24 min reading time

Google “Consumer Electronics Show 2014 wearable devices” and you’ll discover they were this year’s hot topic.

Qualcomm’s CEO Paul Jacobs: “We’re doing a clinical trial in San Diego of a sensor that will actually get injected into your bloodstream and tell you two weeks ahead of time that you’re going to have a heart attack,” and continued, “Wearables will not just be on our bodies… they are going to be inside our bodies.”

Intel announced the ‘Make It Wearable’ challenge to award $1.3 million in cash awards to encourage innovation with Intel technology.

TechCrunch reported, “The new Sony (the Core) and LG (the Life Band Touch) devices… articulate the inherent problem in wearable tech.” They called wearables consumer behavior tracking and analysis devices with “a near-perfect profile of the average day of actual consumers, the kind of data portrait that makes marketers weak at the knees.”

And when asked, “Will people go out, buy, and wear these devices on a daily basis?” CNET Senior Editor Dan Ackerman answered, “The problem is there are so many from so many manufacturers, they all work differently, they all have different platforms… I can’t imagine too many of these lasting until the second generation.”

Are you working on any wearable functionality?

Have you tried any – or perhaps you have a prediction which will be among the wearable winners?

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We’ll talk about wearables, specifically Google Glass’ impact on healthcare, at May’s 10x Medical Device Conference. See the agenda at http://medgroup.biz/10x-agenda

If you’d like a list of our confirmed guests and speakers, email me at JHage@MedicalDevicesGroup.net.

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At the risk of shutting down her mail server, meet Medical Devices Group Advisory Board member Sue Sarkesian.

She’s my go-to person for group members looking for work in the medical device industry.

See http://medgroup.biz/get-new-job

Sue can help you with:
• Career development for medical device and life science professionals
• How to best utilize LinkedIn in your job search
• Strategies for passive and active candidates in this job market
• Documents, portfolios, and online/social media presence for candidates

Sue is presenting at 10x and, as an added bonus, she’ll include a free phone consultation for the first ten to register for the workshop. (Ask about discounts for those in transition.) See http://medgroup.biz/career-workshop

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This week’s discussions:

Health insurance a bad deal for 93% of under age 65
http://linkd.in/bum-deal

Will bionics help people walk again?
http://linkd.in/Bionics-Man

Where is the price transparency in medicine?
http://linkd.in/tryin-to-be-transparent-here

What do device reps need in order to attend a patient treatment grand round?
http://linkd.in/whats-required

Referral programs for implantables?
http://linkd.in/referring-implantables

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Make it a great week.

Joe Hage
Medical Devices Group Leader

P.S. We’re looking for experts outside the US to enlighten the group about the medical device industry in your country. Contact me if you’re interested.

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Juan José Janer
Estudió en Colegio Europa, Malaga
A wearable medical device must be only that, a wearable device which can be used also for collecting necessary data, and not looks like a medical device before other people.
Mixing something which makes the patient feel comfortable with his/her device, and not showing his/her device as an illness control, will always be good.

Donald Osborne
Anesthesiologist / former biomedical engineer
I find this discussion fascinating, as it is such a broad application of engineering science to healthcare. My perspective might be somewhat philosophical but rather than consider if people, consumers and patients will choose to buy the product, let’s consider whether or not patients need the technology as defined by clinical needs. I believe that this technology could prompt the development of clinical protocols for the use of wearable technology. Let’s then consider who would be the purchasers in that case. If I am healthy and I choose to do something to monitor a deviation from “healthy”, then I might go out and purchase my own wearable. But if I am ill or predisposed (chronically or acutely) to some illness, then my physician might view a wearable as part of my care. It has been recognized over recent years that there is value to detecting instabilities in patients at the earliest possible time. Some of those instabilities might be detected by a wearable. In hospitals if certain defined clinical variations occur, a Rapid Response Team (by that name or something similar) will come and visit the patient, before a more serious (and more expensive) event occurs. If wearables trigger RRTs to respond to patients maintained in a clinically less acute setting, then there is the prospect for reduced cost of care and I think that is what will drive the greatest sale of such devices. It might also apply to discharges. The ER doc who suspects that the abdominal pain or short of breath patient can go home to call his doctor tomorrow might feel better if he retains some clinical connection with the patient other than “admit for observation”. I suspect that it will be the hospital, or more likely, a healthcare system who ends up as a potential purchaser. I just think this is more potential for the use and sale of these devices. The key remains, in my opinion, the issue of clinical utility. If that cannot be demonstrated I think the sale unlikely.

