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“Consistent, continuous point pressure. Saving time. Maintaining dignity.

Rebecca Foreman

Rebecca Foreman

Rebecca Foreman

Rebecca Foreman

Damage Means More Surgery

Rebecca Foreman

Rebecca Foreman

Precious Time

Rebecca Foreman

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Rebecca Foreman

Agenda
• Dialysis & Product Overview • Needs & Benefits Foreman • Our Solution • Biomedical Considerations Flothmeier • Manufacturing • Sales & Marketing • Financials & Wrap-Up Nick Kastango Rebecca Bill Yeung Jennika Nick Kastango Sid Jain Bill Bronander

Rebecca Foreman

Dialysis & Product Overview

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Nick Kastango

Dialysis Process

Nick Kastango

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Plunger (to apply pressure)

Adhesive wings (to attach device to body)

Base (sits against body)
Nick Kastango

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

• Consistent continuous pressure at a single point • Custom levels of pressure • Comfortable • Easy to use • Minimal chance of infection
Nick Kastango

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Needs & Benefits

Rebecca Foreman

Nurses’ Needs

Rebecca Foreman

Consistent & Continuous Pressure

Rebecca Foreman

Point Pressure

Rebecca Foreman

Benefits to Nurses
Better provide quality care to bleeder Frees up nurses’ time to help other patients

Rebecca Foreman

Patient Needs

Rebecca Foreman

Comfortable

Rebecca Foreman

Effective

Rebecca Foreman

Benefits to Patients
Reduces the time patient constrained to chair. Lessons the burden of treatment Maintains patient dignity

Rebecca Foreman

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Our Solution

Bill Yeung

Customer Needs
• Applies pressure at a single point to stop bleeding • Custom pressure • Comfortable for patients • Easy to use • Will not crosscontaminate patients
Bill Yeung

Brainstorming

Bill Yeung

Consistent Continuous Pressure
• Adhesives hold OnPoint in place • Plunger applies pressure at a single point to stop bleeding • Ratchet mechanism applies pressure consistently and continuously

Bill Yeung

Adjustable Pressure & Ease of Use
• Ratchet design allows OnPoint to apply custom levels of continuous consistent pressure • Adjust pressure using only one hand
Bill Yeung

Comfort
• Small base and profile to fit a wide variety of curvatures • Flexible – Made of propylene – Base is more flexible – Plunger is more rigid • Raised base to make room for needle

Bill Yeung

Clean & Safe
Disposable • Device is sterile right out of the package • No risk of improper sterilization • No risk of crosscontamination

Bill Yeung

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Consistent continuous pressure at a single point Custom levels of pressure
– Ratchet

Comfortable
– Small base – Raised base

Easy to Use
– Ratchet design

Minimal chance of infection
– Disposable

Bill Yeung

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Biomedical Considerations

Jennika Flothmeier

Protocol

Jennika Flothmeier

Regulatory Concerns
•Class I Medical Device
•Presents minimal risk for harm to the user. They are not intended for use in supporting or sustaining life. They are of importance in preventing impairment to human life and may not present a potential unreasonable risk of illness or injury

Surgeon’s Glove

Mechanical Wheelchair

Adhesive Bandage

Jennika Flothmeier

Regulatory Concerns
•510(K) Exempt
•“A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device”

Jennika Flothmeier

Regulatory Concerns
• Class I and 510(K) exempt
– No pre-market approval necessary – No additional costs

Jennika Flothmeier

Intellectual Property Concerns

Jennika Flothmeier

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Manufacturing

Nick Kastango

Prototyping
Stereolithography (SLA) to produce part

Nick Kastango

Prototyping
SLA’ed part used to create silicon mold

Nick Kastango

Prototyping
Silicon mold injected with urethane to create prototypes (~25 per mold)

Nick Kastango

Prototyping Costs
Item Unit Cost Quantity Item Cost 25 25 600 600 $7,500 $6,250 $6,000 $6,000
Nick Kastango $25,750

Base mold $300 Plunger $250 mold Base $10 prototype Plunger $10 prototype

“Turn-Key” Manufacturing
Injection molded

Purchased pre-cut

Injection molded

Nick Kastango

Creation of Molds
• For plunger and base • Machining of two 4-cavity steel molds • Life of mold = up to 500,000 parts • Cost for set of molds = $25,000

Nick Kastango

Injection Molding
• Injection of propylene into mold • Large production runs • Material and labor costs of $0.12 and $0.10

