During design verification, how many samples should you use for testing? A consultant answers the question.

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

Today’s question comes from a start-up in Minneapolis, MN:

Q: We are planning to launch a second generation of a currently existing product in our portfolio for plaque excision. The product is currently undergoing design verification, but we do not have a standard operating procedure (SOP) or work instructions that specify sample sizes. During design verification...

November 21st, 2014

Could Republicans' triumph in the midterm elections be the kiss of death to the 2.3% medical device tax?

By Jim Dickinson

One thing the new Republican majority in the U.S. Senate has made certain is the early end of Obamacare’s 2.3% medical device excise tax at the hands of both Democrats and Republicans, despite its negligible impact on anybody.

More a convenient source of political hyperbole than actual economic detriment, the tax became a poster-child of broad unhappiness with President Barack Obama’s management style in general and the reputed ills of Obamacare in particular.

The day before the midterm elections gave Republicans full control of Congress on November 3, the nonpartisan Congressional Research Service provided lawmakers solid backing to repeal the device tax, even if they...

November 17th, 2014

Boston Scientific has had a great year with strong financial results, but from a legal perspective, it seems that someone has put a pox on the house of the the Natick, Massachusetts company.

On Thursday, a federal jury ordered Boston Scientific to pay a total of $26.7 million to four plaintiffs for making faulty transvaginal mesh products. And then a lawsuit filed by Johnson & Johnson over the Guidant acquisition that has been languishing in court for two years is now...

November 14th, 2014

With the pace of innovation in the medical device industry occurring at an ever-faster clip, getting products to market quickly is the name of the game. As a result, many OEMs are turning to automated solutions to replace manual assembly processes—especially when it comes to fluid dispensing.

Automated fluid dispensing technology can speed assembly, reduce risks, and enable increased precision—all of which can help medical device manufacturers get better products in their customers’ hands faster.

To help OEMs looking to transition from manual fluid dispensing to an automated system, MD+DI presents Technology Roundup: Boost Throughput and Improve Process Control with Automated Dispensing Solutions, sponsored by ...

November 12th, 2014

Sometimes the highest level of innovation occurs by merely improving an existing device to meet the user’s needs.

By Annie Diorio-Blum

Recently, there has been a trend among medical device companies to focus on innovation and new product development using a “human centered design” approach. Human centered design can have several meanings, but generally it is associated with frequent touch points with the end user at each step in the product development cycle.

However, despite the opportunities for improvement, companies can be understandably hesitant about transforming their entire product development process to include iterative loops with end-users. They already invest a significant amount of time and money developing medical devices to suit the needs...

November 11th, 2014

AdvaMed has had a presence in China for the past few years, but on Monday, it formalized its desire to be in the populous Asian nation.

The medtech industry association and advocacy group based in Washington, D.C., officially opened its China location in Shanghai at a ceremony in Beijing. The move is not surprising given how the medtech industry is looking east to find growth amid a slowdown and challenging healthcare environment in the U.S. and Europe.  

"Today we celebrate the culmination of months of effort to officially open AdvaMed’s representative office in China,” said Stephen Ubl , president and CEO of AdvaMed in a news release. “The new facility in Shanghai – where many of our member companies have their China headquarters – will substantially enhance the association’s ability to...

November 11th, 2014

Medical device manufacturers need to activate their own processes to adequately anticipate and mitigate the safety, security, and business risks that come with connected medical devices.

By Scott Sheaf

Connected medical devices are opening up new possibilities for patients and providers—and introducing new risks to patient safety, data privacy, and IP protection.

At Black Hat 2014, held in Las Vegas in August, the Medical Device Security Roundtable attracted more than 100 attendees eager for answers. But if they came looking for answers, what emerged were more questions that the industry must address—and soon.

Here are five key questions that medical device manufacturers should be asking themselves now.

Are Existing Regulations Enough?

So far, FDA’s...

November 10th, 2014

A new global Laboratory Analytical Workflow standard aims to provide plug-n-play connectivity between IVD tests and health informatics systems.

By Jean Rhame


The IVD Industry Connectivity Consortium (IICC), in partnership with the International Healthcare Enterprise (IHE), has developed a global interoperability standard that is ready for laboratories and IVD manufacturers to adopt. The...

November 7th, 2014

While highly contagious, it is apparently very difficult to contract Ebola unless you are actually taking care of someone who is sick. So all the hyperventilation around quarantining people is a bit misplaced.

If you are looking for the real killers of the human race, look no further than the following infographic - a collbaoration between Good and Column Five - that gives a view of the pandemics that we have encountered through time.

Click on the image for a larger view:


November 7th, 2014

The term compromise seems to have a new ring in the air given the results of the mid-term election.

And while President Barack Obama was clear that he wasn't going to undo the Affordable Care Act, there may be some space now to consider smaller provisions in the law that are problematic.

Already there are rumblings and speculation about what parts of the law may see a demise and what the Republican-led Senate should ask for.

The device tax one, at least on the surface, may be easier to dispense with. The Congressional Research Service has recently described the tax as "challenging to justfy" even though it says its effects are relatively small.  The...

November 6th, 2014