ICU Medical Inc. is boosting injection molding capacity, bringing sterilization services in-house and looking at foreign production.
ICU has 42 presses for injection molding thermoplastics and liquid silicone rubber at its San Clemente headquarters - an increase from 30 presses at the beginning of the year, and three in 1994.
The firm is constructing electron-beam-sterilization capability in Ensenada, Mexico. Within two years, it plans to establish a substantial molding and assembly site in Europe, Asia or Latin America.
``A decision has been made to do that,'' said Keven Hanly, director of technical operations. ``We haven't started on it yet, [but] we have plans.''
ICU develops disposable intravenous connectors that protect health-care workers and patients from exposure to infectious diseases.
In San Clemente, ICU occupies 106,000 square feet, including a Class 100,000 clean room of more than 24,400 square feet for highly automated molding and assembly. Thirty-eight process technicians, material handlers and operators keep the presses humming 24 hours a day.
As of January, ICU employed 476, including 250 in an Ensenada assembly facility that opened in late 1998. The firm has sales in 58 countries.
The company has boosted production by improving efficiency. ``This year, our volume in units is up over 75 percent'' vs. last year, Hanly said in a plant tour.
Eighteen Toshibas and nine Engels mold thermoplastics, while 12 Engels, two Toshibas and a Milacron Roboshot handle the liquid silicone rubber. None of the machines is older than seven years. Presses with clamping forces of 55-180 tons operate with closed-loop controls and high-cavity tools to make small parts.
Statistical-process-control software sets stringent parameters. If a molding process parameter deviates, a robot rejects 100 percent of the errant shots.
Unlike many shops, ICU does not allow any standard loss on scrap. ``If I buy $100 worth of resin, I get $98 worth of product,'' Hanly said.
ICU turns its finished goods' inventory 60 times per year. ``After I mold it and before I assemble it, I may have as much as four hours of componentry, but no more,'' Hanly said.
Two nearby injection molding firms make thermoplastic parts for ICU, sometimes for overflow and at other times as a stepping stone while ICU increases production capacity.
ICU uses Automated Assembly robots mostly, but also builds robots for automatic LSR manufacturing and end-of-arm tooling. Thirteen mold makers also build all prototype tools up to 16 cavities.
On the thermoplastic end, ICU processes polybutylene terephthalate, acrylic, polycarbonate alloy and clear ABS. Automated assembly devices run 60-70 cycles a minute. A continuous-motion machine is en route that can assemble hundreds of Y-locks per minute.
``The next machine, a whole new generation for us ... can do the output of five, six or seven times'' each existing machine, Hanly said.
A Multivac machine thermoforms sterile packaging.
ICU has ventured into LSR contract manufacturing, primarily for medical products. LSR contract work, growing about 50 percent each year, accounted for less than $1 million in 2001 sales.
The company is constructing a second building on its 94-acre Ensenada site and will have sterilization capability by December. The sterilization equipment and facility will cost about $5 million. Having the capability in-house will save a day or two in production cycles, Hanly said.
ICU projects 2002 capital expenditures of another $8 million to $10 million, principally for molding machines, molds and automated assembly machines.
The company dates to the early 1980s when George A. Lopez, a medical internist, lost a patient when a needle came out of an injection site. Dissatisfied with available connectors, he began inventing protected-needle products and other solutions that led to formation of the business in 1984. Lopez is ICU chairman, president and chief executive officer. He no longer has a medical practice.
ICU reported profit of $15.4 million on 2001 sales of $69.1 million. Sales may exceed $85 million this year. Among key customers, Abbott Laboratories Inc. of Abbott Park, Ill., represented 53 percent of 2001 sales, and B. Braun Medical Inc. of Bethlehem, Pa., was 19 percent.