Conducting business as usual wasn’t an option for the medical device industry in 2013. Healthcare reform and a challenging regulatory environment, coupled with the growing impact of globalization, consumerization, and mHealth, forced manufacturers to reevaluate their businesses in order to compete in a new era of healthcare. And while an ominous cloud of uncertainty hung over the medtech industry this year, one concept became crystal clear: Adapt or risk becoming obsolete.

The impetus for much of the medtech makeover this year, of course, was the Affordable Care Act (ACA). With its emphasis on value- or outcomes-based healthcare and reducing healthcare costs, ...

December 9th, 2013
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MD+DI takes a look back at the our most popular stories from 2013. Catch up on some of the big stories you may have missed.

 

Futurist Thomas Frey predicted that, by 2030, 2 billion jobs will be lost to automation. Here's one technology that could very much be responsible for this in the manufacturing sector.

 

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December 6th, 2013
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Jawbone has introduced the newest model of its wearable health monitor – Jawbone UP24 - and it may signal a trend toward wearables providing more meaningful outcomes for patients. The new hardware and Apple IOS-based software offers real time, continuous tracking and monitoring via Bluetooth Smart along with continuous feedback, notifications, and challenges toward new fitness and diet goals. The company envisions the new Jawbone as a push into the Internet of Things, integrating the health monitor into your daily activity and with other devices around your home and office.
 
Jawbone UP24 can tell when you're...
November 13th, 2013
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A master harms list can help ensure consistency across all your company's risk management documents and promote compliance by giving everyone the same starting point.

              

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 and second installments here.

Risk management is a sore point for a lot of medical...

November 11th, 2013
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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.

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October 30th, 2013
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