There are only 70 or so days left in 2012, but that doesn’t mean there isn’t a lot of critical activity still in play. Here are a couple of things to keep track of. November 6: Who will choose the new faces on the Supreme Court? Several members of the Supreme Court are approaching retirement, which makes the upcoming presidential election even more important. Justice Ruth Bader Ginsburg is 79 and nearly certain to vacate her seat before 2016. Justices Scalia and Kennedy are both 76, while Justice Breyer is 74. How many of these last three will hang it...

We have been hearing a lot about the death of innovation in the field of medical technology for the past few years, a victim; it would appear, of a sluggish worldwide economy and more stringent regulation and reimbursement policies. However, a closer look reveals that medical device innovation is still very much alive, and will continue to thrive both in the U.S. and overseas. Medical Device Daily’s “Med-Tech on a Mission: Strategies to Drive Innovation” addresses the status, prospects and challenges that epitomize this market and identifies distinctive research agendas and tactical business development approaches that have the proven records,...

Most of the entries here at the MDD Perspectives blog address med tech, but I’m going to go off topic and address the compounding pharmacy issue, because it is at risk of becoming an FDA issue. As we all know, the New England Compounding Pharmacy (NECP) is said to be the source of the tainted methylprednisolone injections that led to the multiple cases of meningitis, and now the predictable cry has gone out to have FDA regulate compounding pharmacies. The idea is understandable, but let’s find out what’s...

Trekkies and non-Trekkies alike will recognize the expression “resistance is futile” as a favored saying among the drones of the Borg collective of Star Trek fame. Obviously I’m paraphrasing with the title of this essay, but let’s ask ourselves a question: Is it a big deal that the Department of Health and Human Services still does not have an agreed-upon standard for electronic health record (EHR) interoperability? HHS has been yakking about this since 2005, when Mike Leavitt ran the department. Now we have Kathleen Sebelius and still no...

One of the many lessons I have learned as an Army wife is that in the military, if you’re not at least five minutes early to an appointment, you’re late. So I had to laugh when Mike Dunford, senior VP of human resources at Covidien (Dublin, Ireland and Mansfield, Massachusetts), told me that in a room full of military veterans, “by 7:40 everybody was in their chairs and ready to go” for an 8 a.m. meeting Monday. Dunford, a former Marine, is a...

The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks at the number of lawsuits and withdrawn guidances, it’s difficult to avoid the urge to characterize the past three years in terms of clichés, such as “a bull in a china shop.” Perhaps the poster child for all this was the Menaflex 510(k), which we have discussed before. FDA’s rescission of this application was the most political move at FDA...

I have been reporting medical technology news for close to six years and one thing that has consistently amazed me during that time has been the fact that simplicity often beats bells and whistles. The most recent example of this is the newly launched Kickstart Kinetic Orthosis from Cadence Biomedical (Seattle), a wearable device designed to help people with weakened muscles or disabilities regain mobility and independence. Amazingly, this new device was inspired by the anatomy of horses. It turns out a researcher from the Cleveland...

Sometimes we can avoid irritation in our work lives, sometimes not. Sept. 20 was a day when some pretty annoying themes crept back into my workday via coverage of a session dealing with the NIH budget. Regular readers of the MDD Perspectives blog know this is something of a pet peeve of mine, but when one considers the laggardly budget at FDA, the NIH budget discussion is nothing short of mind-numblingly over the top. To wit: During a Sept. 20 press briefing at the National Press Club, Rep. Ed Markey said the prospect of 8-10% cuts to the NIH budget...

There’s a lot of consternation and maybe even a little constipation of late about the U.S. federal budget, and rightly so. If the White House and Congress can’t come to some resolution about budget sequestration, the FDA budget could tighten enough that user fees would disappear, which would cripple the agency. Complicating matters further is the series of tax issues – a convergence dubbed the fiscal cliff – that ripen at the end of this year, giving everyone inside the Beltway more to worry about. This is all difficult enough without an election, so it’s easy to be pessimistic. And...