Medical Device Innovation
Examples and Lessons
From the MEDRC
Brian W. Anthony
Co-Director, Medical Electronics Device Realization Center
Director, Master of Engineering in Manufacturing Program
© 2013 MIT
Outline
MEDRC – Medical Electronics
Device Realization Center.
One example project from the
MEDRC.
© 2013 MIT
Medical Electronics Device Realization Center
MEDRC
© 2013 MIT
Medical Electronic Device Realization Center
- MEDRC
Medical
Devices
Device Realization Research
at the intersection of Medical
Tech, Electronics, Data, and
Tangible Devices
Impact clinical needs, by innovating
usable and manufacturable devices,
leveraging the power of the
semiconductor industry and Boston /
Cambridge Ecosystem.
Micro
Electro
nics
Tangible
Devices
Big Data
© 2013 MIT
MEDRC – Collaboration Partners
 Industry, academics, and
clinicians  maximizes
chance of project success.
 Industrial scientist on-site at
MIT  company stays
engaged, project stays
relevant, technology
transferred to the company.
 Early prototypes placed in
“customers” (clinicians) hands
in parallel with research
technology development.
Employees
MIT
MEDRC
Needs, Perspectives
Companies
Hospitals,
Physicians
© 2013 MIT
Our Vision – Ecosystem
Medical Electronic Device Solutions – devices,
applications, systems.
Strong interaction between medical device /
microelectronics companies and physicians /
clinicians.
Research to lead to technology results that
Industrial Sponsors can turn into products.
Boston: Medical Device Hub
© 2013 MIT
Sensor-Data-Information-Use
System Flow
Health Care Sytem
Data:
Hospital
Patient
Sensors
Acquire
Analyze
Distribute
Information for defined Needs:
Use
© 2013 MIT
Sensor-Data-Information-Use
System Flow
Supply Chain
Data:
Factory
Machine
Sensors
Acquire
Analyze
Distribute
Information for defined Needs:
Use
© 2013 MIT
Need
‘State of health' information*
can:
Prevent worsening of [clinical]
status,
Early intervention,
Reduce the need for emergency
care
Reduce [health] care costs,
Improve outcomes and quality of
[health care],
Increase quality lifespan, and
Lead to new understandings.
ER
Disease
Acuity
(Severity)
Office visit
Home
$
Cost
$$$$$
Health Care
System
© 2013 MIT
Information over time
© 2013 MIT
Application Areas and Technology Examples
Wearable Devices
 Vital signs monitors including cuffless blood pressure
Minimally Invasive Monitors
 EEG measurements for Epilepsy patients
“Point of Care” Instruments
 “Lab on a Chip” for blood, urine, saliva analysis
Imaging
 Smart Ultrasound
Data Communication
 Body Area Network
© 2013 MIT
Highlighting new and cross pollination of technologies
ENHANCED ULTRASOUND
© 2013 MIT
Increasing the Productivity
(usability), Cost Effectiveness,
and Diagnostics Capability of
Ultrasound Imaging Systems
© 2013 MIT
Rate
Increasing the Productivity
Cost Effectiveness,
(usability), Cost
and Diagnostics
Capability of
Quality
Ultrasound Imaging Systems
© 2013 MIT
Ultrasound System Flow
Contact
State
ˆ
ˆ
ˆ
F
contact , xrel ,  rel
Imagery
Analysis
Diagnostics
© 2013 MIT
Ultrasound System Flow
Contact
State
ˆ
ˆ
ˆ
F
contact , xrel ,  rel
Imagery
Analysis
Diagnostics
© 2013 MIT
Sonographer variation
© 2013 MIT
1 Sonographer, 3 Patients
40
BMI 36
BMI 24
BMI ~25?
35
force (N)
30
25
20
15
10
5
0
-5
0
100
200
300
400
500
600
700
800
time (sec)
Mean force (N)
BMI 36,
BMI 24,
BMI 25,
Run 579
Run 114
Run 116
14.1
4.5
5.2
© 2013 MIT
Force Variation
16
1
5
13
33
Mean axial force (N)
#Years
Experience
14
12
10
8
6
Female sonog.
Male sonog.
