July 26, 2016 Invincible Invisibility

Volume 3 | Issue 8

Providing manufacturing services to the medical devices industry, Avail has established its reputation on a bedrock of integrity.

Sooner or later we, or people we love, need hospital care. We derive the comfort we seek for ourselves and for our loved ones from knowing that medical professionals trust nothing but the highest-quality superior medical devices. Although we might recognize the product names on devices we see in hospitals and clinics, most of us would not recognize the name of the actual manufacturer of those superior sterile medical devices. The company behind many of those superior products is Avail Medical Products of Dallas, Texas, the “silent partner” to the giants of the disposable medical devices industry.

You might say that Avail is the enabler to the medical devices industry, to whom the company provides turnkey medical contract manufacturing services. “We are invisible to the outside world, but we handle the manufacturing and sterilization of products for companies with instant name recognition,” says Tom Thompson, executive vice president of sales and marketing.

Avail provides thousands of product lines to hundreds of customers, including most of the 10 largest U.S. companies offering disposable medical products.

Behind the Scenes
“It’s difficult to explain to people what we do. Because of confidentiality agreements, we can’t hold up a specific product we make,” he continues. “But we make many of the disposable medical items you see in hospitals.” These include sterile-packaged IV bags and infusion sets, venous reservoir bags, coronary catheters and dispenser coils, injector assemblies, all kinds of prep sponges, respiratory valve assemblies, enteral bags, collection bags and various infusion catheters.

“Our customers are companies wanting to focus on developing their markets and growing their businesses, while assigning to us the fixed costs of manufacturing,” says Thompson. Avail’s customers design the products they contract Avail to manufacture. “We offer our customers a broad clean-room manufacturing capability and a solid medical-device quality system without the fixed costs normally associated with device manufacturing,” says Thompson.

Since most of the products Avail manufactures are fluid-path products, which need to be sterile, it is very critical that bio-burden and particulate counts are kept low. “We need a controlled environment so we can control the bio-burden,” explains Thompson. The sterilization processes are validated, either by Avail or by the contracting company.

“We can provide environments ranging from Class 100 to Class 100,000. The lower the number of particulates per cubic foot, the cleaner the air,” says Thompson. The company also has controlled areas that are not HEPA-filtered, but in which workers wear shoe covers, hair covers and gowns. “The environment in which we manufacture products depends on what the application is and how clean the environment needs to be to produce that product.” In the end, the manufacturing environment is chosen to fit the product’s application and sterilization requirements.

“When companies choose to outsource their medical devices, they need to have the utmost confidence in Avail because the products will have their name on it,” says Thompson. “The reason they choose us is because we have an experienced team with a strong track record, and all of our facilities are ISO 9002-registered.”

Creme de la Créme
Establishing such a respected position in the industry does not happen overnight. Avail is a company with multiple locations and a synergistic approach to its business. Its facilities include one in Bellefonte, Pa., one in Asheville, N.C., two in San Diego, two in Tijuana, Mexico, and one at its headquarters location in Dallas.

Because many of the products it produces contain injection-molded parts, Avail does its own clean-room injection molding. “Another of our specialties is radio-frequency and impulse heat sealing because we manufacture so many kinds of medical bags and bladders that have to be sealed in that manner,” says Thompson.

Another of Avail’s core competencies is its catheter tipping and flanging.

“The production of catheters requires forming a tip that can penetrate the skin with minimal pain,” explains Thompson. “This requires the precision forming of plastic for a specialized application. We provide tens of thousands of these products a day with a high degree of precision and repeatability.

“We use a variety of bonding techniques because this medical plumbing usually has tubing and injection-molded parts and manifolds,” says Thompson. “All of these components have to be connected so that they don’t leak. So we use ultraviolet methodology, ultrasonic welding and swedging, and solvent bonding.” The company also does a variety of printing, including hot stamping, pad printing and flexographic printing.

Avail also provides multiple packaging options including automated form-fill and seal. “In addition, we run all the materials-requirement planning for most of our customers. We find that it’s a lot easier and less contentious if we plan and buy all the material and maintain vendor certification through periodic vendor audits,” says Thompson.

The company employs manual, semi-automated and automated assembly. “If a customer has a fairly new product, we usually use manual assembly because chances are they will modify the design, and volumes are relatively low,” says Thompson. “Once they’ve optimized the design and they see some success in their market, unit-volume demand increases and we will then start implementing automation to reduce the labor content of the product.” High volumes for the company are runs in excess of 50,000 pieces per day of a particular product.

Silence is Golden
Avail’s distinction in the industry is its commitment to protect its partners’ confidentiality as well as promising not to compete in its clients’ markets. “Many other companies doing what we do wind up competing with their clients in the same marketplace,” says Thompson. “Our reason for being is solely to serve medical products marketers. It’s not a situation, as with some other companies, that our clients are using our excess manufacturing capacity. We are there only for our customers.”

The company looks toward continued double-digit growth. “We expect to finish 2001 approaching $100 million,” says Thompson. The company employs about 1,750 people in about 370,000 square feet of facilities. More than 1,000 of the total number of employees work in Mexico, where Avail is building a third facility that will take its Mexico manufacturing space to about 115,000 square feet.

Avail looks to a future in which it will be the “biggest and best medical-device contract manufacturer in the world,” says Thompson. “We already are the leading non-proprietary manufacturer in the United States, but we are continuing to improve our current operations, as well as planning to add additional capabilities and locations. We are exploring ways to get involved with our customers’ projects in an earlier stage.” The company plans a global strategy based on its current strong domestic position as a non-proprietary medical-device contract manufacturer, and an aggressive Global strategy abroad. “We have definitive plans to increase the breadth of our product offerings. The more we can do to help our customers enjoy success in their own markets, the faster we will grow,” concludes Thompson.

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