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I’m using this week’s announcement to build on a post from my friend Sailesh Chutani, CEO of Mobisante. Shortened for brevity, he writes,
“The premise of wearables is if folks could instrument themselves with appropriate sensors and become aware of lack of physical activity in their lives, they would began to pay attention to it, thereby become fitter and healthier.
Early data suggests wearables quickly becomes shelf-ware after an initial uptick in interest. Suffice to say that there has always been market for wellness products in our society; wearables are just the latest entrants that serve that need.
The first two are related since the makers of wearables in their desire to be not regulated by the FDA shy away from making any clinical claims. And the medical community is not likely to take the risk of using un-regulated devices to make clinical decisions for obvious reasons.
The third, data integrity, becomes important if providers are going to use that data to make clinical decisions. If that data can be hacked, the results could be disastrous. Privacy issues are beginning to be addressed as these devices start to become HIPAA compliant but there is a lot more that needs to be done.”
His full article here: http://bit.ly/Sailesh-on-wearables
He also writes:
If companies making these devices decide to get regulatory approval and become available for clinical use, that could have a significant impact in several areas.
Population studies and clinical trials:
… and “Stand-alone devices may become dominated by a small number of players such as Apple. It is quite probable that Apple watch does to fitness bands what Microsoft Office did to standalone spreadsheets, i.e. make them non viable. However, these technologies could find a home if they are integrated into clothing, exercise equipment, and our environment in some way.”
Do you agree with today’s subject line… that wearables are essentially worthless until they have clinical verification and enhanced security?
Do you believe any device will ever truly be secure? See “Which MedDev Company Will Implode First?” at http://medgroup.biz/implosion
Related discussion, “Launching without FDA Clearance” at http://medgroup.biz/no-clearance
What’s your assessment of the state of the wearables market?
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If you missed it – or want to watch it again – go to http://medgroup.biz/ISO-13485-webinar for complimentary access.
Make it a great week.
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John G. Caruso
CDISC, a non-profit data standards organization that develops standards for many kinds of data, has created some basic device-specific data standards in collaboration with CDRH, members of the device industry and academics. They are useful, but would need to be expanded to address the needs of the wearables market. Without cross-company collaboration, we will end up generating vast amounts of data that are very hard to use.
Paul M. Stein
Back then, I stated that “wellness” was kind of like fine art, “People can’t describe what it is, but they know it when they see it.” Well, I believe that to still be true, but the number of people has been getting smaller and smaller.
In this day of reducing healthcare costs and taking ownership of ones healthcare, there will absolutely be greater room for home testing of several disease processes like SIDS, fevers, epilepsy, atrial fibrillation, and obstructive sleep apnea with much more complex wearable medical devices. On the therapeutic side, implantables, not wearables, will continue to rule due to their greater sensitivity and specificity.
Anyone who has worked with internet backbone providers knows only too well how easy it is for ‘bad actors’ to hack, block or intercept traffic and the general public may be surprised at the amount or equipment, software and people it takes to keep the public internet providing the far from safe service used by billions of people.
The fact that many internet users trust anti-virus software developed by companies whose very existence relies upon the constant presence of virus attacks should make them stop and think twice about trusting the internet for any sensitive information.
We at MEDEX Spot plan to use satellite to connect our retail store based Unmanned Micro Clinics (UMC) to hospital medical call centers manned by medical practitioners. This way we provide persons with medical conditions with the ability to have low cost virtual medical examination by trained medical staff using an array of FDA-approved medical instruments in our UMC cabins over secure private satellite links which are not connected to the public internet.
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