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Post by boca1girl on Sept 17, 2019 9:11:47 GMT -5
It depends on how FDA labels the device. Simple medical devices, like thermometers and blood pressure monitors, can be sold anywhere while other devices can be dispensed only on the orders of a physician (i.e. the sale requires a written prescription); that implies a level of regulatory infrastructure Apple stores do not have. Since BluHale is intended to dispense a prescription drug it will probably be available through the same channels as Afrezza itself. For the sake of discussion, how hard would that be to develop? I know it is not the same thing, but Apple can manage educational orders that require verification. And Apple already has at least one certified prescribing app in its store. Perhaps Apple could not handle walk-in purchases with a prescription, but I'm open to the idea that they may have the infrastructure to be able to handle simple medical devices that are prescribed electronically in advance (through a certified e-prescribe app) without too much trouble. Having said that, I think your last line is the most likely. Besides which, why would Apple even want to bother until sale sales of Afrezza are many many multiples beyond where they are now. I thought BlueHale was just a metering device. It doesn’t dispense the drug, or assist dreamboat to dispense, does it? |
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Post by harryx1 on Sept 17, 2019 9:41:22 GMT -5
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Post by wsulylecoug on Sept 17, 2019 10:00:13 GMT -5
For the sake of discussion, how hard would that be to develop? I know it is not the same thing, but Apple can manage educational orders that require verification. And Apple already has at least one certified prescribing app in its store. Perhaps Apple could not handle walk-in purchases with a prescription, but I'm open to the idea that they may have the infrastructure to be able to handle simple medical devices that are prescribed electronically in advance (through a certified e-prescribe app) without too much trouble. Having said that, I think your last line is the most likely. Besides which, why would Apple even want to bother until sale sales of Afrezza are many many multiples beyond where they are now. I thought BlueHale was just a metering device. It doesn’t dispense the drug, or assist dreamboat to dispense, does it? From my understanding it does two things... 1. It shows (in real-time) a profile that represents your inhalation level of effort in reference to the ideal level of effort profile with the purpose being to match the ideal profile ensuring the delivery of the maximum amount of Technosphere product. 2. With regard to Afrezza, it senses the size of cartridge (4, 8, or 12 units) placed in the inhaler. That's the data used for feedback purposes with the BG profile. |
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Post by uvula on Sept 17, 2019 10:08:12 GMT -5
Bluehale is used instead of dreamboat. It is essentially a dreamboat with sensors.
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Post by ktim on Sept 17, 2019 10:15:53 GMT -5
I thought BlueHale was just a metering device. It doesn’t dispense the drug, or assist dreamboat to dispense, does it? From my understanding it does two things... 1. It shows (in real-time) a profile that represents your inhalation level of effort in reference to the ideal level of effort profile with the purpose being to match the ideal profile ensuring the delivery of the maximum amount of Technosphere product. 2. With regard to Afrezza, it senses the size of cartridge (4, 8, or 12 units) placed in the inhaler. That's the data used for feedback purposes with the BG profile. In regard to 1, I think dreamboat was designed to deliver a uniform dose over a very large range of inhalation efforts, so that there isn't a need to achieve some "ideal" level. At least that is what MNKD has said in the past. Hopefully that is the case... i.e. ease of use, and consistency regardless of factors that might vary a person's lung capacity temporarily. Beyond brief initial training in doctors office for Afrezza, I think that feature has much more relevance potentially with PAH, where monitoring changes in inhalation effort might have clinical significance. |
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Post by ktim on Sept 17, 2019 10:16:43 GMT -5
Bluehale is used instead of dreamboat. It is essentially a dreamboat with sensors. Bluhale is a snap on device that fits on top of the disposable dreamboat. |
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Post by ktim on Sept 17, 2019 10:25:56 GMT -5
