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Suppliers Shrink Valves for Small and Portable Devices

PRODUCT UPDATE

Suppliers Shrink Valves for Small and Portable Devices
As portable and minimally invasive devices increase in number, the size of valves continues to decrease for gas and liquid applications.
Stephanie Steward
Burkert's Type 6650 "Flipper" solenoid valves are only 4.5 mm wide, and are designed to be mounted directly above 96 and 384 microtiter plate instruments.

Providing more mobility to patients who suffer from long-term illnesses or who are recovering from surgery can free up hospital resources and increase treatment options. As such, a demand for more-flexible and less-invasive medical devices and remote patient-monitoring equipment has driven the industry to continue to decrease the size and increase the capabilities of their products. As the push for portable and minimally invasive devices gains steam, OEMs require smaller valves that can accommodate these design demands while still meeting flow-control requirements. In response, suppliers have employed creative thinking and strategic use of design tools to produce new valves that offer the tiny size and high throughput that OEMs seek.

Small Valve, Large Orifice

Solenoid valves direct the flow of air and gases in a fluidic module that typically incorporates miniature diaphragm pumps, compressors, or vacuum pumps. Over the years, as portability has become a more-common factor in device design, the challenge for suppliers has been to produce smaller, lighter components, including miniature solenoid valves, to fit in these medical devices, according to Dan Schimelman, director of business development at Hargraves Technology Corp. (Mooresville, NC; www.hargravesfluidics.com).

In trying to meet this challenge, Hargraves realized that simply reducing the size of the valve resulted in a smaller orifice, which restricted throughput, effectively sacrificing higher performance for a smaller package size. To address this design problem, the company focused instead on reducing the overall size of the valve while maintaining a large orifice. The result is its Magnum 10-mm series of miniature solenoid air and gas valves designed with an orifice up to 1.9 mm that the company claims can outperform many larger solenoid valves.
The positive impact of a much larger orifice and corresponding higher flow rate translates to an advantageous drop in the differential pressure that a pump must work against in a fluidic system, according to Schimelman. Potential advantages gained by incorporating a Magnum valve into a device include utilizing smaller, lighter pumps; less noise; and extended pump life. "Portable medical devices benefit from the high flow and high efficiency of Magnum valves that are optimized in conjunction with a miniature diaphragm pump or compressor," Schimelman says.

For applications that require fluidic modules to perform as efficiently as possible, the ability to optimize the power required to operate the solenoid valve that controls flow, pressure, or vacuum provides the added benefit of reducing current draw and heat generation. Since extending battery life is an important criterion to a portable medical device's market success, configuring a fluidic module with higher-efficiency and higher-flow solenoid valves has become a key technology driver, Schimelman says.

The large orifices of the solenoid valve also can benefit device applications that have chambers or cuffs to fill, pressurize, or evacuate in a timely manner, such as deep-vein thrombosis therapy or other compression-therapy devices. When equipped with a Magnum valve, these devices can provide a more-responsive therapy by pressurizing and evacuating the cuff faster, according to Schimelman. "Some of the applications can see this time reduced [by as much as] one-third the typical fill or evacuation [rate]," he adds.

Burkert Fluid Control Systems (Irvine, CA; www.burkert-usa.com) has also been paying attention to how portable and point-of-care devices are driving OEMs' demands. It has reengineered its 10-, 16-, and 22-mm valves with larger orifices to achieve higher pressures while consuming less power.

"The industry continues to look for [characteristics such as] smaller size, proven reliability, lower-power, higher throughput, and less waste," says Burkert microfluidics market segment manager Craig Occhiato. "Our Type 6650 'Flipper' solenoid valve [has the] mechanical advantages to meet or exceed the life science industry requirements," says Occhiato. The valve is only 4.5 mm wide, and is designed to be mounted directly above 96 and 384 microtiter plate instruments and other applications requiring tiny valves.

Analysis Tools Speed Up Time to Market

South Bend Controls' proportional solenoid valve, the PSV-PB, is designed for applications that require operation at multiple pressures or low pressures.

