10 min reading time

Under a barrage of negative press, wellness company HealBe attended this year’s Consumer Electronics Show with their GoBe calorie counter.

See:
“Hands-On with the Healbe GoBe at CES 2015”
http://ow.ly/HdjyK
“Have You Contributed to a Health Scam?
http://ow.ly/HcR8v
“Healbe isn’t Indiegogo’s first giant medical scam”
http://ow.ly/HdjjK

On a related discussion about diabetes earlier this week, frequent Medical Devices Group contributor Paul Stein wrote,

“It’s truly unfortunate that the public at large does not have the basic scientific knowledge to understand how truly impossible a device like this is. So, all of crowdfunding, a previously fairly reliable source of vital initial funds for many budding products, takes a monstrous hit. Because of these new scammers, it now becomes all the more difficult for startups.”

So I ask the group,

Is it possible the GoBe device works well enough to help the public manage their calorie intake?

Is the GoBe a medical device? Does it require FDA clearance?

Might a future calorie-counting implantable device be next?

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Therapeutic Solution for High Blood Sugar

Diabetes Patients Are Hacking Toward a Bionic Pancreas

How will fitness trackers, monitors, and medical device data be used in litigation?

Commercial insurance for medical devices?

What do you do with your equipment in need of repair?

“Must” Cover Topics for a one semester medical Device course for Engineering Technology students

Medical Devices Security: What has been done?

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12 Steps for UDI Submissions to the FDA GUDID

Hundreds have registered for the live event next Thursday, January 21 at noon Eastern Time.

Sign up at http://medgroup.biz/UDI-in-2015 for the replay, slides, and transcript even if you can’t make the live event.

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It’s down to the Seahawks, Packers, Colts, and Patriots.

At http://medgroup.biz/superbowl, guess the winning Super Bowl score and you might win free admission to the 10x Medical Device Conference.

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Rohan Ramakrishna
Senior Quality Engineer at Medtronic
This is a really interesting topic! Based on my background in biochemistry, as a fitness enthusiast, and as an individual who as researched many heart rate monitors (HRMs) and ultimately decided not to purchase one, I thought I’d provide my enthusiastic (and long) input.

As I’m not too well read on the actual product design, I’ll have to assume that there is some sort of sensor similar to the types that are currently in the market. The majority of the HRMs in the market work similarly to the way a medical Pulse-Ox will work (light being transmitted through the skin). But because the pulse oximeter also has the added function of being able to read oxygen levels due to limited invasive light entering through the skin, it becomes a Class II regulated device ([http://www.fda.gov/RegulatoryInformation/Guidances/ucm341718.htm|leo://plh/http%3A*3*3www%2Efda%2Egov*3RegulatoryInformation*3Guidances*3ucm341718%2Ehtm/1waP?_t=tracking_disc]).
According to the FDA guidance documents, this product is technically considered more invasive than something like a stethoscope since it is introducing something into the body, even if it just light, it is reaching close to the classification of the Pulse Ox. The claim of calorie counting is claimed by many of the HRMs in the market. In fact, a simple Google search for “heart rate based calorie calculator” will yield plenty of results, so the claim that this product can calculate calories burned is probably atleast 85% accurate.

The claim it can calculate calories based on your food intake? Now that is questionable, because in order to calculate what macromolecules (for example, sugars with regard to diabetes) are floating in your blood, you need to be able to analyze the blood, like a blood test, and this product does not come into contact with the blood stream. Even the Pulse Ox requires a 510k if there is a”significant SpO2 algorithm modification,” and seeing as how there is apparently an added algorithm to detect and measure sugar levels, this algorithm itself is enough to warrant a 510k. Even if the light is stronger and the sensor is made to be highly sensitive, I think there is only so much that can be done without damaging the skin while trying to get a readout. In the long run, if this product is accurate, then there is some sort of damage occurring on your wrist. Or perhaps the relatively wide surface area is able to place light at specific angles in order to read the macro-molecules, similar to the way a spectro-photometer works in a chemistry lab. If that is the case, it may not be noticeable in such a short time. What if impact damages components within the arteries?

In short, based on the limited information we have been provided on the product, my conclusion is that its just a really fancy Pulse-Ox, unless they divulge the mechanics of their technology.

Is it possible the GoBe device works well enough to help the public manage their calorie intake?
Yes. If normal, less fancy HRMs are getting the sort of attention they are, and encouraging better eating habits and improved fitness, this product can atleast do that. However, in my opinion (as someone who has made and is continuing to make fitness transformations) nothing beats accomplishing a fitness goal by manual calorie-counting, hitting the gym, and going through the experience of fitness transformation on your own. It is a life changing experience.

Is the GoBe a medical device? Does it require FDA clearance?
Absolutely. If there is introduction of an invasive material (even if it is light), it is considered Class II, and it should require FDA clearance because it has invasive light, along with algorithms for specific macro-molecules.

Might a future calorie-counting implantable device be next?
Sure, why not? If they can figure out how to perform a continues blood test from within the body in a short time with an extraneous display, then power to them. It will automatically be Class III of course.

