A broad initiative, complete with a guidance document, to improve CDRHâEUR(TM)s premarket evaluation process could be coming soon. The agency is reevaluating its system for premarket review and will be working harder at monitoring the performance of products after approval. FDA also wants to communicate more effectively with the broader medical community and keep patients more informed about device issues. This includes a new approach to releasing information about recalls.
Guidant Corp. suffered yet another setback yesterday when it announced it would scrap its drug-eluting stent slated for introduction in Europe because of manufacturing defects. The New York Times reports that European introduction of the Xience V stent has been pushed back to the third quarter of this year, and the company has taken a $15 million write-off for the first quarter. The firm found that about 1% of the products made in its Temecula, CA plant were not meeting specifications, but did not specify the production problem that caused them. No patients were harmed. The move does not affect the acquisition of Guidant's assets by Boston Scientfic Corp. and Abbott, and does not push back the timetable for U.S. market introduction. That's not expected until 2008. What may be affected is how long until Guidant gets out of FDA's doghouse.
Unfortunately, this is not the first time stent technology has caused messy lawsuits. With so much at stake in this market, chances of any firm relenting are slim. So the lawyers will battle it out.
The report does a nice job of showing how its functions support CDRH, and is worth checking out.
This is an advance over conventional transdermal technology, which also feeds medication through the skin but can only do so in a "prepackaged" format.
To send a nomination, please email mddi@cancom.com with the following information: your name, employer, email address, and phone number; the name, location, and annual revenues (if public) of the firm you'd like to nominate; a list of the firm's key products (they may be on the market or in development); and a brief explanation of why this company is one to watch. Please send your nominations no later than Friday, April 7, 2006. We hope to see your suggestions, and if you have any questions, please contact us at mddi@cancom.com.
The medtech industry consistently delivers high-quality products to the public. The Bad: Such a system could promote incentives to use a cheaper treatment rather than the best treatment available. The Ugly: Value-based purchasing could easily tie into gainsharing programs, which AdvaMed has vehemently opposed. Ubl pointed to diabetes as an example of where an efficiency slide could occur. The New York Times recently published an article that discusses the high cost of treating diabetes. With a value-based purchasing system, physicians may be reimbursed for providing treatments that increase the quality of care for diabetes. However, if it standardizes product selection, substandard products may become the preferred devices. Industry must not allow substandard products to become the standard of care.
It's possible the test could eliminate a number of ICD candidates, which would be bad news for Medtronic, Inc., St. Jude Medical Inc., and Boston Scientific Corp., which is soon to acquire Guidant Corp. But it could also show that patients not considered as candidates for an ICD should have one. Either way, this should be a useful tool to help doctors and patients reach a decision.
SPOTLIGHT
A low-pressure gas-plasma system is available for surface modification and ultrapure cleaning of medical components. The A400 gas-plasma system has a 16 × 16 × 19–in. aluminum chamber, is cleanroom compatible, and is available in both tabletop and tall freestanding cabinet versions. Gas introduction via mass-flow controllers and magnetic valves ensures precise gas measurement. Programmable logic control with error monitoring, recipe storage, and operator lockout ensures process repeatability. Plasma generation is via microwave frequency, resulting in low process temperatures and maximum chamber use, since no internal electrodes are required. Typical applications include surface modification of polymers prior to bonding, printing, or coating; attachment of chemical functional groups to enhance surface receptivity; and ultrapure cleaning of metals, ceramics, or polymers.Coating services
A company offers standard as well as custom coating services to OEMs. The firm is a licensed applicator of Teflon and Whitford Worldwide coatings, and also manufactures its own CRC brand of fluoropolymers. Services range from project definition and design to quality control and just-in-time delivery. High-volume, flexible manufacturing capabilities allow production of both small quantities and larger weekly releases quickly and cost-effectively, according to the company.
Boyd Coatings Research Company, Inc., Hudson, MA
www.boydcoatings.com
Repeatable stent-coating system
A spray coating process system is well suited for medical devices where small particle sizes, surface quality, and coating weight consistency are crucial. The equipment may be used with various polymer solutions to produce drug-eluting stents, among other devices. The equipment includes process controls and precision-engineered microatomizers that enable the desired coating amount to be homogeneously and repeatably applied to a substrate in a single coat, resulting in savings in production time and less product scrap and coating waste compared with multicoat processes.
Ioos systems LLC, San Diego, CA
www.ioossystems.com
Surface treater
A high-performance surface treater provides a safe and effective means of cleaning surfaces and raising surface energy to promote the adherence and bonding of a wide variety of materials. It effectively removes grease, oil, oxides, and silicone as a pretreatment and preparation for bonding, soldering, or gluing. It can be used on both conductive and nonconductive surfaces. The Dyne-A-Mite IT delivers a high-velocity stream of charged ions to an object’s surface. Through direct contact, these particles positively charge the object’s surface, increasing its surface energy and making it more receptive to inks and coatings.
Enercon Industries Corp., Menomonee Falls, WI
www.enerconind.com
Antimicrobial coating
An antimicrobial coating prevents the growth of commonly occurring organisms such as E. coli, staph, and candida on medical devices such as urinary stents and incorporates lubricious polymers, effectively reducing tissue trauma and toxicity. The RepelaCoat material is extremely durable and retains its physical integrity even after hundreds of cycles.
AST Products Inc., Billerica, MA
www.astp.com
Dry-film lubricants
Dry-film lubricants are suitable for metal, plastic, and ceramics. Packaged for dip or spray applications, these ozone-safe coatings can lubricate catheters, cutting tools, staplers, hypotubes, and complex assemblies into which components must slide smoothly. The microdispersion lubricants deposit thin, smooth films without streaking. This improves the feel of the device and also facilitates assembly, particularly in automatic systems.
Micro Care Corp., Southern Pines, NC
www.vertrelsolvents.com/dryfilm
Anodizing services
A surface treatment has been developed for aluminum. The Ano-Med finish has been engineered to have small porosity to prevent entrapment of microorganisms. The finish withstands ultraviolet light, salt spray, and heat exposure, as well as Sterrad sterilization cycles and chemical sterilization.
Highland Plating Co., Los Angeles, CA
www.highlandplating.com