C. Yusuf Mumtaz
Medical Device Sales Executive
Make sure the device is designed for medical use only. Otherwise…

http://www.thedailyshow.com/watch/thu-january-23-2014/gfail%7Cleo://plh/http%3A*3*3www.thedailyshow.com*3watch*3thu-january-23-2014*3gfail/eYj_?_t=tracking_disc]

Anthony Antonuccio
Business-minded software product executive with expertise in leading innovative organizations through complex growth.
I believe the consumer wearable devices market ‘will’ be huge. It’s still emerging IMO. Recall early smartphones and how awkward they were until Apple introduced the first generation of the iPhone in 2007. 7 years later, the 5th generation iPhone exists, Samsung nipping at their tail for market share, the market has matured, and many vertical applications are able to leverage these now commodity devices and platform to serve their markets, including medical applications. These devices have become a universal medium to extend their functionality into niche markets. Some may require an additional device to attach or communicate with a smartphone. Yet, the smartphone has cost reduced the entire solution cost significantly given it’s a universal power house serving the imagination of innovation.

My point is, when wearable devices stick with the consumer and mature to high saturation levels, only then will they be a suitable and cost effective mass market platform to leverage for vertical markets, such as medical. Until then, proprietary wearable medical devices will cost more, serve fewer, and be single purpose. Devices such as a watch, a camera, a GPS device, a compass … etc., are likely far less owned by young adults since their smartphone is a ‘good enough’ alternative, replacing these single purpose applications. Imagine the time when a wearable device hits this consumer acceptance level whereby you feel naked without having it in your possession. I believe it’s a when not if. When it happens, things will get really interesting in this space.

Rebecca Herold
CEO, The Privacy Professor | Author | Expert Witness | Entrepreneur| Founder, SIMBUS, LLC
If there is any data involved that is considered to be protected health information (PHI) under HIPAA, then the device must have appropriate safeguards built in that meet all the applicable HIPAA and HITECH requirements. Most medical devices, as they’ve been described throughout the various discussion, will have such data involved, and so must meet the scrutiny of the HIPAA regulators (The Department of Health and Human Services as well as every U.S. State Attorney General’s office) in addition to the FDA which is enforcing its own regs.

We have already seen that these smart devices are going to be exploited and used by hackers and criminals; the first “Internet of Things” successful hack attack occurred late-December 2013 through early January 2014; where over 100,000 smart devices were used to send out 750,000 malicious and phishing messages. You can see more about this in many places, including at: http://blogs.mcafee.com/consumer/internet-of-things-cyberattack%7Cleo://plh/http%3A*3*3blogs.mcafee.com*3consumer*3internet-of-things-cyberattack/6Lts?_t=tracking_disc]

The fact is, if you have any type of computing device with data collection and/or storage capabilities, it must have security controls built in. Even if there were no regulatory requirements to do so, if/when something bad happened, the players involved (which includes the medical device company) would be subject to civil suits.

FYI: I’m covering these and other info sec and privacy issues at a workshop at the May 10X conference.

Matthew Romey
Director – Medical Device Consulting at Azzur Group
Saileekrishna: I believe you that the consumer wearable device market is huge. Is the consumer *medical* device market really that big? (i.e. not Nike Fuelband, but Dexcom G4, etc.)

This brings up the elephant in the room… in the age when mobile phones coupled with wearable devices can provide prodigious data streams of personal information: what constitutes a medical device? Where is the dividing line? This is still being debated and, to be frank, I’m way behind on the debate! Any comments on the latest news on the FDA-slash-regulatory front would be much appreciated.

Perhaps this is a new topic (?).

Sai Krishna G
Lead Analyst at Beroe Inc
Wearable Medical device market is not a small market it is close to 6bn USD

Matthew Romey
Director – Medical Device Consulting at Azzur Group
Anthony:

I think your summary hits it right on the head! Your first two points relate to patients’ needs and wants. The fact that patients’ needs and wants are probably too numerous to mention shows the HUGE opportunity in wearable technology. Your third point speaks to the concept of connecting wearable technology with “mobile health”. This is where there is an enormous amount of uncertainty due to the reasons I described in a previous post. As you said, mobile health is in its infancy… not to mention HIPAA concerns.

What an interesting discussion!

Juan José Janer
Estudió en Colegio Europa, Malaga
Hi David,
The huge market for medical wearable devices are devoted, in a vast majority to the patients. But you make the point, Most of patients are looking for the latest technologies, gadgets, etc, and there is a misconception about technology applied to the medical field.
Doctors and surgeons are looking for anything that might help them to increase accuracy, data information and imagen of high resolution to help, prevent or treat patients. Can you tell me if your device can shared information with the HIS – RIS – PACS, from hospitals or clinic systems?.
Thank you.

