This Week In Devices [4/13/2012 ]

TEDMED 2012 is Underway!


Is St. Jude Trying to Hide Defective Heart Devices?

April 13th, 2012

In a Q&A session at TEDMED, Larry Brilliant, president and CEO of Skoll Global Threats Fund, asked FDA commissioner Margaret “Peggy” Hamburg, MD how she envisions balancing regulatory responsibilities “with the need to move innovative products through the pipeline.” Achieving that balance is one of the agency’s highest priorities although it remains a challenge, she said.

 Peggy Hamburg at TEDMED
 Larry Brilliant and Margaret Hamburg discussed the regulatory timelines of both drugs and medical devices at TEDMED. 

Hamburg stressed the importance of “smart regulation” in levelling the playing field for developers of innovative technologies...

April 13th, 2012

We take it as a matter of fact that technological devices generally get more powerful and less expensive over time. And, over the years, it has become apparent that electronic devices can radically change countless facets of our lives—from picking out music to finding out how to get from point A to B.

But even the latest electronic devices are essentially “smaller versions of the rigid bricks they have always been,” said David Icke, CEO of conformal electronics maker MC10, speaking at TEDMED on April 11 in Washington, DC. “They are solid, boxy, and often uncomfortable to use.”

David Icke at TEDMED 2012

These drawbacks also apply to medical electronics, Icke pointed out. Home-monitoring devices can be cumbersome to lug around. And, in the hospital, electronic devices require that...

April 11th, 2012


Eventually, I’ll have something to say about device usability. This time, though, I want to talk about something else—the usability of FDA submissions. Most of the people working on medical devices have gotten the message that medical devices need to be reasonably easy to use, at least far as ease-of-use relates to safety. It follows that it’s necessary to apply a methodology:
Stephen B. Wilcox, Ph.D., FIDSA
  1. Studying how devices are used under real-world circumstances (i.e., contextual inquiry). 
  2.  Applying technical information about users, both “physical human...
April 11th, 2012

The crowd at TEDMEDTEDMED 2012 kicked off yesterday in Washington, DC, with a session addressing the theme of “embracing the unconventional.”

The four-day conference brings together experts from a variety of disciplines to share knowledge and imagine the future of healthcare. The first session featured acrobatic and musical performances and talks by a lawyer, a graphic designer, and the founder of a healthcare nonprofit.

People working in healthcare tend to connect in silos, with specialists interacting mainly with others in the same field, said TEDMED curator and emcee Jay Walker. The goal of conference, he said, was to assemble a diverse crowd to...

April 11th, 2012

Five Questions with Tim Mohn, Associate Director, Enterprise Quality Management Systems at Johnson & Johnson

1. Why are customer complaints important to medical device companies?

Device manufacturers are required to record, track and trend customer complaints according to the Quality System Regulation (QSR) defined in 21 CFR Part 820. In addition, FDA Part 803 regulations require firms that have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify the FDA of the incident.

2. How do device companies typically manage this process?

This varies by company, but most struggle to maintain global visibility to the entire complaint process. Many companies have multiple layers of systems, from call intake systems supporting regional call centers to service and repair systems to inventory systems to CAPA systems. These are all designed to meet a specific business need, but none are designed to...

April 10th, 2012


Beginning April 10 MD+DI will be offering coverage of the TEDMED 2012 conference being held from April 10-13 in Washington D.C. Be sure to keep checking for the latest news, ideas, and medical device innovations being unveiled at the conference.
What is TEDMed?
TEDMED is a community of passionate, leading-edge thinkers and doers who come from every discipline within the fields of health and medicine, as well as from business, government, technology, academia, media and the arts. Every year, the community gathers at the annual TEDMED Conference, where TEDMED delegates “think out loud”...
April 9th, 2012


MDEA Finalists Announced

The finalists of the 2012 MDEA Competition can be viewed at

Google’s Project Glass Goggles.

By now you've probably seen Google's latest project. Clearly it promises some exciting things for the day-to-day consumer, even if they make the glasses ad enabled. But what about for the medical industry? Brian Buntz examines the potential of Google's Project Glass as a medical device.
April 6th, 2012

2011 saw a new award added to the roster of the Medical Design Excellence Awards (MDEAs)—the Lifetime Achievement Award. The bar for this new award is quite high. It honors an individual whose contributions during a long career have had a demonstrable impact on technological, business, and cultural advancements in medical devices. There was no question that the 2011 recipient, Alfred Mann, Chairman and CEO of MannKind Corporation, was worthy of the honor. Mr. Mann’s achievements were off the charts.

2012 brings us an equally worthy candidate, yet with a slight twist. Presenting this year’s Lifetime Achievement Award to Dr. Thomas Fogarty will be a man worthy of the award himself—Dean Kamen. The awards ceremony takes place on May 23, during the MD&M East...

April 5th, 2012

April 4th, 2012