The US is losing its competitive edge...

An article in the Startribune, Minneapolis, explains a study by PricewatterhouseCoopers, predicting that in the coming decade the US will lose its competitive edge in medical devices to countries such as China, India and Brazil. Why? We don't invest in our future!

510(k) viewed from Italy

From Italy comes to us Dr. Maria Donawa, who discusses The Evolving US 510(k) Review Process in a well-wrought, interesting article. The FDA's struggles are followed not only here in the US, but all over the world! I'm just crossing my fingers that the FDA won't succumb to the "runaway bureaucracy" syndrome that is so infectious in government circles. Alas, I'm not optimistic...

FDA's registration and listing: opaque and impossible

I consider myself an "old hand" at registering medical device companies, but I still manage to get myself in trouble. As you probably know, registration must be done on the FDA's website. Recently I tried to register a US subsidiary of a foreign company, and I could not find a way to enter the foreign company's information! Worse, there used to be (albeit in a difficult-to-find place) an email address where one could contact the FDA and get help, but I could not find that anymore! So much for a "customer friendly" and "transparent" FDA.

FDA venturing into medical device design?

What's happening? The FDA announced that they are starting an "External defibrillator improvement initiative" to get industry to improve defibrillators. This is a very interesting development and makes me wonder if we're headed towards government-prescribed "innovation". In my mind this is a slippery slope, and I'd love to hear your comments!

Changes to the 510(k) process - California Healthcare Institute

The California Healthcare Institute has published a white paper titled "Upcoming changes to the 510(k) Process: New Approval Pathways and the impact on Medical Device Development and innovation", available by clicking on the "white paper" link. Interesting reading!

FDA to rescind 510(k) clearance

The FDA is taking steps to rescind the 510(k) clearance of a knee implant because they made errors in the original clearance process. Now we finally know they really are bureaucrats, even though they present themselves as being "scientific". Apparently procedure takes precedence over science. This device has so far been used in over 300 cases over a period of 10 years without any complaints. Read this article in the WSJ and don't forget to go to the Comments tab.

OCTANe's Medical Device & Investor Forum

The annual MDIF will be held this year on 25-26 October in Newport Beach, CA. For more information about the Forum, go to MDIF. Find out who will attend.