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Team #2 
Wearable monitoring system to increase patient compliance 
and improve success rate of PTSD therapy 
Mark Bly Kent Lee Imad Libbus 
Founder Industry Expert Principal Investigator 
Mechanical Eng, MBA Biomedical Eng, MBA Biomedical Eng, PhD 
12 yrs industry experience 13 yrs industry experience 12 yrs industry experience 
Total Customer Interviews: 125 (80 face‐to‐face)
Existing PTSD Therapy 
• Re‐imagine 
traumatic triggers 
• PTSD best treated 
by de‐sensitization 
to triggers 
Image Source: The Hurt Locker (2008) 
I don’t want 
to experience this 
again 
• No objective way to 
track engagement 
• Poor compliance, 
high drop‐out rate
Wearable Monitoring System 
Wrist 
Monitor 
Smart phone or 
tablet 
Cloud 
Smart phone or 
tablet 
Patient 
Therapist
Week 1 Canvas
Customer Segments – VA/DOD psychologists 
appear to be initial customer segment 
VA/DOD PTSD 
Psychologists (n=10) 
VA/DOD Non‐PTSD 
Psychologists (n=5) 
Community 
Psychologists (n=4) 
Hypothesis: 
• Room for improvement in 
PTSD treatment and 
therapy compliance 
Experiments: 
• Does improving 
compliance make a clinical 
difference? 
Results/Next Steps 
• Therapy compliance and 
dropout limits PTSD 
improvement 
• Potential first customer 
Hypothesis: 
• Physiological monitoring 
is useful to other 
psychologists 
Experiments: 
• What is the compliance 
of other therapies? 
• Other non‐PTSD pts? 
Results/Next Steps 
• New segment ‐ Pain 
and anxiety disorders 
• Compliance and 
dropout are issues 
• Need more data 
Hypothesis: 
• PTSD patients are 
treated in a community 
setting 
Experiments: 
• What type of patients 
do community 
psychologists treat? 
Results/Next Steps 
• Not focused on PTSD 
patients 
• Limited funds for new 
technology 
• Ignore for now
“Prolonged exposure needs to be 
used more. 50% of patients drop out 
because it’s too intense, but those 
who finish therapy do better.” 
Shannon Kehle‐Forbes 
Psychologist, Minneapolis VA Medical Center 
“Decreasing dropout and increasing 
patient compliance during therapy 
are equally important tasks.” 
Nishant Patel 
Psychologist, DC VA Medical Center
Value Proposition Canvas 
Cost Savings 
Increased 
Likelihood of 
Recovery 
Faster 
Recovery 
Simplify 
Clinical 
Practice 
Patients 
don’t engage 
Patients 
don’t comply 
30% Patient 
dropout 
Treat PTSD 
patients 
Alleviate 
symptoms 
Improve 
patient 
quality of life 
Time/Effort 
to attend 
sessions 
Therapist 
Patient 
Payer 
Therapist 
& Patient 
Data 
Security
Week 4 Canvas
How do we deliver these value 
propositions?
Critical Path – PTSD Application 
• 5 years to collect evidence to support wide 
adoption in VA Medical Center 
Monitoring System Development 
Market 
Entry 
Updates, Fixes, Trial Support 
Clinical Trial – therapy vs. therapy + 
Aclaris System 
Clinical Study to Evaluate Patient/ 
Therapist Use and gather data for 
Algorithm Development 
2015 2016 2017 2018 2019
“Could your technology be used 
for biofeedback? Current 
biofeedback devices are hard to 
use and expensive.” 
