Yesterday, FDA announced the availability of a draft guidance for industry entitled “Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring.”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The draft guidance is available from the FDA website.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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Patent Reform: Strategies to...

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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This week, we featured a story about how a vibrating glove developed at Georgia Tech could enhance the surgeons' dexterity. It could also be used to treat conditions that cause numbness of the fingers. In addition, we added a feature article on toxicology and biocompatibility testing of ophthalmic drug-device combination productions.

August 23rd, 2011
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Intrauterine devices could be poised to become America's most popular contraceptive, thanks to the Affordable Care Act. These devices haven't been able to live up to their potential, garnering fewer than 6% of all contraceptive users in 2005.

But the change could come soon, says a recent article from Slate.

Amanda Marcotte examines the traditional reasons IUDs were overlooked, including the Dalkon Sheild— an IUD introduced in the 1970s that injured women and created a bad reputations for the devices. It also reviews an even more significant barrier to adoption: cost.

But the cost barier is going away. The Department of Health and Human Services recently announced that it would classify contraceptives as preventative care, meaning that by 2013, insurers must provide these services without a copay...

August 23rd, 2011
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Computer security specialist Jay Radcliffe recently got the attention of many—including the popular press—after he successfully hacked his insulin pump onstage as part of a presentation at the Black Hat security conference (for more on that, check out our blog post titled "Insulin Pump Hacking: Sensationalism or Legitimate Threat?").

In response, representatives Anna Eshoo (D - CA) and Edward Markey (D - MA) have asked the Government Accountability Office to investigate the FCC's attempts to protect medical devices using wireless technologies from hacking.

The following is excerpted from a letter the two lawmakers recently wrote to the GAO:

As senior members of the Energy and Commerce Committee, we would like GAO to report on the extent to which FCC is:

1. Identifying the challenges and risks posed by the...

August 22nd, 2011
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