metal hip implantOne of the most popular article for the month of August on Qmed was a piece on metal-on-metal implants. The article, written by MPMN editor-in-chief Shana Leonard, argues that the future of metal-on-metal implants was already in question. But the IOM report, she argues, could cast even more uncertainty over their future:     

With the IOM's recommendation to develop a new regulatory framework for these (and other) Class II devices, however, [metal-on-metal (MoM)] implants may face some serious regulatory challenges. While a completely new system is somewhat unlikely, it is clear that change, in some form or another, is on the horizon for MoM implants and...

August 30th, 2011
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As MD+DI editor Thomas Blair writes in a recent news story, it's no secret that many people in the industry were skeptical, even scornful, of the Institute of Medicine's recent recommendations to do away with the 510(k) process. I recently spoke with an industry contact who shared that view. He described the IOM's report as a "disappointment" for industry as well as for FDA. When asked why the New England Journal of Medicine chose to defend the decision, he said that that publication generally takes a pro-government, anti-industry position, so it wasn't much of a surprise.

Another industry professional, who also shall remane nameless, said he didn't "know what the IOM was smoking" when they recommended the 510(k) process be abolished. In his...

August 30th, 2011
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Yesterday, FDA announced the availability of a draft guidance for industry entitled “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.” The document was designed to facilitate the development of risk-based monitoring strategies and plans for clinical investigations of drugs, biologics, and medical devices. In addition, FDA says the document should improve human subject protection and the quality of clinical trial data.

The draft guidance is available from the FDA website.

—Brian Buntz

August 30th, 2011
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This week in medical devices, EMDT's Norbert Sparrow examines health technology assessments at 40, MPMN's Shana Leonard ponders metal-on-metal hip implants, MassDevice looks at how medical device technology could help Steve Jobs, and Forbes.com posits Boston Scientific as a stock to buy. Enjoy, and have a great weekend! 

August 26th, 2011
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FDA’s new guidance on submitting 510(k)s for changes  to an existing device will substantially increase the number of submissions required and cause significant delays for the release of all medical device improvements. This guidance, titled “Deciding When to Submit a 510(k) for a Change to an Existing Device," suggests a new 510(k) is needed whenever a “safety” complaint is fixed, a new alarm is implemented, or a “known failure mode” is eliminated. This is just part of the huge scope change from the previous 1997 version of this document. Unless the industry can mount a substantive challenge to this guidance, it has the potential to significantly slow an already lengthy review process.

The FDA is really out of line on this one; its interpretation of changes that “could...

August 26th, 2011
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 Vention Medical (Salem, NH) is branching out into Europe. The medical device outsourcing company announced that it has acquired Irish medical tubing company Ansamed (Boyle, Ireland). Prior to the move, Vention had eight locations: six in the United States, one in Costa Rica, and one in Puerto Rico. According to a press release, the acquisition is part of a plan to grow globally. 

From the release:

The acquisition of Ansamed will expand Vention Medical's capabilities in the development and manufacturing of specialty catheter-based devices used in a range of interventional and surgical procedures. Ansamed's technology and breadth of experience in extrusion and braided tubing will add to Vention’s strong portfolio of capabilities in balloons, shrink tubing, and catheter assembly. In addition, Ansamed will establish a strategic presence for...

August 26th, 2011
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As part of the strategic realignment, Surmodics announced a reduction of approximately 9% of its total workforce.

Included in the cuts are Philip D. Ankeny, senior vice president and CFO, and Jan M. Webster, vice president, human resources. In conjunction with these departures, Timothy J. Arens, currently senior director and general manager, in vitro diagnostics, has been named vice president of finance and interim CFO, and Joseph J. Stich, currently vice president, marketing, corporate development and strategy, will assume the leadership responsibilities for the IVD business. In addition, Bryan K. Phillips will assume human resource responsibilities.

One of MD+DI's guest bloggers, Josh Simon weighed in on Surmodics realignment:

My humble opinion is that they tried to spread themselves a little...

August 25th, 2011
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IP should start in product development. That's the advice of Andrew Kimmel, a partner at Knobbe Martens Olson & Bear. But just how are product developers supposed to do that? "It's one of those tricky questions," says Kimmel.

The difficulty is that product developers might not understand exactly where patenting fits into the product life cycle, but loss of IP rights could be disastrous for large and small firms alike. 

Join noted intellectual property law expert Andrew I. Kimmel, and Rich Nass, director of content, UBM Canon, for a valuable webcast live on September 13th at 2PM ET.

—Heather Thompson

 

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August 25th, 2011
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Healthcare's traditional resistance to cloud computing is drifting away. According to the CDW 2011 Cloud Computing Tracking Poll, 30% of healthcare organizations are now either implementing cloud-based technology or already using it.

Health Data Management attributes cloud tech growth to the technology's flexibility, cost savings, and convenience.

However, there are challenges to moving to a cloud system, such as loss of control over critical I.T. systems and sensitive data. Even so, there are ways for health care organizations to manage such risks and reap the rewards of the cloud.

I encourage you to read the article from James M. Kunick, to understand the risks, benefits, users rights, and other considerations involved in considering cloud computing.

Heather Thompson

 

August 24th, 2011
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