When designing the large orifice of its solenoid valves, Hargraves used finite element analysis (FEA) to analyze the flow throughput and flux efficiency of the magnetic field created by the valve in order to increase the valve's flow capabilities. Vernay Manufacturing Inc. (Yellow Springs, OH; www.vernay.com), which provides standard and custom precision fluid-control components, has also benefitted from using tools like FEA and computational fluid dynamics (CFD) when developing valves for liquid applications. Vernay used FEA and CFD to respond to a request from a customer to make its Supra-Valve line of elastomeric check valves smaller and capable of holding to tighter functional tolerances, according to John Madewell, Vernay's director of sales.

"We can model the valve using the FEA and CFD tools [to predict] how the valve will work in its intended application," Madewell says. "This benefits the OEM by reducing the time to market [by allowing] our customers to bypass the traditional route of multiple prototypes."

Although the company has been developing miniaturized parts for years, it is noticing the increased demand for even smaller valves more recently, Madewell says. To fulfill this need, the company offers a valve, approximately 3-4 mm in diameter, that is used in minimally invasive surgical applications.

Stick with Standard, or Get Customized?

Even with these advances in valve technology, however, some OEMs may still struggle with weighing the benefits of choosing a standard valve that will work for their needs versus opting to customize a valve to meet specific application requirements.

South Bend Controls Inc. (South Bend, IN; www.sbcontrols.com), a developer of fluid-control components, offers flexible options to OEMs in this situation. To help its customers, the company provides core technologies and products that can be easily modified to meet customers' application-specific requirements. For example, it offers a proportional solenoid valve, the PSV-PB, that is designed for medical ventilator applications, specifically those that require operation at multiple pressures or low pressures. However, the valve's orifice size, coil resistance, and spring rates can be modified to meet specific needs, according to the company's vice president and general manager, Peter Hutchings.

Flexibility and customization are crucial to advancing valves used in medical devices. But the biggest concern is still keeping up with the industry's demand for smaller and more-efficient components for the increasingly miniaturized and portable device market. "The requirements for mobility, both for ambulatory and sustained treatment, are moving away from the hospital," Hutchings says. "This shift is driving the need for smaller components for more-portable devices that require less energy than their predecessors, yet maintain the same reliability requirements."


Copyright ©2008 Medical Product Manufacturing News

Clarity on Manufacturing Rules for Combination Products May Come Soon

The office put out a draft guidance in 2004 about how these should be integrated for combination products, but has not issued any further official word. Nguyen implied that the proposed rule on GMPs won't be too different from the 2004 draft guidance. "When it comes out, you won't be too surprised," he said. "In the meantime, work with us and have patience." The draft guidance states that before the constitutent parts are combined, they should follow the manufacturing rules that already govern them. Once they are combined, they should follow one set of rules, and incorporate select provisions from the other set of rules. Manufacturers should have a plan in place that determines which of those provisions are and are not needed. But the guidance is unclear on which set should be primarily followed for which products, when exactly "combination" occurs, and what to do about products that are used and/or marketed together but not manufactured together. The office is also about ready to publish a guidance on imaging devices for use with radiopharmaceuticals, Nguyen said. Also forthcoming are two guidances on autoinjectors, he added. One will cover the regulatory pathway for them, and the other will cover testing and other technical information.

