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TRANSCRIPT
A Temporary Prosthetic for Lower Leg Injuries
Mike Sanders - CEOMark Roberts - CTOSeth Gonzalez - CMO
Inspiration
The Pain: Problem and Current Solutions
Strengths: Low cost: $20-$75 Can traverse various terrains Most common choice: High Awareness
Weaknesses: Movement is slow Uncomfortable to use for long periods Hard to store Requires both hands for use
Current Solutions: Crutches
Strengths: Faster to move long distances Less effort required for use Claim reduced muscle atrophy
Weaknesses: Extremely bulky Hard to store and transport Can't traverse the stairs or tight spaces Requires both hands for use Expensive: $150-$850
Current Solutions: Knee Scooter
The Pain:
• World wide cost of sports injuries: $1 Billion• 79% of these occur in lower extremities
• Over 5 Million total lower leg (below knee) injuries annually
• 3.4 Million of these visit the emergency room each year
• US ambulatory aid market: $220 Million
Monetizable?
1. Those with temporary lower leg injuries want a hands-free mobility device
2. We can inexpensively repurpose prosthetic devices and apply it to a new market
3. There are no acceptable hands-free devices currently on the market
The Pain: Hypothesis
Business Model Canvas
Hands-free mobility
Superior recovery mobility experience
How? Prosthetic tech to the temp-injured Deliver inexpensively to both insured and uninsured patients through device sale and rental
Consumer/User
Orthopedic doctorsPodiatrists- Recommendat
ion- prescriptions
Online/web presenceMedical Supply StoresDoctor offices:- Orthopedic- Podiatrist- HospitalMedical Supply RentalAthletic Departments
Customer/UsersPatients with lower-leg injuries (5m)
Insurred/Uninsurred
Patients under 50
Retail/RentalMedical Supply Stores
Doctor’s offices- Orthopedic- Podiatrist
Online distributors
Prefer to pay through insurance
Fixed pricing on device
Weekly rental rate
For both rental and sale customers currently pay for DME out of pocket, through insurance or both
Device manufacturer
Doctor/professional
Prosthetic manuf.- Technology- Relationshi
psMotivations:Product diversity
Superior mobility solution
Patient satisfaction
Revenue share
Doctor/Supplier relationship
Warranties
Patient/consumer marketing
Patent
FDA approval
Insurance registration (HCPCS)
R&D
Consumer testing
Value proposition:
High initial FC
Develop economies for lower material VC
Cust. Acquisition
Rent, utilities, salaries
Product delivery
Device registration costs (FDA, etc)
Concept Validation
Surveyed 50+ respondents
Results:Concept
MVP• More stability
needed• Better traction• Aesthetics/shape of
leg• Strapping system
Prototype #3
• Natural Mobility:20-40 degree knee
flexion10-15 degree ankle
flexion• Advanced Leg
PerformanceCompliant membersComposite materials
• Collapsible for Easy Storage
• Greater Stability
MVP
MVP
Feedback:200+ students50+ adults (age: 30-50)
Customer Validation
4th
2th
Top 8
1st
“Why hasn’t anyone thought of this before?”
“I wish I would have had this ____ months/years ago …”
“This is way better than crutches”
“What about FDA approval?”
“Will insurance cover this?”
“What is the actual patient process in device selection?”
“Who will actually pay for it?”
“Did you actually talk to doctors/distributors/insurance
companies?”
“Did you get out of the building?”
