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Articles from 2010 In April

Faster Electronics Make Noise with Miniature Devices

When integrating electronics into end-use devices, OEMs typically desire low noise and a high signal-to-noise ratio for optimal performance. However, a new breed of electronics developed by European researchers actually employs noise as part of the signal, which they believe could someday contribute to faster electronics.

As devices shrink, so do electronics. And noise, which accompanies all signals to some degree, becomes an increasing problem. "Electronics is based on switches, which can turn on and off signals. The smaller the switches are, the more complex circuits can be realized," explains Lukas Worschech, coordinator of the EU-funded SUBTLE project and a professor at the University of Wurzburg. "However, with increasing miniaturization of electronic circuits, an increasing fraction of the applied power is converted into nondeterministic signals that add to the ambient noise. It is sometimes referred to as the thermal death of electronics."

To address these miniaturization limitations, researchers involved in the SUBTLE project explored the option of using noise to increase the signal. By applying the physics phenomenon of stochastic resonance (SR) to signals, the group can increase signal clarity by tuning noise within it. "This is the SUBTLE solution: Do not avoid noise, but exploit noise by SR. This is [made] possible by utilizing the feedback action between switches and conducting channels," according to Worschech. "That is what naturally happens in nanoelectronics; the conductors are very closely spaced to each other. The interaction can even be tailored by the shaping of the conductors."

Capable of enhancing the signal, tailored feedback action is present as a result of the tightly compacted quantum-confined electron channels. "This tailored feedback enhances the signal," according to a release on ICT's Web site. "The devices employ two allied phenomena: back action on the channel gate and noise-induced switching. A channel gate is used to route a signal, and back action is like feedback in an audio system. The subsequent noise can be used to switch the circuit from one channel to another."

The resulting electronics could, according to the researchers, allow for the development of smaller, cheaper, and more-efficient circuits. Visit the research project's Web site to read more about the new electronics.

University of Michigan Scientists Invent Microfluidic ICs

Still image from a video shows how one circuit serves as the clocking signal of another circuit so that the branching fluids switch in unison. (Image courtesy of University of Michigan)

In order to simplify lab-on-a-chip devices for portable medical tests, University of Michigan researchers have created microfluidic integrated circuits. As reported in Science Daily, these microfluidic circuits regulate fluid flow without assistance from outside systems--just as electronic circuits route the flow of electricity on computer chips without external controls.

"In most microfluidic devices today, there are essentially little fingers or pressure forces that open and close each individual valve to route fluid through the device during experiments," explains Shu Takayama, an associate professor in the University of Michigan department of biomedical engineering and the principal investigator on the project. "That is, there is an extra layer of control machinery that is required to manipulate the current in the fluidic circuit." Bobak Mosadegh, a doctoral student in Takayama's lab, adds, "We have literally made a microfluidic integrated circuit." A paper on this work, "Integrated Elastomeric Components for Autonomous Regulation of Sequential and Oscillatory Flow Switching in Microfluidic Devices," appears in the journal Nature Physics.

Microfluidic technology has been hindered by the requirement that each valve on a chip must be controlled by an off-chip actuator or pump. To overcome this limitation, Takayama's research group has devised a strategy for automatically networking the fluidic counterparts of key electrical components--including transistors, diodes, resistors, and capacitors--to regulate fluid flow. Since these components are made using conventional techniques, they are compatible with all other microfluidic components, such as mixers, filters, and cell culture chambers, the researchers remark.

"We've made a versatile control system," Mosadegh said. "We envision that this technology will become a platform for researchers and companies in the microfluidics field to develop sophisticated self-controlled microfluidic devices that automatically process biofluids such as blood and pharmaceuticals for diagnostics or other applications. Just as the integrated circuit brought the digital information processing power of computers to the people, we envision our microfluidic analog will be able to do the same for cellular and biochemical information."

FDA Asks Manufacturers to Step Up Security Measures

The agency urges manufacturers to notify both law enforcement agencies and FDA's Office of Criminal Investigations as soon as a theft occurs. But it also stresses the responsibility of manufacturers to prevent the crime in the first place. "Firms engaged in providing medical products and infant formula to the public have a fundamental responsibility to continuously review their warehouse physical security and security practices and procedures for transporting products to ensure that measures are in place to minimize the risk of warehouse and cargo theft," the letter says.

Disposable Diagnostic Devices May Rely on 'Smart Plastics'

Plastic electronics are enabling the development of novel diagnostic devices, such as a sensor wristband for patient monitoring. Image: Fraunhofer.

A host of cost-effective disposable diagnostic devices could soon be made possible by 'smart plastics.'  Researchers at the Fraunhofer Institute for Reliability and Microintegration IZM (Munich) are currently developing multiple lab-on-a-chip devices that rely on plastic chips for some of their advanced functionality.