Please correct me if I’ve misunderstood anything, as I’m fairly new to regulatory and still learning.

Mosharof H
Adjunct Faculty, New Jersey Institute of Technology
My recent USA invention (approved) in “Molecular Profiling Generation” showed a promising path. With respect to this, another innovative work ongoing. Please let me know if my inputs can contribute in R&D. Regards, Mosharrof , email: mmhsarker@gmail.com

Peter Lorraine
laboratory manager at GE
We need a device that measures calories consumed and slows or speeds up your internet connection accordingly. Play one addiction against another.

Paul R. Garrett, MD
President, Smith Consulting, LLC
As a physician with some public health training, IMO if someone wants to claim that wearing aluminum foil on their head encourages them to exercise or eat right, I’m fine with it.

Edward Bukstel
CEO at Clinical Blockchain
Critical elements to the success of a product in this space include efficacy and outcomes. Whether achieved via patented or proprietary technology the fact that a device performs as advertised is significant and should be supported by clinical studies and science. FDA approved trials is a best case scenario. It seems that some of the “personal devices” that are hitting the market have an added element of user perspective that may not be founded in science but instead there is a perceived belief that there is a certain benefit. This perception is supported by anecdotal evidence coming directly from users via social media platforms. This “perception” is not clinical validation of a product or a device, but may reflect metrics, that are clinically irrelevant, such as “number of downloads.” Going back to the stethoscope example, does anyone really believe that there is validation of a product with 3 million “physician downloads”?
[http://www.cultofmac.com/57226/three-million-doctors-download-iphone-stethoscope-app/|leo://plh/http%3A*3*3www%2Ecultofmac%2Ecom*357226*3three-million-doctors-download-iphone-stethoscope-app*3/9wk9?_t=tracking_disc]

Clinicians and researchers may look at these types of claims with disdain. But, unfortunately, this type of data, in today’s market, is being factored into the “perceived” success or benefit of a product, irrespective of solid science.

David Lim, Ph.D. RAC, CQA
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
Geoff, to better assess whether it is a”Holy Grail or Scam,” we need to go beyond the bottom line technical specifications. I shared to improve our awareness among other things. At least, you seem to have squared away the differences. One can also use both devices for comparison of physiological outcome measurements.

Geoff Waite
with TTP – The Technology Partnership
Thanks Dr. Lin for the reference to the Bodymedia. Interesting similarities in the hardware. However, I think that to compare them in the context of this discussion is somewhat meaningless. The Bodymedia product uses skin conductance (not impedence?) to improve their estimation of calorific BURN during exercise, while the Healbe product claims to infer calorific INTAKE from skin impedance (via the step of cellular release of water during glucose uptake). These are very different claims and quite different measurements.

Peter Lorraine
laboratory manager at GE
The patent Dr Lim references is actually far clearer than the Gobe literature and presents more transparent results. In the case of the patent, the invention shows scatter plots and a correlation of 0.57 with very large errors. They also show results with a correlation of 0.8 that estimates calories by asking what you ate (breakfast lunch dinner, light, medium, heavy meal) which seems to get you within a few hundred calories. But they actually show scatter plots that enable you to estimate the performance – this looks like real data and would prompt me to look closer if I was curious. The invention itself seems unlikely to be granted – the primary claim is the use of two different sensor outputs to calculate blood glucose where several possible types of sensor are listed in later claims – my guess is this would need to get far more specific in the claims to be granted. If you can get a patent that covers all wearable calorie consumption or glucose meters that could be worth a lot but it is likely you will be restricted to how you do it in the application (rather than just claim the function).

I do not think this addresses the question of whether the Gobe sensor works, what level of performance it has, or even what Gobe claims it can do.

[http://www.google.com/patents/US20120149996|leo://plh/http%3A*3*3www%2Egoogle%2Ecom*3patents*3US20120149996/DKET?_t=tracking_disc]

Edward Bukstel
CEO at Clinical Blockchain
[http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm|leo://plh/http%3A*3*3www%2Efda%2Egov*3MedicalDevices*3DeviceRegulationandGuidance*3Overview*3ClassifyYourDevice*3ucm051512%2Ehtm/fJ-M?_t=tracking_disc]
The FDA considers a tongue depressors and bedpans as a Medical Devices. A stethoscope measures an “internal body metric” but falls into the same category as a bedpan. There is no question that some of these gadgets maybe quackery. But, it is also true, that like a stethoscope, some of these gadgets may provide meaningful information. I don’t believe any patient or physician will allow surgery to be performed based upon a couple of data points from a non-FDA approved device. Certainly, there can be some benefit in early detection (based upon clinical evidence) as well as monitoring. ,

Scarlet Markarians, ASQ CQA
Senior Quality Auditor, Global Compliance
One more guidance I’m sure you all are aware of that I just checked and may be relevant since GoBo has a mobile app is FDA’s guidance on: “Mobile Medical Applications” which gives an idea which apps FDA would be interested in exercising enforcement to regulatory requirements. Some of their examples surprise me I must say…page 24 discusses a mobile app that allows the collection of blood pressure data and uploads it to health records and according to the Guidance that app would not be subject to regulatory requirements?

