A new MD+DI ebook sponsored by Cirtec explains how strategic outsourcing partnerships can help you cut costs and fuel innovation.

The medtech industry today is changing rapidly, with products growing increasingly complex and competition getting stiffer. At the same time, medtech OEMs are fighting a war for talent. In this challenging landscape, what's an innovator to do?

The answer is outsource. You can't do it all yourself, so why try? Forging strategic alliances with contract partners whose strengths complement your own is essential to doing business.  

A new MD+DI ebook, Strategic Outsourcing...

November 20th, 2015

OEMs can turn to micromolding to help cut costs and enhance performance of drug-delivery devices. 

Lindsay Mann 

Micromolding can produce parts that are much smaller and more detailed than those possible to make using traditional molding processes.


The area of drug delivery is seeing an influx of innovation, with new solutions aimed at making the process of administering drugs to patients more convenient, painless, and effective. One manufacturing process playing a key role in this evolution is micromolding, an injection molding method...

November 20th, 2015

The American Medical Association is asking for a ban on direct-to-consumer advertising of prescription drugs and devices, but how realistic is it in the era of consumerization of healthcare. 

Arundhati Parmar

Earlier this week the American Medical Association called for an advertising ban on direct-to-consumer promotion of prescription drugs and medical devices.

The concern is that millions spent on such promotion artificially drives up the cost of drugs by increasing demand for them even while there are less costly...

November 20th, 2015

MD+DI associate editor Marie Thibault discussed the future of medtech with TechnologyAdvice Expert Interview podcast

Josh Bland

Marie Thibault, associate editor at Medical Device and Diagnostic Industry, was a recent guest on the TechnologyAdvice Expert Interview Series.

In this episode, we discuss recent trends in FDA...

November 20th, 2015

Startup boards need to realize that the same founder/CEO may not be the perfect leader as the company matures and evolves.

Morten Nielsen

Although some medical device, diagnostics, and other life sciences startups evolve from inception to full-scale commercial success with one CEO, doing so is not common. A startup goes through vastly different phases throughout its scale-up, and few chief executives can transform themselves as their organization dramatically changes.

The highly talked about diagnostics startup Theranos has come under scrutiny lately, with...

November 19th, 2015

A number of medical devices have come under fire this year, but FDA doesn't have "imminent hazard" authority to take a device off the market. Even if FDA did have such authority, would it put it to use?

Jim Dickinson

Unlike its much-earlier (1938) mandate from Congress to manage drug safety, FDA’s 1976 mandate to manage medical device safety gives it no “imminent hazard” authority to summarily remove a sufficiently dangerous medical device from the market.

Perhaps that doesn’t matter much. FDA has only used that authority once—in 1977 to remove the diabetes drug phenformin from the market after it was found to have a 50% fatality rate by causing lactic...

November 18th, 2015

Startups should heed the Theranos warning: When you raise millions of dollars to develop a product, remember the processes that help get that product to market, including proper implementation of a robust quality management system.

David Amor

Theranos CEO Elizabeth Holmes


In the medtech industry, there’s an adage about FDA warning letters and 483s: “It’s not a matter of if but when.”

Many reputable organizations have experienced FDA scrutiny and...

November 17th, 2015

It is paramount for medical device companies to ensure standard purchase and supply documents address key requirements, legal terms, and specifications.

Henry Kopf and Amish Patel

In the medical device industry, most companies are both buyers and seller of various goods, services, and products. Buying and selling these goods, services, and products are basic activities that underpin daily operations of nearly any business. It is important to understand that even the most basic transaction, such as repeat transactions carried out by a form purchase order and order acknowledgement, are in fact legal contracts. The terms a purchaser or component supplier...

November 16th, 2015

Drug-coated balloons will be used more often in treating periperal artery disease in the U.S. at the expense of standard angioplasty and peripheral stents.

Arundhati Parmar

  DCB, drug-coated balloon, PAD
The IN.PACT Admiral drug-coated balloon is inflated and inserted into the blocked artery  


U.S. physicians will increasingly adopt drug-coated balloons to treat peripheral artery disease at the expense of percutaneous transluminal angioplasty and peripheral stents, according to a survey conducted by RBC Capital...

November 16th, 2015

One of clinicians' greatest fears is that they'll be rendered obsolete by new technology. Could it really happen?

Ben Torres

The fear of being replaced pierces right through the heart of technology-resistant clinicians, generating notions that something like the Skynet will somehow terminate healthcare providers and replace them with robots that provide patient care. But I would argue that this is nothing more than a misconception. Perhaps it exists due to provocation from investor Vinod Khosla, who stated that technology would replace...

November 13th, 2015