Eyesight to the Blind?

The processor would send those impulses to the implanted electrodes. And the activity on the electrodes would enable patients to see images. It would not result in a full range of sight -- primarily because it is impossible to replicate the function of the retina with a digital camera -- but it might enable patients to identify objects and recognize faces. But the ability to deliver high-resolution images to the brain should improve over time. The inventor, John Pezaris of Massachusetts General Hospital in Boston, says the best candidates for the device are those who are totally blind, whether from birth or from an illness or traumatic head injury. For those who are partially blind, the risks of the surgery may not outweigh the benefits they could reap.

FDA Expresses Concern About Stent-Graft Deaths

The company says that the advisory fails to take into account that the system has a lower rate of short-term deaths than surgery.

Stent Testing Guidelines Imminent

Senate Asks for $375 Million Boost in FDA Budget

Transforming FDA LogoThe Senate has passed a resolution to give an additional $375 million to FDA's fiscal year 2009 budget, reports the New York Times. The main impetus appears to have been Baxter's tainted heparin that might have never reached these shores had FDA inspected the Chinese plant where the problem occurred. For some Senators, that incident amplified the numerous recently released reports stating that the agency does not have nearly enough funds to accomplish its mission. It is not yet known whether the House would agree to the contents of the resolution. There is no similar language in the budget bills it passed, but as The Alliance for a Stronger FDA points out, it is very rare that budget items are addressed specifically in the language of such bills. However, the Times article implies that there may be a split among Congressional Democrats on the timing of a budget increase; some want it immediately, while others may prefer to wait until President Bush leaves office because they don't think his administration has any desire to fix FDA's problems, and they don't think that top FDA officials are capable of fixing them.

Unearthing New Opportunities on the Nanoscale


Unearthing New Opportunities on the Nanoscale

By 2014, $2.6 trillion in global manufactured goods, or about 15% of total global output, will incorporate nanotechnology, according to the independent advisory firm Lux Research (New York City; www.luxresearchinc.com). One of the areas where the continued growth will be most apparent is in the healthcare sector. Nanotechnology research with implications for the medical device industry is progressing rapidly, and academic institutions and medical device firms continue to make strides in bridging the gap between research and commercialization. The University of California at Los Angeles has announced the launch of the California NanoSystems Institute (Los Angeles; www.cnsi.ucla.edu), created with the expressed purpose of fostering partnerships between industry and university researchers. Elsewhere in the world, a recently formed company in the United Kingdom, NanoCentral (www.nanocentral.eu), offers to advise and assist companies in implementing nanotechnology equipment and services within existing business models. In this feature, MPMN reports on several advancements in nanotechnology that have the potential to revolutionize medical product manufacturing in the years ahead. The innovations covered could have applications as varied as drug delivery, power supply, implantable device components, diagnosis, and detection.

Daniel Grace

Nanotubes Enable Development of Paper-Thin Battery

Toss a paper airplane, and, for a few entertaining seconds, there is the illusion of flight. But in the not-so-distant future, flying paper could cease to be illusory, thanks to a new electrical component made almost entirely of paper. The component can function as a battery, a supercapacitor, or a hybrid of both. Researchers anticipate a wide variety of applications for the component, including a number of novel possibilities related to medical devices, according to findings published in the August 13 issue of the Proceedings of the National Academy of Sciences.


Sensor Could Provide Forewarning of Asthma Attacks

A recently developed nanotube sensor is reactive to minute amounts of nitric oxide, a gas prevalent in the breath of asthmatics, according to University of Pittsburgh (Pittsburgh, PA) professors who developed the sensor. If fitted in a handheld device, the tiny component could allow users to remove the element of surprise from asthma attacks. In addition to detecting attacks early on, a device incorporating the sensor could provide a portable method for patients and their doctors to regularly monitor their symptoms and tailor treatment accordingly.


