In 2011, the latest versions of IEC 60601-2-25 ed. 2.0, Electrocardiographs; and IEC 60601-2-27 ed. 3.0, Electrocardiographic Monitoring Equipment, were released. Both standards have the identical test for defibrillation protection, and they have been significantly revised from their previous versions for this test. A new switch, named S3 in the standard has been added, a resistor value has been changed from 470k to 390k, and the circuit topology has been changed, for the common mode test. For both common and differential mode tests, the test requires that the test pulses be delivered in a proscribed time period of 20 seconds between pulses. For the common mode test, five pulses of each polarity are delivered with 20 seconds between pulses. For the differential mode test, the test is repeated for each lead wire in turn, until all lead wires are tested.

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February 28th, 2012
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Bill BIll BettenBetten recently attended the 5th International Advanced Technologies and Treatments for Diabetes (yep, the poor guy just had to go to Barcelona). Afterwards, he was kind enough to provide MD+DI with his observations from the event, highlighting trends in the sector.

What were some diabetes trends that you noticed?

A keynote talk was given on “What Next for Diabetes Technology: Strategic Directions for the Next 10 Years,” by J. Pickup of London. The five highlighted buzzwords included cost effectiveness, nanomedicine, mobile health, optical sensing, and closed-loop insulin delivery. A point that he made is that insulin pumps, for...

February 28th, 2012
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When was the last time your company spent money on market data? How much did it spend and—perhaps most important—what did you do with the data? Research is useless unless it inspires timely action.
 

But access to actionable data is rare in the medical device industry. Research reports can be obtained, sure. But often the materials that companies pay $1000–$4000 for comprises charts and analysis cobbled from public data, and perhaps a survey. The analysis of such reports might be interesting, but they provide only a snapshot.
 

What is really needed is a system that helps build a business plan. A universally recognized data source with the capability to capture a complete view of the medtech industry has been a key missing ingredient. That’s why UBM Canon decided to seek...

February 24th, 2012
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The hype over “bioabsorbable” stents has heightened after Abbott’s vascular stents obtained a CE mark last year and will reportedly soon be available in Europe. But, here in Japan, a very small company has already developed its own version of bioabsorbable stents. The Japanese stents garnered a CE mark in 2007, and are now sold in 11 European countries and Turkey.  

It’s amazing that the virtually unknown Kyoto-based company is in the vanguard on bioabsorbable stent development.
When I interviewed company president and co-developer of these novel stents, he showed great pride and confidence in his stents, but he also suggested he wanted to keep a low profile in the U.S. Why is that? He replied jokingly, “We don’t want to be like Gulliver in Brobdingnag, [the fictional land in Jonathan Swift's satirical novel Gulliver's Travels occupied by giants.]”
 
For more about what he has to say about...

February 21st, 2012
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After a turbulent few years, J&J's CEO William Weldon is resigning from his position, says CNN. Alex Gorsky will take over in Weldon's place.

Weldon has taken serious criticism for the company's missteps, and was called out for complacency by Sydney Finkelstein, just a few months ago in the New York Times. Weldon was with the company for more than 40 years. He was one of the most respected executives in the industry for a long time.

The company’s recent successes have been primarily attributed to Gorsky and Sheri McCoy, who were seen as front runners to take over the company upon Weldon's anticipated retire. “The company is giving the reins to a coleadership that promises to make fearless decisions,” Richard Lincoff told me...

February 21st, 2012
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As Atul Gawande, MD has explained in The Checklist Manifesto, the medical field has learned much from the use of checklists in aviation, which have been used for decades to reduce errors. In medicine, checklists are used, for instance, in surgery to reduce morbidity and mortality.

In addition, simulation technology, which has been used extensively in aviation, is also increasingly being adopted by the field of medicine, where physicians are using it to train for difficult procedures.

Andrew Dallas is a pilot and the president and CTO of Full Spectrum Software. 

The iPad has shaken things up in...

February 21st, 2012
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Everybody knows that they are supposed to eat 4-5 servings of fruit and vegetables per day, but how many people actually do it? Some of us try, most of us fail, and we tell ourselves we’ll do it right in the future. There is an analogy in product development that is very similar – building solid requirements prior to development. They are the vitamins and fiber that lead to a healthy product! Anyone who has been building products recognizes the need for a well-written product requirements document (PRD) before starting design and build of their product – most people have been burned by late requirements before. So why do companies continue to throw money at prototypes and design/build cycles before they’ve gathered requirements from stakeholders and customers? 

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February 17th, 2012
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As a solutions-oriented designer, developer, and manufacturer of surgical devices, Pro-Dex, Inc. is focused on providing the best options for our customers. In most cases we have the in-house expertise to deliver cost-effective, efficiently machined parts to our customers.

However, when a situation arises where our capabilities might not be the best option for a customer or potential customer, we look to industry partners to help us strategically provide the most innovative, economical solution possible.

This is why at this year’s MD&M West, we reached out to Phillips-Medisize Corporation. Phillips-Medisize was recommended to us by another industry partner in our search to learn more about...

February 16th, 2012
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Most companies understand the significance of strategic marketing, but the medical technology industry’s cautiousness to protect intellectual property and avoid legal ramifications can often restrict effective, innovative marketing efforts. This is why it has been refreshing to hear conversations on MD&M West’s exhibit floor and in Innovation Briefs presentations about the importance of “openness” in the medical technology sector—especially when it comes to marketing.

As one Innovation Brief speaker noted, even though medical technology is a large, $350 billion market, it is a highly fractured industry, with companies fiercely protecting their turf.

However, Medtech’s historically limited approach to collaboration and one-size-fits-all approach to marketing is antiquated in today’s high-tech, high-touch industry.

With healthcare reform, diverse constituents with different needs, and a host of other challenges facing...

February 16th, 2012
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BY Tricia Rodewald 

In an era of stringent FDA regulations, limitations to innovation and a looming medical device tax, outside-the-box thinking is what ultimately enables medical technology companies to offer the most value to customers and patients.
 
This is why our company, Pro-Dex, Inc., a medical device design, development and contract manufacturer, looks to maximize trade show events, like MD&M West, by aligning with companies that demonstrate creative problem-solving, processes and strategic partnerships.
 
Two companies that we met at this year’s MD&M West whose technologies and tenets reflect out-of-the-box thinking are: Source Scientific (Irvine, CA) and Minnetronix (St. Paul, MN).
 
 
Source Scientific
 
Efficient processes are crucial to a medical technology company’s ability to...
February 16th, 2012
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