Dila-Pro
The World’s First Smart Cervical Dilator
Benjamin Lee, CEO
Anne Kwei, CTO
Matthew Lee, CMO/CRO
Grace Shih, CFO
Clark T. Hung, Ph.D.
Rachel Masch, M.D., M.P.H.
The Problem
500,000 manual cervical dilation procedures annually in the US
Current
Dilators
Uncontrollable
Dilation Rate
Insufficient
Dilation
Lacks PatientTailored
Specifications
Inadvertent
Induction of
Labor
No Established
Protocols
Extreme
Patient
Discomfort
Tissue Damage
The Solution
Dilation Features
Current Products
Our Product
Cervix Dilation
Cost Effective
One Insertion Application
Applicability to All Procedures
Comfortable and Tailored Dilation
Preservation of Cervical Integrity
DilaPro
The World’s First Smart Cervical
Dilator
-portable and discreet
-safe and efficient
-patient tailored
Initial Prototype Design
Current Prototype
Rigid Air Tube:
1) Easy insertion
2) Air feed
3) Infrared emitter anchor
Infrared
sensor
Infrared
emitter
Diameter Measurement System
Prototype Testing
Pump Control
Pressure
sensor
Infrared
emitter/
sensor leads
Ni-DAQ
Prototype Testing
Electrical Lead
to Computer
Manual
Air Supply
Air Lead to
Pressure Gauge
Prototype Demonstration
Hardware Refinement
Small Peristaltic Pump
– Pumps set volume of air into the balloon per turn
– Vary RPM to vary rate of dilation
Proximity Sensor
– Single, small unit
– Ease of product preparation
Algorithm Details
Dilation Rate a
Continuous Monitoring of:
1) Pressure
2) Diameter
3) Dilation Rate
Outputs/Display:
1) % Completion
2) Approximate
amount of time
remaining
Input:
Desired Diameter
Base Rate:
0.5 cm/hr
Diameter= Desired
Stop Pump
Signal Completion
Dilation Rate a
Threshold Determination
• Procedure: Stretch 10% at 0.05 mm/s = 3 mm/min
• Maximum peak stress ≈ 100 kPa
• Expectation for cervix dilation: <100 kPa stress due to slower
dilation rate and known tissue relaxation due to force applied on
cervix
Myers, K. M.; Paskaleva, A. P.; House, M.; Socrate, S., Mechanical and biochemical properties of human cervical tissue. Acta Biomater 2008, 4 (1)
Prototype Testing
• Obtain Bovine Calf Cervices
– Similar size and shape to human system
– Tension test
• Test Balloon System
– Readouts: calculated parameters vs. real parameters
– Anticipated Difficulties
• Incorporating low-voltage electronics into the cervix
– Should be safe given proper seal
– Alternative mechanical ways of sensing diameter
• Bursting the balloon
– Operating well below the burst pressure of the
balloon
– Two-way pump allows us to deflate the balloon if
needed
Summary
• Substantial need and market for new cervical
dilator
• Advanced and innovative design
– Efficient, patient-tailored dilation
– Protection of cervical integrity
• Prototype progress reflects design feasibility
and device potential
Semester Timeline
April 29
Poster
presentation and
prototype
demonstration
April 16
Bovine cervix
testing
April 2
Prototype design,
calibration, and
program finalization
April 23
Completion of
workable prototype
and data analysis
Acknowledgements
Dr. Clark Hung
Professor of Biomedical Engineering
Dr. Gordana Vunjak-Novakovic
Dr. Rachel Masch
Associate Director of Family Planning, Beth Israel Hospital
Dr. Rujin Ju
Beth Israel Hospital
Professor of Biomedical Engineering
Dr. Elizabeth Hillman
Assistant Professor of Biomedical Engineering
Keith Yeager
Matthew Bouchard
Graduate Student in Biomedical Engineering
Sarindr Bhumiratana
Senior Staff Associate, Laboratory Manager
Graduate Student in Biomedical Engineering
Dr. Aaron Kyle
Lauren Grosberg
Lecturer
Graduate Student in Biomedical Engineering
Cost-Effectiveness
We expect each device to be used approximately 5 times per week
(5 times/week) x (52 weeks/year) x 2 years = 520 device usages
$2100 per unit/520 usages = $4.04/usage
$4 + $40 (disposable components) = $44, the total cost per usage of Dila-Pro
Comparable to the cost of current dilators
Business Model
Phase
11
Phase
Develop a final
marketable
version of DilaPro
Phase 2
Phase 3
Phase 4
In Vivo
Testing of
Dila-Pro
Launch Dila-Pro
Improve and
update
Dila-Pro
FDA
Approval
Application
Market to
physicians
Establish
relationships
with clinics and
hospitals
Maintain
strong
