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Are you at a loss for improvements to make to devices under development at your company?  Wonder where the potential for improvement lurks?  Better bioengineering in general could well be the key, depending on your device. Consider the benefits associated specifically with antiseptic (or asepsis) augmentation.

Hospital-acquired infections can lead to sepsis, which may result in multi-organ failure and death.  An effective prophylaxis built into your device can help prevent the spread of these infections.  Granted, there are microorganisms out there which do not respond to the standard approaches. You have probably heard of vancomycin which is used to treat some of the toughest bugs.  There are increasing incidences of vancomycin-resistant organisms; but that is not the only reason innovative solutions are especially called for in this area.

Medicare, the sole source of insurance for so many of our elderly, is moving toward a new model of reimbursement concerning all hospital-acquired complications.  That new model does not reimburse for such complications.  When admitted, the patient’s maladies will be logged and new indications that develop during a hospital stay will be considered “acquired” - like development of decubitus (pressure) ulcers for example.  I am not arguing for or against the wisdom of this reimbursement philosophy, though on the surface it appears fraught with difficulties.  Finally, McGuckin, Waterman, and Shubin found evidence suggesting “that (1) consumers will use infection data in selecting and/or leaving a hospital system and (2) consumers are ready to be empowered with information to ensure a positive outcome.” 

Both changes in reimbursement and changes in consumer attitudes provide energy behind asepsis technology development—and subsequent benefits to hospitals clear.  What can you do to help?  Until next time.

Stephen Quinn, CEO
Ratner BioMedical Group LLC

Ok, time to geek out a bit. This is the kind of stuff I love:

Plastic molecules with an iron atom at their core could substitute for blood in emergency situations. Researchers from Sheffield University in Yorkshire, England reported their work on artificial blood to BBC News.

The researchers say that the artificial blood is light to carry, does not need to be kept cool, and can be kept for longer periods of time than regular blood.

They also say the artificial blood could be cheap to produce. The scientists are looking for extra funding to develop a final prototype that would be suitable for biological testing.

The National Institutes of Health just awarded a $6.3 million grant to a team of scientists to design and construct a molecular therapy that can restore eyesight to people suffering from age-related macular degeneration and other retinal degenerative diseases. The Chicago Tribune reports that scientists in the fields of bioengineering, chemistry, molecular biology, ophthalmology, pharmacology, and physics will work to create a device that can substitute for the dead photoreceptor.

The researchers say the device will consist of three molecular components. The first anchors the device to appropriate sites on nerve cells of the inner layer of the retina that communicate with the optic nerve. The second component must have light sensitivity. And the third should respond to that light by activating the nerve cells to which the device is anchored.

Chief among concerns for the team is that of biocompatibility. “The introduced device cannot have a toxic side effect or be rejected by the patient’s body,” explains David R. Pepperberg, director of the Photoreceptor Research Laboratory in University of Illinois at Chicago’s Department of Ophthalmology and Visual Sciences. Pepperberg leads the study.

It may be an opportunity for biomaterials makers to contact Pepperberg to see if he is looking for input on biocompatible materials. Industry should be willing to provide materials or funding for important studies such as this one. University-level science often struggles to bridge the gap to commercial use.
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A protoype of a nanometerscale generator can produce continuous direct current electricity by borowing enery from its environment, such as inside the blood stream. Researchers from the Georgia Institute of Technology led by Zhong Lin Wang, Regents’ Professor in the School of Materials Science and Engineering created the device.

This prototype is a few steps ahead of other nanogenerators for several reasons. For one, the new version is made from vertically-aligned zinc oxide. The material is peizoelectric and semiconducting, as well as nontoxic and biocompatible. Earlier versions used platinum-coated silicon, which were not as effective. In addition, the vertical alignment has nanowires that move inside a zig-zag plate electrode, harvesting power from several nanowires at a time, rather than just one nanowire at a time, as in the original design.

The protoype is made by first growing an array of vertically-aligned nanowires approximately a half-micron apart on gallium arsenide, sapphire or a flexible polymer substrate. A layer of zinc oxide is grown on top of substrate to collect the current. The researchers also fabricate silicon zig-zag electrodes, which contain thousands of nanometer-scale tips made conductive by a platinum coating.

The electrode is then lowered on top of the nanowire array, leaving just enough space so that a significant number of the nanowires are free to flex within the gaps created by the tips. Moved by mechanical energy such as waves or vibration, the nanowires periodically contact the tips, transferring their electrical charges. By capturing the tiny amounts of current produced by hundreds of nanowires kept in motion, the generators produce a direct current output in the nano-Ampere range.

