For the last Medtech Pulse post of 2009, I decided to jump on the bandwagon and briefly contribute to the annual end-of-year ballyhoo. Join me for some year-end reflection and thoughts about the year ahead of us. Also, please feel free to add your own thoughts or comments below. Around this time last year, speculation ran rampant as to what the state of the economy would be in 2009 as we hesitatingly tip-toed into a new year predicted to be full of uncertainty and negativity. What was going to be the impact of the recession on the industry? Was the medtech industry recession-proof? Would we lose our jobs? And the answers to these panicky questions proved to be mixed. Some of the year's events panned out as expected: As the general economy suffered, so did some companies serving sectors of the industry that cater to elective procedures, such as plastic surgery and orthopedics. However, patients weren't the only ones holding back as times got tough; many hospitals shied away from capital equipment purchases, opting to hold out until the economy bounced back a little. Obstacles such as these proved that the medical device industry is not recession-proof. Further driving the point to close to home were the lay-offs and plant closings that many companies unfortunately experienced in 2009 as multiple medtech firms looked to cut costs in a hostile economic environment. Change was afoot as well in the supplier pool, as the dire domestic automotive industry left little option for suppliers looking for other industries into which they could diversify. This drastic alteration in Michigan's manufacturing makeup introduced a new kind of supplier to the medical device industry supply chain. But for those that muddled through and ended up now with their heads above water, the year wasn't all bad. Some companies showed profit; however, it appears that most companies were satisfied to merely maintain. The general attitude of the industry this year was that flat was the new gain. It's all anyone could hope for, really. Economic doom and gloom aside, there were some highlights. Despite the tumultuous economy, we saw a host of exciting developments at the R&D level this year, which gives us hope for the advancement of a plethora of medical technologies. Plus, new products found their way to market and suppliers unveiled exciting products and services to enhance OEMs objectives. I don't think anyone is too sad to say goodbye to 2009, though. Instead, we welcome 2010 with the promise that it brings. Emergo Group Inc. (Austin, TX) surveyed a sampling of more than 1000 professionals in the medical device and IVD industries last month, which revealed a general attitude of cautious optimism for 2010. For example, 71.7% of respondents expect sales to increase in 2010 from 2009, while 17.0% anticipate that sales will stay the same and less than 5% predict an overall decrease in sales. In addition, 51.6% report that they think their company would have more employees one year from now and 34.2% forecast that the number of employees will remain the same. Only about 10% portend that their firms will have fewer employees next year. Most telling--and most encouraging--however, is that 53.1% of respondents express a "somewhat positive" outlook for the overall medical device/IVD business environment and 17.5% go so far as to categorize their sentiments as "very positive." Likewise, investment firm Leerink Swann foresees that most healthcare sectors will outperform 2009 in 2010. We can only hope. As we march into 2010 with cautious optimism, I would like to thank you all for visiting our blog--launched at the end of January 2009--and relying on Medtech Pulse and MPMN as your medical device manufacturing information sources. We'll see you in 2010! -- Shana Leonard Editor, Medical Product Manufacturing News/Medtech Pulse

