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Articles from 2009 In June


Thank You, Carl Marotta

His accomplishments can be attributed to a strong commitment to quality, service and performance as well as his solid technological capability and leadership.  CarlâEUR(TM)s developments in adhesive technology and packaging innovation had a significant impact on the medical device packaging industry.  All CarlâEUR(TM)s friends at Oliver-Tolas will miss him not only for his technical expertise, but for his kind and gentle nature." At MD&DI, we will miss his expertise as well as his friendship. He was named as an industry pioneer in our 25th Anniversary issue in 2004. Our sincerest condolences to family and friends.

Comco's Microabrasive Equipment Can Deburr PEEK Implants

Microabrasive blasting can be used to deburr small medical implant components without causing damage to the parts.

Microabrasive blasting can be used to deburr small medical implant components.

Microabrasive blasting equipment from Comco Inc. (Burbank, CA) can be used to deburr medical implants made of polyetheretherkeytone (PEEK). The biocompatibility and chemical resistance of PEEK make it suited for use in implant manufacturing. However, machining PEEK implants typically generates burrs that can be cumbersome and difficult to remove manually, according to the company. The equipment supplier is offering its microabrasive blasting technology as an alternative to laborious manual deburring. The fine abrasive stream from a blaster can quickly deburr implants and implant components without damaging the small features machined into the parts. Using a soft abrasive, such as sodium bicarbonate, the equipment has the cutting effectiveness required to deburr parts without cutting or burning the surface, according to the supplier. To determine the most-efficient microblasting method for a specific application, the company offers sample part testing services.

Jamestown Plastics Expands Two Facilities

Jamestown Plastics (Brocton, NY), a contract manufacturer specializing in thermoforming, is adding equipment to its two facilities in order to increase its capabilities. The expansion project includes installing a 3 x 4-ft single-station thermoformer at its plant in Brownsville, TX, as well as a 5 x 7-ft rotary thermoforming press at its Brocton headquarters. The company expects the single-station machine to increase its capacity by 15% and the rotary press will support existing product lines, increasing capacity by 25%. The company also anticipates increasing its workforce later this year. "Everybody in plastics sees that the current economic downturn has resulted in a great deal of quality used equipment being available to the market," says Jay Baker, president, Jamestown Plastics. "Companies like ours are adding used equipment now because those deals probably won't exist a year from now." Each of the company's facilities also houses a Class 10,000 cleanroom for plastic medical device manufacturing operations. In addition to components for medical devices, the company offers thermoformed packaging.

New Scale Offers Micromotor Developer Kits

New Scale's developers' kits can help simplify integration of miniature linear motors and position sensors into medical devices.

New Scale's developers' kits can help simplify integration of miniature linear motors and position sensors into medical devices.

Motion systems provider New Scale Technologies (Victor, NY) is offering developers' kits to help ease integration of its smallest linear motor and highest-resolution miniature position sensor into small medical devices. Featuring the company's Squiggle piezoelectric micromotor and Tracker NSE-5310 miniature position sensor, the kits serve as reference designs for closed-loop OEM system integration. The DK series kits can help simplify evaluation and integration of these miniature motion technologies for such medical devices as microrobotic surgical tools, miniature digital microscopes for endoscopy, and point-of-care instruments. The kits also can be used to develop devices for automated disease screening, drug discovery, and industrial machine vision and distributed sensing applications. In addition to the Squiggle and Tracker products, the DK kits include a slide assembly reference design tool for mechanical integration that demonstrates proper mounting, loading, and alignment. The kits also include a drive card with the company's NSD-1202 motor controller application-specific integrated circuit (ASIC). The ASIC serves as an electrical reference design tool for use in various stages of development, from initial product evaluation to prototype development. Powered by two AA batteries, each kit comes with the company's Pathway software, which controls the kit via a USB interface that is connected to a PC. The software enables evaluation of the motor and sensor using a graphical user interface. It also allows a user to develop and test scripts using the scripting interface and provides the necessary ASCII codes that the OEM would need to use in its embedded system or microcontroller. The Squiggle linear micromotor measures 2.8 Ã-- 2.8 Ã-- 6 mm, and the Tracker position sensor with on-chip digital encoding is offered in chip-on-board packaging as small as 3.9 Ã-- 2.5 mm. Both the micromotor and the magnetic sensor array provide 0.5 µm resolution.

CRT-Ds Effective for Mild Heart Failure

Results showed a 29% reduction (p = 0.003) in death or heart failure interventions from CRT-Ds when compared with traditional implantable cardioverter defibrillators (ICDs). Boston Scientific Corp. sponsored the four-year study which was conducted by Arthur J. Moss, MD, of the University of Rochester Medical Center. The company said the full report is expected to be presented and published later this year.

Biological Fuel Cell Breakthrough Could Empower Medical Devices

Researchers at the University of Georgia (UGA; Athens) have developed a method for growing molecular wire brushes that conduct electrical charges. Made up of chains of thiophene and benzene attached to metal surfaces as ultrathin films, the brushes could lead to the fabrication of biological fuel cells that may one day power devices that interface with living tissue, such as pacemakers, cochlear implants, prosthetic limbs, and biochemical sensors. “The molecular wires are actually polymer chains that have been grown from a metal surface at very high density,” remarks Jason Locklin, a UGA chemist who has spearheaded the research together with graduate students Nicholas Marshall and Kyle Sontag. “The structure of the film resembles a toothbrush, where the chains of conjugated polymers are like the bristles. We call these types of coatings polymer brushes. To get chains to pack tightly in extended conformations, they must be grown from the surface, a method we call the ’grafting from‘ approach.” To make the polymer brushes, the scientists laid down a single layer of thiophene as the film‘s initial coating and then built up chains of thiophene or benzene using a controlled polymerization technique. “This technique gives us the control to systematically vary polymer architecture, opening up the possibility for various uses in electronic devices such as sensors, transistors, and diodes,” notes Locklin. Ranging in size from 5 to 50 nm, the ultrathin films are too small to see, even with the aid of a high-powered optical microscope. While flexible electronics is a large and growing area of research, it‘s still in its infancy, Locklin says. “For example, we don‘t yet understand all of the fundamental physics involved in how electrical charges move through organic materials.”

