Image courtesy of Flickr user ultramega.

It’s a noisy world, and that is one of many reasons why in leak testing and other non-destructive testing, “accuracy” is not “accuracy” in the way that a rose is always a rose.

This is what I mean: if someone tells you that their leak tester can deliver 0.05% accuracy full scale for pressure decay leak testing, and let’s suppose...

January 26th, 2012
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Medical Design Excellence Awards 15th AnniversaryThe Medical Design Excellence Awards (MDEA) program is extending the deadline until February 8, 2012.
 
Our goal is to reward the highest caliber medical devices on the market today. You can find out more about our criteria for submission at http://www.mdea.com
 
The MDEA is the only design completion that considers clinical excellence on par with design and usability. It is unique among its class. Winners of the MDEAs demonstrate benefits to patients, and to the overall healthcare system, in addition to employing state-of-the-art design technology, human factors.
 
After the jury selects finalists, winners are...
January 26th, 2012
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AdvaMed 2012: The MedTech Conference has opened the call for program panel proposals for its event held at the Boston Convention & Exhibition Center in Boston, Mass., October 1-3, 2012.

The AdvaMed 2012 conference will feature an expanded eHealth and Health IT track, extended company presentations, a CEOs Unplugged Super Session on the exhibit hall floor, and a special “Salute to Massachusetts” closing reception. The educational program will consist of 11 tracks containing a series of 75-minute panels addressing industry advancements and challenges. Program track topics include: In Vitro Diagnostics, Key Health Policies, Business Development & Finance, Compliance Best Practices, Emerging Growth Company Issues, Executive Workshops, eHealth & Health IT, Legal, Quality,

AdvaMed 2012 encourages prospective organizers to submit panels that are novel, timely, relevant and valuable in educational content, impart helpful lessons learned, or share...

January 25th, 2012
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The much-anticipated (and unbelievably wordy) "MEDDEV 2.1/6: Guidelines on the Qualification and Classification of Stand-Alone Software Used in Healthcare within the Regulatory Framework of Medical Devices" has just been published. Guidance has been sorely needed by industry, as stand-alone software plays an increasingly important role for clinical purposes. As Erik Vollebregt, a Dutch lawyer specialising in the life sciences, remarks: "There is an app for everything these days." How this software meshes with EU medical device regulations that were drafted with embedded or pre-installed software in mind has been a dilemma for manufacturers. This document, although not legally binding, will set some parameters that are expected to be followed within the member states of the European Union.

In a blog post on...

January 25th, 2012
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Industry wasn’t shy about lodging complaints to CDRH this year. The center released its annual report today.
Among 461 reported contacts (53% of which were complaints or disputes), 278 of those came from industry.

Some other numbers you might find interesting: 

CDRH types of complaints 2012

 

CDRH reasons for contacting Ombudsman 2012

January 25th, 2012
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Change seems to be afoot in Japan's regulatory approach to medical technology. Nothing dramatic yet, but, as Japan Medical Design and Manufacturing Technology Editor Miki Anzai has reported on medtechinsider, the government seems to be more receptive to streamlining the product approval process and encouraging innovation. For example, a strategic council was established in January 2011 to promote medical innovation, a key policy goal under the nation’s new growth strategy, and the government has made some efforts to improve the regulatory system to encourage exports and secure a more stable supply of medical devices within Japan. The outreach continues, as the Pharmaceuticals and Medical Devices Agency (...

January 25th, 2012
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VentureBeat recently ran a piece hailing the Quantified Self as one of the big trends of 2012. Based on self tracking, the Quantified Self movement might be characterized as "better living through self measuring" rather than the DuPont slogan "better living through chemistry."

One prominent device that exemplified this self-information-gathering trend is the Fitbit pedometer. The device not only keeps track of the number of steps a person walks but it can also estimate distance walked, calories burned, and even how well one sleeps.

Countless other examples abound: There is the iPhone ECG and non-medical device examples such as the Withings Wifi...

January 24th, 2012
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The medical device industry will continue to experience turbulence in the next decade or so, and India will be among the beneficiaries, according to Professor Balram Bhargava of the All India Institute of Medical Sciences. As noted on the medtechinsider India blog, Bhargava outlined a scenario that includes a thinning medical pipeline in the west, an exodus of manufacturing operations to India, and an ad hoc alliance of China, Israel and India joining forces to develop devices for western consumption during a lecture at Judge Business School, Cambridge University. Bhargava predicted that India is "poised to lead in a decade of frugal and affordable innovation that will impact global...

January 24th, 2012
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this week in devicesAmong stories in this edition of "This Week in Devices," EMDT's Norbert Sparrow covers further developments in l'affaire Pip—the recent breast implant scandal—and the resulting calls for more regulatory scrutiny.

  • Pip Implant Scandal: Fix What’s Broke. Then Stop. (EMDT)
  • Stryker Improves Culture, Engages Employees (Orthotec)
  • Inside the Dexcom Seven Plus Continuous Glucose Monitoring System (MED)
  • Luciano Cattani Takes Over as Eucomed Chief Executive Ad Interim (medtechinsider)
  • St. Jude Responds to Riata Summit (Massdevice)

 —Brian Buntz
 
 
 

 

January 23rd, 2012
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Who deserves the most resounding "boo hiss?" Read below and see who gets our raspberry award. If I missed one, let me know in the comments section. I also wanted to point out that being a "bad CEO" can also mean acting with integrity. See who the best "worst CEO" is for 2011.

 

 

*The Bad

 

Stryker Chairman, President, and CEO, Stephen P. MacMillan

Stryker Corp. announced plans on Nov. 10 to lay off 5% of its worldwide staff (about 1000 people) to cut costs. MacMillan said the decision was a result of “a...

January 20th, 2012
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