Proactivity Is Key When It Comes to COA Studies

Anthony Blank, vice president of cardiovascular regulatory affairs for Boston Scientific, offered some pointers during a session at the Regulatory Affairs Professionals Society meeting this week. First, he said, the company needs to work with FDA to determine what the key unanswered questions will be at the time of approval. Once those are identified, the sponsor needs to determine what their data requirements are, and whether a COA study is the best way to get that data. "What steps can be taken to maximize data integrity and minimize complexity?" he asked. "How might the data enhance patient care? Never forget that. You have to walk away with answers to those questions before you agree to a COA." Second, firms should make sure the studies aren't too complex. "Study procedures outside the range of normal patient care will impede enrollment and create noncompliance issues," he said. "A complicated patient enrollment process will delay enrollment. Extra patient follow-ups will lead to missed visits. And collection of extra data without a plan can lead to new questions. The data need to be as reliable as they are in premarket studies." His other recommendations include: * Know the COA requirements for similar devices, and understand their successes and challenges. Do not underestimate the complexities and challenges associated with a COA study. * Meet with the FDA review team often. Discuss the likelihood of a COA study being needed, and what questions it should address. Discuss alternative sources of data, such as literature on similar products. These discussions can help firms design better premarket studies as well. * If applicable, reach an agreement on a COA study design before the advisory panel meeting. Panel members like to offer suggestions about COA study design, and their ideas are often not practical. * Don't commit to a study that's impractical or too expensive. It is tempting to agree to whatever the agency asks for in order to get the PMA approved as soon as possible. But rubber-stamping FDA's offer could lead to problems later. * Explore getting a continued-access IDE. This will enable a sponsor to start collecting COA data before final PMA approval.

510(k) Process Could Come Under Fire

We believe it works well, is flexible, and is not undemanding," said Patricia Shrader, senior vice president of corporate regulatory and external affairs for Becton Dickinson, who spoke at a session on the FDA Amendments Act of 2007. "But the GAO report may not be entirely positive. And if the GAO says the bar must be raised, then the impact on IVDs may be rather disproportionate." Similarly strong words were uttered by industry and CDRH personnel during the conference's CDRH executive staff briefing. "The majority of products which have turned out to have severe problems are not 510(k)s," said Susan Alpert, senior vice president and chief quality and regulatory officer at Medtronic. "This program has not created a significant risk for the American public." Pamela Adams, senior vice president and COO at Etex Corp., said the attacks on the 510(k) program arise from misconceptions, particularly that 510(k) products can get on the market without clinical data. In fact, 10-15% of 510(k) applications include clinical data. She said AdvaMed is working to educate policymakers and the media about these misconceptions. CDRH Director Daniel Schultz said the 510(k) program has matured over the years into something that "allows us the flexibility to apply appropriate criteria and thresholds." But, he said, industry should not view the program as an easy way to market, and should not balk if the center asks for more data. "If we want the 510(k) program to survive, and to be based on risk, it has to work both ways," he said. "We will ask for less information about simpler devices, but we will ask more and harder questions as the technology advances. `It's just a 510(k)' is a phrase that should be taken out of our lexicon." -- Erik Swain

In Brief

NEED TO KNOW

In Brief

Gore (Elkton, MD; www.gore.com), a supplier of expanded PTFE and medical products such as membranes and cables, is celebrating its 50th anniversary. Operating 45 facilities around the world, the company has been a fixture on Fortune magazine’s list of best companies to work for since 1984. . . .Omni Components Corp. (Hudson, NH; www.omnicomponents.com) has been named Supplier of the Year in 2007 by Orthofix International (McKinney, TX; www.orthofix.com), an orthopedic products company. Supporting Orthofix with engineering and manufacturing services, Omni earned the honor based on its service, delivery, and quality of product. . . .Investment management company Berwind Corp. (Philadelphia; www.berwind.com) has acquired Specialty Coating Systems Inc. (Indianapolis; www.scscoatings.com), a company specializing in parylene conformal coating services, systems, and materials. . . .Testing services provider Microtest Laboratories (Agawam, MA; www.microtestlabs.com) has doubled its analysis capabilities by acquiring another MicroSeq microbial identification system. Using the new system, the company can provide precise bacteria and mold identification tests in 24 hours, compared with the one-week turnaround some traditional tests require. . . .The ISSAC Award for Innovation competition, presented by ISSAC Medical (Tustin, CA; www.issacmedical.com), is offering a $10,000 cash prize this year to the individual or group that best demonstrates innovation in the field of drug-eluting combination products. The deadline to register for the competition is December 1. The company specializes in the processing of drug-eluting components found in medical devices. . . .Siemens Energy & Automation (Alpharetta, GA; www.exiderdome.com) presents exiderdome, a multimedia, hands-on, traveling industrial automation expo. Touring across the United States until May 2009, the show will stop in New York City this November and Charlotte, NC, in December. . . .Premier Research Group S.A. (London; www.premier-research.com), a provider of clinical research and trial services to medical device manufacturers, is now certified to ISO 13485:2003 standards. The company has experience with such medical applications as analgesia, oncology, and infectious disease treatment. . . .Family-run CNC Software Inc. (Tolland, CT; www.mastercam.com) is celebrating its 25th anniversary since developing the original Mastercam 2-D CAM program. The current version of Mastercam can help product designers with a variety of operations, including milling, wire EDM, and plasma and laser cutting. . . .Tekra Corp. (New Berlin, WI), a supplier of engineered plastic films, has been named an authorized dealer of Sabic Innovative Plastics’ (Pittsfield, MA; www.geplastics.com) polycarbonate film products in the United States and Canada. Sabic manufactures high-performance Lexan, Valox, and Ultem film products. . . .Lubrizol Specialty Chemicals Manufacturing Co. (Cleveland; www.lubrizol.com) is expanding its Estane specialty thermoplastic polyurethanes facility in Shanghai to meet growing demand. Manufacturing capacity will be nearly doubled at the Song Jiang plant.


