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...

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...

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,...

In this blog, we've explored the issue of NIH funding twice. The first time, we examined the reported fiscal spending numbers (here) and the second time, we examined funding by program areas (here), but now we have the budget/deficit ceiling debate, and yet we still see examples of truly nonsensical arguments about NIH funding. Let's acknowledge at least one thing: It makes no sense to fatten the NIH basic research pipeline when we know FDA can never keep up with it. It's akin to putting up a larger water...

I remember reruns of a cartoon about a character named Tooter Turtle, who was always appealing to Mr. Wizard to send him back in time for some form of jollies or other, and when the whole thing went south, Tooter would yell out, “help Mr. Wizarrrrrd!” At which point, Mr. Wizard would cluck about the futility of it all in his central European accent and bring Tooter back with the incantation, "drizzle, drazzle, druzzle, drome; time for zis one to come home." I never had any idea what that drizzle-drazzle stuff was all about, but it worked for Mr. Wizard....

There is an Irish aphorism which states: "Anything that keeps a politician humble is healthy for democracy." The same might be said of bureaucrats. What sometimes strikes me as odd is that you can easily find coverage of the miscues of corporate America, but few media outlets are as punctilious about reporting on government's ill-intended moves. Here, then, are five reasons to mistrust government at least as much as device makers. Five: The Thompson Memo In 2003, this memo directed federal prosecutors to offer leniency to a corporate defendant if the defendant was willing to waive attorney-client privilege and/or willing...

First, just to let you know dear reader, this is a Casey Anthony-free blog posting. Those who are skeptical of the device industry in this world are legion, but there are a lot of reasons to cast the occasional baleful glance at government as well. What's interesting is how many in the media automatically assume that any clash between FDA and industry is necessarily the fault of industry. Case in point: I was at the American Diabetes Association annual scientific sessions about two weeks ago and had a conversation with another member of the press. She said more or less...

The U.S. House of Representatives is expecting a vote this week on its patent reform bill, but unlike passage of the Senate bill, the House bill has to deal with a potentially crippling conflict. This conflict was set up by the provision dealing with fees collected by the Patent and Trademark Office, which is on a collision course with the budget-cutting mood in the House. Another difference between the two bills is the inclusion of the prior user defense in the House bill, but I'm going to propose that the real question here is not whether the House and Senate...

FDA's Center for Devices and Radiological Health published the results of its analysis of decisions on 510(k) applications between 2006 and 2010 (see the pdf of the report here), including some data from as far back as 2001, and several features jump out to the casual observer. The problem for CDRH managers is that the report suggest a number of stories – several of which the agency fails to tell – that will do nothing to dial down industry's pushback against FDA's more aggressive enforcement/compliance regime. The report is also certain to do nothing to drain the increased pressure on...

Last week, the Advanced Medical Technology Association (AdvaMed; Washington) put on its Superman cape and unveiled a set of policy recommendations that it hopes will preserve America's position as a leader in medical technology innovation. Dubbed the Competitiveness Agenda (which can be seen in more detail by clicking here), AdvaMed is issuing out a call to arms to the government to not overlook the med-tech industry.  Here's the problem that the med-tech industry is facing. Imagine for one moment that you're on the brink of not being able to pay your mortgage. Slowly and steadily you're getting behind on the bills...