8 min reading time

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.

OBSTACLES
The biggest obstacles for adoption in clinical practice seem to be:
a) lack of awareness in the medical community,
b) absence of clinical claims by these devices,
c) integrity and privacy of data collected by these devices.

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:

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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.

In diagnosis:
People who have some complicated conditions that are hard to diagnose would probably benefit from an extended observation and data collection regime to see how their body is behaving over an extended period of time.

In therapy:
These devices could help measure how the body is responding to treatment, especially for complicated or experimental treatments.

In monitoring:
High-risk patients who normally be kept in a controlled environment could live in less controlled environments and potentially autonomously if they felt reassured that help would not be far away.

Population studies and clinical trials:
Data collection for these is very expensive and time consuming using the traditional methods but could become very straightforward and cost effective using wearables.”

… 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.”

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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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Video, slides and transcript for ISO:13485 webinar are ready

Thanks to the hundreds who attended Jon Speer’s workshop last week.

If you missed it – or want to watch it again – go to http://medgroup.biz/ISO-13485-webinar for complimentary access.

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. Our free CE Marking webinar from notified body TUV SUD is today. Register at http://medgroup.biz/New-CE-Marking-Rules

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Dale Henn
President • CEO at BODYLOGIC WEARABLES
Talk about canary in the coal mine….I wonder what the apparel would show if worn in mainland China. Yikes!

John G. Caruso
CAD designer drafter seeking my next opportunity.
Slightly off topic, but this is interesting: https://genesisnanotech.wordpress.com/2015/10/13/graphene-coated-e-fabrics-detect-noxious-gases/

Guy Allbrook
InTouch Health
You need to research Sotera Wireless.

Heather Thompson
Creating B-to-B content for medical device and digital health publications.
Compared with the technology they are poised to replace (heart monitors, glucose meters, scales, diet diaries, sleep trackers, etc. wearables are exponentially less expensive and far more accurate. Calling them wellness products is a bit insulting. Wearables have the potential to actually pinpoint the watershed moment when a person switches from healthy to sick. If that isn’t value, I’m not sure what is. The key to adoption is either addiction or automation. We need to make wearables one or the other (or both).

Karen Boyd
Owner / Operator at QMS Consulting LLC
Whether wearables are worthwhile or worthless is a matter of perception. Those who wear them obviously find them useful for one reason or another – be it a fashion statement, a proactive measure or reminder of physical health, or both. Those who argue against the medical validity and worthiness of wearables have legitimate concerns. There is no replacement or substitution for direct medical analysis, diagnosis, and prescribed treatment, IMO. However I don’t necessarily discount the advent and usefulness of wearables. Although the bulk of them may not be physically or clinically accurate, I think they can at least provide a psychological (or feel good) benefit for those who buy into them. Better to initiate or motivate oneself toward positive goals and health benefits than to sit idle. Even if the snazzy little fitness gadget serves only to boost self-esteem, it’s worth it to that wearable wearer. Just be sure to visit your doctor or clinician for regular check-ups too!

Edward Dolan
Merchandiser at OneSource Distributors
I worry far less about security (although it is an issue) and far more about what will motivate the wearer to continue using the wearable; to persist in letting this device intrude on their time and attention.

Joe McMenamin
Medically trained health lawyer; telehealth advisor; public speaker
I suspect most clinicians will remain skeptical so long as the signal-to-noise problem remains unsolved. It seems possible, though not inevitable, that competent analytics might change that in time.

Max Shurgalin
R&D Professional. Innovator. Broad technical know-how. Expertise in medical device system design, R&D program management
I would not categorize current wearables as “worhtless” wellness products but certainly they are more of a toy than a device at a high level of utility for anything practical. Except perhaps for medical insurance companies, who are interested in them for the purpose of better insurance risk management. Perhaps soon we will all be required to wear “activity” monitoring wrist bands to be eligible for any reasonably priced medical insurance 🙂

Kit Howard
Senior Director of Standards Development and Education at CDISC
One thing to keep in mind with respect to data collection for use in clinical claims (or anything else) is that the data are largely useless if they cannot be aggregated. Today, there are no data standards among companies for most device types – in fact, some companies even use different data structures in their own different related products. This means that data, at best, can be combined within a device model, but to get real power, it must be pooled, and pooled across devices and companies.