Copyright ©2008 Medical Product Manufacturing News

Congress Scrutinizes Device Ads

Those present at the hearing debated how the ads can give patients "unrealistic expectations" and lead to the overuse of expensive technologies (as stated by Kevin Bozuc a board director of the American Association of Orthopedic Surgeons) versus AdvaMed president Steve Ubl's stance that by helping patients learn about new technologies and treatment options, DTC ads can initiate critical discussion between doctors and their patients. Professor Ruth Day, PhD, from Duke University discussed how these ads influence consumers and can inhibit their understanding of the potential risks, but her sentiment, not surprisingly, wasn't shared by Ubl. "The idea that a patient would undergo a complex and invasive procedure based on an advertisement, or that a physician would agree to perform them if inappropriate for a patient, is difficult to imagine," Ubl said. He also stressed that FDA and the Federal Trade Commission presently have the legal authority to regulate false or misleading ads involving devices. William Boden, MD, a professor of medicine at the University of Buffalo suggested that ads be banned for at least two years after devices are approved. Committee Chairman Herb Kohl (D-WI) had been holding hearings on drug and device marketing for 15 months and plans to continue pushing FDA in its oversight. "Physicians and consumers must be appropriately educated about these critical devices and their benefits and risks alike," he stated. "What we do in the near term will be dependent on the proactive actions of FDA and industry."

How Safe is BPA in Medical Devices?

The study in The Journal of the American Medical Association found that adults with the highest BPA levels in their urine had more than double the chances of having diabetes or heart diseases versus those with the lowest levels of the chemicals. According to a Gail McCarver, a pediatrician interviewed by USA Today, the FDA report on BPA underestimates the exposure level of the chemical among children. So now what? Advocates are urging the agency to revise its stance that BPA is safe for daily use. The president of the National Research Center for Women & Families, Diana Zuckerman, is calling for clear warning labels on products made with BPA. McCarver suggests that manufacturers start replacing the plastic with another chemical. Senator Charles Grassley (R-Iowa) sent a letter to FDA requesting copies of communication with the American Chemistry Council, the group that funded a study referred to by the agency in its report on BPA. Although JAMA's study is causing quite a stir among safety advocates, it still points out the independent follow up studies must be conducted to confirm their findings and offer more insight into how exposure could potentially cause adverse outcomes in humans. For some background info: The National Institute of Environmental Health Sciences (part of the National Institutes of Health) has a pretty good run down of how BPA is used, along with some facts, timelines, and links about the chemical.