David Starr
Strategic Business Leader | Tech Transfer & Innovation | Solving Problems & Uncovering Pragmatic Pathways to Success
What about wearable medical devices for the clinician? At Sonivate Medical we develop miniaturized finger wearable ultrasound probes. This enables the clinician to “see, feel and do” real time, leverages the innate motor control and precision of the fingers and hand, and is intuitive to use and learn how to use.

Carolynn Johnson, Ph.D.
Human Factors & User Research Manager, Daedalus
Sorry, Juan, but I am not really following your latest post. If a device is intended to be wearable or have wearable components, then the wearability of that device is critical. I would apply this to non-invasive devices (the contacts that detect glucose), those that are minimally invasive (an insulin pump) and those that are more invasive (VADs, such as the HeartMates). The invasiveness may limit where a device can be worn, which obviously must factor into the design, but it does not negate any of the arguments that have been made regarding the importance of the form factor.

Juan José Janer
Estudió en Colegio Europa, Malaga
Thank you Caroline for your reply, You are right it is a factor, (one factor among others) but is a major factor to take in consideration when talking about wearable non invasive devices.
Unfortunately I do have a lot of experience in Diabetes I and II and all the problems derived from it (ulcers, etc) but again you have to agree with me that the origin of the debate was that of wearable medical device, not implemented or as you said in your previous comment “…. at the insertion site….”.
When I first saw your post about if a wearable medical device can be or should be “sensual” I answered with different arguments, about accuracy, specificity, and Sensibility or even prognosis short and or middle term .
o wear a hat or a watch or a nice gadget, is not same as to have a medical implantable device, which in your case, is extremely helpfull, as for other patients that needs a constant level of insulin control.
Thank you.

Anthony Antonuccio
Business-minded software product executive with expertise in leading innovative organizations through complex growth.
All good points. What I’ve surmised from the comments thus far is that:
1. form factor matters (internal or wearable), but only as part of the value equation for what the device actually does translates into acceptance and usage.
2. One size doesn’t fit all. Many use cases, many solutions. Nevertheless, a huge market opportunity going forward.
3. No clear winners/losers as the mobile health market is still in its infancy.

Carolynn Johnson, Ph.D.
Human Factors & User Research Manager, Daedalus
I disagree. The scale of the medical device is only one factor. And I am guessing that you are not familiar with the latest generations of insulin pumps, if you are classifying them as not a wearable. These patch pumps (OmniPod specifically) are now self contained devices that adhere to the body at the insertion site and are continuously worn for up to 3 days (nor do most eliminate the need for test strips, as they are generally not continuous glucose monitors). If you wear a device on your body, it is a wearable device. The Fitbit is a wearable device. Contacts that detect glucose levels are wearable devices. All such devices need to devote serious consideration to wearability.

Juan José Janer
Estudió en Colegio Europa, Malaga
I forgot to mention that such reading of insulin will be made in a future through contact lenses.
Sorry.

Juan José Janer
Estudió en Colegio Europa, Malaga
I agree with Mr. Clawson,
But again, we MUST be sure that we are using the same scale of wearable MEDICAL devices.
I’m sure that any person suffering a painfull pathology will do anything in order to stop it. This is only an example. Unfortunately and as far as I know, today it doesn’t exist any Wearable device to reduce significantly pain or to eliminate the pain. If such would existed I’m sure that most of pain patients will wear anything.
The insulin pump is not a wearable in the terms we have been exposing here, (non invasive) but if we can obtain the level of glucose mmol/ or glicogen mg%, really that will be of aid to millions of patients suffering Diabetes, because they will stop using needles or lancets and the strips blood reading reactives.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
Anthony & Carolynn, the Brick is a good metaphor to make us think when we use the word cure, but most people will wear a device for other purposes.

But the real trick today is getting people to wear a brick for various aspects relating to both Monitoring for general activity levels and Detection of early adverse medical conditions.

There will be a lot of study and experiment in how to overcome the psychological resistance to wearing a device particularly when a lot of people say “But, I feel fine.”

Insurers and physicians will push some of the testing and monitoring and I won’t be surprised to see insurers offer discounts for people who use certain devices to detect adverse changes early. There has to be a carrot for most people.

Carolynn Johnson, Ph.D.
Human Factors & User Research Manager, Daedalus
Anthony – Yes, a person would wear a 20 lb brick around their neck to cure cancer, but ONLY if there were no other option. The problem (?) is that if another option doesn’t already exist, you can bet its being developed. And once another company offers that 10 lb brick, no one is going to wear the 20 lb brick (I really like this analogy). So to be successful, you have to develop not only the best option right now, but the best option in the near future at least. So it is about the form factor. As the wearer of a medical device that has competitors, I looked very carefully at the form factors and user interfaces, because the realized benefit was the same for most of the options I considered.