The remainder included a start-up working on a converged platform for physicians-patient communications, a smartphone app developer focused on fitness games, a call-in physician consultation service, and a tablet-based patient check-in device for physician offices. $22.1 million -- CardioMEMS develops implantable wireless sensors that track cardiac output, blood pressure and heart rate. Investors: Arcapita Ventures, Boston Millennium, Foundation Medical. $20 million -- Autonomic Technologies develops implantable devices aiming to soothe severe headaches. Lead Investor: InterWest Partners; Also: Kleiner Perkins Also: Polaris Venture Partners, Caueld & Byers, The Cleveland Clinic. $11.6 million -- Phreesia develops automatic patient check-in device and service to improve patient-provider relationship. Lead Investor: BlueCross BlueShield Venture Partners; Also: Polaris Venture Partners, HLM Venture Partners and Long River Ventures. $9.8 million -- BiancaMed develops wireless monitoring devices, including motion sensor that detects heart rate and respiration. Lead Investor: Seventure Partners; Also: ePlanet, Enterprise Ireland, and ResMed. $9 million -- TelaDoc Medical Services is a national network of primary care physicians that diagnose illness, recommend treatment, and prescribe medication over the phone. Lead Investor: HLM Venture Partners; Also: Cardinal Partners, Trident Capital. $7.5 million -- WellAware develops wireless remote monitoring systems that track the daily activities of cared for individuals in the home. Investors: Valhalla Partners, .406 Ventures. $5 million -- Myca Health combines an EMR, a comprehensive admin system, and the ability for doctors to communicate with their patients via a variety of channels. Investors: BlueCross BlueShield Venture Partners, Sandbox Industries. $3.6 million -- Echo Therapeutics develops of a wireless blood glucose monitor for diabetics. Investors include Cotswold Foundation. $3 million -- BL Healthcare's platform, TVx, gathers info from Bluetooth-based wireless medical devices at home and displays it on the TV. Investors: Undisclosed. $1.6 million -- Monica Healthcare develops wireless technology for monitoring the health of expectant mothers and babies. Lead Investor: PUK Ventures; Also: atapult Venture Managers ,University of Nottingham. $535,000 -- Wireless Medcare develops medical applications for wireless and web-enabled devices. Investors: Carilion Biomedical Institute, Optimum Sensor Holdings. $160,000 -- GymFu develops motion-detecting iPhone fitness apps that include peer challenges to keep users motivated. Lead Investor: Channel 4's 4iP. Undisclosed -- eCardio Diagnostics is a service provider of remote cardiac monitoring for arrhythmia diagnosis. Lead Investor: Sequoia Capital. Undisclosed -- MiLife develops a personalized online fitness coaching system and wireless monitoring device. Investors: New Venture Partners, Unilever Ventures. Undisclosed -- Zephyr Technology makes real-time physiological and biomechanical monitoring tech for defense, first responder, training and research markets. Lead Investor: Motorola Ventures.

Organovo (San Diego) has teamed up with Invetech (San Diego) to develop a 3-D medical printer that can produce synthetic blood vessels for use in coronary bypass surgery. The system might also be used to produce tissues and organs for transplants one day. "Building human organs cell by cell was considered science fiction not that long ago," remarks Fred Davis, president of Invetech, a design and contract manufacturing company that built the 3-D printer for Organovo. "Through this clever combination of technology and science, we have helped Organovo develop an instrument that will improve people's lives, making the regenerative medicine that Organovo provides accessible to people around the world." To "print" an artery, researchers begin by taking a cross-section picture of the object they wish to build. "We use that as a map to paint by numbers," says Keith Murphy, CEO of Organovo. The technology lays down cells in three dimensions with accuracy to within 20 µm. The particles used in the construction are made up of stem cells that are formed into tiny spheres and cylinders. Objects take about an hour to build, and then the cells fuse together on their own in the course of 24 to 48 hours, locking the object in shape. Creating an artery for use in coronary bypass surgery involves the use of three different cell types: endothelium cells on the inside, smooth muscle in the middle, and an exterior layer of fibroblasts. The arterial segments are 5 to 20 cm long with an interior diameter of 0.5 to 5 mm. Arteries with larger interior diameters can be built with Teflon or Dacron, but smaller-diameter ones clot when they are built using synthetic materials. The printer fits inside a standard biosafety cabinet for sterile use. It includes two print heads, one for placing human cells and the other for placing a hydrogel, scaffold, or support matrix. Invetech developed a computer-controlled, laser-based calibration system to repeatedly position the capillary tip to within microns, which is necessary to ensure that the cells are placed in the right position. The printed blood vessels are expected to be used in clinical trials in three to five years. "Scientists and engineers can use the 3-D bioprinters to enable placing cells of almost any type into a desired pattern in 3-D," Murphy comments. "Ultimately the idea would be for surgeons to have tissue-on-demand for various uses, and the best way to do that is get a number of bioprinters into the hands of researchers and give them the ability to make three-dimensional tissues on demand." More information on this technology can be obtained in the article "3D Printer Builds Artificial Blood Vessel," published by Information Week.

And improving economic conditions could lead to more elective procedures being performed in 2010 -- particularly orthopedic procedures like hip and knee replacement surgeries.

