Device selection

1. Wearable Biosensor in
Movement Disorders Trials
Emily Kunka

2. Soft, flexible, conforming
biosensor
● Vital signs
● Activity level/actigraphy
● Posture classification
● Electromyography (EMG)
● Muscle activation
● Sleep metrics
Multiple sensors can be worn simultaneously to
provide a synchronized stream of data points to
contextualize natural behavior.
MC 10’s BioStamp
https://www.mc10inc.com/

3. ● QUALITY/COMPLIANCE - FDA 510K cleared, medical grade, clinical quality
● VALIDATED - Robust clinical trials, publications, usability testing, case studies
● CONFIGURABLE - Ability to manipulate sampling type and rate
● WELL- DESIGNED - Simple/straightforward, intuitive interface and application
● USER EXPERIENCE - Comfortable, unobtrusive, and discreet to wear/adhere
● DATA ACQUISITION - Ideally passive data collection (i.e. bluetooth)
● COMPATIBILITY - API to integrate with third party systems or other devices
● DATA INTEGRITY/SECURITY - Data is transmitted and stored securely in the cloud
● ACCESSIBLE ANALYTICS - Dashboard for remote monitoring and reporting
Best-Fit Selection Criteria

4. Value-Added
Real World Data
Evidence-based repeated
measures represent a more
accurate picture of the
subject’s functional abilities,
disease status, and response
to therapy. Inter-rater
variability and bias are
reduced, ensuring measure
reliability and objectivity.
Data is collected in real-time
and may uncover novel
endpoints.
Time and Cost Savings Burden Reduction
● Patients spend less time
performing assessments,
affecting enrollment and
retention.
● Simplified workflows for
study teams (less data
entry, reduced capacity
for transcription error,
single unit replacing
disparate systems or
devices).
● Potential for fewer visits.
● Can reduce or replace
requirements for copious
outcome assessments.
● Eliminate need to
identify, qualify, and
utilize additional
facilities (i.e. nerve
conduction or sleep lab)
● Device is small, reusable,
easy to ship and make
available at scale.

5. Time
Savings
Cost
Savings
Comments
Assessment
● Assessment will still occur at Baseline
and EOT
● Occurrence removed at visits 3, 5, and 9
3 hours
per pt
$150
1
Timed 25 Foot Walk Test
*Estimated at 1 hour with
set-up and instruction
● Assessment was at visits 3, 5, and 7
● Assessment removed completely from
schedule of assessments
1.5 hours
per pt
$75
2
Barnes Akathisia Rating
Scale (BARS)
*Estimated at 0.5 hour
● Only occurring in person at a lab at Screening
and Baseline visits
● All other assessments taken via the sensor at
visits 2, 4, 6, 8 and 10
5 hours
per pt
(investigator
time)
$1,000
3
Electromyography
Study Application Phase IIb study; N = 50 participants;
10 visits per participant
Total
9.5 hours
per pt
$1,225
per pt
$61,250 for 50 participants
*Estimated to take 1 hour in a lab