Place
Business Model Canvas
Hands-free mobility
Superior recovery mobility experience
How? Prosthetic tech to the temp-injured Deliver inexpensively to both insured and uninsured patients through device sale and rental
Consumer/User
Orthopedic doctorsPodiatrists- Recommendat
ion- prescriptions
Online/web presenceMedical Supply StoresDoctor offices:- Orthopedic- Podiatrist- HospitalMedical Supply RentalAthletic Departments
Customer/UsersPatients with lower-leg injuries (5m)
Insurred/Uninsurred
Patients under 50
Retail/RentalMedical Supply Stores
Doctor’s offices- Orthopedic- Podiatrist
Online distributors
Prefer to pay through insurance
Fixed pricing on device
Weekly rental rate
For both rental and sale customers currently pay for DME out of pocket, through insurance or both
Device manufacturer
Doctor/professional
Prosthetic manuf.- Technology- Relationshi
psMotivations:Product diversity
Superior mobility solution
Patient satisfaction
Revenue share
Doctor/Supplier relationship
Warranties
Patient/consumer marketing
Patent
FDA approval
Insurance registration (HCPCS)
R&D
Consumer testing
Value proposition:
High initial FC
Develop economies for lower material VC
Cust. Acquisition
Rent, utilities, salaries
Product delivery
Device registration costs (FDA, etc)
Customer Validation
MVP
MaterialsGreat flexion in lower appendageProtect against hyperextensionBig toe is important in balance
DesignLonger leg restPadding materials (Osgood-Schlatter’s)
Overall“[We] like this concept! [We] would recommend it“
“People are looking for other alternatives to crutches”
“You look like you have done your homework”
“You need to show this to Dr. Faux”
Customer Validation
MVP
“This is a great idea … I would recommend it, definitely worth looking at”
“Shoulders aren’t designed to be weight bearing joints, knee scooters have been nice for this reason”
“An especially good for patients and for a person with a leg injury combined with an upper extremity injury”
“Cool idea, I like the idea… that’s clever”
“Protect and pad the peroneal nerve so you don’t end up with drop-foot”
“You ought to show this to Dr. Faux and Lance our bracing specialist”
Customer Validation
3 Physical Therapists
MVP
3 Orthopedic Surgeons
2 Orthopedic Technicians - Bracing & Cast Specialists
2 Podiatrists
Like it/Recomm
end
Cost Prescribe Distribute
N/A
N/A
* With insurance
Channel Validation
MVP
Mark McGuire – International Orthopedic Care“Great idea, I have never seen anything like it, that’s probably because you started with prosthetics”
“More and more people are trying to avoid crutches”
AHM Agent“For insurance, the patient needs an HCPCS Code”
Trends: Ordering 0nline Scooter
rental
HCPCS CODE is E0118 Crutch substitute, lower leg platform, with or without wheels
Business Model Canvas
Pricing Strategy Validation
Crutches: Average: $50Knee Scooters: Average: $400
Sale Price: $200
Insurance: 70%
Cost to the patient: $60
HCPCS CODE is E0118 Crutch substitute, lower leg platform, with or without wheels
Crutches: Average: $5*Knee Scooters: Average: $35
Rental Price: $30
*Insurance: 70%
BOM MTL CostKnee Pad (Dense) 1.50$ Knee Pad (Soft) 1.50$ V. Leg (Plastic) 4.50$ Velc Straps (3) 1.50$ H. Leg (Plastic) 4.50$ V. Stab Arm (2) 2.00$ Curv Stab Arm (2) 3.50$ Support (horiz) Bar 2.50$ Bracket (Main) 3.00$ Adjust BTM Arm Center 2.50$ Adjust BTM Arm Outer (4pcs) 4.00$ Viberglass Foot Pcs 9.00$ Heel Pad (Soft) 1.00$ Heel Pad (Rubber) 1.00$ Heel Pad (Traction) 1.00$ Toe Pad (Soft) 1.00$ Toe Pad (Rubber) 1.00$ Toe Pad (Traction) 1.00$ TOTAL 46.00$
Sales EstimatesEmergency Room Visits per year 3.40 MillionNon-emergency Room Visits (Est.) 1.70 MillionTotal Below Knee Injuries/year 5.10 MillionCovered by Insurance 74%Insured injured customers 3.77 Million% Will require mobility devices 10%Potential Customers 0.38 MillionSales Price $200 per unitRevenue from Sales $75.5 Million
Market Opportunity: Device Sales
Sales EstimatesEmergency Room Visits per year 3.40 MillionNon-emergency Room Visits (Est.) 1.70 MillionTotal Below Knee Injuries/year 5.10 MillionCovered by Insurance 74%Insured injured customers 3.77 Million% Will require mobility devices 10%Potential Customers 0.38 MillionSales Price $200 per unitRevenue from Sales $75.5 Million
Market Opportunity: Device Rental
Rental EstimatesEmergency Room Visits per year 3.40 MillionNon-emergency Room Visits (Est.) 1.70 MillionTotal Below Knee Injuries/year 5.10 MillionCovered by Insurance 26%Uninsured injured customers 1.33 Million% Will require mobility devices 10%Potential Customers 0.13 MillionAverage rental weeks per customer 3 weeksTotal rental weeks per year 0.40 Million weeksRental Price $30 per weekRevenue from Sales $4.0 Million