Juan José Janer
Estudió en Colegio Europa, Malaga
As I have seen in the previous comments, most of us are using different scales of wearable MEDICAL devices.
1st.: A medical device for people who already are suffering an illness and needs to be monitorzed? all day? most of the day? several times a day?
2nd. A medical device for those who wants to prevent the ongoing of the pathology or illness?
3rd. The wearable device for those who are already educated and concious about the capabilities of such devices for improving their performance in ie: Sports, etc?
4th.- Do people (who are not in the business) have understood the difference between to have to wear a medical device control…. and the “fashion kits” that can be used and shared with their Pc’s, smart watches, etc…? Podometers, heart rate, burned calories, etc?
5th. If any one if able to develop a device (nanotechnology, biosensors, etc) that can help people to do a normal life, allowing the patient to know his/her health status and proceed acording to the data collected and at the same time no one else is going to know that the person is suffering a disease. That’s the saint Grial.

Anthony Antonuccio
Business-minded software product executive with expertise in leading innovative organizations through complex growth.
I’m new and please excuse my lack of direct experience in this sector. In my career, I’ve experienced a lot of technology ahead of the curve. Some stuck, most didnt. I truly believe that new miniaturized mobile devices (today’s vogue: wearables) will be game changing to advance patient health. However, it’s not about the device form factor. It’s about the realized benefit from the perspective of the patient. One would where a 20lb brick around their neck if it cured their cancer. Not to be trite, just making the point that benefit less pain equals value. Value is a ratio, and innovation strives to improve the nominator while reducing the denominator. Looking forward to advances in this industry area. /AA

Adam Bilney
Medical Device Designer / Mechanical Engineer / Project Manager
Great to see a number of comments here discussing how important ‘good design’ is for wearable tech. It’s all very well to have the best technology in the world, but if you haven’t designed it with the end-user in mind then your chances of success are pretty low! Get a few good industrial designers involved and it’ll make the difference between a best-seller and a me-too device.

Salvatore Emma, Jr.
Operations, Product Development, and Business Strategy Executive
I am the CEO of the worlds largest manufacturer of silver/silver chloride sensors for biomonitoring applications. Over the past year, we have seen a definite uptick in orders from developers and R&D departments looking for our simple sensors to monitor cardiac rhythm and brain activity.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
The other key item is that “lifestyle choices” are behind many chronic diseases. Heart disease, stroke, respiratory, diabetes, cirrhosis and STDs are mostly preventable and affect far more than HALF of all adults (half of adults have or have had an STD.)

Hence, we are talking about people being willing to accept warnings and alter lifestyles. That gets down to psychological issues and I’m not sure the availability of wearable & implantable devices will be used until AFTER chronic disease surfaces for most people.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
I view a good part of the task as one of inspiring people to consider on/in body sensors & then acclimatizing them to the idea of the need for on/in body sensors on a continuous basis even when healthy.

Lots of people resist monitoring and testing when “I feel fine.”

I don’t know how we get to a tipping point where it starts to “take off”. Perhaps it is when it is super miniaturized, wireless powered, monitored and logged to your computer of your choice and it reminds people when they do something that is not good for them.

Brett Saunders
Director of Change Management at Medsec and General Counsel for Health Sector clients Saunders Commercial Lawyers
Assuming the device is functional, accurate and userfriendly, a wearable could be concealed or in plain view. If it is concealed, users will at least require ergonomic, sleek, and functional design. If it is in plain view, a lot will depend on weather it is worn on the arm or elsewhere on the body. If it is worn on the arm, like a watch, design parameters are much wider (let’s face it, we have all seen ugly watches). If the wearable and it is in plain view elsewhere on the body, the design element is almost insurmountable. As Christopher so eloquently put it, the dipshit factor is significant. If the wearable has real medical significance however, like for instance a cochlear implant (which has a wearable element of the design attached to the back of the head), the dipshit factor will be but one of the factors effecting take up. If I were able to hear for the first time, I would probably be prepared to ware a shoe on my head.

