By Scott Sheaf
The keynote address at this year’s Black Hat network security convention was delivered by Dan Geer, chief information security officer at venture capital firm In-Q-Tel. In-Q-Tel works closely with the U.S. Intelligence Community and Geer is known in the security industry as a visionary and thought leader. In his address, “Cybersecurity as Realpolitik” Geer laid out a set of recommended policies that he believes will help mitigate the ever-growing problem with software security. As a medical device developer, I found his recommendations far-ranging and somewhat unrealistic, but nevertheless, as keynote addresses should be, his ideas are very thought-provoking.
August 19th, 2014

Late last week news emerged that Medtronic hired a lobbying shop run by former senators Trent Lott and John Breaux to lead an effort to block Congressional efforts to make tax inversions more difficult.

More specifically the goal of these lobbyists would be to forward the medical device maker's agenda to acquire Ireland-based medical supplies maker for $43 billion. If successful, this would be one of the largest tax inversion in American history, and Congress is up in arms about corporations trying to escape high taxes in the U.S. and moving off shore for a...

August 15th, 2014

Parks Associates has created this infographic recently that shows how heads of U.S. broadband households are using online digital health tools and services.

But a more detailed blog post from the market intelligence company provides a more specific answer about what specific activities U.S. consumers have performed under the overall umbrella of online health services. The answers are based on a survey the company conducted in the fourth quarter of last year and the infographic is based on that. 

Here's what Parks Associates asked consumers and how they responded:


August 13th, 2014

A well-written procedure documenting the complaint management process, including the creation of a complaint form, is required by the QSR. 

By Bob Mehta

I have always experienced great difficulty in trying to fathom why medical device manufacturers fail to invest in developing effective approaches for complaint management. After all, when a customer calls to complain, the information garnered as part of the complaint process can be used to strengthen the organization as a whole, improving the product performance and the quality management system (QMS).

In the U.S. medical device industry, not only is the effective handling of complaints warranted, it is mandated by FDA, with the requirements delineated within the agency’s quality system regulation (QSR). For those of you...

August 11th, 2014

As autonomous, intelligent medical devices that effectively manage chronic conditions without constantly reminding patients of their disease become reality, will human factors engineers still be needed?

As patients and caregivers become key stakeholders, human factors engineering and user-focused methods are becoming increasingly important in medical device design. But will these practices soon be rendered obsolete?

During a panel at the MD&M East conference in June, Steve Wilcox, principal and founder of Design Science, made a quip in response to being asked about the future that had a room full of human factors engineers nervously laughing.

“Where things are going is for all of us human factors types to be out of...

August 8th, 2014

The Center for Drug Evaluation and Research regulates advertising and promotion of drugs more strenuously than CDRH regulates devices. Maybe it's time for a change.

By Jim Dickinson

Historically, U.S. law has given the Federal Trade Commission (FTC) primary authority to regulate the advertising and other promotion of prescription medical devices not otherwise restricted by FDA. 

Keep up to date on all the goings-on at FDA by attending the MD&M Minneapolis conference October 29 & 30, 2014.

Restriction most commonly occurs in the conditions of...

August 5th, 2014

Having already conquered social media, original Star Trek star George Takei has boldly gone where innovators hope many physicians and patients will be going in the near future – the world of mHealth. Takei visited the AAPR's Innovation@50+ Health Expo in Boston and got a crash course in digital health from Quantified Care, a company working to launch the first curated mobile health marketplace for physicians and patients, when he underwent a “smartphone physical” featuring devices like the AliveCor EEG, CellScope, and the Mobisante iPhone-based ultrasound.

 Watch as Takei takes his physical and explores Boston's booming biomedical industry.

August 5th, 2014

By Noreen King

Noreen King

Like many U.S.-based contract manufacturers, I have been a big proponent of onshoring manufacturing for over a decade.

And it’s easy to see why. When you consider the quality and communication challenges, increased time to market, rising wages in China, the increased cost of shipping, and political and environmental factors, one thing becomes clear: Onshoring is smart business.

Meet U.S.-based contract manufacturers at the MD&M Minneapolis...
August 4th, 2014

Offshoring can help manufacturers cut costs and get their products to patients in emerging economies around the world. But it's not the right move in every instance.

Get more advice on best practices for medtechoutsourcing at MD&M Minneapolis, October 29 & 30, 2014.

In general, says Julia Wall, an analyst with Decision Research Group, medical devices of moderate complexity are best suited for outsourcing to offshore entities.

“If you look at FDA’s classification of devices, Class I, II, and III, the devices...

August 1st, 2014

In a recent conversation with a device industry professional, it became clear how the reality on the ground for device vendors has shifted in the last few years.

The gentleman enlightened me that the nonprofit Fairview Health Services, a large health system in Minnesota, had dramatically reduced the number of orthopedic vendors.

“I would love to know why they did that,” said Shaye Mandle, President & CEO of Lifescience Alley, in a recent interview.

Mandle knows the answer of course - every hospital and health system in the country is scrutinizing costs, and in many cases either pressuring vendors to lower their cost or share in some operational risk.

Nonetheless, it’s still an interesting exercise to know how hospitals are making these...

July 31st, 2014