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Articles from 2004 In December


Technical Support Services

Originally Published MPMN November 2004

PRODUCTS

Products


Technical Support Services

A provider of sterilization and validation services offers technical support. The TechTeam technical support group at Steris Isomedix (Mentor, OH; www.isomedix.com) can assist in revalidation procedures, as well as new product validation. Other support services include product development, materials testing, and protocol generation.


Color Braid Silicone Hose

Flexible, braid-reinforced silicone hose features a colored tracer line. AdvantaPure (Southampton, PA; www.advantapure.com) offers the color braid silicone hose as a means for quickly identifying transfer and processing lines. The sterilizable hose is made from low volatile grade, platinum-cured silicone elastomer. Polyester braiding, including the tracer line, is then applied to enhance pressure-carrying capabilities. A final outer layer of silicone completes the product. Hose sizes range from 1/16 to 1 in.; available braid colors include red, blue, green, and yellow.


Pinch Clamp

A pinch clamp can be opened with a simple finger squeeze from any angle. The Easy Open pinch clamp from Z-Man Corp. (Grand Rapids, MI; www.zmancorp.com) is designed to reduce accidental pulling on tubing lines. Offered in a variety of colors, the clamp can accommodate tubing sizes from 3 to 6.3 mm. Samples are available from the company upon request.


600 - 700 W Switch Mode Power Supply

High-wattage single-output power supply units can be customized for medical device OEMs. The GPMP 600/700 series from Condor D.C. Power Supplies (Oxnard, CA; www.condorpower.com) comes as a stand-alone or rack mount unit. Its power input is 90-265 V ac, 47-63 Hz single phase. Output configurations from 24 to 48 V dc are available. The unit comes fully enclosed in a 12.4 x 4.86 x 2.48 in. package. Low output noise and low current leakage are standard features.


Liquid Transfer Pump

Safe, uniform transfer of drug samples is possible with a software-controlled peristaltic pump. The Steritest Equinox liquid transfer pump from Millipore (Billerica, MA; www.millipore.com) can be used for sterility testing in horizontal and vertical Class A/Class 100 laminar flow hoods. The pump's intelligent system enables analysts to download custom procedures from a PC onto the pump. An auto-close pump head simplifies loading and unloading of the device's tubing. Transfer time can be preset using the built-in timer. A patented pressure control system consistently monitors canister pressure, ensuring that the system is running within acceptable limits at all times.

Copyright ©2004 Medical Product Manufacturing News

Sneak Peek: Product Update

Originally Published MPMN December 2004

PRODUCT UPDATE

Sneak Peek: Product Update


Preserving the sterility and integrity of packaged biomedical products is necessary, yet many testing methods can damage the packaging, seal, or contents. A new line of noninvasive oxygen measurement systems from OxySense Inc. (Dallas, TX; www.oxysense.com) allows manufacturers to assess oxygen levels within containers, bottles, and packages without puncturing or destroying the seal. The OxySense 4000 is fully portable and self-contained, with an integrated 8.4-in. display, built-in processor, and automatic infrared temperature sensor. The 200T model attaches directly to a laptop or PC. Applications include oxygen permeation studies for packaging of sterilized medical devices and anaerobic testing in sealed containers.


Read more about advances in testing and inspection equipment and services in the January/February 2005 issue of MPMN.

Copyright ©2004 Medical Product Manufacturing News

Strong Fundamentals Form MedTech Foundation

Originally Published MDDI December 2004

Medtech Snapshot

Corporate Finance

Analysts predicted a strong year for medical devices, with exciting new developments to stimulate funding, growth, and revenues. Earlier this year, Scott R. Davidson, senior research analyst with Piper Jaffray, predicted that 2004 would see an above-average amount of mergers and acquisitions in the medtech industry.

“We will see offensive M&A, in which companies look to the next leg of growth, but also to defensive M&A, to protect market leadership and existing franchises,” Davidson said.

By mid-year, the industry had already seen 74 mergers and acquisitions (see the table on page 58 for a list of the key mergers and acquisitions in 2004).

The tables and charts on these pages provide a look at the financial health of the device industry. Indicators include a chart comparing industry performance with Standard & Poor's 500, a list of the industry's key mergers and acquisitions, and the top 40 medical manufacturers worldwide, ranked by revenue.


Copyright ©2005 Medical Device & Diagnostic Industry

Medical Technology in the Big Healthcare Picture

Originally Published MDDI December 2004

Medtech Snapshot

General Healthcare

Medical Technology in the Big Healthcare Picture

According to the Centers for Disease Control and Prevention (CDC), the nation's health has improved overall, in part due to the resources that have been devoted to health education, public health programs, health research, and healthcare.

