First Person
Jan 04, 2012
1. How can a record be a “land mine”? “Land mine” is a term we use for a record buried in your company’s files. If discovered in...
Aug 08, 2011
After reading the recently released IOM report on 510(k)s, I started thinking about how FDA can do better. Here are my  recommendations on how to fix FDA...
Apr 22, 2011
As the battle rages on in Washington over the nation’s overspending and physicians leave their traditional practices for premium-driven boutique...
Jan 05, 2011
I’m terrified of something coming in 2012. No, I’m not talking about the end of the Mayan calendar, but what I am afraid of is something that will...
Aug 06, 2010
A growing number of companies—from technology start-ups to the Fortune 500—are participating in a phenomenon that goes by several different names,...
May 14, 2010
Andrew Dallas With the continued uncertainty regarding how much additional information FDA will ultimately require for the 510(k) and PMA application...
Mar 03, 2010
 Medical device manufacturers have much to gain by using social media, such as increased access to patients and users. The benefits, however, are tempered...
Mar 01, 2010
  Paul Broud Despite the continuing stock market turmoil since the beginning of 2010, investment bankers and a few companies are trying to pry...
Mar 01, 2010
While Congress is abuzz over the prospect of healthcare reform, many in the medical device field are atwitter over the explosion of Internet-powered healthcare...
Jan 01, 2010
The use of devices to treat diseases is often reserved for patients who have failed a few drug therapies. This tradition is partly driven by doctors...