Materials Maker Supplies PVC-Free Fabric for Medical Applications
The Cooley Group's engineered polymer system can replace PVC in blood pressure cuffs, as well as in other medical applications.
Broadening its business horizons and changing with the times are hallmarks of the Cooley Group (Pawtucket, RI). An 80-year-old company with origins in the awning fabric business, the Cooley Group has adapted its plastic-producing capabilities over the years to suit numerous industries and applications ranging from outdoor furniture to military fabric to blood pressure cuffs.
In the 1950s, Cooley shifted its operations to focus heavily on engineering fabrics made from polyvinyl chloride (PVC). More than half a century later, as the most recent example of its ability to adjust to the needs of the market, the company has branched out once more to produce materials that are PVC-free.
PVC is not only one of the most widely used plastics in the medical industry; it’s also one of the most controversial. For several decades, PVC has reigned as the primary plastic for medical devices ranging from IV bags to tubing. But in recent years, some critics have become leery of PVC, owing to the frequent addition of the common plasticizer DEHP to the material. Studies report that when it leached out, the additive caused birth defects and infertility in some animals. A backlash against PVC has ensued. However, since studies have been inconclusive as to human toxicity, staunch supporters of PVC continue to employ the material because of its flexibility and processibility.
Observing this polarization in the medical community, the Cooley Group has engineered plastic materials both with and without PVC to satisfy the varying markets. Cooley will promote MedGuard, its PVC-free proprietary polymer system, during its maiden excursion to MD&M East as an exhibitor. The compound is suited for use in such applications as blood pressure cuffs, body bags, tubing, and linings for medical structures. Like PVC, MedGuard is flexible and weldable by radio-frequency, ultrasonic, and hot-air processes. By contrast, however, the fabric can be incinerated for a cost-effective and environmentally friendly means of disposal, according to Darius Shirzadi, business manager for Cooley’s medical products.
As a further testament to its ability to change with the times, Cooley is conscientious about the environment with its processes, as well as with its products. “We don’t use a lot of the hazardous or toxic chemicals in our process. Our process involves hot melt, so we melt the compound directly onto the fabric whether it’s a polyester or a nylon,” Shirzadi explains. “We don’t have to run a lot of our fabrics through a chemical bath and that is what a lot of times causes a lot of off-gassing or odors typically in other processes that make reinforced fabrics.”
And for those companies continuing to design with PVC, Cooley offers flexible reinforced fabrics engineered with PVC, as well as polyurethanes, polyolefins, and thermoplastic rubbers. The supplier also provides custom compounds to enhance the performance of the fabric for a particular application. “We develop our own polymer compounds,” Shirzadi says. “We do basically anything that is plastic related that can be used for flexible membranes and fabrics.”
Sensors Provider Introduces Wireless Network Platform
Banner Engineering will exhibit its Presence Plus series of vision sensors (above), along with a new wireless network platform, the Sure Cross DX80.
With more than 15,000 sensor-related products on the market and more than 25 years’ experience as photoelectric sensor specialists, Banner Engineering (Minneapolis) is ready to expand its offerings to include wireless network technology. The company will introduce the SureCross DX80 wireless network platform at MD&M East.
“This is the first wireless network platform built from the ground up by sensor specialists,” says Steve Wong, the company’s business manager for the medical industry.
The platform modules are designed for integration with sensors and for reliability in extreme environments, while eliminating the need for wiring runs. One or more nodes function on the same frequency level and receive signals from sensors that are relayed to a custom-configured wireless gateway station. The network can interface with any of the firm’s sensors, including analog and discrete styles, as well as with sensors from other companies.
“It will interface well with existing equipment, making it easy for manufacturers to integrate,” Wong says.
As with many of the company’s products, the Sure Cross DX80 has a wide range of possible applications. Medical manufacturers can use the wireless platform to perform product counting and verification during the manufacturing process.
Also of interest to medical manufacturers, and to be displayed at MD&M East, is the company’s PresencePlus P4 series of vision sensors. FDA requires that all components in medical devices be traceable, and the PresencePlus P4 series offers an affordable, all-in-one option for small-scale medical manufacturers who wish to incorporate bar code tracing, says Wong.
Looking ahead, developers at Banner Engineering view the medical sector as a source of long-term growth for the company. Says Wong: “We will continue to offer the medical industry the most complete line of sensors, from compact miniature sensors all the way to high-powered laser sensors with high resolution and precision.”