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.

Dale Henn
President • CEO at BODYLOGIC WEARABLES
I do wish somebody would enforce “claims” to limit these devices to “estimated” or “approximate” and that will give companies an opening to be motivated to invest the capital to create devices that can be used in clinical and sports settings. When you can buy a Fitbit knockoff for $13, it is demotivating for even Fitbit to move towards a clinically validated device. Typically regulators go after the easy targets, meaning the serious and scientific companies and avoid those that sell and market contraband. Just go to Amazon and other places. It should be easy to weed out the bad faith players but that doesn’t seem to happen. I want the Apple and Fitbits to succeed at developing a category but I also want the entrepreneur to succeed and the landscape is not in their favor. We can only hope.

Dale Henn
President • CEO at BODYLOGIC WEARABLES
Two comments…First, I don’t agree wearables are worthless and until regulatory validates these devices, they won’t be adopted. Medical professionals including doctors can influence behavior by positive reinforcement when patients use wearables. Rather than get caught up in the detail of regulatory and whether the numbers are accurate, simply acknowledge the use is a good thing and the number should be viewed as a daily “index” vs. real. So, if my “index” numbers like calories or miles or steps are higher today than yesterday, it is a fairly safe assumption that energy output and activity was also greater and that’s a good thing. The first step is to use the products as guides and not miracle products. Second, it appears most people are equating wearables to monitors of the human body. If so, the world is in for a big surprise by the end of this year. The definition of health related wearables is about to change in a very positive and disruptive way. I guess the best way to put the negativity is to lighten up a little. Use the current wearables as a guide, a reinforcement, a tool in the tool chest of health and as time goes by, clinical validation will happen. One such example is Metalogics Corporation. This is the only known wearable device in the world that measures real calories. The data has been researched, validated with the best in class researchers and engineers and hasn’t gone to market for many of the reason cited in this post … the need to walk before they run. For those interested in that item as a way of putting a picture with the explanation and since I did mention it, you can see a little info at www.metalogicscorp.com. This isn’t the direction I was alluding to but wanted people in this post having a dialog that these things with clinical validation do exist and are coming….

Ja’Nohn Bowen
Offering Development Leader, GBS Offering Management at IBM
From a consumer perspective I couldn’t agree more. From a semiconductor salespersons perspective this is a frightening reality. As of late I’ve been engaged in a very real set of conversations evaluating product that matters. The. CAGR doesn’t matter as much as the genuine and measurable purpose.

Mark Aloia
Global Lead, Health Behavior Change, Philips HealthTech
There is one thing missing from this conversation. FDA approval still does not mean adoption by patients/consumers. Medication adherence is also poor, despite the advocacy of the medical community. The uptake of wearables only speaks to desire of consumers, but experts in behavior change need to influence design and interaction to create real change on an individual basis. There are examples out there, but they are few and far between. Creating behavior change requires knowledge of people, not just knowledge of technology.

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
“It’s time to drop one of my told-you-so cards from a couple of years ago.” Funny, Paul Stein.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
It’s time to drop one of my told-you-so cards from a couple of years ago. Back then, when the “wearables” thingy was the hottest of topics, I stated that they would be viewed as toys UNLESS they were to be used as real diagnostic or therapeutic medical devices. Since then, there have been literally hundreds of companies working with the same small grab bag of sensors, producing flashy YouTube videos, and going no where fast.

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.

VINCE WATERSON
Chairman
I agree that wearables are essentially worthless until they have clinical verification and enhanced security? I also agree that the data collected from these devices transmitted over the internet may be hacked. The notion that anyone who has a medical condition that needs speedy diagnosis is going to rely on the software diagnosis of a wearable is misguided. The vast majority of people who have non-life-threatening conditions still wish to have a medical person examine them. This fact is supported by government statistics which show that at least 20% of the 117 million people who visited hospital ER rooms in 2013 had minor medical conditions nevertheless they visited ER because they preffered a person not a machine to make the diagnosis.

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.