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Archive for May, 2009

Medical Devices Adjust Their Frequency

Friday, May 29th, 2009

Established about 10 years ago by the Federal Communications Commission (FCC), the Medical Implants Communication Service (MICS) was established in response to a petition by implant manufacturer Medtronic (Minneapolis) for a designated frequency reserved specifically for implant communication. Since then, the 402–405 MHz frequency band has been allocated to provide “ultra-low-power, mobile radio service for transmitting data in support of diagnostic or therapeutic functions associated with implanted medical devices.”

The FCC has now decided to expand the radio-frequency spectrum dedicated to implants. In addition to the current 402–405 MHz-band, the MICS spectrum will now be expanded to include the frequency bands that  bookend it. The 401–402- and 405–406-MHz bands will now be reserved for medical devices as well.

MEMS Sensor Will Assess Lower-Back Pain

Thursday, May 28th, 2009

As the leading cause of adult disability, spinal conditions are widespread. An estimated 26 million people per year in the United States report suffering from back pain severe enough to cause them to seek medical care. To address back ailments, a sensor supplier and a device manufacturer are partnering to manufacture a MEMS sensor that will assess and treat mechanical lower-back pain.

MEMSCAP (Research Triangle Park, NC), a supplier of MEMS-based products, and OrthoMEMS (Menlo Park, CA), a medical device company that develops biomedical applications for patented MEMS and wireless technologies from the Cleveland Clinic, will develop and commercialize the OrthoChip, a miniature batteryless wireless pressure sensor that will provide an objective measurement of spinal disk pressures. The sensor will detect pressure differences between normal and mechanically unstable spinal segments and communicate the results telemetrically to a readout unit. The technology is expected to provide indications for surgical and nonsurgical treatments.

“OrthoMEMS is an attractive partner because of its strong business and scientific team and the significant commercial potential of its spine application,” remarks Steven Wilcenski, general manager of the MEMSCAP custom products business unit. “This partnership is in line with our strategic commitment to be the lead manufacturer of MEMS in medicine.”

“MEMSCAP has a clear track record of success in developing and manufacturing high-value-added MEMS sensors for medical use,” states Douglas Lee, chairman and CEO of OrthoMEMS. “This strategic partnership adds real value across our full product cycle—from the design-in phase to the market launch of our ground-breaking product that changes the way clinicians interact with the human body.”

e-Zassi Secure Online Community Assesses Medical Device Designs

Wednesday, May 27th, 2009

Contract manufacturer Zassi Medical Evolutions (Fernandina Beach, FL) has launched a spin-off, e-Zassi.com, that will function as an online community that enables subscribers to privately and securely market their medical technologies to potential development partners so that intellectual property is not jeopardized. Currently offering three-month trial memberships, as well as free 12-month memberships for students, the program is designed to facilitate connections between investors and venture capitalists with academic researchers, technology-transfer departments, and service providers.

The e-Zassi program uses an innovation assessment tool to identify what it calls device network attributes to evaluate critical elements of the device design and use those attributes to match the designer with appropriate investors. The information gathered for the device profile is also used by the system to identify elements of the design that are hindering it from being successfully funded, licensed, developed, or commercialized. Such elements that the system screens for include having a clear regulatory classification and direction, as well as identification of material manufacturing, distribution, and sales concerns, associated clinical endpoints to support the safety and marketing claims to earn market clearances, and potential reimbursement and market landscape issues.

The system is currently being used to assess technologies for cardiology, urology, orthopedic, and minimally invasive surgery applications. In light of the recent economic downturn and an overall drop in venture capital the medical device manufacturing industry in the first quarter of 2009, the company hopes that members of industry and students will take advantage of this online community in order to bring together partnerships and get devices to market faster.

Medtech Industry Prime for Investment, Report Says

Tuesday, May 26th, 2009

By now we’re all aware that the medtech industry is not, in fact, recession proof. It is, however, relatively resilient and faring much better than various other sectors. And things are looking up in terms of investment, at least. The Psilos Group (New York City), a venture capital firm focused on healthcare, has released a report examining the issues and trends that will shape healthcare investment in 2009, and has identified the medtech industry as a significant opportunity for investors.

“Healthcare investing will not be for the faint of heart in 2009. The combined impact of a tough economy, spiraling healthcare costs, and a new U.S. presidential administration will result in a significant uncertainty and risk for investors,” the report begins. However, it continues with the assessment that the country “is poised to establish a ‘new healthcare economy.’” Psilos predicts that this year will see the beginning of a 10-year transformational cycle that will drastically alter the healthcare system.

