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FDA Chief Nominated, but Hearing Timetable Uncertain

The Associated Press reports that two Democratic senators, Hillary Clinton of New York and Patty Murray of Washington, will put the nomination on hold until the agency decides whether to allow Plan B, an emergency contraceptive pill, to be sold over the counter. That has been a political football for some time now. It's too bad that von Eschenbach will be kicked around, too, because of it.

Semiconductor Firms Partner to Build Next-Generation Medical Devices


INDUSTRY NEWS


Semiconductor Firms Partner to Build Next-Generation Medical Devices

Corinne Litchfield

A provider of structured application-specific integrated circuits (ASICs) has teamed up with a maker of semiconductors to develop technology for use in medical manufacturing. ASIC maker

AMI Semiconductor (AMIS; Pocatello, ID; www.amis.com) and MagnaChip Semiconductor (Seoul; www.magnachip.com), a mixed-signal semiconductor manufacturer, have formed a partnership to create technology platforms for next-generation medical devices. As a result of the partnership, both companies say they will be capable of designing and manufacturing medical devices with more functionality, expanded memory, and high reliability.

The companies will first work on a 0.18-µm process targeted at medical applications requiring ultralow power and secure memory. Initial process development will take place in Magna Chip’s manufacturing facility in Cheongju, Korea, where employees from both firms will work together to improve the process. Pilot production is expected to begin sometime in the second quarter of this year.

Next-generation medical devices, such as those used for nerve stimulation in pain management, spinal cord injuries, and epileptic seizures, often require highly technical designs that result in the need for a specialized manufacturing approach. Other medical market segments, including cardiac rhythm management and continuous glucose monitoring, will also benefit from these new platforms, the companies say.

“We believe that this relationship will benefit the entire AMIS business, providing our business units the capability to design ICs with high gate counts,” says Chris King, president and CEO of AMIS. “In addition, it offers turnkey customers the next-generation, specialized process technology required to produce robust solutions for demanding medical applications.”

Copyright ©2006 Medical Product Manufacturing News

Some Relief for Patients with Recalled ICDs

This is certainly reassuring to those affected by the recalls from Guidant Corp. and Medtronic, Inc. It also shows that Guidant's difficulties with disclosing its devices' failures may have created more problems than they solved.

The (Orwellian?) Future Is Now for Patient-Data Chips

The firm is targeting Washington, DC to be the first large metropolitan area with multiple hospitals that can read the chip. If the chip can be read, it provides immediate identification of and medical records for patients who, for example, may have been admitted to the hospital unconscious. This technology is creating excitement because of its ability to speed care and prevent errors. It’s also a source of concern about privacy issues, as some wonder whether the ability to scan RFID from a distance will make unauthorized access to medical records easier, or whether the technology will otherwise be abused. Let’s hope the technology receives more publicity in the future, so patients have as much information as they need to make the right choice.

Durable Implantable Devices Materialize with Ceramics


INDUSTRY NEWS


Durable Implantable Devices Materialize with Ceramics

Shana Leonard
Ceramic coatings on devices such as this drug-eluting stent equip metal materials with ceramic properties.
Though the term ceramics may induce flashbacks of arts and crafts at summer camp, the material is emerging as a versatile resource for the medical device industry. Favorable properties such as corrosion resistance, low density, and hardness equip ceramics to withstand the harsh conditions of the body. The growing trend toward using the biocompatible materials in implantable devices may just be the shape of things to come.

One area in which ceramic use is expanding is hip-replacement implants. Conventional hip replacements consist of metal-to-plastic components. However, the friction of the components, especially those made from polyethelene, produces debris. In turn, the debris causes inflammation, which reduces the efficacy of the product over time. This results in the need for revision surgery after roughly 15 to 20 years.

Component erosion rarely posed a problem in the past. Because patients requiring hip replacements tended to be elderly, their life spans were not supposed to outlast that of the implant. However, the demand for replacements from both younger patients and older people who continue their active lifestyles into retirement thrust revision surgery to the forefront of hip-replacement concerns.

Ceramic components may quell these concerns. “Studies have shown that ceramic particles produce less cell reaction than poly or metal particles,” says Keith Ferguson, business development manager for Morgan Technical Ceramics (San Mateo, CA; www.morgantechnicalceramics.com). “Loosening of hip joints may be caused by particulates generated in the implanted joint, so ceramic appears to be a favorable choice.”

