The playwright George Bernard Shaw is credited with having said, “the single biggest problem in communication is the illusion that it has taken place,” a remark device makers might apply to their interactions with FDA and the Centers for Medicare & Medicaid Services. Those two agencies might have similar observations about device makers, too. Still, we’ve all discovered it’s not always easy to communicate clearly, especially when complex matters are at hand. So let’s dig into the story behind a recent development at FDA and a long-standing communication hurdle between CMS and device makers. FDA recently issued a draft standard...

A routine physical turned out to be a nightmare for me last year when it was discovered that my white blood cell count was significantly low. It was also the catalyst behind my drive to make sure that any physician I go to now can get overnight if not instant results from a lab once my sample is being tested. At the time, I was just getting over a severe cold that I had received from my now 2-year-old daughter - which was the ultimate culprit of the white blood cell shortage. However, at the time, when I questioned the...

Developments in the world of medical devices vary by region, but a few recent stories from the pages of Medical Device Daily give a good sense of just how turbulent the global market is. MDD has beefed up its OUS coverage of late, providing a lot of detail on some vital markets, including Asia and Europe. For instance, a story from last month by our correspondent Kristine Yang states that the China Food and Drug Administration (CFDA) released a new set of regulations in July...

Sometimes little nuggets of information don’t mean much, but sometimes they mean a lot. It’s not always clear, though, is it? Following are a couple such nuggets, but I’ll let the reader decide what they’re worth. In a recent congressional hearing, Sen. Patty Murray, said something that surely gave providers a nasty case of the hives. Murray, who chairs the Senate Budget Committee, said at a July 30 hearing that bundled payments “could help incentivize coordination and efficiency” by “creating fixed payments for...

A story of bureaucratic overreach, clinical trial data disclosure, and Washingtonian flights of fancy with a tip ‘o the hat to Voltaire. In a castle of Silver Springalia, belonging to the Baron of Our-Way-or-the-Highway, lived an industrious youth endowed with the most inventive of manners. The old servants of the Baron preferred that the youth, named Indeed!, be the supplicant of the Baron, needful of the Baron’s approval in all things. The youth was expected to address the Baron as “oh Lord!” and laugh agreeably at all the...

A decade ago it would have been hard to imagine a bioabsorbable tissue-lined stent graft capable of treating blood vessels that have been ripped apart by a bomb, or a spray-on solution that would promote the regrowth of your own skin after a traumatic injury or burn, or even a portable machine that could treat deadly infections like sepsis in much the same way that dialysis machines treat kidney failure. But today these innovations and many more are being developed to treat wounded warriors and will someday be used not just on the battlefield but in civilian hospitals as well....

Marvel Comics' popular character Wolverine is known for his ability to heal from nearly any wound. Researchers at Drexel University in Philadelphia have developed an ultrasound technology aimed at giving patients who suffer from chronic wounds, an extra boost in recovering from the injuries. And while it's not anywhere near the level of Wolverine's powers (he is a fictional character after all), initial studies show promising results for the device. In the study, researchers treated patients suffering from venous ulcers, which account for 80% of all chronic wounds found on lower extremities and affect approximately 500,000 U.S. patients annually, a...

If you like controversy, a job at FDA would be right up your alley, but it’s tempting to think some of these controversies are contrived. The question of the influence of user fees on FDA reviews has surfaced (yet again), but even those who would like to do away with the user fees might find this latest rehashing a bit over the top. An article titled “Risky Drugs: Why the FDA Cannot Be Trusted” at the website for Harvard University is the latest to take...

A cynic’s guide to the galaxy might suggest everyone in healthcare is in it strictly for the money, but it’s tough to tell. After all, what can you do without the stuff? Even FDA and NIH are constantly clamoring for more. Does anyone ever accuse them of having been corrupted by the almighty dollar? Maybe a few who gripe about FDA user fees, but that’s about it. Following are a couple of stories about the greenback and how these stories might play out between now and the end...

A few years back my brother-in-law Sam was starting a new job and was required to get a physical as part of the hiring process. A standard X-ray revealed a spot on his lungs and further testing confirmed it was cancer. The diagnosis came about two years after he’d quit smoking, but he had been a smoker for many years and was somewhere in his early 40s. Thankfully, because it was caught and treated so early, he is still with us today and doing great. But what if he hadn't had that physical? Earlier this week the U.S. Preventive Services...