An innovation process developed by a team at Stanford University (Palo Alto, CA) in collaboration with hundreds of representatives from the medtech sector is described in Biodesign: The Process of Innovating Medical Technologies. The concept is designed to help medical technology innovators increase their chances of success in identifying important clinical needs, inventing new medical devices and instruments, and implementing these advances in patient care. A Web site has been created to serve as a companion to the text, providing readers with relevant links to support the Getting Started sections at the end of each chapter, content updates, short videos of experts in the field, and more. Published in September 2009, the book divides the innovation process into three phases: identification, invention, and implementation. These phases are further subdivided into six stages and 29 core activities, each of which is discussed in its own chapter. The volume includes more than 40 case studies. The book has received high praise from several medtech titans. John Abele, founder chairman of Boston Scientific, says it sums up "everything you ever wanted to know about medical device entrepreneurship and more." Abele adds that senior editors Stefanos Zenios, Josh Makower, and Paul Yock have led an A-class team of experienced device company builders to produce a reference document to guide an aspiring device entrepreneur through all the challenges of getting an idea to market. In the video below, Zenios discusses the concept behind the book.

Although the system isn't meant to be used as a replacement for the alignments that prosthetists do with their own eye, Compas provides the additional data that can help doctors improve the alignment of a prosthesis. Alberto Esquenazi, director of a gait and motion analysis lab in Elkins Park, PA, tells the New York Times that Compas is part of a new generation of tools that offer objective alignment assessments.

Biomedical products provider Admedes Schuessler GmbH (Pforzheim, Germany), hopes to set up shop in Livermore, CA, according to company and city officials. The new plant would generate more than 30 high-salary jobs and would be the first major investment by a business of its kind in Livermore. Because biotech companies tend to cluster, the hope is that others will follow, officials said. The 18-year-old manufacturer of heart valve cages and vein stents stands to receive approximately $150,000 for its efforts "Startups often want to locate near us so it's easier to get (their companies) going," remarks Eric Veit, vice president of Admedes. "Maybe we'll have a new biotech cluster in Livermore." While the German-based company maintains a sales office in Ireland, it derives about 85% of its business from the U.S. market, spurring interest in opening an American-based manufacturing facility, Veit says. In addition, the proximity to Lawrence Livermore and Sandia national laboratories--known hubs for laser technology--makes Livermore a logical location for the company, which uses lasers to cut nitinol and stainless steel for medical devices. Of the 50 jobs the Admedes facility is expected to generate, about 30 would be eligible for the $5000 incentive. Instead of being paid over five years, the $150,000 would be paid at once, helping the company to renovate the site of the future plant. In exchange for getting its money at once, Admedes would sign a promissory note saying it would ramp up to full-scale operations within five years of receipt of the funds or reimburse the city. For more information, go to "Biotech Firm Sets Sights on Livermore" by Jeanine Benca, published in the Contra Costa Times.