Morgan Advanced Ceramics produces both Vitox implantable-grade alumina and Zyranox implantable-grade zirconia. According to the company, trials conducted on its HIP Vitox ceramic-on-ceramic hip joints demonstrated a wear rate of as little as 0.032 mm3 per million cycles.

Ceramic-on-ceramic hip replacements may produce less debris than implants having plastic or metal components.

“Ceramic is hard to beat!” says Ferguson. “Ceramic-on-ceramic coupling produces the lowest volume of particulates of any commercial coupling to date.” He also notes that polyetheylene-on-metal, cross-linked polyethylene-on-metal, and metal-on-metal implants may produce 100 to 1000 times more particles than ceramic-on-ceramic implants.

It may be too soon to gauge the effects of time on ceramic-on-ceramic hip replacements. But clinical studies monitored by FDA have indicated that

ceramic hip replacements produce negligible amounts of debris and have the potential to last significantly longer than their predecessors.

Despite the facts, many people remain skeptical of ceramic hip implants, resulting from a 2001 recall of one supplier’s zirconia-based components that experienced fracturing. However, most modern ceramic implants are constructed from alumina, which has demonstrated durability. Since FDA approval of complete ceramic-on-ceramic implants in 2003, there has been little negative backlash.

Currently, ceramic hip replacements are used primarily for younger hip-replacement candidates, or those who lead active lifestyles. Widespread acceptance of ceramic replacements is slow, due to their being relatively new to the market and more expensive than traditional replacements.

Ceramics’ presence in hip replacements is becoming increasingly noticeable, but use of the materials is emerging as a trend in other implants as well.

Regardless of their bioactive properties, ceramics are not always the best choice for an application. Yet nonceramic components and devices can reap the benefits of bioactivity through the use of ceramic coatings. Most commonly used on implants made from metallic alloys, hydroxyapatite coatings facilitate the bonding of bone to implants. The bone-bonding capabilities of hydroxyapatite are often credited with prolonging the life of hip and knee implants.

“We believe in the long-term biocompatibility of ceramics,” says Laurent-Dominique Piveteau, project manager for Debiotech SA (Lausanne, Switzerland; www.debiotech.com). “These are, most of the time, inert materials that have shown excellent behavior when implanted. By using them as thin coatings on a metallic substrate, we combine the best of two worlds: we have the mechanical properties of the metals, but the body is in contact with the stable ceramic.”

Debiotech has licensed a ceramic technology to produce the Debiostent, a drug-eluting stent that features a ceramic coating for biocompatibility. The company also attributes unique drug-absorption properties to the porous ceramic coating, thus establishing the material as suitable for some drug-delivery applications.

The firm plans on applying the coating to other implantable devices in the future. “We will be able to combine short-term drug delivery and long-term stability,” says Piveteau. “After implantation, the devices will locally release drugs over a few days or a few weeks. In the longer run, when the drug isn’t needed any more, we will have an implant that integrates easily into the body.”

Though the rise of ceramics in coatings and hip replacements is perhaps the most noticeable, ceramic use is becoming increasingly prevalent in components for other implantables. Greatbatch Inc. (Clarence, NY; www.greatbatch.com) produces a range of electromagnetic interference (EMI)–filtered hermetic feed-throughs. Feed-throughs are integral pieces in such implantables as pacemakers, cardioverter defibrillators, neurostimulators, and cochlear electronic devices, protecting these life-supporting devices from exposure to EMI. Feed-throughs and other ceramic implantables play vital roles in enabling normal lifestyles for patients with otherwise debilitating problems.

“Ceramics will continue to play a strong roll in implantables. In addition to hips, all other load-bearing joints are good candidates for ceramics, including the spine,” says Ferguson.

Beyond their use for implants, ceramics are impacting the medical device and manufacturing community through their use in various other devices. Piezoelectric ceramics are frequently employed in transducers for computed tomography and ultra-sonic imaging systems. Meanwhile, ceramic bearings for linear motion applications withstand harsh environments and meet stringent manufacturing requirements issued by FDA.