@Terrance, because of the blood pressure measurement as a feature claim and corresponding sensors and accelerometer on GoBo and even if it does not make any references to specific diseases or conditions, you may be very correct in saying that this should at least get a 510K submission. At the end of the day medical practitioner should be very careful when using mobile app data alone to diagnose or treat a disease without knowing where the app stands with the FDA.

Andrei Kamandzenka
Project Manager at Softeq
Let me put it yet a bit different. Real value of patents is outside of patent office, R&D unit or manufacturer. It is determined by happy customers and jealous competitors – if there’s a bunch of them then a patent is great (no matter how scientifically or technically perfect it is).

David Lim, Ph.D. RAC, CQA
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
You are actually sharing very practical aspects/perspectives for others to consider. To have a patent/application that can survive various challenges, “must be” would be more relevant. But in practice though, some patents are not so great, having no real value. In those, “might be” would be more relevant as it fails to disclose enabling embodiments.

Andrei Kamandzenka
Project Manager at Softeq
Thank you for the compliment, but first, I’d say might be rather than should be.
Second, both good and bad products might be considered as having good technical and scientific background – underlying physics phenomena and laws, electronic components and beautiful drawings and manuals. With only one difference – bad product won’t work.
Let’s say I’m just a bit more pessimistic than you.

David Lim, Ph.D. RAC, CQA
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
You nicely put all the scope in a way. In fact, key ingredients/findings/data from “research papers, reports, drawings, verification and validation documents, etc.” should be part/basis of patent applications/patents including incorporation by reference.

Andrei Kamandzenka
Project Manager at Softeq
Dr. Lim, with all due respect to your accomplishments and titles I would not agree that patents themselves are scientific and technical basis. I can support my humble opinion with just a couple of simple arguments – patents are derivatives of mostly favourable scientific and technical documents emphasizing how new (i.e. different) the inventions are; patents are aimed at legal protection of inventions’ owners money (just like a fence around land with no trespassing sign no matter how valuable the land is); patented invention is not a synonym to efficient/effective product (sometimes they are issued even before the product drawings are finalized – e.g. to protect future investments). Thus patents are mostly legal documents securing rights of authors and owners. Scientific and technical basis for me are research papers, reports, drawings, verification and validation documents from 3rd party experts (not involved with the inventors).

Terrance Malloy
CEO, CalHealth, Inc. MDMouse A Remote Health Monitoring Company
The FDA is certainly interested. They were not interested in the past primarily because they were considered personal devices with little or no medical value.
Now that the general public is downloading this apps like candy, they have become very interested. Moreover, they are interested because the data these apps are generating are beginning to be shared with physicians. This is completely different.
This if from the FDA itself so …….

David Lim, Ph.D. RAC, CQA
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
@Scarlet, that is what I meant when I state “At this point, I suppose FDA would not be interested in looking into these kinds of products as a priority” based on my views as well as after reading [http://fdaguidance.net/2015/01/general-wellness-fda-policy-for-low-risk-devices/|leo://plh/http%3A*3*3fdaguidance%2Enet*32015*301*3general-wellness-fda-policy-for-low-risk-devices*3/4FFE?_t=tracking_disc]

David Lim, Ph.D. RAC, CQA
FDA Consultant Speaker | Drugs, Biologics, Medical Devices & IVDs, Combination Products, 483s, & FDA Inspection
@Andrei, I was referring to the patent references of what I have reviewed recently. A few of those patents are the basis of BodyMedia’s product similar to Gobe. You have to look through few of those patents as I have done. If you don’t consider the contents of patents (granted or even applications) as the “scientific and technical basis,” then your views and interpretations are largely different from mine as I consider the contents of “patents” or “patent applications” highly scientific and technical. Some people may even say that “patents or patent applications” are the most technical documentation. Scientific and technical aspects of innovative research generally lead to patent applications and if successful, granted patents. This is not to say that all patents are enforceable. In addition, only a subset of patents can lead to making $$$ at the end. By the way, the contents of the patents can be considered to be the heart of describing “functionality and performance” of a device or whatever it claims to. Note: I am a former patent prosecutor still in good standing licensed to practice in patent cases before the USPTO.

Paul R. Garrett, MD
President, Smith Consulting, LLC
Scarlet, you may have saved the day with: [http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm429674.pdf|leo://plh/http%3A*3*3www%2Efda%2Egov*3ucm*3groups*3fdagov-public*3%40fdagov-meddev-gen*3documents*3document*3ucm429674%2Epdf/lXuE?_t=tracking_disc]
I must read it. THX

Paul R. Garrett, MD
President, Smith Consulting, LLC
1) The grocery store toys are getting more and more sophisticated while MDs tools are getting more like toys–see some iPAD apps for “professional use”.
2) Medical decisions are more and more made by the public for themselves (internet self doctoring)
3) Medical “professionals” are getting watered down in training and title.