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Articles from 2009 In September


Call for Comments on Petition for Testing Nitinol

The nitinol inclusions, especially those that leave residue on the surface of finished implantable devices (e.g., stents) are the main culprits of stent fracture, nickel leaching that leads to allergies,  restenosis, and stent thrombosis. Up until this point is has been impossible to test efficiently stent for inclusions." "However," he says, "a newly developed inclusion detection test has provided a way to efficiently test every single nitinol stent before implantation. On the basis of this test, a citizen petition was filed with FDA, requesting the test's implementation." To view and comment on the petition, please visit www.regulations.gov Under  "Enter Keyword or ID", type the petition docket number: 2009-P-0362 and click  on the "Search" button.

Parmatech Acquires MIM Business from Morgan Advanced Ceramics

Parmatech-Proform Corp. (Petaluma, CA), a wholly owned subsidiary of ATW Cos. (Warwick, RI), announced today that it has acquired the metal injection molding (MIM) business of Morgan Advanced Ceramics (MAC; New Bedford, MA). The acquisition serves to strengthen Parmatech's MIM capabilities for a variety of industries, including the medical device market. Through the acquisition, Parmatech will build on its experience with fabricating metal injection-molded components and capitalize on MAC's proprietary MIM process to reinforce its offerings in the field. In addition, the acquisition will enable Parmatech to increase prominence on the East coast, expand production capacity, and ensure quality. "We anticipate the combination of our businesses will prove beneficial by empowering us to serve our customers better," comments Peter C. Frost, president of ATW. "This change in ownership will strengthen our relationships with customers and enhance the high level of service we provide."

Getting a Grasp on Robotics

The device currently uses a power grip to pick up larger objects, but the researchers would like to add a precision grip, which would enable users to pick up items like a pen. Barrett Technology Inc., a company that specializes in robotic manipulators (Cambridge, MA), has licensed the technology. Barrett was spun off from MIT's artificial intelligence lab in 1990.

Algae Enables Battery Breakthrough

Four views of an algae-based battery show algae's structure, a schematic diagram of the battery's construction, and a finished prototype.
Four views of an algae-based battery show algae's structure, the battery's construction, and finished prototypes.

When people think of algae, they often picture the green film that forms on the surface of swimming pools. But now, researchers in the Nanotechnology and Functional Materials Department of Engineering Sciences at the Ångström Laboratory of Uppsala University (Sweden) have found another use for these photosynthetic organisms: batteries.

Constructed primarily from algae, paper, and salt-water, the thin and flexible batteries use thin mats of tangled cellulose fibers as electrodes and a saline solution as an electrolyte. A potentially inexpensive and environmentally friendly alternative to conventional lithium batteries, these algae-based batteries may eventually be used to power cheap medical diagnostic devices. Potential applications include a variety of low-power portable devices, such as wireless sensors and medical implants.

Despite extensive efforts in recent years to develop new cellulose-based coating substrates for battery applications, satisfactory charging performance proved elusive. However, Maria Strømme, professor of nanotechnology and leader of the Uppsala research group, and fellow researcher Albert Mihranyan saw the possibility of using algae for energy-storage applications because of the organism's large surface area.

Consisting of a nanostructure of algal cellulose coated with a 50-nm layer of polypyrrole, their invention represents an entirely new electrode material for energy-storage applications. Batteries based on this material can store up to 600 mA per cm³, with only 6% loss through 100 charging cycles. "You don't need advanced equipment to make the batteries," explains Strømme.

"Our success in obtaining a much higher charge capacity than was previously possible with batteries based on advanced polymers is primarily due to the extreme thinness of the polymer layer," says Gustav Nyström, a PhD student involved in the project.

"We have long hoped to find some sort of constructive use for the material from algae blooms and have now shown this to be possible," Strømme says. "The battery research has a genuinely interdisciplinary character and was initiated in collaboration with chemist professor Leif Nyholm. Cellulose pharmaceutics experts, battery chemists, and nanotechnologists have all played essential roles in developing the new material."

TPU Manufacturer Unveils New Facility

Argotec has opened its new headquarters and manufacturing facility in Greenfield, MA.