Wang and his group members expect that with optimization, their nanogenerator could produce as much as 4 watts per cubic centimeter, based on a calculation for a single nanowire. That would be enough to power a broad range of nanometer-scale biomedical applications, including biosensors implanted in the body, environmental monitors or even nanoscale robots

The research was sponsored by the Defense Advanced Research Projects Agency (DARPA), the National Science Foundation (NSF), and the Emory-Georgia Tech Center of Cancer Nanotechnology Excellence. Details of the nanogenerator are reported in the April 6 issue of the journal Science.

At the ASME Frontiers in Biomedical Devices conference in Irvine, CA, yesterday, Warren Grundfest talked about the ingredients to developing a successful medical device business. Grundfest is a physician and scientist at UCLA’s School of Bioengineering. Amont other things, he talked about creating a good team, involving regulatory and quality early in the process, and pursuing intellectual property rights as soon as possible.

Most significantly, however, Grundfest stressed choosing a product idea that has a solid, practical use in the industry. “People come to me with new ideas for biomaterials all the time,” he said. “I don’t care if you have the most amazing new hydrogel ever invented. I want to know how it’s going to be used.”

Taking into account the applications for a biomaterial may be a simple lesson, but it’s one that the biomaterials community often forgets. And the reminder is always welcome.

The Society for Biomaterials has a feature on its Web site called “Biomaterial of the Week.”

This week the site focuses on hydrogels, commonly used for scaffolding in tissue engineering. It is a great overview that is specifically useful to biomaterial engineers. It even provides Wikipedia links to common materials used to create hydrogels.

The Society is also looking for ideas for more biomaterials of the week. If you have a suggestion, contact SFB’s Web editor, Thomas Webster at Thomas_Webster@brown.edu.

The 2nd Annual Frontiers in Biomedical takes place this week (June 7-8) in Irvine, CA. I’ll be in attendance, so check back for conference highlights.  

There should be some very interesting presentations. I spoke with Walt Baxter of Medtronic who is cochair of the conference. He said that there was increased emphasis on industry driven presentations that focus on presenting science in biomedical devices that comes directly from industry. That includes work in biomaterials. It’ll be interesting to see what comes out of the practical side of the biomedical conference.

Macromolecular Bioscience has a special issue on macromolecular biomaterials, guest edited by Diego Mantovani. The journal has made select articles free on its Web site until June 18, 2007.   The issue focuses on successful strategies for enhancing communication between cells and materials, which is one of the major challenges in biomaterials science. Montovani is a professor in biomaterials and bioengineering, in the department of mining, metallurgy, and materials engineering at the Université Laval, Québec, Canada.

If you took all the most cutting edge medical device and tissue engineering technology in existence at the universities and labs across the world and were able to collapse time and make them immediately (and safely) available in the medical marketplace—what would happen? It would be a profound paradigm shift. But, the delta between what is happening in the lab and what is happening in the clinic continues to grow. Governing agencies are aware and often provide fast track procedures given certain conditions. Those agencies (per se) are not the problem. The problem, my friends, is one of finance.

In states that are truly supportive of biobusiness, like Pennsylvania, favorable models exist like the greenhouses model described by Barbara Schilberg in Genetic Engineering & Biotechnology News. The program dedicated $100 million from its tobacco settlement funds to create three regionally-focused life sciences ‘greenhouses.” The initiative also awarded $60 million to three venture funds to provide the next stage of capital. With the money, the Philadelphia greenhouse developed a $20-million seed fund.

Please send me your funding story or model for seed funding in the biomedical/biotech space; I’ll relate back any interesting ones. Until next time, ciao!

On a related note, don’t miss TERMIS North America 2007 in Toronto. TERMIS is the Tissue Engineering and Regenerative Medicine Society (Chaired in North America by Dr. Anthony Atala). See www.regenerate-online.com for more details.

Stephen Quinn, CEO
Ratner BioMedical Group LLC

Buried in a Forbes article from from May 31, 2007 about dissolving stents was an interesting view point from Joachim Kohn. Kohn is director of the New Jersey Center for Biomaterials at Rutgers University. When asked to give perspective about the results of a German study, he disagreed that biodegradable magnesium stents are the wave of the future. Moreover, he said that the biomaterials industry itself was suffering from lack of interest.

“Biomaterials were hot in the 1990s,” he said. “Everyone in the United States was interested in biomaterials. But a field has to be matured, and before that happened, we moved on to other things, such as nanomaterials.”

In context, Kohn was giving his opinion on the success potential of a magnesium stent, not necessarily the industry as a whole. He could have been talking specifically about biodegradable biomaterials. But the question remains, are universities and specialized centers giving up on biomaterials? Perhaps before sounding the death knell, we should look at the real possibilities of the industry and maybe redefine some terms.