Hopefully not lost in all the comings and goings of more than 8,500 people at the J.P. Morgan Healthcare Conference in San Francisco last week were some important take-home messages about the future of med-tech, a future that promises many challenges for the industry, but also many rewards for those willing to follow promising trends. 1. Healthcare Information Technology is going to be big this year and probably into the foreseeable future. This is the final year in which hospitals and physicians can demonstrate meaningful use and get maximum healthcare dollars under the stimulus, so there should probably be some clarification...

As mentioned in a posting earlier this week, my wife and I were out for dinner recently and made the acquaintance of some opinions about FDA and the industries it regulates. Opinions about FDA ranged from awful to terrible, and doctors and industry fared no better. It seems a lot of people think user fees conscript FDA, and some see the agency, industry and physicians as some sort of malevolent troika that would have made the Kremlin of Leonid Brezhnev proud. Maybe I'm too close to it...

Forgive me for ripping off Dickens, but a good headline is priceless. This posting, however, is about two tales of an agency (located near Washington) with which we are all familiar. For the first tale, FDA recently re-classified diagnostics for the Yersinia genus of bacteria (Bubonic plague, just in case you were wondering) as covered in the Nov. 18 edition of Medical Device Daily, and FDA stated in the Nov. 17 edition of the Federal Register that an advisory committee had recommended such a change back in 2002. This is not the only example of a request for a device...

Long-time observers of FDA's regulation of therapeutic medical devices will note an oscillation over time, and we are now in a period in which the pendulum has reached as far as it can in one direction and is now headed the other way. The only question is how far. It's not tough to find parties that have a hand in this. Congress finds it difficult to keep a steady hand because there are two parties with their different worldviews. Ditto those in the executive branch. Perhaps there is an inevitability to the back-and-forth at FDA's Center for Devices and...

I don't directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is just the start of the investor conversation, but in an age in which indications for use are becoming increasingly narrow, it's probably the last question, too. After all, we have radio-frequency ablation devices approved for paroxysmal atrial fibrillation, but not for persistent or long-standing afib....

By Adi Renbaum, senior VP for health policy and reimbursement, Neocure Group Cook Medical's Zilver PTX is likely to become the first peripheral drug-eluting stent (DES) to be approved in the U.S., after an FDA advisory panel voted unanimously in favor of the device on Oct. 13. Approval would give the sponsor, Cook Medical (Bloomington, Indiana) access to a peripheral arterial disease (PAD) market valued at $1 billion, depending on whose figures one relies. I attended the Oct. 13 advisory committee hearing for the device and observed the panel members comment that this was among the best submissions they had...

Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new country where the language, culture, and rules were completely foreign to me. I was concerned, at first, that my lack of a medical or scientific background would hinder my ability to cover the space adequately. But I learned quickly and before I knew it I was well-versed on the differences between a drug-eluting stent and its bare-metal cousin, the pathway...

Anyone who reads this blog on a regular basis knows I'm leery of big government, and I usually criticize government (most often FDA) for what it does rather than what it fails to do. It appears to be time to give FDA the once-over once again, this time over the agency's omissions regarding social media. As readers of Medical Device Daily know, the Center for Devices and Radiological Health has proposed using social media for compliance and enforcement activities, which I covered in the Oct. 7 edition. I should...

  Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they've tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a very few device makers. In the Federal Register notice of Oct. 11, the two agencies state that the two-year pilot for parallel review won't accommodate more than five applications per year. When FDA and CMS initially tried to drum up interest in the idea, a number of observers told me industry would never flock to the idea in any numbers...

After Johnson & Johnson (J&J, New Brunswick, New Jersey) said that it was going to discontinue its work in the drug eluting stent (DES) market, my eyes then began to focus on Medtronic (Minneapolis), which has recently taken a beating in the wallet and court of public opinion with its bone growth product, Infuse. I began asking myself how much longer before Medtronic finally abandons ship on this application. I mean if there ever was a shining example of a device that has caused problems for a company then Infuse is it. The med-tech juggernaut was dealt what one would...