4
18
20
22
24
26
28
Patient BMI
30
32
34
36
© 2013 MIT
Ultrasound System Flow
Contact
State
Analysis
ˆ
ˆ
ˆ
F
contact , xrel ,  rel
Diagnostics
Imagery
Machine
Intelligence
Assistance,
Guidance
Desired
State
Fcontact, xrel , rel
© 2013 MIT
Enhanced Ultrasound Probes
Human-in-the-loop
Position and
Orientation
Control
Automatic
Force
Control
© 2013 MIT
Force control, haptics applied to Imaging Process
FORCE CONTROL AND
MEASUREMENT PROBES
© 2013 MIT
Video
© 2013 MIT
In the clinic…
© 2013 MIT
Force Probes – Clinical Tests - Increased Information from controlled acquisition
Matthew Gilbertson, Shih-Yu Sun, Aaron Zakrzewski, Bill Vannah, Sisir Koppaka, Brian Anthony
Force-controlled probe

DMD clinical tests at Boston Children’s Hospital
(prototype 3)
Tissue Properties
Force = 5N
Force = 5.5N
Elasticity image
QUS Biomarkers for DMD Progression
Video
© 2013 MIT
DMD and Control
© 2013 MIT
DMD and Control - Processed
© 2013 MIT
DMD and Control - Processed
Quantities (“MEASUREMENTS”) extracted from Ultrasound Images depend on applied force.
© 2013 MIT
DMD vs Control – Classification Performance
Classification
Performance
100%
Known
acquisition
state is
important.
Unknown
state.
0%
Muscles
© 2013 MIT
Computer vision, mobile robotics applied to body mapping
FREEHAND LARGE VOLUME 3D
© 2013 MIT
Probe– Concept
Ultrasound probe
equipped with a camera
© 2013 MIT
Probe Tracking for
Freehand Large Volume 3D
© 2013 MIT
Skin Features
abdomen
neck
lower leg
© 2013 MIT
Video
© 2013 MIT
Video
© 2013 MIT
In-Vitro: curved surface
volume error: +6.30%
© 2013 MIT
In-Vivo: femoral artery
© 2013 MIT
6-DOF Ultrasound Probe Tracking (via Skin Mapping)
Matthew Gilbertson, Shih-Yu Sun, Aaron Zakrzewski, Bill Vannah, Sisir Koppaka, Brian Anthony
In-Vivo:
femoral artery
Skin feature tracking.
© 2013 MIT
Reslice v.s. Real Scan – neck
reslice
reslice
direct
direct
© 2013 MIT
Reslice v.s. Real Scan – abdomen
reslice
direct
© 2013 MIT
Computer vision, mobile robotics applied to body mapping.
Manufacturing process control applied to patient monitoring.
FREEHAND ULTRASOUND
REALIGNMENT
© 2013 MIT
Realignment
Goal: Move the probe to a target pose, at which an US
scan has been previously acquired.
www.radiologyinfo.org
© 2013 MIT
Realignment – Intuitive Interface
© 2013 MIT
Video
© 2013 MIT
Realignment – (difference images)
…during realignment process…
…at realignment.
© 2013 MIT
Technology Cross-Pollination
Workflow analysis applied to medical
imaging workflow enhancement
Force control, haptics applied to Imaging
Process
Computer vision, mobile robotics applied to
body mapping
Manufacturing process control applied to
patient monitoring
© 2013 MIT
Enhanced Probes and Workflow
Enhances ability to get
quantitative information
out of US imagery
 Dimensions, Volumes,
Tissue properties, “Image
Measurements”
Enhances “visibility” into
the US imaging process
 Repeatable acquisition
 Detect change
 Reduce training
© 2013 MIT
Summary – Fostering Innovation in Medical Devices
 MEDRC – Medical
Electronics Device
Realization Center.
 Part of Boston Medical Innovation
Ecosystem
 Partners and proximity matter.
 Enhanced Ultrasound
 One example project from the
MEDRC.
 Highlighting new and cross
pollination of technologies
Culture
 Pre-competitive collaboration
Employees
MIT
MEDRC
Challenges, Perspectives
Companies
Hospitals,
Physicians
Ecosystem
Professional Capital
Big and Small Partners
Pharma
Bio
…
© 2013 MIT
Thanks to
 Matthew Gilbertson
 Shih Yu Sun
 Aaron Zakrzewski
 Sisir Koppaka
 Bill Vanah, PhD
 Anthony Samir, MD
 Seward Rutkove, MD
The Mass General
Hospital
Boston Children’s
Hospital
Singapore MIT Alliance
GE Healthcare
ADI
Maxim
© 2013 MIT
Thank you.
Medical Device Innovation
Examples and Lessons
From the MEDRC
Brian W. Anthony PhD
banthony@mit.edu
© 2013 MIT