Rental EstimatesEmergency Room Visits per year 3.40 MillionNon-emergency Room Visits (Est.) 1.70 MillionTotal Below Knee Injuries/year 5.10 MillionUninsured patients 26%Uninsured injured customers 1.33 Million% Will require mobility devices 10%Potential Customers 0.13 MillionAverage rental weeks per customer 3 weeksTotal rental weeks per year 0.40 Million weeksRental Price $30 per weekRevenue from Sales $12.0 Million
Business Model Canvas
Hands-free mobility
Superior recovery mobility experience
How? Prosthetic tech to the temp-injured Deliver inexpensively to both insured and uninsured patients through device sale and rental
Consumer/User
Orthopedic doctorsPodiatrists- Recommendat
ion- prescriptions
Online/web presenceMedical Supply StoresDoctor offices:- Orthopedic- Podiatrist- HospitalMedical Supply RentalAthletic Departments
Customer/UsersPatients with lower-leg injuries (5m)
Insurred/Uninsurred
Patients under 50
Retail/RentalMedical Supply Stores
Doctor’s offices- Orthopedic- Podiatrist
Online distributors
Prefer to pay through insurance
Fixed pricing on device
Weekly rental rate
For both rental and sale customers currently pay for DME out of pocket, through insurance or both
Device manufacturer
Doctor/professional
Prosthetic manuf.- Technology- Relationshi
psMotivations:Product diversity
Superior mobility solution
Patient satisfaction
Revenue share
Doctor/Supplier relationship
Warranties
Patient/consumer marketing
Patent
FDA approval
Insurance registration (HCPCS)
R&D
Consumer testing
Value proposition:
High initial FC
Develop economies for lower material VC
Cust. Acquisition
Rent, utilities, salaries
Product delivery
Device registration costs (FDA, etc)
FlexLeg is a:• Class I Medical Devise • "Substantially Equivalent" to a Crutch
Therefore, FlexLeg is: • Exempt from Premarket Approval application process (PMA)• Investigational Device Exemption process not required (IDE)
Meaning: Register with the FDA and we can go to market!
Key Resources Validation
Durable Medical Equipment• Insurance covers 50%-80% for the patient• Register as a supplier to receive HCPCS Code (E0118)• Doctor writes a prescription: patient may purchase at
medical supply store, online or pharmacy
FDA Agent: Geeta PamidimukkalaFDA/CDRH/Office of Device Evaluation• Disclosed our device to understand parallel review
What we found out: • FlexLeg classifies as an orthosis, limb brace• Therefore exempt from: 510k, PMA and IDE
Business Model Canvas
Business Model Canvas
Hands-free mobility
Superior recovery mobility experience
How? Prosthetic tech to the temp-injured Deliver inexpensively to both insured and uninsured patients through device sale and rental
Consumer/User
Orthopedic doctorsPodiatrists- Recommendat
ion- prescriptions
Online/web presenceMedical Supply StoresDoctor offices:- Orthopedic- Podiatrist- HospitalMedical Supply RentalAthletic Departments
Customer/UsersPatients with lower-leg injuries (5m)
Insurred/Uninsurred
Patients under 50
Retail/RentalMedical Supply Stores
Doctor’s offices- Orthopedic- Podiatrist
Online distributors
Prefer to pay through insurance
Fixed pricing on device
Weekly rental rate
For both rental and sale customers currently pay for DME out of pocket, through insurance or both
Device manufacturer
Doctor/professional
Prosthetic manuf.- Technology- Relationshi
psMotivations:Product diversity
Superior mobility solution
Patient satisfaction
Revenue share
Doctor/Supplier relationship
Warranties
Patient/consumer marketing
Patent
FDA approval
Insurance registration (HCPCS)
R&D
Consumer testing
Value proposition:
High initial FC
Develop economies for lower material VC
Cust. Acquisition
Rent, utilities, salaries
Product delivery
Device registration costs (FDA, etc)
1. The end user is not the only customer2. “Get out of the building” both fun and NECESSARY3. Validate, validate, validate
Next Steps
What we learned
1. Keep getting out of the building!• Contact and understand online medical supply retailers• Talk with Dr. Faux and more professionals
2. Meet with manufacturers: ACT & Otto Bock3. Finish product website: FlexLeg.com4. Obtain various registrations (FDA, HCPCS, etc)
FlexLeg makes your daily life with a lower leg injury more
like your daily life without one.
Similar product to Prototype #2, yet it still has limitations that are remedied by the features and abilities of FlexLeg:
Sales Price of iWalk-Free: $400
Competing Product:
• Natural Mobility:20-40 degree knee
flexion10-15 degree ankle
flexion• Advanced Leg
PerformanceCompliant membersComposite materials
• Collapsible for Easy Storage
• Greater Stability