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Shuren Lands at Next Stop on Regulatory Tour

Like the audience in Minnesota, many attendees at the most recent meeting complained about a host of issues in getting medical devices approved. These problems included delays at FDA, mixed signals, and unpredictability. Manufacturers, particularly start-up firms, said that these issues caused confusions and threatened their businesses.

“To the investors in my company, it has become increasingly clear that prestated and prenegotiated rules of the game can now be capriciously and arbitrarily changed, and that good science no longer suffices for FDA clearance,’’ said attendee Eric Bornstein, chief science officer at Nomir Medical Technologies.

Shuren admitted that “There’s much the center can do to be consistent with industry. We have cases where the manufacturer is right that we can do better.’’

This Week In Brief: June 22, 2010

Bear Power Supplies (Phelps, NY) has achieved ISO 9001:2008 certification at its 32,000 sq-ft design and manufacturing center. The company designs and manufactures standard and custom power supplies for medical applications, among others, including ac-dc and dc-dc convertors.

Action Fabricators (Grand Rapids, MI) has announced the expansion of its medical division with the launch of Laminin Medical Products, which will focus on the contract engineering, manufacturing, assembly, and packaging of medical products. The company will leverage its parent firm's experience in manufacturing adhesive-backed products to serve the wound-care and medical device markets.

Healthcare-management company United American Healthcare Corp. has acquired Pulse Systems LLC (Concord, CA). Pulse Systems provides contract manufacturing services to the medical device industry, focusing on precision laser-cutting capabilities and the processing of thin-wall tubular metal components, subassemblies, and implants, primarily in the cardiovascular market.

Nitinol Devices & Components Inc. (Fremont, CA) has announced plans to establish a new center for R&D and manufacturing in San Jose, Costa Rica, later this year. The plant will produce medical guidewires that combine the company's core expertise in nitinol processing technology with extrusion, coating, and assembly operations for medical device companies.

Precision machining service provider Marshall Manufacturing (Minneapolis) has unveiled a redesigned Web site . Features of the new site include user-friendly navigation, videos demonstrating the company's automated Swiss machining cell, a plant tour of capabilities, company history, equipment list, news, and other information.          

Onyx Medical Corp. Breaks Ground for Headquarters

The new facility represents a $6.5 million total investment, including both the building and capital equipment expansion, and the resulting creation of at least 17 new jobs. 

Agfa HealthCare Enters Agreement with HealthTrust Purchasing Group for Computed Radiography Products

Agfa HealthCare's entire line of CR hardware, software, accessories, and service maintenance agreements is covered in this contract. Effective April 1, 2010, this contract will be the latest in a progression of Agfa HealthCare's ongoing relationship with HPG and its member facilities that spans back to 1999. Agfa HealthCare also has a Film, Dry Media, and Imagers on contract with HPG.

Toshiba Expands Diagnostics at Northstar Health System

With the Aplio MX, NORTHSTAR Health System is able to complete the same advanced ultrasound exams that are usually performed with larger, more expensive ultrasound systems. NORTHSTAR is using the high-end radiology capabilities of the system to perform a full spectrum of exams, including breast, OB, abdomen, vascular studies, and echocardiograms. Additionally, the Aplio MX allowed NORTHSTAR Health System to start a vein clinic to treat varicose vein patients, along with utilizing the system for vein mapping and OR procedures. Ultrasound is particularly beneficial for varicose vein patients, as it clearly visualizes the veins for treatment planning without radiation dose.

Ohio Governor Designates Cleveland Health and Technology Corridor an Innovation Hub

A $250,000 state grant, administered by the Ohio Department of Development, will support the Corridor and bring together the Cleveland Health and Technology Corridor partners, including the Cleveland Clinic, University Hospitals, Case Western Reserve University, Cleveland State University, the Greater Cleveland Partnership, the Cleveland-Cuyahoga County Port Authority, the Cleveland Foundation, the Cuyahoga County Department of Development, the City of Cleveland, MidTown Cleveland Inc. and BioEnterprise.

The goal of the Ohio Hub strategy is for a region to leverage its resources to attract clusters of connected businesses, encourage new investments and an influx of talented workers, and create new opportunities to grow jobs and develop Ohio’s key industries.

To be designated an Ohio Hub, a region must identify core technological strengths that support a nationally recognized industry sector in a defined urban area that includes an anchor research institution. The designation consists of a commitment from both the state and region to work collaboratively and target economic development efforts toward building upon those identified strengths.

The Cleveland Health and Technology Corridor will focus on promoting entrepreneurship, economic development and commercialization in the bioscience field, focusing on the development of medical devices for cardiovascular, imaging and neurostimulation applications. The Cleveland Hub currently includes 75 biomedical companies, 45 high-tech companies and 50,000 healthcare and biomedical employees

New York Times Features Smart Heart Implants

As she says, defibrillators including the Consulta from Boston Scientific, the Cognis from Medtronic, and the Epic from St. Jude Medical  "are part of a new wave of smart implantable devices that is transforming the care of people with heart disease and creating a bonanza for researchers." The devices have transmitters that send data over 20–30 ft, meaning that key data capture, such as weight and blood pressure can happen at the bedside, communicated over the phone.

These devices, which are being tested in clinical trials, have the potential to save lives, reduce medical expenses, and provide guidance for heart patients toward managing their symptoms.

Medical Design Excellence: Award-Winning OEMS

Among those pictured are representatives from Alter G, Angiotech, Bayer ConvaTec, DNA Genotek, Hamilton Medical, HealthCare, Innovia, iRhythm, Jolife, LBT Innovations, Mako Surgical Corp., Oralflo Technologies, Orthocare Innovations, Philips, 3M, and Xhale.

Carbon Nanotube Battery Promises to Boost Power, Energy Storage

The pores between the nanotubes shown in this transmission electron microscopy image can store lithium ions in a high-power battery. (Image by Nature Nanotechnology)

Researchers at the Massachusetts Institute of Technology (MIT) have developed a lithium-ion battery with a positive electrode made of carbon nanotubes that delivers 10 times more power than a conventional battery and can store five times more energy than a conventional ultracapacitor, according to MIT's Technology Review.

Because lithium-ion battery electrodes made from carbon nanotubes offer high surface area and high conductivity, they could improve energy and power density over conventional forms of carbon. But working with the material has proved challenging because most methods for assembling carbon nanotubes require a binding agent that lowers the conductivity of the electrode and leads to the formation of clumps of material that reduce the surface area. In contrast, the electrodes made by chemical engineering professor Paula Hammond and mechanical engineering professor Yang Shao-Horn have a high surface area for storing and reacting with lithium. Because lithium is stored on the surface, it can move in and out of the electrode rapidly, accelerating battery charging and discharging.

The MIT researchers' electrode assembly process creates dense, interconnected, porous carbon-nanotube films that do not require fillers. The scientists begin the process by creating water solutions of carbon nanotubes with positively and negatively charged groups. Then, they dip a substrate into the two solutions, causing the nanotubes, attracted by differences in their charge, to cling to one another in uniform, thin layers. When they are heated and removed from the substrate, these films can store a great amount of charge and release it quickly, acting like an electrode in an ultracapacitor.

In an article in the journal Nature Nanotechnology, the MIT team demonstrates that lithium ions in a battery electrolyte react with oxygen-containing chemical groups on the surface of the carbon nanotubes in the film. Because of the large surface area and porous structure of the nanotube electrodes, there are many places for the ions to react. They can also travel in and out rapidly, giving the nanotube battery high energy capacity and power, Shao-Horn says.