Posts tagged ‘marketing medical devices’

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

Marketing Medical Device Patents in the US

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

Appelfeld Zer Fisher is a patent firm that provides patent drafting, filing and prosecution of patent application. Additionally, Appelfeld Zer Fisher provides a unique service of providing good business advice on how to find investors and/or strategic partners for your unique inventions. As a part of this additional service, which happens to be highly important to all of our clients, I dedicate these next few posts.

Many fledgling medical device firms or inventors are posed with the question as to where it is best to introduce technology. For example, firms or inventors have the option to begin production and advertising in the United States. Alternatively, there are many other countries where such devices can be introduced.

Of course there are many factors that affect these decisions, but I would like to bring to your attention one very important issue in this blog with respect to product introduction.

The United States physicians and surgeons are exceptionally keen on writing articles about medical devices. Such an article may be an analysis of the efficacy of the product, which draws on a survey of several hundred uses of the product including clinical trials of several hundred patients.

Such a survey is of course fair and competent and can do your medical device a great service. This is particularly true if your medical device is a unique solution to a well known problem.

On the other hand it is often the case in the US that a reviewing physician or surgeon will publish an article regarding one surgical or medical experience in which the reviewer found a flaw in your device.  The article may enhance the reputation of the surgeon for finding “flaws” in your invention. But the article will spell the doom or your technology – no matter how “off base” the author is.

In other words, the US market is exceptionally sensitive to “untoward”, even completely unanticipated results that result from misuse of your devise.  It can be highly problematic to introduce an award-winning device in the US, only to have your success destroyed by a “renegade” article by a lone, perhaps incompetent, surgeon who failed to follow the guidelines of the instructions you included with your device.

OK, so this is Rabbi, Dr. Yosef Freedland, Surgeon and Patent Attorney signing off with the advice that a great way to lose weight is to eat while you are naked and in front of a mirror. Restaurants will almost always throw you out before you can eat too much.

February 25, 2009 at 12:27 am 3 comments


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