Nanostructures Get in Shape for Drug Delivery

Block copolymers can be found in rubber soles for shoes, and, more recently, in portable memory sticks (flash drives) for computers. Soon, the material might be found in the human body as well. Researchers have discovered how to make synthetic polymer molecules assemble and form into long cylinders, a nanostructure potentially suited for drug-delivery applications. The finding was first reported in the August issue of Science by a research team lead by Darrin Pochan, associate professor at the University of Delaware (Newark, DE), and Karen Wooley, professor at Washington University (St. Louis).


Emerging Challenges: Nano Surveys Serve Disconnection Notices

Firms commercializing nanotechnology lack a clear procedural roadmap for navigating governmental environmental, health, and safety (EHS) standards, according to a new survey conducted by the Project on Emerging Nanotechnologies (www.nanotechproject.org). Many firms also lack the necessary information to meet regulatory expectations.


Software Provides Peek into the Body--and the Future

Actual in-body nanorobots for the purposes of diagnosing and treating harmful conditions on the cellular level are years away. For now, scientists can only imagine. Nanorobot prototyping software, however, may allow researchers to use their imaginations in more sophisticated ways.


Copyright ©2008 Medical Product Manufacturing News

Manufacturers Continue to Expand in China

Covidien is tripling its workforce at the site, and Inverness Medical is relocating a plant from England to China. However, a lawyer quoted in the article says it's easier to win damages against a company that is sells defective products manufactured in China than in the United States. The Baltimore attorney, Ronald Miller of Miller & Zois LLC, also notes that jurors might feel that companies are cutting costs by making products in China, while sacrificing the safety. Despite the negative press given to sites in China, the majority of device companies probably employ the same strict quality controls there that they use in the United States and overseas. As presence in Asia continues to accelerate at a very rapid pace, companies will need to make sure that they really stick to strong quality standards, even if it means spending a bit more money.

Company Debuts World’s Smallest Color SVGA Display


Company Debuts World’s Smallest Color SVGA Display
Daniel Grace
The CyberDisplay SVGA LVS features a pixel size of 11.25 µm square--1000 times smaller than the pixels used by flat-screen televisions.

By incorporating single-crystal silicon transistors, Kopin Corp. has developed what it claims is the world’s smallest color SVGA display. The CyberDisplay SVGA LVS measures 0.44 in. diagonal—the same size at the company’s current VGA display—but with a higher resolution of 640 × 480 pixels. Endoscopic and vision-aid systems are among the display’s potential medical applications.

The display uses the same design architecture as large LCDs, but with a pixel size of 11.25 µm square—1000 times smaller than the pixels used by flat-screen televisions. Single-crystal silicon transistor technology, as contrasted with the polysilicon transistor technology used in such everyday small displays as cell phones, provides high pixel density, allowing for sharp color images despite the small pixel size. A planar multimetal layering process, a nanotechnology process for liquid-crystal alignment, and a cell-gap liquid-crystal assembly process further enabled development.

Previously, the company’s smallest color SVGA display had been 0.59 in. diagonal. Power consumption has also been reduced compared with the company’s previous small SVGA model, down to 70 mW from 100 mW. Low power consumption is essential with a display of this size, notes Hong Choi, chief technical officer. “A display this small is designed to be optically magnified by an eyewear device in order for the image to be vivid,” he says. “For such a device to be practical, it must be battery operated, so the display can’t consume very much power.”

A device incorporating the display would function similarly to a microscope, with the user looking through a lens that enlarges the subject—the subject in this case being the display. Such a device could be incorporated in endoscopic systems, according to Choi. “In today’s systems, the image from inside the body is displayed on a monitor that the surgeon must occasionally glance up to, and continuously glancing up and down takes up time and also increases the chance for error,” Choi says. “A high-resolution eyewear device would allow the surgeon to see clear, detailed images inside of the body without having to move his head.” Choi adds that the display’s small size would enable such a device to be light and unobtrusive, allowing the surgeon to simply shift his or her eyeline below the device (like with a pair of spectacles) in order to see the operating field in plain view.

In the past, Kopin’s products have been used primarily in the consumer and military markets, but the company is aiming to increase its presence in the medical device sector, according to Choi.