Argotec has opened its new headquarters and manufacturing facility in Greenfield, MA.

Argotec Inc. (Greenfield, MA), a supplier of thermoplastic polyurethane (TPU) film and sheet to medical device manufacturers, has opened a new 95,000-sq-ft headquarters and manufacturing plant. The addition of the new facility increases the company's total operations to more than 150,000 sq ft. The added capacity will benefit the production not only of existing ArgoMed films for medical device and wound-care products customers but will also provide the company with flexibility to explore new markets and applications, says president and CEO Bruce Wilby. "It will create greater efficiencies throughout our entire production process, letting us focus more of our resources on research and development." The new plant houses two blown-film and nine flat-die extrusion lines. Seven of the flat-die lines are housed in an 8000-sq-ft hard-walled cleanroom, with each individual line enclosed in its own Class 10,000 soft-walled cleanroom environment. All seven extruders, along with the raw resin handling equipment, are positioned outside the cleanroom. Only the final heated polymer passes through the wall to the flat die and winding apparatus. "Add to that our cleanroom operator certification program, the separate changing rooms and gowning requirements we've instituted, and the interlocking entrance and exit doors to guarantee no one enters the cleanroom until the first of the two doors is securely shut behind them, and the net result is an exceptionally clean product," Wilby remarks.

Laser Deposition Method May Revolutionize Fabrication of Joint Implants

Team members review data using a laser deposition system. The system works by depositing layers of a powdered mixture of metal and ceramic materials, melting the powder with a laswer, and then solidifying each layer to form parts.

Members of the laser research team at Purdue University review data using a laser deposition system. The system works by depositing layers of a powdered mixture of metal and ceramic materials, melting the powder with a laser, and then solidifying each layer to form parts.

With the demand for artificial hips in people under the age of 40 expected to reach 40 million annually by 2010 and 80 million by 2030, scientists are hard at work developing methods to expedite their manufacture, reduce their cost, and increase their durability. Take Yung Shin, professor of mechnical engineering and director of the Center for Laser-Based Manufacturing at Purdue University (West Lafayette, IN). "We have 200,000 total hip replacements in the United States," he remarks. "They last about 10 years on average. That means if you receive an implant at 40, you may need to have it replaced three or four times in your lifetime." Shin is pioneering technologies that use lasers to create longer-lasting medical implants and arterial stents. One of his techniques involves depositing layers of a powdered mixture of metal and ceramic materials, melting the powder with a laser, and then immediately solidifying each layer to form parts. Known as "functionally gradient coating," this technique for forming parts one layer at a time is suitable for coating titanium implants with ceramic materials that mimic the characteristics of natural bone, Shin explains. "Titanium and other metals do not match either the stiffness or the nature of bones, so you have to coat it with something that does," Shin said. "However, if you deposit ceramic on metal, you don't want there to be an abrupt change of materials because that causes differences in thermal expansion and chemical composition, which results in cracks. One way to correct this is to change the composition gradually so you don't have a sharp boundary."

Researchers have used this laser deposition process to create a porous titanium-based surface and a calcium phosphate outer surface, both designed to better match the stiffness of bone than conventional implants. By creating a strong bond between the material being deposited and the underlying titanium, steel, or chromium, the method can create a bond that is at least seven times as strong as that required by industry standards.

In addition, the process enables the fabrication of parts with complex shapes that are customized for each patient. "These are not like automotive parts," Shin says. "You can't make a million that are all the same." He envisages a time when medical imaging scans will be sent to laboratories where implants will be made using laser deposition. "Instead of taking 30 days like it does now because you have to make a mold first, we could do it in three days. You reduce both the cost and production time."

Additional research is needed before the techniques will be ready for commercialization. Future work will involve studying shape-memory materials that are similar to bone and also have a self-healing capability for longer-lasting implants.

