http://hackaday.com/2014/07/13/open-source-glucose-monitoring-an-the-front-lines-of-innovation/
Dexcom G4 Glucose Monitor
http://www.youtube.com/watch?v=qfXTdAxX09s
1. What's the price? Ultimately, most patients should receive a discounted price of about $800 for the G4 Platinum starter kit, which includes the receiver, transmitter, and charger. Although the actual cash price is $1,198, most insurers have agreements with Dexcom to pay a discounted price for the patients they cover – the benefits of buying in bulk! [http://diatribe.org/issues/48/test-drive]
Dexcom G4 Glucose Monitor
http://www.youtube.com/watch?v=jeuBTgK68jc
QUESTIONS?
Cellcom Partners with Telcare to Offer Diabetes Management Solution
[http://www.nsightnews.com/Press-Releases/cellcom-partners-with-telcare-to-offer-diabetes-management-solution.html]
Interesting project, but this guy probably needs to be more afraid of the FDA(Food and Drug Administration) rather than the company.
Unfortunately medical devices are expensive to produce, the FDA regulates every aspect. I write firmware for glucose meters, so I have to deal with this every day. There is an huge amount of code that goes into these little things and its incredibly complicated. Every line and branch is verified and tested. Years of R&D and millions of dollars go into even the simplest meters. Yes, there can be harm to the user. What happens if your ‘hacked’ interface produces incorrect data and you administer too much or too little insulin? CGM is even scarier when its controlling a pump. Your basically putting your life in the hands of the people who wrote the code.
Priority 0: Safety of the customer
Priority 1: Cost and schedule
Unfortunately medical devices are expensive to produce, the FDA regulates every aspect. I write firmware for glucose meters, so I have to deal with this every day. There is an huge amount of code that goes into these little things and its incredibly complicated. Every line and branch is verified and tested. Years of R&D and millions of dollars go into even the simplest meters. Yes, there can be harm to the user. What happens if your ‘hacked’ interface produces incorrect data and you administer too much or too little insulin? CGM is even scarier when its controlling a pump. Your basically putting your life in the hands of the people who wrote the code.
Priority 0: Safety of the customer
Priority 1: Cost and schedule
The problem this project will not get very far in the US. Having
worked in a FDA regulated, electronic medical firm I know about the
FDA process having worked as a technician with engineers that work with
regulatory for return units including FDA and death investigations for
defibrillators. Glucose monitors come under the FDA as a Class II
device. There regulatory issue that need to be followed:
Establishment registration,
Medical Device Listing,
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
Investigational Device Exemption (IDE) for clinical studies
Quality System (QS) regulation,
Labeling requirements, and
Medical Device Reporting (MDR)
One cannot simply whip up or legally modify the device. Then there liability. This make Open Source verer impracticable. It is not just company the guy needs to worry about but also the FDA.
Establishment registration,
Medical Device Listing,
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
Investigational Device Exemption (IDE) for clinical studies
Quality System (QS) regulation,
Labeling requirements, and
Medical Device Reporting (MDR)
One cannot simply whip up or legally modify the device. Then there liability. This make Open Source verer impracticable. It is not just company the guy needs to worry about but also the FDA.
