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Articles from 2009 In April


Magnetic Beads Find Blood Poisoning Attractive

An experimental method for treating blood poisoning, or sepsis, is being tested at Children's Hospital (Boston). Based on the use of magnetic beads and magnets to draw out harmful organisms from infected blood, the therapy holds promise for curing a condition that kills approximately half of its victims—often within a few hours. The treatment relies on tiny magnetic beads coated with an antibody for attracting the bacteria invading the blood system. First, the blood is removed from the body through a small tube made from a fine, meshlike material, beside which is another tube with salt water flowing through it. After removal from the body, the blood is mixed with the magnetic beads, which attract passing bacteria. Then an external magnet is activated, pulling the beads and the bacteria through the mesh wall into the salt water. Finally, the clean blood is pumped back into the body, while the bacteria are discarded. Sepsis develops rapidly when bacteria get into the body through wounds or infections in the ears, lungs, or urinary tract. Particularly dangerous to the very young, the elderly, and the sick, the ailment is caused by toxin-producing organisms that damage cells. Some of the organisms attack the walls of small blood vessels, causing them to leak and resulting in a severe drop in blood pressure. Starved of blood, major organs begin to shut down. By gradually removing the patient's blood and treating it outside the body, the new method for curing sepsis aims at preventing the overproduction of cytokines, proteins generated by the immune system that are supposed to ward off infection. However, in the case of sepsis, such large quantities of cytokines are produced that they not only attack dangerous bacteria but healthy cells as well. This reaction, in turn, causes inflammation deep within the body. Don Ingber, a doctor who helped develop the technology, remarks, "It offers a potentially new weapon to fight pathogens in septic children and adults. It works simply by removing the source of the infection."

NRC Canada Reinvests in R&D

Responding to the need to increase revenues and productivity in Canada's manufacturing industries, National Research Council Canada (NRC; Ottawa, ON, Canada) has launched what it is calling an R&D strategy to boost innovation in the next couple of years. Investing more than $6 million in the project from 2009 to 2012, the council outlined its R&D plans in the Spring issue of its quarterly publication NRC NewsLink, explaining that one of the council's main objectives is to strengthen the global competitiveness of Canada across the supply chain. In the current economy, many manufacturers are suspending R&D efforts just to survive, explains council president Pierre Coulombe in his President's Outlook column in the same issue. "But reduced R&D today means less opportunity tomorrow. R&D can't be cosidered a luxury, not in this economy," he writes. "We need to use all the resources at hand to help Canadian manufacturers innovate today and compete among the world's best." Following his lead, the council has put together a team of experts from several of its institutes to focus on developing new materials and enhancing processing technologies. Researchers will work to create lighter, safer, more-affordable, and environmentally friendly materials, according to the council. These will include polymer blends, foams, composites, films, nanomaterials, ceramics, and specialty metals. The team also will try to help minimize energy consumption, waste, and greenhouse gas emissions associated with such processes as machining, robotics, automation, joining and surface technologies, molding, and nanoscale manufacturing of polymers and metals. The initiative is supposed to benefit primary materials producers, engineering firms, machinery manufacturers, and component producers in Canada so that they will be better equipped to compete globally. It also aims to develop decision-aid systems to improve manufacturing quality, efficiency, and environmental safety. To do so, researchers will work to advance computational and sensing technologies that incorporate modelling, simulation, and interaction hardware, according to NRC. Coulombe also detailed in his article several current government incentives and investments that will help Canadian manufacturers retool and boost their productivity for long-term success. These efforts will help companies continue to put money into R&D, even if that innovation does not lead to immediate profitability, he writes. "We must shorten the timeline for innovations to flow from the lab to the marketplace so that companies see a quicker return on investment. Putting NRC's expertise to work on these areas of R&D will generate good economic returns."

Harmonizing China

Department of Commerce and China's State Food and Drug Administration (SFDA) have agreed to harmonize standards for medical devices being developed, so that China can become a more successful player in the medtech sector. In the talks, the two parties discussed ways to further streamline ChinaâEUR(TM)s device registration process. ChinaâEUR(TM)s SFDA delegates explained their countryâEUR(TM)s new adverse event reporting regulation.

Pizza Tossing Puts New Spin on Micromotor Design

Australian researchers found that studying professional pizza tossing could enable better motor design for medical applications.

Australian researchers found that studying professional pizza tossing could enable better motor design for medical applications. Image: Monash University.