Laser Systems Provider Helps Customers Meet Regulations
A circle-cutting laser system by Laser Photonics.
For many developers and manufacturers of medical technology products, the introduction of several new government safety regulations in recent years is viewed as an imposition. At Laser Photonics (Lake Mary, FL), it is viewed as an opportunity.
A provider of carbon and fiber laser systems to several industrial sectors, the company believes there is growth potential in the medical market. New regulations in part explain this optimism, and the decision to appear at MD&M East for the first time is indicative of the company’s high hopes for the market.
The company offers equipment and services that can be used to address regulatory requirements concerning device marking, surface treatment, and product identification. Minimal burrs, narrow and parallel kerfs, perfect surfaces, minimal thermal damage, edge hardening, edge tapering, and perfect marking are just some of the requirements demanded of manufacturers of medical instruments, implants, and equipment. Bar coding is also increasingly in demand by medical manufacturers as a way to track individual components in end-user devices.
“We believe we offer novel technology that allows companies to meet these requirements cost-effectively, through user-friendly products,” says Demitri Nikitin, the company’s CEO.
The company will showcase a range of products at MD&M East, including a new offering, the Little Giant, an entry-level fiber laser marking and engraving system in the Fiber Tower line. Designed for small-scale marking operations, the system can be carried by one person and offers 30,000 hours of mean time before failure. It is a stand-alone system that can be powered by any 110-V outlet. The system makes high-quality marks on production parts, including unique identifiers for traceability, lot and date codes, and serial and part numbers.
Also highlighted at the show will be the SBM 1200 fiber laser cutting system, designed to allow medical manufacturers to make precision cuts in materials that are difficult to work with using conventional equipment, including heavy-gauge stainless steel and reflective copper. These materials are used to make a wide variety of highly precise parts such as bone inserts, brackets, and screws, as well as surgical instruments.
Titanium Parts Maker Casts Sights on Healthcare Industry
While capable of high-volume runs, a titanium caster caters to custom and small-volume requests.
You might say that three-year-old titanium casting company Tinomics Inc. (Ft. Myers, FL) is one of a kind. According to the firm, it has no competitors in this country that serve consumers and small custom part needs.
“A lot of the larger casting facilities won’t even talk to you unless you’re going to order 10,000–20,000 units. Most of the titanium we see out there was machined and firms that did want to cast titanium would have to go to these big foundries. They could barely get the time of day unless they had the volume,” says Mark Esguerra, director of sales and marketing. “That’s where we fit in. We’re able to do large-scale production, but we also cater to the people who want a single custom piece.”
But just because Tinomics doesn’t have competitors breathing down its neck doesn’t mean that employees are sitting back and relaxing. After all, there’s a reason the competition is minimal: The process is extremely difficult.
Requiring numerous engineers and various steps, the titanium casting process begins by making a mold of the desired part that is then injected with hot wax. After the wax solidifies, the firm connects everything with wax and pours an investment compound around it. Next, the covered mold is placed in a kiln where the wax burns out and leaves an impression. Finally, the mold is put into the furnace and the engineers cast the molten titanium into it. The mold is then cracked apart to reveal the desired component.
And while the process is labor-intensive, the biggest obstacle is actually the inherent properties of the material, according to Esguerra. “The difficulty all falls within the atmosphere—or lack thereof—in which the titanium is cast,” he explains. “It takes a lot of energy to melt the titanium, which is why it is cast under vacuum. Another huge factor is the design of the pieces; factors such as different thicknesses and complex designs with a lot of direction change can have profound effects on the flow of the titanium and the fill rate. The state at which it is molten is [only] milliseconds. Once it’s put in the mold, it’s solid instantly.”
Though its capabilities are not exclusive to titanium—it also casts stainless steel, zirconium, nickel alloys, and cobalt—Tinomics derives the majority of its business from casting the alloy. Characterized by its hypoallergenic, lightweight, strong, and corrosion-resistant nature, titanium is suited for medical, especially orthopedic, applications.
To date, the company has mainly produced dental implants, jewelry, and nonrotary aerospace parts, but is trying to break into the device industry as well. Fueled by these expanded business interests, the company will exhibit for the first time at MD&M East in June. In addition to orthopedics, the company is pursuing one-off custom work. Esguerra envisions that Tinomics’s capabilities would suit the quick turnaround of custom plates, rods, or parts based on 3-D renderings produced from a patient’s CT scan or other medical reconstruction techniques, for example.
