Offloading Device for the Reduction of Foot Complications in Diabetic Patients Michael Osborne Michael Osborne Rod Aliabadi Rod Aliabadi Patrick Gonzales Patrick Gonzales Colin Smith Colin Smith

Diabetes and the Effects Affects 20.8 million Americans Affects 20.8 million Americans Insufficient insulin production or action Insufficient insulin production or action Neuropathy Neuropathy Foot deformation Foot deformation Poor circulation Poor circulation Decreased healing Decreased healing

Device Specifications Affordable Affordable As or more effective than current products As or more effective than current products Made of resilient, supportive, malleable, and soft materials Made of resilient, supportive, malleable, and soft materials Can be adjusted for changes Can be adjusted for changes More attractive versatile than current products More attractive versatile than current products Light weight Light weight

Our Current Plan Insert for any deep, loose shoe Insert for any deep, loose shoe Perforated layers for customization and offloading- eliminate labor cost Perforated layers for customization and offloading- eliminate labor cost Surrounds and conforms to foot to offload-different foams Surrounds and conforms to foot to offload-different foams Rigid toe box, sole and heel protection Rigid toe box, sole and heel protection Slide with foot and provide vertical force support Slide with foot and provide vertical force support Low cost by eliminating labor Low cost by eliminating labor Booklet to advise patients and clinicians on advisable changes for a given morphology Booklet to advise patients and clinicians on advisable changes for a given morphology

“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 Market? $27, million people in the US 6% incidence = $34,927,776,000

How Does Medicare Fit into the Picture? Two options –O–O–O–One pair of depth-inlay shoes and three pairs of inserts –O–O–O–One pair of custom molded shoes with inserts If… –D–D–D–Diabetes, amputation, past ulceration, calluses, neuropathy, poor circulation…

So what’s the Problem? Industry + Medicare can not adequately meet the patients medical or financial needs.

Healing/Offloading Boots Current designs utilizes removable units to eliminate weight on current ulcers Current designs utilizes removable units to eliminate weight on current ulcers

Orthopedic Preventive Footwear Orthopedic footwear attempts to distribute weight to prevent foot ulcers Orthopedic footwear attempts to distribute weight to prevent foot ulcers

Our Design Previous offloading devices Customized orthotic footwear Customizable Orthopedic Insert for Offloading

Expert Advice/Correspondence Advisors Paul King, Ph.D.Professional Engineer Paul King, Ph.D.Professional Engineer Naji Abumrad, M.D.General Surgeon Naji Abumrad, M.D.General Surgeon Robert Schwartz, M.D.Vascular Surgeon Robert Schwartz, M.D.Vascular Surgeon Horace Watson, M.D.Orthopedic Surgeon Horace Watson, M.D.Orthopedic Surgeon Future Advisors Jared CobbFormer CIO of Sole Supports Jared CobbFormer CIO of Sole Supports Kong Y. Chen, Ph.D.Diabetes Research Kong Y. Chen, Ph.D.Diabetes Research Mike MonziNopco specializes in orthopedic shoes Mike MonziNopco specializes in orthopedic shoes Monet CalanNashville Orthotics and Prosthetics Monet CalanNashville Orthotics and Prosthetics Customers/PatientsQFD Customers/PatientsQFD

Future Goals and Budget Next Steps: Further Patent Research Further Patent Research Innovation Workbench Innovation Workbench Materials Research Materials ResearchTimeline: Present-DecemberResearch/Preliminary Design Present-DecemberResearch/Preliminary Design JanuaryDetailed Design(Safety/Drawings) JanuaryDetailed Design(Safety/Drawings) February-MarchPrototype Construction February-MarchPrototype Construction AprilTesting/Analysis AprilTesting/AnalysisBudget: $2000? $2000? –Materials, Pressure Distribution Testing (Labview), Existing Devices, Prototype Manufacturing, and Basic Machining Tools