(Cost issues are the one negative.) But Taylor cautioned that the fate that has befallen the pharmaceutical industry could strike devices as well. Pharma went from a "good job" rating of 79% in 1997 to 44% in 2005. And the seeds are there for an approval drop for medical OEMs. Only 26% of the general public believes that the device industry is effective at communicating important health care issues. Only 21% say they would give it the benefit of the doubt if it came under media pressure. Only 20% believe industry accepts accountability for its actions. This perception has to change. At the end of the event, a panel of FDA and industry leaders discussed this very issue. One of the things agreed upon was that, while covering up adverse events is wrong, so too is releasing information when not enough facts are known about the overall problem. This could cause an unsubstantiated media frenzy, which, given the perceptions that already exist, could destroy consumer confidence in devices. We don't need a repeat of what's happened to Big Pharma.
In fact, nanotechnology may be one of the few topics both President George W. Bush and Senator Hillary Rodham Clinton agree on.
In 2003, Clinton cosponsored the 21st Century Nanotechnology Research and Development Act. The act, which was passed and signed into law, authorized programs for nanoscience, nanoengineering, and nanotechnology research.
And the President’s 2007 budget provides more than $1.2 billion for the multiagency National Nanotechnology Initiative (NNI).
This brings total investment in the NNI to more than $6.5 billion, nearly triple the budget it received when it was established in 2001.
With all the media coverage, no doubt most people have at least heard of nanotechnology. Still many people can’t quite wrap their heads around the concept.
Chris Phoenix, director of research for the Center for Responsible Nanotechnology, tells a story about an e-mail message he received on the center’s Web site. First, the writer complimented the site as being very informative. Then he asked whether any dangers associated with nanotechnology might apply to his new Apple Nano iPod.
He’s not the only person out there who is confused about nanotechnology—which is why we’ve put together a special section about its uses in the medical device industry.
Starting on page 30, you’ll find an article that gives a broad overview of some of the issues facing nanotechnology. Several stories follow that describe how nanotechnology is being put to work in healthcare and related fields. We’ve also included a roundtable interview with nanotechnology experts Phoenix, Mansoor Amiji, and Christine Peterson.
There is still plenty of room at the bottom. The use of nanotechnology is surely going to expand in our industry. We’ll be there to cover it, and we welcome your input and suggestions for future issues.
EPI’s multilayer manifold is designed for use in harsh chemical environments.
The multilayer design uses a proprietary bonding process. Diffusion bonding is used to adhere a carbon-filled PFA layer to a virgin, unfilled PFA layer. This process can create internal flow paths and chambers without the use of solvents, adhesives, or gaskets. The integrated fluid paths minimize connections and solution volumes while also eliminating leak points. These features combine to reduce production costs and improve user satisfaction, says EPI.
EPI offers custom PFA manifold development to instrument OEMs. Surface-mount valves, pumps, sensors, fittings, and other components can be included in the manifolds. The PFA material is translucent, which allows viewing of the fluidic channel.
PFA material combines properties of PTFE and FEP. According to the company, PFA outperforms both materials in continuous-use testing.
Instrument manufacturers can now have the company’s manifolds designed with chemically resistant valves and other surface-mount features. The resulting units give manufacturers an integrated fluid control plug-and-play assembly. The firm also makes multilayer bonded manifolds from other thermoplastic materials.
Also on the agenda is a "Healthcare Opinion Leaders Symposium," with speakers like Gail Wilensky, former HCFA administrator and former advisor to President Bush on health issues. Wilensky frequently testifies before congressional committees and acts as an advisor to members of Congress and other elected officials. Perhaps we'll get some insight as to what these opinion leaders have to say about some of the device industry's biggest issues. On the other hand, these are some big names, but most of the action will likely take place behind the scenes.
Prefabricated modular cleanrooms are suited for Class 100 or better conditions.
Prefabricated and preengineered, the cleanrooms are easy to assemble and offer a less costly alternative to conventional cleanroom construction, according to the company. Modules are comprised of heavy-gauge steel panels that are welded together and feature reinforcement bracing. The cleanrooms require a solid, level floor for support.
Available in a range of sizes, the cleanrooms offer flexibility. Because of the ability to add panels or disassemble the modules, the freestanding rooms can be reconfigured for expansion or relocation.
“With a prefabricated room, there is reduced engineering time, reduced engineering cost, and the rate of manufacture can be faster,” says Kevin Weist, president of Clean Air Products. “It comes into a facility and just requires assembly; there is less on-site construction time, less on-site construction mess. It has the ability to be disassembled and moved or relocated, so one does not lose the capital investment within a space.”
Designed with a high concentration of ceiling filters, the cleanrooms are suited for Class 100 or better conditions. The units feature HEPA-filter ceiling banks in addition to a HEPA-N-SEAL double-gasket seal to prevent leaks. The final filter is close to 100% effective on particles as small as 0.3 µm; some competing cleanrooms start at only 50% coverage, says Weist. The cleanrooms provide high air change per hour and good uniformity of flow, he adds.
Additional cleanroom features include humidity control to ±2% relative humidity, as well as temperature control ranging from comfort cooling to precise settings at ±0.5°F. The firm also offers customized features.
Imaging services would absorb more than one-third of Medicare cuts if the bill were to stand unchanged. This underscores how shortsighted Congress can be, and how much work industry has to do to get Washington to appreciate the true value of medical technology.
Adhesives can be cured using visible instead of ultraviolet light with a new system from Henkel Corp.
of Alameda, CA.) It's understandable for a newspaper to focus on the surgeon, patient, and hospital, as those are details its readers would want to know. But none of this would have happened without the R&D efforts of St. Francis. If the mainstream media is so quick to idenitify companies when they are accused of misconduct, it should be equally quick to identify them when they are responsible for medical breakthroughs. It's only fair.