Improved healthcare technologies, procedures, and medicines have also reduced mortality and morbidity associated with many chronic diseases and conditions. The cost of these advances, however, has been considerable, says CDC's “Chartbook on Trends in the Health of Americans.”

Total healthcare expenditures were $1.5 trillion in 2002, according to the Centers for Medicare and Medicaid Services. More than one-third of the nation's spending falls to public agencies. In 2002, national health expenditures increased 9.3% and will climb an average of 7.3% to reach $3.4 trillion by 2013, according to HDMA (see chart at right). The charts on this page provide a view of U.S. healthcare expenditures and the expected growth rate over the next decade.



Copyright ©2005 Medical Device & Diagnostic Industry

More and Better: The Future of FDA

Originally Published MDDI December 2004

EDITOR'S PAGE

More and Better: The Future of FDA

Shorter review cycle times, more inspections, and better postmarket studies are among the improvements in store at FDA.

Devices are different, CDRH director Daniel Schultz told attendees at the MD&M Minneapolis conference in October. “Devices are a group of varied products,” he said. “FDA's regulatory system must match that diversity.” Noting such developments as computers that can be swallowed, Schultz said, “This is where the action is.”

And, he said, with the advent of drug-eluting stents and other combination products, devices will soon no longer be just devices. “The line will disappear between drugs, devices, and biologics.”

With the blurring of that line, Schultz said, FDA needs new mechanisms to address these new products. Early interaction with FDA is critical for the changing industry.

Schultz noted that FDA's performance with PMA review times suffered during the mid-1990s and early 2000s. “We don't want to go back,” he said. “We want to expedite PMAs of combination products.”

Schultz said the agency's hope is to move toward “real-time supplements” so that progress is not interrupted. “The modular PMA program would allow companies to send information as it is available,” he said. “The reviewer can review the data over time without compromising safety and effectiveness.”

Schultz said FDA would like to eliminate the “middle step” of the deficiency letter to enable a 180-day, one-cycle review time for devices. “We have a responsibility to work with industry to make [a shorter review cycle] happen,” he said. “We will need more than one cycle for some products, but most will fit into one cycle.”

FDA's performance goals, he said, include meeting with companies up front, developing modular PMAs, and issuing guidances. FDA's goal is to hit a target of approving 90% of its PMAs within 320 days by 2007. “Guidance documents are critical to meeting these goals,” Schultz said.

He noted, however, that even with modular PMAs and one-cycle reviews, problems could still arise. “FDA needs to get out and do inspections. The field force did more inspections in 2004 than anticipated, but we are still far from meeting our statutory requirements. The truth is, we are never going to get there. And, it's not just that we need to do more; we need to do better.”

Schultz said FDA's aim is to align its resources with patient risk. Long-term safety, he said, will have to be looked at throughout the product life cycle. “We want to speed products to market without compromising safety and efficacy.”

He said, too, that implementing a strong postmarket program would help shift some of the burden away from FDA's premarket group. “Many approval studies are ill-conceived, and FDA is not good at tracking and enforcement.”

Better postmarket study design is essential. A better balance of pre- and postmarket requirements ultimately would free FDA's ODE staff to focus more on premarket reviews. Improved postmarket studies would also generate data for enhanced labeling. Such data could also be used to develop the next generation of products. It is essential that FDA take the steps necessary to ensure that it keeps up with the changing device industry.

The Editors

Copyright ©2004 Medical Device & Diagnostic Industry

Manufacturers: Fewer but Stronger

Originally Published MDDI December 2004

Medtech Snapshot

Manufacturing

Medical device manufacturing appears to be healthy. The charts on these pages indicate that the industry is indeed strong, with only slight decreases in the number of manufacturers.

The number of FDA-registered medical device establishments decreased just 12% from 2003 (12,560) to 2004 (11,071). Bryan Benesch in FDA's Office of Compliance says a significant source of the decrease is related to database cleanup. He notes, however, that some of the decrease is attributable to companies that in the last year have gone out of business.

If the annual registration form is returned as undeliverable by the post office, CDRH researches the status to determine whether the establishment is no longer in business. “We have done a significant database cleanup of these types of records in the last year,” says Benesch.

The only major change was in the number of FDA-registered rebuilders and refurbishers, which declined from 416 to 10. According to Benesch, the decrease is primarily the result of the agency cleaning up its files. “These establishment types are not required to be registered, and we have been canceling their registrations,” he explains.

