4 min reading time

There were 274 companies listed under “Wearables” at the Consumer Electronics Show last month.

237 under “Health and Biotech.” 87 under “Biometrics.”

That’s at the CONSUMER Electronics Show.

See http://medgroup.biz/device-design for access to our free webinar, “Designing Health for Consumers,” if you’re working on the creation of connected solutions for patient monitoring, scheduling, tracking, or drug delivery.

Tom KraMer, Medical Devices Group Advisory Board member, and Mark Schwartz, CEO of Product Development Technologies (PDT) will discuss:
• How consumer vital tracking and clinical grade devices are converging

• The issues developing these devices and how they’ve been solved in past development programs

• The four types of connectivity solutions by level of complexity

• How to decide which device type and development route is best for your application

The slides, video replay, and transcript available for all who register, whether you can attend live or not: http://medgroup.biz/device-design

What questions do you have for our presenters?

Which device design issues keep you awake at night?

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ASIA-PACIFIC SUMMIT

I’m attending the Asia-Pacific Summit for Medical Devices in San Diego on March 5 and 6.

See http://AsiaPacificDeviceSummit.com

It’s for teams who want additional regulatory training to support your business in the Asia Pacific.

They are flying in experts from Singapore, Jakarta, Sydney, Kuala Lumpur, and Beijing to make it easy for you to discuss current strategies for the whole Asia-Pacific region at one convenient meeting.

If you can’t make the whole event but are a drive away, stop by for the cocktail hour on March 5 so we can meet in person.

That link again: http://AsiaPacificDeviceSummit.com

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Discussions You May Have Missed

Is FDA naive and dangerous by stating “some wearables do not need controls?”
http://bit.ly/out-of-control-wearables

Wireless Connections to Medical Devices
http://bit.ly/wireless-dvcs

23andMe Makes Headway in Claims
http://bit.ly/23-headway

How to get a “free sale certificate” for a medical device-class II (IVD) that is not FDA approved?
http://bit.ly/free-sale-certificates

Greed, Food, and Healthcare
http://bit.ly/Greed-Food-Healthcare

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Karl Schulmeisters
Principal and Founder at ExStreamVR
Sorry the formatting engine of LinkedIn is just awful The three bulleted points in my above post started with

“Many are solutions in search of a problem”

“A lot of the wearbables are just badly designed”

“As a consequence of the FDA opting not to regulate Wellness devices…”

Sorry – apparently copy/Paste from Word to LinkedIn does not work quite right.

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
As I noted at the top, “There will be a HUGE shakeout in these wearables and devices in the next 4 years.”

Karl Schulmeisters
Principal and Founder at ExStreamVR
There are a couple of other rose colored elephantine living room objects that challenge wearables:

1) Many are solutions in search of a problem. The premier example of this is The Belty [http://www.cnet.com/news/meet-belty-the-ridiculous-but-strangely-popular-show-stealer-of-ces-unveiled/|leo://plh/http%3A*3*3www%2Ecnet%2Ecom*3news*3meet-belty-the-ridiculous-but-strangely-popular-show-stealer-of-ces-unveiled*3/At9q?_t=tracking_disc]
2) Many of the wearables are just badly designed. Microsoft’s Handcuff.. (sorry Band) [http://www.engadget.com/2015/02/16/microsoft-band-user-review-roundup/|leo://plh/http%3A*3*3www%2Eengadget%2Ecom*32015*302*316*3microsoft-band-user-review-roundup*3/ajZD?_t=tracking_disc] is probably a good example here
3) With the FDA opting not to regulate “Wellness” devices we are seeing explosion of “snakeoil”. Researchers for the American Cancer Society, writing in the American Journal of Preventative Medicine noted that out of 148 Android and 252 iPhone smoking cessation apps
a. None used the most proven technique of text messaging
b. Only 4% recommended using approved medications
c. The Average score of adherence to best known practices was 12.9 out of 42.

So we shall see how this shakes out but I suspect you will see a bunch of lawsuits coming
4) And much of the reason for this is because the current generation of developers out there are particularly poorly suited for building “wearable” devices that have any sort of serious uses.

In the SaaS/Web/Mobile Device world – not only is “continuous deployment”, Regular Patch Management, and “rolling updates” common – they are considered “best practices”. This is completely the inverse of how “embedded systems” are designed, developed, and tested.

So the mind set of most wearable developers is frankly the inverse of what is necessary to build a quality, reliable, medically sound device.

Fleury Rey
STRATEGIC THINKER & PRAGMATIC DOER | DIGITAL & INNOVATION | BUSINESS DEVELOPMENT, MARKETING, GLOBAL COMMERCIALIZATION
A valuable review is available as a book: “Wearing Embodied Emotions, A practice Based Design Reseach on Wearable Technology” – Secil Ugur. The future of care is Human Centric.

Austin Walters
Bringing Innovation to Life in Healthcare
It’s true that too many fail to understand the real needs arising from existing care processes, or make the investment to close the gap with either research during product development cycle, or training and education afterwards. Changing an industry still involves a lot of good old fashioned people work.

Joe Camaratta
General Manager at MedAvante-ProPhase
I agree with Bo and David. Wearable manufacturers are focused on the device, and not the workflow that allows the information to be used by providers. Some large players are looking to own the aggregation and communication of information from multiple devices and they will consolidate the market.

David Lee Scher
Cardiologist, #DigitalHealth Consultant, Award-Winning Blogger
I would like to present a small but important concept. No technology is a solution. It is a tool, and when incorporated into a process involving other humans around which a vision for health or wellness is designed, it then becomes part of a solution. Developers tend to forget that in the ‘build it and they will
come’ system. Involving clinicians (not necessarily physicians, but pertinent professionals to the tool’s use) and patient/consumer users in development is also critical. [http://davidleescher.com/2015/02/17/five-imperatives-of-user-experience-ux-design-in-mobile-health-technology/|leo://plh/http%3A*3*3davidleescher%2Ecom*32015*302*317*3five-imperatives-of-user-experience-ux-design-in-mobile-health-technology*3/01up?_t=tracking_disc]

Burrell (Bo) Clawson
I research patents & design products to get a patented competitive position: Over 30 patents.
There will be a huge shakeout in these wearables and devices in the next 4 years.

It is confusing for both consumers and healthcare providers as to what is real, will work a long time and what will survive over time.