Caryn Seebach 
Psychologist, DC VA Medical Center
Biofeedback: An Existing Market 
• Clinical Applications 
– Anxiety disorders 
– Chronic pain 
– Migraines and tension 
headaches 
• Cumbersome system 
• Requires extensive training 
• Can be costly ($5,000+)
MVP – Biofeedback System 
• A stepping stone to the long‐term opportunity 
Wrist Monitor – 
collects physiological 
data such as HR and 
skin temperature 
Smart phone or 
tablet – displays 
physiological data 
Patient 
Therapist
Critical Path – Biofeedback Application 
MVP Development 
Validation of Physiological 
Measurements in Clinical 
Setting 
Time to market 
reduced by 3 years 
Monitoring System Development 
Updates, Fixes, Trial Support 
Market 
Entry 
Market 
Entry 
Clinical Trial – therapy vs. therapy + 
Aclaris System 
Market 
Entry 
Clinical Study to Evaluate Patient/ 
Therapist Use and gather data for 
Algorithm Development 
2015 2016 2017 2018 2019
Validating our Biofeedback VPs 
• Easy to use (<5 min to train user) 
• Suitable for all patients (monitors multiple 
parameters) 
• Meets data security requirements
Customer Archetypes for MVP 
PTSD Exposure 
Therapist Early Adopters 
PhD in Psychology 
Trained in PE Therapy 
VA/Military Base/Academic 
Tech‐Savvy 
Male or Female 
Age 30 – 40 years 
Biofeedback Practitioners 
Masters in Psychology 
Certified in Biofeedback 
Hospital Clinic or Independent 
Clinic 
Treat Pain, Anxiety 
Male or Female 
Age 45 – 55 years
Week 10 Canvas
Biofeedback is a Stepping Stone to 
PTSD Monitoring 
MVP Development 
Validation of Physiological 
Measurements in Clinical 
Setting 
Monitoring System Development 
Updates, Fixes, Trial Support 
Market 
Entry 
Clinical Trial – therapy vs. therapy + 
Aclaris System 
Clinical Study to Evaluate Patient/ 
Therapist Use and gather data for 
Algorithm Development 
2015 2016 2017 2018 2019 
PTSD Monitor Biofeedback Monitor 
Market 
Entry 
Market 
Entry
SBIR Phase II Readiness 
• Status: Go with a nominal pivot 
IRL 5 
Path to Revenues, OP Plan, Cust 
Data points 
High Fidelity MVP 
Business Case Defined 
Left‐side of the Canvas 
Right‐side of the Canvas 
Product/Market Fit 
Problem/Solution Validation 
Low Fidelity MVP, Clinical Paths ID’d 
First Pass Canvas 
IRL 2
Lessons Learned Video 
https://www.youtube.com/watch?v=f1eJ7Y7PauQ

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Aclaris medical I-Corps@NIH 12-10-2014

  • 1. Team #2 Wearable monitoring system to increase patient compliance and improve success rate of PTSD therapy Mark Bly Kent Lee Imad Libbus Founder Industry Expert Principal Investigator Mechanical Eng, MBA Biomedical Eng, MBA Biomedical Eng, PhD 12 yrs industry experience 13 yrs industry experience 12 yrs industry experience Total Customer Interviews: 125 (80 face‐to‐face)
  • 2. Existing PTSD Therapy • Re‐imagine traumatic triggers • PTSD best treated by de‐sensitization to triggers Image Source: The Hurt Locker (2008) I don’t want to experience this again • No objective way to track engagement • Poor compliance, high drop‐out rate
  • 3. Wearable Monitoring System Wrist Monitor Smart phone or tablet Cloud Smart phone or tablet Patient Therapist
  • 5. Customer Segments – VA/DOD psychologists appear to be initial customer segment VA/DOD PTSD Psychologists (n=10) VA/DOD Non‐PTSD Psychologists (n=5) Community Psychologists (n=4) Hypothesis: • Room for improvement in PTSD treatment and therapy compliance Experiments: • Does improving compliance make a clinical difference? Results/Next Steps • Therapy compliance and dropout limits PTSD improvement • Potential first customer Hypothesis: • Physiological monitoring is useful to other psychologists Experiments: • What is the compliance of other therapies? • Other non‐PTSD pts? Results/Next Steps • New segment ‐ Pain and anxiety disorders • Compliance and dropout are issues • Need more data Hypothesis: • PTSD patients are treated in a community setting Experiments: • What type of patients do community psychologists treat? Results/Next Steps • Not focused on PTSD patients • Limited funds for new technology • Ignore for now
  • 6. “Prolonged exposure needs to be used more. 50% of patients drop out because it’s too intense, but those who finish therapy do better.” Shannon Kehle‐Forbes Psychologist, Minneapolis VA Medical Center “Decreasing dropout and increasing patient compliance during therapy are equally important tasks.” Nishant Patel Psychologist, DC VA Medical Center
  • 7. Value Proposition Canvas Cost Savings Increased Likelihood of Recovery Faster Recovery Simplify Clinical Practice Patients don’t engage Patients don’t comply 30% Patient dropout Treat PTSD patients Alleviate symptoms Improve patient quality of life Time/Effort to attend sessions Therapist Patient Payer Therapist & Patient Data Security
  • 9. How do we deliver these value propositions?
