Kinetikos was named one of MD&DI's 50 Companies to Watch in the June issue. I've always kept an eye on Integra since I started covering life sciences for a New Jersey newspaper 10 years ago. Back then I did a feature on its artificial skin technology and other projects it had in development. I was impressed by what the company was up to but shocked that it wasn't getting much recognition from Wall Street or the public. That started to change a year later when Wall Street veteran Stuart Essig was hired as CEO. Essig and his team have gotten Integra the high profile it deserves, and built it into a multi-market, multi-technology player. If they like what they see in Kinetikos, chances are Kinetikos is really doing something right. DeviceTalk will return on Wednesday, July 5.

The management-controls issues had also been raised during inspections conducted in 2000 and 2002. During the 2005 inspection, Baxter placed a worldwide hold on both products after the design defects were discovered. CDRH has always been suspicious about the reliability of infusion pumps, and this incident will reinforce that.

It is pieces like this, which show how medical devices affect an individual person's life, that will go a long way toward convincing the public and the government of the value of medical technology.

The new initiative underscores that and is something that must be paid attention to.

Yet the news was enough to send the firm's share price down 5.6% yesterday, as Wall Street analysts grow more pessimistic about the company's ability to overcome quality problems. But Boston Scientific made itself what it is today by challenging expectations and defying conventional wisdom. It will need more of that magic, in spades.

Wall Street traders aren't the only ones who may have misinterpreted the news: Last week a friend who saw the report mentioned to me about the products being "dangerous," when the article said no such thing. The concern is that the polymers used to elute the drugs might be causing clots. But there is no definitive proof yet, nor is there evidence that those risks, if they exist, outweigh the benefits of the enhanced performance drug-eluting stents bring compared to bare-metal stents. So bring on more research, and let this be a reminder how even accurately reported bad news can become overblown quickly.

This could be bad news for Boston Scientific, which assumed Guidant's liability and is now looking at a stronger case against it. Would Jim Tobin and co. do it all over again? You have to wonder.