At the root of the technology is polymer electronics. Referred to as polytronics, the field focuses on the fusion of functional materials with electronics. "In a networked world oriented towards people, inexpensive, multifunctional systems are needed--for example in assisted living. In order to build up the infrastructure necessary for this, electronic systems have to be produced in large quantities, in a cost-effective manner on large substrates. And with polymer electronics, this would be perfectly possible," says Karlheinz Bock, head of the polytronic systems division at IZM.

Using plastic chips as the base for lab-on-a-chip devices could offer a significant cost advantage over conventional manufacturing, according to the scientists. Fabricating the products entails dissolving the polymer materials and then recapturing them via a printing process as flexible sheets or by roll-to-roll production for larger batches.

Among the disposable diagnostic devices for which the researchers are exploiting polytronic technology are a pocket-sized lab used to test for travel-related thrombosis and a sensor-based monitoring wristband that can detect and warn pacemaker patients of hazardous proximity to electromagnetic fields. Read more about these devices enabled by polytronics and how they are made.

FDA Issues Draft Guidance on Infusion Pumps

ery failure were among the most common complaints.

The guidance includes tips for manufacturers submitting 510(k)s. For example it says that companies should consider performing a use hazard analysis, which identifies any hazards particular to their infusion pumps. The agency also recommends that a clinical evaluation be conducted that evaluates device performance and human factors.

Infusion pump problems have been on the radar of the new FDA leadership. In March, the agency convened a panel on insulin pumps. You can read the full transcript here.

The Need to Unscramble CAPA

Contrary to what the CAPA acronym suggests, corrective action isn’t always accompanied by preventive action. “The

CAPA acronym causes confusion because many companies think a preventive action is something you do after corrective action to prevent a nonconformity from recurring. A preventive action is taken in response to data that indicates a potential nonconformity may occur sometime in the future,” Jacobs explains.
The CAPA acronym has become so misleading, according to Jacobs, that the Global Harmonization Task Force (GHTF) has decided not to use the term in their proposed document “Quality Management System—Medical Devices—Guidance on Corrective Action and Preventive Action and Related QMS Processes.” It states in the introduction, “The acronym ‘CAPA’ will not be used in this document because the concept of corrective action and preventive action has been incorrectly interpreted to assume that a preventive action is required for every corrective action.”
The GHTF draft guidance will be explored at Jacobs’ session. She says it is of value because it outlines four phases—planning, measurement and analysis, improvement, and input to management—that OEMs should use to handle the CAPA process.
During the measurement and analysis stage, Jacobs says manufacturers should begin with design control when identifying data sources that are indicators of product performance. By outputting the design control process, OEMs can identify which processes “to monitor relative to the essential outputs of the device design and risks associated with the failure of the design through risk control decisions. Risk control decisions can be linked to a process and the output of that process monitored,” Jacobs says.
Horizontal analysis is another important part of the measurement and analysis phase. Jacobs defines horizontal analysis as investigating both a single data source and different data sources to determine the significance of a problem. “It’s important to recognize relationships and linkages between data sources so the extent of nonconformity can be determined.” 
When it comes to the final phase recommended by GHTF—management input—Jacobs stresses the importance of managers being involved in both the approval and oversight process. This ensures that the proper resources are allocated to supporting the CAPA process.
Additionally, Jacobs says, “If management doesn’t understand the CAPA process, they may unintentionally drive the wrong behavior in pushing for CAPAs to be closed, because they assume aging CAPAs are a bad thing.” Unlike complaints, there is no timeline for processing CAPAs. 
“Not all CAPAs are created equal,” Jacobs says. Therefore, manufacturers should make sure to devote the proper amount of time to investigating and implementing each CAPA. “Each CAPA needs to be specific to the problem being solved,” she says.
To learn more about the other presentations being offered at the MD&M East conference session, visit

