Last week Matthew Holt published a Year in Review issue of his FierceHealthcare email newsletter. The last item caught my eye.
device companies are introducing wired and wireless communication technologies
into their products. Meanwhile, implantable devices like stents, catheters and
pumps are continuing to use more and more pharmaceuticals integral to their
design. So, big medical device manufacturers like Medtronic and GE are finding
the boundary between software, pharmaceutical and biotech companies increasingly
blurred. The question of who regulates medical software is not too far behind.
And howdy. It seems like everyone's getting out of their comfort zone. These new connectivity and pharmacological features are as new and different for the customer as it is for vendors. The needs assessment and vendor selection process has been turned on its head.
Based on conversations I've had the FDA is indeed watching, they take their role in protecting the public seriously indeed. Conversely, there doesn't seem to be much interest in extending their regulatory mandate beyond its current scope. But Matthew is right, things are changing. If the industry adapts with embracing best practices and new standards, this prospective regulatory burden can be avoided. But if the industry chooses to stick with the "tried and true" approach of the past (sadly, a tendancy of health care) we're in for some radical changes.
Its a good time to be a connectologist!
[Hat tip: FierceHealthcare]