relationship
with
customers
Manufacturing Cost
8-Year Projected Balance (units in thousands)
2010
2011
2012
Investment
2013
2014
2015
2016
2017
1
500
0
0
0
0
0
0
-0.95
-195
-10
-10
-10
-245
-245
-10
0
-5
0
0
0
-5
-5
0
Legal Fees
0
-10
-50
-50
-50
-50
-50
-50
Salary ($100,000 ea)
0
-400
-400
-400
-800
-1,000
-1,000
-1,000
Advertising
0
0
-10
-100
-100
-100
-500
-500
Unit Production ($200 ea)
0
0
-10
-20
-40
-60
-90
-110
Unit Distribution ($2000
ea)
Balloon Production ($10
ea)
Balloon Distribution ($30
ea)
Trade-In ($500 ea)
0
0
100
200
300
400
500
500
0
0
-130
-390
-780
-1,300
-1,950
-2,600
0
0
390
1,170
2,340
3,900
5,850
7,800
0
0
0
0
25
50
100
150
Recycled parts ($50 ea)
0
0
0
0
2.5
5
10
15
Yearly Profit
0.05
-110
-107
439
966
1,726
2,817
4,457
Net Worth
0.05
-110
-217
223
1,189
2,915
5,732
10,189
Research
and
Development
Custom Balloon
Company Objectives
Our Advantages
Mission
Nothe
major
competition
To• be
pioneers
of the next-generation of cervical
dilation
technology
• Among
the first to address this problem
• Access to first-rate equipment
Our• Vision
Mentorship of expert advisors
To design an innovative and cost-effective cervical
dilator that uses advanced, smart technology with an
emphasis on patient needs
Market
$200 million
cervical dilation
market per year
25%: ~$50 million
cervical dilators
Dilation Features
Current Products
Cervix Dilation
Cost Effective
One Insertion Application
Applicability to All Procedures
Comfortable and Tailored Dilation
Preservation of Cervical Integrity
Our Product
Dila-Pro
The World’s First Smart Cervical Dilator
portable and
discreet
safe and
efficient
patient tailored
Future Plans
Prototype Design and Testing:
1) Finalize design and
calibration
2) Bovine cervical
phantom testing
3) Combine measured
pressure and dilation to
create dynamic
biofeedback
4) Maximize portability by integrating air pump and
monitoring device
Manufacturing Cost
Disposable Parts
Balloon
Other (tubing, air rod, sensors)
Selling For
Profit
Dollars ($)
-18
-2
40
20
Non-disposable Parts
Programmable Chip
Air Pump
Other (pressure sensor, wiring, casing)
Selling For
Profit
Dollars ($)
-20
-60
-20
2100
2000
Profit Per Year Per Unit = $7,200
Financial Outlook
$2,100
$40
• ‘Trade-In’ for $500
• Devote funds to R&D and advertising
• ~50% of the market and second product release by 2017
Technical Feasibility
• Short Term
– Design and Calibration
• Balloon Integrity – determine burst pressure
• Accurate measurement of pressure and dilation – repeated
calibration schemes
• Dynamic dilation – response to pressure and diameter
thresholds
– Cervical Phantom Design and Testing
• Phantom simulates physiologic conditions
– Quantitatively comparable pressure
– Viscoelasticity
• Balloon functions safely under pseudophysiologic conditions
– Moisture, temperature
• Long term
– Animal Model Testing
– Human Clinical Trials
Regulatory Approval
• Classification: Part 884 Subpart E – Obstetrical and
Gynecological Surgical Devices
• Device Class: Class III
• Previous synthetic and expandable cervical dilators have been labeled
class III
• Novelty of the device lends itself to a class III classification
• Requirements for FDA Approval: Premarket Approval (PMA)
•
A scientific, regulatory document that demonstrates the safety and
effectiveness of the class III device
• Nonclinical Laboratory Studies - Device properties, phantom tests, animal
models
• Clinical Investigations - Safety, efficacy, and all other data obtained from
human clinical trials
• Due to the nature of our device (low risk and unlikely to pose unreasonable
risk of illness or injury), we do not foresee any major obstacles to obtaining
FDA approval for Dila-Pro
Algorithm Details
• Programming
–
–
–
–
–
–
Input: desired dilation diameter
Baseline dilation rate: 5 mm/hr = 1 cm/2 hr
Actively calculate: diameter and pressure
If external pressure > threshold, slow down dilation
If external pressure < threshold, speed up dilation
If calculated diameter = desired diameter, hold
dilation, signal completion
– Display: % completion or approximate amount of time
remaining
• Arduino Computing System
– Small, centralized system