Nick Kastango

Adhesive Wings
• Custom cut • Hypoallergenic, medical-grade adhesive • Tabs for one-handed opening • $0.15 per set

Assembly and Packaging
• Assembly of base, plunger, adhesive wings • Each device sealed in individual blister pack

• 12 devices per box (with literature) • $0.30 for materials and $0.35 for labor
Nick Kastango

Sterilization
• Sterilization using gamma radiation • $0.25/unit

Nick Kastango

Bill of Materials
Item Material for plunger Adhesive wings Blister pack Unit Cost $0.10 $0.15 $0.20 Material for base $0.12

Included literature$0.05 Outside packaging $0.05 $0.67/unit for materials
Nick Kastango

Manufacturing Costs
Variable Costs Device assembly Blister pack sealing Box assembly/inspection Sterilization $0.20 $0.05 $0.10 $0.25 $0.60/unit for manufacturing

Total cost per unit = $1.27
Nick Kastango

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Sales & Marketing

Sid Jain

MPC 250 Clamp

Sid Jain

Hemoband

Sid Jain

Manual Pressure
“15 minutes of my life I will never get back”

Sid Jain

Market Share
Clam 33% p: Hem oband: 0% Other: 4%

Manual (Nurse) 33.33%

Manual (Patient) 29.67%

Sid Jain

Market Size

Source: USRDS

Sid Jain

Market of Entry
375,000 dialysis patients at 5,000 clinics 37,500 patients at 500 early adopter clinics 2% of patients are bleeders They receive dialysis three times a week on two access sites For 52 weeks a year

Sid Jain

Selling price
• 15 minutes of Nurse’s time at $20.85/hr
– $5.22 per access site

• Packs of 12
– One week’s supply for the average clinic – $60 per box

Sid Jain

Market Strategy

Sid Jain

Free Samples
• 50 targeted clinics with 1 box each • Focus on small chains & independents • Include survey & ordering information

Sid Jain

Telemarketing
• • • • Call targeted clinics in the US Direct contact with the customer Rapid response Cost: $80,000 per year

Sid Jain

Conferences
• Meet and advertise to patients, nurses, and industry professionals • Cost: $5,000 each 1. 2. : March 8-10, 2009 :October 9-11, 2009

Sid Jain

Catalogs
Reach 3,000 clinics: • Fresenius Medical Care • DaVita / Gambro

Sid Jain

Selling

Sid Jain

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Clinical Trials & Journals

Jennika Flothmeier

Clinical Trials

Jennika Flothmeier

Clinical Trials
•Purpose is to show our product is: •Safe •Effective •A significant improvement to current products available

Jennika Flothmeier

Journals

Jennika Flothmeier

“Consistent, continuous point pressure. Saving time. Maintaining dignity.”

Financials

Bill Bronander

First Year Investment
Development (Q1) Prototyping Marketing & Support Ramp-Up (Q2-Q4) Set of 4-Cavity Molds First Year Production Patent Clinical Trials Journal Advertisements Telemarketing Total Investment Required $26,000 $26,000 $25,000 $213,000 $45,000 $75,000 $30,000 $60,000 $500,000
Bill Bronander

First Year Financial Summary
• Sales Volume
– 500 early adopter clinics using one box/week – Per quarter increases:
• 5% increase in clinics reached • 5% of clinics reached use 2 boxes/week
Year 1 Production Costs OnPoint Volume (Units) Sales Revenue $(213,000) 78,000 $390,000

Bill Bronander

Financials
• Main Expenses
– – – –

• Revenues

Molds – Box of 12 devices Production (sold for $60 per Clinical Trials & Journal Ads box) Selling, General & Administrative

Return on Investment = 581%

Bill Bronander

Cash Flows

• NPV = $2,054,959 • Break Even: Quarter 5 & 150,000 units sold
Bill Bronander

“Consistent continuous point pressure, Saving time. Maintaining dignity.”

Acknowledgements
• Professor Pat Costa • Dan Scansaroli, Jeremy Walsh, Adam Levy • Forge Medical
– Dr. Timothy Clark, Phil Croxford – Peter Gorky, David Gorky

• Fresenius Medical Corporation
– Donna Joaquim, R.N. – Nadine Miller, Sam DeAngelo

• • • •

Phyllis Hageter, R.N. (St. Luke’s Hospital) Ed Graham (ProtoCAM) Ken Raines and Rudy Millicent (B. Braun) Kevin Morrisey (OraSure)
Nick Kastango

“Consistent continuous point pressure, Saving time. Maintaining dignity.”