Originally Published MPMN May 2008

MD&M EAST

First-Time Exhibitors

Quick Couplings Provider Makes the Right Connections

Daniel Grace

Couplings for medical applications are often relied upon to provide more than secure connections. In fact, an equally important function can be to prevent connections. Patient-care instruments, for example, can suffer in the field if improperly used in conjunction with other instruments or with untested disposable products. In a worst-case scenario, patient safety and the OEM’s reputation can be at risk. For these reasons, OEMs of such instruments stand to benefit from products by LinkTech (Ventura, CA), says Randy Rehder, company president.

“We can design couplings in order to prevent third-party disposables from being connected to [a customer’s] instrument,” says Rehder. “[They] can be based on one of our proven designs, but customized to eliminate interaction with any other fittings except the company’s own.”

Custom design, though a growing part of the company’s business, is an outgrowth of the firm’s seven product lines. These families consist of a variety of plastic and metal couplings, most of which are designed specifically for the medical industry. The company’s couplings are currently incorporated in cardiovascular and respiratory equipment, hospital air-support surfaces, and oxygenators.

Many of the couplings’ design elements are unique, according to the company. The couplings feature integral end terminations to eliminate leak points, stainless-steel latches and springs that click when connected, and a full-face design intended to prevent misfired latches. Shutoff valves and multiple choices for O-rings are also available.

The three-year-old company believes the exposure it received at MD&M West this year was invaluable. “There was a lot of interest in our products at the show, and our decision to come to MD&M East for the first time is based largely on our previous experience [at MD&M West].”

LinkTech is even taking the opportunity to introduce its latest product line at the show. The 50 AC product series—produced using lean manufacturing principles—is designed to provide latch-type, luer-lock couplings at a lower cost than similar couplings supplied by the company. “We hope the new couplings will be of interest to customers looking to develop new disposable medical products,” Rehder says.

www.linktech.biz

Booth #2559

Family-Run Pneumatics Supplier Offers Medical Valves

Stephanie Steward

In 1941, William Leonard Clippard Jr. accomplished what some consider the American dream; he turned an observation into a thriving business. He realized that automating test fixtures using air could be advantageous to increasing productivity and subsequently developed a line of miniature fluid power devices. Those valves, fittings, and cylinders became the standard product line for Clippard Instrument Laboratory (Cincinnati).

Today, the company has a worldwide distribution network and customers who have been using Clippard products in their equipment for four decades. “[Clippard’s] miniature devices have a natural fit in the medical industry [because] the need for low-power, lightweight products with precision operation is very important in this industry,” says Paul Gant, sales manager.

Recognizing the critical need for cleanliness and purity in medical device manufacturing, Clippard recently introduced valves cleaned for oxygen service and valves with lubricants suitable for a variety of medical applications. Its components can be used in surgical instruments, monitoring devices, anesthesia machines, ventilators, and other medical applications.

The company also offers testing services to meet specific customer requirements. Expanding its engineering and marketing efforts for medical applications, the company has created a new systems division that can provide complete assembly solutions incorporating Clippard valves and accessories.

Communicating with and understanding the needs of its customers is a challenge the company takes seriously, says Gant. Clippard offers its own fluid-power educational kit for engineers and technicians. The kit was originally created in the 1960s to assist those who needed practical application assistance as part of an overall tutorial in all aspects of motion control. Moreover, the multigenerational family-run company knows the value of passing on its knowledge to the next crop of engineers. It supports the Fluid Power Educational Foundation and the For Inspiration and Recognition of Science and Technology (FIRST) organization. Clippard is one of several manufacturers to assist the FIRST competition program for high school students, which encourages young people to develop their talent for innovation.

www.clippard.com

Booth #2080

Precision Motion Company Gets ‘Smart’ Materials Moving

Shana Leonard

Founded in December 2006, Piezo Resonance Innovations Inc. (PRII; Bellefonte, PA) has already established itself locally, being named the Outstanding Technology Company of the Year by the Chamber of Business and Industry of Centre County. By exhibiting at MD&M East this year, the company hopes to further expand its visibility in the marketplace.

Positioning itself as an outsourced R&D division for medical device manufacturers, the firm specializes in smart materials—which encompass piezoelectric, electromagnetic, magnetostrictive, and shape-memory technologies—for precision motion devices.

“We can take a static tool and add an active component to make that tool function better,” says Maureen Mulvihill, company president. PRII is incorporating its technology into various blades for eye, soft-tissue, and hard-tissue surgeries with the aim of enabling more-accurate incisions based on the ability to vibrate a device at a certain frequency. Ophthalmology, vascular entry, hard-tissue penetration, and minimally invasive surgery could also benefit from the firm’s offerings.

PRII is supported by a corporate management team with more than 70 years of combined experience in such areas as active materials device development and implementation, medical device development and manufacturing, and electronics, actuator, and transducer development. Armed with these capabilities, the company can design a motion device, prototype it, test it, conduct field evaluations, and manufacture it in small volumes. PRII also has a network of partners that can perform large-scale manufacturing for commercialization.

“We have expertise in the piezoelectric area and the smart-component area, we have medical device experience, and we have electronics experience,” Mulvihill says. “We can do the entire package, from the component to the medical device to the electronics to the drive mechanism, for OEMs.”

www.piezo-res.com

Booth #1080

Fiber Firm Targets Tissue Engineering, Orthopedics

Shana Leonard

Established in 1920, Concordia has been producing engineered fibers for such diverse products as tennis rackets and BMW air bags. But it was a customer’s request for a collagen-based hemostatic fabric and the cleanroom built for the associated operations in 2003 that piqued the company’s interest in the medical device industry as a viable target market.

