This Week in Devices [ 5/25/12] : Are Medical Devices a Ticking Time Bomb?

 

Medical Devices – A Ticking Time Bomb?

  • The Economist examines the potential dangers as medical devices become more digitized and networked

    Source: The Econonmist



     

Medical Device Manufacturers get a Little Help from NASA

  • Since they aren't launching space shuttles anymore NASA engineers are reaching out to other industries to provide assistance and expertise – including companies in the medical device sector.

    Source: ...

May 25th, 2012
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Amy Klobuchar (D-MN) has been a staunch supporter of the medical device industry since she was elected to the U.S. Senate in 2006. Last year she joined with Scott Brown (R-MA) to form the bipartisan Senate Medical Technology Caucus to raise awareness about issues faced by the industry. She has also sponsored legislation to streamline FDA; introduced the Innovate America Act, which calls for R&D tax credits for companies; and is fighting to reduce the medical device tax.

MD+DI: How did you first become involved in the medtech industry?

Klobuchar
: Minnesota is a national leader in medical device innovation with companies small and large creating good jobs and life-saving products. I have worked with our business leaders to help foster an environment that promotes...

May 22nd, 2012
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Kathryn Stecco, MD is a medical device executive, entrepreneur, and a surgeon who is the co-founder and chief medical officer of Altai Medical Technologies (San Jose, CA), which specializes in mobile health, medical device, biotech and health information technologies. At Altai Medical Technologies, Stecco leads medical research, guides in vitro and in vivo pre-clinical research, and develops domestic and international clinical and regulatory strategies.

She also works as a medical consultant EndoShape Inc. (Boulder, CO) and Allurion Technologies Inc. (Wellesley, MA). In addition, Stecco serves as the medical director of Nfocus Neuromedical Inc. (Palo Alto, CA). She also has a concierge medical practice and operates a sole proprietorship that specializes in due diligence on emerging medical technologies for venture capital firms, medical device...

May 21st, 2012
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How can the Medical Industry be More Like Facebook?

  • In the wake of Facebook's IPO, Forbes' Matthew Herper wonders if the medical industry can inspire the same level of innovation and investment as the social network.
 

Patient's Voices are Changing Medical Devices

 

Medical Devices...

May 18th, 2012
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FCC chairman Julius Genachowski has announced at a press conference today that the FCC will consider opening segments of the wireless spectrum for monitoring medical patients. If approved next week at the FCC's commission meeting it will make the U.S. the first country to allocate wireless spectrum for medical body-area networks (MBANs). The networks will allow information from mobile and wireless-enabled medical devices to be transmitted in hospitals, doctor's offices, and, eventually, even patients' homes. Device manufacturers will be able to streamline their product development and enjoy increased spectrum capacity and reliability.

Currently almost 50% of all patients in US hospitals are not monitored. In his statement Genachowski says that MBANs will enable patient monitoring in real time that is both accurate and...
May 17th, 2012
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Leslie A. Saxon, MD is the chief, division of cardiovascular medicine at the Keck School of Medicine of the University of Southern California, and the executive director and founder of the USC Center for Body Computing.

The USC Center for Body Computing (CBC) is a wireless health innovation center. The USC CBC brings together the Keck School of Medicine and USC's world-renowned School of Cinematic Arts with the university’s schools of business and engineering. The CBC creatively synthesizes medicine, engineering, business, communications, and entertainment arts into new paradigms that will innovatively enhance the quality of life, especially for the...

May 17th, 2012
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An NIH-funded trial is investigating the use of the BrainGate neural interface system, which would enable paralyzed patients to control a robotic arm solely with the mind. In a recent study document in Nature, two patients with tetraplegia were able to use the system to make complex reach-and-grasp movements. To accomplish that feat, neurosurgeons implanted into the motor cortex recording devices that are about the size of a baby aspirin. The electrodes were then able to record the patients' neuronal signals that fire when the patient intends to move. The resulting impulses are translated into the movement of an external robot. 

Brian Buntz is the editor-at-large at UBM...

May 16th, 2012
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No one ever said product development is easy. Medical device development in particular is a very complex and variable process with threats to success emerging at many points along the way. However, there are components you can put in place to ensure the smoothest path possible.  
 
1. Wait Until the Technology is Really Ready
A common mistake is to move a technology out of research and into development before it is ready. Having a technology working on the bench is far different than proving it can be commercialized while still maintaining adequate performance. Take the time up front to turn a proof-of-technology breadboard into a proof-of-commercialization breadboard. Use this breadboard to analyze critical performance areas.
 
For example, if the technology is going to be used in a small, hand-held product, perform power consumption calculations so...
May 16th, 2012
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Christy Foreman, director of the Office of Device Evaluation at CDRH
As director of the Office of Device Evaluation (ODE) at CDRH, Christy Foreman is responsible for one of the most critical departments at the center. She has been with FDA for 16 years, gaining extensive experience as a reviewer in ODE’s Anesthesiology and Defibrillator Devices Group, a deputy director in the Office of Compliance, and then the deputy director for science and regulatory policy at ODE.
 
Foreman has an impressive resume, but her advice to young professionals is simple and straightforward—find a mentor, someone who can serve as a guide before you navigate into the complex...
May 15th, 2012
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Jane Orient, MDIn February, MD+DI interviewed Jane M. Orient, MD, an author and a practicing physician who had, at the time, just written a piece titled "Shall We Take the Liberty of “the 1%”?" In the interview, Dr. Orient shared her thoughts on everything from the physician shortage to electronic medical records (EMR).

A reader wrote in expressing his thoughts on the article: 

I find the opinion article by Brian Buntz/Dr. Jane Orient interesting more for the attitude it displays than for the content itself. Before dealing with medical devices, I spent a long time in the...

May 11th, 2012
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