From components to coatings, the employment of ceramics in implantable devices is a growing trend in the industry. Proving that they aren’t just for vases, ceramics are improving the quality of life and extending lives.

Copyright ©2006 Medical Product Manufacturing News

Heart Device Could Treat Migraines, but to What Extent?

A trial in Great Brtain found the device could reduce the frequency and severity of migraines, but not prevent them, as investors had hoped. StarFlex is approved for treating a congenital heart defect called patent foramen ovale, or PFO, in which a flap of tissue is pushed open when a patient is under stress. The British study shows that there is probably a link between PFO and migraines. What exactly it is, and to what extent StarFlex can help, will be the subject of future studies.

Latest Cypher-Taxus Battle a Wash

Both were found about equally superior to radiation therapy, and both were found to be similarly effective in diabetics. Expect more head-to-head studies in the future as each firm looks for whatever competitive advantage it can get.

National Cancer Institute Strives for Goal with Nanotechnology

NANOTECHNOLOGY

National Cancer Institute Strives for Goal with Nanotechnology

Shana Leonard

In 2003, the National Cancer Institute (NCI; Bethesda, MD; www.cancer.gov) director Andrew von Eschenbach, MD, stated the organization’s Challenge Goal to the Nation: to eliminate the suffering and death due to cancer by 2015. In a nation that attributes more than half a million deaths each year to the disease, this is a challenge.

Curing cancer in the next decade may seem overly idealistic, but it is not infeasible, thanks to nanotechnology. Developments in the field may pave the way for a variety of nanodevices purposed for the detection, treatment, and prevention of cancer. If carried out from concept to completion, nanodevices may help curb instances of cancer and, ultimately, cure the disease.

NCI has taken a number of steps in an effort to secure its goal. Heavy funding for the NCI Alliance for Nanotechnology in Cancer enables focused R&D. In addition, the institute has drafted a comprehensive cancer nanotechnology plan, which identifies specific objectives and goals. The institute has also assembled a multidisciplinary team, which brings expertise in cancer biology, clinical oncology, engineering, and physical sciences, with hopes of facilitating progress.

Progress may come in the form of such proposed nanodevices as nanopores, nanoshells, and dendrimers. Nanopores could improve DNA sequencing to detect anomalies in genes, while nanoshells could destroy cancerous cells without harming healthy neighboring cells. The dendrimer embodies the ideal nanodevice, as it would theoretically carry out multiple tasks. Capabilities would include recognizing, killing, and the subsequent status reporting of cancer cells.

Among NCI’s most significant expectations are clues about tumor development, which may lead to improved methods of cancer detection and early treatment. “Our public health dilemma right now with most solid tumors is not being able to find disease before metastatic spread,” says Gregory Downing, MD, director of the office of technology and industrial relations for NCI. “The biggest impact could be on solid tumors, where we have nothing that provides us with sentinel vision of the disease before it’s too late.”

Understanding how cancer develops is one of the primary objectives of NCI. However, treatment and prevention of recurrence remain pressing issues as well. Nanotechnology-based probes and biosensing capabilities will allow physicians to more accurately assess just how aggressively to treat patients, according to Downing.

Cancer treatment is the area in which NCI anticipates the quickest results from nanotechnology. The organization speculates that nanoparticle-based drug-delivery systems and sensing or reporting systems will lead to targeted drug delivery to cancerous cells. Targeted drug delivery may prove less toxic than currently available chemotherapeutic agents, says Downing.

Despite advancements in manipulating nanotechnology for cancer-related research and development, several hurdles remain in NCI’s path to its goal. Obvious difficulties arise when working with parts invisible to the naked eye. Identifying parameters so that experiments can be reproduced and understanding interactions between physical materials and living systems are two of the challenges that researchers face, according to Downing.

Obstacles are apparent outside the lab as well. Nanotechnology has garnered criticism in terms of ethics and safety. As is the case with many governmental and nonprofit organizations dealing with nanotechnology, NCI underscores the need to properly educate the public. Though NCI and Downing admit that the effects of nanotechnology inside the body are still unknown, as is the toxicity of materials used in nanotechnology, they are quick to provide assurance that safe practices will be enforced.

