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Articles from 2007 In January


FDA, VHA to Share Safety Information

Transforming FDA LogoFDA and the Veterans Health Administration announced a formal agreement to share information and expertise related to the review and use of medical devices and other FDA-regulated products. The goal of the Memorandum of Understanding is to enhance postmarket safety data collection. By working together, the agencies hope to identify, validate, and analyze product risks more effectively. Within 30 days, there will be a meeting to establish procedures and safeguards. The VHA has been at the cutting edge both of adopting medical technology and of implementing patient safety measures. FDA could learn a lot from its experiences.

Bush Order Limits FDA Guidance

Transforming FDA LogoToday's Washington Post has a Bloomberg News column that assesses the impact of a Jan. 18 executive order issued by President Bush that curbs the powers of federal agencies to regulate industry through guidance. This is hugely significant for the device industry as FDA relies heavily on guidance documents to regulate manufacturing and quality issues. The concern, not only expressed by FDA-regulated industries but by many industries regulated by the federal government, is that issuance of guidance had come to serve as back-door rule writing, without being subject to the same scrutiny that proposed new rules are. Under the order, federal agencies must submit to the Office of Management and Budget for review any guidance with an impact of $100 million or more, and must make such guidances available for public comment. An agency must also state the "specific market failure" that the guidance would help cure. If implemented properly, the order could make FDA more accountable, which is sometimes necessary.

Stent Manufacturing in Iran?

They want to manufacture coronary and peripheral bare-metal and drug-eluting stents and offer them to Iranian hospitals at a more affordable price. The firm is looking to buy stent technology and the equipment to manufacture it. Anyone interested in doing business with STAMD should contact its executive director, Alireza Khajeh, at khajeh.alireza@gmail.com. US firms should be aware that there may still be in place trade sanctions that prevent them from doing business with Iranian companies.

Selling Drug Unit Reshapes Cardinal Health

The sale is part of Cardinal Health's committment to making healthcare "safer and more productive," according to Cardinal President and CEO R. Kerry Clark. Cardinal Health's medical device business, which generates $1.6 billion in revenue, includes surgical instruments, gloves, interventional radiology products, and respiratory care products.

Latest Device Giant: Covidien

The new company will be called Covidien and will be based in Mansfield, MA, giving the state a second device-industry titan to accompany Boston Scientific. The 43,000-employee company with more than 10,000 products will focus exclusively on the medical market and hopefully avoid the financial shenanigans that brought down its soon-to-be-former parent company. If Tyco shareholders and the SEC approve, the spinoff would happen in April.

J&J, Abbott Report 2006 Earnings

In its conference call to analysts, J&J said that stent sales fell 15% in the fourth quarter, and that it has abandoned plans for development of an internally designed next-generation stent. That likely means it will have to rely on the technology it acquires from Conor Medsystems to remain at the forefront of the stent market. Abbott, meanwhile, reported a gain of $389 million in global sales of vascular devices, and development continues on the next-generation stent technology it acquired from Guidant via Boston Scientific.

Icahn to the Rescue of Cyberonics?

Icahn has accumulated a 9.77% stake in Cyberonics and is backing an effort to have three directors replaced, Reuters reports. With the shakeup in management, rumors have started that the firm will be sold, and potential buyers may think they can get a bargain compared to what competitors Advanced Neuromodulation Systems and Advanced Bionics went for. But you can be sure Icahn will do whatever he can to increase the company's value before a sale. Cyberonics was named one of MD&DI's 50 Companies to Watch last June. We were right -- but for a different reason.

FDA Approves First Generic Device

But because of the 510(k) approval standard of "substantial equivalence," the industry has a long history of "me too" products. Is GMD's model significantly different from that? The staff of MD&DI will find out when we meet with the company at the MD&M West show next month. Stay tuned.

Von Eschenbach Names Two Top Aides

Transforming FDA LogoFDA Commissioner Andrew von Eschenbach has named two people, one of whom should be very familiar to FDA observers, to top positions in the agency. Janet Woodcock, MD will assume a newly created position, Chief Medical Officer, which will oversee scientific and planning operations. Woodcock has previously been Deputy Commissioner for Operations and director of the agency's drugs and biologics centers. John Dyer, MPH, has been named Deputy Commissioner for Operations and Chief Operating Officer. He will focus on issues concerning management, business processes, and information technology. He was previously COO at CMS, where he helped implement the vast reforms at that agency. In other words, Woodcock's charge will be to ensure the agency fulfills its scientific mission. Dyer's will be to ensure it fulfills it with as few bumps in the road as possible. Success in both is badly needed in this era of tribulation for the agency.

