Mobile Medical Applications - Where do we go from here?

With the recent announcement of 510(k) clearance of a retinal examining attachment and companion app can we now declare the outcry against the FDA finished?

I expect to continue this series on mobile medical applications as the industry finds new and better ways of using our Android phones, iPhones, <gasp> Windows 8 phones, <shocker> Blackberries, and any other new-fangled cell-phone to enhance our lives medically (just please spare us the Facebook phone, OK? The last thing I need is for my friend to "like" that I just went into surgery and my blood pressure is dropping!). What I don't expect is to have some new, breaking, or controversial opinion shared here every week. Why?

The buzz is gone.

The technology will continue to develop, that is for sure. Mobile technology, be it through your cellular device or even something as technologically savvy as the HealthSpot Station will help to increase the effectiveness of our national healthcare with an added value of (hopefully) decreasing the cost to obtain healthcare services. Continued development in this area will continue to change the landscape of just exactly how we stay healthy.

But it won't be front-page news.

It's not "loud" enough. People aren't as outraged about how the FDA is "stifling innovation" basically because - in so many words - it isn't stifling innovation. Software developers and manufacturers who are new to this game are beginning to understand that, while the regulatory pathway may increase time-to-market, the regulatory process can be forecasted and is certainly more predictable than the one we receive on the 5:00 PM news.

Furthermore, the approval process for the new mobile technologies is, essentially, no different from the approval processes for existing devices. A retinal scanner will be a retinal scanner. A glucose monitor will be a glucose monitor. A heart rate monitor will be a heart rate monitor. There may be some additional controls (software development and validation, consideration of frequency of transmissions for wireless product under the MBAN frequency range, etc.), but most technology currently being developed uses software, and is trending toward using more wireless technology.

In a sense - this is nothing new, people.

And that's great news for the industry.

-RTK