aclaris medical i-corps@nih 12-10-2014
TRANSCRIPT
Wearable monitoring system to increase patient compliance and improve success rate of PTSD therapy
Mark Bly Kent Lee Imad LibbusFounder Industry Expert Principal Investigator
Mechanical Eng, MBA Biomedical Eng, MBA Biomedical Eng, PhD12 yrs industry experience 13 yrs industry experience 12 yrs industry experience
Team #2
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 wantto 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.”
“Decreasing dropout and increasing patient compliance during therapy are equally important tasks.”
Shannon Kehle‐ForbesPsychologist, Minneapolis VA Medical Center
Nishant PatelPsychologist, DC VA Medical Center
Value Proposition CanvasCost Savings
Increased Likelihood of Recovery
Faster Recovery
Simplify Clinical Practice
30% Patient dropout
Patients don’t engage
Patients don’t comply
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
2015 2016 2017 2018 2019
Clinical Trial – therapy vs. therapy + Aclaris System
Clinical Study to Evaluate Patient/ Therapist Use and gather data for
Algorithm Development
Updates, Fixes, Trial Support
MarketEntry
“Could your technology be used for biofeedback? Current biofeedback devices are hard to use and expensive.”
Caryn SeebachPsychologist, 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
2015 2016 2017 2018 2019
Validation of Physiological Measurements in Clinical
Setting
Time to market reduced by 3 years
Monitoring System Development
Clinical Trial – therapy vs. therapy + Aclaris System
Clinical Study to Evaluate Patient/ Therapist Use and gather data for
Algorithm Development
Updates, Fixes, Trial Support
Market Entry
MarketEntry
MarketEntry
Validating our Biofeedback VPs
• Easy to use (<5 min to train user)
• Suitable for all patients (monitors multiple parameters)
• Meets data security requirements
PTSD Exposure Therapist Early Adopters
PhD in PsychologyTrained in PE Therapy
VA/Military Base/AcademicTech‐Savvy
Male or FemaleAge 30 – 40 years
Customer Archetypes for MVP
Biofeedback Practitioners
Masters in PsychologyCertified in Biofeedback
Hospital Clinic or Independent Clinic
Treat Pain, AnxietyMale or FemaleAge 45 – 55 years
Week 10 Canvas
Biofeedback is a Stepping Stone to PTSD Monitoring
MVP Development
2015 2016 2017 2018 2019
Validation of Physiological Measurements in Clinical
Setting
Monitoring System Development
Clinical Trial – therapy vs. therapy + Aclaris System
Clinical Study to Evaluate Patient/ Therapist Use and gather data for
Algorithm Development
Updates, Fixes, Trial Support
Market Entry
Biofeedb
ack Mon
itor
PTSD
Mon
itor
MarketEntry
MarketEntry
SBIR Phase II Readiness• Status: Go with a nominal pivot
IRL 5
First Pass Canvas
Problem/Solution Validation
Low Fidelity MVP, Clinical Paths ID’d
Product/Market Fit
Left‐side of the Canvas
Business Case Defined
High Fidelity MVP
Path to Revenues, OP Plan, CustData points
Right‐side of the Canvas
IRL 2
Lessons Learned Video
https://www.youtube.com/watch?v=f1eJ7Y7PauQ