For cochlear see: https://encrypted-tbn2.gstatic.com/images?q=tbn:ANd9GcTDW3C0FZyncWh_4aG1Pa-mMN7pKE-fRJ16J1F2-21Jr1zQimBX|leo://plh/https%3A*3*3encrypted-tbn2%2Egstatic%2Ecom*3images%3Fq%3Dtbn%3AANd9GcTDW3C0FZyncWh_4aG1Pa-mMN7pKE-fRJ16J1F2-21Jr1zQimBX/EDxk?_t=tracking_disc]
Christopher Buteau
Software Development Senior Manager at Dassault Systèmes
The biggest hurdle wearables have is not making the customer look like a dipshit. The idea is cool and the tech is there…but who is going to a bar or party with google glass on their face.

Juan José Janer
Estudió en Colegio Europa, Malaga
I think that when it comes to health wearable devices, there are two key components: the physical control needed of the person who wears it, and the possibility to hide that its a medical device trhough a nice design, that can be showed to third parties with “some pride” or sense of, why not, “sensual”.

Juan José Janer
Estudió en Colegio Europa, Malaga
If a wearable device is doing what it has to do, I do believe that the meaning of sensual should be related to the grade of satisfaction that the patient must obtain when using it and when people around look at it. That’s real marketing issue.

Carolynn Johnson, Ph.D.
Human Factors & User Research Manager, Daedalus
The accuracy of a medical wearable as a priority goes without saying. However, once you move beyond that – let’s assume that your device is accurate, reliable, and efficient – should the ID of a medical device be “sensual” in the sense that Amit is talking about?

Juan José Janer
Estudió en Colegio Europa, Malaga
I’m scared to know that someone said they should be “nearly sensual” a medical wearable device should be efficient and accurate in its goal.

Carolynn Johnson, Ph.D.
Human Factors & User Research Manager, Daedalus
This article came out in which the designer of the Fitbit says wearable devices need to be “nearly sensual” – http://qz.com/168620/the-designer-of-the-fitbit-says-wearable-devices-need-to-be-nearly-sensual/%7Cleo://plh/http%3A*3*3qz.com*3168620*3the-designer-of-the-fitbit-says-wearable-devices-need-to-be-nearly-sensual*3/kSpZ?_t=tracking_disc]. I’m curious what everyone thinks about this?

Juan José Janer
Estudió en Colegio Europa, Malaga
You are right Greg; sorry for the mistake in writting, But obviously the information provided have to deal with false postives or negatives, Thank you

Greg Smart
Digital Health Consultant, Founder at 500 More
I think you mean sensitivity and specificity, although accuracy and precision would be more appropriate terms.

Brett Saunders
Director of Change Management at Medsec and General Counsel for Health Sector clients Saunders Commercial Lawyers
I am not sure what you mean but thankyou for your comments.

Juan José Janer
Estudió en Colegio Europa, Malaga
I do agree with you, and that’s why I stated in the last paragraph that specifity and sensibility of the medical weareables are the most important things to take into accounbt.

Brett Saunders
Director of Change Management at Medsec and General Counsel for Health Sector clients Saunders Commercial Lawyers
The legals are not the issue. All relevant laws can and must be complied with. The real issue is whether wearables are capable of delivering sufficient benefit to wearers to sufficiently offset relevant cost and risks. As usual, beyond product development, marketing is where all the action is.

Juan José Janer
Estudió en Colegio Europa, Malaga
I personally believe that nothing that can help to improve quality life and issues related to health remote control of patient should be stop; the problem about Data Mining and confidential exposure of patients information to third parties that are not directly related to those patients must be responsibility of the Government policies, and strict normative and rules to be imposed to the companies.
Depending on which country, the contact lenses or wearable medical control devices to monitorize heart diseases or any other pathology that have to be controlled all day long, ie. (European Council of Health, European Union), have a set of rules and indications to be followed by all people involved in said business.
Probably the most important thing to take into account is the specificity and sensibility of those wearables.

Tom Coss
Informatics Guy
Rebecca, I strongly share your concern and regard for privacy, especially in regard to home generated objective data. The potential good news is that this data can be encouraged by reward over punishment, the proverbial carrot rather than a stick. By this I mean data turned into patient specific information and shared at the direction of the patient with those who care. We’ve seen first hand, largely by mistake, how valuable this can be in achieving outcomes, even unintended ones.