A team of researchers at the MicroNanophysics Research Laboratory at Monash University (Clayton, VC, Australia) is tossing out a new concept: Taking a cue from professional pizza tossing could lead to the design of better micromotors for surgical applications. In a recent study, the researchers examined pizza-tossing techniques by professional chefs, predicting that the specific motion used could impact such factors as effort, speed, and ease of handling. They were able to break the movement of the tossed disk down into four phases: parabolic flight, impact, sticking contact, and sliding contact. During their investigation, the scientists also found that advanced chefs are often able to perform multiple tosses of the dough, which is when a person is able to do multiple tosses before the dough comes to rest in his or her hands. This advanced technique typically entails a helical motion for the first toss followed by a semielliptical motion for subsequent tosses. It's also similar to the operation of standing wave ultrasonic motors (SWUMs) because they both convert reciprocal input into continuous rotational motion using the same mechanism, according to the researchers. SWUMs function by employing friction caused by the ultrasonic vibration of a stator, which is designed to perform elliptical motion, to spin a rotor. Through this study, however, the researchers have discovered that the reason for this elliptical motion could be different than originally thought. This insight could, according to the researchers, lead to better motor operation. "Our work is focused on developing effective microactuation technology—devices and physical understanding of phenomena at the micro- to nanoscale that can be used to deliver controlled and powerful motion for microrobotics, mainly for surgery," says James Friend, coauthor of the study. "This study's greatest achievement is that it answers may of the more perplexing questions in how ultrasonic piezoelectric motors actually work: Why does the choice of materials in them not work as expected? Why do they make such unbearably loud noises when improperly designed? Why do the rotors not spin as expected, and so on."

Artificial Larynx Nears Trial Stage

So far, ProTip has validated the biocompatibility and cell colonization of the porous titanium used in the implant. It also recently started marketing a thyroplasty prosthesis for laryngeal surgery and is in the final design phase of its phonatory implant. In addition to throat applications, ProTip is developing porous titanium implants and prosthesis for the ear and nose.

Good News from the Buckeye State

Northeast Ohio's biomedical sector is booming. At least that's the word from the brand-new edition of the quarterly Cleveland Plus Economic Review, issued by Team Northeast Ohio (Team NEO; Cleveland). According to the review, the gross regional product for the area's biomedical sector—which includes pharmaceuticals and therapeutics, medical devices and equipment, and R&D—has grown at an annual average rate of 7.4%. Outpacing average biomedical industry growth in the nation as a whole, the region's biomed field is being fueled by a strong healthcare sector, the area's long history of skilled manufacturing, and the inflow of venture capital from outside the state. Over the past five years, the region's biomedical industry has grown more than 37%. While manufacturing has historically played an important role in the economy of Northeast Ohio, the region's manufacturing focus has shifted. In the past five years, the medical device and equipment sector has grown 75%. For example, prior to 2003, Astro Manufacturing & Design Inc. (Eastlake, OH), a full-service contract manufacturer that serves the implantable medical device and medical equipment markets, derived more than 50% of its revenue from the automotive industry, remarks Rich Peterson, the company's vice president of business development. "By the end of 2008, we had evolved our production to the point that more than 60% of our revenue comes from work done for customers in the medical and biomedical markets.” Since 2005, Ohio has received $783.9 million in new venture capital funding. In 2008, it received nearly $200 million in such funds, in addition to $600 million in grants from the National Institutes of Health (NIH; Bethesda, MD), making the state the second largest recipient in the Midwest of outside venture capital and biomedical funding. The Cleveland area alone in 2008 received $150 million in venture capital funds and $250 million in NIH grants. The growth of Northeast Ohio's biomedical sector has been driven in part by the emergence of new companies. Since 2007, 10 of 22 new companies recruited by Team NEO have been in the biomedical field. Joining Team NEO in the recruitment of new companies—including spin-offs and start-ups—are the state's Department of Development (Columbus, OH), BioEnterprise (Cleveland), JumpStart (Cleveland), the Cleveland Clinic, Case Western Reserve University (Cleveland), the BioInnovation Institute (Akron, OH), and the Global Cardiovascular Innovation Center (Cleveland). Even the Cuyahoga County commissioners have jumped into the act, approving a $425 million medical mart project that will encompass a convention center and a shopping center for medical equipment and other healthcare-related products. At the center of it all is Cleveland. "Cleveland is well known as a research and clinical center," notes Baiju Shah, president of BioEnterprise. "We're starting to become known as an innovation center. And then to have the medical mart, it just helps us as we're trying to position Cleveland as a healthcare city. It's another signature element."

