From the Editor
FDA on Free Speech and How to Respond to Tweets
Feb 06, 2012
In December, FDA released a draft document titled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical...
Blue Skies or Clouds Ahead for Medtech Industry? Experts Make Their 2012 Predictions
Dec 14, 2011
Albert Einstein once cautioned about making predictions, saying, “One need only think of the weather, in which case the prediction even for a few days...
State of Medtech 2011 and Beyond: A SWOT Analysis
Nov 21, 2011
I thought it might be interesting to look at the medtech industry objectively and identify the key strengths, weaknesses, opportunities, and threats it faces....
FDA Says SCIENCE, But Is the Agency Spin Doctoring?
Oct 27, 2011
Earlier this year, FDA commissioner Margaret Hamburg put science at the forefront of the agency’s strategic priorities, saying, “I would like to...
A Big Thumbs Up for a Plan to Rate Medical Devices
Sep 27, 2011
Yelp.com has changed how many consumers interact with goods and services. The site relies on reviews by actual customers, editors, and experts to provide...
How I Learned to Stop Worrying and Love Digital Healthcare
Aug 29, 2011
The healthcare system is experiencing a health and wellness revolution—and industry has to catch up. Patients are demanding more and better access to...
Epic Fail: IOM Disappoints in 510(k)s by Not Doing Its Job
Jul 29, 2011
In a move akin to Martin Luther nailing his theses to a wall, the Institute of Medicine (IOM) released its long awaited and controversial recommendations for...
Exit Strategies: Why Have So Many CEOs Retired or Resigned This Year?
Jun 30, 2011
It’s hard not to notice. There seems to be a changing of the guard in the medical device arena this year. And many of the CEOs who have moved on are from...
MDUFMA III Won’t Really Solve Review Problems
May 02, 2011
Next year FDA will look to renew for a third time the Medical Device User Fee and Modernization Act (MDUFMA). As such, it seems a good time to look at the...
A Permanent R&D Tax Credit Is a Great Idea. We Can Do More.
Mar 28, 2011
A bill proposed by Rep. Kevin Brady (R-TX) is designed to provide a permanent R&D tax credit. The American Research and Competitiveness Act of 2011 has...