A DNA-based assembly technique developed by South Korean scientists can precisely engineer gap distances in nanoparticle dumbbells to optimize the sensing capability of DNA and RNA molecules using surface-enhanced Raman scattering (SERS). "This could lead to a highly sensitive--ideally single-molecule-sensitive--and quantitative biomolecule detection with great multiplexing capability," comments Jwa-Min Nam, an assistant professor in the department of chemistry at Seoul National University. Eventually, straightforward, faster, and more-accurate disease diagnosis at a lower cost could be possible using our approach." Relying on the Raman effect--the change in the frequency of monochromatic light, such as a laser, when it passes through a substance--SERS can identify specific molecules by detecting their characteristic spectral fingerprints. However, while the technology has great potential for chemical sensing, the large nonlinearity of the effect makes reproducible SERS sensing difficult, according to an article at Nanowerk. Reporting their findings in "Nanogap-Engineerable Raman-Active Nanodumbbells for Single-Molecule Detection," the team of researchers show that Raman-active gap-tailorable gold-silver core-shell nanodumbbells (GSNDs) have single-molecule sensitivity with high structural reproducibility. To fabricate a single-molecule detector, the scientists first modified gold nanoparticles with two different kinds of DNA sequences--a protecting one and a target-capture one. A gold nanoparticle with a diameter of 20 nm (probe A) was functionalized with two kinds of a 3'-thiol-modified DNA sequence. Another one, a 30-nm gold nanoparticle (probe B), was functionalized by two kinds of a 5'-thiol-modified DNA sequence. By modifying the molar ratios of the two kinds of sequences, the target-capture DNA per probe can be modified. Cy3, a Raman-active dye, was preconjugated to the target-capture sequence (probe B alone) so that the dye could be located at the junction of the single-DNA interconnected probes A and B. With the Cy3-modified DNA located at the junction site between the DNA-tethered gold nanoparticles--a distance of 3 to 4 nm--the gold nanoparticle surface was coated with silver by means of a nanoscale silver-shell deposition process to form the GSNDs. "We believe that our method and findings could lead to high cross section-based SERS sensing and single DNA detection in a highly reproducible fashion," Nam comments. "Since our DNA-based nanostructure fabrication synthetic strategy is pretty flexible and many other nanostructures could be generated for various other applications, this work could be a breakthrough for the field." Nam explains that his team's results are important for several reasons. First, the DNA-directed and magnetic separation-based nanostructure synthetic scheme opens opportunities in the high-yield synthesis of specific nanostructures for materials science and biodetection applications. Second, unlike the conventional strong electrolyte-induced nonspecific nanoparticle aggregation, the DNA-directed nanodimer assembly method can be easily scalable to produce targeted SERS-active nanoprobes. Third, the scientists established a silver-shell coating-based nanogap-engineering method. Fourth, the nanogap-engineering of GSNDs allows for exploring hot SERS structures in an efficient and straightforward fashion. Fifth, the synthetic and detection strategies provide new ways of overcoming long-standing problems in controlling the nanometer gap, nanogeometry, dye position, and environment in Raman and materials research."

In addition, companies reporting between $100 million and $150 million would pay an excise tax on 50% of their revenues; the rate for companies with more than $150 million in annual sales would be 100%. If approved, the amendment would  make the excise tax a deductible item and would also call for the tax to take effect in 2013, instead of 2010. So here is the question: would these adjustments make a device tax palatable to industry?

Manipulating magnetic forces is becoming all the rage in medical research these days, including using magnets for microfluidic connectors. Finding the idea of innovating disease detection attractive, a team of scientists from Yale University (New Haven, CT) has employed magnetizable liquids to rapidly manipulate and sort various cells. The researchers speculate that this technique could improve the speed and sensitivity of tests for a host of diseases and disorders. The cell manipulation process relies on the use of biocompatible ferrofluids, which consist of magnetic nanoparticles suspended throughout a liquid solution, and a device designed with integrated electrodes. Attracted to the magnetic field generated by the electrodes, the ferrofluid-based nanoparticles gravitate toward it, consequently forcing the nonmagnetic cells to move along specific channels. "It's like the cells are surfing on magnetic forces," explains Hur Koser, associate professor at the Yale School of Engineering & Applied Science. "When we turn on the magnetic field, the nonmagnetic cells are pushed immediately up to the top of the channel." Cells can be sorted based on size, elasticity, and shape, depending on the frequency applied, according to the team. Unlike other cell manipulation processes, the Yale technique doesn't involve the attachment of biomarkers or labels to the cells and neither extensive preparation nor postprocessing is required. More importantly, however, it could expedite and improve diagnostic tests for such diseases as cancer and HIV. For example, current tests may take hours or days to yield results because the concentration of the disease in a given sample may be so low that it takes a significant amount of time to randomly make contact with a sensor. With this technique, however, the nonmagnetic nanoparticles are quickly attracted to the applied magnetic field, thereby effectively ushering the potentially diseased cells directly toward a sensor. The researchers hope that this efficient approach could ultimately improve the sensitivity of existing detection technologies by several orders of magnitude. Potentially able to manipulate and sort red blood cells, sickle cells, and bacteria in a sample, the technology could also allow for the eventual development of portable sensors designed for physicians to bring into the field for point-of-care detection and diagnosis. View the researchers' video demonstrating how microparticles can be directed to specific channels in the ferrofluid.