It depends on how FDA labels the device. Simple medical devices, like thermometers and blood pressure monitors, can be sold anywhere while other devices can be dispensed only on the orders of a physician (i.e. the sale requires a written prescription); that implies a level of regulatory infrastructure Apple stores do not have. Since BluHale is intended to dispense a prescription drug it will probably be available through the same channels as Afrezza itself. For the sake of discussion, how hard would that be to develop? I know it is not the same thing, but Apple can manage educational orders that require verification. And Apple already has at least one certified prescribing app in its store. Perhaps Apple could not handle walk-in purchases with a prescription, but I'm open to the idea that they may have the infrastructure to be able to handle simple medical devices that are prescribed electronically in advance (through a certified e-prescribe app) without too much trouble. Having said that, I think your last line is the most likely. Besides which, why would Apple even want to bother until sale sales of Afrezza are many many multiples beyond where they are now. I would suspect BluHale will not require a prescription, since it is simply monitoring the dosing. I believe there is an add on device for RAA pens to do the same that doesn't require a prescription. I agree with you that Apple would be unlikely to carry it. Not a lot of Afrezza users, and only a subset of those using OneDrop and I personally doubt even a large percentage of the those users would want to add bulk to their dreamboat simply to avoid hitting a button or two to record their dose. Seems like before deciding what to dose they are already going to be interacting with their tool set... checking BG, recording meal, etc. This will likely be available directly from Mannkind and/or from OneDrop. |
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Post by uvula on Sept 17, 2019 12:49:28 GMT -5
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Post by jay1ajay1a on Sept 17, 2019 13:02:45 GMT -5
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Post by prcgorman2 on Sept 17, 2019 13:13:27 GMT -5
I guess that makes Bluehale a snap-on tool. (Couldn't help myself.)
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Post by ktim on Sept 17, 2019 14:12:07 GMT -5
Since it attaches to the top and the top is the portion that contains the mouthpiece, it isn't replacing that. It is merely snapping onto the outside and characterizing the inhale via the acoustics detected from the outside of the dreamboat. Though I do really wonder how they solved the problem of identifying which cartridge is used. There was speculation here as to whether that could be determined from the acoustics. Last year it seems they talked about adding some "fiber optic" based system to detect the cartridge color but that would seem to mean modifying the dreamboat, which isn't something they've now mentioned with regard to the new integration with OneDrop. I suspect that the TreT inhaler might have a more elegant version of BluHale built into it from the beginning. |
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Post by lakers on Sept 19, 2019 1:00:57 GMT -5
One Drop, the digital health specialist that markets diabetes management tools, has found a new partner and investor in Bayer. The German pharma led One Drop’s $40 million series B round and licensed its technology for its “bio-digital efforts” in areas beyond diabetes.
New York-based One Drop offers hardware and software to help people manage their diabetes, including a Bluetooth-enabled blood glucose meter, test strips and lancets as well as a mobile app and various coaching programs. These are available individually or as part of a “gestational diabetes package” or a subscription-based “diabetes package.”
The One Drop app works with FitBit trackers and Dexcom glucose monitoring systems on iPhone and Android devices. Apple has even begun selling One Drop’s chrome-plated glucose meter alongside its iPhones and Apple Watches in some of its U.S. retail stores. These integrations, One Drop says, are why its reach is so deep. It estimates that nearly 1.5 million people in 195 countries use its technology.
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Post by porkini on Feb 24, 2020 16:26:15 GMT -5
One Drop, the digital health specialist that markets diabetes management tools, has found a new partner and investor in Bayer. The German pharma led One Drop’s $40 million series B round and licensed its technology for its “bio-digital efforts” in areas beyond diabetes. New York-based One Drop offers hardware and software to help people manage their diabetes, including a Bluetooth-enabled blood glucose meter, test strips and lancets as well as a mobile app and various coaching programs. These are available individually or as part of a “gestational diabetes package” or a subscription-based “diabetes package.” The One Drop app works with FitBit trackers and Dexcom glucose monitoring systems on iPhone and Android devices. Apple has even begun selling One Drop’s chrome-plated glucose meter alongside its iPhones and Apple Watches in some of its U.S. retail stores. These integrations, One Drop says, are why its reach is so deep. It estimates that nearly 1.5 million people in 195 countries use its technology. I've noticed the past month or so that One Drop has been sponsoring NPR broadcast programs such as the BBC World News and I believe some other programming. During the brief sponsor message that they receive, it is highlighted that One Drop is available in such pedestrian places as Walmart and Walgreens - so, expanding beyond Apple Stores and Amazon. |
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