Archive for April, 2009

More about how one article can be a complete disaster for you

Hi, Rabbi, Dr. Yosef Freedland, Surgeon and Patent Attorney on Medical Devices here.

So, returning to the renegade surgeon who misused your medical technology and writes an article on a singular experience:

Such a disaster can occur even when hundreds of clinical trials have proved your device to be efficacious, and that the flaw reported by the article is in fact a single occurrence that has no bearing on the overall efficacy of your product; for example where the surgeon explicitly failed to follow instructions clearly printed on the packaging brochure.

Examples of such cases, where single flaws that were later corrected spell the doom of any marketing in the United States are many. One such case occurred with a very viable product from a company we will refer to as Expanding IM Inc.

Expanding IM Inc. developed a unique expanding rod that installs in the intramedullary (IM) canal of a fractured long bone. The Expanding IM Inc. IM rod allows a surgeon to not only align a fracture in the long bone, but prevents torsion between fractured bone portions of the long bone when expanded.

There are a variety of already existing surgical devices on the market that prevent poor alignment between fractured bone portions of long bone.

For example there are rods that insert through the longitudinal axis of the long bone and have transverse lock screws in the upper and lower portions of the rod that prevent torsion between the Bone portions.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon and Patent Attorney signing off with the observation about cold weather, that:

At minus 80 degrees – Polar bears move south, Green Bay Packer (and Buffalo Bills) fans order hot cocoa at the game.

April 27, 2009 at 9:51 am Leave a comment


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