Testing Service Expands Analytical Chemistry, Materials Characterization Department

NAMSA (Northwood, OH) has opened an expanded analytical chemistry and materials characterization facility. The new facility houses three laboratories, including a wet chemical lab, an instrumental services lab, and a volatile analysis lab. By doubling it chemistry testing capacity, the company plans to introduce new testing capabilities such as inductively coupled plasma spectrometry and volatiles analysis USP 467. "We believe this move positions us to provide enhanced turnaround time, better work flow to increase our testing workload, and more efficiencies," remarks Joe Grappin, NAMSA's chemistry manager. "With the renovated and expanded space, we are able to add equipment and personnel to meet the increasing needs of materials analysis required by medical devices and combination products." In addition to achieving better turnaround times and increased speed to market, NAMSA's R&D team will also have increased capabilities to develop additional materials characterization assays. Given these improvements, the company's decision to expand the chemistry lab was an easy one to make, according to NAMSA's president John Gorski. "We continue to invest in our people, facilities, equipment, and clients because we believe that developing relationships and trust is the right thing to do. It has been a key to over 40 years of success," comments Gorski. "Even during this economic downturn, NAMSA is committed to providing the best possible medical device testing services by growing our business and expanding our capabilities."

Governors' Message to Baucus: We Oppose the Device Tax

The tax, as outlined would apply regardless of the size of the company or its profitability, which would have an undue effect on small and mid-sized firms. In addition, the letter states the governors' belief that such a tax would ultimately increase healthcare costs. This is the second such letter sent by leaders of states that have strong ties to medical devices. Earlier this month (September 16, 2009), a letter from Senators of Minnesota and Indiana to Baucus carried a similar message to the one issued today. In related news, the Associated Press released news that Baucus has backed down from a portion of the tax, which had previously included over-the-counter devices, including condoms and tampons. The tax will no longer include exempted consumer items of $100 or less. This last-minute switch means that contact lens solution, maxi-pads, and home pregnancy tests -- among many other items -- will not be taxed. However, items that are not exempt in this back pedal, such as wheelchairs, insulin pumps, and hearing aids, coould still have an effect on patients. AP reports that "The medical devices industry says that eventually, the taxes will get passed on to consumers."

Study Says Enterprise Software Best for Quality

Download a free copy of this research at:  http://3.ly/qJp. (Note: the study is available for free until October 2, 2009. After that, it costs $399.) The report also cites an increased investment by best-in-class manufacturers in manufacturing operations management systems, especially those with embedded capabilities to perform enterprise quality management across all manufacturing operations. The results involve high overall equipment efficiency, on-time and complete shipments, and regulatory compliance for a reduced cost of quality.

Controlling Nanoparticles in Biological Systems

Nano- and microscale particle systems have become a key component in biomedical applications such as drug-delivery systems. Their small size and potential for modification and functionalization make them suitable for performing specific tasks in the body. Yet, controlling these materials at the structural level to create particles capable of complex interactions with biological systems remains a challenge. Joerg Lahann, associate professor in the chemical engineering department at the University of Michigan (Ann Arbor), and his team of researchers are rising to that challenge. Using a microscale fluid manipulation system dubbed electrohydrodynamic cojetting, an electrospinning process in which thin fibrous strands are drawn from a liquid using high voltage, they believe that they can control nanoparticles' interactions with biological systems. As reported in the materials science journal Advanced Materials, Lahann's team utilizes this system to synthesize dual-compartment, biologically compatible polymer particles with the ability to selectively self-associate with human endothelial cells found in the lining of blood vessels. When they are incubated with these cells, the particles display a strongly specific binding pattern because one of their compartments has been modified with the protein streptavidin, which interacts strongly in biological systems. As a result of this selective funcationalization process, one hemisphere of a particle exhibits strong affinity with a cell surface while another does not, leading to spatial control at the cellular level. Since only one side of each particle is attracted to the cells, they form into layers, just one particle thick, on the cell surface. Having demonstrated the fundamental concept of selective particle control, Lahann and his cothinkers hope to build more-sophisticated multicompartmented building blocks suitable for use in more-complex biohybrid designs. Finer control over the particle architecture, they believe, will allow for the creation of different particle morphologies and functionalities, paving the way for the design of novel, complex systems for use in areas such as regenerative medicine, medical imaging, and diagnostics.