Convincing Customers of Your Company's Value

The biggest hurdle thus far has been getting medical device companies to recognize that plastic is as strong as metal. "Changing the mentality is going to be hard," Eric Godin, account manager at IPL, told MD&DI at MD&M East. In addition to the strength of plastic, Godin said the material provides practical advantages like ease of cleaning, because the injection molding process produces no seams in the finished product. This means bodily fluids can't seep into cracks in a bed rail, for example, and instead can be simply wiped off the surface and the area disinfected. Godin is confident that the company's ability to offer customers upfront engineering expertise from prototyping to production will help push IPL further into the medical device market. Part of IPL's strategy was one seen by many exhibitors at MD&M East this year. These days, more and more device companies want to work with contract manufacturers that can not only make custom products, but can offer a full range of services in-house. As a result, many suppliers are promoting themselves as a one-stop shop to attract future customers. Working with one supplier as opposed to several is not only more convenient for companies, but it's oftentimes more cost efficient as well.

Supplier Offers Scientific Injection Molding

Helix Medical LLC (Carpinteria, CA) reports that it has begun to incorporate scientific injection molding (SIM) practices into its liquid silicone rubber (LSR) molding operations. Combining product design, tool design, material selection, and process development from the polymer point of view, SIM enables manufacturers to control critical process parameters to ensure that parts are optimally produced without defects. Although the methodology has been in use for some time in thermoplastic injection molding, it is relatively new to LSR molding. By applying the SIM process to LSR products, the company claims that it can develop processes in which potential defects are identified before the validation stage, saving clients time and money. Driven by reliable documentation and data collection, SIM provides higher yields, lower material consumption, and greater process robustness than conventional injection molding, according to the company. The application of SIM principles delivers better flow control and fewer visual defects while increasing part integrity. “Scientific injection molding allows us to produce consistent product quality through process repeatability from machine to machine, part to part, and setup to setup,” remarks Edward Callahan, vice president and general manager of Helix Medical's Gloucester, MA, operations. “This methodology has allowed us to provide the documented standardized processes and the quality assurance required to support our customers‘ regulatory requirements. We deliver superior value for our customers and partners by investing the time up front during the development stage.”

FDA Needs Backbone in Device Approval, Experts Say

d. Only by demanding more-thorough, scientific device evaluations can FDA hope to reestablish consumer confidence in its ability to protect the public's health," Maisel told the panel, adding that the agency is too reliant on the device industry's ability to police itself. Marcia Crosse, health care director for GAO also spoke. She said that FDA seemed unable to thoroughly review medical devices before they are approved and continue to monitor them for problems once they are put into use. However, AdvaMed spoke up to defend the regulations that govern the agency. "FDA has comprehensive authority to regulate medical devices through a combination of premarket and postmarket controls," Stephen Ubl, president of AdvaMed, said in a release from the association. So, there are several questions being raised: 1. Is FDA doing its job? 2. Does the agency already have the regulatory weight to properly oversee medical device approvals? 3. If so, what are they lacking to properly do the job? 4. If not, what new legislation would solve the problem? What do you think?

National Safety Month: Work-Related Injuries Are Down

In recognition of National Safety Month, the U.S. Bureau of Labor Statistics (BLS; Washington, DC) has released data on work-related fatalities and nonfatal injuries and illnesses. The data shows that the rates of fatal and nonfatal injuries have declined between 1992 and 2007. This data consists of the latest statistics available; preliminary data for 2008 will be released in August 2009. From 1192 to 2007, the overall rate of fatal work injuries was down from 5.2 to 3.8 per 100,000 workers. The majority of workplace injuries and illnesses, however, do not result in fatalities. Total injury and illness incidence rates, as well as rates for cases serious enough to warrant days away from work, showed a decline between 2003 and 2007. Although rates of nonfatal injury and illness are on declining, the category of manufacturing industries showed the highest rate of incidence (5.6 per 100 full-time workers) compared with other categories, such as construction (5.4), trade and transportation (4.9), and professional and business services (2.1). The BLS data reflects an assertion by the American Society of Safety Engineers (ASSE; Des Plaines, IL) that American manufacturers' ability to maintain effective work safety and health programs is a factor in their increased share in the international marketplace. "U.S. manufacturers are doing a good job competing with international companies," says Michael Coleman, ASSE manufacturing practice specialty administrator. "By not cutting safety and health programs in this economic downturn and by doing a better job through internal innovations, [offering] ongoing education and training, working smarter, and looking at automation innovations, U.S. companies are holding onto and gaining in market share worldwide." Citing a report released today from the Federal Reserve Bank of Philadelphia (Philadelphia) that states that the U.S. manufacturing sector has shown its best performance since September 2008, ASSE is stressing that, while companies are doing more with less, employers need to remember that workplace safety and health is not an area to cut from, according to Coleman. "In order to remain viable long-term, a company must maintain a solid safety process even through difficult times," he says. "The most-successful companies also have the strongest safety performance." ASSE will be hosting its annual Professional Development Conference and Expo in San Antonio June 28–July 1. The event will feature a keynote address by U.S. Department of Labor secretary Hilda Solis, as well as education sessions and roundtable discussions.