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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 Medical Wearables
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 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
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 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)
 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)
 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)
 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)
HIPAA
 Access control
 Audit controls
 Integrity
 Person or entity
authentication
 Transmission security
HIPAA Technical Safeguards
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
• Dimensions: 46.8 x
45.5 x 11.3mm
• Retail price ca $460
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
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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Medical Wearable Devices

  • 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
  • 5. Tech Should Work Together Wearable Mobile App Cloud platform
  • 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?
  • 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
  • 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.

Notas do Editor

  1. http://www.idtechex.com/research/reports/wearable-technology-2014-2024-technologies-markets-forecasts-000379.asp
  2. http://techcrunch.com/2014/02/14/state-of-the-early-wearables-world/
  3. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm
  4. Medical: Examples given include products that make claims regarding such conditions as obesity, eating disorders, anxiety, autism, muscle atrophy or erectile dysfunction.
  5. HIPAA is the federal Health Insurance Portability and Accountability Act of 1996. The primary goal of the law is to make it easier for people to keep health insurance, protect the confidentiality and security of healthcare information and help the healthcare industry control administrative costs.
  6. http://www.hhs.gov/ocr/privacy/hipaa/administrative/securityrule/techsafeguards.pdf
  7. http://mordorintelligence.com/product/global-wearable-market-growth-trends-and-forecasts-2014-2019/
  8. http://www.marketsandmarkets.com/Market-Reports/disposable-medical-devices-sensors-market-1259.html
  9. http://webfeeds.brookings.edu/brookingsrss/topics/healthit&x=1
  10. Portable bio-data logger – by Zephyr FDA approved Specs: Monitor Posture Monitor Activity Monitor ECG* Transmission Range: 10m Dimensions: 46.8 x 45.5 x 11.3mm Retail price ca $460
  11. Portable glucose level monitoring – by Medtronic. FDA approved Specs: 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. Functionalities: Battery powered digital recorder connected to a sensor is inserted into the patient’s abdome Docking station (MMT-7742) for refueling the battery & download data and import into software (proprietary Medtronic CareLink iPro™ Therapy Management software. Measurements: 35.8 x 28.8 x 9.4 mm
  12. Pain relief with electrotherapy – by Omron. FDA cleared Specs: 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 direcly on the skin (large surfaces) operated by 2 1,5 V batteries (AAA)=22.8 hours of continuous usage Retail price: ca. $30.