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Medical Wearables презентация
Содержание
- 1. Medical Wearables
- 2. Technology Sensors Connectivity Data analysis Legal &
- 3. Technology (Device Form Factors)
- 4. Enabling Technologies
- 5. Tech Should Work Together
- 6. Big Picture
- 7. What is the medical device?
- 8. “an instrument, apparatus, implement, machine, contrivance, implant,
- 9. Medical Device or Fitness Tool?
- 10. Medical vs Fitness
- 11. Does the product’s intended use and claims
- 12. Does the product’s intended use include a
- 13. Is the disease or medical condition a
- 14. Does the claim use language that the
- 15. HIPAA
- 16. Access control Audit controls Integrity
- 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
- 23. Portable Glucose Level Monitoring (by Medtronic)
- 24. Pain relief with Electrotherapy (by Omron) Transcutaneous
Technology Sensors Connectivity Data analysis Legal & Regulatory FDA HIPAA Usability Market Touched by Medical Wearables
Слайд 2Technology
Sensors
Connectivity
Data analysis
Legal & Regulatory
FDA
HIPAA
Usability
Market
Touched by Medical Wearables
Слайд 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."
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
Слайд 11Does 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
YES->look at next slide
NO-> It’s not a general wellness product
General Wellness Test (part 1)
Слайд 12Does 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
Yes -> Look at next slide
No -> Is it safe?
Yes->General Welness
No-> Not a wellness device
General Wellness Test (part 2)
Слайд 13Is 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
No -> Not a wellness device
Yes -> Look at next slide
General Wellness Test (part 3)
Слайд 14Does 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
No -> Not a wellness device
Yes -> Is it safe?
Yes->General Welness
No-> Not a wellness device
General Wellness (part 4)
Слайд 16Access control
Audit controls
Integrity
Person or entity authentication
Transmission security
HIPAA
Technical Safeguards
Слайд 22Portable 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
Retail price ca $460
Слайд 23Portable 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
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
Слайд 24Pain 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.
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.
