Conclusions
At the end of January 2010, FDA held a public meeting on the interoperability of medical devices. At that meeting, many of the speakers talked about the need for systems integrators. The favorite analogy was the aircraft industry where two primary manufacturers are big enough to set specifications for individual component suppliers to assure interoperability. By analogy, some people at the meeting suggested hospitals and other end-users play that role with medical devices.
For mHealth, that’s problematic if neither the systems integrator nor the individual component suppliers secure the necessary FDA clearance for the system as a whole. FDA regulates systems as systems. So if the individual component companies don’t take on the responsibility of FDA compliance for the system, it’s up to the integrator. Perhaps some hospitals want to take on that role and secure the necessary clearance from FDA. That could make some sense. But frankly it seems far more likely that an independent third party would play the systems integrator role, securing FDA clearance, and then selling that system to multiple hospitals and other caregivers. Either way, FDA will want to make sure the systems are safe and effective.
There are probably many different ways FDA can assure the safety and effectiveness of the systems. In my next article, I’ll offer some suggestions for where I personally think all of this is heading.
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