These experiences led me to the Parable of the Stick: http://theheartcloud.com/2013/08/23/the-parable-of-the-stick/%7Cleo://plh/http%3A*3*3theheartcloud.com*32013*308*323*3the-parable-of-the-stick*3/5JUz?_t=tracking_disc] – I’d appreciate your thoughts. //tom

Rebecca Herold
CEO, The Privacy Professor | Author | Expert Witness | Entrepreneur| Founder, SIMBUS, LLC
Today Google made a big splash with their announcement of smart contact lenses: http://www.forbes.com/sites/alicegwalton/2014/01/17/smart-contact-lenses-glucoseproduct-leave-it-to-google/%7Cleo://plh/http%3A*3*3www.forbes.com*3sites*3alicegwalton*32014*301*317*3smart-contact-lenses-glucoseproduct-leave-it-to-google*3/1x4V?_t=tracking_disc]

I agree that the potential for great benefits is huge with wearables. But, as you probably can anticipate Joe, I also see great potential for misuse of the associated data and privacy infractions. With what entities will all the data from these wearables be shared? With what other data bases will the data be included within, and analyzed using the increasingly more powerful Big Data Analytics? Etc…

Along with the potential for great good, it will result in even greater good to ensure the privacy issues are considered, and privacy controls and practices are built into these great new devices. Swift adoption without considering privacy leaves open many privacy risks.

Russell James
Product Innovation / Medical Device / Emerging & Advanced Technologies / Mobile, Wearable & Embedded Devices
Will you take a pedometer app for a walk if I tell you it will reduce your health insurance bill? Some businesses are counting on it.

You’re fooling only yourself if you think doctors are not interested. About 10 years ago they said doctors wouldn’t wear heads up displays in the OR, How many doctors wore Google Glass in the OR last year?

Many people wear medical devices every day.

When the solution is right the adoption will be swift.

Matthew Romey
Director – Medical Device Consulting at Azzur Group
Mark: “It’s a massive prize for whoever gets there first”

Hey, no argument here. I’d love to be able to give you an implantable, continuous glucose monitor. It is a massive prize, which everybody knows. Hence the hundreds of millions of dollars (or more) spent to date. The fact that nobody has succeeded yet shows just how difficult the task is.

Having worked on continuous glucose sensing for over 10 years, I can say this from experience. Two main issues are: 1. the body’s response to a foreign object, typically by encapsulation, which hinders glucose diffusion to the sensor and 2. stability of the glucose sensing element. Glucose oxidase and other proteins have limited lifetime in vivo, and boronic acids tend to be readily oxidized unless properly protected.

And to those who wish for the true holy grail of a non-invasive method, I point them to John Smith’s free on-line book “Hunting the Deceitful Turkey,” which documents the years and years of research on noninvasive glucose monitoring, and describes why it still eludes us to this day.

http://www.mendosa.com/noninvasive_glucose.pdf%7Cleo://plh/http%3A*3*3www.mendosa.com*3noninvasive_glucose.pdf/2ioo?_t=tracking_disc]

Todd Walsh
Digital Business Development at HP
Terrific topic and conversation! I’ve enjoyed reading everyone’s commentary.

As a technology and consumer marketing professional, with a passion for wellness and fitness, I am very jazzed with the possibilities. “Wearables” themselves are certainly not going to motivate lazy people to get up off the couch. No chance for that. Here is the big, macro trend I am excited about though: by being able to monitor every day health patterns and trends using wearables and the cloud, consumers increasingly become empowered to take charge of their health conditions, outside of the traditional healthcare system. The archaic nature of semi-annual, annual check ups with an HCP gets overhauled by consumers having highly usable technology and services at their disposable to better take charge of their own health. (This does not replace visits to the HCP or ongoing counseling by the HCP, but it certainly improves it.) I believe the tipping point will be a combination of price point ($99, $49, etc.), usability, and the one or two killer features where consumers have to have it. I don’t think today’s wearables provide this. Also, I look at the wearables market as it is today as the MP3 player market was pre-iPod — lots of different small, players in the space. However, MP3 and digital music did not really take off until the incredible iPod (and incredible Apple marketing engine!) + iTunes hit the market. My prediction is that we’ll continue to see many small, innovative players in the wearables space in the near term, and eventually we’ll see someone like an Apple come out with the big play (the killer hardware+app), and that will be the tipping point.

Life is movement.

Todd

Mark Lainchbury
Purchasing Information Manager at NHS HSMC
Matthew Romey

Joe wanted a tipping point and with a potential market of 20% of Americans. It’s a massive prize for whoever gets there first

Appreciate the problems, of course, it’s a bit like Nuclear Fusion, which whenever you ask, is always “Twenty Years Away”

Tom Coss
Informatics Guy
Then there is the matter of information consumption http://theheartcloud.com/ is all about what information is important and who needs to know.

