Those in the business of therapeutic or diagnostic devices know how quickly things can change, so let's take a quick look at a few stories that appeared in Medical Device Daily in August 2009. After all, two years are less than the average time needed to get a patent through the U.S. Patent and Trademark Office, which is another story. Aug. 12, 2009: Schultz out at CDRH; Shuren to serve as interim director On Aug. 11, 2009, the Internet was abuzz with reports that Dan Schultz, MD, had stepped...

CPAP. Such an innocent-seeming acronym, no? It stands for continuous positive airway pressure, which also comes across as pretty harmless. I use one of those things, though, and I have to tell you something. They're a colossal pain in the you-know-what. The only thing worse than a CPAP machine strapped to your face is obstructive sleep apnea (which I have) or central sleep apnea (which I don't as far as I know). Here's the deal. You strap one of these masks over your face – over your nose in this case – and it blows air past the obstruction...

On This Date: The birth of Emil Theodor Kocher, MD, Swiss surgical pioneer With the pace of change in the modern world and the emphasis on what's just around the corner, it can be edifying to take a moment to ask where we've been. And so we reflect for a moment on the work of Emil Theodor Kocher, MD, who was born 170 years ago on this date, Aug. 25, 1841. Kocher was born in Berne, Switzerland, where he earned his medical degree in 1865. He took the position of director of surgery at the Inselspital (Island Hospital), also in...

Life is full of choices, not all of them pleasant. For device makers of late, this definitely holds true. Firms in the venture capital end of things are not necessarily worried that VC has utterly abandoned med-tech, but it would appear that the start-up might find the going tough, even though firms with a little more development are getting more love from investors. As my colleague Amanda Pedersen noted in Medical Device Daily recently, a recent report by CB Insights (New York) indicates that the number of VC deals for med-tech continues to tail off, dropping from 184 in...

Robert Langer A few weeks ago while working on a story about a new type of gel material that could be implanted into scarred vocal chords to restore their normal function, I was pleasantly surprised to receive a call from industry legend and the father of drug delivery Robert Langer, PhD. Langer, the David H. Koch Institute Professor in the Department of Chemical Engineering at Massachusetts Institute of Technology (MIT; Cambridge), is a renowned expert in developing polymers for biomedical applications. Admittedly, five years ago, at the start of my Medical Device Daily career, I would not have been...

Tuesday night during its quarterly meeting, the Southeastern Medical Device Association (SEMDA; Norcross, Georgia) unveiled its new logo and its new website, which is set to go live in the very near future. SEMDA seems to be increasing its presence and that’s a good thing because it and other trade associations are going to play a very important role in helping med-tech companies traverse the healthcare landscape in the near future. And med-tech companies are going to need it. The upcoming changes set to take place on the healthcare landscape are going to have a dramatic impact on med-tech companies...

Most of us had to take a course or two in economics to get a bachelor’s degree, but few of us remember very much from those lessons. I can't say for certain that Econ 101 is where I first heard the expression “return on investment,” or ROI, but it's an expression that has stuck with me ever since. The notion may gain greater prominence where healthcare payers are concerned in the years to come, thanks to the well-publicized Medicare crunch, but it's tough to imagine that the congressional Gang of 12, charged with finding further ways to close the U.S....

The deal struck by Medtronic (Fridley, Minnesota) regarding an evaluation of adverse events associated with off-label use of the InFuse bone morphogenic protein is conspicuous, but not so much because it will cost the firm $2.5 million to have Yale University (New Haven, Connecticut) review the data, as reported in the Aug. 5 edition of Medical Device Daily. As described by MDD managing editor Holland Johnson, this effort will be made very public and is being touted as a new level of transparency that may set the standard for future such activities. In the meantime, however, it might be enough...

In today's edition of Medical Device Daily, I write that the proposal by the Institute of Medicine to trash the 510(k) mechanism in favor of a brand new scheme is impractical and will gain no traction. Not only does industry find this impossible to choke down, but even Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health, remarked that FDA believes “that the 510(k) process should not be eliminated,” although Shuren said he and his team are “open to additional proposals” for “continued improvement.” One caveat to the rejection of the IOM proposal is that even though...

If you enjoy participating vicariously in exercises in futility, take a gander at what's going on in Washington with regard to user fees for medical device reviews. Yesterday, Sen. Richard Burr (R-North Carolina) told FDA commish Margaret Hamburg, MD, than any user fee legislation that does not incorporate non-FDA days into the calculation of total 510(k) review days would face “a long and laborious process” to get the required legislation through the Senate Health, Education, Labor and Pensions Committee. Burr's position was essentially that FDA has not met the turn-around on applications called for in the previous user fee handshake,...