Russia Plans to Release New Medical Device Regulations

Impending new medical device regulations in Russia are expected to make the regulatory system more streamlined. The regulations are expected to be released in the next few weeks. A blog post on medtechinsider details the expected changes in more detail.

One of the reasons Russia is changing its regulatory system is to make it easier for medtech manufacturers to export their products, said Sergey Tsyb, head of Department of Chemical Industries and Bioengineering Technologies within Russia’s Ministry of Industry and Trade, in an interview with EMDT Editor in Chief Norbert Sparrow last November. Medical device registration in Russia is challenging, especially for foreign companies, and you can't easily get answers by picking up the phone. According to the...

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January 27th, 2012
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Opening Up Innovation in Medtech
light bulb
Image from Flickr user Matthew Wynn. 

Co-founder of Sun Microsystems Bill Joy famously said: “No matter who you are, most of the smartest people work for someone else.” That statement has since gone on to be dubbed “Joy’s Law.”

So, assuming that declaration is true, it makes sense to look elsewhere to find genius—not matter where that else may be. There are many proponents backing this notion in, for...

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January 27th, 2012
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Is 2.3% Sales Tax Really Too Much Headwind for US Medtech? Observations from Across the Pond
NIck Woods, Hill Woods Medical Media
Nick Woods was a founding partner of Atlantech Medical Devices Ltd, until recently CEO of Tissuemed Ltd and now director of Hill Woods Medical Media Ltd and Editor of European Medical Device News Site, medlatest.com.

I’ve admired the U.S. medical device industry for 26 years now, from the perspective of being part of it and being an observer of it. I’ve attended congresses and marvelled at the sheer scale of the thing. I mean look at it... AAOS next month will again be a gigantic showcase of everything orthopaedic and goodness knows how many thousands of orthopods...

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January 27th, 2012
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Accuracy Apples and Accuracy Peaches—What Does that Vendor Quote Really Mean?


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...

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January 26th, 2012
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Medical Design Excellence Awards Extended

 

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 announced at a...
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January 26th, 2012
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AdvaMed 2012: Do you have a Panel Topic?

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...

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January 25th, 2012
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European Commission Publishes Guidance on Stand-Alone Medical Software

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...

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January 25th, 2012
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Quick Stats: CDRH Releases Annual Complaints Report

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

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January 25th, 2012
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Japan's Medtech Regulatory Body Goes Back to School

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 (...

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January 25th, 2012
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The Quantified Self, Big Data, and Medicine

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...

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January 24th, 2012
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