The percentage breakdown of manufacturers remained steady across the nation. The number of manufacturers decreased fairly evenly nationwide (only Oregon and New Mexico increased, and Idaho and Louisiana remained the same as in 2003).

In September 2004, CDRH hired a new contractor to process registration and listing submissions. The phone and fax numbers have changed. The new contractor can be reached by phone at 240/276-0111; fax: 301/527-9187, or e-mail at reglist@cdrh.fda.gov. For policy questions, contact CDRH at 240/276-0110; fax 240/276-0140; or e-mail rlprogram@cdrh.fda.gov.

Copyright ©2005 Medical Device & Diagnostic Industry

Drug-Eluting Stents Show Effectiveness in High-Risk Patients

Originally Published MDDI December 2004

NEWSTRENDS

Drug-Eluting Stents Show Effectiveness in High-Risk Patients


The Cypher sirolimus-eluting coronary stent emits drugs inside an artery, preventing restenosis in high- risk patients.

Erik Swain

A number of studies show that drug-eluting stents may be beneficial to certain high-risk patients. These findings could ultimately further expand the market for the blockbuster technology. Drug-eluting stents have already been shown to prevent restenosis over several years.

The studies were presented at the Cardiology Research Foundation's Transcatheter Cardiovascular Therapeutics conference in September. They offer good news for Johnson & Johnson's Cordis Corp. (Miami) and Boston Scientific Corp. (Natick, MA), the two makers of the drug-eluting stents currently on the market.

A South Korean study found that drug-eluting stents have performed well in patients with long lesions, who are at high risk for restenosis. Results showed that drug-eluting stents outperformed bare-metal stents, and J&J's Cypher stent outperformed Boston Scientific's Taxus. The study, from the ASAN Medical Center in Seoul, is the first to focus exclusively on those patients. It was not organized or funded by any manufacturer.

“This study is important because it shows how drug-eluting stents are performing over the long term with challenging patients,” said principal investigator Seung-Jung Park, ASAN's chief of interventional cardiology. He said this is an important and growing patient population.

Brian Firth, Cordis's vice president for medical affairs and health economics, says the study could indicate that “we have the right drug and the right release polymer. We know that pretty much all stents by themselves have the same restenosis rate.” Firth says that mechanically the Cypher stent is consistently reducing late loss more effectively than Taxus. Late loss is a measure of tissue growth inside the stent. A lower rate of late loss correlates to a lesser chance of adverse events occurring.

In another independent study, researchers at Hospital Clinicos San Carlos in Madrid, Spain, found that Cypher reduced late loss in diabetic patients 88% better than bare-metal stents. Diabetics are another patient population considered difficult to treat with stents. These patients are more likely than the average patient to have inflammation as a result of stenting. “The default treatment for diabetics has been bypass surgery, because they are thought not to do well with angioplasty,” Firth says.

He says these studies might further accelerate the shift from surgery to stenting. “Cypher works extremely well across all subgroups,” he notes.

For its part, Boston Scientific announced successful two- and three-year follow-up results from its earliest Taxus trials. The continued success indicates that Taxus likely prevents in-stent restenosis and doesn't just delay it, the company says.

“The results we are seeing mean that the achievements in the clinical trial are being duplicated in the real world,” says Eric Simso, Boston Scientific's vice president of stent marketing. “It tells us that the way we release paclitaxel holds back [restenosis]. That gives us more confidence to say that this just works, and let's now focus on what happens with high-risk patients.”

As for the results touted by J&J, Simso says it is too early to draw conclusions other than that stenting “is not a disaster” in those high-risk patients.

The new findings won't immediately lead to expanded indications in the United States. Those can only come with new, company-sponsored randomized clinical trials. But they might lead to elimination of some contraindications in other countries. These results might also encourage doctors to try stenting on patients not previously considered for it.

Some firms hoping to compete with J&J and Boston Scientific also announced encouraging results at the conference. Guidant Corp. (Indianapolis) reported that late loss for its drug-eluting stent was 0.10 mm after six months, compared with 0.84 mm for a bare-metal stent. The results come from a 60-patient prospective trial. A pivotal trial is scheduled to begin in the first quarter of 2005. Conor Medsystems Inc. (Menlo Park, CA) reported that its paclitaxel-eluting cobalt chromium stent showed an in-stent restenosis rate of 1.9% and a target lesion revascularization rate of 1.8% after four months. Other potential players in the market include Medtronic Inc. (Minneapolis) and Abbott Vascular Devices (Redwood City, CA).

