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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)
Tech Should Work Together
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
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)
Access control Audit controls Integrity Person or entity authentication Transmission security HIPAA Technical Safeguards
MarketMedical Device Market by Territory
MarketDisposable Medical Devices
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.