Op-ed contributor Jeffrey R. Ellis says despite its flaws, the medical device and diagnostic industry has a vested economic interest in making healthcare reform a success.

By Jeffrey Ellis

It is said that “all politics is local.” Similarly, all medical care is personal. The fundamental relationship in medical care is between the patient and physician. This has been forgotten in the national effort to extend healthcare security to all Americans. The main flaw in the national insurance enrollment effort, aside from the technical problems of the Web site, is that it basically links patients with insurance companies, not with doctors or accessible patient treatment centers.

Far better would be an effort to engage physicians and affiliated hospitals and clinics to sign up patients, as is currently done for Medicare and Medicaid patients, and for prospective patients to find out what local medical services providers will...

November 8th, 2013
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Mining risk management files, postmarket data, and input and output can lead to surprising discoveries that will improve your products.   

Editor's note: This is the second installment in David Amor's Med-Dev from Scratch: Compliant Innovation column dedicated to helping entrepreneurs build their medical device companies in a compliant and streamlined way. Read the first installment here.

A former colleague once asked me why companies weren’t using risk management to create more innovative products. A bit confused, I pressed her to continue the thought process that I clearly didn’t understand. Using failure mode and effects analyses (FMEAs) to revolutionize the pacemaker industry? Launching mitigations and risk controls that are awarded multiple patents? As preposterous as these concepts sounded to me at the time, the...

November 4th, 2013
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MD+DI's Must-Read Stories – October 2013
 
Catch up on seven of MD+DI's most popular, interesting, and informative content from last month.
 
 
November 4th, 2013
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Despite unprecedented advances in laboratory medicine, the Medicare agency is dealing with the in vitro diagnostics boom with an unprecedented series of roadblocks, odd rules, and price cuts.

By Bruce Quinn, Foley Hoag LLP

Bruce QuinnWe are living through a period of unprecedented advances in laboratory medicine, as evidenced by a just-released FDA report, “Paving the Way for Personalized Medicine.” In this report, FDA describes how it is generating informative new guidance documents, improving the internal collaboration between drug and in vitro...

October 30th, 2013
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Jimmy is an energetic 6th grader who loves soccer, video games, and (secretly) a girl one year ahead of him in school. He also has asthma attacks and often gets wheezy at night—so much so that he has trouble concentrating on his homework. His family has a cat, but he’s allergic to it; spending too much time near the cat often causes him to have a major asthma attack that lands him in the hospital.

Jimmy’s mom reminds him each morning to use his inhaler, but sometimes she leaves for work before he goes to school and he forgets. He has a reliever in his school bag that his teacher reminds him to use, but sometimes it runs out. Jimmy’s soccer coach often has to bench him because he’s out of breath.

At a workshop on designing next-gen medical devices at MD&M Minneapolis, attendees were tasked with designing a new device to help Jimmy manage his condition.

...

October 30th, 2013
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By Ali Tinazli, Sony DADC BioSciences

Ali TinazliThe translation of innovation from academia to a commercial setting is becoming increasingly complex owing to the sophistication of new solutions as well as the challenging financial and regulatory environments. To make that leap, products must demonstrate the potential for financial sustainability in the marketplace and, of course, high technical performance. In order to achieve the latter, however, new solutions are often based on nano-, micro-, or biotechnologies, which, in turn, pose challenges to entrepreneurs in terms of the definition of the product specifications, manufacturability, and competitive cost structure. Here are some tips for overcoming these three potential barriers to success.

Product Specifications: Depending on...

October 29th, 2013
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By Lisa Benson, Technical Writer, Multisorb Technologies

In vitro diagnostic (IVD) devices play a pivotal role in diagnosing and monitoring the health of millions of people globally. As such, ensuring the reliability, accuracy, and viability of a given device is absolutely critical. An IVD device will only remain as reliable as its packaging permits; therefore, it is imperative that the product integrity remains intact from the production line through the distribution chain to the end-user. 

Learn more about the important role sorbent solutions play in IVD devices in a related presentation by Adrian Possumato, vice president of healthcare packaging at Multisorb Technologies, at the ...
October 29th, 2013
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People often insist that the Affordable Care Act will bring monumental change to the U.S. healthcare industry. But beyond predicting cost cutting and accountable care, most don’t offer many specifics about what that change will look like.

Yesterday at MD&M Minneapolis, Nicholas Donoghue, associate principal at business advisory firm McKinsey & Co., looked into his crystal ball to give attendees an idea as to how the law is likely to impact hospitals in the coming years.

Some of his predictions were surprising.

Hospitals’ margins will improve in the short term but degrade in the long term.

As uninsured people gain health insurance through the...

October 29th, 2013
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An open letter to Margaret Hamburg and Jeffrey Shuren wonders whether the medtech industry is a resolute warrior or an idealistic fool in the quest for collaboration with FDA.

By Mark DuVal, DuVal & Associates, P.A. 

Despite industry’s current focus on the negative impact of the medical device tax, that policy issue pales in comparison to more-foundational problems with FDA. The agency poses an escalating threat to industry through its inconsistent interpretations of regulations and guidance documents; delays and inability to make decisions; general risk averseness; increasing and unreasonable expectations for data; and desire to regulate every aspect of the development, study, manufacture, and commercialization of medical devices.  

So...

October 28th, 2013
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A debate at the 25th annual TCT Conference on the merits of robotic surgery for the treatment of mitral valve disease actually came to more common ground than conflict. While the patient perceptions of robotic surgery can be debated, both panelists agreed on a key point – robotic surgery is effective, but it is not for every patient and it is certainly not ready for prime time.

A. Marc Gillinov David H. Adams
Daytime television has treated robotic surgery...
October 28th, 2013
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