Courtesy of Octane

Congress Rep. Fred Upton blasts FDA's bureaucracy

Some quotes from his recent article "A defibrillator for American jobs": Overzealous and burdensome regulations — produced right here at home — also play a role in our stubbornly high unemployment rate and lackluster business growth. And What’s producing these potholes for this critical domestic industry? An inhospitable regulatory environment caused by the Food and Drug Administration is a primary culprit. 
I couldn't agree more. Good to see that Congress is taking notice.

Discussion over effectiveness of 510(k) process

An interesting discussion is shaping up about the future of the 510(k) process. The IOM (Institute of Medicine) recommends to chuck the 510(k) process in favor of something else - even if this something is ill-defined. The FDA vigorously defends its sickly child. AdvaMed is scared about the uncertainty facing the industry. Read this article in Fierce Medical Devices, which has several links to more background information.

The FDA's 510(k) report card

The FDA admits that the average 510(k) review time has increased (to 140 days!) but blames the industry: "FDA data shows that total review time – the time it takes FDA to review an application and for companies to respond to questions that arise during that review – has increased primarily due to companies taking more time to respond to requests for additional information."; see CDRHReports/ucm263385.htm.
From personal experience I know this to be a half-truth. The reason companies need to take more time is that the FDA requires more information than before, and information that was previously not required. So who is the bad guy here?
In my experience, the FDA is making it more and more difficult for the medical device industry to get devices approved, and they're doing this without being upfront, honest and transparent about it.

Kickbacks - read this article

Once in awhile I come across questions regarding kickbacks and how/how much can we legally compensate professionals who work with us? MassDevice, a New England medical device periodical, gives some good pointers in this article. Worth reading if you have these sorts of questions!

Labeling and photographs in a 510(k) database?

The FDA is considering to start a publicly accessible database that will contain labeling (user manuals!) and pictures of 510(k) cleared devices. FDA is organizing a "discussion meeting" on April 7th in their offices in MD. Attendance is free after registration. What is your position on this issue? Let me know!

In development: stretchable electronics

First time I heard about this: NW University and UofI (both in IL) are developing "stretchable" electronics to be used in catheters. See this interesting article about an application for minimally invasive heart surgery. Before you know it, this technology will invade everyday products and gadgets!

Medical device development: an endangered species?

An article in the StarTribune (Minneapolis-St. Paul) argues that big device companies are spending too much time adding features to existing product lines and too little time developing new technologies. Add to that the unfavorable investment climate for startup companies, and a bleak future for new products emerges.

Yes, the FDA's failures have been all over the news

But still, I think it is important to post this article about the impact on the US Medical Device industry.

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.

FDA's 510(k) process changes: group in Congress is pushing back

A group of 12 lawmakers from the House of Representatives asked the FDA to delay implementation of five proposed changes to the 510(k) process until the FDA provides more details. They did so in a letter to Dr. Hamburg. See the FDA Law blog for more details.

Small gets smaller and smaller...

When I went to college, integrated circuits were "small" and decreasing in size rapidly. Nowadays nanotechnologies work with structures only a few tens of nanometers in size, and researchers turn these into baffling technologies! The latest is depositing fluorescent dyes inside living cells! Even if it's way out of your everyday interest, read this article about Quantum dots.

Is vacation a "right" or a "bonus"?

For Germans (Europeans in general) it's the first, for Americans the second. Read this interesting article about productivity in Germany and the US. As a Dutchman, I can attest that it's true!

Keeping tabs on FDA's performance

Fortunately, the FDA does that for us, and all we need to do is to access the right webpages to find the information. This is how the FDA describes the program: "FDA-TRACK is a new agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures. These measures are developed by the program offices across the FDA and reported on a monthly basis. Each quarter, monthly performance data is analyzed and senior managers present this data to FDA senior leadership." The FDA Track page can be found at the FDA website. Since I am interested in medical devices, I also look at the CDRH Premarket Dashboard.