Resources

For discussion purposes, let’s assume that there is a broad consensus that patients would benefit if new drugs and devices could get to the US market sooner. Current market barriers can be fearsome: long timeframes, high cost and regulatory uncertainty. How can we fix this problem? What costs and risks are involved in getting products […]

The Ernst & Young “Pulse of the Industry: Medical Technology Report 2011” was released last month, bringing with it a host of data, recommendations, and insight applicable to medical device manufacturers of all sizes. The report, which was presented at the Advamed 2011conference, aims to offer a global analysis of the entire medical device industry from a […]

FDA advances public health, protects consumers, regulates products and is an important force in our national economy. Now, FDA is being challenged by Congress and the President to justify itself as a positive force in the advancement of American innovation and as a contributor to US competitiveness. This is precipitating an identity crisis at FDA. […]

More than two years ago, FDA Matters suggested that one of FDA Commissioner Hamburg’s goals would be making it easier for stakeholders to anticipate agency actions. I was looking beyond transparency (see what FDA is doing and has done). I hoped the FDA would focus on the larger virtue of predictability (being able to anticipate […]

Most GMP training that I encounter is not necessarily bad–just irrelevant. In fact the same could be said for the Training Department in general. They jealously guard their turf and deliver mediocre, perfunctory training. Names get checked off the list, and the Training Department goes about their business being irrelevant. (Ouch!) There is nothing that […]

In most discussions of science and medicine, there is an implicit assumption that the human body is a machine—complex and biological, but still a machine. If we could only understand all the mechanisms, processes and parts of that machine, then we could prevent and cure disease. Yet, the further we travel into the biology of […]

This past spring, medical device companies – and all other organizations participating in clinical trials – became subject to a new Final Rule regarding informed consent. Specifically, the FDA implemented changes to existing informed consent regulations that now require the submission of clinical trial descriptions to the public ClinicalTrials.gov databank. Trial participants must be informed of […]

Smaller medical device companies aren’t imagining things – it really does take longer to receive 510(k) approval for medical device developers with fewer than 100 employees than it does for larger industry players.  This startling information comes from a study published this summer by researchers at Northwestern University, which took a hard look at how […]

Did you know that your career can be ruined, or you can even do jail time, in a product recall? It has happened. Read here. And here. All FDA and DOJ have to show is that you ‘should have known’ about problems with your product. “I didn’t know” is NOT a defense! That low standard […]

The cover of Fortune magazine popped off the newsstand shelf last month: What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the World’s Largest Drug Company.” (August 15, 2011) Amidst the story that recounted epic boardroom intrigue, one section described the impact that these political shenanigans had on […]