Comments on: Medical Device Industry Primer?

Question: Medical Device Industry Primer?

nancoix — Fri, 01 Aug 2008 06:41:03 -0800

I'm about to begin work at a medical device company (as a paralegal) and would like an introductory book on the subject. I've scoured Amazon, but haven't found anything that's a general overview, with chapters on history, business climate, FDA and regulatory issues, litigation -- just a smattering of everything, with perhaps emphasis on legal / regulatory. Most books are more specialized. Or are there websites or white papers along these lines? Recommendations, please!

By: TedW

TedW — Fri, 01 Aug 2008 07:04:03 -0800

ECRI puts out a lot of information related to medical devices, although much of it is for members. In particular their medical device safety reports are a goldmine of information on what can go wrong.

You will have a hard time finding a single comprehensive source on"medical devices". That term is very broad. It covers everything from suction catheters to orthopedic screws and plates to heart-lung machines. If your company specializes in a particular field of medicine there are textbooks that may help; for example, there are several good books on anesthesia equipment; here is one of the more popular.

By: acoutu

acoutu — Fri, 01 Aug 2008 08:20:46 -0800

I wrote my masters thesis on a particular segment of the medical device industry, particularly the buying process. It's about 5 years old now, so perhaps not helpful...?