  • 10. Critical Path – PTSD Application • 5 years to collect evidence to support wide adoption in VA Medical Center Monitoring System Development Market Entry Updates, Fixes, Trial Support Clinical Trial – therapy vs. therapy + Aclaris System Clinical Study to Evaluate Patient/ Therapist Use and gather data for Algorithm Development 2015 2016 2017 2018 2019
  • 11. “Could your technology be used for biofeedback? Current biofeedback devices are hard to use and expensive.” Caryn Seebach Psychologist, DC VA Medical Center
  • 12. Biofeedback: An Existing Market • Clinical Applications – Anxiety disorders – Chronic pain – Migraines and tension headaches • Cumbersome system • Requires extensive training • Can be costly ($5,000+)
  • 13. MVP – Biofeedback System • A stepping stone to the long‐term opportunity Wrist Monitor – collects physiological data such as HR and skin temperature Smart phone or tablet – displays physiological data Patient Therapist
  • 14. Critical Path – Biofeedback Application MVP Development Validation of Physiological Measurements in Clinical Setting Time to market reduced by 3 years Monitoring System Development Updates, Fixes, Trial Support Market Entry Market Entry Clinical Trial – therapy vs. therapy + Aclaris System Market Entry Clinical Study to Evaluate Patient/ Therapist Use and gather data for Algorithm Development 2015 2016 2017 2018 2019
  • 15. Validating our Biofeedback VPs • Easy to use (<5 min to train user) • Suitable for all patients (monitors multiple parameters) • Meets data security requirements
  • 16. Customer Archetypes for MVP PTSD Exposure Therapist Early Adopters PhD in Psychology Trained in PE Therapy VA/Military Base/Academic Tech‐Savvy Male or Female Age 30 – 40 years Biofeedback Practitioners Masters in Psychology Certified in Biofeedback Hospital Clinic or Independent Clinic Treat Pain, Anxiety Male or Female Age 45 – 55 years
  • 18. Biofeedback is a Stepping Stone to PTSD Monitoring MVP Development Validation of Physiological Measurements in Clinical Setting Monitoring System Development Updates, Fixes, Trial Support Market Entry Clinical Trial – therapy vs. therapy + Aclaris System Clinical Study to Evaluate Patient/ Therapist Use and gather data for Algorithm Development 2015 2016 2017 2018 2019 PTSD Monitor Biofeedback Monitor Market Entry Market Entry
  • 19. SBIR Phase II Readiness • Status: Go with a nominal pivot IRL 5 Path to Revenues, OP Plan, Cust Data points High Fidelity MVP Business Case Defined Left‐side of the Canvas Right‐side of the Canvas Product/Market Fit Problem/Solution Validation Low Fidelity MVP, Clinical Paths ID’d First Pass Canvas IRL 2
  • 20. Lessons Learned Video https://www.youtube.com/watch?v=f1eJ7Y7PauQ