The report cites data from the National Venture Capital Association stating that investment in medical devices fell by 15% in 2008 with a dramatic drop in the fourth quarter. Psilos urges investors to help the industry by challenging investors to expand their annual investment rates to $3.6 billion in medical technologies and goes on to emphasize the investment potential of the medical device industry, owing to its faster growth rate, shorter product development cycles, lower capital requirements, and easier regulatory approval processes, as compared with the biotech or pharmaceutical industries. Furthermore, according to the report, medical device companies do not necessarily “have to be big to succeed,” unlike in other industries, because industry leaders tend to dominate the market through their  constant acquisitions of smaller companies with innovative ideas.

“The risk and reward dynamics of this type of environment are tailor-made for venture capital, and our nation needs us as a partner in this important venture,” the report states. To view a copy of the report, go to http://www.psilos.com/outlook.html.

Georgia Tech has Medical Devices on its Mind

Friday, May 22nd, 2009

The establishment of the Global Center for Medical Innovation (GCMI; Atlanta) was announced this week at the 2009 BIO International Convention held in Georgia this year. Touted as the first of its kind in the Southeast, the center will serve to accelerate the development and commercialization of next-generation medical devices and technology. Located adjacent to the Georgia Institute of Technology (Georgia Tech; Atlanta), GCMI will combine the resources of the university with those of Saint Joseph’s Translational Research Institute (Atlanta), Piedmont Healthcare (Atlanta), and the Georgia Research Alliance (Atlanta).

Among the institution’s offerings will be a medical device prototyping center, production of evaluation devices according to CGMP guidelines, and the ability to manage, coordinate, and aggregate intellectual property from the parties involved. In addition, Saint Joseph’s will make available the opportunity for preclinical studies of new technologies. These combined capabilities will enable the development, testing, and prototyping of new technologies in such focus areas as cardiology, orthopedics, and pediatrics. The center is expected to help device start-ups, as well as established companies, from both Georgia and outside the state alike to actualize their ideas.

“Medical device companies in the Southeast have long suffered a disadvantage compared to competitors that have access to long-established support networks,” says Nicolas Chronos, president of the Saint Joseph’s Translational Research Institute. “The new Georgia center will allow companies to contract with a single entity for comprehensive development activities, create a single location for investors seeking qualified medical device companies, and allow innovations developed by multiple institutions to be combined to create more useful devices.”

Recycle Your Sensors!

Thursday, May 21st, 2009

What do users of electronic medical devices do when they have to replace sensors or batteries? They probably throw the old ones away, jeopardizing the environment. To avoid the harmful effects of placing electronic components in the garbage, Alpha Source Inc. (Milwaukee), a global distributor and manufacturer of new and replacement medical devices and accessories, has teamed with Maxtec (Salt Lake City), an oxygen sensor manufacturer, and Elite Energy Distribution (Milwaukee), a recycling company, to recycle used oxygen sensors and batteries.

With the aim of promoting customer savings and protecting the environment, Alpha Source will give customers a free oxygen sensor for every 12 old ones they send in. Upon receiving the spent components, Maxtec will recover the small amounts of platinum and lead they contain and recycle the metals.

The goal of Alpha Source’s battery recycling program is to provide customers with a safe way to dispose of used batteries. By keeping batteries out of landfills, customers will ensure their compliance with environmental and hazardous-waste transportation regulations and thereby reduce their exposure to liability claims.

Infrared Spot-Curing System Provides Localized Curing

Wednesday, May 20th, 2009
The iCure AS200 provides localized curing for precision assembly applications without heating adjacent components.

The iCure AS200 provides localized curing for precision assembly applications without heating adjacent components.

IRphotonics (Hamden, CT), a designer and manufacturer of infrared-based materials and systems, has completed a successful field trial of its iCure AS200 infrared spot-curing system with ITF Labs, a developer of fiber-optic systems, high-powered components, and optical sensors. The trial was conducted using adhesive 353ND on an optoelectronics device, which required localized curing without heating adjacent components.

Using infrared light to generate heat, the in-line fiber-optic system can deliver faster and stronger cures than traditional curing methods, according to the supplier. It is specifically designed for automated manufacturing processes that require rapid adhesive curing and localized heating of bonded assemblies. The system is both portable and can be integrated into a permanent production line, according to the supplier. “In addition, the in-line fiber-optic light guide allows the curing to be anywhere within the reach of the light guide and makes it very accessible to automation,” says Isabelle Pilon, director of communications for IRphotonics.

For ITF, the iCure system provided the control and flexibility necessary to apply the appropriate heat and duration to thermally cure its components. The company plans to incorporate the system into its optoelectronic assembly processes, according to ITF engineering director Alexandre Wetter.

To provide localized curing, the iCure’s lightguide directs light energy precisely where it is required, explains Pilon. Traditional curing methods, such as thermal ovens, cure with heat, but cannot be localized. The directional aspect of the iCure light allows for bonding and assembly without heating adjacent areas, such as heat-sensitive plastics or other heat-sensitive components. “This is particularly important for disposable medical devices in which microelectronics assemblies are joined to mechanical assemblies where the glued parts need to be brought to a curing temperature that is often beyond the mechanical limits of adjacent substrates,” says Pilon.

