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Articles from 2009 In January

Peptides vs. Superbug: The Ultimate Showdown?

Image Credit: University of British Columbia

Image Credit: University of British Columbia

High rates of infection stemming from surgical implantation are causing device manufacturers to scramble for bacteria-fighting coatings and additives to incorporate in their products. Researchers at the University of British Columbia (UBC; Vancouver) have discovered that synthetic-form, short, tethered, cationic antimicrobial peptides have demonstrated efficacy at killing bacteria that come into contact with them. Naturally occurring peptides, or 'nature's antibiotics,' combat bacteria in humans and animals and are located in various cells and tissues. Mimicking these proteins, the researchers created the cationic peptides as soluble antibiotics for use in coating implants. The distinguishing characteristic of these peptides is that they are active when tethered to a surface, whereas some peptides that are successful antibiotics in solution are not effective when applied to a substrate, according to Robert Hancock, principal investigator and Canada Research chair in pathogenomics and antimicrobials at the UBC Department of Microbiology and Immunology. In recent years, the rise of the antibiotic-resistant 'Superbug' has made treatment of implant-associated infections increasingly difficult. The UBC researchers believe that applying short-tethered cationic antimicrobial peptides to implant surfaces could provide a nonantibiotic solution to inhibiting bacterial growth on devices. An in-depth explanation of the research appears in the January 30 issue of Chemistry and Biology.

Methods Machine Tools Turns 50

In 2009, Methods Machine Tools (Sudbury, MA) will be celebrating its 50th anniversary. Since its humble beginnings in 1958 as a three-person operation equipped with only a few refurbished machines, the company has swelled to employ more than 300 people, expanded to include seven facilities and technology centers, and installed more than 27,000 systems. Among the company's offerings are EDM machines, five-axis machining centers, multitasking CNC lathes, and robotics. Throughout this year, Methods Machine Tools will be marking this milestone at various industry events and through various promotions. The celebration will culminate in a three-day Methods Milestone open house event from September 15–17.

EaglePicher Medical Power Moves to Texas

EaglePicher Medical Power supplies batteries for implantable medical devices, such as its Micro Cell battery, which can be deployed via a minimally invasive catheter.

EaglePicher Medical Power supplies batteries for implantable medical devices, such as its Micro Cell battery, which can be deployed via a minimally invasive catheter.

EaglePicher Medical Power LLC, an EaglePicher company, is in the process of moving its headquarters to Plano, TX. The company supplies primary and rechargeable batteries for implantable medical devices. Previously located in Joplin, MO, the supplier plans to open its new facility in March 2009, complete with a state-of-the-art research and development center. The 20,000-sq-ft center will house laboratories and equipment for testing and manufacturing lithium batteries. The Texas location was chosen to help the company better focus on the markets it serves and to provide room for growth. Having experienced an increase in growth and innovation in recent years as a result of demand for smaller, lighter-weight, more-advanced batteries, the company also plans to open a manufacturing plant at the Plano headquarters in the future. It currently operates two manufacturing facilities and one R&D center in Joplin. The company's batteries are suited for use in such medical devices as pacemakers, ICDs, heart monitors, pain-management devices, cochlear implants, and neuromodulation systems. It offers a range of electrochemistries for implantable applications, including lithium-ion, lithium manganese dioxide, lithium thionyl chloride, and lithium carbon monofluoride.

