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Wearable technology innovation in healthcare and medical devices

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Dr. Steven LeBoeuf, President and Co-Founder of Valencell, presented these slides at IDTechEx 2016. Here's a quick summary:
- Wearable biometric technology (optical heart rate monitors) has accelerated to the point where it is accurate enough for at least some medical purposes
- In some ways wearable biometric technology is actually outpacing medical technology
- With lower costs, better form-factors, and new features, advanced wearables are now enabling ambulatory mobile healthcare, with a focus in prevention, screening, and disease management
- One point of friction is merging the rather chaotic exploration and rapid innovation of fitness wearables with the methodical discipline of clinical validation
- Companies that can apply medical-style validation to these innovative wearable sensor technologies are best-poised to find success in the marketplace

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Wearable technology innovation in healthcare and medical devices

  1. 1. How consumer wearable technology is driving innovation in healthcare and medical devices IDTechEx Sensors USA November 17th, 2016
  2. 2. ©2016 Valencell. Inc Outline • Historical timeline of the wearables market • The effect of disruptive advances to wearable sensors • Current B2B market pull in health/medical wearables • Challenges and optimism in merging consumer tech with medical use cases • Summary – key take-ways
  3. 3. ©2016 Valencell. Inc Heart Rate Chest Straps Activity Trackers GPS Armband Calorimetry Wireless vital signs monitors Integrated solutions/ smart- devices 1980 2000 2006-09 20122010 Mobile Tracking Apps 2013 Wrist/arm activity trackers 2014 -16 Compelling use cases 2017-18 2019-20 Health/medical wearables Wearables are trending towards familiar form-factors, and more compelling user cases (including health)
  4. 4. ©2016 Valencell. IncVALENCELL CONFIDENTIAL INFORMATION Disease management Guided fitness training Prevention Sleep quality Diet management Stress Management Health diagnostics Wearable optical sensor systems are now demonstrating performance levels suitable for medical use cases
  5. 5. ©2016 Valencell. Inc Atrial fibrillation identification has been demonstrated using optical sensor systems embedded in audio earbuds & wristbands VALENCELL CONFIDENTIAL INFORMATION, PATENTS GRANTED & PENDING Valencell OHRM ECG Valencell OHRM ECG Normal Poincaré Plot Atrial Fibrillation Detected
  6. 6. ©2016 Valencell. Inc -40 -30 -20 -10 0 10 20 30 70 80 90 100 110 120 130 140 150 160 170 DiffSBP Mean SBP Bland-Altman SBP -30 -25 -20 -15 -10 -5 0 5 10 15 20 40 50 60 70 80 90 100 DiffDBP Mean DBP Bland-Altman DBP R² = 0.7106 70 80 90 100 110 120 130 140 150 160 170 70 80 90 100 110 120 130 140 150 160 170 BenchmarkSBP Model SBP SBP Regression Analysis R² = 0.5453 40 50 60 70 80 90 100 40 50 60 70 80 90 100 BenchmarkDBP Model DBP DBP Regression Analysis Error = -0.1 ± 9 mmHg (mean ± SD) Error = 0.0 ± 8 mmHg (mean ± SD) Systolic & diastolic blood pressure tracking has been demonstrated via finger & earbud-based optical sensor systems VALENCELL CONFIDENTIAL INFORMATION, PATENTS GRANTED & PENDING
  7. 7. ©2016 Valencell. Inc Commercial innovation in consumer biometric wearables is beginning to outpace that of medical monitoring technology $10,000 clinical biometric data collection system $500 consumer biometric data collection system
  8. 8. ©2016 Valencell. IncVALENCELL CONFIDENTIAL INFORMATION Market pull for wearable biometric sensors in 5 key categories Personal Health (Prevention) Clinical Research Disease Management Disease Diagnosis Therapeutics Description General fitness and wellness sensors having prevention-based UX Sensors for measuring biometrics and activity used in clinical research Sensors for chronic disease management, such as COPD, asthma, diabetes, and cardiovascular disease Sensors for screening or diagnosing diseases, such as sensors for atrial fib, arrhythmia, and hypoxia Sensors that provide active feedback for controlling therapeutic medical devices Example Products Omron Wellness; HealthKit Actigraph products; BIOPAC products; ResearchKit Philips HealthSuite iRhythm atrial fibrillation sensors; Omron hypertension screening Medtronic insulin pump systems & neurostimulators FDA Regulated No Typically not Yes Yes Yes – very highly
  9. 9. ©2016 Valencell. Inc Moving from consumer to medical wearables requires partnerships… but these two markets tend to clash VALENCELL CONFIDENTIAL INFORMATION, PATENTS GRANTED & PENDING Consumer fitness wearables • Crowdfunded + light VC • Glam marketing • Accuracy not a top priority • Loose on validation • Roman personality • Looks for ways to avoid FDA • 2-year timelines Medical wearables • Heavily venture-backed • Conservative B2B marketing • Accuracy is critical • Heavy on validation • Greek personality • FDA approval is critical to success • 7+ year timelines
  10. 10. ©2016 Valencell. Inc FDA regulation is not the bottleneck with new medical wearables… Use case validation is the key obstacle Prototyping (~2 - 5 weeks) Use Case Validation (~year) Feasibility Testing (~1 - 2 weeks) Accuracy Validation UX Validation Independent Clinical Validation FDA Approval (510K)
  11. 11. ©2016 Valencell. Inc Success in the medical wearables market will require both an understanding of the consumer market and clinical validation VALENCELL CONFIDENTIAL INFORMATION, PATENTS GRANTED & PENDING
  12. 12. ©2016 Valencell. Inc Key take-aways… VALENCELL CONFIDENTIAL INFORMATION, PATENTS GRANTED & PENDING • Mobile fitness technology has accelerated to the point where it is accurate enough for at least some medical purposes • In some ways mobile fitness technology is actually outpacing medical technology • With lower costs, better form-factors, and new features, advanced mobile fitness technology is now enabling ambulatory mobile healthcare, with a focus in prevention, screening, and disease management • One point of friction is merging the rather chaotic exploration and rapid innovation of fitness wearables with the methodical discipline of clinical validation • Companies that can apply medical-style validation to these innovative wearable sensor technologies are best-poised to find success in the marketplace
  13. 13. Thank You!

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