German Manufacturer Establishes North American Operation

NEED TO KNOW

German Manufacturer Establishes North American Operation

Maier Machine Works (Wehingen, Germany; www.maier-swiss.com)—a German manufacturer of precision, Swiss-type turning centers—has formed a subsidiary, Maier USA (Webster, MA; www.maierusa.us). The offshoot operation opened its doors in March and now serves as the company’s North American headquarters and warehouse.

The facility in Webster features a technology center stocked with Maier machines for sales purposes, customer application testing, and customer training. Distributor training, user seminars, machine support, and full spare-parts inventory are also available at the plant, which is located an hour from both Boston and Providence, RI.

A solid polymer concrete base weighing 8500 lb is the cornerstone of Maier’s machining technology. It is designed to eliminate vibration and ensures accuracy to within ±0.0001 in., according to the company. Seven different series of the company’s machines are available, and each can be supplied with a number of end-use-specific options. Ranging from units with 4 axes and 11 tool stations for processing simple parts to machines with 15 axes and 38 tool stations for complex production work, the company’s equipment has been installed in 26 countries since being made commercially available less than a decade ago.

“Maier machines feature a unique modular design that allows us to create the most optimal machining solution for each customer,” says Jim Kucharski, Maier USA’s national sales director. “Building a machine this way—using plug-and-play components—is efficient, and customers pay only for the features their specific applications require.”

Maier USA is in the process of expanding its network of distributors in the United States, Canada, and Mexico. All machines are designed, built, and certified to quality standards at the Maier Machine Works headquarters in Germany.


Copyright ©2008 Medical Product Manufacturing News

Cardiac Implant Market Expects Rebound

The fact that current drugs don't always do the trick could also help implants that treat and manage coronary and peripheral artery diseases, cardiac arrhythmia, congestive heart failure, and valve defects. Pacing devices will stay at the top among cardiac implants and are expected to increase 7.8% each year to hit $8.7 billion in 2012. Improved drug-eluting stent design, along with a lower risk of complications could push cardiac stents and stent-related implants to $6.4 billion in 2012 (a more than 10% annual increase). The study also covered tissue heart valves, which are expected take some demand from mechanical heart valves. Improvements in diagnostics will also increase the use of implantable heart monitors for patients with congestive heart failure.

Zeus Launches Analytical Laboratory

MD&M MIDWEST 2008: EXHIBITOR NEWS

Zeus Launches Analytical Laboratory

Leveraging its experience in the design and production of polymer tubing, Zeus Inc. (Orangeburg, SC), has launched Polymathic Analytical Labs, a subsidiary focusing on polymer characterization. In addition to promoting its own core tubing competencies, Zeus will be discussing the capabilities of its nascent business endeavor while exhibiting at MD&M Midwest.

Manned by analytical chemists, polymer scientists, biomedical engineers, process engineers, controls technicians, and product development technicians, Polymathic Analytical Labs can support OEMs’ chemical, electrical, mechanical, thermal, microscopy, and sample-preparation needs. Moreover, advanced material analysis is available for bioabsorbables, fluoropolymers and Teflon, nylon, polyamides, PEEK and PEK, polyetherimide, polyester, polyethylene, and self-reinforced polyphenylene.

“Our people understand the science, performance, and processing of plastics on a molecular level—knowledge a typical start-up company can’t duplicate,” says Mike Tourville, executive vice president of business development and strategic marketing.

The ISO 17025:2005–accredited laboratory is equipped to perform a range of services that include failure and defect analysis; formulation and deformulation of products and materials; process monitoring; contaminant identification; material selection consultation and inspection; and contract research and development. Furthermore, the company has access to an affiliated machine shop, which enables it to design and fabricate test equipment quickly in order to meet standard or nonstandard test specifications, should the need arise.

“We’re positioned as a resource for unbiased, independent analytical data and counsel—a role that is absolutely critical in bringing new technology to market,” says Bob Ballard, vice president, research and strategic business development.

Polymathic Analytical Labs, a Zeus Co.
www.polymathiclabs.com
Booth # 2919

Copyright ©2008 Medical Product Manufacturing News