A USA Today article examining the growing popularity of business clusters puts the medical device industry in an interesting light: as the possible cure for what's been ailing the United States' stumbling manufacturing sector. Population centers that were built to support once-great industries, so the thinking goes, will be able to pull themselves back from the brink by becoming the place for, say, medical device manufacturing. 

From the article:

Cluster theory holds that manufacturers and suppliers often want to be in proximity to collaborate on product design. Companies want to be near universities to benefit from the latest innovations. And bigger clusters attract still more companies that seek access to a large pool of skilled workers.

The article focuses on Cleveland, where there has been a concentrated effort to foster a biotech cluster, and Astro Manufacturing and Design, a company based in nearby Eastlake, OH, that is part of...

June 7th, 2011
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 Companies able to use technological advancements to make medical devices more intelligent, faster, and cost-effective have made great strides in the industry. Breakthrough advancements have improved patient monitoring, safety, and outcomes, reduced recovery time, and prevented costly complications.

Although U.S. companies make up more than half of the listing of the top 100 medical device companies, the proliferation of international giants shows that the industry is generating more profits from global outreach efforts. Emerging medical device markets are anticipated to grow at much faster rates than the United States in the years to come. China and India are forecasted to generate double-digit annual growth during the next five years due to their manufacturers' ability to develop quality devices at a lower cost.

The Johnson & Johnson family of businesses remains the world's largest and most diverse medical device and diagnostic company. During 2010,...

June 7th, 2011
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  AdvaMed released a "competitiveness agenda" this week, in which it spelled out six policy recommendations for improving the medical device industry's standing in the United States. Most of the recommendations were fairly standard, including calls for an accelerated device approval process and a boost to the R&D tax credit. One proposal, however, stands out as especially bold: The advocacy group wants the White House to create an "office of medical innovation policy" that would act to ensure that the government's actions are supportive of medical device "innovation."

From an outline that the group put on its Web site:

The office would serve as a focal point for groups and...

June 6th, 2011
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By: Nancy Duarte-Lonnroth 

Medical device makers are already bracing for unprecedented new pressures they expect to face as FDA gears up to make major changes to the clearance process for medical devices under section 510(k). As more-sophisticated devices have come onto the market, FDA has been asking for more data than it might have previously. Amid heightened scrutiny and demands for more information, firms can expect to dedicate more time and money to the clearance process—and that is never good news. In addition, OEMs will need to look beyond their own walls to ensure that their partners are also well-prepared to comply with stricter requirements.

The amount and type of data that may soon be needed to support a 510(k) product review process is somewhat of a contentious issue for medical device companies. But regardless of the kind of data required, the revised process is certain to test—severely, for some—the ability of device...

June 6th, 2011
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With George W. Bush already on tap to speak at its annual conference in September, AdvaMed added another prominent conservative politician to the bill, announcing that Indiana governor Mitch Daniels will join the former president in addressing attendees. Daniels does not quite have the star power of the ex-prez, but he does have the business-friendly Republican bona fides. From the press release:

Daniels’ first legislative success was focused on the creation of the public-private Indiana Economic Development Corporation which replaced a failing state bureaucracy in the mission of attracting new jobs. In each of its first four years of existence, the agency... was associated with more than $18 billion of new investment.

Daniels will, in a fashion, serve as an "opener" for...

June 3rd, 2011
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 Rep. Erik Paulsen (R-MN), a well-known champion of the device industry, says that he's putting together legislation that would revamp the medical device approval process. Paulsen was a witness at Thursday's hearing about the device industry in front of the House Oversight Subcommittee on Healthcare. 

"We're throwing some ideas together right now to help streamline the [FDA], make sure it's a more predictable and transparent process," Paulsen said after the hearing, as quoted in TheHill.com. Paulsen hit the expected notes, citing the faster path to market for devices in Europe. "It's getting harder and harder to bring lifesaving devices to the marketplace in the...

June 2nd, 2011
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Engineers at Vanderbilt University have developed a simple technique for stamping patterns onto a special class of nanomaterials. The development could lead to a new, cost-effective method of creating components for drug-delivery devices and biological sensors. The research was described in the May issue of Nano Letters.
 
Electrical engineering professor Sharon Weiss
The procedure is used with porous nanomaterials, which have unique properties, owing to their sponge-like composition. Potentially suitable for use in a variety of applications, the materials have until present been difficult and expensive to process. Vanderbilt professor of electrical...
June 1st, 2011
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ReGen Biologics filed a lawsuit in the U.S. District Court for the District of Columbia against the FDA, saying its plan to rescind approval of the device is "arbitrary and capricious."

FDA approved ReGen's Menaflex knee repair device in 2008, despite protests by FDA scientists that it provided little, if any, benefit to patients. When Obama-appointed officials reviewed the decision last year, they concluded that the device should not have been approved. They said the agency's review was influenced by outside pressure, including lobbying by lawmakers from the company's home state of New Jersey.

 

Related Stories

FDA Rescinds Menaflex Knee, What About Other Devices on the Market?

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June 1st, 2011
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 A sales rep from Boston Scientific was apparently paid  $200,000 more than he was supposed to be paid, due to an administrative mistake. The device maker is suing Michael J. McCormick to get the funds back. From the Pioneer Press:

The company said it offered to remedy the situation by offering McCormick a new employment agreement that would account for the overpayment, which Boston Scientific says came to $200,605.46. But McCormick rejected the proposal, the lawsuit claims, and contacted the company earlier this month to say he was resigning.

I guess that means he won't be getting a fun, "Bank Error in Your Favor" card. (h/t MassDevice)

— Thomas Blair

 

May 27th, 2011
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According to a Stanford University study that's been making waves over the last few days, a biological agent from Medtronic that is used in back surgeries may be linked to a condition that causes sterility in men. From the Web site MedPage Today

The Stanford team found that in their patients use of recombinant human bone morphogenetic protein-2, or BMP-2—marketed as Infuse by Medtronic—was associated with a measurable rate of retrograde ejaculation, a condition that causes sterility.

Earlier research did not link the product with the condition, but then, that research was performed by doctors with financial ties to Medtronic. And, as they say, therein lies the rub. Because the clinical trials that were performed in order for the product to gain FDA approval did find evidence of a connection. According to MedPage Today, a clinical trial from 2002 found that "five of 78 men treated with BMP-2 developed the...

May 27th, 2011
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