Scientists Develop Cancer-Killing Polymer Implant

Harvard University scientists have invented an implant that attracts and trains cells to kill cancer. An immunotherapeutic approach, the technique uses polymer material to induce the body‘s immune system to recognize and destroy tumors. Immunotherapy usually removes immune—or dendritic—cells from the body, exposes them to chemical activators and cancer-specific antigens, and then reintroduces them into the patient. However, most dendritic cells die when they reenter the body. Confronting this problem, a team led by Harvard bioengineering professor David Mooney constructed a polymer that attracts dendritic cells by releasing a kind of chemical signal called a cytokine. The cells then enter spongelike holes in the polymer, where they become active. While attracting cancer-specific antigens to train the dendritic cells, the polymer is also covered with fragments of DNA whose sequences are typical of bacteria. When cells grab on to these fragments, they become highly activated, causing them to act as if they are in the midst of an infection. In cancer situations, tumors prevent the immune system from generating a strong response, but the simulation of infection provides the strong response required to kill tumors. Mice with a deadly form of melanoma that have undergone Mooney‘s experiment have achieved a survival rate of 90%. In contrast, conventional immunotherapies that require treating dendritic cells outside the body are only 60% effective. If Mooney‘s approach proves successful in humans, the polymer device may achieve faster FDA approval than cell therapies do, which face steep regulatory hurdles. The polymer material has been used safely in humans—for example, in biodegradable sutures. Predicting that safety tests involving large animals (the step before human trials) will progress quickly, Mooney expects to begin clinical trials of the cancer immunotherapy soon. A more-detailed account of this immunotherapeutic approach is available at

Contract Manufacturer Offers Regulatory Submission Program

Contract manufacturer BC Tech, which specializes in Class I, II, and II devices, now offers a regulatory submission program.

Contract manufacturer BC Tech, which specializes in Class I, II, and II devices, now offers a regulatory submission program.

Product development and contract manufacturing services provider BC Tech (Santa Cruz, CA) has expanded on its current capabilities to offer a regulatory submission program. Designed to make the most of quality assurance measures already in place, the program runs parallel to the company's development and manufacturing processes to anticipate regulatory milestones so that products can be properly submitted and then approved. This format is supposed to help reduce regulatory costs and time to market, according to the company. The program includes assistance with FDA 510(k) and PMA submissions, investigational device exemption applications, and relevant product safety certifications. In addition to risk analysis, the company offers documentation for design controls, prototyping, verification procedures, and manufacturing operations. Experienced in producing Class I, II, and III devices, the company employs manufacturing groups that specialize in mechanical engineering, industrial design, electronics, software, and bioresearch.

Advice to Device Makers: Be Like Barack

Such criticism, although not without merit, is easily explained as a necessary tradeoff. An approval system that is relatively fast means that life-saving devices get to patients more quickly. More troubling are reports of letters written by FDA scientists to various law makers, most recently to the Obama administration. In those letters, the scientists accuse FDA managers of bullying, coercion, and worse, in order to push through approval of certain devices. They imply that the managers are in league with device manufacturers, or that those managers are themselves bullied by lawmakers into forcing a quick decision. Another seeming indicator of FDA's lax stance on devices is the abandoned plan to write rules and firm deadlines for the testing of all Class III devices. This delay allows many Class III devices to be passed with minimal testing. The GAO released a report recommending that FDA to fix its process for approving complex medical devices. An op-ed piece from the Times today reviews these arguments, concluding that, "Given its sorry performance in so many areas important to public health and safety, [FDA] is ready for a major overhaul." So what can device makers do to avoid criticism, or to defend itself should the spotlight turn away from FDA and onto OEMs? Be dull. Media attention is best stemmed by being too boring to cover. Or you could take a lesson from President Obama and be so charming, so logical, and so level-headed that the New York Times can't help but love you. Heather Thompson

Xtent to Layoff Nearly All Workers

In the meantime, the manufacturer of drug-eluting stents is seeking the help of an investment bank in order to pursue some kind of strategic deal to "maximize the value of our assets." Xtent's market value is estimated at less than $5 million and this low price could potentially pique the interest of larger players like Boston Scientific or J&J.

