It's a question recently asked by Eric Wieferring of the Star Tribune, and one that deserves close consideration.
 
There has been a lot of talk about innovation lately, but Wieferring says in terms of research and development, there is a distinct emphasis on the development part. 
 
And if true innovation is going to happen, we need some disruption. Drawing a parallel from the high-tech computer industry, the article reviews what happened to computers in the 1980s and 1990s.
 
According to the article: 
Computermakers increasingly competed on the basis of product features, such as chip speed and price. Ditto for software firms, which tacked gewgaws onto increasingly clumsy programs. Shrinking profit margins and the dominant positions of industry leaders, such as Intel and Microsoft, made it increasingly tough for new entrants to get on the screens of computer users.

What the...

March 1st, 2011
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A prototype for an implantable eye-pressure monitor for glaucoma patients contains the first complete millimeter-scale computer, according to researchers from the University of Michigan. Such minute computer systems could usher in an array of new computing applications. Three faculty members from the university, professors Dennis Sylvester and David Blaauw, and assistant professor David Wentzloff, are leading the research. "The next big challenge is to achieve millimeter-scale systems, which have a host of new applications for monitoring our bodies, our environment and our buildings,” says Blaauw. “Because they're so small, you could manufacture hundreds of thousands [of the systems] on one wafer.”
 
The researchers recently presented their work at the International Solid-State Circuits Conference in San Francisco,...

February 28th, 2011
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 With Congress set to come back from a recess next week, we figured it would be a good time to take stock of how things look to be shaping up with regard to the ongoing budget battle and the fate of funding for the National Institutes of Health (NIH).
 
Last time we checked, the NIH seemed relatively safe, but was being eyed by Republicans with freshly sharpened scythes. Sure enough, the GOP-controlled House approved a bill last weekend that would reduce the budget by $61 billion, including a reduction in funding for the NIH by $1.6 billion. This was in contrast to the budget request that President Obama had released prior to that, which included an increase in funding for the NIH of $745 million. 
 
Then, on Friday, Republicans announced a stop-gap measure that would keep the federal government operating through March 18, two weeks past the deadline for coming to a funding agreement. Democrats indicated that they...

February 25th, 2011
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Here's something that would make longtime Spiderman baddie Doctor Octopus smile: Researchers at the Karolinska Institute in Stockholm, Sweden succeeded in making people believe that they had three arms.
 
As detailed by Scientific American and The New York Times, researchers had each subject sit and place their hands flat on a table, with a fake right hand positioned next to the real one and a cloth cover making it look like all three hands were natural. When researchers stroked each right hand with a brush, some subjects reported feeling as if they had two right hands. When researchers threatened the fake right hand with a knife, some subjects flinched and had the same physiological reaction they would if a real hand was being threatened. 
 
According to the researchers, the results, which were published in PloS ONE, an online scientific journal, suggest that the brain may be capable of shifting its...

February 24th, 2011
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Much of nuclear medicine depends on a steady supply of an isotope called molybdenum-99—“Mo-99” for short. A byproduct of nuclear fission, Mo-99 is used to produce another radioactive substance, technetium-99m, which is employed in more than 16 million nuclear imaging procedures every year in the US alone. These include sentinel node biopsies in cancer surgery, bone scans, and cardiac stress tests, to name a few.

But the supply of Mo-99 and other radioisotopes has been unreliable at best. All of the Mo-99 used in the US is imported, with the main source being the National Research Universal (NRU) reactor at Chalk River, Ontario. A shutdown for repairs in May 2009 contributed to a global radioisotopes shortage. Although the reactor has been back in operation since August 2010, it is scheduled for closure by 2016.

The shortage showcases a critical gap in the supply chain....

February 23rd, 2011
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If your dream is to get hired by Medtronic, it may be time to ask yourself, what happens to a dream deferred? Medtronic has announced plans to eliminate up to 2000 jobs as it deals with sluggish sales and a stagnant share price fueled by uncertainty over its next CEO.
 
"Everyone is focused on who the leadership is going to be," said Edward Jones analyst Aaron Vaughn. "Until the new CEO comes in and articulates his plan, what we learned this morning is that the company is in the same straits it's been in for the last 24-36 months."
 
Some financial analysts have clamored for the medical device giant to separate its divisions, i.e., separate the cardiovascular units from faster-growing segments for diabetes and pain management. Medtronic isn't convinced. CFO Gary Ellis told Reuters that the advantages of diversification will become apparent to investors over the long term. Besides, when your hands are in so many pots, it can be...

February 23rd, 2011
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The virtual event dubbed Technological Advances in Implantable Devices was a smashing success, at least by my metrics. Those metrics may be subjective, but with over 1000 registered attendees, it’s hard to argue with my logic. The event was co-hosted by our MD+DI, MPMN, and OrthoTec brands.

In a nutshell, we set out to answer the questions surrounding the best way to design a medical device, what materials will be available in the near future, and what risks are involved. If you spent a little time at the event, you would have come away with those answers. Fortunately, the event is archived for six months, so you can still go back and browse around, sit in on the sessions/panels, and browse the exhibit hall.

You can also catch the keynote address, delivered by Venkat Rajan, an industry manager for medical devices at Frost & Sullivan. Drawing...

February 18th, 2011
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 As if anyone needed a reminder, industry and FDA seem to be fairly out of sync when it comes to device regulation. A story in The Wall Street Journal highlights just how significant the distance between these two camps can be. The article takes a look at the ongoing saga of Johnson & Johnson’s Sedasys system, a device that was designed to deliver a sedative to patients but was rejected by FDA during the premarket approval process last April. 

The rejection centered around propofol, the drug that the device was designed to be used with. Propofol is currently supposed to be administered by an anesthesiologist, but J&J’s device was designed so that it could be used without one present. FDA wants data on how the device stacks up against anesthesiologists. The agency is claiming that it told the company about this early in the process, and the company never complied; the company is claiming that it was never told to provide this data, and that it...

February 18th, 2011
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If you don't get our weekly newsletter, you may have missed a pretty fun project I worked on to celebrate my seven-year anniversary at MD+DI.

You can subscribe here, so that you don't miss another newsletter, but I've also included my editor's note, as well as some comments I heard back from readers.

 

2-15-2011

MD+DI Redux: Giving Power to the Present

This week, I have reason to celebrate and reflect. February 9 marked my anniversary at MD+DI. Seven years ago, I was introduced to the world of medical devices and diagnostics. Since then, I have been challenged and fascinated by the innovation this industry brings to healthcare. I feel privileged to serve this industry and the brilliant minds that work so hard to save lives.

To celebrate, I've decided to take a look at some of my favorite features from the past 7 years. I’m...

February 17th, 2011
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This is something I have heard a lot recently. But it’s not true. The Quality System Regulation 21 CFR Part 820 includes requirements for design controls. The regulation requires design validation to ensure your design or design changes will meet both defined user needs as well as your defined intended uses. All of these must be defined in your design input requirements documentation. The regulation also requires that design validation be done under actual or simulated use conditions with production or production equivalent units. If design validation were only user testing, the regulation would not allow for simulated use conditions.

FDA clarifies this in their Design Control Guidance for...

February 17th, 2011
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