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Medical Wearables
Prepared for Personal Analytics Meetup
By Gene Leybzon, Jan 2015
 Technology
 Sensors
 Connectivity
 Data analysis
 Legal & Regulatory
 FDA
 HIPAA
 Usability
 Market
Touched by M...
Technology (Device Form Factors)
Enabling Technologies
Sensors
Computing
Power
Network
Connectivity
Tech Should Work Together
Wearable
Mobile
App
Cloud
platform
Big Picture
What is the medical device?
 “an instrument, apparatus, implement, machine, contrivance,
implant, in vitro reagent, or other similar or related artic...
Medical Device or Fitness Tool?
Medical vs Fitness
Medical
Device
Diagnose
Treat
Fitness
Device
Informational
Educational
 Does the product’s intended use and claims refer to
sustaining or offering general improvement to
conditions and functio...
 Does the product’s intended use include a claim
relating to a disease or medical condition?
 Yes -> Look at next slide
...
 Is the disease or medical condition a chronic one for
which it is well understood that healthy lifestyle
choices may pla...
 Does the claim use language that the product may
help to reduce the risk of, or may help living well with,
a chronic dis...
HIPAA
 Access control
 Audit controls
 Integrity
 Person or entity
authentication
 Transmission security
HIPAA Technical Sa...
Market Size
Market
Medical Device Market by Territory
Market
Disposable Medical Devices
Market mHealth
Medical Wearable Devices
on the market already
(and approved by FDA)
Portable bio-data Logger
(by Zephyr)
• Monitor Posture
• Monitor Activity
• Monitor ECG
• Transmission Range:
10m
• Dimens...
Portable Glucose Level Monitoring
(by Medtronic)
Continuous glucose monitoring
system
• Professional use only
• >3 days (o...
Pain relief with Electrotherapy
(by Omron)
• Transcutaneous electric nerve
stimulator (TENS)
• Program circle button contr...
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Medical Wearable Devices

View on Medical Wearables from different angles:
- Technology
- Market
- Usability
- Regulatory (FDA and HIPAA)

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Medical Wearable Devices

  1. 1. Medical Wearables Prepared for Personal Analytics Meetup By Gene Leybzon, Jan 2015
  2. 2.  Technology  Sensors  Connectivity  Data analysis  Legal & Regulatory  FDA  HIPAA  Usability  Market Touched by Medical Wearables
  3. 3. Technology (Device Form Factors)
  4. 4. Enabling Technologies Sensors Computing Power Network Connectivity
  5. 5. Tech Should Work Together Wearable Mobile App Cloud platform
  6. 6. Big Picture
  7. 7. What is the medical device?
  8. 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. 9. Medical Device or Fitness Tool?
  10. 10. Medical vs Fitness Medical Device Diagnose Treat Fitness Device Informational Educational
  11. 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. 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. 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. 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. 15. HIPAA
  16. 16.  Access control  Audit controls  Integrity  Person or entity authentication  Transmission security HIPAA Technical Safeguards
  17. 17. Market Size
  18. 18. Market Medical Device Market by Territory
  19. 19. Market Disposable Medical Devices
  20. 20. Market mHealth
  21. 21. Medical Wearable Devices on the market already (and approved by FDA)
  22. 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. 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. 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.

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