A keynote by medtech inventor and entrepreneur Dean Kamen prompted one engineer to look back on what inspired his career.

By Bill Betten

Kamen spoke at the MD&M East Exposition in New York City this past June.

I recently attended a speech by inventor and entrepreneur Dean Kamen. Kamen is most famously known as the inventor of the Segway, but in this case he was being recognized as the recipient of the 2014 MDEA Lifetime Achievement Award for his contributions to the medtech industry. Listening to his keynote address at the MD&M East Exposition in New York City triggered some thoughts...

August 29th, 2014

No offense to the Dutch company Medtronic acquired this week, but it's the second acquisition the Minnesota device maker announced a day later that is worth paying attention to.

And it's not just because the second acquisition was more expensive.

Here's the facts:

On Tuesday, Medtronic announced that it is buying Sapiens Steering Brain Stimulation, a deep brain stimulation firm for about $200 million in cash. The company, based in Eindhoven, the Netherlands, is developing a DBS lead with 40 individual stimulation points. The company will become part of Medtronic's neuromodulation business, and in the future serve as a as a global research and development center for that business. The acquisition is a small, tuck-in acquisition that all large companies make...

August 29th, 2014

The folks over at Top Masters in Healthcare have donned their imagination hats to create this thought-provoking infographic about how the hospital room of tomorrow might look like.

As the infographic notes, all these gadgets and devices will certainly not be in one room together - honestly, it might scare off patients if they are taken into a hospital room to find an artificial womb, though many women might cheer. 

But the infographic captures in one fell swoop, what can be achieved in medicine through advanced in technology and science.  


August 22nd, 2014
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