I think you can get around the red tape if the app doesn't make medical recommendations. As long as it just tracks the data, I don't believe it would need to be registered as a type-2 medical device.
What if we dont recommend treatment...more so utilizing the analytics they dont track. We wouldn't recommend, every case is different. That is between the user and their medical professional
I would guess that collecting data in this case could still fall under regulatory preview, and that you would also need to qualify your sensors (Pebble) too.
It really would be best to speak to someone familiar with Canadian medical device data. Much cheaper to do things right from the start (e.g., develop under IEC 62304) than to fix things later after getting a nasty gram from the Canadian FDA equivalent. Maybe through very careful marketing you can work around potential problems, or maybe not. I think that this project is in an area that requires an expert opinion, however.
This is a great idea. Unfortunately for me I have/had petit-mal seizures, because of that I don't think the method by which this tracks seizures would work for me.
I was literally thinking this would be amazing until I realized this is really only for grand mal seizures. My father has suffered from petite mal seizures his entire life.
Have it text a family member when a seizure is detected so they can follow up with a phone call in a little bit to make sure everything is ok.
As more and more 911 centers accept SMS messages, it might be cool to allow the user to specify some threshold after which an automated text is sent to 911. The vast majority of epilepsy related seizures do not require an ambulance, but in the event of a seizure that does not stop in a 'normal' time frame[1], it could get help coming that much faster.
I just lost a really close friend about three weeks ago to epilepsy. He had a massive seizure and died in his sleep. His roommate found him next to his bed the next morning. I can't help but think about how his death could have been avoided, so I absolutely see the value in this feature. As far as I can tell, notifications would be THE feature of a system like this.
Thank you for sharing that. It's very hard having someone you love and feeling powerless to help them at some moments. Sharing this really meant alot :) thank you
Since the app is intended to be used while sleeping, it would be pretty easy to include a preprogrammed address in the 911 message (perhaps with a geolocation 'sanity check' just in case the wearer is traveling).
I think notifying a friend or family member is probably the most important thing. They can follow up from there.
Text-to-911 is growing in availability (in the US, anyway), but it's far from universal:
Silly to move forward with medication dosage and other management with just generalized tonic clonic seizures. Leaving out partial complex seizures and the like would be required information. Most temporal lobe seizure patients have a much greater partial to generalized seizure ratio.
Also these seizures leave post ictal symptoms to make such seizures notable to the patient. Partial seizures not so much. Those complex partial and absence patients are the target group for benefit.
I've been looking for something like this for ages - I have a family member who suffers from generalized tonic clonic seizures and have been looking at ways to try and do remote tracking.
The #1 feature request I would have is the ability to nominate a mobile number to get an SMS alert if a seizure is detected.
Is there any chance of getting early access to this ? I'd be really happy to be an Alpha tester and would be highly motivated to give you guys as much feedback as possible from the p.o.v. of a family using it to monitor epilepsy.
So for me I think the killer feature would be the SMS alerting. Other features which would be just below that:
(1) Ability to export raw data (to .csv ?) and graphs (to .xls ?) in case we wanted to run our own analysis
(2) Ability to markup the data with "events". For example if someone had a seizure we could record it against the data set, or mark any false positives.
(3) If you enabled (2) and had buy-in from your customers about using this data you could have a very powerful data set to improve your seizure detection algorithms by looking for common patterns in the data set.
Then slightly lower importance would be:
(4) Community forums where users could exchange ideas, tips, experiences etc.
And finally:
(5) Better platform support (iOS, Apple Watch etc), but personally I think it would make sense to prove the product and feature set on 1 platform first before branching out.
Have sent you an email in case you want to discuss any of this in more detail.
As an epileptic I doubt that this kind of device "can help them (the epileptics) adjust their medications." My neurologist adjust my medications every 6 months after studying my blood analyses, standard EEG and sleep EEG.
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[ 4.5 ms ] story [ 84.3 ms ] threadAn individual's data can help adjust their medications, change eating patterns and maximize sleep schedules.
That sounds like it's being used to guide treatment.
It would be worthwhile to speak to someone familiar with Canadian medical regulations.
It really would be best to speak to someone familiar with Canadian medical device data. Much cheaper to do things right from the start (e.g., develop under IEC 62304) than to fix things later after getting a nasty gram from the Canadian FDA equivalent. Maybe through very careful marketing you can work around potential problems, or maybe not. I think that this project is in an area that requires an expert opinion, however.
I love the name, love the idea, keep it up!
But we will update soon that might help! (another hardware platform wants to contribute)
Have it text a family member when a seizure is detected so they can follow up with a phone call in a little bit to make sure everything is ok.
As more and more 911 centers accept SMS messages, it might be cool to allow the user to specify some threshold after which an automated text is sent to 911. The vast majority of epilepsy related seizures do not require an ambulance, but in the event of a seizure that does not stop in a 'normal' time frame[1], it could get help coming that much faster.
[1] http://en.wikipedia.org/wiki/Status_epilepticus
Would you see anything else of value?
I think notifying a friend or family member is probably the most important thing. They can follow up from there.
Text-to-911 is growing in availability (in the US, anyway), but it's far from universal:
http://transition.fcc.gov/pshs/911/Text_911_Deployments.pdf
The #1 feature request I would have is the ability to nominate a mobile number to get an SMS alert if a seizure is detected.
Is there any chance of getting early access to this ? I'd be really happy to be an Alpha tester and would be highly motivated to give you guys as much feedback as possible from the p.o.v. of a family using it to monitor epilepsy.
(1) Ability to export raw data (to .csv ?) and graphs (to .xls ?) in case we wanted to run our own analysis
(2) Ability to markup the data with "events". For example if someone had a seizure we could record it against the data set, or mark any false positives.
(3) If you enabled (2) and had buy-in from your customers about using this data you could have a very powerful data set to improve your seizure detection algorithms by looking for common patterns in the data set.
Then slightly lower importance would be:
(4) Community forums where users could exchange ideas, tips, experiences etc.
And finally:
(5) Better platform support (iOS, Apple Watch etc), but personally I think it would make sense to prove the product and feature set on 1 platform first before branching out.
Have sent you an email in case you want to discuss any of this in more detail.
As an epileptic I doubt that this kind of device "can help them (the epileptics) adjust their medications." My neurologist adjust my medications every 6 months after studying my blood analyses, standard EEG and sleep EEG.