Kopin Corp., Westboro, Massachusetts

Copyright ©2008 Medical Product Manufacturing News

Edwards CEO Named AdvaMed Chair

He said his priorities will include raising awareness about the value of medical technology, enhancing industry ethics, and strengthening relationships with key stakeholders.

Supplier Turns Pollutants into Plastic


Supplier Turns Pollutants into Plastic
Stephanie Steward
A carbon dioxide-based polymer (pictured above in resin form) has the consistency and viscosity of honey.

Green manufacturing trends have driven engineers to take seemingly far-fetched notions of making plastic out of any crop or waste material and turn those ideas into practical realities. Novomer Inc. is one such company, customizing performance characteristics of its ecofriendly plastics, which are made with waste products like carbon dioxide.

Developed by Geoffrey Coates, the company’s cofounder and chief scientific officer, along with his research group at Cornell University, the plastics-making process uses catalysts to create polymers whose source materials contain 30 to 50 % carbon monoxide and carbon dioxide. This technology can significantly reduce the amount of petroleum products and fossil fuels typically required for manufacturing polymers, according to Novomer president Charles Hamilton.

Novomer bonds liquid epoxies with carbon dioxide in a reactor similar to a pressure cooker with the help of a catalyst, such as beta-diiminate zinc acetate. The catalyst material is then filtered out of the honey-like liquid after it is removed from the reactor. Because the process is based on synthetic chemisty, Novomer has a great amount of control and flexibility in manufacturing the materials.

“The ability to use synthetic chemistry to make these materials allows us to provide very high quality control and custom performance characteristics—such as heat resistance and time to reabsorption,” says Hamilton. “Device makers can work together with Novomer to specify precise performance characteristics for medical polymers. We’re not limited by the narrow window of customization that biologically derived polymers are limited to.”

Making polymers based on biological materials has been possible for some time; however, the concept was considered somewhat of a novelty because the high manufacturing cost discouraged large-scale production, according to the company. Its process not only reduces that cost, but also gives the firm more control over the composition of the materials

“We have the option of making biodegradable materials or more-enduring materials, depending on the need,” says Hamilton. “We can make a variety of high-performing bioabsorbable custom materials, such as high-melt-point PLA, high-performance PHA, and bioreabsorbable polymers, from carbon dioxide,” he says. The green materials can be made to deliver drugs slowly over time or for bioreabsorbable applications, like implants, stents, or orthopedic devices.

“There are many players, large and small, working on new green polymers,” says Hamilton. “What sets Novomer apart is our ability to very precisely control simple building blocks like carbon dioxide and epoxies using catalytic chemistry to make high-performance materials.”

Novomer Inc., Ithaca, NY

Copyright ©2008 Medical Product Manufacturing News

Wireless Implants Can Be `Hacked,' Study Finds

Implanted devices that use wireless technology are vulnerable to being `hacked,' or accessed in an unauthorized manner, a new study finds. The authors of the study, which was performed on a lab bench and not in live patients, were able to send unauthorized commands to wireless devices such as pacemakers and implantable cardioverter-defibrillators. These commands enabled them to reprogram settings, retrieve patient data, and even deliver potentially fatal shocks. The study won't be presented until May at a computer security symposium. But its findings, conducted by a team from the Beth Israel Deaconess Medical Center, the University of Massachusetts, and elsewhere, were reported in the Boston Globe this morning. William Maisel, MD, the study's lead author, emphasizes that it takes extreme technical skill to be able to hack an implanted device, and that no cases of this happening in real life have ever been reported. Therefore, he says, the benefits of the devices far outweigh the risks of being hacked. Nonetheless, the study suggests fixes such as alerts and encryption that could help prevent or deter attacks. And its authors believe that attacks could become more likely as longer-range wireless technologies come into use in medical devices. So the study omits certain information that would be useful to potential hackers. This sounds like something you'd see on an episode of Law & Order or House. Let's hope it remains in the realm of fantasy.