This document discusses medical wearable devices and related topics. It covers the key technologies that enable medical wearables like sensors, computing, and connectivity. It also addresses regulatory considerations regarding whether a device is classified as a medical device or general wellness product based on its intended use and claims. Finally, it provides examples of medical wearables already on the market, including devices that monitor bio-data, glucose levels, and provide pain relief through electrotherapy.

1. Medical Wearables
Prepared for Personal Analytics Meetup
By Gene Leybzon, Jan 2015

2.  Technology
 Sensors
 Connectivity
 Data analysis
 Legal & Regulatory
 FDA
 HIPAA
 Usability
 Market
Touched by Medical Wearables

3. Technology (Device Form Factors)

4. Enabling Technologies
Sensors
Computing
Power
Network
Connectivity

5. Tech Should Work Together
Wearable
Mobile
App
Cloud
platform

6. Big Picture

7. What is the medical device?

8.  “an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related article, including
a component part, or accessory which is:
 recognized in the official National Formulary, or the United States
Pharmacopoeia, or any supplement to them,
 intended for use in the diagnosis of disease or other conditions, or in
the cure, mitigation, treatment, or prevention of disease, in man or
other animals, or
 intended to affect the structure or any function of the body of man or
other animals, and which does not achieve its primary intended purposes
through chemical action within or on the body of man or other animals
and which is not dependent upon being metabolized for the
achievement of any of its primary intended purposes."
Definition of Medical Device

9. Medical Device or Fitness Tool?

10. Medical vs Fitness
Medical
Device
Diagnose
Treat
Fitness
Device
Informational
Educational

11.  Does the product’s intended use and claims refer to
sustaining or offering general improvement to
conditions and functions associated with a general
state of health: weight management, physical fitness,
relaxation or stress management, mental acuity, self-
esteem, including personal appearance, sleep
management, or sexual function?
 YES->look at next slide
 NO-> It’s not a general wellness product
General Wellness Test (part 1)

12.  Does the product’s intended use include a claim
relating to a disease or medical condition?
 Yes -> Look at next slide
 No -> Is it safe?
 Yes->General Welness
 No-> Not a wellness device
General Wellness Test (part 2)

13.  Is the disease or medical condition a chronic one for
which it is well understood that healthy lifestyle
choices may play a part in helping to reduce its risk or
impact?
 No -> Not a wellness device
 Yes -> Look at next slide
General Wellness Test (part 3)

14.  Does the claim use language that the product may
help to reduce the risk of, or may help living well with,
a chronic disease or condition, as discussed in this
guidance?
 No -> Not a wellness device
 Yes -> Is it safe?
 Yes->General Welness
 No-> Not a wellness device
General Wellness (part 4)

15. HIPAA

16.  Access control
 Audit controls
 Integrity
 Person or entity
authentication
 Transmission security
HIPAA Technical Safeguards

17. Market Size

18. Market
Medical Device Market by Territory

19. Market
Disposable Medical Devices

20. Market mHealth

21. Medical Wearable Devices
on the market already
(and approved by FDA)

22. Portable bio-data Logger
(by Zephyr)
• Monitor Posture
• Monitor Activity
• Monitor ECG
• Transmission Range:
10m
• Dimensions: 46.8 x
45.5 x 11.3mm
• Retail price ca $460

23. Portable Glucose Level Monitoring
(by Medtronic)
Continuous glucose monitoring
system
• Professional use only
• >3 days (or more) of patient
interstitial glucose level
monitoring
• Retail price for the entire kit
(includes MiniLink™ wireless
transmitter charging device,
test plug, user guide, insertion
device and sveral glucose
sensors): ca. $1,625.
• Measurements: 35.8 x 28.8 x
9.4 mm

24. Pain relief with Electrotherapy
(by Omron)
• Transcutaneous electric nerve
stimulator (TENS)
• Program circle button controls
3 set programs for the arm,
lower back and the leg/foot;
arrows control 5 intensity
levels
• 2 pads to attach to the body
and apply the therapy not
directly on the skin (large
surfaces)
• operated by 2 1,5 V batteries
(AAA)=22.8 hours of
continuous usage
• Retail price: ca. $30.