Copyright ©2004 Medical Device & Diagnostic Industry

Steady Growth in Tentative Times

Originally Published MDDI December 2004

Medtech Snapshot

Market Size

Despite fluctuations in both the domestic and world economies, the U.S. medical device industry remains a vibrant and progressive industry, according to the U.S. Department of Commerce (DoC).

Steady growth in the U.S. market will be tempered by “poor economic performance and cost containment in Europe and Latin America,” according to Espicom Business Intelligence, a research group based in the UK. The firm notes that many Asian markets are now performing strongly again. Leading markets in central Europe that became EU members in 2004 are also performing well.

The largest market for medical equipment is by far the United States. The Americas make up 56.3% of the world market, followed by the European Economic Area, which makes up 22.9%. However, the medical industry is a global industry, and medical device manufacturers look increasingly to developing countries for future growth, according to DoC.

The graph below provides a snapshot of how each sector in the U.S. device market has grown in the last 25 years. The pie chart at right shows a relative breakdown of the the medical device market worldwide.



Copyright ©2005 Medical Device & Diagnostic Industry

Photocatalysts Could Keep Devices Cleaner

Originally Published MDDI December 2004

NEWSTRENDS

Photocatalysts Could Keep Devices Cleaner

Erik Swain

Research into photocatalytic technology indicates that it might show promise for use in sterilization or decontamination of medical devices.

Tony Byrne, a professor at the University of Ulster (Jordanstown, Northern Ireland), told attendees at September's MEDTEC conference in Galway, Ireland, that applying titanium oxide nanoparticles to devices should remove organic pollutants. The nanoparticles also target proteins that sometimes remain on reused devices after reprocessing, he said.

Photocatalysis is the use of a catalyst to accelerate a photochemical process. Adding light and the catalyst to an organic material and oxygen produces water and carbon dioxide.

There are a number of photocatalysts. Titanium oxide has proven the best for practical use, Byrne said. It is insoluble at the pH levels encountered in the process. It is also photostable and photoactive. In addition, it is inexpensive and readily available. It has the proper band gap and can degrade a wide range of organic materials.

Most application research has focused on uses for water and air purification. But a self-cleaning glass product has just been commercialized, and scientists are looking for other ways to apply the technology, Byrne said. His primary reason for attending MEDTEC was to assess the device industry's interest in pursuing commercial applications.

Titanium oxide could be a fit for devices because it is nontoxic and resists corrosion, he said. He noted that it can kill a wide range of microorganisms. It does not require other chemicals for the process to begin. Only ultraviolet light is needed. The process can occur at ambient temperature and pressure. It can be switched on or off. And, he said, it could likely be incorporated into existing decontamination and disinfection regimes. Currently the University of Ulster has two research projects under way involving photocatalysts and medical devices.

“The first project indicates that we might be able to make smart catheter materials that can serve as an early warning system to detect microbial contamination,” Byrne said. This system, he said, could enable the development of smart implants that are prevented from causing infection.

Byrne said the second project could lead to the manufacturing of a self-cleaning instrument. He noted that it could be a technology for sterilization or decontamination of medical devices.

Copyright ©2004 Medical Device & Diagnostic Industry

Renewed Industry-FDA Cooperation Set Tone in 2004

Originally Published MDDI December 2004

Medtech Snapshot

Regulatory

The climate at FDA over the past year remained one of accessibility. Even with the departure of commissioner Mark McClellan, the progress set in motion continued under acting commissioner Lester Crawford. Crawford assured attendees at AdvaMed's annual conference that FDA would continue to be open to feedback from industry as the agency brings its new programs to fruition.

“There's a spirit of cooperation between FDA and industry—not that industry is enthralled with everything FDA does, but there have been some monumental changes and a real change in attitude,” Jeffrey Gren told MD&DI earlier this year. Gren is director of the Office of Health and Consumer Goods, International Trade Administration, for the Department of Commerce.

The statistics on the following pages reflect data from the CDRH 2003 annual report. Of particular note, third-party organizations reviewed 190 510(k)s, a 50% increase over the previous year (see the graphs on page 62). ODE attributes the increase in part to the implementation of MDUFMA user-fee provisions that require applicants to pay a fee when submitting 510(k)s directly to FDA without a third-party review.

This was the first year that MDUFMA was in full swing. During 2004, the Office of Device Evaluation (ODE) hired more than 70 employees across a range of disciplines. ODE also made great strides toward standardizing the review process of IVDs, said Steve Gutman, MD, director of the Office of In Vitro Diagnostic Device Evaluation and Safety.



Copyright ©2005 Medical Device & Diagnostic Industry