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.