Originally Published MPMN March 2002
Originally Published MPMN March 2002
INDUSTRY NEWSAvail Opens Third Facility in Mexico, Tech Center in Dallas
Growing up in Southern California, I would occasionally head south to Tijuana, Mexico, in pursuit of cherry bombs and sundry other illicit devices. Gradually, my infatuation with pyrotechnics faded, and so did my occasional trips to TJ. Some 30 years on, I'm once again lurching through the chaotic streets of the quintessential border town, but this time my mission involves devices of a different sortnamely catheters and other medical disposables.
|Avail's new 40,000-sq-ft facility in Tijuana, Mexico, is dedicated exclusively to serving the production needs of a medical device OEM.|
I was invited by Avail (Dallas, www.availmed.com), a full-service contract manufacturer catering to medical device OEMs, to visit its facilities in Tijuana and, in the process, witness firsthand the region's transformation. While Tijuana remains a magnet for thrill seekers of all persuasions, it has also emerged as a bustling economic center and, by some accounts, is the second-largest city on the West Coast after Los Angeles. Avail opened its first assembly plant on Mexican soil in 1988, and the company hasn't looked back since. The opening in December of a new 40,000-sq-ft plantbringing Avail's total number of facilities in Tijuana to threeis yet one more vote of confidence in the area.
"Globalization is a well-entrenched principle among our customers," says Avail president J. Randall Keene, but he acknowledges that some visitors experiencing the local color for the first time on the drive to the business park are taken aback. "Do I really want to make my devices here?" has been the initial reaction of a handful of OEMs. "But their impression changes completely once they tour our facilities," he adds.
Avail's state-of-the-art plants equal those located in the United States in terms of available technology and quality systems. They do lack one thing compared to their U.S. counterparts: high labor costs. The device manufacturer that is outsourcing its operations to Avail's new plant will cut its production costs by more than 40%, according to Keene. "That represents an annual savings of more than $10 million," he notes.
But low-cost labor is only part of the incentive, adds Keene. The $1.5 million facility houses a Class 10,000 cleanroom and a 20,000-sq-ft controlled manufacturing area. Approximately 2400 different part numbers are currently manufactured there, and it has the capacity to produce more than 500,000 parts per month.
"Scale is a big differentiator for us," says Keene. "The new facility has nearly 600 different pieces of automated and semiautomated equipment to support manufacturing. And our quality systems mesh with those of the OEM." Other contract manufacturers may not have that level of integration, Keene adds, and the customer is left with little recourse but to subsidize the supplier's QS operations.
All of the systems at the Tijuana plant connect to the company's microwave communications system, which is linked to its main computer network in San Diego. This allows all data collected in the plant to be shared within the company's network on the U.S. side to assist with materials management, scheduling, and manufacturing resource planning.
Avail's commitment to getting the job done right and on time begins the moment a deal is inked, Keene adds. After signing the contract in January 2000 to relocate a customer's manufacturing operations to Tijuana, Avail immediately began plans for the dedicated facility. Nine months later, the manufacturing areas were completed and in production.
|A Technology and Development Center provides device OEMs with assistance in the design, engineering, and approval of new products.|
Meanwhile back in Texas, Avail announced the opening of a 10,000-sq-ft Technology and Development Center near the DallasFort Worth International Airport. The center is ISO 9000 focused and, according to Keene, provides turnkey solutions for product development and contract manufacturing. Personnel can also assist with regulatory approval.
"You would be amazed at the number of device companies that need assistance finishing a product," says Keene, reflecting on the reason that Avail decided to establish a tech center. "We can work with them to complete it," he says, noting that Avail's integrated services are capable of taking the project from concept to cost-effective manufacturing in a seamless process.
"Because our technical design support resides in-house," says Avail's vice president of technology and development, Fred Borsini, "our customers will save time and money. It's a matter of accountability. We design devices to be built, integrating initial concepts into our manufacturing processes," he says. "Our customers minimize expensive redesign and iteration time, thereby reducing overall costs and time to market."
Engineering activities at the center include verification and validation testing, materials selection, biocompatibility testing, process development, gauge and test-fixture development, packaging design, production development, and 510(k) preparation.
"Customers appreciate our assistance with 510(k) submissions," notes Borsini. "Our team has a strong quality and regulatory background, so we know which tests to conduct and which data to collect." Borsini has 12 years' experience in product development and injection molding, while Brian Highley, tech center engineering manager, has a decade of experience in medical product development among some of the world's leading device OEMs.
In addition to product development support and value-added engineering, Avail's array of services includes plant consolidation; injection molding design and construction; radio-frequency, laser, and electronic welding; lamination, die-cutting, and printing; and packaging and sterilization management.
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