Wearable technology innovation in healthcare and medical devices

How consumer wearable technology is driving innovation in healthcare and medical devices

IDTechEx Sensors USANovember 17th, 2016

©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


Heart RateChest 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/medicalwearables

Wearables are trending towards familiar form-factors, and more compelling user cases (including health)

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©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


Atrial fibrillation identification has been demonstrated using optical sensor systems embedded in audio earbuds & wristbands

VALENCELL CONFIDENTIAL INFORMATION, PATENTS GRANTED & PENDING

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Normal Poincaré Plot Atrial Fibrillation Detected


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R² = 0.710605341205325

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Systolic & diastolic blood pressure tracking has been demonstrated via finger & earbud-based optical sensor systems



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

©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


Moving from consumer to medical wearables requires partnerships… but these two markets tend to clash


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


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)


Success in the medical wearables market will require both an understanding of the consumer market and clinical validation



Key take-aways…


• 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

Thank You!

Wearable technology innovation in healthcare and medical devices

Health & Medicine

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