9000 and other quality standards.
Implementation costs $100,000-$150,000 depending on the client's existing systems and needs for consulting services, Loyd Olson, Fourth Shift vice president of marketing and product development, said at a news conference.
``ISO 9000 certification is crucial to a large percentage of medical device manufactuers,'' he said. The partnership will ``reduce the time and cost associated with implementing and managing the ISO 9000 process'' and meeting Food and Drug Administration requirements for lot trace, assured data quality, materials management and vendor qualification capabilities.
Bloomington, Minn.-based Fourth Shift is a global software applications supplier. LumenSoft is based in Minneapolis.
Foster firms introduce line of flexible nylon
Sister companies Foster Corp. of Dayville, Conn., and Foster West Corp. of North Las Vegas, Nev., introduced a line of medical-grade flexible nylon compounds.
The compounds use various blends of nylon elastomers, nylon 11, nylon 12 ``and another polymer,'' Larry A. Acquarulo, president, said in an interview.
The materials have a superior stiffness for use in catheters, hubs and shafts, are compatible with radiopaque fillers and are trademarked as the Fostalon 5000 series.
Acquarulo said the Nevada operation is planning to relocate by mid-1998 into a facility of about 10,000 square feet. Now, the operation employs six and occupies 4,000 square feet.
The Connecticut firm employs 29 and occupies 20,000 square feet.
The custom and specialty compounding business was formed in 1989 and sells about 85 percent of its output for medical devices and catheters.