The discrepancies that arise with nanotechnology research were the impetus behind establishing the National Characterization Laboratory (NCL). The NCL is responsible for crafting a universal vocabulary for nanotechnology in order to facilitate research. Also, the organization serves as a nanotechnology hub of sorts, providing a central resource for parameters and research so that scientists can build upon existing results or repeat experiments with ease.

Because of its extremely small components and complex technology, nanotechnology has yielded few concrete results as of yet. However, Downing points out that even if some concepts are not accomplished, the intense R&D is invaluable.

“To be candid, I think we need to see a real fundamental breakthrough in one element of cancer, that we couldn’t or can’t do with contemporary biology,” he says. “If there isn’t some sort of transformational aspect in which this has some impact on clinical medicine, I think we will have explored in depth the capabilities that these materials provide. I think that we would like to see what impact biology can have to help drive technology development.”

But if the plans fueled by nanotechnology do pan out, the results could have a global impact. Though attaining NCI’s goal may seem like a pipe dream now, nanotechnology may prove to be the factor that transforms the dream into a reality.

Copyright ©2006 Medical Product Manufacturing News

British Fabrication Tool Enables Nanomaterial Growth

NANOTECHNOLOGY

British Fabrication Tool Enables Nanomaterial Growth
Shana Leonard
A tool enables the growth of carbon nanotubes at low temperatures.
From cancer research to electronics, carbon nanotubes are believed to be at the foundation of many high-tech applications made possible by nanotechnology. However, few ways of growing them currently exist. One method of nanotube growth can raise substrate temperatures to more than 1000°C, but this can compromise the quality of the material. In response to this dilemma, two entities have collaborated to produce a low-temperature fabrication tool for nanotube growth.

A partnership between CEVP Ltd. (Newhaven, East Sussex, UK; www.cevp.co.uk) and the University of Surrey’s Advanced Technology Institute (Guildford, Surrey, UK; www.ati.surrey.ac.uk) afforded the development of the NanoGrowth tool. The product will enable scientists and engineers to grow carbon nanotubes with repeatable results at temperatures below 100°C.

Growing carbon nanotubes at low temperatures is possible due to the tool’s use of a thermal control system that maintains the growth substrate at room temperature, according to the company. The machine can also function at conventional high temperatures, if desired.

“Most products and applications involving carbon nanotubes are still in the research phase,” says Ben Jensen, technical director at CEVP. “So, we are confident that by giving this capability to developers, this will allow integration of carbon nanotubes into products far faster than previously was possible.” Medical imaging, implantable sensor technology, microdrug delivery, and lab-on-a-chip components are among the medical applications that may benefit from carbon nanotubes.

The product may even facilitate growth of other nanomaterials, including silicon and tungsten oxide nanowires on suitable substrates, according to CEVP.

Current material growth is limited to 3-in. wafers and substrates. However, the company predicts that its process will be capable of running on 6-in. wafers by March 2007, says Jensen. And by August 2008, the firm’s goal is to have achieved stable and repeatable growth on 12-in. substrates, he adds.

The firm forecasts that the NanoGrowth tool will spur the commercialization of carbon nanotubes. Several groups have configured tools for nanotube growth in labs, unavailable for commercial use. Others have converted PECVD and diamond deposition tools to perform nanotube growth for profit; but these tools have limited capabilities at low temperatures, according to Jensen. “We believe that this is the first commercially available tool that is capable of high-precision aligned carbon nanotube growth on temperature-sensitive substrates,” he says.

And the tool’s design reflects market sensibility. The unit has a tool package and recipes for nanotube growth. Users can follow the recipes, modify them, or ignore them and set their own parameters. The tool is also equipped with NanoSoft, the company’s touch-screen supervisory control and data acquisition interface and control software.

The NanoGrowth tool signifies nascent steps in integrating nanotechnology into actual products.

“We hope it will [give] scientists and engineers a way of taking carbon nanotubes out of the lab and finally putting them where they should be: in next-generation technology,” says Jensen. “I know that this is a bold statement, but so far this material has offered so much potential across a wide range of industries. But because of manufacturing and processing issues, the results still have a long way to go before the material’s full capabilities are realized,” he adds.

Currently undergoing trials, the NanoGrowth is slated for release in March 2006.

Copyright ©2006 Medical Product Manufacturing News