Medical Device Daily Perspectives

Top Five Things to Watch for in 2011

August 31, 2011 – 8:45 AM | By Mark McCarty | No comments yet

In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit.

Flashback: Three med-tech stories from August 2009

August 29, 2011 – 6:49 AM | By Mark McCarty | No comments yet

[caption id="attachment_809" align="alignleft" width="150" caption="A quick look back at Aug. '09"][/caption]

Top Five Reasons to Hate CPAP Machines

August 26, 2011 – 7:44 AM | By Mark McCarty | 7 comments

On This Date in History

August 25, 2011 – 1:00 AM | By Mark McCarty | No comments yet

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.

Picking your poison: Wall Street or Venture Capital?

August 21, 2011 – 4:26 PM | By Mark McCarty | No comments yet

Phone call from legendary Langer

August 18, 2011 – 5:41 PM | By Amanda Pedersen | No comments yet

Trade Associations are life jackets for med-tech in age of uncertainty

August 13, 2011 – 4:14 PM | By Omar Ford | No comments yet

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.

The future of healthcare spending: Will ROI be King?

August 10, 2011 – 4:13 PM | By Mark McCarty | No comments yet

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.

Medtronic’s $2.5M InFuse fix: Off-label use + implant = headaches

August 5, 2011 – 1:02 PM | By Mark McCarty | No comments yet

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 to give the firm's senior managers a nice cluster of migraines.

IOM’s proposal to scrap the 510(k) is kaput: What’s next?

August 1, 2011 – 7:31 AM | By Mark McCarty | No comments yet

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.”