Has anyone here actually dealt with the FDA?
If anyone here has had experience with getting FDA approval for medical devices I would appreciate comments from them. I have experience in FDA submissions for drugs and they can be very frustrating to deal with in terms of making any changes in any aspect of the drug approval and production process. If one looks at the baby step approach that Medtronic has used in adding features to its insulin pimp line, it should be obvious that making wholesale changes to a device is time-consuming and expensive. I use a Medtronic 530g insulin pump with the CGM(continuous glucose monitor). The sensor communicates to the pump via radio. The pump and glucose meter also communicate with each other in the same fashiom. I am in far more danger of mis-entering blood glucose values manually than I am from someone trying to cause me harm by hacking my pump. These systems are low-poower systems. The pump runs on a single AAA battery which lasts about two weeks with vibration mode on. The transmitter lasts about two weeks also before being recharged but as the sensors only last six days, I recharge the transmitter each time I change a sensor. When the sensor and pump are on opposite sides of my body, communication stops. In order to have decent encryption you need a decently powered CPU which these insulin pumps don't have. Yes, you could design an entirely new pump with a "modern" CPU but then the entire unit(pump, meter, remote control, CGM transmitter) would have to be validated by the FDA. Here in the US the new versions of the pumps are available 12 - 18 months after they are in UK/EU. And that is for each of those baby step improvements.
If a patient is worried about someone hacking their pump(I'm not) or remebering when the gave themselves their last bolus(I am) then it is simple to look at either the bolus history or amount of active insulin on the pump.
Finally, new drugs are launched without having hundreds of thousands of test subjects, and yes, people do die from new drugs, drug interactions, and drug allergies. It is a risk-benefit analysis. I use my pump because it works for me, far better than multiple daily injections. I would say that it is far more hazardous to be driving a car either in the US, EU, or on some of those tiny hedge roads in the UK.