Entrepreneur Al Werth, founder of the development company Twin Bay Medical, is dedicated to bringing next-generation thinking to the medical assemblies and devices manufacturing market. A Journeyman Tool & Die Maker by trade, in 1999 Werth hit upon an idea for a tubing retainer so revolutionary it would become the industry standard for biotech within months of being introduced. This was the beginning of BarbLock™ retainers, a fluid handling success story that has since spawned a bevy of new products and has made Werth—who began as an apprentice at age 14—a potentially wealthy man.
ColeParmer.com: What makes BarbLock unique?
Albert A. Werth: BarbLock is the only retainer system on the market that joins flexible tubing and barb fittings with a full 360 degrees of radial compression and seal. When you lock up a BarbLock retainer, you truly get a full 360-degree compression on the barb ridge. You get a durable, leak-free seal.
ColeParmer.com: How is that different from, for example, hose clamps?
Werth: The rest of the planet attempts to retain below the barb ridge—you can retain there, but it's impossible to seal a plastic fitting in that area. BarbLock retainers use a sleeve-and-collet configuration. Inside the collet is a retainer ring, which mimics cable ties and hose clamps. But what sets the retainer apart is that the BarbLock system is as tall as it is large in diameter, which gives a full 360-degree compression to the entire fitting including the barb ridge—which no one else has.
ColeParmer.com: How did you get interested in this field?
Werth: I have a 35-year background in Tool & Die making and injection molding for the sports medicine and automotive industries. I spent five years with Pilot Industries; Pilot was all about fluid handling systems. We were so dedicated to eliminating leaks, that we would perform helium leak tests to detect finite leaks, that would become leaks—and lead to permeation in fluid systems. It was always our bone of contention that the best barb fitting design had no parting line on the first barb.
ColeParmer.com: How did you come up with the idea for BarbLock?
Werth: We found that the biotech industry basically used cable ties to retain silicone tubing onto barbed fittings. The failure mode with cable ties, is that they are capable of creating their own channel leaks. Silicone is very very tricky to retain. In fact, we actually got the idea while touring a pharmaceutical facility in Florida. During the tour, we had just walked away from a biobag in a containment when an employee came to shift the bag. Instead of using the handles on the bag, he shifted it with the silicone tubes that are attached to the biobag's barbed fittings, and pulled one off the silicone tubing in the process. As a result, a very expensive pharmaceutical that was being produced leaked into its containment. We thought, there really has to be a better way to retain those fittings than by using cable ties. Thanks to the hard work of John Schmitz of TC Tech, and his army of professionals involved in the bioPharm industry, in its first five months BarbLock became the new industry standard for attaching silicone tubing on to barbed fittings.
ColeParmer.com: How many units have you sold?
Werth: We will be over 2 million units by the end of 2003, and we're now taking it into other industries. For example, we just finished exhibiting at the Medical Design & Manufacturing (MD&M) 2003 West show—the world's largest medical device OEM event—in Anaheim, California. And I can say without reserve that we probably had the busiest booth at the show. Our tag line was "Remove toxic adhesives and solvents from medical assemblies."
ColeParmer.com: What was the significance?
Werth: There has been a big push to eliminate the use of vinyl tubing, adhesives, and toxic solvents in medical products throughout Europe. It has basically been banned. So, now manufacturers have an alternative in BarbLock retainers.
ColeParmer.com: Banned?
Werth: When you look at any type of medical assembly, there needs to be a way to attach the tubing to the device. In the States, that's often done through the use of an adhesive or solvent. So, every time you submit a device to the FDA, you have an adhesive or toxic solvent on this device and they just shrug their shoulders because there is nothing else available—at least there wasn't until now. The BarbLock system does not introduce any type of adhesive or solvent into the joint.
ColeParmer.com: What type of testing regimen is required for developing a product like this? Is FDA approval necessary?
Werth: Well, you don't have to go through an agency, because we don't come into contact with fluids or gasses. But we had to show potential customers the sealing and pull-off properties of the device. So, we have thousands of hours of test data with single-tier and multi-tier fittings, and with different types of tubing—silicone, vinyl, braided, reinforced, and unreinforced. We've put a tremendous amount of effort into making sure we have the best product on the market. The fact is, BarbLock retainers will out perform other systems up to seven to one.
ColeParmer.com: Do you approach each market differently?
Werth: In some cases we've reformulated our retainer specifically for each market. For example, when we began directing our focus toward the automotive and appliance markets—which have higher pressure demands—we sought to increase the robustness of the assembly. So, we looked at the 125-series, which is perfect for fuel line applications but is also used with silicone in medical devices—we make it out of a USP Class VI material for medical, while automotive is just a high-impact polypropylene. Anyway, we analyzed the geometry of the 125-series and thought we'd change the size and shape of our retaining ring slightly to obtain better retention. But after testing the changes we found that the original geometry was indeed the most robust product. We had hit on the optimum geometry the first time around.
ColeParmer.com: I understand you have several new products on the horizon?
Werth: We introduced two new products at the recent MD&M West Show. We introduced SureSeal, which is a next-generation tubing clamp, and NeoBarb, which is a fitting specifically designed for use with the BarbLock retainer.
ColeParmer.com: Let's take them one at a time. Tell us about SureSeal.
Werth: We studied all the tubing clamps on the market, and decided we had to come up with something revolutionary or the industry would just look at it as an also ran. So we went to our automotive background and realized one of the best latching sys
tems available is a compression/cam-type latch—which we integrated into a U-frame and upper-jaw assembly. The result is an extremely robust clamp that outperforms basically any other clamp on the market and has a retail price point very similar to the DuraClamp—the industry standard.
ColeParmer.com: And the NeoBarb fitting?
Werth: We decided there was the need for a better barb design for the medical industry. See, the best way to retain most tubing is with a compression-type retainer—i.e. BarbLock—in conjunction with a multi-tier fitting. But most medical assemblies call for fittings of maybe 3/16 or 1/8-inch OD, and you would not be able to put silicone or C-Flex products on that barb because the fitting would be too long. Once you start loading silicone tubing on fittings it is only willing to travel a short distance before it starts rolling back inside of itself. When you pull silicone it thins or reduces, which causes the majority of failures and disconnects for standard retainers. So, we set out to design a multi-tier fitting that would be the length of a single-tier fitting. What we came up with was a single-tier barb that, in the retainer area, has two rings that mimic multi-tier fittings. And when you put this in assembly with a BarbLock retainer, it's as if you glued the silicone onto the barb. The geometry is such that it works with the BarbLock system to create two more retainer rings. So it's like the BarbLock retainer now has three retainer rings.
ColeParmer.com: Availability?
Werth: Early Summer of 2003 for both products.
ColeParmer.com: Well, it sounds like you're generating some very effective and innovative new products.
Werth: We are. And we're having a lot of fun doing it! But you have to remember that nothing is possible without an idea. It takes a lot of very talented designers, engineers, and mold makers to bring these programs about. You need investors willing fund new ideas, distributors like selling your products, and sales professionals to demonstrate your products to the masses to bring about success in the market.