Automating Stent Production, One Step at a Time

PROFILE

Automating Stent Production, One Step at a Time
A laser cutter is the cornerstone of what ultimately may be a fully automated system
Klaus Vollrath
The control system is equipped with a touch screen monitor.

Stent manufacturing currently is characterized by multiple manual operations and open-loop, batch-oriented quality assurance procedures. The development of advanced stent products, however, requires an even greater degree of repeatability and process control than has been the norm. Diode-pumped fiber laser cutting systems can play a key role in achieving increased speed, accuracy, and process control, according to Eduard Fassbind, CEO of Switzerland-based Swiss Tec AG. Operating facilities in Zürich and Schann, Fassbind designs and builds custom turnkey laser-based micromachining systems. The company recently developed equipment for a medical device OEM in Germany that led to a dramatic increase in productivity. The customer considers the laser cutter to be the cornerstone of a process that will go from tube to stent without any manual intervention.

“The emergence of new generations of stents created the need for an in-depth redesign of the entire manufacturing process chain,” says Michael Giese, CEO of eucatech AG in Rheinfelden, Germany. The firm fabricates devices for use in interventional cardiology and radiology; stent systems and related equipment are a specific focus. The advent of drug-eluting stents has led to new, more-stringent standards, notes Giese. For example, to ensure that the correct amount of drugs are embedded in a stent, US FDA prescribes a restricted scatter bandwidth for the total surface area of the stent. This significantly narrows allowable tolerances from the traditional 15% to a mere 6 to 8%. These requirements, accompanied by a trend toward a reduction in strut dimensions from about 110 µm to as little as 60 µm, made the company’s existing laser cutting systems obsolete. As Giese further considered the ramifications of evolving demands from the marketplace, it became clear to him that the entire process-chain layout would have to be reassessed. A semiindustrial approach involving scattered manual operations and batch-oriented quality assurance ultimately will be replaced by a monolithic, IT-based total quality management system, notes Giese. He has begun building the foundation of such a system.

A new tube-cutting, -drilling, and -welding system from Swiss Tec enabled a stent manufacturer to dramatically increase productivity and reduce rejects.

A Cut Above

“Laser cutting is the start of the process chain,” says Fassbind, “but it is crucial that it be done right to achieve the desired final result.” For the eucatech project, the firm used a tube-cutting, -drilling, and -welding system equipped with a 50-W diode-pumped fiber laser source from SPI Lasers Ltd. (Southhampton, UK). Carefully tailored to meet the requirements of maintenance-free always-on industrial-scale production, the Swiss Tec micro-T15 comprises a sturdy granite base, linear-drive x-axis, proven laser forming and focusing system, and state-of-the-art control system. The latter includes a CCD camera to monitor the focus of the laser beam on the workpiece. Spot sizes in the 10- to 12-µm range and cutting speeds of 500 to 600 mm/min are routinely achieved. By contrast, the previous tool only achieved cutting speeds of 150 to 200 mm/min. Fassbind has run tests on systems attaining cutting speeds of 800 mm/min with promising results; ultimately, he anticipates achieving speeds beyond 1000 mm/min.

Diodes Pump Up Laser Performance

“One of the features we like best about the new plant is the diode pump technology,” says Giese. The company’s previous equipment used lamps, which have a relatively short, approximately 2000-hour, life span. They also can cause drift, which affects the laser beam’s performance and can result in inconsistent results. All too often, substandard or out-of-tolerance parts would be produced after only a few hundred hours of lamp life, says Giese. “We would have to stop production while the laser system was thoroughly readjusted. The task could take more time than a full shift, and it required the involvement of highly qualified—and highly paid—specialists,” explains Giese.

Diode-pumped lasers, on the other hand, can be serviced by nonspecialized personnel and remain stable over a long period of time. Since the new system was installed, downtime has been cut in half, machine usability has soared to more than 90%, and the percentage of rejected parts has diminished, according to Giese. Moreover, throughput has doubled compared with the old system.

“The laser cutting system is just the first building block in what will be a complete automated production chain,” explains Giese. Thus far, he has installed an inspection system and a heat-treatment station. Eventually, additional plants and robotic and conveyor systems will be integrated into the process chain.

Because of the scale of this project, Giese required more from his equipment supplier than simply machine-building capabilities. He needed someone who “would be willing to team up in an ongoing innovation process. This aspect played a key role in our selection of Swiss Tec,” says Giese.

Swiss Tec will be exhibiting at MD&M West 2007 in Anaheim, CA.

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