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FDA Medical-Device Regulator Leaves to Take Position at Microsoft Health Solutions Group – Director of Regulations and Pol

Posted Mar 01 2010 6:55pm

This is a nice change with not leaving to go to either a drug or medical device company.  With her experience at the FDA I’m sure she will be able to help the world of Health IT and of course have former on hands knowledge on where she feels IT innovation could really help. image

In the news of late, the FDA wants to revamp the fast track approval process to ensure safety, and yet on the other side of the coin we hear about the FDA and NIH working together with a goal of getting drugs and devices out to consumers faster, so it makes you wonder, which is it going to be safety or time elements. 

As I have said before, the software with devices is a huge part of all of this and you do not want the devices out there without the assurance that it has been debugged and tested as thoroughly as it can be.  Also one important matter that seems to be forgotten at times is the fact that the programmers are not working with patients and software at the same time, so their perception might be different than it would be in actual use.  I experienced that when writing code for my EMR in the fact that I thought I had a process written that would be a real winner, but when put into use was not the answer I thought it would be and would go back to modify either for ease of use or functionality, or a host of a few other things that could occur.

With medical devices safety is all about the software.  BD 

WASHINGTON—The director of the Office of Device Evaluation, one of the highest-ranking positions at the Food and Drug Administration, is leaving this month to join the Washington lobbying office of Microsoft Corp., according to an email she sent Monday morning.

Donna-Bea Tillman, who has been with the FDA's Center for Devices and Radiological Health since 1994, said in the email that she will become part of the software giant's health-solutions group as the director of regulations and policy. The FDA confirmed her departure. Microsoft didn't immediately return messages seeking comment.

Dr. Tillman came under fire last year in an FDA report about the agency's December 2008 approval of a knee-surgery device called Menaflex, made by ReGen Biologics Inc. of New Jersey.

Dr. Tillman said in an interview that she won't personally lobby. She said she will be part of the company's effort to beef up the development of medical information-technology systems and expand the profile of its health group in Washington.

In an email to the device division staff on Monday, Dr. Tillman, who has a doctorate in biomedical engineering from Johns Hopkins University, said she was interested in the potential for health IT to "reduce the skyrocketing cost of health care."

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