Offloading Device for the Offloading Device for the Reduction of Foot Reduction of Foot Complications in Diabetic Complications in Diabetic PatientsPatients

Michael OsborneMichael Osborne Rod AliabadiRod Aliabadi Patrick GonzalesPatrick Gonzales Colin SmithColin Smith

Diabetes and the Diabetes and the EffectsEffects Affects 20.8 Affects 20.8

million Americansmillion Americans Insufficient insulin Insufficient insulin

production or production or actionaction

NeuropathyNeuropathy Foot deformationFoot deformation Poor circulationPoor circulation Decreased healingDecreased healing

Device SpecificationsDevice Specifications

AffordableAffordable As or more effective As or more effective

than current productsthan current products Made of resilient, Made of resilient,

supportive, supportive, malleable, and soft malleable, and soft materialsmaterials

Can be adjusted for Can be adjusted for changeschanges

More attractive More attractive versatile than current versatile than current productsproducts

Light weightLight weight

Our Current PlanOur Current Plan

Insert for any deep, loose Insert for any deep, loose shoeshoe

Perforated layers for Perforated layers for customization and customization and offloading-eliminate labor offloading-eliminate labor costcost

Surrounds and conforms to Surrounds and conforms to foot to offload-different foot to offload-different foamsfoams

Rigid toe box, sole and heel Rigid toe box, sole and heel protectionprotection

Slide with foot and provide Slide with foot and provide vertical force supportvertical force support

Low cost by eliminating laborLow cost by eliminating labor Booklet to advise patients Booklet to advise patients

and clinicians on advisable and clinicians on advisable changes for a given changes for a given morphologymorphology

“Within the rapidly growing diabetes market, companies will find it extremely challenging to protect their market share because of intensifying competition, no longer can a manufacturer concentrate on just one segment and lead the market. Apart from having an ambitious product line strategy, manufacturers need to enter into other diabetes segments in order to not only protect but also grow their market share.”

-Ajit Baid (2003)

CEO, F&S industry analysis

Is There a Legit Is There a Legit Market?Market? $27,987 $27,987 20.8 million people in the US20.8 million people in the US 6% incidence6% incidence

= $34,927,776,000= $34,927,776,000

How Does Medicare Fit How Does Medicare Fit into the Picture?into the Picture? Two optionsTwo options

– One pair of depth-inlay shoes and One pair of depth-inlay shoes and three pairs of insertsthree pairs of inserts

– One pair of custom molded shoes One pair of custom molded shoes with insertswith inserts

If…If…– Diabetes, amputation, past Diabetes, amputation, past

ulceration, calluses, neuropathy, ulceration, calluses, neuropathy, poor circulation… poor circulation…

So what’s the So what’s the Problem?Problem?

Industry + Medicare can not adequately meet the patients medical or financial needs.

Healing/Offloading Healing/Offloading BootsBoots

Current designs Current designs utilizes removable utilizes removable units to eliminate units to eliminate weight on current weight on current ulcersulcers

Orthopedic Preventive Orthopedic Preventive FootwearFootwear

Orthopedic Orthopedic footwear attempts footwear attempts to distribute to distribute weight to prevent weight to prevent foot ulcersfoot ulcers

Our DesignOur DesignPrevious offloading devices

Customized orthotic footwear

Customizable Orthopedic Insert for Offloading

Expert Advice/CorrespondenceExpert Advice/Correspondence

AdvisorsAdvisors Paul King, Ph.D.Paul King, Ph.D. Professional EngineerProfessional Engineer Naji Abumrad, M.D.Naji Abumrad, M.D. General SurgeonGeneral Surgeon Robert Schwartz, M.D.Robert Schwartz, M.D. Vascular SurgeonVascular Surgeon Horace Watson, M.D.Horace Watson, M.D. Orthopedic SurgeonOrthopedic Surgeon

Future AdvisorsFuture Advisors Jared CobbJared Cobb Former CIO of Sole SupportsFormer CIO of Sole Supports Kong Y. Chen, Ph.D.Kong Y. Chen, Ph.D. Diabetes ResearchDiabetes Research Mike MonziMike Monzi Nopco specializes in orthopedic shoesNopco specializes in orthopedic shoes Monet CalanMonet Calan Nashville Orthotics and ProstheticsNashville Orthotics and Prosthetics Customers/PatientsCustomers/Patients QFD QFD

Future Goals and BudgetFuture Goals and Budget

Next Steps:Next Steps: Further Patent ResearchFurther Patent Research Innovation WorkbenchInnovation Workbench Materials ResearchMaterials Research

Timeline:Timeline: Present-DecemberPresent-December Research/Preliminary DesignResearch/Preliminary Design JanuaryJanuary Detailed Design(Safety/Drawings)Detailed Design(Safety/Drawings) February-MarchFebruary-March Prototype ConstructionPrototype Construction AprilApril Testing/AnalysisTesting/Analysis

Budget:Budget: $2000?$2000?

– Materials, Pressure Distribution Testing (Labview), Existing Devices, Materials, Pressure Distribution Testing (Labview), Existing Devices, Prototype Manufacturing, and Basic Machining ToolsPrototype Manufacturing, and Basic Machining Tools