FDA released its draft guidance for CGMPs for combination products in January 2015, painting a clearer picture of the answer to this question.

By David Amor
 

In the “MyQuickConsult Question Grab Bag" series, David Amor, cofounder of medical device consultant marketplace www.myquickconsult.com, will answer one question submitted by clients for the MD+DI readership.

Don't miss David Amor's session on "Dissecting Verification, Validation, and Transfer Phases to Improve Your Current Desing Control Protocols" as part of the...
February 2nd, 2015
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With more than 25 years in business providing medical product design and development to the medtech industry, Fallbrook Engineering has seen a wide array of medical device startups succeed as well as fail.

Whether your product is a simple disposable or a complicated computer-controlled therapeutic system, the secret to developing a successful device is simple – there is, in fact, no secret.

With a detailed plan supported by an undying enthusiasm and the knowledge that you will likely have to work hard for a long time, a successful venture and a new product brought to market is wholly attainable.

Here are five practical points for medical device startups to consider in order to achieve success:

...
February 2nd, 2015
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Editor's Note: Charlie Chi founded OtisMed and sold it to Stryker in 2009. In December, Chi pleaded guilty to three misdemeanor counts of fraud linked to the shipment of OtisMed devices that weren’t approved by FDA to surgeons throughout the US. He is awaiting federal sentencing in March.

By Charlie Chi

Congrats on becoming an entrepreneur.

You have a great idea and now you want to raise millions of dollars to start your venture. The sobering fact is that med tech venture investments and deal flows are at an all-time low. However, recent investments in healthcare by nontraditional players such as Google as well as market consolidation in the medtech industry provide opportunities for entrepreneurs with unique product or service differentiations.

The good news is that there is still...

January 30th, 2015
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The settling of the American West has a lot in common with medtech's move to incorporate wireless technology. 

By Dr. Liam Pender

Wireless connectivity in the medical device industry has introduced turmoil in a market used to predictability. Companies are positioning themselves to make the most of this new opportunity by embracing the new technical challenges, the evolving regulatory climate, and uncertainty about the market.

The settling of the Western frontier in America was a historic saga that has been blown up with heroic tales of romance and violence, but the reality was less glamorous. Western pioneers faced a high level of toil on their journeys, during which nothing was guaranteed except hardship and uncertainty.

There are many aspects of...

January 30th, 2015
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Medical device manufacturers must build robust systems that bring business value while complying with quality regulations.

By Marcelo Trevino

Corrective and preventive action (CAPA) investigations could reveal problems that might take months to fix properly. Perhaps they will reveal the need to hire additional employees, buy new equipment, install new systems, or perform other time-consuming tasks to correct the issue.

  • How many CAPAs are open?
  • How many are closed?
  • Were they addressed in a timely fashion?
  • Are root cause investigations adequate and effective using a structured methodology?...
January 29th, 2015
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Megamergers was the big trend in the medtech world in 2014, and analysts and experts alike believe that the move to a value-based healthcare system will require scale in the future.

Bigger is better.

So it would seem to make sense for smaller players like St. Jude Medical to merge with another company or be swallowed up by a bigger entity.

Apparently not.

In an earnings call Wednesday, Daniel Starks's CEO made it amply clear that he did not share the current conventional wisdom about size and medtech strength in a changing landscape. 

Here's an edited version of the exchange that took place between Deutsche Bank analyst Kristen Stewart and Starks, according to a...

January 28th, 2015
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Recent warning letters have shed light on common mistakes companies make when responding to 483 findings. Here are a few best practices for addressing FDA’s concerns and mitigating the risk of further regulatory action. 

By Kristen Grumet

                            

In 2014, FDA conducted 527 medical device compliance inspections in the United States, almost half of which resulted in the issuance of an FDA Form 483. 

The window for ensuring that FDA will consider a response before taking further regulatory action is a mere 15 business days after the close of an inspection. As such, companies are expected to correct all deficiencies within that timeframe—a difficult and highly...

January 28th, 2015
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The repeal of the 2.3% medical device tax seems more possible now than in the preceding two years because of a Republican Congress and strong bipartisan support.

To take advantage of the wind beneath its sails, AdvaMed, the industry trade group and lobbyist, announced results of a new survey of its membership on Wednesday about what it describes as the damaging effects of the device tax. The Washington, D.C.-based association found that the tax will resulted in 39,000 fewer jobs over the next five years.

Another survey shows a much less dire view of the impact.

AdvaMed's email survey was sent to its more than 300 members between Nov. 20 and Dec. 12 eliciting a grand total of 55 responses. The responding companies...

January 28th, 2015
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In October, there was love in the air in Chicago.

At the annual conference of AdvaMed, the medical devices industry's largest lobby group, you couldn't go two steps in McCormick Place without hearing how great the Food and Drug Administration was. This was in marked contrast to the barbs that has been thrown at the agency over the years from device makers citing charges that the agency was slow in responding, burdensome and inconsistent in its requests for data and profoundly mercurial.

In response to a question from this reporter at the conference about this "love fest" FDA's Jeffrey Shuren remarked that the agency had listened to industry and made changes to become more collaborative, more efficient and less...

January 26th, 2015
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For wearables to catch on, designers need to consider how they will affect the people who use them. 

By T. Grant Leffingwell

Jins Meme, wearable, smart glasses

Jins Meme smart glasses were one of many wearables on display at CES.

 

If the 2015 CES consumer technology show is any indication, wearable computing has entered the mainstream. Wearables aren’t just for wrists anymore. The hottest buzz at CES surrounded gadgets that track us from head to toe, from things like headbands that measure brain waves to slippers that stimulate blood circulation.

Yet for all this consumer demand, the year didn’t start off well for wearables...

January 23rd, 2015
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