Acquiring seed money through a Rhode Island economic development fund, Concordia launched Concordia Medical (Coventry, RI) in 2005 with the intent of focusing on biodegradable fibers suited for medical implants. Further buttressing the new business venture was the acquisition of nonwoven felt business Albany International that year.

The cornerstone of Concordia Medical is BioFelt, the company’s brand of nonwoven felt engineered from a biodegradable polymeric fiber similar to those used in sutures and some orthopedic applications. “We are reproducing the felt from fibers that are processed in a very unique way, which creates this porous, three-dimensional structure that is very hospitable to cells,” says Art Burghouwt, executive vice president of Concordia Medical.

BioFelt promotes the growth of cells and autologous tissues into organized structures of continuous tissues both in vivo and in vitro, according to Burghouwt. “There’s a series of clinical trials under way involving human implantation of organs, like bladders, that have been formed and grown on our BioFelt, so there’s clearly some human use in that sense,” he adds. It also could be used in cardiovascular applications for growing arteries and heart valves, for example.

Currently, Concordia Medical derives a significant portion of its business from the orthopedics sector. The company has been involved with the development of fiber-based implants for such applications as rotator cuff and ACL repair. In the future, Concordia anticipates possibly expanding to cartilage regeneration and meniscus repair. Furthermore, BioFelt has already been approved for a dental application and is in preclinical phases for a variety of advanced research projects.

The company’s core business stems from contract development and manufacturing, using its proprietary processes to cater to medical device OEMs. In addition to polymer science and material testing know-how, the company offers a strong engineering background and a broad fiber and fiber-processing skill set, Burghouwt says. Beyond BioFelt, Concordia Medical also provides knitted meshes, braided structures, fibers and polymers, and a variety of other fiber-based materials.

www.concordiamedical.com

Booth #961

Cutting Tools Manufacturer Taps into Joint-Repair Market

Stephanie Steward

Precision Edge Surgical Products (Sault Sainte Marie, MI) has about as many words for cutting tools as the Inuit are said to have for snow. The company began manufacturing burs in 1989. Now, in addition to burs, its array of cutting tools includes surgical instruments, drills, rasps, blades, taps, and reamers.

The contract manufacturer’s product line expansion can be attributed to its monitoring of the market. “As the orthopedic industry evolved—and hip and knee joint–replacement, spinal, and reconstructive surgeries were increasing in numbers—we needed to diversify our cutting tool– manufacturing processes to meet the ever-changing needs of our customers,” explains Greg May Sr., technical director. Since then, the company has continually integrated lean manufacturing techniques in order to improve its processes.

The company has also continued to physically expand. Originally operating out of an 1100-sq ft facility, Precision Edge next outgrew a 14,000-sq ft plant, and ultimately ended up at its current 37,000-sq ft, ISO–certified headquarters. The space is needed to accommodate the growing list of cutting tools it manufactures. Surgical instruments, such as drill guides, cannulae, inserters, and obturators, can be produced using stainless steel, titanium, and a variety of engineered plastics. More than 1000 types of carbide and diamond-coated burs are manufactured with head sizes ranging from 0.5 to 10 mm. Solid and cannulated drills, rasps for contouring bone, orthopedic reamers, and more than 400 styles of blades are offered. “There will always be new technology in the medical industry and the possible need to diversify [the company’s product line] again,” May says. “We are anticipating 2008 as a growth year, especially in the joint-repair sector,” he adds.

In addition to manufacturing cutting tools and instruments, the company also provides grinding, machining, finishing, and small-run prototyping, as well as design and development services. When manufacturing bone taps, the company’s engineering team uses product-simulation software to provide preproduction reviews of complex thread forms.

www.precisionedge.com

Booth #1064

Firm Offers Array of Techniques for Analyzing Materials

Daniel Grace

Materials selection is among the most difficult aspects of developing new medical implants. Surfaces must be clean or sterilizable, bonds must be secure and leakproof, and biocompatibility and corrosion resistance are essential. Added to the long list of challenges is the impracticality for most companies of maintaining in-house the full assortment of specialized analytical instruments and experts necessary for comprehensive material characterization and troubleshooting.

Enter Evans Analytical Group (Dublin, Ireland). The company offers surface, organic, and microscopic analysis to aid in the research, development, and characterization of biomaterials for medical devices. Specific services include failure analysis, contaminant analysis, contamination testing of polymers, and analysis of adhesion failure.

Key to the firm’s success is its range of instruments and techniques—the largest fleet of its kind in the industry, according to the company. “Particularly useful for medical manufacturers is our expertise in gas chromatography/mass spectrometry (GC/MS) analysis,” says Pat Lindley, regional vice president. “It’s a customary FDA regulatory test for analyzing volatile compounds in biomedical devices and polymers, and we can use it to help companies get through the approval process.”

GC/MS analysis works by identifying volatile compounds and separating them into individual components using a temperature-controlled gas chromatograph. During the process, a sample is injected into the chromatograph and passes through its column, which separates mixtures into individual components as they pass through at different rates. The result is a quantitative analysis of the components, along
with a mass spectrum of each. The company draws on its experience with handling nonstandard samples to offer alternative approaches for getting samples into the GC/MS instrument that otherwise would not be amenable to this method of analysis.

Among the company’s other instruments for the medical industry are a variety of surface analysis and elemental mapping tools, including those for Auger electron spectroscopy, focused ion-beam transmission electron microscopy, and scanning transmission electron microscopy. To date, the company has worked with manufacturers of stents, pacemakers, catheters, and trocars. Fifteen worldwide laboratory locations in seven countries enable the company to provide fast turnaround, according to Lindley.

Though the company’s typical role is that of a transactional problem solver, it will also be on the lookout at MD&M East for potential long-term partnerships. “We definitely have an interest in joining up with customers to help them develop new materials and processes,” Lindley says.

www.eaglabs.com

Booth #981

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