For medical students, residents, and attendings aspiring to develop a new medical device that is FDA approved for patient use, there are a few things you should remember:
First, don’t star in Grey’s Anatomy while your experimental device is demonstrated by faux doctors performing faux procedures on faux patients. People might think you are a faux doctor helping the other faux doctors install a faux heart failure device.
Second, in your excitement after the shoot, avoid saying things to main stream media like: "This kind of attention is important to create awareness and to help people that are out there that have a heart problem and have been given no option of therapy to learn that there is an option." Really don’t say this after your FDA trial has begun in "Kansas, Kentucky and Ohio." Statements like those might run afoul of the FDA guidance statement for the recruitment of study subjects.
Third, don’t have the actors describe the device as "crazyballs." Because the device is experimental and hasn’t even completed clinical testing and evaluation in the US, such a claim might fly in the face of FTC deceptive advertising guidelines.
Finally, don’t have your local NBC news station promote (with video clip) your stardom, too. (Seriously, promoting an ABC show?) By doing so, your local newscasters really create the perception that your hospital system (that benefits financially from your study) really wants to get the notice out, too.
Remember: real doctors with real medical devices that they are hoping to get FDA approved would never think of doing such a thing.
Would they?
-Wes
Addendum: Seems Grey’s Anatomy has a habit of doing similar promotions (h/t@AlecGaffney via Twitter)
