The future of device regulations: the EU model or the FDA approach?
The demise of the Global Harmonization Task Force as a regulator-plus-industry forum for harmonization – or “convergence,” as the cautiously optimistic like to say – was met with little more than silence from the trade associations, but one can be…
An obvious solution to an aggravating problem
An Army wife friend of mine is diabetic and has been taking insulin for eight years. Last fall she and her husband were moved to a new duty station where she was assigned a new primary care manager at a…
Is med-tech really ready for total transparency?
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.
What’s up, doc? Survey says ‘lying weasel’ doesn’t only apply to miscreant football coaches
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.
Once again, the FDA budget dynamic
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…
Myriad, Prometheus and life science patents: The End of Days?
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…
Medtronic, the face of Med Tax opposition?
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…
Unhappiness of physicians is reflected in some startling numbers in career-recommendation survey
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.
Is the U.S. no longer the dominant player in med-tech?
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…