Featuring a 200-W lamp with a power density of up to 80 W/cm2, the system also can reduce curing time by up to 75% compared with traditional curing methods, according to the supplier. Compared with curing oven methods, which require cooling and venting rooms, the iCure can be used at a workstation or it can be fully automated  by attaching the lightguide to a robotic arm. It also features a monitoring system that is designed to enhance the unit lamp’s performance and extend its lifespan.

In addition to precision assembly and bonding of semiconductor and other miniature components, the unit can be used for bonding and fixing plastic and glass components and lenses. It also can be used for microsoldering, localized heat welding of thermoplastics, and spot-curing of thermal epoxies.

Metal-Reinforced Silk Weaves New Possibilities

Tuesday, May 19th, 2009

Someone alert Spiderman: The Max Planck Institute of Microstructure Physics (Munich, Germany) has increased the ductility and strength of spider silk by infiltrating it with metal ions. In addition to further empowering fictional superheroes, this breakthrough could pave the way for reinforcing other natural and synthetic materials. “Mechanically improving collagen using our technique might open several new possible applications, like artificial tendons,” Mato Knez, who is heading the research at the Max Planck Institute, told New Scientist.

Metal ion–infused spider silk can be stretched twice as much and can absorb ten times more energy than natural spider silk before it breaks, according to the researchers. To achieve the fortified fibers, the team adapted an atomic layer deposition (ALD) technique, which is typically employed for coating processes involving metal oxides. Dubbed multiple pulsed-vapor phase infiltration by the researchers, the modified technique consists of a 40-second individual pulse duration compared with a duration lasting only fractions of a second for the conventional ALD process. Lengthening the pulse duration enables the metal to actually infiltrate the material rather than just coating the surface.

In order to fortify any fiber in this manner, the natural material must contain proteins as its primary components, according to the team. “We assume that the metal atoms bind the protein molecules to each other,” Knez notes. With this in mind, the researchers hope that their findings could lead to the strengthening of various protein-based biomaterials as well as synthetic materials.


Flying High with Medical Device Materials

Monday, May 18th, 2009

What would you do if you had a Boeing aircraft manufacturing facility in your backyard? You would use it as a jumping-off point for producing medical devices. At least that’s what Wichita State University has in mind. The university’s National Institute for Aviation Research (Wichita, KS) and Via Christi Research (Wichita, KS) hope to receive a $27.1 grant from the Kansas Bioscience Authority (Olathe, KS), which was created by the state legislature in 2004 to help create new jobs in the life sciences industry, to manufacture medical devices using the same lightweight, flexible material used in airplanes.

University researchers have their eyes on aircraft composite material—fiber laid down in a matrix that is then embedded in a plastic or other resin. The lightweight but strong and spongy or flexible material, which has already been developed and tested by the Wichita State aviation institute, can be employed to create devices such as hip replacements, battlefield splints, and hospital gurneys.

Home to several aircraft manufacturing plants, Wichita boasts an aircraft industry workforce with experience developing and making composite materials. However, the industry is volatile, notes Michael Good, director of business operations at Via Christi Research. “On a chart, the manufacturing line for aviation goes up and down like a roller coaster ride, almost every three to seven years,” he comments, “but the line on manufacturing medical devices goes straight up.”

Researcher Paul Wooley said that the authority’s investment committee is recommending giving the project about $4 million a year over five years. The seed money would be used to buy equipment and hire engineers and researchers. With estimates that the project could generate at least 2,600 jobs in the first decade, it is not surprising that as many as 25 local composite manufacturing companies have expressed strong interest.

IVD Industry in Trouble?

Friday, May 15th, 2009

A new report released by Kalorama Information (New York City) states that the in vitro diagnostics (IVD) industry, like many other sectors of the medical industry, could be in store for a challenging few years. With the success of the $47-billion industry hinging on hospital spending, the outlook is not especially sunny, according to the report. “Hospital financing is in jeopardy, income is down and cash is strained. For the IVD industry, this could mean fewer purchasers of equipment and reagents,” says Shara Rosen, lead diagnostics analyst for Kalorama and lead author of the study.

Shrinking stock portfolios, difficulty obtaining credit, and fewer patients with insurance are forcing hospitals to cut spending budgets. Furthermore, inevitable consolidation of struggling hospitals reduces the customer base. Reinforcing these points, the study cites a survey conducted by the American Hospital Association that revealed that 40% of responding hospitals anticipated losses in the first quarter of 2009. But while Kalorama identifies the substantial challenges facing the industry, it also remains optimistic about the viability of the industry. “So much of the IVD market is still critical to the basic investigation of a disease that it’s hard to imagine a cutback in those core areas,” Rosen concludes.