In a fantastic case of science-fiction-meets-reality, Qualcomm created the X Prize Foundation to challenge developers and innovators to create a Star Trek Tricorder. The prize? $10M!

While much more effort would go into developing said device than, say, buying a powerball ticket (too bad I don't live in Missouri!), the creation of a device that can provide accurate, real-time diagnosis with that level of portability would revolutionize healthcare. Enter Scanadu.

Please humor me - go to their website to view their promotional video. That device is truly incredible if you think about how it changes healthcare. When my son gets a rash on his skin, we'll be able to diagnose if it's an allergic reaction, a viral rash, eczema, or just dry skin! Well, maybe...

For as excited as I am that the tricorder may exist as a working product in our lifetime, I'm equally cognizant of how "interested" the FDA will be. The primary red flag I see is their website tag-line: "Sending your smartphone to med school." Alright, so Scanadu is admitting in that tag-line (and in the video if you watch) that Scanadu will essentially take care of the initial diagnosis. The app would be the doctor! Scanadu will need some pretty powerful software validation records, usability test records, and one monster of a risk management file to prove that they are equivalent or better than a doctor's diagnosis. That's one tough task.

I can understand the concern that FDA is stifling innovation. The Scanadu product represents an enormous change in how we stay healthy; however, with great power comes great responsibility, and the FDA will ensure Scanadu has balanced both prior to launch. I can't say that I blame them when my iPhone might be able to tell me that I have melanoma.

Scanadu is expected to be on the market (in WalMarts, Walgreens, etc.) in late 2013, though I fully expect it to be closely evaluated by FDA and delayed past that time period.


Image Credit: Mike Seyfang on Flikr

We are passionate about your success. Tell us more about your regulatory and quality needs to learn about how we can help.

Book a Consultation


To display custom copy instead of global copy in this section, please go to Show Global Content for Bottom CTA? toggle in the "Contents" tab to the left, toggle it off, save, and then REFRESH the page editor, the custom text will then show up and ready to be edited.

Turning the global content back on will be the same process, go to the toggle and toggle it back on, save and refresh!