Matthew Romey
Director – Medical Device Consulting at Azzur Group
Mark: Hey, I’d love to get you an implantable glucose monitor. If it were easy, it would have been done already. Senseonics (previously Sensors for Medicine and Science) has been working on this for over 15 years and counting. A really neat design, but the challenges are many.

http://senseonics.com/news/first-implantable-continuous-glucose-sensor-to-achieve-high-accuracy-performance-in-people-with-diabetes%7Cleo://plh/http%3A*3*3senseonics.com*3news*3first-implantable-continuous-glucose-sensor-to-achieve-high-accuracy-performance-in-people-with-diabetes/VMfo?_t=tracking_disc]

James McGahee, Ph.D.,CBET-I, CMSgt Ret
Sourcing Specialist Senior, Biomedical Electronics at Spectrum Health
One of the problems I see trying to manage wearable patient owned devices as part of In-House Clinical Engineering programs, is that there are expectations from care managers that are difficult to respond to. We have patients with implanted pump technology that have been categorized Life Support and have mandated inspections. Getting patients to return with devices that require annual service/battery changes is problematic at best. I expect that occupational assist and therapeutic devices provided to patients for use outside the medical practice locations will become the defacto responsibility of the equipment management team when they fail to operate as expected.

Carolynn Johnson, Ph.D.
Human Factors & User Research Manager, Daedalus
As a User Experience professional who wears a wearable medical device (OmniPod Insulin Pump), I see the wearable market as hinging on convenience. In my case, the OmniPod increases convenience beyond that provided by the alternatives. In the case of a smart watch used in conjunction with a smart phone (as in you must have the smart phone with you for the smart watch to function), does the watch increase convenience for the user? In my opinion, no, and it will not succeed. If your smart watch replaces your phone, then yes, it stands a better chance.

Benjamin Chiu
Board Director and CFO at Maisense Inc.
I think the reality is people have limited space to wear something, and people need a strong demand to wear it all the time (or as needed). However sometimes people just follow the fashion, sometimes it is not easy to comprehend by rationality…

Mark Lainchbury
Purchasing Information Manager at NHS HSMC
Stop mucking about and get me a Implantable Blood Glucose Monitor which bluetooths a warning to an app on Phone when my blood sugar goes low.
Recharged ( in forearm ?) by induction overnight.

Brett Saunders
Director of Change Management at Medsec and General Counsel for Health Sector clients Saunders Commercial Lawyers
Wearables have been around for years and have been evolving incramentaly into new areas monotoring new functions and presenting data in new ways. Wearbles will continue to evolve both in terms of sophistication, size and data output. The bleading edge of this development is the depth of functions that the devices can detect, the transfer of user friendly data and the ability to turn real time data into immediate healthcare oriented solutions. The drivers in this space will fragment into consumer based products where the interface will be king and the medical fields where real time data can be harnassed to aid the delivery of timely treatment. I for one are of the view that consumer based products are “sexy” but ultimately of marginal utility. I am not saying they will not continue to evolve. Deaper and wider market penetration in the wearable devices consumer sector will continue to turn on the ability of manufacturers to develope meaningful ways to present complex data to everyday users. I can guarantee future issues will arise in connection with consumer reliance and actions based on wearable device data. Tight and conprehensive disclaimers will be the order of the day.

Stuart Karten
President/Founder- Karten Design
Paul and Greg, you’re right–many of these fitness devices and apps seem to be a “solution looking for a problem.” Most of the people who buy FitBits and the like are already fitness-minded individuals who already exercise regularly, etc. The real problem is, like Greg said, getting the couch potatoes to move into the fitness-minded category… We have yet to see a device or an app that can do that…

Where wearables CAN currently help is by keeping people motivated once they’ve made the decision to change their behavior. The real “winners” will be devices and apps that don’t just show people their data—they will go even deeper by analyzing the data and providing actionable insights that help people reach their goals.

For instance, my firm designed a medical concept app (the Latitude Heart Coach) that connects heart failure patients with the data collected by their implanted defibrillators (ICDs). The app doesn’t just visualize the data and stop there, though—it also tells users what to do with the information (i.e., makes approved medical recommendations) and uses motivational “coaching” techniques to keep people engaged. By revealing insights little by little (“progressive disclosure”) and giving users the autonomy to choose what info they wish to see at any given time, the app helps people maintain a sense of control over their experience. Users can also share their data with their caregivers and support networks, helping them stay accountable over time.

To your point, Paul, I think apps like this could be a good alternative to the “subscription services” you were mentioning. Devices that are informed by good research and are designed to be highly interactive could stand on their own. I think we can look forward to seeing more of these types of devices that not only make data accessible, but also help make lasting behavior change possible by making the data actionable and keeping users engaged.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Matthew and Greg, totally agree. By themselves, these things are as good as that piece of expensive exercise equipment, highly used or gathering dust in the basement, and if uses, doctors wouldn’t care or know what to do with the data. However, the whole self-care, fitness scene is something that has always been a tangential world unto itself. So, these new devices will allow novel business models to pop up to tap into it.