Finite-Element Modeling Could Improve Brain Implant Design

European research group has developed a design strategy that it thinks will enhance brain implant functionality while reducing harmful side effects.

A European research group has developed a design strategy that it thinks will enhance brain implant functionality while reducing harmful side effects.

Used to treat such conditions as Parkinson's disease and essential tremor, deep brain stimulation (DBS) represents an emerging market poised for significant growth in the next several years. With the hope of improving brain implants, IMEC (Leuven, Belgium), Europe's largest independent research center focused on nanoelectronics and nanotechnology, presented a new design strategy for the development of brain implants this week at the Design, Automation & Test Europe (DATE) conference. Current DBS probes employ millimeter-size electrodes that stimulate the brain in an unfocused way and may have unwanted side effects, according to IMEC. Precise, targeted stimulation and fewer side effects could be enabled, IMEC suggests, through much-smaller electrodes. "To have a more-precise stimulation and recording, we need electrodes that are as small as individual brain cells," comments Wolfgang Eberle, senior scientist and project manager at IMEC's bioelectronics research group. "Such small electrodes can be made with semiconductor process technology, appropriate design tools, and advanced electronic signal processing. At DATE, we want to bring this message to the design community, showing the huge opportunities that the healthcare sector offers." Using finite-element modeling of the electrical field distribution around the brain probe, the group was able to develop prototype probes featuring 10-µm electrodes with various topologies. IMEC believes that this strategy could be the key to better brain implants. Finite-element modeling was performed using COMSOL multiphysics simulation software, which allowed the researchers to examine the mechanical properties of the probe during surgical insertion as well as to evaluate the effects of temperature on the device. The scientists found that by adapting the penetration depth and field symmetry, the electrical field could be steered around the probe, consequently delivering high-precision stimulation. To realize closed-loop systems, the researchers developed a mixed-signal compensation scheme that allowed for multielectrode probes equipped to provide dual functionality by way of stimulation and recording.

Provider of Cleanroom and Contamination Testing Services Expands

Microtest Laboratories (Agawam, MA) has increased staffing in an effort to expand its contamination and cleanroom testing services. By assisting manufacturers to identify, assess, and resolve a range of cleanroom and environmental contamination problems, the company assists manufacturers in controlling their environments to ensure regulatory compliance. The company has also purchased an additional MicroSeq microbial identification system in order to double its microbial identification and analysis services. A DNA-sequence-based system that enables technicians to identify bacteria isolates that are not viable or easily identified, MicroSeq systems are beneficial for identifying microbes in medical device manufacturing applications. Microtest‘s environmental services group is composed of microbiologists with experience in applying testing technologies in cleanroom and other controlled environments. Their work meets or exceeds ISO, EU, and FDA cleanroom testing requirements. The company's services include ISO certification and cleanroom validation to any ISO Class required for all controlled environments; HEPA filter repair, replacement, and installation for all controlled environments; and viable sampling to evaluate contamination by aerobic and anaerobic microorganisms. In addition to surface testing and analysis and active and passive air sampling, it performs nonviable air particulate sampling and testing to ISO 14644 guidelines, the EU Annex, or both standards. Disinfection validation, gowning validation, DNA-sequence-based microbial identification using in-house identification systems, and compressed-air and gas testing are also part of the company's offerings.

DOD Raids Siemens Medical Solutions

Converting CAPA to an Advantage: For Further Reading

Medical Devices: Current Good Manufacturing Practice, 21 CFR 820
www.fda.gov/cdrh/fr1007ap.pdf
Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR 58
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
Medical Device Quality System Manual: A Small Entity Compliance Guide
www.fda.gov/cdrh/dsma/gmpman.html
Medical Device Reporting
www.fda.gov/cdrh/mdr
Medical Device Recalls, Corrections, and Removals
www.fda.gov/cdrh/devadvice/51.html
Guide to Inspections of Quality Systems
www.fda.gov/ora/inspect%5Fref/igs/qsit/qsitguide.htm
AdvaMed Points to Consider When Preparing for an FDA Inspection under the QSIT Corrective and Preventive Action Subsystem
www.advamed.org/NR/rdonlyres/E54C4BA9-A454-4FFE-8480-A7807529C9CC/0/pointstoconsider6501.pdf
Guidance for Industry: Product Recalls, Including Removals and Corrections
www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm
ISO 13485:2003: Medical Devices —Quality Management Systems—Requirements for Regulatory Purposes
www.iso.org