“Right now our biggest challenge is getting the word out that we’re here. If people haven’t explored it [custom titanium casting] in the past, they almost don’t believe that we can do what we can do,” Esguerra says. “[The goal is to] really introduce to people the advantages of casting over machining, which would be zero material loss, design flexibility, the fact that we keep things in-house, and we pride ourselves on protecting the designs of our clients.”
Jet Precision Metal Hopes to Partner with Device Firms at MD&M East
Jet Precision Metals Inc. offers a value-added approach to sheet-metal fabrication.
Representatives from Jet Precision Metal Inc. (Hawthorne, NJ), a sheet-metal fabricator, have been attending MD&M East shows for several years, but never before as an exhibitor. The company’s decision to raise its profile at the show parallels its strategy to raise its profile in the medical industry.
“It’s a good industry right now, a growing industry,” says Ed Harmon, director of sales and marketing. “A lot of customers in other industries are going offshore, but because of FDA and copyright concerns, medical customers are staying. We are going to the show hoping for good things.”
Opportunities to meet potential customers face-to-face are important for a company that places emphasis on what it calls a value-added approach, which means providing additional services to customers beyond the core service, metal fabrication, and in turn acting more as a partner than a vendor. “It’s not enough just to do metalwork,” Harmon says. “We serve as a custom job shop for customers so that rather than having to manage and work with 25 different vendors they can come to us and end up with a product that’s 75% complete.”
Beyond metal fabricating, the company offers services as diverse as device assembly (including cabling and electromechanical assembly), painting, plating, packaging, labeling, and inventory stocking of finished customer products. The company maintains a long-term partnership with a manufacturer in China in case a customer needs assistance in outsourcing any part of the production process.
The value-added approach has led to lasting relationships with specific customers, even as long as 20 years, according to Harmon. The majority of the company’s work in the medical sector in the past has been on operating instrumentation and support for autoclave devices.
The company believes its customer service approach is well suited to the current business climate. “For economic reasons, no one is building huge inventories right now,” Harmon says. “We can enable fast delivery of product by providing one-stop shopping to customers, which allows them to avoid having to deal with many different vendors and purchase orders.”
Polyurethane Producer Pays Close Attention to Customers, Big and Small
American Polyfilm Inc., a provider of polyurethane films, offers small minimum-order sizes and short lead times.
Family-owned and -operated, American Polyfilm Inc. (Branford, CT) is accustomed to working closely with its customers.
The supplier of polyurethane products specializes in small-run custom jobs that require tailoring to the specifications of a given project, and that often require revisions based on customer requests. This approach is especially suitable for customers hoping to establish a new product and needing sample or prototype versions. Based on one-on-one consultations, new films are routinely developed by American Polyfilm to meet specific requirements.
Victor Cassella, company president, understands that for customers in need of custom services, and for companies hoping to provide them, success is often contingent upon finding the right partner. “We’ve walked the floor at MD&M East in the past and noticed that it’s a well-attended event,” he says. “This is our first time with a booth and we’re hoping to find the right people.”
Owing to its combination of strength, biocompatibility, and innate antimicrobial qualities, polyurethane has many medical applications. The company produces aromatic polyester and polyether polyurethane films and aliphatic polyurethane films. It has worked with customers in the past to incorporate polyurethane into a variety of products, including breathable wound dressings, surgical gloves, medical bags, organ retrieval bags, and hospital mattresses. Polyurethane is malleable, and the company can cut, sew, weld with heat or using RF technologies, vacuum-form, laminate, or print it to suit specific applications.
Though the company prides itself on its small minimum-order size, it doesn’t want to present itself as exclusively small scale. The company possesses the capacity to fill large orders, and is constantly trying to expand its capacity, Cassella says. Whatever the scale, the company offers short lead times, as short as 2 weeks for stock materials.
RFID Tag Company Claims One Size Does Not Fit All
Due to limited size selection, customers shopping for pants often have to settle for off-the-shelf styles that may not be the most flattering or best fit for their body type. Customers in the market for radio-frequency identification (RFID) tags encounter the same problem, says Pete Kuzma, vice president of business development for RCD Technology Corp. (Quakertown, PA).
