Post
by ProfessorEd » Fri Jun 12, 2009 9:19 am
The law is perfectly clear they cannot market this as a medical device without FDA approval. Getting this approval is expensive and requires studies they apparently have not undertaken. I am certain they have debated the wisdom of seeking this approval, and suspect they would do it if they had the funding. If they did seek approval it would use some version of the same technology, but would be a different device legally, and probably a much more expensive one (I suspect such a version would have multiple sensors.
As I mentioned earlier, there are obvious virtues to integrating such technology into CPAP headgear and could probably be profitable for the company that could do so and offer an unique product (protected by patents).
One well known cost to the current regulatory system is that many potentially useful devices never get to market (and a benefit is that much junk does not get to market and what does is better tested).
A concern I have here is that these regulations may keep the company from providing information that could be lifesaving to patients. Rather than saying seee your doctor if you suspect you have a medical condition (good advice, especially for those with insurance or non-poverty level incomes) they could possibly put in their literature a brief description of apnea and periodic limb movement conditions. Many buying this product, or thinking about it probably are doing so because they know their sleep is not restful, and some probably suffer from apea or another condition.
Assuming this product does at least part of what it is supposed to do, I can imagine it accidentally discovering indications of problems. Frequent arousal may indicate a problem or long periods in pbed without sleep. Ideally they might say the normal ranges are so and so, and suggest seeking further advice if well outside of these ranges. This might help some people and probably could save lives. while I think such warnings could be worked in with proper language. Not, "you appear to have X or to be sick" (a diagnosis which makes it a medical device), but "the following dat is well outside of normal ranges and you may wish to consult a doctor". While the latter is less likely to promote a doctor's visit, it probably still could save lives. It could generate additional income for doctors and lead to good will for the company among them, and possibly additional business. I can easily see a doctor with a patient reporting insomnia (actually one of the most common complaints), suggesting this product for a patient who has no obvious medical issues. I t could be more effective and easier for the doctor than suggesting better "sleep hygiene" (which to be useful requires the doctor to spend considerable time explaining what should be done and answering questions).
Admittedly some doctors are not too interested in such data. I use a doctor at the George Washington University clinic and they do not have the equipment to read the output from my machine in spite of their money. At home lab laid out almost $25 from a reader and with the aid of a mysterious disk that arrive in the mail with some software on it (thanks to whoever sent it) I can now access data they cannot.
I can imagine a discussion which goes as follows. "You suffer from excessive day time sleepiness (ETS). I notice from this data you typically go to bed at 2 AM and get up at 6 AM. I think going to bed earlier might solve your problem."
I think I would purchase this device if there was some evidence that it had accuracy within a single patient (i.e. it correctly indicated which nights you got more deep sleep, or even which nights I got more sleep (I can get time in bed with the machine on from my data recording device). This requires more studies of subject that run over several nights.
Studies have repeatedly shown people have trouble estimating how long it takes to fall asleep and how often they awaken. Many cases of waking up are not remembered. My 7 year old claims he has trouble going to sleep although observation shows he is always asleep shortly after being put to bed. There is a real need for such a device in the medical market (that can be used at home) to separate those with insomnia (inability to fall asleep or stay asleep) from those whose sleep is not restful enough. However, this device is probably not it, and if it is, the law prohibits the company from maketing it for this purpose.
However, the uses I and other have in mind are for optimizing our sleep, determining whether what we ear, when we exercise, what we do before bedtime, when we last have coffee etc. Supplement companies have bcome very good at marketing their products within the legal limits. The Life Extension Foundation put out a magazine which is mainly articles about supplements (and under freedom of the press can discuss how various supplements help people of various types, including lthose with diseases. In the magazine are there are ads for the supplements they sell (just in case you decided you wanted to buy something that might help you with a condition you have). The ads are correctly phased to stay within the law.
I suspect at some point, this firm will be selling a popular magazine on sleep which provides much useful information (hopefully) and just possibly includes ads for this device (and probably other sleep related products). There is a very large market for such a magazine since poor sleep and insomnia are very common. Those that watch TV know there a many firms advertising sleep related products (mattresses, sleeping bills, melatonin, supplements, etc.) and these are most likely to be bought by those with sleep problems. The above is some free advice for the company from a retired business school professor.
Last edited by
ProfessorEd on Fri Jun 12, 2009 11:35 am, edited 1 time in total.