This Week In Brief: April 27, 2010

Formerly Finsbury Surgical Ltd, Sheffield Precision Medical (Sheffield, UK) has been launched to work with OEM partners on the design and development of orthopedic  instruments, including assemblies, rasps, reamers, drills, and screws. The company can take a product from concept through to design, prototyping, and batch manufacture. 
Polymer supplier PolyOne (Avon Lake, OH) has announced that its NEU Specialty Engineered Materials LLC subsidiary (NEU; North Haven, CT) offers an expanded portfolio of high-performance engineered thermoplastic solutions and services to the medical device industry. The company acquired New England Urethane Inc.'s assets in December.
Plasmatreat GmbH (Steinhagen, Germany) will celebrate the opening of its U.S. sales and technical center in Elgin, IL, by hosting a plasma technology symposium and open in house in June. The agenda will include presentations related to the latest developments in the field of atmospheric plasma surface treatment. The newest generation of in-line Plasmatreat equipment will be demonstrated and product samples will be on display.   
Production logistics solutions and conveyor systems provider FlexLink is celebrating 30 years in business. The Swedish company will fete its accomplishments at local events throughout the year; its U.S. branch is located in Allentown, PA.
Signal Transformer (Inwood, NY), which specializes in the design and manufacture of power transformers and high-frequency inductors for the medical device industry, among others, has launched a new Web site. Developed to provide easy product selection and in-depth technical information, the Web site allows users to search for parts in a variety of ways and features photos; data sheets containing detailed product descriptions, specifications, and design features; a technical library; a FAQ section; description of services; and an online request form. 




Texas Cashes in Chips for Cardiac Stents

As the saying goes, everything's bigger in Texas. And if recent activity in Austin is any indication, the medical device industry is no exception.

Although not yet on par with Massachusetts, Minnesota, or Southern California, Texas is steadily cultivating the growth of this high-tech sector. Central Texas and Austin, in particular, are emerging as hotbeds of medtech activity, according to a recent article in the Austin American-Statesman. The Greater Austin Chamber of Commerce told the publication that at least two dozen medical device and healthcare technology companies currently call Central Texas home.

Capitalizing on an existing local skilled workforce, Central Texas has seen a rise in medical device activity as regional employment in the semiconductor industry has declined. The article cites a study by AngelouEconomics claiming that an estimated 5215 people in the region work in the medical device industry, which is up 8% from three years ago.

Contributing to the development of the area's medtech growth are such factors as local funding and encouragement by VC firms; startup support; and the opening of regional facilities by established medical device companies. Notably, Minnesota-based St. Jude Medical (St. Paul) is expanding its presence in Central Texas by opening a new 85,000-sq-ft facility in Southwest Austin.

Read more about the Lone Star State's increasing presence in the medical device industry at the Statesman's Web site.

PMA Voting Process to Change

“By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them.”

Changes address staffing issues and voting procedures, as well as other areas, according to the press release. A significant change in the way votes are cast will be the use of a ballot system instead of a show of hands. Officials hope that this will help prevent a single vote from immediately influencing other panel members; however, votes will be publicly tallied and panel members will be identified by their vote after all are cast.

The changes are in response to increases in the number of medical device advisory panel meetings. From 2008 to 2009, device panel meetings increased from 10 to 17 and major topics discussed increased from 14 to 20. Officials expect this number to rise in 2010 and beyond.

The FDA hopes that this new voting process will more accurately present the full range of scientific opinion and enable more in-depth discussions about the safety and effectiveness and risks vs. benefits

Secant Expands Biomedical Textile Manufacturing Capabilities

Secant Medical (Perkasie, PA), a designer, developer, and custom manufacturer of biomedical textiles, has announced that it is expanding its manufacturing capacity. The company is adding a 40,000-sq ft facility in Quakertown, PA, to support current and future business growth resulting from market development trends in tissue engineering and transcatheter technologies. In addition, it has also redesigned its entire methodology for custom developing and manufacturing products for medical device manufacturers.

Industry experts predict the total market for tissue engineering--including heart valve repair and replacement, musculosketetal bone and ligament repair and replacement, and urological bladder slings--will surpass $11.5 billion by 2016. "We are also monitoring the healthy market growth of transcatheter technology for minimally invasive surgical procedures, which is driving an increased need for biomedical textiles," states Karen West, general manager of the company's advanced technology and materials group. "While we see an upward trend in the market, we are well aware of the challenges that device manufacturers face from healthcare reform and other events. We must carefully balance these market dynamics in our long-term planning, particularly as it pertains to our clients' needs."

"Secant Medical is taking these proactive steps in capacity expansion and process changes to manage existing and future business growth," explains Steve Chadwick, the company's president and CEO. "The newly acquired facility allows us to more aggressively address expanding supply needs in the biomedical textiles field. At the same time, our new product development process ensures we can remain aligned closely with clients' development requirements, from concept through commercialization, despite rapidly growing markets."

The company has delineated and reengineerd a series of value-added services to ensure more rapid, cost-effective, successful project implementation of cusotmers' device innovations, according to West. "The resulting integrated process better leverages our continuum of services at every stage of the client's development path. It's a smarter, more streamlined approach to apply the quality, collaboration, and scientific support we bring to the table. Combined with our expanded technology and manufacturing capacity, Secant Medical is very well positioned to meet the changing needs of our client base in both the near and long term."