Since most RFID companies offer a few standard products in a limited variety of sizes and configurations, OEMs may have to resign themselves to using a tag that is not optimal for a particular application simply because of a lack of options, according to Kuzma. In contrast, RCD’s competencies lie in application-specific RFID design so that a customer is provided with a tag that best suits its intended use.
“We sort of design something optimized for each application,” Kuzma says. “Especially in medical devices, we’re seeing a need for special sizes, in some cases made out of special materials either for FDA compliance or basic chemical and water resistance.”
Kuzma credits the influence of the Web for RCD’s newfound partnerships in the medical industry. Though the company was established in 2001, RCD only created an enhanced Web site detailing its capabilities about a year ago. Upon doing so, the company was inundated with requests from medical-oriented OEMs dissatisfied with off-the-shelf products and seeking custom RFID tags, Kuzma says.
“Because of the number of projects that were initiated by laissez-faire marketing, we decided that there’s really an unmet need in the [medical] market,” he adds.
Addressing this need, RCD offers custom RFID designs to manufacturers for traceability from point of manufacture to distribution to patient. Specializing in the development of flexible copper antennas, the company purchases microchips from an outside supplier and then employs its own patented fabrication process to attach each microchip to an antenna.
The traditional etching process for making high-performance antennas for RFID chips is expensive, according to Kuzma. He notes that along with having a pricy setup, the process wastes costly metal and produces hazardous waste which rasies disposal problems. Conversely, RCD uses special inks to print a nonfunctional antenna design onto which copper is electroplated. Since it is an additive process, there is no wasted metal or hazardous waste, Kuzma says. Moreover, the process is capable of cost-effective high-volume runs, but has a very small penalty for short runs.
The company will be championing this fabrication process as well as its custom RFID design services during its premier appearance as an MD&M East Exhibitor. RCD will also be hyping the benefits of an RFID tag over those of a bar code for medical applications, which, to the firm, center on convenience.
“It’s extremely reliable over time and it doesn’t wear away like a bar code might. It’s faster to use because of the noncontact nature of the read,” Kuzma states. “It’s just easier to find the data because you just get into proximity to a reader and it finds the tag and pulls the data out. And, depending on what you want to do, you can store more than just a license plate; you could actually store secure but specific data about the machine, so if there’s a recall it just makes things easier.”
Cable Company Forges Connection with Medical Market
A long-time supplier to the telecommunications industry, Custom Cable recently diversified its business opportunities to offer medical wiring harnesses and associated services to OEMs.
For more than 25 years, Custom Cable (Tampa, FL) has been serving the telecommunications needs of such corporate giants as Walt Disney World, Motorola, FedEx, and Ticketmaster. In the past year, however, the cable company’s capabilities have caught the eye of major players in an entirely different field—the medical industry.
“A few companies like Siemens Medical and Hitachi Medical had noticed Custom Cable for our cabling expertise and our qualifications—our ISO, UL, and TL certifications,” says Sean Loomis, Custom Cable’s business development manager. “That got us thinking; we need to diversify and this [industry] seems like it might be a good fit for us.”
Responding to interest from these bigwigs, Custom Cable has entered the market as a supplier of medical wiring harnesses to OEMs. The company aims to expand its reach in the industry and to attract more OEM customers while making its debut as an exhibitor at MD&M East. There, the firm will showcase its products and discuss its intentions for future manufacturing projects in the healthcare sector.
While diversifying business is an incentive to serve medical OEMs, Loomis speculates that it will also actually help the company to improve its manufacturing processes to better serve its customers in other industries. “For the last 25 years, we’ve basically seen one set of how to do things, how to manufacture something, qualifications,” Loomis says. “But the medical industry has some of the highest standards in all of manufacturing, so I know that we can learn a lot—not only from what our customers are looking for, but also from what our competition is doing for the medical side.”
In addition to offering wiring harnesses, the supplier counts prototyping, overmolding, kitting, potting, and automation among its capabilities. Project management, standards compliance, and consulting are also available. But the company’s skill set is not limited to just these services; workers rally behind the motto, “If it can be done, Custom Cable can do it.”
And while its can-do attitude caters to the needs of corporate America, the cable company manages to keep things in perspective and give back to the community as well. Steelcase Inc., the owner of Custom Cable and a supplier of office interiors, has set the gears in motion to “go green.” Following suit, Custom Cable is making a concerted effort to implement environmentally conscious practices throughout its operations. The company designates special bins for copper and PVC waste, employs filtration in manufacturing, and even recycles everything from copper to stray paper.