Years ago at another publication, one of my former colleagues made one of the greatest rookie mistakes a person could make during their career. He triumphantly displayed how much money he was being paid to several reporters in the newsroom. The pandemonium was classic. Many marched up to management and demanded salary adjustments, using this poor naïve writer's pay as a "negotiating" ground. I wonder if something similar to this scenario will play out when the Physican Payment Sunshine Act will go into effect. I realize that med-tech said that it doesn't mind the transparency, but are companies considering the...
The recent hubbub about ex-University of Arkansas football coach Bobby Petrino, which centered on the latest examples of his propensity for lying to his superiors, got me to thinking. Not so much about how proven prevaricator Petrino finally lied his way into the ranks of the unemployed, although I did enjoy reading statements such as this classic from SI.com writer Michael Rosenberg: “The . . . university is shocked to discover that its lying-weasel football coach is a lying weasel.” Rather, the extensive coverage of the circumstances of Petrino’s self-inflicted fall from grace led me to revisit a question that...
No doubt some are tired of hearing me go on about the FDA budget, but industry thinks the agency is under-funded, too. Most who are part of this discussion believe FDA would be more functional with appropriate appropriations, but they ignore the dynamic necessary to fully fund FDA. Hence, the dysfunction persists. To wit: Dealing with FDA’s public affairs staff is typically not a bad experience unless they have to consult with others at the agency on fairly detailed matters. For instance, I’d written last year about a Federal Register notice addressing pre-emption of state law with regard to the...
“Take it back!” “No, I won’t take it back, you stop bothering me!” “I said . . . take it back!” No, I didn’t hear this exchange at the playground in my neighborhood. Nor did this occur at the customer service counter of my local department store. But rather, this is the tone of a med-tech spat taking place in the “virtual” sandbox that has been taking place this week; one which has caught the attention of industry observers. St. Jude Medical (St. Paul, Minnesota) is miffed about a recent paper published in the journal Heart Rhythm written by...
The Supreme Court decision in Mayo v. Prometheus and the Court’s remand of Myriad have provoked a lot of angst on the part of those in the life sciences. Still, the degree to which these cases might prove cataclysmic is tough to forecast, and those who think Chicken Little is overdoing it have some basis for skepticism. So in the spirit of Prometheus and Epimetheus, the sibling Greek deities whose names translate respectively as forethought and afterthought, let’s examine the prospects for patents in this strange new world. First, let’s ask Epimetheus about the Supreme Court decision in KSR v....
Don’t look now, but Medtronic has quite possibly just become the poster child of the opposition against the Medical Device Tax. During a call with analysts in February, the med-tech giant said that it expected to pay up to $175 million in costs because of the tax. When the news broke, Medical Device Daily, as well as other media outlets, picked up the story, and rightly so. Outside of regulatory issues with the FDA, the Medical Device Tax is the biggest concern that keeps device makers up at night. Right now device makers are struggling to find a way they...
As I read through one particular healthcare-related news item recently, the lyrics to the old “If you’re happy and you know it” song just plain took over my subconscious thinking. You know the one I’m talking about: “If you’re happy and you know it, then your face will surely show it.” It may not come as any great surprise that smiles aren’t adorning the faces of too many doctors these days, what with Medicare payment cuts, the looming impact of healthcare reform, skyrocketing malpractice premiums and other lesser complaints and concerns. But all that notwithstanding, it was just short of...
In the March 15 issue of Medical Device Daily, there were two stories that discussed the medical technology industry in the U.S., and neither of them cast a particularly flattering light on the current state of affairs. In fact, it appears that this once proud and successful domestic industry is on life support. Perhaps the most credible criticism came from Tom Fogarty, a legendary entrepreneur in the medical device field. In a story written by Senior Staff Writer Amanda Pedersen, Fogarty asserted that “it’s reached a point in the field of medicine that we in the U.S. are no longer...
At Medical Device Daily we’re usually fortunate enough to talk to a lot of the movers and shakers in the medical device industry. Company CEOs, doctors, researchers, and other industry leaders who are truly on the front lines of medical innovation are regular sources for our daily stories. But every once in a while we get to talk to someone who has had such a massive impact on this industry that it leaves us a little bit star struck to have the opportunity to speak with...
It’s hard to believe by looking at the 11.5” cultural icon, but Barbie is celebrating her 53rd birthday today. Perhaps her life in plastic is the reason she looks so great for her age but the Society for Vascular Surgery is putting a different spin on the doll’s birthday – noting that Barbie has always maintained an active lifestyle. The organization is using the milestone to highlight the importance of women’s vascular health issues. “Women in their 50s should remain active,” said Kellie Brown, MD, a member of the Society for Vascular Surgery. “Thirty minutes of exercise daily, eating healthy,...