How to create a social application for life sciences without getting fired
by Josh Bernoff
That's the title of my latest report, and it's not a joke. All your social application instincts here will get you in trouble. In the topsy-turvy world of regulated medical products and devices, the FDA calls the shots -- and it hasn't made clear what's allowed. In fact, one person I interviewed for this report called back extremely worried about getting fired if I spoke about the company's application, even though it's right out there on the Internet for everyone to see. The level of concern and paranoia here is breathtaking.
To conduct this report I conducted 25 interviews, including 10 pharma companies. All the pharma company interviews were confidential for obvious reasons. (As usual, the report is available for clients only or for a fee. Or you can get the slides from my presentation at HealthCampBoston for free.)
Because of the regulation, I structured the report around risk. Since every company in the pharma industry tells me "we are the most conservative company in the pharma industry", I decided to focus on who has the most to gain from social applications. Because if you don't have a lot to gain, the regulatory issues mean you may have a lot at risk, and it's not worth it. Among the important risks are companies violating rules on adverse events reporting, off-label usage, and fair balance.
This led me to the following chart:
In this chart we plot all the medical conditions we analyze on two scales. On the horizontal scale we locate points based on the question "Do the people with this condition participate in social media?" On the vertical, we use our judgment on how much those people could benefit from social applications.
For example, Depression is in the upper right quadrant ("Misery Loves Company") because it has socially active sufferers and because those people can benefit from helping each other out with support and information. At the other extreme, people with osteoporosis don't participate much (because they're older) and wouldn't get all that much out of it if they did.
The report lays out strategies based on which quadrant you're in. Upper right quadrant, you want to look at less conservative, more effective strategies like pre-moderated communities, like alli circles and sponsored communities like the type 1 diabetes community Juvenation, sponsored by Novo Nordisk.
If you're in "Connectors Who Don't Care" or "Lonely Fellow Sufferers," consider more conservative strategies like restricting open text fields, as AstraZeneca did with its Celebration Chain application for Arimidex, or vetted contests, like Fight HIV Your Way for BMS' Reyataz.
There's lot of other advice, but probably the most important is to involve the regulatory staff in your company early. Otherwise they'll shut you down before you launch. Get 'em in on the planning.
Looking forward to your reactions. And it sure would be great if the FDA would set some clear policies on this.