Glucose Sensor: Coolest Tattoo Idea Yet

A cell glows red after being injected with nanosensors that fluoresce in the presence of sodium. Credit: Heather Clark, Draper Laboratory

A cell glows red after being injected with nanosensors that fluoresce in the presence of sodium. Credit: Heather Clark, Draper Laboratory

Tattoos are all the rage these days. But scientists at Draper Laboratory (Cambridge, MA) are working toward the development of a different sort of "tattoo"—one that will monitor diabetics' blood-sugar level. Headed by Heather Clark, analytical chemist and task leader of Draper's biomedical engineering group, a team of researchers is working to develop a biosensor that can be injected into the skin much like tattoo dye. Under infrared light, the device will fluoresce, informing diabetics whether or not they need to inject insulin following a meal. The monitoring technology will fall somewhere between noninvasive sensors for detecting glucose through the skin via infrared light and implanted devices for continually monitoring blood sugar and dispensing insulin. The concept consists of 120-nm beads coated with a biocompatible material. Each bead contains a fluoroescent dye and sensor molecules that are designed to detect specific chemicals such as glucose and sodium. When injected into the skin, the sensor molecule pulls the target chemical into the polymer from the interstitial fluid that surrounds the cells. To compensate for the newly acquired positive charge of a sodium ion, for example, a dye molecule releases a positive ion, causing the molecule to fluoresce. The level of fluorescence increases with the concentration of the chemical target. Scientists can employ different recognition molecules to measure different targets, including chloride, calcium, and glucose. The video below shows sodium rushing into heart-muscle cells grown in a dish. As happens during a normal heartbeat, sodium flowing into the heart coincides with contraction and modulates the sensors‘ fluorescence (video by Heather Clark, Draper Laboratory). The technology is unique, explains Clark, "because it doesn't have any components to be used up." Glucose strips, for example, detect glucose using an enzyme that must be replaced continually. "Other monitors, even nanosensors, have a limited lifetime, which makes implanting them difficult." The researchers have already conducted successful animal tests of a sodium-sensing version of the nanosensor that may eventually be used to monitor dehydration. When injected into the skin of mice, the polymer beads fluoresce in response to saline injections. While the glucose monitor has been shown to work in a solution, animal tests are still pending. Although the technology looks promising, the researchers have much work ahead of them before the sensor is ready for human testing. While the beads didn't appear to trigger an immune reaction in initial animal tests, notes Clark, more studies must be performed. In the meantime, Clark projects that a future sensor may be injected into the surface layers of the skin, shallower than tattoo inks, "so that it sloughs off over time." A fluorescence monitor resembling an optical mouse would then be used to measure the light emitted by the tattoo, and the sensor would be reinjected periodically.

AdvaMed's Ubl Straightens Out NYT Device Coverage

on Device TestingâEUR incorrectly characterized the device review process as "lax." In the published letter, Ubl says: FDAâEUR(TM)s premarket review process involves extensive review of specifications and performance-testing information, and in many cases clinical data, before being made available to patients. For the higher risk devices, FDA requires comprehensive clinical data for approval. The Government Accountability OfficeâEUR(TM)s report on FDAâEUR(TM)s review process, the focus of the article, limited its comments primarily to a small subset of 20 devices that the FDA has yet to classify, not the review process as a whole. In fact, the GAO report demonstrates that FDAâEUR(TM)s process is working as intended so that all devices are subject to the appropriate level of regulation to ensure their safety and effectiveness.

Bioscience Industry Boosts Oregon Economy

The study shows that the sector contributed nearly $3.5 billion in direct revenue, more than 13,630 jobs and $800 million in biotech workers' personal income to the state economy in 2007. The comprehensive analysis, conducted by ECONorthwest, shows that those employed in the bioscience sector fared substantially better in take-home pay than other workers in Oregon. "With its continued and anticipated growth curve in Oregon, the data show that biotech is likely to beat the current recessionary trends," says Nathan Gibson, vice president of business development for Skanska and chair of the board for the Oregon Bioscience Association. "The significant multiplier effect illustrates the true impact of the growing cluster in this state, and now we know its impacts are profoundly more extensive than many knew."