I can see how many of the folks who buy these things will join subscription services (to be developed) to watch, interpret, and supply advice for best “lifestyle practices”. There’s much more to these devices than just the devices themselves.

Now, the big question is, will any of this amount to anything to improve one’s health? The majority of the people who buy these things are fairly motivated to begin with, so the answer for them is most likely “no”. However, again I can see, if these devices enter the realm of gifts for that obese friend or relative, along with a year’s subscription to the TBD service, then a whole new avenue of real heathcare might open up. Life Coach-type entrepreneurs, think about this one carefully.

Greg Smart
Digital Health Consultant, Founder at 500 More
It seems to me that the problem with the wearables market as it exists today is that these devices don’t actual solve a problem any real person has. They might ‘cool’ at the moment and there might be potential but accumulating data doesn’t achieve any real, tangible goal. If I decide to exercise more I have a load of issues to resolve before tracking my activity becomes useful. I need to summon up some motivation from somewhere, I need to decide how and where I will exercise (running, gym, cycle to work, play sport), I might need some practical skills, some clothing. I might be embarrassed or fearful. I may be short on cash and wanting something that’s free to do. I may be short on time and trying to decide what to give up.
Only if I’ve got over all these issues (and maybe many more) do I make the leap into action, and then, mostly, I do ‘whatever’ for a couple of weeks and give up.
Monitoring technology is, and will continue to make great progress in developing unobtrusive, accurate data acquisition devices but the real key to unlocking value is figuring out how to use the data to empower people to solve the problem of “I want to exercise in principle, but in practice I’m going to sit here and watch TV”.

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
The FDA uses the term “monitor” regarding diseases to indicate that a product would be a medical device, and many of these are monitors of a sort. So, this raises a very important question for any of us wishing to get into the “wearables” sort of business. To what extent are these regulated medical devices, e.g. baby monitors for SIDS, sleep apnea monitors for adults?

One thing is for certain. Crowdfunding to gain working capital for the development of these has worked in the past, and I look forward to seeing more in the future.

Matthew Romey
Director – Medical Device Consulting at Azzur Group
As someone who has spent his entire career developing sensors for continuous monitoring, this new trend towards “wearable” health is very exciting from a technology standpoint. Nevertheless, I see lots of barriers to entry for these types of devices.

One of the main advantages of personal monitoring devices is supposed to be their ability to connect to the cloud and create an overall “ehealth” profile for each individual. But I have serious doubts that this model will catch on rapidly. I reported on this in my blog after October’s OCTANe Medical Device Investor Forum (MDIF) when Dr. Harry Greenspun, MD, Advisor for Healthcare Transformation & Technology at the Deloitte Center for Health Solutions (CDHS), spoke about mobile Health (mHealth):

“Although the growth in healthcare apps has been enormous, Dr. Greenspun said, it has mostly been concentrated in wellness and fitness. The fitness industry realized early that making fitness information social allows people to set their fitness goals. Leader boards shame you into exercising, etc. Yet, while this has resulted in a huge increase in the data we are collecting about ourselves, most of it is of no interest to doctors.

The paucity of true medical apps to date can be explained by the substantial barriers to entry.
1. Privacy: privacy is an enormous barrier to data sharing. Nobody wants to digitize “the rash that they got in Vegas.”
2. Errors: Some data measuring devices are not particularly accurate. In addition, mobile devices often lose signal and are not reliable.
3. Data on quality of care: While sites like Yelp provide information to the customer, they usually conflate service (the doctor’s demeanor, staff behavior, the facilities) with quality of care. Until customers have reliable data on quality of care, they will not be able to make use of mHealth data to make the right decisions.”

I’d love to be wrong on this. Feel free to disagree; if you convince me I’m wrong you might make my day!

Joe Hage
🔥 Find me at MedicalDevicesGroup.net 🔥
Thanks, Joe. And thanks for doing a marketing workshop at 10x. Looking forward to it!

Joe Doyle
SVP, Strategic Marketing and Development
Love this article and recap. Thanks, Joe!

Jack Hagerty
Medical Device Engineer specializing in V&V Testing
To the MCS (Mechanical Circulatory Support) industry, “wearables” are old news. Thoratec has been making implantable pumps for nearly three decades. The current industry focus is to get rid of the “perc” cable to power them which includes both interal and external wearables.

Toby Leete
Senior Strategist at IQVIA
See http://www.equivital.co.uk/ for wearable inspiration. They have been in this market for over 10 years.